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Generic Drug Makers Won’t Be Liable for Product Defects, Supreme Court Says

In a tightly contested 5-4 vote, the Supreme Court moved to prevent makers of generic drugs from being held liable against defective products. The precedent was set by a ruling in favor of Mutual Pharmaceutical Co, which is owned by Sun Pharmaceutical Industries, Ltd. The ruling overturned a previous multimillion dollar settlement ruling that was in favor of a resident of New Hampshire who alleged that using a generic drug caused her irreparable harm due to an unsafe chemical design.

Justice Samuel Alito, who voiced the majority opinion of the court, commented that state law could not supersede federal laws on prescription medications, which are approved by the FDA (U.S. Food and Drug Administration). This, combined with a federal law that was passed in 2011 that stated that generic prescription drug makers are immune to liability and instead the primary makers of branded drugs are, sets a liability landmark that would prevent people from suing generic prescription drug makers for product defects in the future.

Public Citizen, a prominent watch group for consumer rights, stated that this ruling would compromise the safety of patients who rely upon more affordable generic drugs. About 80 percent of all drugs sold in the U.S. are generic brands.

“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, told Reuters in a recent interview.

He was specific to point out a primary concern that most problems associated with drugs are not fully realized until decades after the release of the drugs and their approval by the FDA. By the time the problems are noticed, most variants of said drugs are being sold as generic brands, and often there are no longer the primary branded versions even available on pharmacy shelves

Mutual Pharmaceutical had asked the court to overturn a previously ruling in favor of plaintiff Karen Bartlett of New Hampshire. She alleged that she took Mutual’s generic non-steroidal anti-inflammatory drug, Sulindac – a generic version of Merck & Co Inc’s Clinoril – back in 2004. The side effects, she purported, caused a rare and serious adverse reaction that caused skin burning and peeling across her body resulting in severe pain and permanent disfigurement.

Mutual’s primary defense was that federal law couldn’t supersede state law, and they won the ruling in Supreme Court as a result.

“Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce,” the majority decision read.

The case is Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142.

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