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Brand Name Drug Makers May Be Held Liable in Alabama for Injury From Generic Drugs – Wyeth et al v. Weeks

By January 25, 2013July 17th, 2019Dangerous Drugs

As a pharmaceutical liability attorney, I was extremely pleased to see a decision from the Alabama Supreme Court that could help people injured by generic drugs receive fair compensation. The U.S. Supreme Court has held that generic drug manufacturers cannot be sued in state court for failure to warn, because their warnings are required to be exactly the same as the name-brand drugs’ warnings and they do not have primary control over name-brand warnings. In Wyeth et al. v. Weeks, the U.S. District Court for Middle Alabama certified a question to the Alabama Supreme Court, saying that subsequent Alabama federal-court decisions have contradicted one another about whether a name-brand manufacturer may be held liable for statements it made about its own drug, even though the injury is from the generic version. The Alabama Supreme Court ultimately decided that they could, finding the manufacturing process irrelevant.
The case was brought by Danny and Vicki Weeks, who allege that Danny Weeks suffered injuries from long-term use of metoclopramide, the generic name of the name-brand drug Reglan. Weeks does not allege that he took any of the name-brand version, but says name-brand manufacturers are nonetheless liable because they failed to adequately warn about the risks of Reglan or misrepresented them. The federal district court hearing that case said four courts in the state had heard similar claims, with three courts saying the plaintiffs could not recover and one (the current court) saying they could. It certified a question of Alabama law to the state’s high court, asking whether state law permits a drug company to be held liable for fraud or misrepresentation based on statements it made in connection with manufacture or distribution of a brand-name drug, by a plaintiff claiming injury from a generic drug manufactured by someone else.
The Alabama Supreme Court started by limiting its holding to manufacturers. The Weekses claimed that Danny’s doctor was materially misinformed by the manufacturers’ misrepresentations about Reglan. The court noted that Alabama, like every other state, has a law that permits pharmacies to substitute a generic for a name-brand drug unless the prescription says they should not, and many health insurance plans have a substitution policy. The high court found that Danny should not be precluded from making a fraudulent misrepresentation claim by the fact that the pharmacy did substitute a generic drug. The FDA and the U.S. Supreme Court have said federal law forbids generic manufacturers from unilaterally changing the labels of their drugs. Using the Supreme Court’s logic from PLIVA v. Mensing and Wyeth v. Levine, it held that name-brand manufacturers are responsible for labeling of generics, and therefore can reasonably foresee that they may be held liable for their safety communications.
Though this ruling applies only to claims brought under Alabama law, it’s an important ruling for dangerous drug lawyers like me. With it, Alabama joins a California state appeals court and a Vermont federal court in finding that name-brand manufacturers can be sued for failure to warn about dangers, even when the drug actually taken was a generic. These precedents, if adopted widely, could undo the damage created by PLIVA v. Mensing, a decision that the Supreme Court itself noted must seem inconsistent with Wyeth v. Levine. PLIVA found that generic manufacturers’ hands are tied because they are required to rely on name-brand manufacturers for safety information; this ruling simply permits injured people to turn to the name-brand manufacturers who were expressly given responsibility for safety. As a defective prescription drug attorney, I’m pleased that injured people may soon be able to get the financial recoveries they need.


If you suffered an injury or illness because you took a prescription drug that turned out to be unsafe, you should call Carey, Danis & Lowe today to discuss how we can help. For a free, confidential case evaluation, send us a message online or call 1-877-678-3400 today.
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