Avandia, a drug produced by GlaxoSmithKline (GSK) and used to control Diabetes, was the subject of a Senate report released Saturday.
Among the report's finding was that "The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public."
The report concluded that "GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner."
The report concluded that GSK failed to do so: "GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug
ACTOS (pioglitazone) might reduce cardiovascular risk."
According to the Associated Press, the FDA had "ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive."
The Senate Report asks the FDA "why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007."
The FDA has issued a statement that review of Avandia is "ongoing," but has offered the following advice for patients who take rosiglitazone (Avandia):
- Don't stop taking your medication without talking with your health care professional.
- Discuss any questions or concerns you have about rosiglitazone with your health care professional.
- Read the Medication Guide that comes with each rosiglitazone prescription to better understand the risks and benefits of your medication.
- Report any side effects with rosiglitazone to FDA's MedWatch program either online, by regular mail, by fax, or by phone.
The FDA urges caution when searching for H1N1 products on the internet because many unapproved H1N1 products purport to prevent, diagnose, or treat H1N1.
The FDA warns consumers of the potential danger of these products and cautions consumers that they should use only FDA approved products from licensed pharmacies. The potential dangers of using unapproved FDA products include an "increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs."
Currently, Tamiflu and Relenza are the only two FDA-approved antiviral drugs to treat H1N1.
With unapproved products, you can't be sure what you're getting. For example, the FDA, in monitoring the web for unapproved products, ordered a shipment of what was purported online to be Tamiflu. The FDA received an an unmarked envelope postmarked from India. The envelope contained "unlabeled, white tablets taped between two pieces of paper." The tablets were analyzed, and it was determined that they contained talc and acetaminophen (fever reducer and pain reliever). The tablets did not contain oseltamivir, the active ingredient of Tamiflu.
Among the products that the FDA has targeted:
- a shampoo said to protect against the H1N1 flu virus
- a dietary supplement said to protect infants and young children from contracting the virus
- a "new" supplement said to cure H1N1 flu infection within four to eight hours
- a spray that claims to leave a layer of ionic silver on one's hands that kills the flu virus
- several diagnostic tests that have not been approved to detect the H1N1 flu virus
- an electronic instrument whose sellers claim uses "photobiotic energy" and "deeply penetrating mega-frequency life-force energy waves" to strengthen the immune system and prevent symptoms associated with H1N1 viral infection
For more info from the FDA, click here
The Las Vegas Sun reports that 2 cases of E. coli have been reported in Clark County, Nevada.
This comes days after the FDA issued a warning regarding Nestle Tollhouse raw cookie dough products due to the risk of E. coli. The warning cautions those who have purchased prepackaged cookie dough products to throw them away. Consumers should not even cook the dough, as the FDA warns that the bacteria may still get on consumers' hands and on cooking surfaces.
As of June 19, 2009, all of Nestle's prepackaged, refridgerated cookie dough products have been recalled. The products can be returned for a full refund. No other Nestle products have been affected.
Since August 2008, about 550 people have gotten sick and eight people have died from the salmonella outbreak. Thousands of peanut butter products have been recalled. The law firm that filed the first lawsuit over the recent salmonella outbreak in certain brands of peanut butter products has added the Kellogg Co. as a defendant.
The suit was filed last month on behalf of a Vermont couple, Gabrielle and Daryl Meunier, whose 7-year-old son became sick after eating peanut butter cracker sandwiches made by Kellogg from products of the Peanut Corp. of America, whose Georgia plant has been identified as the source of the contamination that led to the outbreak. Meunier v. Peanut Corp. of America, No. 1:09-cv-00012 (M.D. Ga.).
Marler Clark, the plaintiffs' firm, added punitive damages to the case in recent weeks after the U.S. Food and Drug Administration concluded that the Peanut Corp. of America knowingly released a product that could have been contaminated.
Bill Marler, a partner at Seattle's Marler Clark, said that Kellogg was added as a defendant because the company manufactured the peanut butter cracker sandwiches and conducted at least two of its own inspections, through a third party, of the Peanut Corp. of America's Georgia plant in 2008. Kellogg spokesperson Kris Charles said the company does not comment on litigation. Peanut Corp. of America has denied wrongdoing.
For the full article, please click here.
A USA Today editorial opined that the Wyeth v. Levine decision opened a new door for plaintiff's rights. During the Bush administration manufacturers were able to avoid lawsuits for defective products as long as the product met federal regulations. The Wyeth decision, however, opens the door for plaintiffs to sue manufacturers despite compliance with federal standards. The editorial argues that the courts will have to strike a balance to protect the interests of both consumers and companies. "States should allow suits but set a high burden of proof on the plaintiffs."
Bert Rein's article in USA Today sets forth an opposing view. He argues that the decision actually creates uncertainty for patients and doctors. He emphasizes that the FDA was created because decisions regarding the risks and benefits of prescription drugs and medical devices should be left up to the experts. Allowing a jury to make these decisions based on an isolated catastrophic event places the interests of one individual over the health interests of the public as a whole.
The Supreme Court's March 4th decision in Wyeth v. Levine could mean increased responsibility for drug companies to adequately warn clinicians and consumers of a drug's risks. Affirming a jury verdict in favor of a plaintiff injured as a result of inadequate drug label warnings, the Supreme Court held that the drug label's warnings were inadequate, rejecting the argument that FDA approval of a label is sufficient to shield a drug manufacturer from state law liability.
The plaintiff, Diana Levine, received the drug Phenergan, an antinausea drug manufactured by Wyeth, by the "IV-push" method (as opposed to the safer "IV-drip" method). The drug was injected directly into her vein, after which it escaped into her artery, caused irreversable gangrene, and resulted in the amputation of her forearm.
Levine brought suit alleging that Wyeth had failed to provide adequate warnings on its label of the risks associated with administering Phenergan by the IV-push method. The jury found in favor of Levine, determining that Levine would not have suffered her injury had Wyeth provided an appropriate warning. Wyeth argued in return that Levine's state law claims were preempted by federal law because Phenergan's labeling had been approved by the FDA. The Supreme Court granted certiorari to determine whether the FDA's approval of drug labels "preempt[s] state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use."
Wyeth argued that it was impossible to comply with the state-law duties underlying Levine's claims and federal labeling requirements at the same time. The Court rejected the argument pointing out that under the FDA's "changes being effected" (CBE) regulation, a drug company may make certain changes to a label upon filing a supplemental application with the FDA but need not wait for FDA approval. "The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan's label does not establish that it would have prohibited such a change."
Wyeth also argued that Levine's tort claims were preempted because they interfered with "Congress's purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives." The Court also rejected this argument, finding that Congress, being well aware of state-law suits, would have enacted a preemption provision if it determined that state law claims were an obstacle to its objectives.
to see full opinion, click here
Congressman John Dingell introduced the Food and Drug Administration's Globalization Act in late January 2009, legislation that if passed would help would help ensure the safety of the nation's food, drugs, medical devices and cosmetics and help restore confidence in the safety of the nation's products, according to the American Association for Justice.
The Act adds registration fees for processing plants to provide increased funding for food safety, increases inspections of manufacturing facilities to every four years, including unannounced inspections, increases penalties for noncompliance and increases food-testing for imported products among other safety provisions. The legislation also gives the Food and Drug Administration increased authority to recall products believed to pose a risk to consumers.
"With the onslaught of reports of contaminated spinach, tomatoes, beef, pet food, and now peanut butter, it is clear increased funding and authority is needed at the FDA like Congressman Dingell's legislation provides," said Bill Marler, a food safety attorney and member of the American Association for Justice's Foodborne Illness Litigation Group.
Find the full AAJ article here.
A safety alert in the February 2007 issue of Consumer Reports says at least two of the 12 infant car seats they investigated -- all of which come with packaging touting federal approval -- should be recalled altogether due to doubts about their safety in a frontal crash. The magazine's crash testers are investigating eight more seats after raising doubts about their ability to withstand a side impact. Asking "What if this were your child?", the magazine's original article reported dummy "infants" violently twisted within their seats, thrown within the carrier from the base of the seat, or flying 30 feet across the laboratory.
Only Two Seats Pass Side Crash Safety Test
In a January 5 interview with National Public Radio, Consumer Reports deputy editorial director Kim Kleman described the problem: The federal National Highway Traffic Safety Administration requires most new passenger vehicles sold in the U.S. to be able to withstand a head-on crash at 30 mph, a head-on crash at 35 mph and a side impact at 38 mph. However, the NHTSA requires that infant car seats be able to withstand only a 30-mph head-on collision. When a team from Consumer Reports tested 12 car seats using the more stringent standards applied to cars, only two seats protected their "infant": the Graco SnugRide with EPS and the Baby Trend Flex-Loc.
Corrections Don't Affect Call For Action
Since its initial testing, Consumer Reports has issued a correction to its side-impact tests, saying a consultation with the NHTSA suggested that the speed of those tests was not accurate. A Jan. 18 press release from the NHTSA said the group's side-impact tests were simulated at 70 mph, twice as fast as they claimed. Until it has results from new tests, the magazine said in a press release, it must withdraw its report. However, the magazine stands by its call for a recall of the Evenflo Discovery seat, saying it did not protect its dummy even during the frontal crash test, and of the Eddie Bauer Comfort seat, which the testers found impossible to install properly. The Discovery has also been the subject of an NHTSA investigation, the magazine noted, after the agency received seven reports of the carrier coming apart in an impact.
"When the car seat does not meet the crash that the car can, that baby is actually the least protected passenger in your vehicle," Kleman told NPR. "We think that this is an outrage. We think that the federal standard absolutely needs to be raised for car seats."
Car seats sold in Europe performed better in the crash tests, Consumer Reports found, noting that European Union safety regulations are stricter than those in the United States and often include a side-impact test.
For more information and the full article, please click here.
This is an update to the earlier blog, Bush Administration Passed Regulstions Allowing Corporate Immunity for Negligence, first published on January 23, 2009.
The Federal Railroad Administration (FRA) and the Pipeline and Hazardous Materials Safety Administration's (PHMSA) last-minute regulation deals a shocking blow to consumers injured by railroads that transport hazardous materials, according to the American Association for Justice (AAJ). The final rule, designed to enhance crashworthiness of rail tank cars for transportation of dangerous materials, includes language that would preempt state tort law claims.
The regulation as finalized would likely prohibit consumers from seeking restitution in the civil justice system when injured by accidents involving railroad transportation of hazardous materials. For example, in 2002 an accident near Minot, North Dakota resulted in an anhydrous ammonia spill, the largest in U.S. history. As a result, local residents suffered from eye injuries, severe chemical burns, asthma and respiratory disorders. With this final rule, the Bush administration has tried to prohibit residents harmed like those in Minot from seeking justice for their injuries.
"It is pathetic the Bush administration would once again try to take away consumers' right to justice with regard to railroad accidents," said AAJ President Les Weisbrod. "With just days left in office, the Administration is protecting corporations instead of looking out for citizens that may be injured, like those in Minot that suffered just because of the location of their home."
In the final rule, PHMSA and FRA dismissed comments filed last year by AAJ and labor unions, saying federal claims can be preempted if the railroad company exceeds the minimum safety requirements. This comes just weeks after preemption language was also included in a railroad regulation establishing security measures for railroads transporting hazardous materials. The regulations are in direct conflict with Congressional intent, which passed legislation which clearly stated that the Federal Railroad Safety Act was never intended to preempt state tort claims and that victims of Minot could receive justice.
For the full article, please click here.
According to a December 22, 2008 ConsumerAffairs.com article, the large retail chain Target has recently started using an in-house recall notification system. Target and the Consumer Product Safety Commission (CPSC) are working together to make it easier for consumers to receive recall notices. Target has utilized its existing gift registry kiosks to supply interested customers with up to date recalled product information. The store has also posted signs informing guests of the new functionality of the kiosks.
