MONTGOMERY, Ala. - (Mealey's) An 8-1 majority of the Alabama Supreme Court on Jan. 11 ruled that Wyeth can be held liable for failing to warn doctors about the risk of long-term use of Reglan if a patient was injured by metoclopramide, the generic version of the drug made by other manufacturers (Wyeth, Inc., et al. v. Danny Weeks, et al., October Term 2012-2013, No. 1101397, Ala. Sup.).
(Opinion available. Document #28-130125-003Z.)
Danny Weeks took metoclopramide and developed tardive dyskinesia, a permanent movement disorder with symptoms similar to those of Parkinson's disease. Weeks and his wife sued Wyeth LLC and current parent company Pfizer Inc., along with Schwarz Pharma Inc., in the U.S. District Court for the Middle District of Alabama.
Schwarz bought the Reglan brand from Wyeth.
Weeks also sued Teva Pharmaceuticals USA and Actavis Elizabeth LLC, the generic manufacturers that made the metoclopramide that he ingested.
Federal Court Asks Question
In 2011, the federal judge granted in part and denied in part a motion to dismiss by Wyeth and Schwarz after the defendants argued that they cannot be liable for injuries caused by a drug they didn't make. The judge said Weeks might be able to state a claim for relief under Alabama law if he could prove that the brand-name defendants had a duty to warn Weeks' prescribing physician and that Weeks has a right to enforce a breach of that duty.
Noting a split among Alabama federal courts on fraud/misrepresentation issues in Reglan/metoclopramide cases, the judge certified a question to the Alabama Supreme Court. He asked if under Alabama law a drug company may be liable for fraud or misrepresentation based on statements made in connection with a brand-name drug by a plaintiff claiming injury from a generic drug made by a different defendant.
Reliance Reasonably Foreseeable
The Supreme Court majority found that a brand-name drug manufacturer could reasonably foresee that a physician prescribing a brand-name drug or its generic version would rely on the warning drafted by the brand-name manufacturer. They noted that prescription drugs are heavily regulated by the Food and Drug Administration and, citing U.S. Supreme Court case law, that brand-name manufacturers are under a continuing duty to report adverse effects and strengthen warnings about their drugs.
In contrast, the majority said that under a different Supreme Court ruling in another metoclopramide case, generic drug makers are required by law to use the same label as the brand-name version of their drugs and cannot add new risk warnings.
"In the present case, the Weekses have alleged that Danny's physician reasonably relied on the representations made by the Wyeth defendants regarding the long-term use of Reglan in prescribing Reglan to Danny," the majority wrote. "In other words, the Weekses are arguing that if a defendant's misrepresentation to a third party causes the third party to take actions resulting in the plaintiff's injuries, then the factual causation link is satisfied and that, here, a misrepresentation to Danny's physician would directly impact the medical care received by Danny."
Warning To Intermediary
The majority acknowledged that once a drug manufacturer warns prescribers about a drug's risk, it has no duty under the learned intermediary doctrine to warn the patient directly. "However, if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient," the majority said.
"The patient must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient's injury," it continued. "In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient."
Answering the federal court's question to it, the majority answered: "Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company."
'Not Fundamentally Unfair'
"In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer," the majority concluded.
Justice Michael F. Bolin wrote the majority opinion. He was joined by Chief Justice Charles R. Malone and Justices Thomas A. Woodall, Lyn Stuart, Tom Parker, Greg Shaw, James Allen Main and Alisa Kelli Wise.
Justice Glenn Murdock dissented. A written dissent will follow.
Weeks is represented by Christopher B. Hood, William L. Bross IV and William L. Garrison Jr. of Heninger Garrison Davis in Birmingham, Ala. Wyeth is represented by Anna Manasco Dionne, George R. Parker, Kevin C. Newson, Lindsey C. Boney IV and Philip H. Butler of Bradley Arant Boult Cummings in Birmingham, Brian M. Vines of Hare, Wynn, Newell & Newton in Birmingham and Leslie A. Benitez of Clark, Thomas & Winters in Austin, Texas.
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Alabama High Court need to stand by what they decided and do not let any The Drug Makers and Law Firm and Corporate America .
Alabama need to stand by their word - Reglan and Metoclopramide ruined my life .