Kelly E. Jones ()
The New York Supreme Court, New York County, recently became the first New York state court to consider the issue of innovator liability and joined the majority of jurisdictions declining to recognize this theory of recovery against brand-name pharmaceutical companies. Innovator liability is premised on the notion that a brand-name, or “innovator,” pharmaceutical manufacturer, which allegedly produced inadequate labeling on its brand-name drug, has a legal duty to warn consumers, even if those consumers ingested the competing generic version, because under the current regulatory scheme it is foreseeable that users and prescribers of generic drugs will rely on the warning labels included with the brand-name drug.
FDA rules require a generic drug label to be identical to its brand-name counterpart; and, as such, proponents of innovator liability argue that innovator manufacturers have a duty to warn end-users, regardless of whether the brand-name or generic version of the drug was ingested. The New York County Supreme Court rejected this theory of liability in Weese v. Pfizer, dismissing the plaintiff’s complaint because the court found no precedent in New York law for the creation of such a duty to warn for innovators where its product was not used.
Courts Dismissing Claims
In Weese, a New York state court considered for the first time, a claim based on a theory of innovator liability. Weese v. Pfizer, No. 153742/12, 2013 N.Y. Misc. LEXIS 4761, at *1 (Sup Ct. N.Y. Co. 2013). The plaintiff in Weese was prescribed and took the generic form of an anti-depressant during her pregnancy which she alleged caused her child to be born with heart defects. Pfizer manufactured the brand-name version of the drug, and plaintiffs alleged it issued an inadequate warning label with its original product. But the plaintiff only ingested the generic version manufactured by a different company. The plaintiff sued Pfizer for negligent misrepresentation, claiming that brand-name manufacturers owed a duty to consumers of the generic version of their drug because federal law requires generic drugs to use the same warning labels as the name-brand drug. See 21 U.S.C. §§355(j)(2)(A)(v), 355(j)(4)(G); 21 CFR §§314.94(a)(8), 314.127(a)(7).
Plaintiff alleged that Pfizer breached its duty to warn by providing an inadequate warning label when they knew or should have known that the label information would be utilized by generic versions. See PLIVA v. Mensing, 131 S.Ct. 2567, 2574 (2011) (“A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand-name drug”). Pfizer moved to dismiss the complaint on the ground that it owed no duty to the plaintiff. The court framed the question presented as “whether a drug manufacturer that did not manufacture the product alleged to have caused injury owes a duty to a plaintiff because of the required identity of warning labels.” Weese, 2013 N.Y. Misc. LEXIS 4761, at *2.
The trial court answered the question presented in the negative and dismissed plaintiff’s complaint in its entirety. The court determined that Pfizer does not have a duty to “stand behind” the products and labeling of another manufacturer because “Pfizer had no intentional role in placing the specific product with the plaintiff.” Weese, 2013 N.Y. Misc. LEXIS 4761, at *4-5. The trial court also cited to New York Court of Appeals precedent holding that foreseeability of injury is not enough on its own to create a duty to warn. Id. (citing Eiseman v. State of New York, 70 N.Y.2d 175, 187 (1987)). In its conclusion, the court declared that a manufacturer’s duty to warn “should not extend to products and labeling over which it has no control, even if those products mirror its own, because it had done nothing toward putting them in the hands of consumers.” Id.
New York just recently considered innovator liability, but the leading case cited by the majority of decisions dismissing the innovator liability theory is Foster v. American Home Products (29 F.3d 165 (4th Cir. 1994)). In Foster, plaintiffs claimed that a generic drug caused the death of their daughter and filed a complaint against the brand-name manufacturer alleging negligent misrepresentation due to the inadequate warnings in the innovator’s label. The district court denied summary judgment as to the negligent representation claim.
On appeal, the U.S. Court of Appeals for the Fourth Circuit held that: “Maryland law does not recognize a cause of action for negligent misrepresentation against one manufacturer for injuries caused by another manufacturer’s product.” Foster, 29 F.3d at 172. The court determined that Wyeth owed no duty to the plaintiffs because the plaintiff did not claim that her daughter had ever taken the brand-name version of the drug. Indeed, in language that has been adopted by many courts dismissing innovator liability claims, the Fourth Circuit stated, “[w]e think to impose a duty in the circumstances of this case would be to stretch the concept of foreseeability too far.” Id. at 171.
