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Archive for December, 2009

Downtown Lawyer was included in Blawg Review #241. A big thanks to Infamy or Praise and Blawg Review for including me.

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Mensing v. Wyeth, Inc., No. 08-3850.

In March 2001, Gladys Mensing’s doctor prescribed Reglan to treat her diabetic gastroparesis, and her pharmacist filled the prescription with the generic version of Reglan, metoclopramide. After taking metoclopramide for four years, Mensing developed tardive dyskinesia, a severe neurological movement disorder. Mensing filed suit against the manufactures of metoclopramide for failure to warn that long-term use of metoclopramide carries a risk of tardive dyskinesia. She claimed that they promoted metoclopramide for long-term use even though the Federal Drug Administration (“FDA”) had approved the drug only for use up to 12 weeks. The manufactures of metoclopramide moved to dismiss Mensing’s complaint on the ground of federal preemption because federal law requires generic manufacturers to duplicate the name brand drug label. The trial court agreed and dismissed Mensing’s claims.

On appeal, the Eighth Circuit Court of Appeals noted that a presumption exists that state police powers have not been superseded by a federal act unless that was the clear purpose of Congress. All new prescription drugs require approval by the FDA before they can be marketed. Manufacturers must provide (1) information about the drug’s safety and efficiency gleaned from clinical trials and (2) a proposed label with appropriate use, warnings, precautions, and adverse reactions. In order to market a generic version of a drug previously approved by the FDA, a generic manufacturer must comply with the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act (“FDCA”) by showing the FDA that (1) the generic drug is essentially the same as the name brand drug and (2) the proposed label duplicates the name brand drug label. Because the FDCA, which has existed for 70 years, and the Hatch-Waxman Amendments, which occurred in 1984, do not contain an express preemption provision, Congress did not intend to grant drug manufacturers immunity from state law claims.

The court then addressed whether a conflict between complying with state law and federal law. Such a conflict can provide preemption if (1) compliance with both is impossible or (2) claims under state law would inhibit Congress’s goals in enacting the federal law. Under the FDCA, generic manufacturers must revise their labels “as soon as there is reasonable evidence of an association of a serious hazard with a drug.” The court stated that merely following the name brand label did not absolve the generic manufacturers of their duty to warn consumers. At the very least, the FDCA requires generic manufacturers to provide such information to the FDA to determine if the labels of both the name brand and generic medication should be changed or a letter sent to medical professional regarding the issue. Accordingly, there was insufficient evidence to find that generic manufacturers could not comply with both state law and federal law.

In addition, the court noted that state law claims for failure to warn emphasize that drug manufacturers, not the FDA, bear primary responsibility for labeling. The court stated that “Congress and the FDA have long viewed state tort law as complementing, not obstructing, the goals of the FDCA.” As such, the court held that no conflict existed between state law and the FDCA, and it reversed the trial court’s decision.

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In March 2006, two New York-area newspapers, the New York Daily News and the Polish Daily News, referred to Shemtov Michtavi as a “key lieutenant” of mob figure Ze’ev Rosenstein and reported that he planned to testify against Rosenstein. Michtavi is currently serving 20 years in prison for drug offenses. He filed a defamation claim against the newspapers, but they were dismissed by the trial court. On appeal before the Second Circuit Court of Appeals, the court upheld the dismissal. The court noted that Michtavi failed to prove that the publications shamed him: “Under New York law, a statement is defamatory only if it would expose an individual to shame ‘in the minds of right-thinking persons.'” The court explained that, because right-thinking people would not “think ill” of someone who cooperates with police, the newspapers’ reports were not defamatory. For the full story, click here.

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