Target will continue updating its website, Target.com, with all safety and recall information and will supply links to the CPSC website. In addition, Target will send e-mails to those consumers who purchased any recalled products on Target.com. Consumers can also sign up for e-mail updates on recalls directly from the CPSC.
For more information and the full ConsumerAffairs.com article please click here.
For more information about the CPSC, please click here.
According to the American Association for Justice, in his last few weeks as President, former President Bush began passing regulations in the Federal Register that provided corporates immunity for negligence. These regulations could "weaken consumer safety protections and limit the ability to hold manufacturers repsonsible for defective and harmful products."
"The Bush administration has weakened consumer safety protections and put corporate profits ahead of consumer safety. We have seen it in everything from medical device rules, seatbelt and school bus safety requirements, railroad security, and prescription drug labels," said AAJ President Les Weisbrod.
Throughout all of its regulating, the Bush administration failed to protect consumers with regard to the National Highway Traffic Safety Administration's (NHTSA) standard regarding roof crush resistance. The current standard was established in 1973 and was developed many years before the widespread popularity of SUV's. The NHTSA has delayed its final publication deadline for the newly finalized standard to April 30, 2009.
"This is a golden opportunity for the Obama Administration to show that they intend make consumer safety a priority," added Weisbrod. NHTSA's pending proposal of the roof crush standard only increased the ability of a roof to withstand a force equal to 2.5 times the unloaded vehicle's weight, a standard that would still result in killing or paralyzing most passengers involved in rollover accidents.
"We hope the next administration takes the time to make a strong roof crush standard that would adequately protect consumers and ensure the right to civil justice is protected," added Weisbrod. The pending rule also included preemption language which could have prevented consumers from seeking justice through the state tort system," added Weisbrod.
For more on this story and a comprehensive list of finalized regulations, please click here.
The American Association for Justice, in conjunction with American University's Washington College of Law, recently released two research papers discussing dangerous foreign products, Defective Foreign Products in the United States: Issues and Discussion and The Social Costs of Dangerous Products: An Empirical Investigation.
The first paper asserts that foreign producers "are protected by the complex web of laws, policies, and practices that make it difficult if not impossible to sue successfully foreign manufacturers in domestic courts." Professor Andrew Popper of American University Washington College of Law discusses the inequities of product liability between foreign and domestic manufacturers and proposes several options to level the playing field. Professor Popper concludes, "stripped of the incentive value the tort system provided, it should come as no surprise that domestic consumers have been exposed to tens of millions of defective products produced by foreign suppliers."
The second paper focuses on the costs of injuries and fatalities associated with three known dangerous products: Ford SUV's with Firestone tires, the pharmaceutical drug Baycol manufactured by Bayer, and all terrain vehicles (ATVs). Professors Sidney Shapiro of Wake Forest School of Law, Ruth Ruttenberg of National Labor College, and Paul Leigh of the University of California at Davis, using the above products as a baseline, find nearly $4.7 billion in medical costs, lost wages, and other costs, excluding the cost of pain and sufferingor other extended costs. The paper looks at compsensation awarded in the tort system and compares it with the actuals costs created by hazardous products and ultimately concludes tort awards are less than the actual costs of the dangerous products themselves. It is difficult to measure the actual costs, however "the tort system provides a valuable service for society to the extent it successfully deters the sale of dangerous products."
A copy of Defective Foreign Products in the United States: Issues and Discussion can be found at http://www.justice.org/Unavailable_and_Unaccountable.pdf.
A copy of The Social Costs of Dangerous Products: An Empirical Investigation can be found at http://www.justice.org/he_Social_Costs_of_Dangerous_Products_An_Empirical_Investigation.pdf.
Following up on the American Association for Justice's campaign to get the word out about complete preemption:
Yesterday the U.S. House Committee on Oversight and Government Reform issued a report saying FDA career staff objected to a change in preemption rules, even saying the central factual justifications for the agency's new positions were false. The report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. Prior to this the FDA had asserted through a rule on drug and device labeling that manufacturers should not be held accountable for failing to update their label with additional risks, if the original label was approved by the FDA.
The report cites Dr. John Jenkins, the highest official in FDA's new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false."
Prior to the rule being issued one FDA career official asserted that the rule "is not as it purports to be, consistent with the agency's role in protecting the public health..."
A copy of the report can be found at http://oversight.house.gov/documents/20081029102934.pdf .
From the Associated Press' Kevin Freking:
Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drug makers, congressional investigators said Wednesday.
At issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.
Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.
"Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."
Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.
...
FDA officials said the agency encourages robust debate on public policy, so some dissension can be expected.
...
In the end, the agency determined that finalizing the rules were the appropriate action.
"It was appropriate because FDA is the public health agency charged by Congress with the responsibility to ensure that drugs and certain medical devices are safe and effective and that the labeling adequately informs users of the risks and benefits of the product," Chappelle said. "In addition, the agency is uniquely qualified to make such important and complex judgments."
Public Citizen, the consumer advocacy group, said the Bush administration had pushed pre-emption clauses in a wide array of regulations.
"This effort to prevent injured citizens from using the courts and holding negligent companies' accountable must be stopped," said Brian Wolfman, director of Public Citizen's litigation group.
The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included.
Normally, consumer protection for product liability is provided for by state law. However, documents obtained by the American Association for Justice (AAJ)'s repeated requests pursuant to the Freedom of Information Act revealed a Bush regulatory strategy that has serious implications on consumer protection. The strategy, which the AAJ has termed "Complete Immunity Preemption," provides for federal rules which preempt the rights states possess to protect their citizens with strict safety standards.
The AAJ reported that the documents obtained reveal that protecting corporations escape accountability has been a top priority of the Bush Administration. Since 2005, 7 federal agencies have issued more than sixty proposed or final rules with preambles containing complete immunity language for corporations. Such language has even snuck into the body of the final rules. The preemption language provides corporations with a new legal theory for immunity in product liability cases.
The AAJ wants to get the word out about these far-reaching preambles, and the danger they pose to consumers.
This comes directly from The New York Times. A version of this article ran on August 17, 2008 on page A1 of the New York edition. This was written by Erik Eckholm and Olga Pierce.
You can find the story online with additional references, at methadone story.
Suffering from excruciating spinal deterioration, Robby Garvin, 24, of South Carolina, tried many painkillers before his doctor prescribed methadone in June 2006, just before Mr. Garvin and his friend Joey Sutton set off for a weekend at an amusement park.
On Saturday night Mr. Garvin called his mother to say, "Mama, this is the first time I have been pain free, this medicine just might really help me." The next day, though, he felt bad. As directed, he took two more tablets and then he lay down for a nap. It was after 2 p.m. that Joey said he heard a strange sound that must have been Robby's last breath.
Methadone, once used mainly in addiction treatment centers to replace heroin, is today being given out by family doctors, osteopaths and nurse practitioners for throbbing backs, joint injuries and a host of other severe pains.
A synthetic form of opium, it is cheap and long lasting, a powerful pain reliever that has helped millions. But because it is also abused by thrill seekers and badly prescribed by doctors unfamiliar with its risks, methadone is now the fastest growing cause of narcotic deaths. It is implicated in more than twice as many deaths as heroin, and is rivaling or surpassing the tolls of painkillers like OxyContin and Vicodin.
"This is a wonderful medicine used appropriately, but an unforgiving medicine used inappropriately," said Dr. Howard A. Heit, a pain specialist at Georgetown University. "Many legitimate patients, following the direction of the doctor, have run into trouble with methadone, including death."
Federal regulators acknowledge that they were slow to recognize the dangers of newly widespread methadone prescribing and to confront physician ignorance about the drug. They blame "imperfect" systems for monitoring such problems.
In fact, a dangerously high dosage recommendation remained in the Food and Drug Administration-approved package insert until late 2006. The agency has adjusted the label and is now considering requiring doctors to take special classes on prescribing narcotics.
Between 1999 and 2005, deaths that had methadone listed as a contributor increased nearly fivefold, to 4,462, a number that federal statisticians say is understated since states do not always specify the drugs in overdoses. Florida alone, which keeps detailed data, listed methadone as a cause in 785 deaths in 2007, up from 367 in 2003. In most cases it was mixed with other drugs like sedatives that increased the risks.
The rise of methadone is in part because of a major change in medical attitudes in the 1990s, as doctors accepted that debilitating pain was often undertreated. Insurance plans embraced methadone as a generic, cheaper alternative to other long-lasting painkillers like OxyContin, and many doctors switched to prescribing it because it seemed less controversial and perhaps less prone to abuse than OxyContin.
From 1998 to 2006, the number of methadone prescriptions increased by 700 percent, according to Drug Enforcement Administration figures, flooding parts of the country where it had rarely been seen.
But too few doctors, experts say, understand how slowly methadone is metabolized and how greatly patients differ in their responses. Some prescribe too much too fast, allowing methadone to build to dangerous levels; some fail to warn patients of the potential dangers of mixing methadone with alcohol or sedatives, or do not keep in contact during the perilous initial week on the drug. And some patients do not follow the doctor's orders.
"Those problems were not soon recognized," said Dr. Bob Rappaport, a division director at the Food and Drug Administration. He added: "Methadone is an extremely difficult drug to use, even for specialists. People were using it rather blithely for several years."
Dr. James Finch, an addiction specialist in Durham, N.C., said, "In the clinical and regulatory communities, everyone is trying to run and catch up with and deal with the causes of methadone overdoses."
This year the federal government started sponsoring voluntary classes that teach doctors the elaborate precautions they should take with methadone, like inching upward from low starting doses and screening patients for addictive behavior. (While Robby Garvin's doctor could argue that the dosage he was taking was reasonable -- one to two 10-mg tablets, three times a day -- and he was cleared by his state medical board, many specialists would have started him on a lower dose.)
In what critics call a stunning oversight, the F.D.A-approved package insert for methadone for decades recommended starting doses for pain at up to 80 mg per day. "This could unequivocally cause death in patients who have not recently been using narcotics," said Dr. Robert G. Newman, former president of Beth Israel Medical Center in New York and an expert in addiction.
The F.D.A. says that in the absence of reports of problems by doctors or surveillance systems, "we would have no reason to suspect that the dosing regimen" might need to be adjusted.
In November 2006, after reports of overdoses and deaths among pain patients multiplied and The Charleston Gazette reported on the dangerous package instructions, the F.D.A. cut the recommended starting limit to no more than 30 mg per day. "As soon as we became aware of deaths due to misprescribing for pain patients, we began the process of instituting label changes," Dr. Rappaport said.
Methadone, which is made by Roxane Laboratories Inc. of Columbus, Ohio, and Covidien-Mallinckrodt Pharmaceuticals of Hazelwood, Mo., creates dependency and is sometimes sought by abusers who say they experience a special buzz when mixing it with Xanax.
While the greatest numbers of methadone-related deaths have occurred among the middle-aged, the fastest growth -- an elevenfold jump between 1999 and 2005, to 615 -- occurred among those age 14 to 24, which experts say may be mainly a result of pill abuse.
Pain experts say the country is seeing a reprise of the abuse and tragedies that followed the introduction of OxyContin, a time-release form of oxycodone that was heavily marketed in the late 1990s. It became a factor in hundreds of deaths and a focus of law enforcement.
OxyContin is still widely prescribed, but a survey of Medicare plans in 2008, by the research firm Avalere Health LLC, found that many did not even include OxyContin on the list of reimbursable drugs. Critics like Dr. June Dahl, professor of pharmacology at the University of Wisconsin, fault the insurance companies for favoring methadone simply because of its monetary cost. "I don't think a drug that requires such a level of sophistication to use is what I'd call cheap, because of the risks," Dr. Dahl added.
Yet for the right patients, methadone can be a godsend. Alexandra Sherman, a patient of Dr. Heit's at his Fairfax, Va., clinic, suffered for years from hip and shoulder pain that "felt like somebody stabbing me with a knife," she said. Pain began to rule and ruin her days.
