Late in March, the Supreme Court heard arguments about whether generic drug manufacturers can be held responsible for prescription drug injuries caused by their products. The Supreme Court is still considering the cases before it: the justices are divided over the issue, but in the meantime at least one district court has weighed in on the issue.
The United States District Court for the Middle District of Atlanta has stated that the name-brand drug manufacturer may be responsible for all injuries caused by the generic version of their drug. In a decision that overturns a number of important precedents in that state’s law, the Alabama Court found that the manufacturer of a name-brand drug had a duty to warn “prescribing physicians” about new dangers related to their drugs, and to make sure that the doctor understood that these dangers also applied to generic versions of the drug. The Alabama law suit related to generic alternatives to Reglan, the same drug being considered by the US Supreme Court. The decision opens the way for additional law suits and angles for people to pursue compensation should the Supreme Court decide that generic manufacturers cannot be held liable for injuries caused by their drugs.
The case centers on the side effect tardive dyskinesia (TD), an incurable neurological disorder. The risk of TD can be significantly increased by long-term use of metoclopramide, whether in its generic form or in the brand-name Reglan. The result of a long-term marketing campaign, Reglan and its generic alternatives are commonly used to treat gastroesophogeal reflux disease (GERD), often for months or years at a time. According to the claimants, the original manufacturer of Reglan, A.H. Robins Company, expressly warranted Reglan for long-term use. The claimants allege that when brand-name defendants Wyeth and Schwarz Pharma, Inc, and took over the risks and liabilities from Robins, they had a responsibility to correct any misinformation disseminated by the prior company, but, instead the name-brand defendants worked to suppress information about Reglan’s true risks.
The plaintiffs allege that they were injured as a result of the brand-name defendants’ actions, and the Court agreed, saying that although a brand-name manufacturer has no duty to warn consumers about a generic manufacturer’s drug, they do have a duty to warn “prescribing physicians” about their drug’s risk, including the physician that prescribed the generic drug to the plaintiffs. The Court’s logic is that to prescribing physicians, and, indeed, in the eyes of the FDA, generic drugs are considered equivalent to the name-brand drug they are designed to mimic. Therefore, any warnings or lack thereof about the brand-name drug, would be considered to apply equally to the generic alternative.
In fact, this is the very argument being forwarded by generic drug manufacturers in the Supreme Court cases. Generic drug manufacturers claim that because the Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act require generic drug labels to exactly match the labels of name-brand manufacturers, they cannot be held responsible for a failure to warn.
The decision also meshes with the stated thinking of Supreme Court Justices who are leaning toward protecting generic manufacturers from liability. According to Justice Antonin Scalia, generic manufacturers are not qualified to make warnings, “This is a generic manufacturer. He doesn’t know anything about science. He knows how to replicate this pill exactly. That’s all he really knows.”
If the Supreme Court decides to protect generic manufacturers from liability, they will have to follow the reasoning of the Alabama District Court decision and shift liability for all generics back to the manufacturer of the name-brand equivalent. While this would protect the business of generic drugs, it may bankrupt the business of the true resource in drug manufacturing, the large pharmaceutical firms that come up with new drugs and treatments, by burdening them with exorbitant expenses related to drugs they never manufactured, sold, or profited from.
To me, the logic is clear: if you sell a product, you have a responsibility to ensure that product is safe for use as labeled. If you profit from a product, you must also be prepared to pay for injuries that result. A decision of this type could potentially be a boon for consumer safety, because it would give generic drug manufacturers an incentive to investigate and expose known side effects that are currently being concealed by name-brand drug manufacturers.
If you have been hurt by a prescription drug, you may be eligible for compensation for your injuries. To learn what compensation you may be able to receive, please call or email the personal injury lawyers of Robert W. Kerpsack, CO. LPA today for a free case evaluation.