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The Search for Liability: Generic Drugs, SCOTUS and The FDA

Last June, the Supreme Court of the United States made a loud statement concerning drug liability and generic drug manufacturing. Even before the decision of Mutual Pharmaceutical Co. v. Bartlett,the policy of liability concerning generic drug liability was ambiguous and under constant attack. In 2011, the Supreme Court decided the case of Pliva v. Mensing, where the court ruled that generic drug manufactures cannot be held liable for the failure to warn of any dangers concerning a particular drug because of the current FDA policy on labeling. Said policy states that generic drug manufacturers are not only not required but legally restricted from altering the identical label of a drug from its brand name counterpart.

However, this has created a barrier for millions of drug users to seek any legal remedy for possible injuries caused by the failure to warn. While the brand name company cannot be held liable for the use of a generic drug, the generic drug manufacturers are not liable because they had no say in the creation of the label.

Hands Legally Tied, Says SCOTUS

The Supreme Court echoed this ruling two years after Pliva, in the case of Mutual Pharmaceutical Co. v. Bartlett. The question presented to the court was similar to that of Pliva, brought to SCOTUS by a woman who had contracted a debilitating skin disease after taking a generic version of the drug Clinoril, produced by the generic drug company Mutual Pharmaceutical Co., a subsidiary of Sun Pharmaceutical Industries of India.

SCOTUS overturned a New Jersey court's ruling which awarded $21 million to the woman. While the court voiced its regret over the situation of the woman, who lost nearly two-thirds of her skin, was placed in a medically induced coma and has been declared legally blind because of a reaction to the drug, the majority decision stated that the injuries "do not relieve us of the responsibility of following the law," written by Justice Alito.

Filling the Black Hole of Responsibility

The law mentioned in the majority decision is the previously mentioned FDA policy that does not allow generic drug manufacturers to alter the labels on the drugs they produce. The court, although upholding the policy, did make a request to the FDA to review it's current policy and determine whether it is indeed designed with the consumer's best interest in mind. A reform to the rules would allow for injured victims of dangerous generic drugs to seek remedy from someone.

On April 1st, 2014, Janet Woodcock, a top pharmaceutical official for the FDA, affirmed the necessity of action to increase accountability for generic drug manufacturers during a hearing before the U.S. House of Representatives health subcommittee. Not surprisingly, the proposal to increase liability has been met with much criticism from the generic drug industry. Opponents of the petition to reform state that any change would cause administrative chaos and confusion in marketing two identical drugs with different labels.

The intentions of drug authorities are to increase liability, promote safety and provide consumers with the legal remedies they deserve in the event of drug dangers. Whether the reform is the appropriate avenue to do so, it is undeniable that a need for some sort of change is inevitable.

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