Conflicts between state and federal laws governing prescription drugs led the Alabama Supreme Court to rule that a plaintiff allegedly injured by a generic drug may sue the manufacturer of its brand-name equivalent. In re Wyeth, Inc., et al v. Weeks, No. 1101397, slip op. (Ala., Jan. 11, 2013). Because the plaintiff’s claim alleged deficiencies in the warning label, and not the manufacturing process, the court found that it was “not fundamentally unfair,” slip op. at 52, to hold the defendant liable. The defendant was responsible for drafting the warnings, and the generic manufacturer’s responsibility was to reprint those warnings. The ruling could affect state-level pharmaceutical cases around the country.
The plaintiffs, a married couple, filed suit against five pharmaceutical companies, alleging that the husband suffered injuries from taking the drug metoclopramide, marketed under the brand name Reglan. The drug is used in short-term treatment of various stomach and intestinal conditions, including persistent heartburn. It has been associated with a risk of tardive dyskinesia (TD), a neurological disorder that affects body movements. The plaintiffs allege that the defendants breached a duty to warn Mr. Weeks’ physician of the risk of TD and other side effects. They concede that he never took brand-name Reglan manufactured by Wyeth, but rather generic variants manufactured by other companies. The plaintiffs claim instead that Wyeth and other brand-name manufacturers “falsely and deceptively misrepresented or knowingly suppressed facts about” the drug. Id. at 6.
The defendants characterized the lawsuit as a product liability claim, while the plaintiffs focused on the allegations of fraud. A failure to warn claim is a form of product liability, but the plaintiffs sought to recover under the state’s fraudulent misrepresentation statute. The U.S. District Court for the Middle District of Alabama, where the plaintiffs filed suit, certified a question to the Supreme Court of Alabama: does state law allow a fraud or misrepresentation claim against a brand-name manufacturer for injuries allegedly caused by a generic drug? After reviewing state law and U.S. Supreme Court precedent, the Alabama court concluded that the plaintiffs’ suit could proceed.
The court noted that all fifty states have laws allowing pharmacists to substitute generic drugs when possible. It reviewed the extensive requirements established by the Food & Drug Administration (FDA) for approval of new and generic prescription drugs, and noted that while a manufacturer of a new brand-name drug is responsible for ensuring “the accuracy and adequacy of its label,” a manufacturer submitting a generic drug for approval must ensure “that its warning label is the same as the brand name’s.” Id. at 14, quoting Pliva, Inc. v. Mensing, 131 S.Ct. 2567, 2574 (2011).
The U.S. Supreme Court noted in Pliva that, while state law may require a generic manufacturer to change its labeling to include additional warnings, federal FDA regulations require generic labels to be the same as the brand-name label. Pliva, 131 S.Ct. at 2574-75. It found that federal law preempted state law in such a situation. Id. at 2581. The Alabama court, applying the Pliva holding, found that the ultimate responsibility for the accuracy of the warning labels for Reglan and its generic equivalents fell on the brand-name manufacturer. Wyeth, slip op. at 52.
The products liability attorneys at Parr Richey Frandsen Patterson Kruse protect the rights of people in Indiana who have suffered injury due to dangerous or defective products, helping them to obtain compensation for their damages. Contact us today online or at 888-532-7766 to set up a free and confidential consultation with one of our lawyers.
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