Manufacturers of Unsafe Products Shielded by Supreme Court Ruling
WASHINGTON, DC — March 6, 2008 — The Supreme Court ruled in favor of limiting lawsuits on product liability. It will now be difficult for individuals to sue faulty medical products that have been approved by the U.S. Food and Drug Administration (FDA). The Supreme Court based its ruling on the fact that the FDA approval process requires manufacturers to prove the safety and effectiveness of their product. The ruling means state lawsuits on product liability are now barred because they would impose safety and effectiveness requirements that are different from federal law. With the shield of the FDA‘s approval, manufacturers will not be held responsible for personal injuries even if their products are unsafe.
The case heard last week, Riegel v. Medtronic, involved a patient whose catheter burst during a medical procedure and wanted to sue the medical device manufacturer, Medtronic. The question before the court was whether or not the patient could sue Medtronic under state law for a medical device that had been approved by the FDA. The opinion, written by Justice Antonin Scalia, will now severely limit a consumer’s ability to seek compensation for injuries that are a result of a federally approved medical device.
At least one justice, Justice Ruth Bader Ginsburg, did not agree with the Supreme Court’s overall opinion of placing business interests over the safety of individual consumers. Justice Ginsburg said that Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.” (WTOP News, February 20, 2008)
Rep. Henry Waxman (D-California) stated, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.” (New York Times, February 21, 2008)
Medical Device Approval and the FDA
To receive approval from the FDA under current federal law, all the manufacturer of a medical device must show is the product’s safety and effectiveness to the FDA. Over the past three months, federal regulators have responded to more than 100 issues regarding unsafe medical devices. Independent groups such as The Institute of Medicine and the Government Accountability Office, as well as the FDA‘s science board, have reported poor management and scientific shortcomings within the FDA. Due to these apparent weaknesses, the FDA may be unable adequately to protect individuals against dangerous and unsafe medical devices, drugs, and food. As far back as 1997, the FDA‘s chief lawyer wrote in a brief, “even the most thorough regulations of a product such as a critical medical device may fail to identify potential problems.” (News Analysis, New York Times, February 21, 2008)
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