Today, nearly 8 in 10 prescriptions filled in the US are for generic drugs, according to the FDA. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.
But who is liable when a generic drug makes sells a bioequivalent drug to a patient who suffers a personal injury from taking it?
Two US Supreme Court cases insulate the generic makers from responsibility, so long as they included the branded drug maker’s warnings. But now courts in California, Vermont, and Illinois have accepted the notion of “innovator liability,” imposing liability on the branded drug maker for injuries caused by a generic drug equivalent.
Research shows that generics work just as well as brand-name drugs. A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. See JAMA. 2008;300(21)2514-2526.
The FDA says that any generic drug modeled after a single, brand name drug must perform about the same in the body as the brand-name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.
Immunizing generic drug makers
California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.
Two notorious US Supreme Courts rulings have immunized generic drug makers from liability in product liability and failure to warn claims.
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), holds that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claim alleging a failure to provide adequate warning labels.
- Mutual Pharmaceutical Co. v. Bartlett, 570 US 2468 (2013), holds that generic drug manufacturers cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.
However, in California, Vermont, and Illinois, these rulings did not protect branded manufacturers from innovator liability claims, because the companies controlled the text of the warning labels.
Plaintiffs argue that the physicians “reasonably and foreseeably” relied on the representations of branded manufacturers when prescribing a generic drug, because physicians understood that generics are bioequivalent to and have the same labeling as branded drugs.
In the event that the branded manufacturer made misrepresentations or engaged in other unlawful activities such as “off-label” marketing, plaintiffs further argue that physicians relied on the branded manufacturers’ misrepresentations, understood that generics are bioequivalent to the branded product, and prescribed the generic based on the branded manufacturers misrepresentations.
Only California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.
Conte v. Wyeth, 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (2008), involved a user of generic metoclopramide who brought an action against Wyeth, the manufacturer of Reglan, the name-brand form of metoclopramide, for fraud, fraud by concealment, and negligent misrepresentation.
The court of appeals held that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent.
In T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), the court of appeals imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.
Note: This decision is currently under appeal. If Novartis wins this appeal Conte would not be overturned, innovator liability would simply end at the point (if) the brand manufacturer discontinued the marketing of the brand drug.
Vermont chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010). The plaintiff filed suit against the brand name and generic manufacturers of metoclopramide for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment.
A federal court interpreted state law, imposing a duty on Wyeth because it was “fair” to do so, and there is no reason, under Vermont law, to limit defendant’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent.
Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, was a wrongful death action against SmithKline Beecham Corporation involving a man who committed suicide after taking paroxetine, the generic version of Paxil.
A federal court interpreted Illinois law to impose a duty of reasonable conduct upon GSK. The plaintiff’s common law negligence and negligent misrepresentation claims survived summary judgment.
Note: Under Illinois law a product liability claim under an innovator liability theory would likely fail where as a negligence claim would survive.
Innovator Liability and Zofran
In an unusual move, Judge Dennis Sailor presiding over MDL 2657, has approved two master complaints, one for branded drug use and a separate Master Complaint for plaintiffs that wish to pursue GSK under innovator liability theories.
Judge Sailor is overseeing 364 lawsuits in MDL 2657 in federal court in Massachusetts, IN RE: Zofran (Ondansetron) Products Liability Litigation.
The most significant difference in the Zofran Brand Master Complaint and the Zofran Generic Master Complaint is in paragraph 101 of the generic master complaint:
101. 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.
Although the Master Complaint does not contain language that limits its use to claims governed by the laws of the three “innovator liability states,” the defense is free to argue these claims based on the laws of the state of original jurisdiction. For states that do not have settled caselaw related to innovator liability, it is likely that the defense will prevail in most cases.
Mensing and Bartlett both turned on an “impossibility preemption argument,” in that is not possible for a generic manufacturer to legally alter the warning label. The generic label most conform exactly to brand label.
What if the brand drug manufacturer also makes a generic version of its own drug? Obviously, the brand manufacturer would control both the brand label as well as the generic label under this circumstance and the impossibility preemption reasoning of Mensing and Bartlett would not apply.
Novartis purchased GlaxoSmithKline’s oncology division in March of 2015. Along with Glaxo’s cancer business came the right to sell Zofran. Novartis also owns Sandoz, which manufacturers a generic version of Zofran. Therefore there is a strong argument that Mensing and Bartlett do not provide protection for Zofran Generics made by Sandoz after May 2015.