Supreme Court protects FDA-approved medical devices from suits

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Supreme Court rules in favor of medical device industry. Source:  

The U.S. Supreme Court, in an 8-1 ruling reached Wednesday, said federal medical device regulations trump state product-liability lawsuits unless the medical device company violated FDA policy.

The opinion affirms a lower court ruling barring a lawsuit against Medtronic and makes it harder for individuals to sue medical-device companies over faults or failures of a device that have been approved for use by the FDA. The ruling only applies to devices that have received premarket approval.

Hundreds of millions are currently at stake in the courts over such cases against FDA-approved products. For instance, Medtronic settled its cardiac defibrillator suit for $114 million just last month. While others involve heart pumps, drug-eluting stents, and artificial hearts, it is not immediately clear how many of the thousands of lawsuits against medical device manufacturers will be affected, though some pending cases will almost certainly be nullified, according the New York Times.

The original case, Riegel v. Medtronic, was brought by Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel died in 2004. For the Supreme Court appeal, his widow represented her husband’s case, asserting that the catheter had design flaws and carried misleading labeling instructions.

Justice Antonin Scalia wrote in the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which states that federal laws regulating medical devices take precedence over state damages claims that are brought without a parallel FDA violation.

Justice Scalia said jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts, the NYT reported. A jury “sees only the cost of a more dangerous designed, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court,” he wrote.

The NYT reported that the majority was persuaded by Theodore B. Olson, the lawyer for the Minneapolis-based Medtronic, who argued before the justices on Dec. 4 that the FDA and not the courts was the right forum for imposing requirements on cutting-edge medical devices.

Justice Ruth Bader Ginsberg, the sole dissenter, said that the majority had adopted an unnecessary “constriction of state authority,” according to the NYT.

The Supreme Court is also hearing several related medical device and drug cases to determine whether FDA regulations bar state court liability lawsuits.

Next week, the court will hear arguments in a case involving Pfizer's Warner-Lambert unit. In the appeal, the court will decide whether federal drug laws bar a Michigan lawsuit brought by patients who used Rezulin, a diabetes drug removed from the market in 2000.