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April 25, 2008

Hospitals More Dangerous After Dark

A new study that appears in the Journal of the American Medical Association concludes that the graveyard shift in hospitals is the most dangerous time for a patient to require a "code blue" for a stopped heart. Researchers found that among the late night cases studied, there were a higher portion of instances where patients were discovered with no heart electrical activity; that is, too late to deliver a lifesaving shock.

According to the Associated Press, "Everyone who works in a hospital is going to look at this and say, 'Are we doing everything we should be?'" said Dr. Charles Porter, a cardiologist at the University of Kansas Hospital in Kansas City, Kansas.

This sounds a bit disingenuous in my experience since nearly every doctor or nurse I've ever talked to is perfectly aware that care declines at night. Among other things, this is common sense.

In fact, and as some readers know, I've previously blogged on the subject of the danger of hospitals at night and on weekends. Doctors know this; nurses know this; even lawyers know this.

Reno Judge Slashes Damage Award

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.

March 14, 2008

Medical Care Costs Climb

Briefly: the cost of medical care posted a small 0.1 percent increase in February as doctors' fees actually fell.

However, medical care, the fastest-rising price category outside of energy, is still up by 4.5 percent over the past year.

March 13, 2008

Nevada Slow to Inspect Endoscopy And Other Surgery Centers

The Reno Gazette reports that the State Health Division has fallen behind in inspecting surgical centers for more than 10 years and has failed to inspect half of all centers over the past six years as is called for by Federal guidelines.

More specifically, State inspectors failed to inspect 22 of Nevada's 50 surgical centers over the last six years and at least one center has gone without inspection for 15 years.

The Director of the Centers for Disease Control and Prevention has indicated that it is assessing whether unsanitary practices are occurring at surgical centers nationwide. Interestingly, she noted "tremendous cost incentive" for clinics to skirt proper procedures.

March 10, 2008

Reno Surgery Center Situation Different So Far From Las Vegas Hepatitis Scare

I've been traveling for depositions the last few days while the story of deficiencies among ambulatory surgery centers has been brewing.

What's clear from the recent publicity regarding surgery centers other than the infamous Endoscopy Center of Southern Nevada is that not so much is clear.


Apparently when the State determined that as many as 40,000 people who visited the Southern Nevada house of surgical ill-repute might be infected with some awful thing or another, the State decided that it might widen its probe. Not completely surprisingly, the State found bad practices elsewhere, including in Reno.

While bad practices are bad practices, it's not clear as of this writing just what the State may have found at locales north, and residents may wish to wait before rushing to judgment. My information is that allegations regarding Digestive Health Center in Reno are misleading and that local press may print clarifications in the coming days. So stay tuned and we'll see what happens.

Here are a few things we know:

First, people who have visited centers that have been cited for deficiencies or have questions about the investigation can talk to an expert by calling the health department's hotline at (702) 759-4636. The hotline can also be used by Northern Nevada residents; there is currently no hotline set up for local calls.

The foregoing was reported by the Reno Gazette Journal, which also indicated that "[f]or now, the state is advising the public to be patient."

Why, though, should the State think that people should or will be patient when the State itself has publicized vague information and directives?

Importantly, there has been no report that I know of that anyone in the Reno or surrounding areas has tested positive for some disease associated with bad practices at any northern Nevada facility. There is no known correlation between the spread of disease and northern Nevada deficiencies. And this distinguishes the northern Nevada inspections from the southern Nevada inspections.

Here are some other things we know:

State police, the FBI and Nevada's attorney general's investigators served warrants today at six southern Nevada medical clinics associated with a facility accused of infecting patients with hepatitis by reusing syringes and vials of medicine. According to the Reno Gazette Journal, police say the raids are part of a criminal investigation of officials at the Gastroenterology Center of Nevada;

Governor Gibbons said today in a news conference that better funding for more inspections of Nevada's out-patient surgical centers likely would not have prevented the unsafe practices that infected six patients with hepatitis C at a Las Vegas clinic. Frankly, this sounds somewhat absurd. Of course more inspections would have been useful. As things now stand, these clinics are inspected sporadically, and inspections occur once every seven or so years. Why wouldn't more inspections serve the public good?

The Nevada Health Department's site isn't especially enlightening, but there is a press release issued as of Friday and I reprint that below. Keep tuning in: I will be watching this story closely and will bring you unadulterated and balanced reports based upon media and independent research. For now, I agree that northern Nevadans should not jump to conclusions.

Here's the State's official press release, which can also be found at State Press Release on Surgery Center Inspections March 7, 2008

SEVERAL ADDITIONAL OUTPATIENT SURGICAL CENTERS
FOUND TO HAVE DEFICIENT PRACTICES

No Further Infectious Disease Reports Identified

Carson City--Nevada Department of Health and Human Services (DHHS) Director
Mike Willden announced today that the Nevada State Health Division, Bureau of Licensure and Certification (BLC) has found several outpatient surgical centers that have had deficiencies noted during Focus Surveys currently being conducted. The Surveys are being completed as part of the State's effort to inspect all fifty Ambulatory Surgical Centers (ASCs) in the state that perform outpatient surgical procedures.

