Court to Decide if Generic Drug Makers can be Held Liable for Dangerous Drug Injuries

March 14, 2013

Almost 80% of all prescriptions in the U.S. are filled with generic medications. These medications can be offered at a lower price than brand-name drugs because the companies that manufacture the generic versions have not invested millions of dollars in the creation and testing of them. Once a patent expires on a drug, other companies can begin to manufacture and sell a generic version of it without getting FDA approval, provided the formula and labeling are not altered in any way.

Such was the case with sulindac, a generic anti-inflammatory drug similar to ibuprofen. Mutual Pharmaceutical Company in Pennsylvania, a subsidiary of another company based in India, was manufacturing sulindac in 2004 when a New Hampshire woman went to her doctor with shoulder pain. He prescribed a clinoril, a mild anti-inflammatory, and she was given sulindac as a generic equivalent. A few weeks after she started taking the drug, her skin began to come off. She ended up losing two-thirds of her skin, requiring a lengthy stay in a hospital burn unit. She also suffered esophagus and lung damage and ended up legally blind. She is now only 53 years old.

As with many other victims of dangerous drugs, the woman filed a lawsuit against the drug manufacturer in the hopes of receiving some compensation for her injuries and suffering. A jury awarded her $21 million, an amount which was also upheld by the Court of Appeals. Now the Supreme Court will hear the case. Groups on both sides of the dangerous and defective drugs argument will be awaiting the higher court's decision.

This would seem to some to be an open-and-shut case. A woman was seriously and permanently injured by a drug manufactured by a pharmaceutical company, and she should be compensated for these injuries. However, the fact that the drug was generic plays a large part in the case. In past cases, generic drug manufacturers have been protected by the higher courts. Why would the higher courts side with the manufacturers? Because generic drug manufacturers are required to reproduce the drug and its corresponding warning labels exactly like the brand-name version. Therefore, according to the courts, they cannot be held accountable for any injuries that occur because they are not responsible for the makeup of the drug or its corresponding labels and warnings.

Where does this logic leave the victims of dangerous drugs? According to patient advocates and personal injury attorneys, those injured will have no recourse against companies that may have cost them tens of thousands in medical bills and lost income and caused them pain and suffering and loss of enjoyment of life. Those who support the higher court's rulings in previous cases think that allowing cases to be decided against generic drug makers would undermine the FDA's authority and may force some manufacturers to stop making generic medications for fear of being sued.

The Kentucky personal injury attorneys at Miller & Falkner have helped numerous people who have been injured by dangerous or defective drugs. Regardless of the Court's decision in this case, they will continue to fight for their clients.


Justices to Take Up Case on Generic Drug Makers' Liability; The New York Times; Katie Thomas; March 4, 2013