In an article on the front of its Business Day section, the New York Times (2/20, B1, Meier) reports that Reps. Henry A. Waxman (D-CA) and Frank Pallone Jr. (D-NJ) “plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision” that “stands as a barrier against suing medical device companies” if the Food and Drug Administration has approved their sale. Meanwhile, “A similar Senate bill…is expected to be reintroduced in coming months.” Since the Supreme Court’s ruling, “judges nationwide…have cited it to dismiss cases against a wide range of manufacturers,” and critics say it “has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.” Meanwhile, “medical device producers and some conservative legal groups have lined up to oppose the legislation, which is supported by plaintiffs’ lawyers.” Still, Pallone believes “patients needed more legal leverage,” and, “Tort actions serve as backstop to the F.D.A. and provide another level of protection.” Additionally, Pallone “expects the House Energy and Commerce Committee to hold hearings this session to question whether the F.D.A. process for approving devices is adequate.”
From the American Association for Justice news release.