Legal News
Justices Shield Medical Devices From Lawsuits
Summary:
Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.
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Defective Products vs. The Supreme Court. They Fight, You Lose
Summary:
On February 21st the US Consumer Product Safety Commission, in concert with Rinnai America Corp, announced a voluntary product safety recall involving the defective product Rinnai EnergySaver Direct-Vent Wall Furnace, due to a potential carbon monoxide hazard.
According to the alert a gasket in the furnace, fuelled by either natural gas or propane, could fail—posing a risk of poisonous carbon monoxide gas leaking into the home.
Carbon monoxide is odorless and colorless, adding further fuel to the fire, as it were. So far there have been 11 reports of carbon monoxide leaking from the Japanese-made furnace, according to the manufacturer. There have been no injuries or deaths—yet.
The recall involves some 50,000 units.
What makes this recall, and the potential for injury or death all the more compelling, is the US Supreme Court decision this week that prevents patients inured by medical devices from suing the manufacturer in State court, provided the device was approved for marketing by the US Food and Drug Administration (FDA), and manufactured to FDA specs.
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Weston doctor wins one of largest compensatory asbestos awards
50-year-old Weston doctor dying of a rare form of cancer has won a $24.2 million products liability verdict against a company that exposed him to asbestos.
Stephen Guilder worked on tractors and cars in the 1970s and early 1980s before attending medical school at the University of Miami. He claimed brakes made by Honeywell International’s predecessor contained asbestos that caused his mesothelioma.
A Miami-Dade Circuit Court jury deliberated for less than three hours Friday before agreeing Honeywell’s negligence caused Guilder’s illness after.
The panel awarded Guilder and his family one of the largest compensatory verdicts against a single defendant in an asbestos case, according to Guilder’s attorney, David Jagolinzer with the Ferraro Law Firm in Miami.
Guilder was awarded $10.1 million for lost earnings, pain and suffering and medical expenses. His wife, Sheila, won $3.6 million for loss of her husband’s services and comfort. His three children, Ariel, 18, Alex, 16, and Ross, 14, were awarded $3.5 million each.
Guilder was diagnosed in September. The case was filed in October and expedited due to Guilder’s shortened lifespan.
Honeywell issued a statement Monday saying it was disappointed with the verdict but was “confident we will ultimately prevail on appeal.”
The trial lasted two weeks.
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