Safety of Generic Drugs Argued in Supreme Court

Dangerous drug lawyers at Pintas & Mullins Law Firm recently reported of the story of a woman, Karen Bartlett, who took a generic form of a pain medication and developed Steven John’s Syndrome, which permanently damaged her lungs, esophagus, and rendered her legally blind. Bartlett was initially awarded $21 million by a state jury trial, but her case was appealed all the way to the Supreme Court, where it now stands.

CNN reporters observing the proceedings have stated that it will be difficult to anticipate how the justices will rule in this case, as the bench appeared cautious while Bartlett’s condition was debated before them. The defendant, Mutual Pharmaceuticals, is arguing that it received FDA approval and that, because it is required to use the same ingredients, labels, and warnings as the brand-name drugs, it cannot comply with safety and marketing regulations.

Justice John Roberts highlighted the state jury’s decision, which found that the risks of Sulindac, the pain medication, outweighed the benefits, and that it should not have been marketed in the first place. Justice Roberts affirmed that this was indeed inconsistent with the initial FDA approval.

Justice Elena Kagan stated that Mutual Pharmaceuticals could be held responsible for the generic’s defects, stating that this case extends to both generic and brand-name drugs, and that the two go hand-in-hand when discussing the drugs’ design defects.

Karen Bartlett’s story illuminates the catastrophic and devastating effects pharmaceuticals can have on an unsuspecting patient. Bartlett suffered from shoulder pain, and was prescribed a generic form of Sulindac, from which she developed a rare hypersensitivity reaction known as Steven John’s Syndrome (SJS). This side effect caused her skin to burn off, leaving open wounds all over her body, even more severe than third-degree burns.

She was placed in a medically-induced coma for 100 days, and had to stay in a hospital burn unit for two months after that. Today, nearly a decade later, she is permanently blind, has undergone 12 surgeries, and suffers from irreversible damage to her lungs and esophagus. She needed help standing in the Supreme Court plaza after the arguments, led down the steps by her lawyer.

In recent years, the Supreme Court has been faced with numerous cases concerning the generic liability from defective drugs. Drug companies such as Mutual repeatedly argue that they should be exempt from product liability lawsuits if the drugs in question have met federal safety approval regulations.

In 2012, the Supreme Court upheld this argument when it ruled, five to four, that generic manufacturers do not share the same levels of responsibility as brand-names. Specifically, it found that generics did not have to update warning labels when significant new risks and adverse events are reported. In this case, the Court ruled that Congress, not the courts, should change the law on generics if it sees fit.

Bartlett based her case on the claim that the drug itself, whether generic or not, was unsafe. A federal appeals court supported this claim, stating that Mutual should have simply taken the medication off the market after receiving initial reports of its excessive dangers.

A second, separate case concerning generic drugs will be heard in April 2013 by the Supreme Court. This case involves the reverse payment agreements between brand-name companies and the competitive generic manufacturers. Reverse payment agreements are when brand-name drugs paying generic companies to stay out of a certain drug market until the brand-name’s patent expires. The case will establish whether or not this practice violates federal anti-trust laws.

A ruling in Bartlett’s case is expected by late spring of 2013. Defective drug lawyers at Pintas & Mullins Law Firm will continue to report on the events surrounding generic and brand-name pharmaceutical litigation. If you or a loved one was seriously injured by a dangerous drug, you may be entitled to significant compensation for any pain and suffering, lost wages, and past and future medical expenses.


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