What are Generic Drugs: Every day, millions of Americans fill prescriptions that are made by generic manufactures. About 8 out of 10 prescriptions filled every day are generic versions. A generic drug is an identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, quality, performance characteristics, and intended use. In fact, because the products are identical equivalents, the FDA requires generic prescriptions to bear the exact same labels on their products as those written for the brand-name version. Generic drugs are about 85 percent cheaper than brand-name drugs and the FDA estimates that they save U.S. consumers about $3 billion every single week. However, there is one downside to taking a generic drug—accountability—or rather the lack thereof.
Can Generic Drug Manufactures Be Held Liable For Consumer Injuries? To date, the answer to that question is “no”. In 2011, the United States Supreme Court in PLIVA v. Mensing, 564 U.S. 604 (2011), held that generic drug manufactures could not be held liable to consumers for a cause of action in products liability suits called a “failure to warn” because under the U.S. Food & Drug Administration’s (“FDA”) rules, generic drug makers could not change the warning labels on their products—only brand-name manufacturers can.
The Mensing decision was followed by another United States Court decision in 2013 in Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), which ruled that generic drug manufacturers could not be sued by patients who claimed the drugs were “defectively designed” which is another popular products liability cause of action. This was a significant win for the drug industry, because the ruling that it overturned was a $21-million-dollar verdict for a lady in New Hampshire who developed a painful and debilitating skin condition after taking a generic version of a pain medication called Sulindac, the brand-name of which is Clinorial. The Court in a 5-4 decision held that because generic drug manufacturers are required by law to make a virtual “copy” of the brand-name, generic drug makers were preempted by law from liability from claims the drugs were unsafe. Id. at 2476-77.
Together the Mensing and Bartlett decisions have become known as the “Mensing/Bartlett Preemption.”
Can State Courts do Anything to Level the Playing Field? To date, the answer to that question is “not much.” Basically, most courts that have considered the issue agree that a brand-name manufacturer is not liable if the plaintiff took the generic form of the medication. However, in 2014, the Alabama Supreme Court in Wyeth, Inc. v. Weeks, 159 So. 3d 649, 653 (Ala. 2014) held thata plaintiff that was prescribed the generic version of Regian and developed tardive dyskinesia could sue the brand-name manufacturer. Defendant Pfizer argued it had no direct relationship with the consumer and thus owed no duty of care—a key element in any negligence case. The Alabama Supreme Court ruled it was “not unfair” to hold a brand name drug manufacturer liable for warning labels, even if the company did not make the generic drug that actually caused the injury. Unfortunately, that ruling was later effectively rendered void by the Alabama State Legislature in 2015 by SB80. Lawmakers decided it was unfair to hold brand-name manufacturers liable for injuries caused by generic drugs, and has since blocked plaintiffs from doing so. At present, brand-name manufactures cannot be held liable for injuries and illnesses caused by generic drugs that they did not make. Thus, any consumer who uses a generic drug and is injured has virtually no legal recourse if the drug is inherently dangerous or if the manufacturer failed to warned about problems
Is a Change on the Horizon? The answer to that question is “maybe so.” In December 2015, the FDA passed a final rule that would allow generic drug makers to alter safety labels that would detail new risks without the agency’s pre-approval. The FDA committed to have the new rule in place by July 2016 but it was postponed again. There are numerous problems with a new rule such as confusion for doctors and hospitals who may face different warning labels on identical generic versus brand-name drugs. However, the FDA appears committed to doing something for consumers who have been left without a remedy for injuries caused by generic drugs. The latest news on this front is that the FDA may come out with a new rule this April 2017. Stay tuned to see which manufacturer will have to stand up and be liable.