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Supreme Court Will Decide If Generic Drug Companies Can be Sued Over Design

Update Date: Mar 20, 2013 09:37 AM EDT
Generic Drugs
The FDA's proposed regulations will require generic drug makers to include all known health risks involved with each drug product. (Photo : Flickr)

The Supreme Court has yet to make a decision regarding whether or not generic drug companies can be sued within state court due to the federal regulations that these companies follow. The company awaiting this decision is Mutual Pharmaceutical Co, Inc., which is asking the Supreme Court to look at its case and overturn the $21 million ruling that the New Hampshire Court jury demanded the company to pay to the Plaintiff, Karen L. Bartlett. Bartlett sued Mutual after she took their generic drug Clinoril in 2004, and now over 60 percent of her body is burned flesh and she is considered to be legally blind.

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Despite these nasty side effects from the prescribed medication used for shoulder pain, Mutual claims that it did nothing wrong but follow the federal regulations places specifically for generic companies. Bartlett's lawyers stated that they seek compensation for her injuries, and are not asking for the drug to be taken off the market. They also expressed that a drug with such bad possible side effects should have come with a warning label. Mutual, however, reiterated the fact that generic drug companies must use the same warning labels as their counterpart brand name drugs. They must also use the same ingredients as brand name drugs, making them as safe as the drugs that were approved by the Food and Drug Administration (FDA).

In 2011, Pilva v. Mensing made it to the Supreme Court, which ruled that generic drug companies cannot be liable for the failure to warn their consumers regarding consequences and side effects if their warning labels are identical to the brand names; labels. Despite this ruling, the state court sided with Bartlett, stating that the company could have decided to not sell a drug with severe side effects.

Clinoril is the generic version of sulindac, which was approved by the FDA in 1978. Mutual got the approval in 1991 to sell it. In 2002, the side effect that Bartlett had from the drug was added as a warning and the warning was updated in 2006.

The Supreme Court will have to decide on the Mutual Pharmaceutical Co. v Bartlett, 12-142 case later on this year.

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