In Northern Nevada, Focus Survey inspections have been done at ten of 19 ASCs. Three
facilities in Reno were found to be deficient due to a lack of using proper antiseptic practices or for not using proper infectious disease prevention procedures. Five other facilities were found to have problems that did not pose an infectious disease risk. In all eight cases, immediate corrective action was undertaken before BLC staff exited the facility. At two facilities, Sierra Vista Surgery Center and South Meadows Endoscopy Center, no deficiencies were noted. In Clark County, the Gastrointestinal Diagnostic Center will receive a formal Statement of Deficiencies on Monday, March 10, from BLC. The deficiencies noted at the facility are similar to those discovered at the Endoscopy Center of Southern Nevada. The facility will have ten days to submit its Plan of Correction to BLC (March 21, 2008). Upon further inspection, if the facility is found to be negligent in adhering to the Plan of Correction, the facility is subject to summary suspension of its license.

"It is important to note there has been absolutely no known infectious disease reports
associated with any of the facilities that were notified of deficient practices," Willden said.
"Further, the Bureau of Licensure and Certification does not leave a facility whose practices pose a threat to public health until corrective action is taken."

Willden said the State Health Division continues to work closely with the Washoe
County Health Division and the Southern Nevada Health Division to monitor any reports of infectious disease any of the three agencies discovers.

Three facilities in the Reno area who were identified as being deficient due to a lack of
using proper antiseptic practices or for not using proper infectious disease prevention procedures are:

St. Mary's Outpatient Clinic at Galena
18653 Wedge Parkway, Reno

Improper sterilization procedures

Digestive Health Center
5250 Kietzke Lane, Reno

Improper sterilization procedures

Sierra Center for Foot Surgery
1801 N. Carson Street, Carson City

Staff admitted reusing syringes

Willden said the State Health Division will post on its website (http://health.nv.gov)
information about all ASC inspections by BLC. Members of the public may call (775) 684-5900
24 hours a day to receive information about any questions related to the inspections or infectious
disease prevention.

March 7, 2008

Nevadans Question Vaccinations

According to an article from PBS: Newshour Extra dated March 7, 2008, a number of parents are blaming vaccinations for the emergence of autism in their children.

Parents are filing their cases in a "federal vaccine court," which was set up to protect vaccine makers from bankruptcy. If the vaccination companies are found at fault, the award plaintiffs will come from a government fund and not from the industry itself.

The parents claim that thimerosal, a preservative in vaccines that contains mercury, caused their children to have autism. This is a preservative that is common in many of the vaccinations given to young children.

A study conducted by the Centers for Disease Control in 2003 disputes this contention and maintains that there is no scientific evidence to show that the preservative causes autism in children.

Some parents argue that autism levels are rising in the U.S. Only one infant in every 10,000 births in the 1880's was diagnosed with autism while that number rose to one in every 166 births in 2003.

Some scientists argue that the increase in autistic children is actually do to the fact that autism is being used more liberally as a label for any child who is mentally retarded or learning disabled. Using autism as the classification of the illness qualifies the child for financial aid and other education assistance.

Nine test cases in this matter are set to be resolved in June and will set the precedent for thousands of other cases to follow.

Nevada Hepatitis Links

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

March 4, 2008

Chinese Take Shot at Nevada Hepatitis Situation

I used to live in Taiwan and I've travelled back and forth to Mainland China many times.

The Chinese do things in subtle ways sometimes.

For years now, China has felt the pressure of U.S. criticism of Chinese safety standards.

This is why it comes as little surprise that China is now running stories in the Chinese press about LOW AMERICAN SAFETY STANDARDS. We shoot at them; they seek out hypocrisy and shoot back.


More specifically, the Chinese Xinhua news agency has run regular stories on this event and reports as of today.

In one story, Xinhua notes that:

An outbreak of hepatitis C at a Nevada clinic in the United States may be "the tip of an iceberg" of safety problems at clinics around the country, said the head of the Centers for Disease Control and Prevention.

In another:

Roger Von Bergendorff, who remains in a coma at Spring Valley Hospital, also has had financial problems, filing for bankruptcy in 2000.

Authorities believe they recovered all the ricin in several vials found last week from the motel near the Las Vegas strip where Von Bergendorff had stayed. But they also checked a home in Riverton where Von Bergendorff had lived with a cousin, Thomas Tholen, as well as three storage containers linked to Von Bergendorff.

The FBI said the searches yielded no health threats. Tholen declined to comment Monday when reached by telephone. He said he had not spoken with investigators. Las Vegas police said that firearms, an "anarchist-type textbook" and castor beans were found in the motel room. The book was tabbed at a spot containing information about ricin.

Public records show Von Bergendorff, 57, used at least six addresses between 1983 and 2007 in cities in Utah and California.

He had lived in Riverton for more than a year before moving to Las Vegas about a year ago, said former neighbor Tammy Ewell. He spent the last three months in a camper belonging to a neighbor, John Walster.

Ewell described Von Bergendorff Monday as an introverted man who wore down his hosts by living rent-free and taking advantage of their hospitality.

She said Von Bergendorff wasn't social with neighbors and often didn't return a friendly wave. But while Von Bergendorff could be awkward around people, he loved animals, she said. She said he returned to Utah several times after he moved to Las Vegas to search for a lost cat.

