Important New U.S. Supreme Court on Liability Following Harm Caused by Generic Drugs

As reported recently in the New York Times, the U.S. Supreme Court is set to hear a new case that will further clarify legal liability rules as they relate to drug errors and pharmaceutical companies. At the heart of the case is whether a generic drug manufacturer can be held liable for the harm caused by a defectively designed drug.

The original case was filed by a woman who was given a prescription for the pain pill known as sulindac by her doctor. The mild medication was intended to provide some relief for her shoulder pain. In reality, it totally changed the woman’s life–and not for the better. The patient suffered from a reaction to the drug which caused severe burning. Here skin literally “sloughed” off. Ultimately she needed to spend months in a burn unit and was in a coma for even longer. By the end of it all the woman was legally blind and had suffered permanent damage to her lungs and esophagus.

Defective Drug Legal Case
The patient filed a lawsuit against the manufacturer of the generic drug. At trial the woman was awarded $25 million which was upheld by a federal appeals court. However, the defendant pharmaceutical business–Mutual Pharmaceutical Company–appealed again to the U.S. Supreme Court. The high court agreed to take the case and will hear arguments soon.

Liability for generic drugs is one of the most hot-button legal issues being discussed these days. Considering that 80% of all prescribed medications are generic, determining who is responsible when the medication causes harm will have ramifications on many patients. The liability may ultimately rest on the exact legal arguments made.

For one thing, the Supreme Court already found in a previous cases that generic drug makers can not be held liable for harm when insufficient warning labels are argued. In that case, the Court found that the generic drug manufacturer is not responsible for the warning label on these products and so cannot be held liable when those labels are inadequate.

However, claiming that a warning label did not address a particular risk is not the only way that an injured patient may seek accountability. In this most recent case, the plaintiff is instead arguing that the drug itself was defectively designed. For their part, the defendant company is claiming that the logic in the warning label case is the same here: they have no control over the design and therefore cannot be held liable when it is defective.

Yet, there is good reason for the court to see things otherwise. Lower courts reasoned that even if the actual design was not under its control, the company was still not required to sell the product. If it was defective, it should have been pulled from the shelves, regardless of whether they or someone else designed it. If the court’s find otherwise, then many are wondering if the generic drug industry will essentially be immune from liability, and patients will have next to no recourse when harmed by these products.

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