Federal Court Rules that Generic Drug Manufacturers Cannot Hide Behind FDA Approval

The Legal Intelligencer reported that in a recent interpretation of the Wyeth v. Levine decision, a federal judge ruled that generic drug manufacturers are not immune from suit because the Federal Drug Administration (“FDA”) approved its generic drug product. In the May 26, 2010 In re Budeprion XL Marketing & Sales Litigation decision, U. S. District Court Judge Berle M. Schiller refused to dismiss a class action law suit filed by consumers who experienced side effects after switching brand-name drug Wellbutrin to generic drug Buproprion.

According to FDA regulations, to receive FDA approval for a generic drug, generic drug manufacturers must submit an Abbreviated New Drug Application (“ANDA”) providing scientific proof that the generic drug is the “bioequivalent” of a brand-name drug. This is shown by using data to prove the generic drug is comparable to the brand-name drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use. This approval process was developed in 1984 by the establishment of the Hatch-Waxman Act (the “Act”). The Act is designed to expedite the availability of less costly generic drugs by permitting the FDA to approve applications to market generic versions of brand-name drugs without costly and duplicative clinical trials.


In Wyeth v. Levine, the U. S. Supreme Court found that Federal law does not trump a state law imposing a duty to warn on drug manufacturers. In this case, Levine sued Wyeth for failing to adequately warn the medical staff who treated her about the risks of the anti-nausea drug Phenergan. After a clinician injected Levine with Phenergan directly into her vein, the drug entered Levine's artery, she developed gangrene, and doctors amputated her forearm. A jury determined that Levine's injury would not have occurred if Phenergan's label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Wyeth appealed the verdict all the way to the U. S. Supreme Court, asserting that Levine’s failure to warn law suit was pre-empted by Federal law because Phenergan's labeling had been approved by the FDA. The Supreme Court upheld the jury’s verdict and rejected Wyeth’s argument, stating that entrusting the FDA with drug labeling decisions does not absolve a drug manufacturer of the responsibility to comply with a state law regarding the duty to warn.


Judge Schiller’s decision in Budeprion expanded on the Supreme Court’s decision in Wyeth. In Budeprion, consumers brought a class action suit against Teva Pharmaceuticals (“Teva”) and Impax Laboratories (“Impax”), two manufacturers of Buproprion. The suit alleges that Teva and Impax became aware of the side effects, which stem from a difference in the method of release of the drug into the body, but failed to warn doctors or patients of the differences between the generic and brand name drug. In response to the law suit, Teva and Impax asserted that the suit should be dismissed because Federal law pre-empts claims arising from a state’s law regarding a duty to warn. Judge Schiller rejected Teva and Impax’ argument by finding that “state law causes of action do not frustrate congressional intent with respect to the regulation of generic drugs.” He opined that the Teva and Impax’ logic would remove any incentive for generic drug makers to monitor the safety of their medications and update labels accordingly after receiving FDA approval. Such an interpretation, Judge Schiller further opined, finds no support in the law.


This decision reminds generic drug manufacturers that while their purpose is to provide a low cost alternative to brand-name drugs, it is important to remember that the health and welfare of the consumer should always come first.


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