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US Supreme Court to Consider Whether Manufacturers of Generic Meds Can Be Sued For Drug Defects

The US Supreme Court will hear the issue of whether the makers of generic drugs can be sued for products liability despite the fact that federal law bars such lawsuits from proceeding. The case, Mutual Pharmaceutical Co v. Bartlett, U.S. Supreme Court, No. 12-142, involves Mutual Pharmaceutical Co.’s efforts to reverse a $21M drug injury award that a jury gave to plaintiff Karen Bartlett over personal injuries she sustained from taking sulindac, a generic non-steroidal anti-inflammatory medication.

Bartlett, who took the drug to treat her shoulder pain, experienced a rare reaction to med and developed Stevens-Johnson syndrome. She is now nearly blind and has burn-like lesions on the majority of her body. Bartlett would go on to file a dangerous drug lawsuit against Mutual under state law in New Hampshire claiming that the med was dangerous and defectively designed.

Takeda Pharmaceutical Co., of which Mutual is an indirect unit, has responded by invoking federal law, which does not allow drugs with FDA approval to be the target of drug defect lawsuits. Per that law, generic drugs must be designed the same as their brand counterparts and come with the same labels and Mutual and other generic medical manufacturers have said that because they have to be designed and labeled exactly as their brand equivalents, it is not up to them to modify a generic drug’s design or labeling.

Earlier this year, a 1st US Circuit Court of Appeals panel of three judges was unanimous in their refusal to have federal law apply to design defect allegations. Finding that there was more than enough evidence showing that sulindac caused Bartlett’s hypersensitivity reaction that left her with permanent injuries, they upheld the jury verdict.

Now, the defendant is appealing to our nation’s highest court, contending that “scores” of courts, both state and federal, had turned down the 1st Circuit’s claim that generic drug makers can be liable under the laws of a state for refusing to cease the sale of products that have federal government approval. Meantime, Bartlett, maintains that the jury award was determined under state law and has no federal law conflict. (In 2011, the Supreme Court’s ruling in Pilva Inc. V. Mensing found that federal law preempts state law claims resulting from allegedly inadequate drug label warnings about possible side effects. However, it did not offer a conclusion on whether consumers can file design defect cases against the makers of generic drugs.)

Mutual Pharmaceutical Co v. Bartlett (PDF)

Pilva Inc. V. Mensing (PDF)

Supreme Court Takes Case on Liability for Generic Drugs, The Wall Street Journal, December 2, 2012


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Whether generic or brand, medications that are dangerous, defective in design, improperly marketed, or come with poor instructions and inadequate warnings can cause serious injuries and even death to consumers. You want to make sure you are represented by an experienced drug defect law firm that knows how to successfully handle your products liability case.

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