See: xinhuanet.com

Other stories Xinhua is currently running deal with China's efforts to improve rural medical care and U.S. statistics which suggest that use of cosmetic surgery in the U.S. soared in 2007.

March 2, 2008

Nevada Hepatitis Doctor Served on Nevada Medical Board

This comes to me once again from Susan Gallagher, Associate Professor at the University of Massachusetts:

Dipak K. Desai, M.D., was re-elected to the position of Secretary-Treasurer of the board. Dr. Desai practices in Las Vegas and has served on the board since September 1, 1993, having just been re-appointed by Governor Miller for his second four-year term. In his capacity as Secretary-Treasurer, Dr. Desai will continue to serve as Chair of the board's Investigative Committee.
It appears that Dr. Desai may have left the Board in 2003...

See also: Medical Board Newsletter

Thanks to Professor Gallagher for her valuable research.

February 29, 2008

Nevada Hepatitis Warning - Endoscopy Center of Southern Nevada Malpractice

Alright, let's get into this.

The subject of controversy is an entity known as Southern Nevada Endoscopy Center.

The Nevada Secretary of State indicates two limited liability companies registered under that name, both active:
The first reflects that Clifford Carrol, MD and the Hari Om Limited Partnership are officers.

The second company, which has the same name but is listed as Endoscopy Center of Southern Nevada II, lists Dipak Desai, MD and Vishvinder Sharma, MD as officers.


There are two entries at the Nevada Secretary of State for Hari Om Limited Partnership.

The first lists Dipak Desai, Kusum Desai and Dilip Patel as partners.

The second, Hari Om II, LLC, shows that it was dissolved on February 7, 2008.

The Nevada Board of Medical Examiners Site does not show disciplinary action for Dr. Carrol. He has had his license here since 1997.

The State Board has disciplined Dipak Desai, MD and the State site provides as follows:

FORMAL DISCIPLINARY ACTION TAKEN BY THE NEVADA STATE
BOARD OF MEDICAL EXAMINERS:

SEPTEMBER 13, 1996

The Investigative Committee of the Nevada State Board
of Medical Examiners filed a formal complaint against
Dr. Desai, the managing partner of Gastroenterology
Center of Nevada, alleging that he was advertising the
practice of medicine in a false, deceptive or misleading
manner by stating that certain members of the medical
group are Board Certified Gastroenterologists when in
fact they are not board certified in Gastroenterology.
Copies; Complaint 12 pages

OCTOBER 23, 1996

The Nevada State Board of Medical Examiners
accepted the Stipulation for Settlement and it was
Ordered that Dr. Desai, the managing partner of
Gastroenterology Center of Nevada, pay the sum of
$2,500 as disgorgement of payments which may
have been received by the group as a result of false
advertisment.

Copies; Order 4 pages Stipulation for Settlement 8 pages

Kusum Desai has been a licensed Nevada doctor (scope of practice listed as critical care, internal medicine and pulmonary disease) since 1980 and has no listed disciplinary actions.

The Board site does not pull up a listing for Dilip Patel.

An advanced search in Google reveals many Dilip Patel's, including an attorney, but it is not clear which Dilip Patel is listed with the Secretary of State.

A Clark County District Court inquiry shows one lawsuit in the mid 90s against a Dilip Patel (perhaps the same individual) in which Mr. Patel is listed as a defendant. This case went to arbitration

For more on the District Court case, see District Court Information on Patel Case

Vishvinder Sharma, MD is listed with the State, is licensed since 1994 and the Board lists no disciplinary actions.

This mess gained intial attention in January 2008 and widespread publicity as of yesterday.

The health district received notification of three acute cases of hepatitis C in January 2008 and subsequently identified a total of six cases to date. Five of the cases had procedures requiring injected anesthesia on the same day.

Following a joint investigation with the Nevada State Bureau of Licensure and Certification (BLC) and with consultation from the Centers for Disease Control and Prevention, the health district determined that unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.

There seems to be fairly universal acknowledgment that the malpractice that may have exposed as many as 40,000 to serious disease stems from the reuse of a syringe (not a needle) that was used to administer medication to a patient was reused on the same patient to draw up additional medication. The process of redrawing medication using the same syringe could have contaminated the vial from which the medicine was drawn with the blood of the patient. The vial, which was not labeled for use on multiple patients, was then used for a second patient (with a clean needle and syringe). If that vial was contaminated with the blood of the first patient, any subsequent patients given medication from that vial could have been exposed to blood borne pathogens.

The Southern Nevada Health District has an extensive question and answer on this subject on its site at Southern Nevada Health District and I will reprint that in another blog today.

IF YOU TEST POSITIVE FOR HEPATITIS C, B OR HIV, AND YOU WERE EXPOSED BY VIRTUE OF TREATMENT AT THE ENDOSCOPY CENTER OF SOUTHERN NEVADA, CHECK OUT OUR CREDENTIALS AND CONTACT US THROUGH INJURYBOARD.

Hepatitis Exposure in Nevada - Public Health Information

The following important public health information is reprinted from the Southern Nevada Heatlh District: www.southernnevadahealthdistrict.com

The Southern Nevada Health District is advising patients who received injected anesthesia medication at the Endoscopy Center of Nevada (700 Shadow Lane) of a risk for possible exposure to hepatitis C and other bloodborne pathogens. The health district is recommending patients who had procedures requiring injected anesthesia at the clinic between March 2004 and January 11, 2008, contact their primary care physicians or health care providers to get tested for hepatitis C as well as hepatitis B and HIV.

