Overruled


Props To Reps. Pallone and Waxman
March 5, 2009, 7:42 pm
Filed under: Ian

The Medical Device Safety Act, which would overturn the Supreme Court’s recent decision giving lawsuit immunity to the makers of dangerous medicial devices, was reintroduced in the House today:

In February 2008, the U.S. Supreme Court, for the first time, immunized medical device companies from lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc., the Court found that those claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision ignores both congressional intent and 30 years of experience in which federal regulation, through the U.S. Food and Drug Administration (FDA), and tort liability played complementary roles in protecting consumers from device risks.

The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removed one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.

The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” Pallone said. “Today, we introduce legislation that gives patients that same right when injured by a medical device. This legislation puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year. We introduce this legislation today with strong bipartisan support, and I look forward to moving it through my subcommittee quickly.”

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