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Alabama Supreme Court Ruling: Brand Name Companies may be Liable for Injuries Tied to Generic Drugs

Sep 5, 2014

In a reaffirmation of its 2013 ruling, the Alabama Supreme Court has held its ruling that makers of brand name drugs may be liable when injuries are tied to the drug’s generic equivalent under certain circumstances.

The ruling, according to the American Association for Justice (AAJ), involves generics produced by other manufacturers and when the brand name drug maker misrepresented the drug and the patient’s prescribing physician relied on the misrepresented information. This case represents the first Supreme Court to rule that individuals may bring such misrepresentation claims against brand name manufacturers.

The case involves a man who developed tardive dyskinesia, a permanent neurological disorder; symptoms include uncontrollable movements. The lawsuit alleges that the man’s tardive dyskinesia was the result of his having had taken metoclopramide, which is the generic version of Reglan. Reglan is prescribed for chronic digestive problems. The man involved and his wife brought lawsuits against five current and former drug makers that sold the brand and generic versions of the drug, according to the AAJ.

Brand manufacturers, including Wyeth, Inc., moved to dismiss the case, arguing that the claims are products liability claims, which may not be filed for “product identification” failure, and that the drug makers are not required to warn about generic drug risks.

Meanwhile, in 2011, the trial court held that those bringing the lawsuits might be able to state a claim for relief under Alabama law if they were able to prove that the brand name firms did, in fact, have a duty to warn, wrote AAJ. In 2013, the Court ruled that brand name drug makers may be liable for misrepresentation claims, according to a prior Trial News report.

Although a number of business interests, such as the U.S. Chamber of Commerce, criticized the decision, Wyeth requested that the case be re-heard, and the Court agreed. The Alabama Supreme Court relied on what is known as the “learned intermediary doctrine.” This provides that a prescription drug maker fulfill its duty to warn users of drug risks. Adequate warnings must be made to prescribing physicians; no duty is required to the consumer, AAJ reported.

Judge Michael Bolin, who wrote for the majority, indicated that, “when the warning to the prescribing health care professional is inadequate, however, the manufacturer is directly liable to the patient for damage resulting from that failure.” Bolin noted that it was “reasonably foreseeable” that, in this case, the physician would rely on Wyeth’s misrepresentation given that federal law mandates brand and generic drug labels to be identical.

“An omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product,” Judge Bolin wrote, noting that the ruling is only applicable to the makers of prescription drugs.

Thousands of Reglan/metoclopramide plaintiffs exist nationwide; some 250 are Alabama residents who are asserting fraud, misrepresentation, and suppression claims against the brand name drug makers.

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