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Recycled Medical Devices Draw Attention

Yahoo News and the AP report today as follows:

TRENTON, N.J. - For eight months during his infancy, Sean Van Duyn gagged, retched and vomited daily. Now 6, the Winter Haven, Fla., boy still can't eat or drink by mouth, instead being fed by a permanent tube in his belly.

Beset by multiple medical problems in his first months, the boy had to have a breathing tube inserted through a hole cut in his neck. The gagging began and continued until his mother, Susan, discovered the tube was misshaped at the end and had been poking the back of his throat the whole time. The tube was replaced, but by then Sean's developing brain was programmed not to swallow; he still cannot.


The family alleged the injury occurred because the plastic breathing tube's tip had been bent during "reprocessing" -- cleaning and heat sterilization -- done at an Orlando hospital even though the tube was labeled for single use only. They won a confidential settlement from the hospital.

The case has fueled the debate over the safety of reusing surgical blades, forceps and other medical devices. The practice was routine until a couple decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent infection spread in the era of AIDS.

Then hospitals, and eventually specialized companies, started "reprocessing" single-use devices, cutting device costs by about half -- without patients' knowledge.

Federal regulators say reprocessing is safe, but original device manufacturers say they can't guarantee recycled products will work correctly -- and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.

A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who's at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient's chart.

"That's like a 'Sue Me!' sticker," and may not be used much, said Josephine Torrente, a lawyer and biomedical engineer who consults for device manufacturers.

Dan Vukelich, executive director of the Association of Medical Device Reprocessors, argues reprocessed products are totally safe because each item is inspected before being shipped.

The device makers and their trade group have been lobbying legislators in several states for bills that protect their interests -- and patients. The battle has a big -- and fast-growing -- financial stake for both sides. Device makers saw combined revenues jump from $48 billion in 2001 to $71 billion last year; reprocessors went from a combined $20 million in 2000 to $87 million in 2004.

Johnson & Johnson subsidiary Ethicon Endo-Surgery is suing the biggest reprocessor, Ascent Healthcare Solutions, for trademark infringement over reprocessing its single-use devices.

"It is impossible to reuse them," said Robert O'Holla, J&J's head of regulatory affairs for medical devices, because they are not designed to be taken apart for cleaning. Yet J&J gets complaints from customers about problems with devices showing excessive wear or bleach on them -- signs of reprocessing.

Ascent Healthcare's regulatory chief, Don Selvey, said only about 2 percent of medical devices -- a category that ranges from MRI machines to reading glasses -- are now reprocessed. He said his company's processes reduce chances of "viable organisms" surviving on devices to one in one million.

Reprocessed devices are soaked in sterilizing solutions, disassembled, blasted clean with a fine powder, reassembled and inspected, then packaged, sterilized and resealed. On average, they're reused three to six times.

"It is as safe and effective as a new device if they meet our requirements," said Larry Spears, compliance chief for medical devices at the Food and Drug Administration.

Since early 2004, when reports of problems with medical devices were first required to note if they had been reprocessed, the FDA has received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm, although some may be duplicate reports.

Reprocessors say they must meet stringent FDA standards after first proving they can safely clean and sterilize each type of device. But the manufacturers main trade group, the Advanced Medical Technology Association, notes about half of the reprocessors' applications for reprocessing of individual devices were rejected by FDA, a sign of the difficulty of properly cleaning complex devices.

Rep. Tom Davis, a Virginia Republican who chairs the House Government Reform Committee, said Friday he plans a fall committee hearing to examine the issue.

"It is unclear to us at this time whether FDA is able to accurately track how often something goes wrong because a device meant to be used once was instead reused," Davis wrote in a statement.

Congress also has asked its investigative arm, the Government Accountability Office, to update a June 2000 report which concluded more oversight is needed. GAO is unsure when it will begin investigating.

Ken Hanover, CEO of the seven-hospital Health Alliance of Greater Cincinnati, said his hospitals have used reprocessed devices for about eight years without a problem.

"There's far more risk of medication errors in a hospital than of a problem arising with a reprocessed device," he said, adding that his hospitals "probably" would honor patient requests to have only new devices used on them.

Children's National Medical Center in Washington, on the other hand, doesn't use reprocessed devices, said surgeon in chief Dr. Kurt Newman.

"We want to use the safest and most sterile equipment," he said.

University of Pennsylvania bioethicist Arthur Caplan has "qualms" about the practice, particularly because patients don't give informed consent -- required when deviating from the standard of care raises safety or efficacy concerns.

"I just think people ought to know what's going on," Caplan said.

Susan Van Duyn, Sean's mother, agreed.

"If anybody can learn from the tragedies with Sean, it's worth telling" his story, she said.

« Defenses in Nevada Negligence Cases - Part I | Main | Recycled Medical Devices Draw Attention »

Damages in Nevada Negligence Cases - Part II

Here is the second part of our continuing discussion of Nevada negligence law.

