Liability of harmful side effects questioned

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

The case, Mutual Pharmaceutical v. Bartlett, involves Karen Bartlett, who took Mutual's sulindac, a generic version of Merck's Clinoril. After taking the drug, Bartlett developed and suffered near-blindness, esophageal burns and lung damage, as well as the skin disorders Stevens-Johnson syndrome and toxic epidermal necrolysis. A jury awarded Bartlett $21 million for her injuries, and the Supreme Court heard the case in mid-March.

The issue is, while Bartlett suffered the injuries after taking Mutual's drug, under federal regulations governing generic drugs, a generic drug company typically does not have to conduct clinical trials — only demonstrate that its product is identical to the branded drug. It relies on the safety and efficacy data collected by the developer of the original branded drug.

"The previous court suggested that the manufacturer in this case, Mutual Pharmaceutical, could comply with the law by simply halting production of the Food and Drug Administration-approved drug in question, sulindac," Generic Pharmaceutical Association president and CEO Ralph Neas said. "This pain drug has been available since 1979, has been dispensed more than 300 million times from 2007 to 2012, and has exhibited a typical safety profile. We cannot confer to unqualified juries the power to undermine FDA rulings and potentially deprive millions of patients the medicines they need. Decisions about the safety and efficacy of drugs belong in the capable hands of the FDA."

In PLIVA v. Mensing, a 2011 case cited by Mutual, the Supreme Court determined that because generic drugs and their labeling are required to be identical to their branded counterparts, generic drug companies cannot be responsible for inadequate labeling.

The case closely follows a ruling by the Alabama state Supreme Court in January in a similar case. The Alabama court ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis make generic versions. Weeks had originally filed the suit in federal court, but the court asked the Alabama Supreme Court to determine if Weeks could sue the branded drug makers.