Generic Drugs and Karen Bartletts Case against them

A suit brought by a 53 year old woman against a generic brand drug manufacturer is set to become a litmus test for patients’ rights, and one which could have far-reaching consequences for the pharmaceuticals industry. The case is Mutual Pharmaceutical Co. v. Bartlett, and at stake are issues which have divided the court on earlier occasions.

Mutual manufactures a drug called sulindac, an anti-inflammatory which belongs to a class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs. Sulindac is the scientific name for a widely used brand name drug called Clinoril, which is manufactured by Merck and was approved by the FDA in 1978. Federal law requires generic drugs to be identical to branded versions: they must have the same ingredients, and must carry the same warnings and safety profile. Known side-effects include a higher risk of heart attack, peptic ulcers, and perforation of the stomach or intestine. A rare, but possible side-effect is Stevens-Johnson Syndrome, and this is what the plaintiff, Karen Bartlett, developed after taking sulindac to relieve shoulder pain.

What happened to Bartlett is nothing short of horrific. After being prescribed the drug in 2004, she began to lose her skin until almost two thirds of it was gone. With more than 60% of her body resembling an open wound, she was placed in a burns unit for two months and spent additional months in a medically-induced coma. She suffered damage to her lungs and oesophagus, and became legally blind despite no fewer than 12 operations on her eyes.

Karen Bartlett sued Mutual Pharmaceutical in 2010, arguing that the drug’s design was flawed. A New Hampshire jury agreed with her argument that sulindac was dangerous and defective, and awarded her $21 million in damages for an experience described as “hell on earth”. The decision was upheld by an appeals court. In a recent interview, Bartlett restated her opposition to the drug. “It was horrible,” she said. “And this medication that I took, sulindac, I don’t think it should be prescribed.”

Now, the issue of whether Mutual can be held responsible for her suffering will be revisited by the highest court in the land. The outcome will have a profound effect on the legal rights of patients who take generic drugs, a market which currently accounts for almost four in every five prescriptions filled in the United States.

Two previous cases have clouded the arguments. In 2009, a court decided in the case of Wyeth v. Levine that a musician who lost an arm after taking a brand-name drug could keep a $6.7 million payout. The pharmaceutical company had argued that by complying with FDA labelling requirements they were immune from liability, but the court ruled on the fact that manufacturers of brand-name drugs can sometimes change warning labels without permission.

No such provision is afforded to generic brand manufacturers, however. In 2011, a court ruled in Pliva v. Mensing that because companies which market generic drugs are bound to follow the labelling guidelines of branded drugs, they cannot be sued for failing to warn consumers about potential risks. In this particular case, the court ruled against two women who had developed stomach ailments and a neurological disorder after taking metoclopramide, a drug which is commercially marketed under the name Reglan.

The repercussions from this decision are of great importance to the vast number of consumers who are given generic brands by their pharmacist. Although there is no tangible difference between the pain and suffering caused by branded or generic drugs, the rights of consumers may be entirely different. In response to the decision in Pliva v. Mensing, Justice Sonia Sotomayor commented that “a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic.”

The case of Mutual Pharmaceutical Co. v. Bartlett will turn on something slightly different, however, as Karen Bartlett’s claim is that her issue is not with the warning label, but rather, with the drug’s actual design. While Bartlett’s lawyers will argue that their client is entitled to compensation under strict liability laws for injury caused by a defective product, lawyers for Mutual are entitled to fall back on the 2011 decision. As Jay P. Lefkowitz, representing the drug company, has said, “There is no principled basis for treating design defect claims any differently from failure to warn claims.”

This will be a case of fine distinctions, but profound outcomes. What the Supreme Court eventually rules in Mutual Pharmaceutical Co. V. Bartlett will dramatically affect the rights of drug companies, and of millions of consumers who use their products every day.