Set forth below are case citations and holdings that deal with damage issues in such cases.

The statutes of repose bar only those actions arising out of design and construction-related negligence, but not negligent maintenance. Davenport v. Comstock Hills-Reno, 118 Nev. 389, 46 P.3d 62 (2002).

Under NRS 41.141, a plaintiff who is fifty percent at fault is not barred from recovery, but his damages are reduced by his own percentage of negligence. NRS 41.141(1); State Farm Auto Ins. Co. v. Commissioner of Insurance, 114 Nev. 535, 958 P.2d 733 (1998).


In Nevada, an abutting property owner or occupant does not have a duty to keep a sidewalk in front of his/her property in a reasonable safe condition, and liability will not lie unless owner created defect in manner independent of and apart from ordinary and accustomed use for which sidewalks are designated. Wiseman v. Hallahan, 113 Nev. 1266, 945 P.2d 945 (1997).

Recovery is barred when the danger is obvious, not because the negligence of the plaintiff is greater than that of the defendant, but because the defendant is not negligent at all. The defendant has no duty to warn against an obvious danger and cannot, therefore, be negligent in failing to give such a warning. Harrington v. Syufy Enterprises, 113 Nev. 246, 931 P.2d 1378 (1997).

The obvious danger rule survives the adoption of comparative negligence statutes. Harrington v. Syufy Enterprises, 113 Nev. 246, 931 P.2d 1378 (1997).

The obvious danger rule does not apply to situations where liability is predicated upon acts other than a failure to provide adequate warning of a dangerous condition. Thus, even where the danger is obvious, a defendant may be negligent in having created the peril or in subjecting the plaintiff to peril. Harrington v. Syufy Enterprises., 113 Nev. 246, 931 P.2d 178 (1997).

Where an unforeseeable supervening cause intervenes between defendant's negligence and plaintiff's injury, defendant is relieved of liability. Dakis v. Scheffer, 111 Nev. 817, 898 P.2d 116 (1995); El Dorado Hotel, Inc. v. Brown, 100 Nev. 622, 691 P.2d 436 (1984).

Express assumption of risk is essentially a contract where the plaintiff signs a document and openly agrees to hold the defendant harmless for known and inherent dangers of a particular activity. Auckenthaler v. Grundmeyer, 110 Nev. 682, 877 P.2d 1039 (1994).

With the single exception of an express assumption of risk, the assumption of risk doctrine has been subsumed by our comparative negligence statute and is no longer a bar to recovery for negligence. Auckenthaler v. Grundmeyer, 110 Nev. 682, 877 P.2d 1039 (1994); Mizushima v. Sunset Ranch, 103 Nev. 259, 737 P.2d 1158 (1987).

Where a foreign substance causing a patron to slip and fall results from actions of persons other than the business or its employees, the business is liable only if it had actual or constructive notice of the condition and failed to remedy it. Chastain v. Clark County School Dist., 109 Nev. 1172, 866 P.2d 286 (1993); Sprague v. Lucky Stores, Inc., 109 Nev. 247, 849 P.2d 320 (1993).

The contributing fault on the plaintiff's part could reduce the plaintiff's recovery under the doctrine of comparative negligence, but it does not negate a finding that the defendants' negligence was the proximate cause of the plaintiff's injuries. Joynt v. California Hotel & Casino, 108 Nev. 539, 835 P.2d 799 (1992); Taylor v. Silva, 96 Nev. 738, 615 P.2d 970 (1980).

NRS 41.500, the Good Samaritan statute, provides that any person who renders emergency aid, gratuitously and in good faith, is not liable for acts of ordinary negligence. The phrase "gratuitously and in good faith," limits the protection of this statute to those situations in which the rescuer was not already under a duty to act. NRS 41.500; Sims v. General Telephone & Electronics, 107 Nev. 516, 815 P.2d 151 (1991), overruled on other grounds in Tucker v. Action Equipment and Scaffold Co., Inc., 113 Nev. 1349, 951 P.2d 1027 (1997).

Critical ingredients of "emergency" situation within meaning of Good Samaritan statute are as follows: suddenness, unexpected necessity for immediate action, lack of time for measured evaluation of alternative courses of action, and respective efficacy and priority of alternatives. NRS 41.500; Buck v. Greyhound Lines, Inc., 105 Nev. 756, 783 P.2d 437 (1989).

The vitality of express assumption stems from a contractual undertaking that expressly relieves a putative defendant from any duty of care to the injured party; such a party has consented to bear the consequences of a voluntary exposure to a known risk. Mizushima v. Sunset Ranch, 103 Nev. 259, 737 P.2d 1158 (1987).

To relieve a defendant from liability under an "act of God" theory, the act must be such a providential occurrence or extraordinary manifestation of the forces of nature that it could not reasonably have been foreseen, and the effect thereof avoided by reasonable care or by the use of those means which the situation renders reasonable to employ. Alamo Airways, Inc. v. Benum, 78 Nev. 384, 374 P.2d 684 (1962).

