SCOTUS ruling favors medical device firms

A defeat for the legal piranhas

Patients who are injured by federally approved medical devices can't collect damages if the manufacturers complied with government standards, the Supreme Court ruled Wednesday. The 8-1 decision in a New York case applies to the riskiest devices, like heart valves and pacemakers, which need Food and Drug Administration approval before they can be sold. The court said the 1976 federal law that required FDA clearance for those products would be disrupted by negligence suits under state law, just as it would be impaired by varying state regulations.

Congress' concern for those injured by FDA-approved devices was outweighed by its "solicitude for those who would suffer without new medical devices if juries were allowed to apply the (injury) law of 50 states to all innovations," said Justice Antonin Scalia in the majority opinion.

The court allowed damage claims for injuries caused by products that violate FDA manufacturing specifications or labeling rules, and left intact an earlier decision permitting a broader range of suits over defects in medical devices that don't require FDA review before marketing. But the ruling - on a day in which the justices also limited states' authority to prevent cigarette shipment to minors - was a substantial victory for businesses and a possible foreshadowing of another case, to be argued this fall, about suits by patients claiming harm from FDA-approved drugs.

The medical ruling is "a victory for a national system designed to maximize the benefits to patients" from exhaustive review by government experts, said Theodore Olson, lawyer for Medtronic, manufacturer of the heart catheter involved in the case. While FDA scrutiny is imperfect, he said, it's preferable to product assessment by a jury that "isn't evaluating the needs of patients all over the country and doesn't have expertise."

The plaintiffs' lawyer, Allison Zieve of the Public Citizen Litigation Group, said the decision was "potentially dangerous for patients," because the prospect of damages against manufacturers is an incentive for safety. The suit was filed by Charles Riegel, whose Evergreen Balloon Catheter burst during a 1996 angioplasty. Riegel survived, after emergency bypass surgery, and accused Medtronic of negligence in the design, manufacture and labeling of the device. He died in 2004 of unrelated causes, and his wife, Donna, took over the suit.

In upholding lower-court rulings dismissing the case, the Supreme Court said the catheter, like other devices requiring pre-marketing approval, receives rigorous scrutiny from the FDA, which spends an average of 1,200 hours reviewing each application and grants approval only to those that provide reasonable assurances that the product will be both safe and effective. Scalia cited a provision of the 1976 federal law prohibiting states from enforcing any requirements for medical devices that differed from FDA standards. A jury's finding that the catheter was improperly manufactured or labeled, despite FDA approval, would amount to an additional requirement, he said. "A jury ... sees only the cost of a more dangerous design and is not concerned with its benefits," Scalia said.

Justice Ruth Bader Ginsburg dissented, saying the 1976 law was not intended to thwart negligence suits. She said Congress passed the law to provide uniform regulation after states - led by California - began their own approval process for medical devices in response to lawsuits over infections attributed to the Dalkon Shield intrauterine device. Wednesday's ruling is "at odds with the (law's) central purpose: to protect consumer safety," Ginsburg said.

Source




Australia: Government sorry over 'mutilation doctor'

"Your government will look after you", once again

The NSW Government says it is sorry, but it can't yet explain why a doctor banned from obstetrics was able to continue performing operations which allegedy left many women mutilated. Dr Graeme Steven Reeves is alleged to have mutilated or sexually abused as many as 800 patients. The NSW Medical Board ruled in 1997 that Graeme Stephen Reeves "suffers from personality and relations problems and depression that detrimentally affects his mental capacity to practise medicine". The board ordered him to stop practising obstetrics, but he defied the ban and took up a position in 2001 as a specialist obstetrician and gynaecologist for the Southern Area Health Service, working at Bega and Pambula hospitals. He was struck off the medical register in 2004.

NSW Health Minister Reba Meagher was today asked by reporters how Dr Reeves had continued to practise when hospital and nursing staff must have known about the type of surgery he was performing. "I don't know what was known then by others around Dr Reeves, but I do know this Government radically overhauled the Health Care Complaints Commission to ensure a greater level of protection for patients that have complaints," Ms Meagher said. Since 2005, hospitals had taken greater care in confirming a doctor's references with the NSW medical board, which has increased its transparency in relation to deregistered doctors.

The NSW Government and police have begun investigations following new allegations about Dr Reeves but it will be some time before authorities determine how he was able to continue to practice as an obstetrician and gynaecologist. "I can't explain that," Ms Meagher said. "But what I can assure the women who are coming forward now is that we will support them in every way we possibly can. "I am sorry that they have had such an awful, awful experience at the hands of somebody who was not fit to deliver a medical service."

Source