Why is the health district making these recommendations?


The health district received notification of three acute cases of hepatitis C in January 2008 and has identified a total of six cases to date. Five of the cases had procedures requiring injected anesthesia on the same day.

Following a joint investigation with the Nevada State Bureau of Licensure and Certification (BLC) and with consultation from the Centers for Disease Control and Prevention, the health district determined that unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.

The exposures did not result from the medical procedures performed.

How were the cases discovered?

The cluster of illnesses came to the attention of the health district in January 2008.

These cases were reported to the health district by area physicians.

Nevada law requires that medical providers notify public health officials when they identify a number of different diseases, including hepatitis C.

The common link between cases was identified through the routine investigation of the cases reported by medical providers, which includes an interview of the patient.

Why did it take several months for this to come to the attention of the health district?

Most people infected with hepatitis C virus do not develop symptoms and do not know that they have been infected. As a result, these infections would not have been reported to the health district.

An infection with hepatitis C that results in the patient developing symptoms (acute disease) is rare so it is an unusual occurrence that brought this problem to the attention of the health district.

On average, two cases of acute hepatitis C are reported each year in Clark County. Six cases have been identified in relation to this investigation.

How were patients exposed?

A syringe (not a needle) that was used to administer medication to a patient was reused on the same patient to draw up additional medication.

The process of redrawing medication using the same syringe could have contaminated the vial from which the medicine was drawn with the blood of the patient.

The vial, which was not labeled for use on multiple patients, was then used for a second patient (with a clean needle and syringe).

If that vial was contaminated with the blood of the first patient, any subsequent patients given medication from that vial could have been exposed to bloodborne pathogens.

How did you determine the link between these cases?

Of the six known cases, five had procedures on the same day. Genetic testing on four of the cases from that day has identified they likely came from a common source.

The patient that had a procedure on a different day does not share a common source as the other four. This indicates the problem that allowed disease transmission to occur was not a one-time event, but had recurred over an extended period of time.

Investigation of the clinic practices identified common practices, which would allow disease to be transmitted in this manner.

What actions have been taken to correct the unsafe injection control practices?

The unsafe injection practices associated with these cases were identified during the investigation conducted in mid-January. The injection practices that lead to the exposure have been corrected, so no new patient exposures should be occurring.

As it can take several months for the symptoms of hepatitis C to appear, additional cases might be identified despite no ongoing transmission of disease.

Who performed the investigation?

The response was led by the Southern Nevada Health District, and the team included members of the Nevada State Bureau of Licensure and Certification and the Centers for Disease Control and Prevention.

Why is the health district also recommending testing for hepatitis B and HIV?

The investigation revealed practices that could have exposed patients to the blood of another patient. Although hepatitis C was the focus of the investigation, hepatitis B and HIV can be transmitted in the same manner.

How many people will be diagnosed with hepatitis C, B or HIV from this investigation?

It is unknown how many people were infected at the clinic. Hepatitis C, B and HIV are routinely found in the population. A significant number of people might have been infected prior to their procedure. Although testing can determine if a person is infected, it cannot determine the source of the infection.

How serious are these illnesses?

Hepatitis C, B or HIV can result in a range of disease severity, and can eventually result in death.

It is important that patients speak with a physician or health care provider if you have one of these diseases. A physician will be able to address specific risks for serious illness and develop a plan to monitor your health.

How many cases of hepatitis C are reported to the health district each year?

On average, two cases of acute hepatitis C are identified each year in Clark County.

Most people who become infected with hepatitis C initially have mild or no symptoms and do not know that they have been infected unless they are tested by a doctor. Only a small percentage of people infected with hepatitis C develop acute disease and have any outward signs of infection.

What is the Southern Nevada Health District's role in the response?

The Southern Nevada Health District is responsible for investigating reports of illness in our community in order to take steps to protect the health and well-being of the public.

Once notified of a reportable disease the health district begins an investigation and works with the appropriate agencies to address any issues identified and make recommendations to help prevent this type of situation from occurring again.

As a patient how can I protect myself when getting these types of medical procedures?

It is important to remember the transmission of the disease in these cases were not related to the medical procedures, but rather to the anesthesia administered to the patient.

When proper injection practices are followed, medical procedures, including colonoscopies or similar procedures, are generally safe.

All health care professionals and medical facilities should follow safe injection practices and infection control procedures. Patients can and should ask their medical providers about the practices used in their facility.
Are these types of medical procedures safe?

Preventive medical procedures are an important part of protecting yourself against the development of diseases, including cancer. If recommended by your physician, there is no reason why you should avoid undergoing these types of medical procedures.

Although this investigation focused on a center that performed endoscopies, the source of the exposure was the way the anesthesia was administered.

What is being done to prevent this from happening again?

The Southern Nevada Health District, the Nevada State Health Division and the Bureau of Licensure and Certification are providing technical bulletins and educational materials to medical facilities and providers in an effort to educate the health care community and prevent these types of incidents from happening in the future.

