Court Approves Suit vs. Brand-Name Drug Maker for Injuries Caused by Generic
A San Francisco woman can sue the maker of a brand-name anti-heartburn medication for failing to properly warn her physician that the generic version of the drug might cause her to suffer an incurable muscular disorder, the California Supreme Court has ruled.
Elizabeth Conte argues that Wyeth Pharmaceuticals failed to provide adequate warnings about the risks of developing tardive dyskinesia from the generic version of Wyeth’s drug, Reglan. Conte took the generic drug for four years before she came down with the permanent condition, which causes grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips, and rapid eye blinking.
Conte’s suit sets a legal precedent in California, representing the first time a manufacturer of brand-name drugs was held responsible in the state for failing to warn of potential side effects of generic versions of their drugs. So far, other state courts have refused to hold brand-name drug makers responsible for injuries caused by generics.
Suit Against Generic Manufacturer Was Dismissed
Conte sued both Wyeth and the maker of the generic drug, but her claim against the generic manufacturer was thrown out of court because there was no evidence that Conte’s physician had relied on inadequate warnings provided by the company. The court found, however, that there was sufficient evidence to argue that her physician might have relied upon Wyeth’s inadequate warnings before prescribing the drug.
Who is to Blame?
Conte’s case raises an interesting question about whether makers of brand-name drugs should be held responsible for injuries caused by generic versions of their drugs. Courts in other states have refused to hold brand-name manufacturers responsible in such situations, saying that brand-name firms face a much more demanding approval process to get their drugs to market and must research the drugs through clinical trials and other measures. By comparison, generic drug makers can simply rely on research data compiled by the brand-name manufacturers in developing their drugs, the courts have held.
But the First District Court of Appeal in San Francisco, which issued its landmark ruling in November 2008, said Wyeth may be responsible for Conte’s injury because the pharmaceutical giant profited from being the first to sell the drug and should therefore be responsible for injuries caused by inadequate warnings of potential injuries.
A Disincentive to Develop Drugs?
Attorneys for Wyeth have said the company should not be blamed for injuries caused by generic drugs the company did not manufacture. By holding brand-name drug manufacturers responsible for people who are injured while taking generic versions of their drugs, courts will create a “disincentive for developing a product,” Wyeth’s attorneys have said. Brand-name drug companies may be more hesitant to develop new drugs if they know that they will be held responsible for injuries caused to patients by generic version of those drugs, drug companies say.
Wyeth Wants it Both Ways
It seems that in the Conte case, Wyeth wants to have its cake and eat it too. On one hand, the company wants to profit from the exclusive marketing of drugs it develops, but when generic forms of the drugs are made, the company does not think it should bear any responsibility. But the reality is that the company that developed a drug and conducted clinical trials on its use is in a far better position to know the potential side effects and risks of injury from taking the drug than is a generic manufacturer who simply relies on studies conducted by the brand-name drug maker.
In Conte’s case, if warnings developed by Wyeth are found to have been inadequate, then the company should bear some responsibility, even though the injury was caused by the generic drug made by another company.
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