[Source: Health and Life Sciences Law Daily, February 21, 2008 - AHLA]
In a front-page story, the New York Times (2/21, A1, Greenhouse) reports that on Wednesday, the U.S. Supreme Court ruled in the case of Riegel v. Medtronic Inc. (PDF) that "[m]akers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration (FDA) approved the device before it was marketed and it meets the agency's specifications."
The Los Angeles Times (2/21, Savage) notes, "The 8-to-1 ruling throws out a lawsuit brought by a widow whose husband was badly hurt and later died after a balloon catheter burst in his chest," and represents a broad reading of "federal law...to protect companies from juries or state regulators."
According to the Wall Street Journal (2/21, A8, Bravin), "[l]ower courts in New York dismissed the suit, finding that a 1976 law immunized Minneapolis-based Medtronic, because its catheter had been approved for sale by the FDA." Wednesday's ruling indicated that "state authority surviv[es] only when Congress explicitly permits it a role." The case presented the question of "whether traditional private-product lawsuits, as well as state regulations, may be pre-empted by federal law."
On the front page of its Business section, the Washington Post (2/21, D1, Barnes) details the dissenting argument from Justice Ruth Bader Ginsburg, who wrote that "Congress did not intend the preemption clause...'to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.'" Previously, in 1996 the court found "that devices approved by the FDA under a less-rigorous process were not protected from state lawsuits." However, "the government reversed its position" in 2004.
USA Today (2/21, Biscupic) reports that the case was "a victory for business interests and a setback for state efforts to protect citizens in health-related areas when the federal government already has entered the field." And, "[t]he Medtronic decision could signal a favorable outcome for drug manufacturers in two pending Supreme Court cases."
According to Reuters (2/21, Vicini, Richwine), "The decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said." Other device makers may benefit from the ruling, as they "have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court." In this particular New York case, "Medtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended."
The AP (2/21, Sherman, Yost) adds, "The case has significant implications for the $75 billion-a-year healthcare technology industry, whose products range from heart valves to toothbrushes." During "a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices."
Turning to the implications the case has for patients, Bloomberg (2/21, Stohr) quotes Allison Zieve, the attorney representing the patient's widow, as saying that the ruling is "[p]retty bad for patients, pretty good for industry profits." Zieve added, "Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices."
Meanwhile, Modern Healthcare (2/21, Blesch) details the reaction of Medtronic CEO Jon Haber, who issued a statement saying that the ruling "ensures that patients continue to have appropriate access to innovative, life-saving medical devices."
Pointing to the broader legal implications of Wednesday's ruling, the Legal Times (2/21, Mauro) reports that "the Supreme Court continued its trend toward freeing companies from the conflicting regulation of 50 different states in favor of one federal regime." The Financial Times (2/21, Waldmeir, Bowe), Forbes (3/10, Fisher), the Wall Street Journal's Health Blog (2/20, Goldstein), and the Boston Business Journal (2/21, Hollmer) also cover the story.