Dr. Heit gave her OxyContin and later, because it seemed to work better and because of the expense, switched her to methadone. Her insurance at one point covered only $500 in prescriptions, which paid for just one month's worth of OxyContin, compared with methadone's cost of $35 a month.
Methadone "has given me my life back," Ms. Sherman said.
But Dr. Heit did not just throw drugs at her problem. He told her that she would also have to try physical therapy as well. They signed a contract listing mutual obligations -- she would follow directions, he would be on call. He starts patients at low doses, makes them bring in their pill bottles so he can count how many are left, and may give urine tests to deter mixing drugs.
Some doctors, like Dr. Theodore Parran of Case Western Reserve University, also require methadone patients to give them the names of relatives or friends they can call from time to time.
But not all doctors have taken such precautions. Tony Davis, a contractor in Victorville, Calif., had just turned 38 in 2004 when, after years of migraines and back pain, he saw a new pain doctor in his Kaiser Foundation Health Plan. The doctor, who had already given him the sedative Xanax, prescribed methadone because of his continued pain.
The second day on the two medications, Mr. Davis said, "I'm feeling really weird,' " recalled his wife, Pebbles Davis. The two lay down for a nap and when she woke up, her husband was dead.
Ms. Davis recalled that the coroner had told her, "Given the medicines he was on, his brain forgot to tell his heart to beat and his lungs to pump." The case went to an arbitrator, who ruled that although Mr. Davis had overused his drugs in the past, the doctor had failed to warn him about the new risks of starting methadone together with Xanax and that the care was substandard. Ms. Davis was awarded more than $500,000. "I never had any idea of the risk nor did my husband," she said.
Another source of danger has been the conversion tables that doctors use when switching patients from one opioid to another -- telling, for example, how many milligrams of methadone would be equivalent to the level of morphine a patient had been taking. These charts, until recently, indicated dangerously high doses for methadone. Newer ones suggest lower levels but many experts say these may be useless because methadone affects patients so variably.
Now, as the government is making new efforts to teach methadone's challenges, some officials and doctors would go further, requiring prescribers to take a course before using methadone.
But many physicians and patient groups are wary of any steps that would slow access to pain treatments.
As early as 2003, alarmed by the rise in methadone-related deaths, the Substance Abuse and Mental Health Services Administration made an urgent call for more systematic and detailed state and national reporting about opioid deaths -- a call that still goes unanswered.
Misuse by abusers was first seen as the problem, but now, said Dr. H. Westley Clark, director of the Center for Substance Abuse Treatment of SAMHSA, "We know that a significant share of the methadone deaths involve doctors making well-intended prescriptions."
A majority of victims also used large quantities of alcohol or benzodiazepine sedatives but few would have died without an opioid as the primary culprit. "You can take a lot of benzodiazepines without dying," said Dr. Charles E. Inturrisi of Weill Cornell Medical Center, who said they strengthen the depressive effect of methadone.
Some doctors prescribe to patients who may be expected to court danger, like Anna Nicole Smith, who died from a drug cocktail including methadone.
Last February, Margaret Moore, 54, who lived alone in South Pasadena, Fla., with a history of alcoholism, depression and chronic back pain from a car accident, was found dead at home. Her doctor had prescribed methadone and valium and, he told investigators, warned her to stop drinking.
Her body was surrounded by empty vodka bottles and a host of pills including bottles of methadone tablets and sedatives. Her death was declared an accident from methadone toxicity.
Since April, SAMHSA has sponsored nine voluntary training courses on the safe prescribing of opioids, and many more are planned, though they will only reach a fraction of prescribers. The agency is also contracting with the American Society on Addiction Medicine to set up a mentoring program, through which prescribing physicians can receive expert advice. The State of Utah has a plan to educate every doctor and pain patient in the state about safe use of methadone and other opioids.
Nancy Garvin, Robby's mother, is one of many relatives of victims who, in the absence of a national registry, have started educational and pressure groups to fight bad prescribing and abuse of the drug.
Still, the death rate appears to be rising, raising the question of what more may be necessary, in law enforcement and in doctor training.
"Methadone can be important for patients when other drugs don't work," said Dr. Inturrisi, "but unless the doctor has the training and resources to manage the patient properly, he's going to get in trouble at a rate that's unacceptable."
My methadone blogs have received a great deal of attention and many comments. I have also received inquiries with respect to whether readers should take methadone.
I urge those with questions to consult doctors to answer questions regarding methadone. I am an attorney and attorneys are the wrong folks to ask for medical advice. I also urge you to be very careful about taking advice from people who are not licensed medical doctors.
Second opinions from doctors never hurt and are often a very good idea. Take the time to figure out whether the doctor you are talking to has a thorough enough background in methadone to give you good advice. Certain specialists, such as pain management doctors, may deal with methadone more regularly than other types of doctors.
And, of course, there is a great deal to read on the internet about this subject. Always consult physicians when possible for questions about whether you should or should not take a particular drug.
From IndoxConsulting.com:
Using enoxaparin or heparin to bridge long-term anticoagulation therapy with warfarin for secondary stroke prevention has been associated with a high risk for serious bleeding in patients with cardioembolic stroke (CES). A retrospective study of 204 CES patients showed that only those who received bridging with enoxaparin went on to have symptomatic intracranial bleeding. Similarly, all CES cases with systemic bleeding were treated with intravenous heparin.
"Our study suggests doctors should think twice before using enoxaparin, or intravenous heparin for that matter, to bridge anticoagulation therapy with warfarin in patients with cardioembolic stroke," principal investigator Hen Hallevi, MD, from the University of Texas Health Science Center at Houston, told Medscape Neurology & Neurosurgery.
Clinical Dilemma
While it is widely acknowledged that CES patients require long-term anticoagulation, the issue of when and how to initiate it remains a clinical dilemma, said Dr. Hallevi.
Routinely bridging CES patients in the acute phase with enoxaparin or heparin until warfarin therapy begins to work is a widespread practice, but one that is not supported by the literature or current guidelines, he said.
He added that the current study was initiated based on anecdotal observations that CES patients tend to have more intracranial and systemic bleeding, also described as hemorrhagic transformation, than other types of stroke patients.
To examine possible explanations for this phenomenon, the researchers looked at the type of treatment administered to CES patients who were admitted to a single stroke center between April 1, 2004 and June 30, 2006 and who were not treated with tissue plasminogen activator.
Patients were categorized into one of 5 possible treatment groups. These included no treatment, aspirin only, aspirin followed by warfarin, intravenous heparin in the acute phase followed by warfarin, and full-dose enoxaparin combined with warfarin.
The study's primary outcomes included serious bleeding (defined as a parenchymal hematoma, grade 2, or systemic bleeding) and stroke recurrence during hospital stay.
Secondary end points included discharge with a favorable outcome (modified Rankin Scale score of 0 to 3), stroke progression, and in-hospital mortality.
All Intracranial Hemorrhage Occurred in a Single Group
Of the total study group, 8 subjects received no anticoagulation, 88 received aspirin alone, 35 were treated with aspirin followed by warfarin, 44 received intravenous heparin followed by warfarin, and 29 received full-dose enoxaparin combined with warfarin.
Hemorrhagic transformation occurred in 23 (11%) patients. Of these cases, 3 were symptomatic. Systemic bleeding occurred in 2 patients, who were both taking heparin.
"We found that all of the hemorrhage cases were in 1 group - those who were bridged with enoxaparin," said Dr. Hallevi. "When you think about it, this is really not surprising, because the good thing, as well as the bad thing, about this drug is that it does exactly what it is supposed to do, it fully anticoagulates," he said.
"We believe the infarct damages the small and medium-sized vessels, which are later reperfused and tend to leak blood. But the difference between this patient group and patients with other types of stroke is that those with cardioembolic stroke get anticoagulated really quickly, which promotes bleeding," he added.
Stroke progression occurred in 11 (5%) of patients and was significantly associated with poor outcome. All except 1 of these cases occurred in the aspirin-only group. In fact, the analysis revealed that patients receiving aspirin alone were 12.5 times more likely to experience progressive stroke compared with individuals on other types of anticoagulation. This finding, said Dr. Hallevi, suggests aspirin may not be as potent as other forms of anticoagulation therapies.
Despite these findings, Dr. Hallevi, cautioned that the retrospective nature of the study cannot prove causality. Nevertheless, he added, clinicians treating CES patients may want to consider these findings before opting for anticoagulation with enoxaparin or heparin.
Arch Neurol. Published online July 14, 2008. Abstract
The rapid rise of the number of deaths by methadone overdose is receiving attention all over the country.
Maurreen Skowran of The News & Observer reported on the increase of methadone deaths in North Carolina as the drug is used more commonly as a painkiller. In her article, found here, Skowan reports on the deadly effects of the drug, even when used as directed.
"Even legal prescriptions can turn fatal when doses accumulate over time into overdoses.
That phenomenon may have contributed to the death of a Winston-Salem woman. Jewel Imperial, 25, a student and musician, overdosed in September 2007. Her father, Bobby Imperial, said she died five days after being prescribed up to 80 milligrams per day for back pain. He declined to identify her doctor because the family is pursuing legal action. Imperial's dosage was more than double the recommended maximum for patients new to opioids, the family of drugs that includes methadone. Her parents didn't know she had been prescribed methadone then. But a few days after she started the prescription, her mother, Nancy Imperial, took her back to the same doctor. Her symptoms were disorientation, aches, sweats, cough and, sometimes, a spacey feeling, her father wrote. She died the next day."
Spike Hurst of Altoonamirror.com reported on methadone's effects in Pennsylvania and the surrounding region in his "Killer or Cure," found in its entirety here. According to the article, methadone could be the region's number one killer.
"It's killing people at therapeutic levels," said Marti Hottenstein, vice president of Helping America Reduce Methadone Deaths, a grass-roots group battling to tighten regulations on the drug. "It's killing more than illicit drugs - drugs it's supposed to help people from."
Hurst's article emphasizes the critical need for education about methadone, quoting Dr. Westley Clark, of the Substance Abuse Treatment Center director for the U.S. Department of Health's SAMHSA agency, the Substance Abuse and Mental Health Services Administration.
Inside state-regulated clinics, education and counseling are part of methadone maintenance programs, Clark said.
Those added measures - combined with "lock boxes" for take-home doses - something SAMHSA recommends - all work to curb the likelihood of overdosing, as well as opportunity for thefts, he said.
But with practitioners, "there has to be a greater emphasis placed on educating them about the dangers of opiates like methadone," said Clark, who believes that, in many cases, there may be better alternatives for pain treatment. He says SAMHSA is working on drug policy and with the federal Drug Enforcement Administration on strategies to "encourage" practitioners to learn more about methadone.
Because things could get worse, Clark said."We need to reach out to patients, the public and the media because we need to be aware that we have a boomer population that will be running into more pain problems associated with getting older. There's going to be that demand [for pain medication]."
His message to physicians: Know the drug. "Know the drug and know your patient," Clark said, because it might be the best option available for those who cannot afford high-priced anesthetics.
Issued back in 2006, this Health Advisory from the FDA warns against the dangers of methadone and includes important prescribing information for its safe use.
FDA Public Health Advisory: Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat
FDA has received reports of death and life-threatening side effects in patients taking methadone. These deaths and life-threatening side effects have occurred in patients newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers. Methadone can cause slow or shallow breathing and dangerous changes in heart beat that may not be felt by the patient.
Prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when their pain is not improved with other non-narcotic pain relievers. Pain relief from a dose of methadone lasts about 4 to 8 hours. However methadone stays in the body much longer--from 8 to 59 hours after it is taken. As a result, patients may feel the need for more pain relief before methadone is gone from the body. Methadone may build up in the body to a toxic level if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements.