What are the recommendations for people who test positive for hepatitis C, B or HIV?

Options for disease management and possible treatment options, as well as regular health monitoring, should be discussed with a physician, who can determine the appropriate next steps for the patient.

Hepatitis Victims May Be Duped By Med Mal Insurance Industry

Nevadans, you were duped by the medical malpractice insurance industry when you voted for the KODIN Ballot Initiative a few years back.

Now those injured through the sheer negligence and stupidity of a group of Nevada doctors may find that they've limited their ability to collect compensation.

Consider, for instance, that damages for pain and suffering are now capped in Nevada at $350,000.00. Evidence of insurance payments can come into evidence. The statute of limitations is now reduced to a year in many situations. The list of penalties for victims goes on and on.

If you got Hepatitis or HIV as the result of medical negligence do you think that $350,000 (before attorneys fees and costs) was enough to compensate you?

Call your state representatives and let them know that KODIN is a mistake.

Nevada Hepatitis Doctor Sued Before

I discussed Dipak Desai, MD, several blogs ago in some detail.

The following useful article was referred to me by Susan E. Gallagher, an Associate Professor at the University of Massachusetts:

Nevada Law Journal Article on Dipak Desai Medical Malpractice:
http://nevadalawjournal.org/pdf/borgerVsLovett.pdf

Back tomorrow with the promised article on why this case of what appears to be plain and substantial medical malpractice reflects what a disaster medical malpractice reform is for Nevadans.

February 28, 2008

Nevada Endoscopy Center Malpractice

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.

Nevada Hepatitis Scare

You know, you might think that you could go the Center for Disease Control website and get some update on what certainly appears to be a full-blown health care crisis in Las Vegas (40,000! Exposed? That's a big number! And that's a preliminary number...).

But the CDC website, at least from my look around just now, is more about some form of static and slow thing. There may be something current somewhere on the site, but whatever it is doesn't jump out to the viewer. And they don't seem preoccupied with our potential Hep C epidemic right now, at least not site-wise.

And there's no analogous state site in Nevada to report on this sort of (seemingly) urgent issue. At least none easily found.

I'm sure some government entity somewhere may have some sort of information about this

In the meantime let's look to one of our great democratic institutions, the private press:

USA TODAY reports that:

The Las Vegas Sun has a statement from the company: On behalf of the Endoscopy Center of Southern Nevada, we want to express our deep concern about this incident to the many patients who have put their trust in us over the years. As always, our patients remain our primary responsibility and we have already corrected the situation.

http://blogs.usatoday.com/ondeadline/2008/02/health-departme.html

It's especially comforting that they've "already" corrected the situation. After only 40,000 potential errors! That's attention. That is diligence...

I'll blog tomorrow morning on how Nevada's recent ill-advised adoption of medical malpractice tort reform could prevent thousands from compensation for what appears to be not only negligence but abject stupidity.

The facts are still coming in; we'll reserve judgment as good Americans do.

But make no mistake: Nevada's adoption of the so-called KODIN (Keep Our Doctor's in Nevada) ballot initiative was a catastrophic mistake whose effects are just now being seen. Nevadans were convinced that they were taking a shot at the trial lawyers when all they were really doing was negating their own right to compensation in serious medical malpractice injury cases.

Come back tomorrow and let's talk about the value of tort reform when it comes to cases like Endoscopy Center of Southern Nevada.

February 22, 2008

U.S. Supreme Court Rules on Medical Device Lawsuits

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."

February 19, 2008

Hospitals More Dangerous After Dark

A new study that appears in the Journal of the American Medical Association concludes that the graveyard shift in hospitals is the most dangerous time for a patient to require a "code blue" for a stopped heart. Researchers found that among the late night cases studied, there were a higher portion of instances where patients were discovered with no heart electrical activity; that is, too late to deliver a lifesaving shock.

According to the Associated Press, "Everyone who works in a hospital is going to look at this and say, 'Are we doing everything we should be?'" said Dr. Charles Porter, a cardiologist at the University of Kansas Hospital in Kansas City, Kansas.

This sounds a bit disingenuous in my experience since nearly every doctor or nurse I've ever talked to is perfectly aware that care declines at night. Among other things, this is common sense.

In fact, and as some readers know, I've previously blogged on the subject of the danger of hospitals at night and on weekends. Doctors know this; nurses know this; even lawyers know this.

If you need hospitalization, try to need it on a weekday.

February 13, 2008

Does Nevada Have Jurisdiction? Part III

This is the last part of my three-part series on the issue of whether Nevada has jurisdiction over a doctor who practices medicine over the Internet from a different state.

1. Many States Have Recognized The Propriety Of Exercising Jurisdiction Over Nonresident Doctors

Courts have found jurisdiction over nonresident doctors where they purposefully directed their actions at plaintiffs' states. For example, where doctors or hospitals have sought business from a state, courts have held jurisdiction over them to be proper in that state. See, e.g., Cubbage v. Merchant, 744 F.2d 665 (9th Cir.1984), cert. denied, 470 U.S. 1005, 105 S.Ct. 1359, 84 L.Ed.2d 380 (1985); Pijanowski v. Cleveland Clinic Found., 635 F.Supp. 1435 (E.D.Mich.1986); Lemke v. St. Margaret Hosp., 552 F.Supp. 833 (N.D.Ill.1982). Whether a party solicited the business interface in the first place is irrelevant, so long as defendant then directed its activities to the forum resident. Lanier v. American Bd. of Endodontics, 843 F.2d 901, 910 (6th Cir.), cert. denied, 488 U.S. 926, 109 S.Ct. 310, 102 L.Ed.2d 329 (1988).


