Monday, June 24, 2013

Another preemption loss in the Supreme Court for consumers injured by generic drugs (CL&P Blog)

Brian Wolfman of  Public Citizen lays out the meaning of today's dreadful generic drug product liability decision (Justice Alito writes for the majority). The only consolation here - and it is just vanity - is that Justice Sotomayor cited me in her dissent in Mutual Pharmaceutical v. Bartlett:

This expanded notion of impossibility pre-emption threatens to disturb a considerable amount of state law.... This could have serious consequences for product safety. State design-defect laws play an important role not only in discovering risks, but also in providing incentives for manufacturers to remove dangerous products from the market promptly. See Levine, 555 U. S., at 578– 579; Bates, 544 U. S., at 451; see also Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability? 109 Yale L. J. 1087, 1130 (2000) (“The tort system can encourage FDA regulatory vigor and competence”). If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have  no recourse. 

Another preemption loss in the Supreme Court for consumers injured by generic drugs (CL&P Blog): by Brian Wolfman 
 "The Supreme Court today held in Mutual Pharmaceutical Co. v. Bartlett that FDA approval of a generic  prescription drug preempts a state-law damages claim premised on the drug's design defect. The 5-4 majority opinion is written by Justice Alito. Basically, Justice Alito says that a design-defect claim is, in effect, a claim that the drug's label should be changed to warn of the drug's design-induced hazards, and state law has no business premising a tort duty on a change in an FDA-approved generic drug label (which is what the Court held earlier in PLIVA v. Mensing). There's a dissent by Justice Breyer joined by Justice Kagan and a dissent by Justice Sotomayor joined by Justice Ginsburg. Another loss for injured consumers' access to the courts. So, after this loss, let's see where we are with access to the courts for people injured by prescription drugs and medical devices."

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