To prevent serious complications from methadone, health care professionals who prescribe methadone should read and carefully follow the methadone (Dolophine) prescribing information
FDA is issuing this public health advisory to alert patients and their caregivers and health care professionals to the following important safety information:
- Patients should take methadone exactly as prescribed. Taking more methadone than prescribed can cause breathing to slow or stop and can cause death. A patient who does not experience good pain relief with the prescribed dose of methadone, should talk to his or her doctor.
- Patients taking methadone should not start or stop taking other medicines or dietary supplements without talking to their health care provider. Taking other medicines or dietary supplements may cause less pain relief. They may also cause a toxic buildup of methadone in the body leading to dangerous changes in breathing or heart beat that may cause death.
- Health care professionals and patients should be aware of the signs of methadone overdose. Signs of methadone overdose include trouble breathing or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients should get medical attention right away.
FDA recently approved new prescribing information for methadone products approved for pain control. The information in the new prescribing information is based on a review of the scientific literature completed by FDA. A Medication Guide for patients is planned.
Prescription painkiller overdose is becoming a common killer in Nevada, and nationally.
According to the National Center for Health Statistics, overdoses caused by prescription painkillers are increasing, and Methadone abuse is escalating more rapidly than any other drug. In fact, methadone overdoses have increased over 500% between 1999 and 2005.
Methadone is given to heroin users in liquid form to treat addiction, and doctors have progressively been prescribing methadone in pill form to treat chronic pain. As reported by Kathleen Fackelmann of USA Today, most methadone overdoses are caused by the abuse of the prescription painkiller pills.
Methadone is difficult to prescribe safely, according to Fackelmann, because it remains in the user's bloodstream long after the few hours of pain relief it provides. Too much methadone in the system will cause a user to go into a coma and stop breathing.
Another difficulty posed by methadone as a painkiller, reported by Holly Ramer of the Associated Press, is that methadone is metabolized slowly. Because a user may not feels its effects immediately, he or she might continue to take them, until the level of methadone becomes deadly.
Check back soon for more entries about the dangers of methadone.
Here's a great link to the Las Vegas Review Journal's Clearinghouse page of links. Highly recommended!
Review Journal Links on Hepatitis Scare: http://www.lvrj.com/hottopics/hepatitis_investigation.html
A number of weeks back I was flying into Vegas, and as we were nearly on the ground I looked out my airplane window and noticed an unusual sight, even for Vegas: the top floor of the Monte Carlo was on fire and there were flames jumping off the top of the hotel. And then, suddenly, the pilot aborted the landing and we were back up in the air. No explanation given.
That's the way authorities now seem to want to handle the Ricin find: they want us up in the air without explanations.
That's fair enough, but if they're going to handle things that way then why reassure us that there's no link to terrorism? Every statement from authorities as of yesterday emphasized that: no reason to suspect terrorism.
Or is it that what they're really saying is that there's no reason to suspect "foreign" terrorism? And since they allegedly know so little, why urge even that conclusion?
Associated Press reports that:
As police tried to piece together how a rare, deadly poison ended up in a motel for transients, the 57-year-old man who could hold the key lay unconscious in a hospital.
Adding to the mystery, police said firearms and an "anarchist type textbook" were found in the same room where the ricin was discovered two days later.
I'm not much of a criminologist, and less of a conspiracy theorist, but when one finds a bunch of Ricin in a transient hotel and along with it they find an "anarchist type textbook," perhaps eliminating terrorism, domestic or foreign, from the list of what's conceivable might be a tad premature.
And if authorities, who according to their own admission don't really know much, then why eliminate the possibility that a man with Ricin and a chemical weapons cookbook might just want to do some harm?
As many as 40,000 infected with Hep C in what looks like a potential mass negligence case against an endoscopy center and possibly a products manufacturer.
Stay tuned to this blog and I will bring you extensive independently researched details on this developing case.
I reprint here a summary from the recent important decision in Riegel v. Medtronic. This comes directly from the People Over Profits Grassroots Action Center:
Riegel v. Medtronic
In this case, Charles Riegel received a balloon catheter made by Medtronic which subsequently ruptured due to overinflation. Riegel developed a heart block and underwent emergency surgery. The Riegels later brought claims against Medtronic in the United States District Court for the Northern District of New York. The court found that the Riegels claims were preempted under the Medical Device Act, and the Second Circuit Court affirmed the decision. In this opinion, the Supreme Court affirms.
Summary
- The Supreme Court holds that state law claims regarding medical devices are preempted under the Medical Device Amendments (MDA) where the device manufacturer complied with federal requirements.
- The Court notes that review of the MDA turns on the definition of "requirements" in the statute. The decision states: "Absent other indication, reference to a State's 'requirements' includes its common-law duties." Thus, the holding expands beyond conflicting State regulations and statutes, which Congress was addressing in the MDA.
Limits of the Decision
It appears that the Court tried to limit the decision in several ways.
- The opinion applies to medical devices only (not approved drugs) based on the preemption language included in the Medical Device Amendments.
- The Court draws a distinction between state law claims made regarding devices approved under substantial equivalent review requirements and section 510(k) pre-market approval requirements.
- The Court discusses the extensive FDA review process for Class III medical devices only, rendering the application of the opinion to Class I and II devices uncertain.
- The Court expressly states that the decision does not apply to cases where the manufacturer did not comply with federal requirements.
- In her dissent, Justice Ginsburg's first footnote states that the "Court's holding does not reach an important issue outside the bounds of this case: the preemptive effect of section 360k(a) where evidence of a medical device's defect comes to light only after the device receives premarket approval."
Attacks on the Civil Justice System
This decision makes several derogatory claims about the civil justice system:
- Justice Scalia claims that the "Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices."
- The opinion claims that lay juries do not appreciate the benefits of medical devices. "A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Washoe District Court Judge Robert Perry has reduced the recent landmark jury award against pharmaceutical giant Wyeth arising from Wyeth's development and marketing of Prempro.
Judge Perry cut the award from $134 million to $58 million. $23 million is allocated toward compensatory damages and $35 million is punitive damages. Wyeth wanted the Judge to reduce the total award to $4 million.
Wyeth is up against 5300 similar lawsuits throughout the United States.
It will be interesting to see what the Nevada Supreme Court has to say about this case since it is almost certainly bound for full appeal.
On December 27, 2007 the Nevada Supreme Court clarified in Awada v. Shuffle Master, Inc., 123 Nev. Adv. Op. No. 57, the manner in which a Nevada District Court may handle mixed claims for legal and equitable relief at trial and found as follows:
In this appeal, we consider the primary issue of whether a district court has the authority to bifurcate the legal and equitable claims presented in a single action, conduct a bench trial on an equitable claim, and then use the findings of fact and conclusions of law from that bench trial to dispose of the case. On this issue of first impression, we conclude that Nevada district courts have discretion to bifurcate legal and equitable claims in a single action and to first conduct a bench trial on an equitable claim. Furthermore, a district court that exercises such discretion may then use its findings of fact and conclusions of law as a basis for disposing of claims remaining in the case, so long as it does so in a manner consistent with Nevada law and our rules of civil procedure.
We also consider whether the district court abused its discretion by sua sponte disposing of the remaining claims in a summary judgment-like manner after conducting a bench trial on respondents' counterclaim for rescission. In this case, the district court did not abuse its discretion when it first considered respondents' counterclaim for rescission and rescinded the parties' agreement. Based on its findings and conclusions, the district court properly disposed of all of appellants' contract-based claims against respondent Shuffle Master, Inc., because those claims could not stand absent a valid contract. However, the district court improperly granted summary judgment as to the claims against respondent Mark Yoseloff and appellants' remaining claims against Shuffle Master because those claims can survive absent a valid contract between the parties. Additionally, the district court erred in resolving those claims without satisfying the procedural requirements of NRCP 56.
Accordingly, we affirm the district court's judgment as to appellants' claims for breach of contract and contract-based claims for breach of the implied covenant of good faith and fair dealing; we reverse the district court's judgment as to appellants' claims for fraud, civil conspiracy, conversion, unjust enrichment, and tortious interference with contractual relations/prospective economic advantage and as to appellants' claims against Yoseloff; and we remand this case to the district court for further proceedings consistent with this opinion.
In the ongoing squabble over Allstate defense attorney Phil Emerson's repeated misconduct in arguing cases at trial, the Nevada Supreme Court rendered its latest decision on January 17, 2008.
In its introduction to Lioce v. Cohen, 124 Nev. Adv. Op. No. 1, the Court stated:
On December 28, 2006, this court issued an opinion in these consolidated appeals.[2] The defendants in each of the four underlying personal injury cases were represented by the same attorney, who gave substantially the same closing argument on behalf of his clients at each trial. Asserting that defense counsel's closing arguments constituted misconduct, the plaintiffs sought new trials, with varying success.
In that opinion, we revised the standards under which district courts are to evaluate requests for new trials based on attorney misconduct. Next, we reversed the denial of the motions for new trials in Lioce v. Cohen and Lang v. Knippenberg, and affirmed the grant of new trials in Castro v. Cabrera and Seasholtz v. Wheeler. Additionally, we determined that the defendants' attorney's closing arguments in Castro and Seasholtz amounted to misconduct, and we remanded those cases with instructions to the district courts to calculate and impose monetary sanctions on defense counsel and his clients.[3] Finally, we referred defense counsel to the State Bar of Nevada for disciplinary proceedings. This petition for rehearing followed. Having considered the petition, answers, amici curiae briefs, and the replies, we conclude that en banc rehearing is warranted in part under NRAP 40(c). We therefore grant the petition in part, vacate our prior opinion in this matter, and issue this opinion in its place. On rehearing, we reach substantially the same conclusion as in our prior opinion, but we decline to impose monetary sanctions on defense counsel and his clients.
Because defense counsel's closing arguments encouraged the jurors to look beyond the law and the relevant facts in deciding the cases before them, we agree that they amounted to misconduct. In determining whether the district courts properly decided that this misconduct warranted new trials or not, we take the opportunity to revise our attorney misconduct jurisprudence. New trial requests based on attorney misconduct must be evaluated differently depending upon whether counsel objected to the misconduct during trial. When a party successfully objects to the misconduct, the district court may grant a subsequent motion for a new trial if the moving party demonstrates that the misconduct's harmful effect could not be removed through any sustained objection and admonishment. With respect to unobjected-to misconduct, we conclude that the district court may grant a motion for a new trial only if the misconduct amounted to plain error, so that absent the misconduct, the verdict would have been different. When ruling on a motion for a new trial based on attorney misconduct, district courts must make express factual findings, applying the above standards.
In these consolidated appeals, we conclude that in Castro and Seasholtz, the district courts did not abuse their discretion by granting the plaintiffs' motions for a new trial, and therefore, we affirm the district courts' orders in those matters. In Lang and Lioce, however, we are unable to ascertain from the record whether the district courts abused their discretion in denying the plaintiffs' motions for a new trial. Accordingly, we vacate those orders and remand those two matters for a new decision on the new trial motions, based on the standards announced today. In addition, we refer defense counsel to the State Bar of Nevada.
Ah the new and complicated world of how email production is handled by courts.
Scott Roseland, at cybercontrols (www.cybercontrols.net), cites to Benton v. Dlorah, Inc., 2007 U.S. Dist. D. Kan, Oct. 30, 2007. There, the plaintiff informed defendant at her deposition that she had deleted e-mails, and defendant filed a motion to compel plaintiff to produce relevant documents, to produce her hard drive, and for sanctions for spoliation of evidence.
Initially, the court ruled that the requesting party (defendant) had not adequately shown that the requesting party had refuted producing party's (plaintiff) assertions that she had produced all relevant documents, but allowed requestor to amend if further discovery demonstrated that producer had not produced all documents or "had spoliated relevant evidence." Id. at *3-*4.
On their subsequent motion to compel, requestors asserted that producer had admitted failing to produce a relevant e-mail, that she used her personal account instead of her work e-mail and admitted deleting "hundreds" of possibly relevant e-mails. Producer responded that requestor's request was not sufficiently tailored, that her personal computer contained personal and privileged information, and that the request constituted a "fishing expedition", not outweighing the harm to her.
