Brand Name Versus Generic Drugs
Generic medications make up nearly 80 percent of drugs filled in the United States, according to the U.S. Food and Drug Administration (FDA). As popular drugs lose their patents, generic drugs are expected to become even more commonplace in coming years. Generic drugs designed to be just as effective as the brand name versions, and cost much less. In terms of product liability litigation however, who is liable when a patient sues for an alleged generic drug injury?
Parker Waichman LLP has decades of experience successfully representing clients in drug injury lawsuits. Our firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.
According to the FDA, generic drugs must have the same active ingredient, strength and dosage form as the brand name version. The route of administration must also be the same; for example, if the brand name is an oral pill then the generic cannot be intravenous. Generic drugs can contain different inactive ingredients from the brand name, the agency states on its website.
The FDA says that generic drug makers must demonstrate that their drug is bioequivalent, or the same as, the brand name. Studies have shown that generic drugs are just as effective as the brand name.
Generally, generic drug makers cannot be sued for injuries allegedly caused by their drugs so long as they include the branded drug maker’s warning, two Supreme Court cases found. However, courts in California, Vermont and Illinois have recently ruled that a brand name drug maker may be liable for injuries caused by generic equivalents.
Liability in Drug Injury Lawsuits for Generic Drug Injuries
The Supreme Court rulings that bar generic drug makers from product liability and failure to warn claims are: PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 US 2468 (2013). Since generic drug makers are required to use the warning included by brand name companies, they do not have control over the warnings and therefore cannot be sued.
However, courts in California, Vermont and Illinois have found that branded manufacturers may be liable for generic injuries because they control the language on their warnings. This is known as “innovator liability”.
Plaintiffs suing for generic drug injuries allege that physicians “reasonably and foreseeably” relied on branded warnings when prescribing a generic version of the drug. If the branded manufacturer engaged in illegal activities or misconduct, such as failing to warn of certain injuries, that would also translate to generic versions. Physicians rely on these alleged misrepresentations to prescribe drugs, since generics are understood to be bioequivalent to the brand name.
In California, an appeals court found that Wyeth was liable for injuries allegedly caused by generic metoclopramide; the brand name version is Reglan. The 2008 case was Conte v. Wyeth. The plaintiff sued for fraud, fraud by concealment and negligent misrepresentation. The court found that Wyeth is liable for warnings that extended to generic versions of its drug. Another California case, T.H. v. Novartis Pharmaceuticals Corp., found that Novartis is liable for generic injuries even though the company sold all rights to the product. This decision is under appeal.
In Vermont, innovator liability was recognized in Kellogg v. Wyeth. The lawsuit sought damages for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment related to generic metoclopramide.
Innovator liability was also imposed in Illinois, in the case Dolin v. SmithKlineBeecham Corp. The lawsuit was a wrongful death claim, filed on behalf of a man who committed suicide after taking generic Paxil, or paroxetine. A federal court imposed a duty of reasonable conduct on branded maker GSK.
Additionally, a judge recently paved the way for plaintiffs suing over injuries allegedly caused by the generic version of Zofran, ondansetron. Lawsuits are consolidated into a multidistrict litigation (MDL) before Judge Dennis Sailor; plaintiffs allege that anti-nausea medication, approved for cancer patients, caused birth defects in pregnant women. Judge Sailor took the unusual move of approving two master complaints, one for branded drug claims and one for generics under innovator liability theories.
The most important distinction in the generic master complaint is in paragraph 101, which states, “Defendants knew or should have known that consumers such as Plaintiffs would foreseeably use the generic bioequivalent of Zofran and rely upon representations and omissions of Defendants as the holders of the NDA for Zofran.”
Filing a Drug or Medical Device Injury Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing a lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).