Defective drug lawyers at Pintas & Mullins Law Firm have written extensively on the case of Mutual Pharmaceutical v. Bartlett, a case about the horrific injuries suffered by a New Hampshire woman, Karen Bartlett, after taking a generic painkiller.
A federal jury awarded Bartlett $21 million when she sued Mutual Pharmaceutical for selling a defectively designed drug, a decision that was upheld by the 1st U.S. Circuit of Appeals. In a 5-4 decision, however, the Supreme Court found that Mutual Pharmaceutical could not be held liable for Bartlett’s injuries, leaving her without relief for a lifetime of medical bills, and American consumers without legal recourse if injured by a generic drug.
The majority decision, written by Justice Alito, conceded that Bartlett’s injuries, which were caused by the NSAID sundilac, were devastating. Bartlett was prescribed sundilac in 2004 to relieve her shoulder pain. Within a few weeks, she developed a rare reaction to the drug, known as Steven-Johnson Syndrome, which caused two-thirds of her skin to slough off. She was placed in a medically-induced coma for several months and was then admitted to a burn unit, where she remained for two more months.
She suffered permanent injuries to her lungs, eyes and esophagus, and is now permanently disfigured and legally blind. She is unable to read, work or drive and requires a feeding tube. Her burn surgeon described the pain caused by sundilac as “hell on earth,” and testified for her in court.
Justice Alito and the four consenting justices ruled that the FDA approved sundilac for sale, and that federal law trumped New Hampshire’s consumer protection laws; New Hampshire requires generic drug manufacturers to change their labels to clearly warn about the known dangers of their drugs, while federal law does not require such action. Justice Alito affirmed that New Hampshire law was without effect in this case, an affirmation that now extends to every consumer in the country purchasing and taking a generic drug.
In most states, pharmacists often substitute generic copies of brand-name drugs because they are significantly less expensive and generic manufacturers are legally required to use the exact same labels and design as the brand name version. Now, when a consumer agrees to purchasing the generic, because they cannot afford the brand-name or they are simply unaware of this new ruling, they are completely waiving their rights to a trial by jury if they are ever injured by that drug. To put this in perspective, about 80% of the prescriptions written in the United States are for generics.
Mutual Pharmaceutical argued successfully that its sundilac was nothing but an exact replica of the brand-name Clinoril, which was approved as safe and effective by the FDA, and which it sold but did not design. This is the second major blow the American generic consumers in as many years. In 2011, the Supreme Court similarly ruled that generic manufacturers could not be sued for improper labeling (Pilva v. Mensing). Now the only plausible avenue consumers have to file lawsuits against these companies is if there is a flaw in their manufacturing processes, which is extremely rare.
Pharmaceutical companies do not need further immunity from liability, and
this decision only further encourages Big Pharma’s notorious and
fraudulent lack of accountability. 80% of consumers must now decide if
they are going to switch to brand-name drugs, which only deepen the pockets
of already giant companies like Bayer and Eli Lilly, or continue to pay
half the price for generics but surrender their right to file a lawsuit
if, say, those drugs cause two-thirds of their skin to burn off and leave
them permanently disabled.
Justice Breyer issued a dissenting opinion, doubting that the FDA intended to have its requirements preempt state laws, or to extend so far as to grant generic manufacturers immunity and penalize consumers. He argued that these companies could, realistically, comply with both federal and state law. Justice Sonia Sotomayor further clarified this, stating the decision was based on an “implicit and undefended assumption,” and that the FDA requirement was actually intended to protect consumers by forbidding generic companies from distributing new drugs without federal approval.
Defective drug attorneys at Pintas & Mullins Law Firm have been advocating for injured consumers for over 25 years, and are extremely disappointed by this ruling. As Justice Sotomayor notes, the decision could have very serious consequences on the safety of drugs and products sold in the United States.