The court ruled that producer must produce the relevant e-mails, which were responsive to requestor's request.
Deleting these e-mails, even if done in good faith and at a time before Plaintiff contemplated her legal action, does not necessarily remove the e-mails from her possession, custody or control. Deleted documents should be retrievable from her computer system and thus remain within in her control.
Id. at *7. The court ordered that if she could not produce the e-mails, "she shall produce for inspection her computer hard drive from which the deleted e-mails were sent. This will allow Defendants to use the services of a computer forensic specialist, if necessary, to retrieve them." Inspection of the drive would be limited to the subject of requestor's request. Id.
The court made no reference to any distinction between accessible and inaccessible data. In effect, deleted e-mails may now have moved into the realm of "accessible" data.
There is and will continue to be lack of uniformity in the way that courts handle production of email and other electronic data.
Antidepressants are again under scrutiny.
According to a Yahoo! News Article dated December 18, 2007, the Supreme Court will hear a case regarding a teen, Christopher Pittman, sentenced to 30 years of prison for killing his grandparents and setting fire to their home at age 12.
His attorneys argue that the lengthy sentence violates the teen's Eighth Amendment protection from cruel and unusual punishment. They claim that this is the only case in the country that gives such a harsh punishment to a minor.
This case is most noted for its association with the drug, Zoloft. I n the original trial, Pittman's attorneys unsuccessfully tried to argue that the drug influenced their client.
According to an August 24, 2004 New York Times article written at the time the original case was pending, most medical experts do not believe in a link between antidepressants and acts of extreme violence and aggression.
Pittman claimed that something told him to commit the murders and that he was feeling isolated and aggravated a few days after starting the drug. Conversely, his doctor's notes about his behavior state that he was energetic and had no plans to harm himself.
The article also makes note of two other cases with similar fact patterns. In 2001, the drug company, GlaxoSmithKline, the maker of Paxil, paid $6.5 million to the relatives of a man in Wyoming who killed his wife, daughter, granddaughter and himself. This was the first time that a jury concluded a SSRI-type of antidepressant may lead users to suicide or homicidal behavior.
In April of 2004, a man in California was acquitted of attempted murder when it was found that his reaction to Zoloft made him unaccountable for his actions.
Zoloft is the most widely prescribed anti-depressant in the United Dates. Following some tests in 2004, the FDA put a "black box" warning on the drug, the strongest warning label that can be given to a drug, because of its association with an increased risk for suicide in children.
Alright, perhaps "plague" is too strong a word...
Last week the Washoe County District Health Department issued a boil water order for Cabela's and Boomtown Hotel and Casino. This was due to total coliform bacteria found in their water supply. According to the Environmental Protection Agency, total coliform bacteria are "natural and common inhabitants of soil and ambient waters (such as lakes and rivers) and are generally harmless. They are usually not found in ground water that is free of surface water or fecal contaminants."
Fortunately none of the 80 people evacuated from the hotel suffered side effects from exposure to the bacteria, symptoms of which include diarrhea, cramps, nausea, possibly jaundice, fatigue and headaches.
Last week the hotels worked to eliminate the bacteria in their water supply, but in the meantime Boomtown hotel wasshut down while the casino remained open. The Hotel appears to have now reopened.
According to the casino's general manager David Williams, "all the water systems have been disinfected including ice, soft drink and coffee machines, and chlorine has been added to the storage tank." He also stated that "we literally have a guy climbing up there [in order to add chlorine to the tank]."
What was the cause of this breakout? The hotel has had a clean bill of health according to Health Department records dating back to 1997, but a new water pump was recently installed. This pump is used to pump water from five wells into a 500,000-gallon storage tank for Boomtown, but it was evidently faulty and allowed bacteria to filter through with the water supply.
The Health Department does require the Boomtown public water system to take a sample for total coliform within its distribution system monthly, which is why this outbreak was caught. Fortunately, because nobody came down with any immediate symptoms this wasn't declared a medical emergency. It's also possible that people did come down with symptoms which they attributed to seasonal allergies, colds or the flu.
The name Aqua-Dots sends chills down the spine of families in the U.S. If you haven't heard about the recall that happened last month, then you are likely in the minority. About 4 million units of the product were recalled last month because they break down into a date-rape drug when ingested.
Currently 10 retailers and companies including Kmart, Walmart, Sears, Target and Mattel are being sued for their negligence in distributing Aquadots. Although they did put a disclaimer on the boxes that the dots are not for young children, it's impossible to police every child every second of every day. It only takes a second for a two-year old to grab a toy on a table and put it in his or her mouth, whether that toy was their elder sibling's or not. Four Australian children and two American children fell unconscious after ingesting the Aquadots, injuries which should not have happened in the first place.
Chinese companies are using increasing amounts of lead in their products to help increase the speed and volume of the toys that they are sending to the US and other countries. According to Macon.com, "lead poisoning - [is] the subject of about one-third of this year's recalls... from Oct. 1, 2006, through Sept. 31, 2007." All told there were about 25.6 million toys recalled this year, though the profiles of recalled toys were much higher this year than in previous years. Some parents are even going so far as to purchase lead testing kits to test on their children's toys or banning the purchase of Chinese made toys for their families all together.
It is true that products coming to the US must meet US standards, but regulating those products is sometimes sketchy. "It's not a new problem, but it's getting worse," said Ed Mierzwinski, consumer program director for the U.S. Public Interest Research Group, which released its annual report 'Trouble in Toyland'. "The reason it's getting worse is that manufacturers have stretched their supply chain to China, and the safety links are broken. Companies are not trying to pay attention to the law because they are not afraid of the CPSC [Consumer Product Safety Commission]."
So all things considered, it would probably be best to be careful of this year's toys and especially careful of most things made in China, not just toys. It's difficult to blame the Chinese for our own woes and even though toy manufacturers are going to put a foul-tasting chemical in Aquadots to prevent children from swallowing them, the fact that they need to in the first place makes a clear point: let the consumer beware.
General Electric recalled 92,000 combination wall and microwave ovens after at least 35 incidents of fire that damaged property, the company and the Consumer Product Safety Commission said Wednesday.
According to a Yahoo News article yesterday, the door switch in the microwave oven can overheat and ignite plastic components in the appliance, the company said.
The lower thermal oven does not pose a hazard and no injuries have been reported, according to the commission.
Department and appliance stores sold the ovens between January 2000 to December 2003.
Tests on more than 1,200 children's products, most of them still on store shelves, found that 35 percent contain lead -- many with levels far above the federal recall standard used for lead paint.
According to an AP article released today, a Hannah Montana card game case, a Go Diego Go! backpack and Circo brand shoes were among the items with excessive lead levels in the tests performed by a coalition of environmental health groups across the country.
For your very own toxic toy guide to to: http://www.healthytoys.org
Relax: your cell phone might not be a bomb after all.
A South Korean man whose death initially was blamed on an exploding cell phone battery was killed by a car accident involving his colleague, police said Friday.
The International Herald Tribune reports (November 29th) that the quarry worker, only identified by his family name Seo, was found dead Wednesday with a melted phone battery in his shirt pocket. Police and a local doctor who examined his body said the battery may have killed the man.
The colleague, identified only by his surname Kwon, confessed to police that he accidentally killed Seo while he was backing up a drilling vehicle but first reported to police that the death was caused by the battery explosion, Min said.
That's quite an alibi...
The insurance industry's $11 million bellyflop against Referendum 67 was an election bright spot for ruling Democrats, who otherwise took their lumps from a frugal electorate that sent establishment ideas packing.
According to Curt Woodward, writing for the AP, the referendum, which allows triple damages in lawsuits alleging bad faith by insurance companies, spawned a lively campaign pitting the industry against trial lawyers.
Supporters said R-67 would give consumers a powerful tool to punish bad actors in the insurance industry. Opponents countered that it was an unnecessary magnet for unfounded lawsuits, and would drive up insurance rates.
But even though Washington voters displayed an anti-tax mood in other races around the state, they weren't swayed by the prospect of higher rates. R-67 cruised to victory, winning about 57 percent of the vote in unofficial returns through Wednesday afternoon.
Approve R-67 spokeswoman Sue Evans said the referendum fit squarely with voters' pocketbook-first mentality: if you pay for an insurance policy, you expect the company to play fair.
"Do people believe that insurance companies are going to be fair 100 percent of the time? Obviously, they don't," Evans said Wednesday. "And obviously, they expect to get what they pay for."
Reject R-67 spokeswoman Dana Childers sounded contrite, pledging to move past the bitter election and work with Democrats in Olympia. But opponents "remain convinced that Referendum 67 will result in more frivolous litigation and higher costs for consumers," she said.
The R-67 campaign was partially a proxy battle for the political parties, since trial lawyers often support Democrats and insurers are typically aligned with Republicans.
Supporters were also asking voters to endorse a plank of the Olympia Democrats' agenda, since the measure passed the Legislature on largely partyline votes and was signed into law by Democratic Gov. Chris Gregoire.
Democratic Insurance Commissioner Mike Kreidler -- up for re-election himself next year -- ended up with the sheen of a two-time winner and is clearly feeling his oats as a consumer advocate.
Kreidler, who successfully urged a double "no" vote on 2005's bruising medical malpractice initiatives, came out strong in favor of R-67 and won.
And even though his endorsement of R-67 in TV commercials prompted the opposition to question why Kreidler would "cede his authority to trial lawyers," Kreidler predicted a return to civility at the 2008 Legislature.
"I warned them in advance that if we were going to go to war, it was going to be difficult for me to do anything other than become active in support of the referendum," Kreidler said Wednesday.
"I would have been happier if we wouldn't have had to fight the battle at all," he said.
A 30-year-old woman was one of four patients infected with HIV and hepatitis after an organ transplant.
According to a Yahoo! News Article dated November 16, 2007, the woman was not informed that the donor engaged in high-risk activities and, after the transplant, she was not immediately tested for HIV. These two circumstances put the University of Chicago, where the procedure was done, and the Gift of Hope Organ and Tissue Donor Network ,in violation of the U.S. Center for Disease Control and Prevention regulations (and also obviously exposes those institutions to potential civil liability.
The only information teh victim received about the donor was that he was a healthy young man. Two years earlier, the woman had rejected a donor because of his high risk lifestyle, leading one to believe that if she had been properly informed about this donor, she may have rejected this donor as well.
The donor was tested for HIV and hepatitis, but the test results were negative. He was listed as a high risk donor because he was a sexually active 38-year old gay man. CDC guidelines say that this type of person should only be used as a donor in case of an emergency.
A petition is being filed on the woman's behalf in Cook County. It asks officials to prevent hospitals and organ procurement centers from destroying or altering records about a donor.
Ever wonder if a Red Bull could mess with your physiology? A better question for anyone who's ever had one might be: ever wonder how it couldn't?
A new study suggests a potential correlation between energy drinks and heart and blood pressure issues. Yahoo cites a new story from Will Dunham at Reuters:
The increasingly popular high-caffeine beverages called energy drinks may do more than give people a jolt of energy -- they may also boost heart rates and blood pressure levels, researchers said on Tuesday.
The results of a small study prompted the researchers to advise people who have high blood pressure or heart disease to avoid energy drinks because they could impact their blood pressure or change the effectiveness of their medications.
The drinks generally have high levels of caffeine and taurine, an amino acid found in protein-rich foods like meat and fish that can affect heart function and blood pressure, the researchers said.
"We saw increases in both blood pressure and heart rate in healthy volunteers who were just sitting in a chair watching movies. They weren't exercising. They were in a resting state," James Kalus of Henry Ford Hospital in Detroit, who led the study, said in an interview.
The increases did not rise to dangerous levels in the group of 15 healthy volunteers, whose average age was 26, the researchers said.
