Pharmaceutical Injury Cases: The Generic Drug Liability Problem

A recent Supreme Court decision protects generic drug manufacturers from product liability claims.

Every day, millions of Americans fill prescriptions that are made by generic drug manufacturers. In fact, over eighty percent of American prescription drugs are generic brands. However, in 2011, the Supreme Court issued a ruling in Pliva v. Mensing that made generic drug makers not responsible for the injuries to consumers.

How Pharmaceutical Products Liability Claims Work

Product liability is a type of personal injury case that arises when a consumer is injured by a defective or dangerous product. These products can include items that are ingested, such as food items or prescription drugs. In general, product liability is considered a strict liability type of tort case. This means that the manufacturers of the drugs are liable for any defect in the drug, causing injury to the consumer, whether the maker was negligent or not. However, there must be an additional theory of liability for a dangerous drug case, because most drugs have warning labels that inform consumers of the side effects. Alternative theories of liability include that the side effect was not included in the warning, that the manufacturer advertised the drug for an off-label use, or that the warning label was not clear as to the potential danger to the consumer.

How Pliva v. Mensing Created a Loophole

The Pliva v. Mensing decision of 2011 is complicated, but in essence it held that generic manufacturers are not liable for the injuries caused by their drugs. Part of this is due to the fact that in order for a plaintiff to prevail in a lawsuit against the drug manufacturer, they must sue them under state laws that are stricter than the FDA’s regulations. This is because the federal law, the FDA, has already approved the drugs for the market. Because federal law usually preempts state laws, the generic companies appealed being held responsible, stating that they couldn’t possibly comply with both the state and federal laws (because they don’t set the makeup of the drug – the brand name does) and therefore the federal law, regulations by the FDA, must preempt the stricter state laws. The Court agreed, thus creating an entire class of Americans who have no legal recourse against the manufacturers of the drugs that injured them.

In the case that is pending, plaintiffs’ attorneys hope that there will be some type of solution that allows plaintiffs to have an avenue to air their grievances against generic manufacturers.

Preserve Your Case

If you were injured by a generic drug, you should still speak with an attorney. Even though it may seem to make sense to wait to hear if the Court’s decision changes, time is not on your side. Depending on the state you live in, there could be a very short statute of limitations that will bar your claim after a certain period of time. (See this page on personal injury lawsuit deadlines by state for the time limit in your state.)

If you file a claim, even under the rules of the Pliva v. Mensing decision, you may be able to at least preserve you right to seek compensation in the future.

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