In Texas, specific jurisdiction is established if the defendant's alleged liability arises from or is related to its contacts within the forum. To establish specific personal jurisdiction over a nonresident physician who treats an unsolicited Texas patient outside of Texas, the patient must show that the nonresident physician, by his actions, knowingly interjected himself into the patient's treatment in Texas. See Clark v. Noyes, 871 S.W.2d 508, 514-16 (Tex.App.-Dallas 1994); see also Kennedy v. Freeman, 919 F.2d 126, 129 (10 th Cir.1990); Wright v. Yackley, 459 F.2d 287, 288-89 (9 th Cir.1972).

The rationale for this rule involves a balancing of the State's interest in the maintenance of the quality of medical care rendered to Texans with the need for Texas residents to have access to the best available medical care regardless of state lines. See Clark, 871 S.W.2d at 516.

In Bullion v. Gillespie, 895 F.2d 213 (5 th Cir.1990), a Texas patient visited a urologist in California, who enrolled the patient in an experimental drug treatment program. The patient then returned to Texas. The California doctor mailed the experimental drugs to the patient in Texas. The drugs injured the patient. See Id. at 215. The Fifth Circuit held that an allegation that the doctor was shipping the drugs to the patient was sufficient to create a prima facie case establishing personal jurisdiction in Texas over the California doctor. See Id. at 217.

In McGee v. Riekhof, 442 F.Supp. 1276 (D.Mont.1978), McGee, the plaintiff, traveled from Montana to Minnesota to obtain treatment from the defendant doctor for a detached retina. The plaintiff then returned to Montana. At the doctor's direction, the plaintiff kept the doctor updated on his condition. After a few weeks, the doctor told the plaintiff he could return to work. The plaintiff did so and suffered a retinal redetachment with a massive retinal tear of the right eye. See Id. at 1277. The plaintiff sued the doctor in Montana.

The Montana federal district court determined it had personal jurisdiction over the Minnesota doctor because the plaintiff was in Montana when the doctor committed the negligent act for which he was sued: advising the patient he could return to work. The court stated: "[b]ased upon the fact the medical service in this case amounts to a new diagnosis, and was rendered to plaintiff while he was in Montana, this court concludes that exercise of personal jurisdiction in this situation is not unreasonable, and comports with the tenets of due process." Id. at 1279. The court stated that "it would be fundamentally unfair to patients to permit doctors to telephonically render services and treatment in Montana, yet shield them from suit in Montana" (emphasis added). Id.

In Kennedy v. Freeman, 919 F.2d 126 (10 th Cir.1990), an Oklahoma patient had a lesion removed by her Oklahoma physician, who sent it to the Texas defendant, Freeman, for a special measurement. See Id. at 127. Freeman measured it and sent a report to the Oklahoma physician that the lesion measure 0.2 millimeters. In fact, the lesion measured 1.2 millimeters. Based on Freeman's incorrect measurement of the lesion, the plaintiff's Oklahoma physician determined no treatment or follow-up care was necessary. Four years later, the plaintiff learned that malignant melanoma had spread over her entire body. See Id. The Tenth Circuit noted that Freeman willingly accepted the sample from Oklahoma, signed a report purporting to establish the size of the lesion and sent it to Oklahoma, and he sent his bill to Oklahoma. Freeman knew the extreme significance of his work and that it would be the basis of the plaintiff's further treatment in Oklahoma. See Id. at 129. The Tenth Circuit ruled that "when a doctor purposefully directs her activities at the forum state, that state has a greater interest in deterring medical malpractice against its residents." Id.

An employee does not himself lack the requisite contact with a forum merely because he acts on behalf of a corporation. Nor does he lack the requisite contact because independent actions of the corporation contribute to events in the forum that give rise to the lawsuit. Courts can constitutionally exercise jurisdiction over a nonresident individual, regardless of his status as an employee, if his actions are a contributing cause of lawsuit-related events that occur in the forum, and if he is reasonably aware that his actions may have an impact in the forum.

Doctors are independently licensed professionals; many are their own corporations. In an age when electronic communication is becoming ubiquitous, doctors will inevitably stretch the limits of their licenses and extend their services to those in other states. Doctors who provide services to nonresident patients may reasonably expect to be hailed into court in whatever jurisdiction they might commit malpractice.

V. CONCLUSION

Why should Nevada adhere to a blanket rule that will result in less protection for Nevada residents in our increasingly electronic age?

The application of the fiduciary shield rule often results in deviation from the law governing personal jurisdiction. In obtaining jurisdiction over a corporate agent, courts must pursue reasoned analysis under the minimum contacts standard rather than reaching easy but incorrect results under the fiduciary shield rule. Courts properly have great discretion in asserting jurisdiction and personal jurisdiction is entirely appropriate in this instance.

