Altria, Medtronic & Wyeth: Decisions that Concern Sales over Safety and Profits over People

Armand Rossetti

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On March 5, 2009 Representative Bruce Braley (D-IA) sent a letter to congress indicating that he was proud to be a cosponsor of the “Medical Device Safety Act of 2009 (MDSA). On March 4, 2009, Representatives Frank Pallone, JR (D-NJ) and Henry A. Waxman (D-CA) introduced the MDSA bill in the House in an attempt to reverse the decision in Riegel v. Medtronic ((06-179).

Braley made the following statement in his letter:

“The civil justice system and the federal regulatory system were always meant to complement each other. Both are necessary to adequately protect Americans. The FDA simply cannot do it alone, and we see examples of this all the time, from pacemakers to peanuts.”

Perhaps Braley’s statement underscores the rational behind the US Supreme Court’s 6-3 decision on Wednesday in Wyeth v. Levine (06-1249). The Wyeth Court said that FDA’s approval of a drug label, in itself, does not shield a pharmaceutical company from state product liability lawsuits. Writing an opinion for the majority, Justice Stevens rejected Wyeth’s argument that it would be impossible for a manufacturer to comply with both FDA and state drug safety labeling requirements. And Justice Thomas sided with the majority, issuing a concurring opinion.

Musician, Diana Levine sued Wyeth in 2000 after a hospital gave her an IV push injection of Wyeth’s anti-nausea drug, Phenergan; she had gone to the hospital for a migraine headache and later developed gangrene in her right arm because of the injection, which ultimately resulted in amputation.

Reportedly, Wyeth’s lawyer disagreed with the high court’s opinion that pharmaceutical manufacturers (and not the FDA) were in the best position to weigh the risks and benefits of a medicine and to assess an explanation of those risks on product labels.

Congress fist introduced the MSDA in 2008 in response to 8-1 Supreme Court ruling in February 2008 in Riegel v Medtronic (06-179). The high court’s holding in Riegel produced a complex result, wherein a claim’s viability would be decided on a case-by-case basis. Unlike the decision in Wyeth, the Supreme Court in Riegel found that a recent preemption clause added to the Medical Device Amendments Act of 1976 barred state law claims under certain circumstances.

Prior to the Reigel lawsuit, the Supreme Court decided Altria v. Good (07-562), a class action lawsuit brought under a state law prohibiting deceptive advertizing. In support of pre-emption, Altria had argued that the FTC’s use of the Cambridge Filter Method standard of measuring tar and nicotine content in American cigarettes impliedly preempted lawsuits against tobacco companies that used those results in cigarette advertisements.

In a 5-4 decision, the Court compared the majority's reasonong Altria v. Good to the Court's holdings Cipollone v. Liggett (505 US 504) and to Lorillard v. Reilly (535 US 525). In his opinion in Altria, Justice Stevens stated that the respondents had based their claim on the duty not to deceive, which was unrelated to smoking and health. The Federal Cigarette and Labeling Advertizing Act indicates that “no requirement or prohibition based on smoking and health shall be imposed under state law.” Therefore, based on the language and intent of the federal labeling statute, the respondents’ claims fell outside the scope of the labeling act’s pre-emption provision.

As a result, the Court rejected Altria’s argument that state law was federally pre-empted, and notwithstanding Altria’s position on pre-emption, Justice Stevens allowed the lawsuit to proceed on the merits and remanded the case to the trial court.

After consideration of all of the above, it is important to note that absent passage and enactment of federal legislation, such as the MDSA, it is likely that the US Supreme Court will continue to address any appealable drug and medical device related pre-emption issues on a case-by-case basis.