Supreme Court Mulls Over Generic Drug Maker Liability
March 21, 2013

Should Generic Drug Makers Be Held Responsible For Injuries?

Alan McStravick for - Your Universe Online

In an article written for redOrbit in January, it was detailed how many physicians will opt to prescribe brand-name pharmaceuticals even when a generic option is available. That story explored the increased costs associated with this practice on the health care delivery system, as a whole.

Unfortunately, there are unintended costs with the administration of generic pharmaceuticals, as well. This fact was made all too clear for Karen Bartlett, a New Hampshire woman who took a generic pain medication for shoulder soreness she was experiencing. Bartlett began taking Sulindac, the generic form of the non-steroidal anti-inflammatory drug based upon the branded Clinoril. Her experience with Sulindac caused her to suffer a very rare but serious reaction that a lower court described as “truly horrific”.

The physiological reaction to the medication, determined to be a form of Stevens-Johnson Syndrome, caused her to endure burns across much of her body. She spent two months in a medically induced coma and has undergone 12 eye surgeries as a result of her interaction with the generic drug. The entire ordeal has left her nearly blind and inhibits her ability to eat normally due to burns to her throat.

According to the Mayo Clinic website, Stevens-Johnson syndrome is a disorder in which your skin and mucous membranes react severely to a medication or infection. At its inception, Stevens-Johnson mirrors flu-like symptoms soon followed by a painful red to purplish rash that spreads and blisters. Ultimately, the top layer of skin begins to die and shed.

Bartlett took the manufacturer of the generic medication to court for damages associated with her ordeal and was awarded $21 million dollars in compensation. But her story didn´t end there. She was in Washington, DC on Tuesday, before the Supreme Court, who decided to take up the case of Mutual Pharmaceutical v. Bartlett, to determine whether or not to throw out the verdict, arrived at by a jury. If the court rules in favor of the manufacturer, precedent will have been set that will bar patients seeking legal recompense against generic drug manufacturers who market an unreasonably dangerous drug, regardless of warnings.

The implications of the court´s eventual ruling, expected sometime in June, will have far-reaching consequences. It has been estimated that 80 percent of prescriptions filled in the US are for generic drugs.

The legal argument at play in this case is whether or not patients should have a right to seek damages against a manufacturer in light of the fact federal regulators already decided the drug was safe for sale.

And this is not the first time the court has waded into this territory. Two years ago, in a 5-4 decision, the court shielded generic drug makers from being held liable for failing to warn patients of potentially harmful side effects.

According to the majority opinion, the makers of generic medications are protected by the warning label that was approved by the US Food & Drug Administration (FDA) for the formula produced by the original manufacturer of the drug. Fault cannot be assessed to the generic manufacturer for not including stronger warnings.

Oral arguments in the case show the justices are skeptical of citizen juries second guessing the safety of a particular drug that was previously approved for sale by federal regulators. Specifically, both Justices Scalia and Breyer questioned whether a jury comprised of ordinary citizens was qualified to decide whether a drug´s benefits outweigh its risks.

Mutual Pharmaceutical´s lawyer, supported by attorneys from the Obama Administration, urged the court to nullify the original verdict and to rule against future juries deciding that approved drugs present too great a danger to be on the market.

However, Justices Sotomayor and Kagan seemed to disagree with that contention. They instead suggested the FDAs approval of a drug extended only to the sale of the drug on the market. Their arguments claimed that approval would not necessarily bar a jury from finding the approved drug was unreasonably dangerous.

Arguing on behalf of Bartlett was Washington attorney David Frederick. His argument before the court stated his client was simply seeking relief for a simple condition of shoulder pain. Unlike medications meant to treat more serious conditions, there should have been a reasonable expectation of a diminished risk of side effects.

"Aspirin and acetaminophen – Tylenol – produce the same kind of pain relief, but they do not produce the kind of [injuries] that Ms. Bartlett had, that caused 60% of her body to burn," he said.

With the prevalence of generic medications on the marketplace, the expected June ruling will have ramifications that could potentially affect a majority of Americans.