January 18, 2008

Does Nevada Have Jurisdiction? Part II

This is the second part of what will be a three-part blog. See yesterday's blog for the issue that the following argument addresses:

A. The Fiduciary Shield Doctrine Is Not Law In Nevada And Even If It Were It Would Not Preclude An Exercise Of Jurisdiction

The fiduciary shield doctrine, a flawed legal theory that has generated confusion and countless inconsistent exceptions, provides that acts performed by an individual in his capacity as a corporate officer may not form the predicate for the exercise of jurisdiction over him as an individual. Marine Midland Bank, N.A. v. Miller, 664 F.2d 899, 901 (2d Cir. 1981). The primary rationale in support of this doctrine is that "it is unfair to force an individual to defend a suit brought against him personally in a forum with which his only relevant contacts are acts performed not for his own benefit but for the benefit of his employer." Id. at 902.


The purpose of the fiduciary shield doctrine is to protect individuals from unreasonable and unjust subjection to personal jurisdiction, not to protect them from liability. Merkel Assocs. v. Bellofram Corp., 437 F. Supp. 612, 618 (W.D.N.Y. 1977). Therefore, the issue that the fiduciary shield doctrine addresses is where a claim can be litigated, not whether a claim can be asserted. See The Fiduciary Shield Doctrine: Minimum Contacts in a Special Context, 65 B.U.L. Rev. 967 (1985).

Many legal commentaries assail the fiduciary shield doctrine as a product of misanalysis and mistake and advocate its total abandonment. Id. at 967.

Courts have sometimes stated that acts performed on behalf of a corporate employer cannot supply minimum contacts for the purpose of jurisdiction over the actor. See Personal Jurisdiction and the Corporate Employee: Minimum Contacts Meet the Fiduciary Shield, 38 Stan. L. Rev. 813 (1986), citing Marine Midland Bank v. Miller, 664 F.2d 899, 902 (2d Cir. 1981); Wilshire Oil Co. v. Riffe, 409 F.2d 1277, 1281 & n.8 (10th Cir. 1969); Allen v. Toshiba Corp., 599 F. Supp. 381, 384 (D.N.M. 1984); Bulova Watch Co. v. K. Hattori & Co., 508 Supp. 1322, 1347 (E.D.N.Y. 1981).

While this approach has been termed the "fiduciary shield rule," the label is misleading for three reasons. First, this approach is usually applied to corporate employees alone, who comprise only a limited subset of all fiduciaries recognized in law. Id., citing Grove Press, Inc. v. CIA, 483 F. Supp. 132, 135-36 (S.D.N.Y. 1980) (fiduciary shield rule does not protect CIA agents from jurisdiction based on wrongful acts performed in their official capacity). See also Idaho Potato Comm'n v. Washington Potato Comm'n, 410 F. Supp. 171, 180-83 (D. Idaho 1975) (fiduciary shield rule does protect state potato commissioners). Second, this approach can operate in a variety of ways, not all of which actually shield an employee from jurisdiction that might otherwise exist. Third, and contrary to Petitioner's contention, the uncertain authority for this approach, and its random application, make it far less than a settled rule.

In fact, several U.S. Supreme Court opinions seem to reject outright the constitutional underpinnings of the rule.
In Calder v. Jones, 465 U.S. 783, 790 (1984), the Court upheld California's exercise of jurisdiction over a reporter who lived in Florida and who was employed by a Florida-based newspaper. The reporter had written an allegedly libelous article about a California resident, which the newspaper published and distributed in California. The Court said that the reporter's acts directed at California justified jurisdiction there. The Court also held that California had properly exercised jurisdiction over the newspaper's president, who had edited the article. In reaching these results, the Court stated that each defendant's contacts with the forum must be "assessed individually." The Court recognized that an employee is not subject to jurisdiction merely by virtue of the employer corporation's contacts with the forum. But it does not follow from this proposition, according to the Court, that an employee is never subject to jurisdiction when he acts in a corporate capacity. The Court did not mention the fiduciary shield rule by name, but held that defendants' "status as employees does not somehow insulate them from jurisdiction." Id.; See also Personal Jurisdiction and the Corporate Employee: Minimum Contacts Meet the Fiduciary Shield, 38 Stan. L. Rev. 813 (1986).

In the companion case of Keeton v. Hustler Magazine, Inc., 465 U.S. 770 (1984), the Court reversed a lower court decision that it did not have jurisdiction over a corporate publisher in a libel action. In a footnote, the Court discussed whether the individual owner and publisher of the magazine might also be subject to jurisdiction. The Court stated, "[i]n Calder v. Jones.... we today reject the suggestion that employees who act in their official capacity are somehow shielded from suit in their individual capacity. Id. at 781, n. 13; See also Personal Jurisdiction and the Corporate Employee: Minimum Contacts Meet the Fiduciary Shield, 38 Stan. L. Rev. 813 (1986)

Courts have frequently expressed dissatisfaction with the results of a blanket application of the fiduciary shield rule. Some courts have recognized that the fiduciary shield rule may represent an improper deviation from minimum contacts analysis. Others have stated that the fiduciary shield is an equitable doctrine that should be applied with discretion. Still other courts have articulated various explicit exceptions to the rule. See Personal Jurisdiction and the Corporate Employee: Minimum Contacts Meet the Fiduciary Shield, 38 Stan. L. Rev. 813, 823 (1986).

