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California may be moving toward a new form of liability. The state Supreme Court declined to hear an appeal from Wyeth in a case the held the drug maker liable for injuries caused by generic versions of Reglan (metoclopramide) made by another manufacturer.
California may be moving toward a new form of liability. The state Supreme Court declined to hear an appeal from Wyeth in a case the held the drugmaker liable for injuries caused by generic versions of Reglan (metoclopramide) made by another manufacturer.
The defendant, Elizabeth Conte, sued Wyeth over what she claimed was false, misleading, and negligent Reglan product information that was reused by generic manufacturers. “It’s a rather novel theory of liability,” said William Fassett, professor of pharmacy law at the Washington State University College of Pharmacy in Spokane, Wash. “This is completely new legal territory.”
The California ruling was the first of three legal blows Wyeth has taken this year. In February, the Food and Drug Administration ordered Wyeth and other metoclopramide manufacturers to add a boxed warning to product labels. The black box warns of tardive dyskinesia associated with long-term or high-dose use. Manufactures must also implement a risk evaluation and mitigation strategy (REMS) to ensure that all patients receive information on the risks. And in March, Wyeth lost a U.S. Supreme Court case, Wyeth vs. Levine, which upheld a $6.7 million product liability verdict against the company, which is being acquired by competitor Pfizer for $68 billion.
Pharmacy law specialists say the U.S. Supreme Court loss is unlikely to affect the California liability case. In the Levine case, Wyeth argued that FDA approval of its Phenergan (promethazine) label preempted Vermont liability law. Federal preemption is not an issue in the Conte case. The new black box warning for metoclopramide is. “At the very least, a black box warning will help prevent other patients from suffering this same injury,” said Conte co-counsel Ralph Pittle, a former pharmacist who has been litigating metoclopramide cases since the mid-1980s.
The Conte case revolves around two issues. One is what Wyeth knew about metoclopramide and its association with tardive dyskinesia and when the company knew it. The second is Wyeth’s liability for injuries associated with product information it published even though it did not manufacture the product that caused Conte’s injury.
“I am troubled by the idea that a brand-name manufacturer could be held liable for a generic product,” said San Francisco attorney Jonathan Klein, a partner in Kelly, Herlihy & Klein, LLP. Klein usually represents pharmacists and pharmacies in litigation. “You should not have to be concerned once your patent has expired,” he continued. “I think it was mistakenly decided.”
The California court reinstated a lawsuit claiming that Wyeth is responsible for tardive dyskinesia that developed after Conte took generic metoclopramide for four years. The product label warned that the drug should not be taken for longer than 12 weeks. Conte’s physician admitted that he did not read the product labeling for any of the three generics she might have taken while under his care.
The physician also said that he might have read Wyeth’s Reglan labeling while in training. That was enough for Pittle and co-counsel Lawrence Masson. The two reasoned that just as generic drugmakers rely on originator firms for clinical data and FDA drug approval, generic firms rely on originator drug labeling. If there are errors, omissions, or misleading language in generic label information based on brand-name labeling, liability lies with the brand-name company that created the language and obtained FDA approval.
Conte sued Wyeth for fraud, fraud by concealment, and negligent misrepresentation. Her attorneys argue that Wyeth knew, or should have known, that physicians regularly prescribe metoclopramide for longer than 12 weeks. The suit also claims that the metoclopramide label minimizes the risk of tardive dyskinesia associated with the extended use of the drug. That is the issue that led FDA in February to require all metoclopramide manufacturers to add a boxed warning for tardive dyskinesia and take steps to alert patients to the risk.
“I expect Wyeth will ask the court to exclude evidence of the black box warning as prejudicial and irrelevant, given the warning was not in place or required by the FDA when Ms. Conte was exposed,” said pharmacy law specialist and legal author Karen Gibbs, a partner in Crowell & Moring LLP in Orange County, Calif.
“If evidence of the black box warning makes it to the jury, the jury will need to consider this new evidence in light of the larger company and regulatory record regarding the safety of this drug and the issue of the adequacy of the warnings on the label for the product sold to Ms. Conte.”
The case is set for trial in December.