But the increases potentially could be significant in people with cardiovascular disease or those taking drugs to lower heart rate or blood pressure, they told a meeting of the American Heart Association in Orlando, Florida.
"While the amount of caffeine in energy drinks or coffee may cause a slight and temporary increase in blood pressure, it would have no greater effect than walking up a flight of steps," the American Beverage Association industry trade group said in a statement responding to the findings.
"So singling out energy drinks in a unique manner, particularly when compared to a more commonly consumed caffeinated beverage like coffee, does not provide a full and proper context for consumers."
BOOSTING ENERGY
The products have names like Full Throttle, Amp and Rush. Red Bull, made by Austrian company Red Bull GmbH, is a market leader. Beverage companies market various energy drinks as soft drinks that can boost a person's energy.
Kalus declined to say which brand of energy drink was used in the study. He said the drinks generally contain similar ingredients, adding, "By giving the brand, it would dilute the message that all of these drinks need to be looked at."
Coca-Cola Co. makes Full Throttle.
The study participants were asked not to consume other forms of caffeine for two days before starting the study and then throughout a study in which they consumed two cans of energy drinks daily over seven days. Each can contained 80 milligrams of caffeine and 1,000 milligrams of taurine.
The volunteers' heart rates rose by about 8 percent on the first day and 11 percent on the seventh day.
Maximum systolic blood pressure -- the top number in blood pressure readings that represents pressure while the heart contracts -- rose by 8 percent on the first day and 10 percent on the seventh day, the study showed.
Diastolic blood pressure -- the bottom number that gives the pressure when the heart relaxes between beats -- rose by 7 percent on the first day and 8 percent on the seventh day.
The study did not identify ingredients responsible for the changes, but Kalus said it probably was caffeine and taurine.
Kalus said the study did not address possible health effects from the way some people consume these drinks, such as mixing them with alcohol.
Apparently, it's the year of the product recall.
Now it's Nike, with their recall of 235,000 football helmet chin straps after receiving reports of head and facial injuries that resulted after the strap broke.
Not surprisingly, the chin strap was made in China. The strap was sold between 2006 and 2007.
You can see pictures of the strap at http://www.cpsc.gov/cpscpub/prerel/prhtml08/08081.html
Merck agreed to pay more than $4 billion to settle the majority of the claims that have arisen from their popular drug Vioxx. Victims and their families claim that Vioxx causes heart attacks and strokes.
Merck has won most of the Vioxx cases that have gone to trial and many observers actually believed that this was a favorable settlement for Merck.
Approximately 38,000 or the 60,000 Vioxx plaintiffs must agree to the settlement for it to proceed. Merck has indicated that it will defend all claims not included in the ultimate settlement.
For more information on this settlement, see the InjuryBoard.com Vioxx page. http://www.injuryboard.com/topic/vioxx--rofecoxib.aspx
See also, Jane Akre's InjuryBoard National News Desk: http://www.injuryboard.com/national-news/merck-to-settle-vioxx-claims.aspx?googleid=28392
As many Northern Nevadans are aware, a Reno jury recently handed down a major verdict against drug giant, Wyeth.
This comes from David Parker writing for the Reno Gazette Journal:
Wyeth plaintiffs Arlene Rowart, from left, of Incline Village, Jeraldine Scofield of Fallon and Pamela Forrester of Yerington listen shortly after the jury ruled in their favor in the trial against the pharmaceutical maker.
Three Nevada women, including one from Fallon, were awarded $99 million by Reno jurors in punitive damages Monday.
The women had claimed hormone replacement drugs distributed by pharmaceutical giant Wyeth caused their breast cancer.
An attorney for Wyeth called the award "an aberration" and said it would be appealed.
The Washoe County District Court jury initially issued a $134.5 million judgment against Wyeth last week, but Judge Robert Perry slashed that to $35 million after it became clear some of the jurors were under the mistaken belief the award was to include punitive damages intended to punish the company.
After lawyers for both sides gave closing arguments again Monday, the judge instructed the five-man, two-women jury to move to the punitive stage of the trial to consider whether the company's actions were so "reprehensible" that additional damages were warranted to punish it and discourage such behavior in the future.
"This verdict is an extreme aberration," said Heidi Hubbard, a partner in the law firm representing Wyeth. "It is inconsistent with every other hormone therapy case to be tried to date and it is inconsistent with the evidence."
The judgment for Jeraldine Scofield, 74, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 65, of Yerington is by far the largest award to date against the Madison, N.J.-based company, which faces about 5,300 similar lawsuits across the country in state and federal courts.
All involve the drugs Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, prescribed for women to ease symptoms of menopause.
The jurors returned at 1 p.m. Monday, two hours after they began deliberations following an impassioned plea by one of the women's lawyers to return a large enough judgment to "get the attention and hold responsible" a company with a net worth of $14.6 billion.
"You already found Wyeth acted with fraud and malice. You found they did wrong. Now you can punish them for what they did to these women," Zoe Littlepage told the jurors.
"We're talking about a company that decided year after year to put their profits and money over the safety of their patients who got breast cancer," she said.
Dan Webb, Wyeth's lead attorney, urged the jury to re-examine the evidence thoroughly and resist the temptation to reissue the original $100 million judgment.
"You'll decide whether you've already punished Wyeth enough," Webb said. "For Ms. Littlepage to suggest you have not captured Wyeth's attention with your verdict is just wrong.
"My client has received the message."
Geraldine Scofield, 75, of Fallon said she was diagnosed with breast cancer seven years ago and is "somewhat optimistic" about her health.
Scofield, whose mother is 93, and who has no breast cancer in her family, remains active.
A mother and grandmother, she loves to quilt and meets weekly with a quilters group here.
When Scofield, who is a widow, was asked why she sued Wyeth, she answered, "because I'm mad and I'm upset that I have to go through the rest of my life worrying about having breast cancer."
The following comes from the American Associaiton of Justice quoting Sheri Qualters at the National Law Journal:
American businesses are filing and fighting fewer lawsuits, according to Fulbright & Jaworski's fourth annual Litigation Trends Survey. Seventeen percent of respondents have not defended a lawsuit in the past year, compared with 11% in the prior year. The rate of corporations bringing at least one new lawsuit dropped to 65%, compared with more than 70% in the prior year and 88% in 2004. Only 22% of in-house counsel expect their companies to be involved in more legal disputes during the next year."
Yesterday I blogged on some of the negative aspects of binding arbitration. Here's more information on why this often misunderstood form of alternative dispute resolution can be problematic.
Buried in the fine print of most consumer contracts - such as credit cards, insurance plans and car deals - is a clause, which waives the buyer's constitutional right to trial by jury. These contracts mandate that consumers give up their rights before a dispute even occurs - this is called "mandatory, binding, pre-dispute arbitration." Arbitration was conceived as an informal, expedited process for resolving routine disputes between businesses. But when it is imposed on a weaker party, such as a consumer, arbitration can be used to defeat valid claims. Arbitration has several unique characteristics that stack the deck against consumers, making it harder for individuals to prevail in a dispute with a business.
Costs are high:An injured party must pay steep filing fees just to initiate a case--seldom less than $750. These fees do not cover the arbitrator's hourly charges, which are generally in the range of $200 to $300 per hour, split between the parties. All these fees must be deposited in advance, and almost always amount to thousands of dollars. Because the injured person has usually sustained a serious loss in the dispute with the business--foreclosure on a home, firing from a job, denial of medical care--most individuals covered by an arbitration clause cannot afford these costs and are forced to drop their cases.
Biased Arbitrators: Even though arbitrators are supposed to be impartial, they are often biased toward business, since only businesses will be repeat users of a particular arbitrator. If an arbitrator knows that a business may use them again and again, they are inclined to rule in their favor.
Limited discovery: Discovery is the process by which parties in a legal dispute obtain information and evidence in the possession of their opponent or third parties. In arbitration, discovery is a privilege, not a right, and many businesses draft arbitration clauses to severely restrict the consumer's ability to obtain necessary evidence. Moreover, since arbitrators do not have the power to enforce subpoenas, claimants must sometimes file lawsuits to get compliance--defeating the purpose of arbitration.
Prohibition of class actions: Nearly every arbitration clause prohibits participation in class action lawsuits. Class actions are the only effective remedy for wide-scale scams that rip off individual consumers or farmers in small amounts. Individuals do not have the time or resources to recognize, investigate, or prove the existence of such fraudulent practices.
Inconvenient locations: Arbitration clauses often require that hearings be held in a location inconvenient to the injured consumer or worker. Individuals may have to bear the cost of long-distance travel to have their case heard. For example, the Internet auction site e-Bay requires its customers to travel to its home turf of San Jose, California, to arbitrate any dispute.
One-way requirements. Most arbitration clauses require only the weaker party (the consumer, employee, or franchisee) to arbitrate his or her claims, while allowing the dominant party (the corporation) to sue in court on its claims. Thus, a sexual harassment victim can be forced to arbitrate a discrimination claim against a former employer, but if the employer sues to stop her from joining a competitor, the employer's claims are heard in court.
No public record. While proceedings and records of the courts are open to the public, most arbitration clauses and provider organizations require that proceedings be kept confidential. As a result, only the businesses that impose arbitration can track past decisions and know which arbitrators have ruled for them. Public discussion of the fairness of an arbitration ruling is discouraged, even if the case raises policy issues of wide concern. Moreover, arbitration sets no legal precedents to guide companies' future conduct.
Limited judicial review. Parties are allowed only limited judicial review of an arbitration award. A decision may only be overturned when there is fraud or "manifest disregard of the law." This is a very high hurdle to overcome because arbitrators are not required to issue written findings of fact or legal conclusions. Oddly enough, courts will refuse to hear appeals of arbitration decisions even when both sides have agreed to let a court do so!
Limited remedies. Courts can provide a range of remedies that are not available to a claimant in arbitration. Injunctive relief--a court order compelling the offending party to do something, or prohibiting that party from taking some action--cannot be obtained through arbitration. Arbitrators often split the difference between the two sides in awarding damages instead of determining the true costs of injuries. As a result, arbitration awards to consumers and employees are substantially lower than court awards.
Information for this blog comes from http://www.peopleoverprofits.org
There have been recent efforts by federal legislators to impose binding arbitration in a variety of contexts.
You may have never heard of Binding Mandatory Arbitration, but that would not prevent this unfair practice, visited on unsuspecting consumers, from destroying your life. Buried in the fine print of many consumer contracts for credit cards, new homes and cars are clauses that stack the deck against American consumers, forcing you to give up your rights to seek justice through the courts. And these contracts force you to surrender your rights before a dispute even occurs.
Binding Mandatory Arbitration prevents defrauded or wronged consumers from taking their cases to court. Instead, their cases are decided by arbitrators who are not bound by the rules that ensure consumers get a fair shake in the civil justice system. Their cases are never heard by a judge or jury and the arbitrators decision is usually impossible to appeal.
Currently, most Americans are bound by at least one Binding Mandatory Arbitration clause, often without their knowledge. Each day more home buyers, credit card users, insurance holders, and car buyers are forced to give up their constitutional right to have their case heard by a jury of their peers. So when powerful business interests take advantage of them, they are left with no recourse or remedy to recover their losses.
Do not get stuck the next time you apply for a credit card, buy a car or sign a contract for a new home. Do not let big corporations push you around.
Learn More About Binding Mandatory Arbitration
www.peopleoverprofits.org/bma
This from the American Association of Justice quoting the New York Times:
"A local pension fund in Michigan filed a shareholder suit yesterday against Mattel and its board, asserting that a mishandling of product safety procedures was responsible for three toy recalls during the summer. The suit claims that Mattel's directors, including the chief executive, Robert A. Eckert, breached their duty to shareholders by allowing the company to delay the reporting of hazardous toys beyond the 24-hour window required by federal regulators. The suit also accuses four directors of selling $33 million shares of Mattel stock from late January to early May and profiting from insider knowledge of coming problems. The suit, by the Sterling Heights Police and Fire Retirement System, seeks compensation from board members for the loss that shareholders may incur from the recalls. It was filed in state court in Delaware, where Mattel is incorporated. Mattel did not respond to a request for comment on the case."