One thing that is clear is that the fiduciary shield doctrine is not the law of Nevada. Under Nevada law, the inquiry as to whether a state may assert personal jurisdiction over a nonresident defendant entails a two-pronged analysis. First, a court must determine whether Nevada's long-arm statute authorizes the assertion of jurisdiction under the given set of facts. Second, the application of the long-arm statute to those facts must satisfy the constitutional demands of due process. If both requirements are met, then jurisdiction over the nonresident defendant exists.

In its Order denying Defendant's Motion to Dismiss, the District Court held that Plaintiff must establish a prima facie showing of personal jurisdiction and cited to Trump v. Eighth Judicial Dist. Court, 109 Nev. 687, 694, 857 P .2d 740, 744-745 (1993). See Order Denying Motion to Dismiss, p.2.

The District Court further recognized that "[d]ue process requires 'minimum contacts' between the defendant and the forum state such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice." Order, p. 2;109 Nev. at 694. The defendant must have sufficient contact with the forum such that he or she could reasonably anticipate being haled into court there. Id. The defendant must purposefully avail herself of the privilege of acting in the forum state or of causing important consequences in that state. The cause of action must arise from the consequences in the forum state of the defendant's activities, and those activities, or the consequences thereof, must have a substantial enough connection with the forum state to make the exercise of jurisdiction over the defendant reasonable. Id.

A state may exercise specific personal jurisdiction only where: (1) the defendant purposefully avails herself of the privilege of serving the market in the forum or of enjoying the protection of the laws of the forum, or where the defendant purposefully established contacts with the forum state, and (2) the cause of action arises from that purposeful contact with the forum or conduct targeting the forum. Id.

The guarantee of due process contained in the fourteenth amendment has been construed as limiting the jurisdiction of state courts to enter judgments affecting the rights or interests of nonresident defendants. Kulko v. Superior Court, 436 U.S. 84, 91 (1978). The parameters for such a constitutional exercise of jurisdiction have been set by the minimum contacts standard.

Nevada Medical Malpractice Statute of Limitations

I will get back to my three-part series on the Nevada jurisdictional question we were analyzing on Monday or Tuesday. First, though, since I've recently mentioned the insurance industry's fraud on the Nevada voters otherwise known as KODIN, I reprint below Nevada's highly restrictive statute of limitations.

If you've been injured as a result of Nevada medical malpractice, the statute below means that you must move fast to secure your rights or your rights will be gone.

NRS 41A.097 Limitation of actions; tolling of limitation.

1. Except as otherwise provided in subsection 3, an action for injury or death against a provider of health care may not be commenced more than 4 years after the date of injury or 2 years after the plaintiff discovers or through the use of reasonable diligence should have discovered the injury, whichever occurs first, for:

(a) Injury to or the wrongful death of a person occurring before October 1, 2002, based upon alleged professional negligence of the provider of health care;

(b) Injury to or the wrongful death of a person occurring before October 1, 2002, from professional services rendered without consent; or

(c) Injury to or the wrongful death of a person occurring before October 1, 2002, from error or omission in practice by the provider of health care.

2. Except as otherwise provided in subsection 3, an action for injury or death against a provider of health care may not be commenced more than 3 years after the date of injury or 1 year after the plaintiff discovers or through the use of reasonable diligence should have discovered the injury, whichever occurs first, for:

(a) Injury to or the wrongful death of a person occurring on or after October 1, 2002, based upon alleged professional negligence of the provider of health care;

(b) Injury to or the wrongful death of a person occurring on or after October 1, 2002, from professional services rendered without consent; or

(c) Injury to or the wrongful death of a person occurring on or after October 1, 2002, from error or omission in practice by the provider of health care.

3. This time limitation is tolled for any period during which the provider of health care has concealed any act, error or omission upon which the action is based and which is known or through the use of reasonable diligence should have been known to him.

4. For the purposes of this section, the parent, guardian or legal custodian of any minor child is responsible for exercising reasonable judgment in determining whether to prosecute any cause of action limited by subsection 1 or 2. If the parent, guardian or custodian fails to commence an action on behalf of that child within the prescribed period of limitations, the child may not bring an action based on the same alleged injury against any provider of health care upon the removal of his disability, except that in the case of:

(a) Brain damage or birth defect, the period of limitation is extended until the child attains 10 years of age.

(b) Sterility, the period of limitation is extended until 2 years after the child discovers the injury.

(Added to NRS by 1971, 366; A 1975, 407; 1977, 857, 954, 1082; 1985, 2011; 1989, 424; 1991, 1131; 1993, 2224; 1995, 2350; 1999, 5; 2001, 1107; 2002 Special Session, 8; 2004 initiative petition, Ballot Question No. 3)


January 17, 2008

Does Nevada Have Jurisdiction Over an Out of State Doctor Who Treats Nevada Patients Over the Internet?: Nevada Issue of First Impression

ISSUE: Whether a doctor practicing medicine in Nevada remotely over the Internet, for a California medical group that contracts with a Nevada medical group to render medical services remotely over the Internet and contractually agrees to be bound by the laws of Nevada, is subject to the jurisdiction of the