On March 16, 2018 the Massachusetts Supreme Court gave the green light for consumers to pursue generic drug injury lawsuits against Merck & Co., Inc. and other companies that manufacture generic drugs for injuries resulting from generic versions of their medications.
Due to a 2011 ruling by the Supreme Court, companies that manufacture generic medications are shielded from lawsuits arising from failure to provide sufficient warning labels because, under federal law, they are required to use the warning label version that the original brand-name manufacturer provides.
The Supreme Court of California issued a similar ruling to Massachusetts as well, holding that manufacturers of brand-name medication have a duty to inform users of the generic versions of their medicines as addition to their brand-name drugs.
Brian Rafferty, a Massachusetts resident, began taking finasteride, a generic version of Merck’s Proscar, in 2010 to treat an enlarged prostate. While he was taking finasteride, he began to suffer from side effects that included sexual dysfunction and discontinued use of the medication. Contrary to the warning labels’ claims, his side effects persisted well after he stopped taking the medicine.
His lawsuit against Merck alleged that in 2008, the warning label for Proscar was updated to in several European markets to include information about sexual dysfunction, but as of 2010 was still not updated in the United States. While his case was initially dismissed by a lower court, the states Supreme Court eventually reversed that decision in a 4-0 ruling.
Chief Justice Raph Gants wrote, “Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product but also the users of the generic product… Shielding brand-name manufacturers from liability entirely would leave consumers with no chance to sue generic drug companies, whose products command about 90 percent of the market.”
However, the court stopped short of agreeing with Mr. Rafferty’s claims of recklessness on behalf of Merck. The court also added, “Because Merck owed Rafferty a limited duty to warn, and because Rafferty, to state a claim that falls within this limited duty, must allege facts supporting a finding that Merck acted recklessly, not just negligently, we vacate the dismissal of this claim and remand the case to the Superior Court.”
However, the decision is the first in the nation to allow drug companies to be held liable for reckless failure to warn customers. Being sued for recklessness as opposed to negligence requires that companies are aware of their actions and do not take the proper steps to correct their mistakes, whereas negligence implies more of an oversight and unintentional mistakes.
The ruling adds a new layer of protection for consumers and opens drug manufacturers in Massachusetts to new liabilities, but is far from finished. In its ruling, the court also found that the defendant must have committed an unfair or deceptive act or practice in the conduct of trade or commerce which causes injury to the plaintiff. It is likely that similar rulings regarding generic drug injury lawsuits in other states will follow, and possibly be appealed to even higher courts.
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