- ROUNDTABLE: Improving patient outcomes, controlling costs with OTCs
- ROUNDTABLE: Pharmacy’s future in sync with technology
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- Reports: ESI may start 'price war' over new hepatitis C drugs
WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.
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 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.
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.
"The previous court suggested that the manufacturer in this case, Mutual Pharmaceutical, could comply with the law by simply halting production of the FDA-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.