U.S. Supreme Court to Rule on Liability of Generic Drug Manufacturers

The U.S. Supreme Court is set to make a ruling on a very important pharmaceutical case this term. At issue is whether a generic drug manufacturer can face a lawsuit for their inability to warn consumers of potentially dangerous side effects.

The case at issue involves the drug manufacturer Mutual Pharmaceutical Co., which has appealed a jury award of $21 million in a case where the plaintiff took a generic NSAID drug made by the company for shoulder pain as prescribed by her doctor, and instead suffered incredibly serious complications. The verdict was affirmed at both the trial and appeal levels.

In this case, three weeks after the woman took the drug at issue, she developed a rare and severe reaction, which caused her skin to peel off, leaving her with burn-like lesions over two-thirds of her body. She spent some of the nearly two months during which she was in a hospital burn unit in a medically induced coma, and has had to undergo 13 eye surgeries.

The reaction, which is considered to have been a severe form of Stevens-Johnson Syndrome, caused the woman to suffer permanent near-blindness, scarred lungs and a constricted esophagus, making it difficult to swallow. She originally sued the manufacturer under state law in 2008 for alleged design defects. Following a 14 day trial, the jury awarded her $21 million for her injuries and suffering.

The appeal centers on the applicability of two prior court rulings, particularly PLIVA v. Mensing, which held that generic drugmakers cannot be sued for failing to warn about certain health risks due to the fact that federal law requires generic drugs to carry the same warning label as their brand name equivalents. Therefore, it remains unclear whether the court will choose to distinguish this case in that it does not solely claim a failure to warn, but also argues a design defect, which again may potentially be excludable under prior case law.

The ruling in this case is monumentally significant, because if the court rules to apply the logic reached in Mensing, which is that generic drug manufacturers cannot be sued for failure to warn about certain risks due to the fact that they are legally required to carry the same label as the brand name drugs, it will virtually eliminate patients’ ability to sue generic drug manufacturers for products liability.

What is particularly disturbing about that conclusion is the fact that many patients receive the generic formulations of drugs without even knowing it when they have their prescriptions filled. In other words, we aren’t simply talking about consumers making a choice between brand name and generic over-the-counter pain or cold medicines. Patients filling their prescriptions for any number of serious ailments could be receiving, as mandated by their health insurance coverage in some cases, the generic product, and thereby unknowingly foreclosing any potential legal claim should they react adversely to the medication.

After hearing oral argument, the court seemed to emphasize the fact that a jury ruling regarding the safety of a drug, whether generic or not, would be tantamount to second guessing a determination made by the FDA, which in the court’s view, would be a violation of the Separation of Powers doctrine.

Harmful or defective products that cause damages to consumers may give rise to a products liability claim. These types of lawsuits seek to reimburse the individual for any potential property damage, injuries, pain & suffering, and in some cases wrongful death.

If you or a loved one has suffered injury or death as a result of a defective consumer product, you should contact an experienced products liability attorney as soon as possible in order to discuss your claim. You may be entitled to damages for your medical bills, pain & suffering, lost wages, or other relief. The hardworking personal injury attorneys at Lebowitz & Mzhen have many years of experience representing the rights of people in the Washington, DC area who have suffered injuries due to defective or dangerous products. Call us today in order to schedule a free and confidential consultation. You can contact us by calling (800) 654-1949 or through our website. Don’t wait to pursue your claim, as your case may be subjected to strict statutes of limitations.

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Judge Finds National Park Service Negligent in Boy’s Fall Death, Washington DC Injury Lawyer Blog, published March 27, 2013

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