« JAMA Discloses Ongoing Conflicts of Interest | Main | Damages in Nevada Negligence Cases - Part II »

Defenses in Nevada Negligence Cases - Part I

Here is the first part of our continuing discussion of Nevada negligence law.

Set forth below are case citations and holdings that deal with damage issues in such cases.

Relief in contribution and implied indemnity is unavailable to the extent those claims arise from the intentional or punitive liability of the party seeking such relief. The Doctors Co. v. Vincent, 120 Nev. 644, 98 P.3d 681 (2004).

Whether Beckwith thought Reccelle was God or his evil master is of no matter because he admittedly struck Reccelle in the eye with the desire of getting away from him. This is a non-accidental intentional act even if Beckwith did not intend to harm Reccelle. Thus, we conclude that Beckwith's act of striking Reccelle is not an occurrence under the insurance policy and is excluded from coverage under the policy language concerning intentional misconduct. Beckwith v. State Farm Fire and Cas. Co., 120 Nev. 23, 83 P.3d 275 (2004).


A government entity is afforded immunity for pre-emergency negligence when the damage caused by the negligent emergency management was exacerbated by the pre-emergency negligence. A government entity, however, is not immune from liability for its pre-emergency negligence that is not intertwined with damage caused by later negligent emergency management activities. Vermef v. City of Boulder City,119 Nev. 549, 80 P.3d 445 (2003).

An employer was not vicariously liable for its employee's negligence when the employee commuted from his home to a jobsite in his private vehicle. Kornton v. Conrad, Inc., 119 Nev. 123, 67 P.3d 316 (2003).

State employees engaged in child protective services are entitled to quasi-judicial immunity when they provide information to the court (e.g., reports, case plans, testing evaluations and recommendations) pertaining to a child who is or may become a ward of the State. When a state agency or its employees provide their decision-making expertise to the court, they act as an arm of the court and are entitled to absolute quasi-judicial immunity. However, once the court makes a decision ratifying the recommendations of the state agency (e.g., placement in foster care, need for further medical evaluation, etc.), the state agency and its employees are no longer acting as an arm of the court. Rather, their function in carrying out the order of the court falls within the executive branch of government and pursuant to their statutory duties. Specifically, quasi-judicial immunity does not apply to state agencies or their employees for the day-to-day management and care of their wards. State v. Second Judicial Dist. Court ex rel. County of Washoe, 118 Nev. 609, 55 P.3d 420 (2002).

The Court declined to recognize an independent tort for spoliation of evidence regardless of whether the alleged spoliation is committed by a first or third party. Additionally, the Court concluded that a negligence claim for spoliation does not exist under the circumstances presented in this case. Timber Tech Engineered Bldg. Products v. The Home Ins. Co., 118 Nev. 630, 55 P.3d 952 (2002).

« Damages in Nevada Negligence Cases | Main | Defenses in Nevada Negligence Cases - Part I »

JAMA Discloses Ongoing Conflicts of Interest

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.

« Best and Worst of Times for Medical Malpractice | Main | JAMA Discloses Ongoing Conflicts of Interest »

Damages in Nevada Negligence Cases

Here is a continuing survey of cases and holdings that pertain to damages in Nevada negligence cases. As always, cases are listed in chronological order starting with more recent cases.

An employer may be liable for punitive damages for acts or omissions of its agents if, but only if, (a) principal or managerial agent authorized doing and manner of act; (b) agent was unfit and principal or managerial agent was reckless in employment or retaining him, (c) agent was employed in managerial capacity and was acting in scope of his employment, or (4) principal or managerial agent of principal ratified or approved act. Smith's Food & Drug Centers, Inc. v. Bellegarde, 114 Nev. 602, 958 P.2d 1208 (1998).

Absent injury to person or property, a plaintiff may not recover in negligence for economic loss. Arco Products Co. v. May, 113 Nev. 1295, 948 P.2d 263 (1997); Local Joint Executive Board v. Stern, 98 Nev. 409, 651 P.2d 637 (1982).


Emotional distress can be an element of damage recovered by a direct victim in a negligence cause of action. Shoen v. America, Inc., 111 Nev. 735, 896 P.2d 469 (1995).

When a party negligently damages the property of another, the damage award should be designed to compensate the injured party in full measure for the total harm proximately caused by the defendant's breach of duty. Nelson v. Peckham Plaza Partnerships, 110 Nev. 23, 866 P.2d 1138 (1994).

Economic loss is something other than property damage. Economic losses include lost profits, lost productivity, lost wages, business expectations and other losses that flow from the loss of the things damaged by the defective product. National Union Fire Ins. Co. of Pittsburgh, Pa. v. Pratt and Whitney Canada, Inc., 107 Nev. 535, 815 P.2d 601 (1991).



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