Louise Story, New York Times 10/11/07
Assembly Bill No. 483 dated March 20, 2007 revises Nevada law regarding the execution of property and wages from a judgment debtor.
The bill makes personal property whose total value does not exceed $1,000.00 exempt from execution. It also exempts tax refunds from federal earned income credit or a similar state law from being garnished.
The original bill includes the proper forms for a notice of the writ of execution, a writ describing the property exempt from execution, and a description of how the judgment debtor can claim these exemptions.
AB 483 adds the above corrections to these forms. To view the full bill, please check here.
http://www.leg.state.nv.us/74th/Bills/AB/AB483.pdf
Nevada law requires that child and adult care facilities be licensed and follow certain rules and regulations. Assembly Bill No. 283 adds new requirements to this law. Chapter 432A of NRS now requires that child and adult care facilities maintain and provide certain information to parents, guardians or legal representatives. New requirements also make failure to comply grounds for revocation of a facility's license.
Section 1 of the new bill adds several new requirements. The bill requires that child and adult care facilities maintain records of licensure, inspections, complaints, and any disciplinary actions. Facilities must make the information available to the public or guardians of those cared for in the facility upon enrollment and upon request.
Section 2 allows the licensing bureau to deny, suspend or revoke the license of any facility that fails to comply with these new regulations. Section 4 allows the health division to deny, suspend or revoke the license of any facility that fails to comply with these new regulations.
Injury attorneys have long been aware of America's increasing problem with prescription pain medicines and the article below, pulled off Yahoo News this morning, confirms that a new national dialogue on this subject is in order. Legal addiction has become a major problem for the United States:
MYRTLE BEACH, S.C. - People in the United States are living in a world of pain and they are popping pills at an alarming rate to cope with it.
The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005, according to an Associated Press analysis of statistics from the Drug Enforcement Administration.
More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during the most recent year represented in the data. That total is enough to give more than 300 milligrams of painkillers to every person in the country.
Oxycodone, the chemical used in OxyContin, is responsible for most of the increase. Oxycodone use jumped nearly six-fold between 1997 and 2005. The drug gained notoriety as "hillbilly heroin," often bought and sold illegally in Appalachia. But its highest rates of sale now occur in places such as suburban St. Louis, Columbus, Ohio, and Fort Lauderdale, Fla.
The world of pain extends beyond big cities and involves more than oxycodone.
In Appalachia, retail sales of hydrocodone -- sold mostly as Vicodin -- are the highest in the nation. Nine of the 10 areas with the highest per-capita sales are in mostly rural parts of West Virginia, Kentucky or Tennessee.
Suburbs are not immune to the explosion.
While retail sales of codeine have fallen by one-quarter since 1997, some of the highest rates of sales are in communities around Kansas City, Mo., and Nashville, Tenn., and on New York's Long Island.
The DEA figures analyzed by the AP include nationwide sales and distribution of drugs by hospitals, retail pharmacies, doctors and teaching institutions. Federal investigators study the same data trying to identify illegal prescription patterns.
An AP investigation found these reasons for the increase:
The population is getting older. As age increases, so does the need for pain medications. In 2000, there were 35 million people older than 65. By 2020, the Census Bureau estimates the number of elderly in the U.S. will reach 54 million.
Drugmakers have embarked on unprecedented marketing campaigns. Spending on drug marketing has gone from $11 billion in 1997 to nearly $30 billion in 2005, congressional investigators found. Profit margins among the leading companies routinely have been three and four times higher than in other Fortune 500 industries.
A major change in pain management philosophy is now in its third decade. Doctors who once advised patients that pain is part of the healing process began reversing course in the early 1980s; most now see pain management as an important ingredient in overcoming illness.
Retired Staff Sgt. James Fernandez, 54, of Fredericksburg, Va., survived two helicopter crashes and Gulf War Syndrome over 20 years in the Marine Corps. He remains disabled from his service-related injuries and takes the equivalent of nine painkillers containing oxycodone every day.
"It's made a difference," he said. "I still have bad days, but it's under control."
Such stories should hearten longtime advocates of wider painkiller use, such as Russell Portenoy, head of New York's Beth Israel pain management department. But they have not.
"I'm concerned and many people are concerned," he said, "that the pendulum is swinging too far back."
Consider:
More people are abusing prescription painkillers because the medications are more available. The vast majority of people with prescriptions use the drugs safely. But the number of emergency room visits from painkiller abuse has increased more than 160 percent since 1995, according to the government.
Spooked by high-profile arrests and prosecutions by state and federal authorities, many pain-management specialists now say they offer guidance and support to patients but will not write prescriptions, even for the sickest people. The increase in painkiller retail sales continues to rise, but only barely. There was a 150 percent increase in volume in 2001. Four years later, the year-to-year increase was barely 2 percent.
People who desperately need strong painkillers are forced to drive a long way -- often to a different state -- to find doctors willing to prescribe high doses of medicine. Siobhan Reynolds, the widow of a New Mexico patient who needed large amounts of painkillers for a connective tissue disorder, said she routinely drove her late husband to see an accommodating doctor in Oklahoma.
Perhaps no place illustrates the trends and consequences for the world of pain better than Myrtle Beach, a sprawling community of strip malls, hotels and bars perched along a 60-mile strip of sand on the Atlantic Ocean. The metro area, which includes three counties, is home to 350,000 people but sees more than 14 million tourists annually, drawn to its warm water, golf courses and shopping.
During the eight-year period reflected in government figures, oxycodone distribution increased 800 percent in the area of Myrtle Beach, partly due to a campaign by Purdue Pharmaceuticals of Stamford, Conn. The privately held company has pleaded guilty to lying to patients, physicians and federal regulators about the addictive nature of the drug.
Use of other drugs soared in the area, too: Hydrocodone use increased 217 percent; morphine distribution went up 180 percent; even meperidine, most commonly sold as Demerol, jumped 20 percent.
It is no small wonder that federal authorities suspected the area was home to a notorious "pill mill," or a clinic that dispenses prescription medication without verifying that it's needed.
The U.S. attorney for South Carolina secured a 58-count indictment in June 2002 against seven physicians and one employee of the Comprehensive Care and Pain Management Center, a nondescript storefront on Myrtle Beach's main drag.
Tipped off by local pharmacists concerned about an increase in the volume of painkiller prescriptions, the federal investigation created a furor in the medical profession. The owner, D. Michael Woodward, was sentenced to 15 years in the case and has relinquished his license.
A second physician, Deborah Bordeaux, had worked at the clinic less than two months before quitting in disgust. Bordeaux, now serving a two-year prison term, was threatened with a 100-year sentence if she did not help the prosecution.
Officials with the Justice Department and the DEA would not discuss what some activists say is a "war on doctors."
Reynolds, the widow who drove her late husband hundreds of miles for his pills, became an activist after the Myrtle Beach indictments. She contributed money to appeal some of the criminal convictions in South Carolina and started the Pain Relief Network, an advocacy organization for people living in pain. She believes the doctors sent to prison were railroaded.
"It was a witch hunt," she said.
Bordeaux's husband, Edworth Swaim, agrees. A retired U.S. Postal Service employee, Swaim believes his wife was sentenced to two years because she would not turn on her former colleagues. Even though Bordeaux had worked at the clinic less than two months and eventually sued over what she alleged was rampant Medicare fraud, he said she did not stand a chance of avoiding prison.
"She wasn't guilty of anything, so she wasn't going to plead to anything," Swaim said. "She was absolutely railroaded, made an example of. I can't tell you how angry I am."
Myrtle Beach physicians are not convinced that the "Myrtle Beach Eight," as they became known, were innocent.
A Myrtle Beach internist who also works in addiction medicine, Brian Adler, said physicians were flooded with patients seeking pain medicine after the clinic was shut down.
The community has a slightly higher-than-average number of older people and relatively high numbers of people between 21 and 64 who describe themselves as disabled.
"There's a significant problem with narcotics in this area," Adler said. After the pain management clinic closed, "all those folks were like rats, scurrying from a burning building, trying to get their fix."
Other physicians were concerned about patients with legitimate needs for painkillers. The federal bust raised the stakes.
When radio commentator Rush Limbaugh settled a federal case charging him with illegally obtaining painkillers, he did not get prison time. Neither did NFL star Brett Favre, who publicly acknowledged an addiction to Vicodin that he obtained legally.
To pain management specialists, they were being blamed for everyone's addiction.
The DEA cites 108 prosecutions of physicians during the past four years; 83 pleaded guilty or no contest, while 16 others were convicted by juries. Eight cases are pending, and one physician is being sought as a fugitive.
In congressional testimony, the agency's deputy assistant administrator, Joseph T. Rannazzisi, estimated that fewer than 1 percent of the nation's physicians -- under 9,000 -- illegally provide prescription drugs to patients. He told lawmakers it is far more common for people to illegally obtain prescription drugs from friends and family members.
"It is not merely illegal but could feed or lead to an addiction and place that loved one in a life-threatening situation," Rannazzisi said.
It is impossible to reliably measure painkiller abuse.
A 2004 government study estimated between 2 million and 3 million doses of codeine, hydrocodone and oxycodone are stolen annually from pharmacies, distributors and drug manufacturers. The AP's analysis only included retail sales and did not include estimates of diverted pharmaceuticals.
John Charles, director of medical affairs at the Grand Strand Regional Medical Center in Myrtle Beach, practices pain management. A few years ago, Charles said, he took a drastic step to reduce his potential legal risks: He stopped prescribing painkillers.
The decision gave him peace of mind, but he does not expect there to be less of a need for painkillers or physicians who prescribe them.
"People with cancer are surviving longer, elderly people are living longer," Charles said. "So, physicians are walking a fairly fine line. We're walking a narrow path. And I think we'll continue to see it for a while."
This from CBS News:
Castleberry Food Co. is recalling every product manufactured on a specific production line in the past two years in response to four cases of botulism poisoning in Texas and Indiana.
The production line is one of "four or five" in its Augusta, Ga., facility. On Saturday night the company also shut down the entire plant for one week while it investigates the cause of the botulism poisoning.
The plant's 450 employees, under terms of their union contract, will not be paid during the closure.
Castleberry recalled 10 hot dog chili sauce products on July 18 after 16 of 17 cans tested were found contaminated with botulism toxin. The cans were manufactured on one production line between April 30 and May 22 of this year. The company says the apparent cause of the contamination is that the product was undercooked and therefore not sterilized.
Botulism is a rare but serious illness caused by consuming foods with the botulinim toxin, a nerve toxin that left untreated can cause paralysis of the arms, breathing muscles and legs. Symptoms, such as blurred vision and slurred speech, generally begin 18 to 36 hours after eating a contaminated food.
Castleberry says no other products have tested positive for botulism. Nonetheless, the company is recalling more than 80 food products intended for humans sold under more than 25 brand names and manufactured on the production line in question.
Also produced on the line, and also recalled, are a number of pet food products. The company says the products are sold in more than 17,000 stores nationwide and in Canada.
A third-party company has been hired to carry out the recall beginning Monday.
Castleberry has posted all the recalled products on its Web site and has set up a consumer hotline: 800-203-4412.
They are telling consumers to remove all products from their homes and dispose of them in double plastic bags. Castleberry says consumers can contact the company (not the retailer) for a full refund.
What's the world coming to when Easy Bake Ovens get dangerous? This from Yahoo News:
The Easy Bake oven, an iconic toy with a four-decade history, has been recalled for the second time in less than a year, government safety advocates announced on Thursday.
In February Easy Bake's parent company, Hasbro Inc., recalled 985,000 of the toys because children were getting their hands and fingers trapped in the front opening, and some were burned. At that time, Hasbro offered a free repair kit to improve the oven's safety.
