Generic vs. Name Brand
The majority of prescriptions filled in the U.S. each day – about 8 out of 10 – are generic versions. They are about 85 percent cheaper, and generally the same in quality and effectiveness.
But there is one major downside to taking a generic drug: Accountability. Or rather, lack thereof.
That is changing, but it has been a slow road. Boston product liability attorneys at The Attorney Injury Group know that for years, patients injured or sickened by generic drugs have been left without remedy. It has to do with regulatory limitations and responsibilities placed on brand name and generic drug manufacturers over content and labeling.
A major U.S. Supreme Court decision in 2011 held that generic drug manufacturers couldn’t be liable for failure to warn because, as justices pointed out, generic drug makers couldn’t change the warning labels on their product. FDA rules stipulated only brand name manufacturers could do that. But, brand name manufacturers couldn’t be held liable for injuries and illnesses caused by generic drugs they didn’t make. That meant the wide swath of consumers who used generic drugs had virtually no legal recourse the drug was inherently dangerous or if the manufacturer failed to warn about problems.
A final rule issued by the FDA is set to be instituted in 2016 that would change this conundrum by giving generic manufacturers the authority to change their labels. However, it is unlikely the action will be retroactive. That means patients whose injuries stemmed from generic drug use prior to 2016 may find it difficult to pursue compensation. It is always worth consulting an experienced injury attorney to fully weigh all options.
What Are Generic Drugs?
Generic drugs are versions that can be produced once the patent expires on a name brand product. In some cases, generic forms of the drug are manufactured at the very same plant.
But the FDA has very specific guidelines that generic drugs have to meet before they can be marketed.
The federal watchdog requires:
- Same active ingredient, strength, dosage form and route of administration as brand name drug;
- Must prove its drug is the same (bioequivalent) of the brand name drug;
- All testing sites, manufacturing and packaging has to pass the same quality standards as brand name drugs.
It’s estimated that generic drugs save U.S. consumers about $3 billion every single week, according to the FDA.
However, because the products are so similar, the FDA had held generic drug makers couldn’t alter labels on the products. All generic prescriptions bore the same labels as those written for the name brand version.
Plivia v. Mensing
In 2011, the U.S. Supreme Court issued a major ruling that stripped patients of a key avenue for product liability action against generic drug makers.
The case, Plivia, Inc. , et al. v. Mensing involved the generic version originally sold under the name brand of Reglan, used to treat digestive tract problems. Active ingredient in the medication was metoclopramide.
Patients were unaware that long-term use of this drug can cause a condition known as tardive dyskinesia, which is a severe neurological disorder. Plaintiffs had been prescribed the brand name of the drug but received the generic version from their pharmacists. They sued the generic drug makers, alleging failure to provide adequate warning labels, and alleged manufacturers were liable under state law for product liability. However, defendant manufacturers countered these claims were pre-empted by federal law because they were not allowed to alter warning labels of their product. Ultimately, the U.S. Supreme Court agreed, granting broad protection to generic drug manufacturers.
Mut. Pharm v. Bartlett
Another major case in 2013 underscored generic drug manufacturer protections. In Mut. Pharm Co. v. Bartlett, the U.S. Supreme Court ruled 5-4 that generic drug manufacturers could not be sued by patients who claimed the drugs were defectively designed.
Deemed a significant win for the drug industry, the ruling overturned a $21 million verdict in favor of a New Jersey woman who developed a painful and debilitating skin condition after taking a generic version of a pain medication called sulindac. The brand name version is called Clinorial.
The court 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.
Together, the Mensing and Barlett decisions became known as the “Mensing/ Bartlett Preemption.”
State Court Actions
Recognizing these actions give consumers of generic drugs few options in the event these drugs cause injury, several state courts stepped with decisions that sidestep the Mensing/ Bartlett Preemption.
In 2014, the Alabama Supreme Court issued its ruling in Wyeth v. Weeks, in which the court held a plaintiff who was prescribed the generic version of Reglan and developed tardive dyskinesia could sue the brand name manufacturer. Defendant Pfizer had argued it had no direct relationship to 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 didn’t make the generic drug that actually caused the injury.
However, 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.
Then there was the 2014 case of Trahon v. Sandoz Inc. by the U.S. District Court for the Middle District of Florida. The federal judge denied a bid by defendants to dismiss a product liability lawsuit after defense presented a preemption argument. Patient suffered injury after being injected with a powerful cancer drug, which was contained in vials later found to be faulty and contaminated with flakes of glass. The court ruled federal preemption didn’t extent to packaging of generic drugs.
Then there is the case of Guvenoz v. Target Corp. , a wrongful death action in which it was alleged a generic drug manufacturer was responsible for causing a patient’s death with an inherently dangerous drug. Defendant manufacturer sought preemption. However, the Illinois appellate court rejected this argument, stating there would be “no safe harbor” for drug makers who sell medications that are irremediably dangerous. The court ruled that the federal government’s rule barring generic drug makers from changing labels doesn’t absolve a company from selling a drug that’s dangerous. The legal duty owed to consumers would be to change the formula, change the label or stop selling the drug altogether.
FDA’s Supplemental Actions Proposing Labeling Changes for Approved Drugs and Biological Products
The U.S. Food and Drug Administration passed a final rule in December 2015 that would allow generic drug makers to alter safety labels that would detail new risks without the agency’s pre-approval.
Initially, the agency had made this commitment after the Mensing ruling to have the new rule in place by September 2015. However, it was later put off to July 2016.
The FDA indicated the lack of generic manufacturer accountability created by the Mensing/ Bartlettpreemption causes concern that companies won’t conduct adequate post-market surveillance, evaluation and reporting of health and safety issues.
Still, the agency is considering a number of alternatives as proposed by the Generic Pharmaceutical Association and other industry power players.
Plaintiffs in these actions face a challenging, complex and evolving area of law. It’s imperative to speak with a law firm you can trust.