July 27, 2007

What’s in a Name: When Will a Name-Brand Manufacturer Be Liable for Injuries Caused by a Generic Medication?

It is a common and accepted practice: a doctor prescribes a name-brand medication, and the pharmacy fills it with a generic. The practice is encouraged, and often even mandated by regulations or insurance requirements, for its cost savings. But what happens if there is a problem? Who is legally responsible if the medication causes an injury? Does the result change if the generic manufacturer is no longer a viable entity? And what if the name-brand manufacturer was the only one to test the medication and provide labeling information that later proved to be inaccurate? To date, the answer has been fairly consistent: the generic manufacturer is responsible for its own product. However, new legal arguments are continually being advanced to assign responsibility to the name-brand manufacturer who is sometimes easier to target and who likely has deeper pockets.

Creative legal counsel are always striving to widen the scope of responsible parties and sweeten the pot of recovery. In the context of generic drugs, there appears to be a resurgence in attempts by plaintiffs’ counsel to assert that a name-brand manufacturer’s liability should be extended to cover injuries from generics, particularly since the generic manufacturer is required to use the same labeling as the name-brand drug as part of gaining Food and Drug Administration (FDA) approval. Recent cases demonstrate, however, that courts continue to limit claims against a name-brand manufacturer for a generic manufacturer’s product. Goldych v. Eli Lilly & Co., No. 5:04-cv-1477 (N.D. N.Y. July 19, 2006); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. May 25, 2006); Laisure-Radke v. Barr Pharmaceuticals, Inc., No. C03-3654RSM (W.D. Wash. March 29, 2006); Block v. Wyeth, Inc., Civ. No. 3:02-CV-1077-N, 2003 U.S. Dist. LEXIS (N.D. Tex., Jan. 28, 2003).

Plaintiffs in these cases generally rely on the labeling requirements for generic drugs to rope the name-brand manufacturer into the litigation by claiming that the physician and consumer relied on the name-brand manufacturer’s labeling and advertising when prescribing and ingesting the generic drug. In a recent case, the generic manufacturer introduced a new twist in order to escape liability, arguing that the "failure to warn" claims against it were preempted by FDA regulations that require a generic-drug manufacturer to submit and utilize the same label as the name-brand drug. Laisure-Radke v. Par Pharmaceutical, Inc., No C03-3654RSM (W.D. Wash. March 29, 2006). Whether the argument is one of preemption or the extension of a "duty to warn" to a name-brand manufacturer, the courts have uniformly looked for guidance to the Fourth Circuit’s decision a decade ago in Foster v. American Home Products, 29 F.3d 165 (4th Cir. 1996).

In Foster, the Fourth Circuit invoked policy considerations, in addition to long-standing legal axioms, and it refused to assess liability to a name-brand manufacturer for injuries caused by a generic medication. The Foster plaintiffs attempted to hold Wyeth liable when their infant daughter died after taking the generic equivalent of Wyeth’s cough syrup, Phenergan. They claimed that (1) the regulatory scheme required name-brand manufacturer liability for generic medications; and that (2) the physician’s reliance on name-brand medication labeling and warnings was foreseeable and, therefore, created a legal duty.

The plaintiffs in Foster, as well as those in more recent cases, pointed primarily to the regulatory scheme for approval of generic medications to support their claims against the name-brand manufacturer. Under the Food, Drug, and Cosmetic Act, generic medications can gain FDA approval pursuant to an Abbreviated New Drug Application (ANDA). An ANDA, in turn, permits generic manufacturers to present data demonstrating that the generic drug is the same as the previously approved drug in terms of its suggested usage, active ingredients, method of administration, dosage, strength and bioequivalence—in lieu of submitting studies required for the initial New Drug Application for originator medications. Thus a generic manufacturer is not required to perform safety and efficacy studies if it can prove its drug is the equivalent of the previously approved drug for which such testing has already been performed and accepted. The same regulations further require that the generic manufacturer use the same labeling as the previously approved equivalent drug.

The plaintiffs thus claimed that this generic- medication approval process warrants liability for the name-brand manufacturer, even where the generic medication causes the injury, because the generic manufacturer must duplicate the name-brand medication and its labeling. According to plaintiffs, a deficient warning in the name-brand labeling necessarily creates the same deficiency in the generic labeling. Hence, the name-brand manufacturer should be liable for any representations concerning the medication and its generic equivalent.

But the Foster court rejected this argument, finding that generic manufacturers have the opportunity "to add or strengthen a contraindication, warning, precaution, or adverse reaction" or "to delete false, misleading or unsupported indications or claims for effectiveness." Accepting the plaintiffs’ argument, the court reasoned, would essentially result in branded manufacturers serving as involuntary guarantors for any and all injuries caused by generic versions of their products—over whose manufacture they had no control and from whose sale they did not profit. Meanwhile, generic manufacturers would have a "get-out-of-jail-free card" to play in every lawsuit brought against them. Such a result was contrary to the maxim in products liability law that manufacturers are held to the knowledge and skill of an expert. Generic manufacturers cannot insulate themselves by blindly relying on the name-brand products and labeling. Thus the court in Foster held that when a generic manufacturer adopts the warnings and representations of a name-brand medication without independent investigation it does so at its own risk.

The plaintiffs in Foster further argued that the regulatory scheme and the customary practice of substituting generic drugs made a physician’s reliance on the name-brand medication’s labeling (and advertising) foreseeable, such that it created a legal duty on the part of the name-brand manufacturer. The court held that this reliance does not create a legal duty where plaintiffs’ injuries were not caused by Wyeth’s product. Again, the court reasoned that such liability would be "especially unfair when . . . the generic manufacturer reaps the benefits of the name brand manufacturer’s statements by copying its label and riding on the coattails of its advertising."

Despite the holdings in Foster and its progeny, plaintiffs persist in bringing claims against name-brand manufacturers for injuries caused by generic drugs, attempting variant arguments under other jurisdictions’ laws. One of those variants may be in jurisdictions that recognize non-identification products liability theories for example, concert of action, enterprise liability and market-share liability.

Neither Foster nor any subsequent published case has yet discussed liability for injuries caused by a generic equivalent in a jurisdiction that applies the non-identification products liability theories. Although these theories have been applied in actions against pharmaceutical companies for drug-related injuries, those cases recognize one essential element to the application of these theories: the plaintiff must not be able to identify the manufacturer who produced the medication. Thus unless the plaintiff cannot identify the manufacturer who produced the medication allegedly causing the injury, it appears that no action in products liability—even under a non-identification theory—would prevail.

If, on the one hand, your client is a name-brand manufacturer facing claims for injuries caused by its generic equivalent, Foster and its progeny provide strong defenses. If, on the other hand, your client is a generic-drug manufacturer, it may face an uphill battle in seeking to impose full or shared liability on the name-brand product. Certain jurisdictions, however, may be more open to such an alternative theory of liability. The cases discussed here, along with your jurisdiction’s specific products liability and tort law, will determine what avenue you must take in order to defend or assert these claims successfully.


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