Since the February announcement, the company has received an additional 249 reports of children getting their hands or fingers caught in the ovens, including 16 reports of second- and third-degree burns. One burn required partial amputation of a 5-year-old girl's finger.
As a result, Hasbro is recalling all front-loading Easy Bake ovens sold since May 2006, even those that were repaired with the free kit distributed after the February recall.
CPSC spokeswoman Julie Vallese said they do not know how many, if any, of the additional 249 injuries occurred in repaired ovens.
The ovens should already be off store shelves, according to Hasbro spokesman Wayne Charness. The company is urging all owners to contact Easy Bake and exchange their ovens for a Hasbro product voucher. For more information, oven owners can call 800-601-8418 or visit http://www.easybake.com or http://www.cpsc.gov.
But this isn't the end of the Easy Bake oven, Charness insisted.
"It does have a 40-year history, so we're trying to get it back out there," he said. "We are working on bringing a new model into the marketplace as soon as we can."
There's a headline on Yahoo News today: China is blaming the media for inflating concerns about product safety (rather ironic on the wake of the execution of the minister in charge of drug safety).
I lived in Taiwan for several years and travelled extensively through China. It is, without doubt, one of the most polluted countries in the world.
China deserves the blame. They endanger the entire world and they need to clean up.
Alright: what was destined to happen happened: the greedy unrealistic judge (with an anger problem perhaps) lost. As well he should have.
Here's the story as reported by the Reno Gazette Journal on June 25, 2007:
WASHINGTON (AP) -- A judge ruled Monday that no pair of pants is worth $54 million, rejecting a lawsuit that took a dry cleaner's promise of "Satisfaction Guaranteed" to its most litigious extreme.
Roy L. Pearson originally sought $67 million from the defendants, claiming they lost a pair of trousers from a blue and maroon suit, then tried to give him a pair of charcoal gray pants that he said were not his.
Pearson arrived at the amount by adding up years of alleged law violations and almost $2 million in common law fraud claims. He then lowered the amount he was seeking to $54 million.
But District of Columbia Superior Court Judge Judith Bartnoff ruled that the owners of Custom Cleaners did not violate the city's consumer protection law by failing to live up to Pearson's expectations of the "Satisfaction Guaranteed" sign once displayed in the store window.
"A reasonable consumer would not interpret 'Satisfaction Guaranteed' to mean that a merchant is required to satisfy a customer's unreasonable demands" or to agree to demands that the merchant would have reasonable grounds for disputing, the judge wrote.
Bartnoff wrote that Pearson, an administrative law judge, failed to prove that the pants the dry cleaner tried to return were not the pants he took in for alterations.
Bartnoff ordered Pearson to pay the court costs of defendants Soo Chung, Jin Nam Chung and Ki Y. Chung. The court costs amount to just over $1,000 for photocopying, filing and similar expenses, according to the Chungs' attorney.
A motion to recover the Chungs' tens of thousands of dollars in attorney fees will be considered later.
Chris Manning, the Chungs' attorney, praised the ruling, which followed a two-day trial earlier this month.
"Judge Bartnoff has spoken loudly in suggesting that, while consumers should be protected, abusive lawsuits like this will not be tolerated," Manning said in a statement. "Judge Bartnoff has chosen common sense and reasonableness over irrationality and unbridled venom."
Pearson did not respond to a call and an e-mail seeking comment. Manning, the Chungs' lawyer, said he expected Pearson to appeal.
During the trial, Pearson testified that he wanted only $2 million in damages for himself -- for his mental anguish and inconvenience -- plus $500,000 in attorney's fees for representing himself. Any additional money that the judge might award would go into a fund "to educate people of their rights under the consumer protection act," he said.
The case garnered international attention and renewed calls for litigation reform.
"This case was giving American justice a black eye around the world, and it was all the more upsetting because it was a judge and lawyer who was bringing the suit," said Paul Rothstein, a Georgetown University law professor.
Rothstein said Monday's ruling "restores one's confidence in the legal system."
This comes from the site "All American Patriots."
The U.S. Consumer Product Safety Commission and the National Highway Traffic Safety Administration (NHTSA), in cooperation with Evenflo Company Inc., today announced a recall of the following consumer product. (To access color photos of the following recalled products, see CPSC's Web site at www.cpsc.gov.)
Name of Product: Evenflo Embrace Infant Car Seat/Carriers.
Units: About 450,000
Manufacturer: Evenflo Company Inc., of Vandalia, Ohio
Hazard: When used as an infant carrier, the handle can unexpectedly release, causing the seat to rotate forward. When this happens, an infant inside the carrier can fall to the ground and suffer serious injuries.
Incidents/Injuries: Evenflo has received 679 reports of the handle on the car seat/carriers unexpectedly releasing, resulting in 160 injuries to children. These reports include a skull fracture, two concussions, cuts, scrapes and bruises.
Description: The recall involves Evenflo Embrace Infant Car Seat/Carriers made before April 8, 2006. The recalled car seat/carriers have model numbers beginning with 317, 320, 397, 398, 540, 548, 549, 550, 556, 597, 598 or 599. The model number and production date information can be found on a white label on the bottom of the carrier and on the top of the convenience base. Models beginning with "5" are units sold with the travel system (compatible stroller). "Evenflo" is on the carrying handle and car seat base. Embrace infant car seat/carriers made on or after April 8, 2006, are not included in this recall.
Sold at: Department and juvenile products stores nationwide sold the car seat/carriers from December 2004 through September 2006 for between $70 and $100 when sold alone and between $140 and $200 when sold with a compatible stroller.
Manufactured in: United States and China
Remedy: Consumers should not use the handle until the repair kit has been installed. The product can continue to be used as a car seat when secured in a vehicle. Contact Evenflo to receive a free repair kit that strengthens the handle latch. Recall notice will be sent to all registered owners of the recalled product. The recalled units should not be returned to the retailer.
Customer Contact: For additional information, contact Evenflo at (800) 490-7497 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the recall Web site at www.embracehandle.com.
A judge in Washington, DC has sued a dry cleaning business for $67 million dollars because it lost his pants.
Stupid lawsuits like this do much to tarnish the good work of America's trial bar.
Needless to say, media outlets, many of which are more concerned with American Idol, Anna Nicole Smith and other "non-news," love this sort of story because it's a story that they incorrectly use to bolster the incorrect notion that "the System's" out of control. There's a market in America for news that's more entertainment, or distraction, than substance.
This is obviously a frivilous suit and will be condemned by trial lawyers across the nation for what it is.
Absurd and aberrational suits like this threaten those victims who are truly wronged and deserve justice. It's a waste and a shame.
Yet another company has announced they are voluntarily recalling pet food involved in the massive recall that is underway. Dog and cat food manufactured by American Nutrition may contain rice protein that was contaminated with melamine. Melamine has turned up in several ingredients used to make pet food including wheat gluten, rice protein, and corn gluten.
However, several of the companies recalling food contend in statements on their Web sites that American Nutrition added the rice protein concentrate to their products without their knowledge or approval.
"It appears that ANI had been adding the unauthorized rice protein concentrate to Harmony Farms products for some time and only told the company when the FDA was about to conclude that some of ANI's rice protein concentrate (supplied by Wilber-Ellis) was contaminated with melamine," said a statement on the Harmony Farms site.
Other companies making similar allegations are The Blue Buffalo Co., Natural Balance, Canine Caviar, Diamond Pet Foods and Mulligan Stew Pet Food.
The melamine in the food has been causing kidney failure in cats and dogs that have eaten the food. Melamine is used to produce plastic kitchenware and is used as a fertilizer in Asia.
Menu Foods has recalled over 90 brands of pet food for dogs and cats and that has many worried. The recall involves wet canned and foil package pet food in the "cuts and gravy" style and includes major brands such as Iams and Eukanuba as well as store brands. Most stores have pulled all of the recalled food from their shelves.
Some of the 60 million cans and pouches of pet food have been blamed for kidney failure in scores of animals and killed at least 16 pets. Neither the manufacturer nor authorities have been able to determine why the pets died.
Since Friday, nearly 100 brands of the cuts-and-gravy style of food have been recalled by Menu Foods of Canada, including popular labels sold at Wal-Mart and other large retailers.
Veterinarians are directing most questions to the Food and Drug Administration's recall Web site. Some have agreed to run blood tests on pets, even though many of the animals have not consumed any of the recalled brands.
The recall is voluntary, so stores are not required to stop selling the recalled food. It is up to consumers to be vigilant and watch out for their pets. Signs of kidney failure include increased thirst, loss of appetite and lethargy.
The following comes from Law.com quoting the Associated Press on October 6, 2006:
The same day a Philadelphia jury ruled that a hormone replacement drug at least partially caused a woman's breast cancer, a Reno woman who is dying of the disease reached an out-of-court settlement with the New Jersey-based drug maker.
Just two days before her trial was to begin, Carol McCreary and Wyeth Pharmaceuticals told Washoe District Judge Robert Perry on Wednesday they have resolved the case. Both sides agreed that the terms of the settlement will remain confidential.
Earlier Wednesday, the Philadelphia jury awarded Jennie Nelson, 66, of Dayton, Ohio, $1 million and her husband $500,000 in compensatory damages. The panel must return to determine whether Wyeth is liable for damages.
Nelson had taken Prempro for five years to treat menopausal symptoms before being diagnosed with breast cancer in 2001.
"Other plaintiffs lawyers will see this as an indication that it's possible to prove causation in a Prempro case, and that will be encouraging to plaintiffs and unwelcome news for Wyeth," Seton Hall law professor Howard M. Erichson said.
"But ultimately, if Wyeth prevails in the second phase, then Weyeth will be 2-and-0 in the Prempro litigation and that will be the significant news," he said.
Madison, N.J.-based Wyeth won the first Prempro case last month when a federal jury in Little Rock, Ark., rejected a similar claim filed by a 67-year-old woman there.
About 5,100 women have filed suits over Wyeth hormone drugs Premarin and Prempro, but just a handful are scheduled for trial this year. The Philadelphia case is the second to go to trial. McCreary's would have been the third.
Wyeth said the company acted responsibly, noting that the Food and Drug Administration in 1995 called hormone replacement drugs the most extensively researched medicines in the United States.
"I am grateful that my attorneys have resolved my case against Wyeth Corporation," she said in a statement. "I am happy to get on with my life and not spend the next several weeks in a courtroom."
In the weeks leading up to the trial, Wyeth representatives said they sympathized with McCreary's situation, but denied that Prempro is responsible for her cancer.
"Science is unable to determine the specific cause of any woman's breast cancer," Wyeth spokesman Chris Garland said before Perry issued a gag order against the two sides in the case. "Despite what plaintiff's lawyers may say, medical experts will testify that the cause cannot be pinpointed."
"The risk of breast cancer associated with hormone therapy is actually lower than the risk of developing a brain hemorrhage from taking aspirin," Garland said.
This from the AP today:
CHICAGO - Just days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of a prestigious medical journal says she was misled again -- this time by the authors of a study linking severe migraines to heart attacks in women.
All six of the study's authors have done consulting work or received research funding from makers of treatments for migraines or heart-related problems. Their research appears in Wednesday's Journal of the American Medical Association, a week after the crackdown was announced.
The authors said they did not report their financial ties because they did not believe they were relevant to the study.
Public Citizen, the consumer watchdog group, has called for women to stop using the dangerous Ortho Evra birth control patch.
Public Citizen warned consumers about the patch over two months ago, but just last week, the FDA acknowledged the increased risk of blood clots, which can ultimately lead to death.
According to the Ortho Evra statement from Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group:
There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.
Ortho Evra lawyers are gathering information and attorneys have filed at least one Ortho Evra lawsuit (on behalf of 10 women) against Johnson and Johnson and its subsidiary, Ortho McNeil Pharmaceuticals.
Ortho Evra was introduced in 2002. Around 4 million women have used the contraceptive since it came on the market.
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