Following Foster’s rationale, numerous jurisdictions have denied innovator liability claims because of concerns with causation and duty to warn. Most recently, the U.S. Court of Appeals for the Sixth Circuit dismissed an innovator liability claim in Strayhorn v. Wyeth Pharms. There the court affirmed the dismissals of seven consolidated cases where plaintiffs alleged that the negligent misrepresentations by Wyeth breached an affirmative duty to accurately label their product because it is foreseeable that a medical professional would rely on the brand-name warning label when prescribing a generic drug. Citing to Foster, the court concluded that “the manufacturer of a name-brand drug has no duty to patients who ingested only a generic version of the drug manufactured by the name-brand drug company’s competitors.” Strayhorn v. Wyeth Pharms., No. 12-6195, 2013 U.S.App. LEXIS 23933, *54, 56 (6th Cir. 2013).
Including Strayhorn, all federal circuit courts to consider innovator liability claims have dismissed the actions so far. See, e.g., Schrock v. Wyeth, 727 F.3d 1273, (10th Cir. 2013) (noting that every federal circuit court has rejected, and the Oklahoma Supreme Court would not recognize, innovator liability); Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) (noting the “overwhelming national consensus” on the issue); Bell v. Pfizer, 716 F.3d 1087, 1092 (8th Cir. 2013); Demahy v. Schwarz Pharma, 702 F.3d 177, 182-83 (5th Cir. 2012). Further, several federal district courts have interpreted state law to mandate the dismissal of innovator liability claims. See Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2010 U.S. Dist. LEXIS 76979, at *21-22 (D.S.C. July 28, 2010) (citing 30 district court cases interpreting state law to require dismissal of innovator liability claims).
Notwithstanding the majority of jurisdictions rejecting the theory, innovator liability has been adopted in some jurisdictions. The theory was first recognized in 2008 by the California Court of Appeals in Conte v. Wyeth. 168 Cal.App.4th 89, 95 (Cal. Ct. App. 2008). In Conte, plaintiff claimed that she developed a neurological disorder as a result of taking a generic drug for four years. Her complaint against Wyeth, the brand-name manufacturer of the drug, alleged fraud, fraud by concealment and negligent representation. Plaintiff claimed that Wyeth knew or should have known of the “widespread tendency to overprescribe the name-brand and generic versions of the drug because the labeling substantially understate[d] the risks of serious side-effects from extended use.” 168 Cal. App.4th 89, 95 (Cal. Ct. App. 2008).
Wyeth moved for summary judgment arguing there was no causal relationship between its product information and plaintiff’s injury and they owed plaintiff no duty of care because plaintiff never used the brand-name drug. The trial court granted Wyeth’s motion for summary judgment concluding that neither the doctor nor the plaintiff relied on the brand-name’s warning label and that Wyeth had no duty to users of the generic version of their product.
The California Court of Appeals overturned the trial court decision and held that even when a plaintiff only claims to have taken the generic version of a drug, the brand-name manufacturer may be held liable for negligent misrepresentation arising from an inadequate warning label because the innovator should reasonably foresee that consumers of generic drugs will rely on the brand-name warning label. Id. at 102. The court further held that reliance should be anticipated because current FDA regulations require generic manufacturers to use the same warning label as the brand-name.
That the defendant did not manufacture or sell the ingested drug does not alter the analysis because brand-name drug manufacturers owe a “duty of care to those people it should reasonably foresee are likely to ingest [the drug] in either name-brand or generic version when it is prescribed by their physicians in reliance on [the innovator's] representations.” Id. at 111. Consequently, California plaintiffs may sue manufacturers of brand-name drugs for negligent misrepresentation if they allege their injuries resulted from reliance on an inadequate warning label.
Similarly, Vermont and Alabama courts have adopted innovator liability. See Wyeth v. Weeks, No. 1:10-cv-602, 2013 Ala. LEXIS *2 (M.D. Ala. Jan. 17, 2013) reh’g granted Wyeth v. Weeks, No. 1:10-cv-602 (M.D. Ala. June 13, 2013), ECF No. 161-1; Kellogg v. Wyeth, 762 F.Supp.2d 694 (D.Vt. 2010). In Kellogg, a Vermont federal district court concluded that under Vermont law, Wyeth, the brand-name manufacturer, owed a duty to provide adequate warning information to the plaintiff’s prescribing doctor because doctors routinely rely on the innovator’s warning even when prescribing a generic version. The court reasoned that whether such reliance actually occurred is a question for trial. Kellogg, 762 F.Supp.2d at 706 (citing Conte, 168 Cal.App.4th 89).
In Weeks, the Alabama Supreme Court, answering a certified question from an Alabama federal district court, declared that Alabama law recognized a duty for brand-name manufacturers to provide adequate warning information to the users of generic versions of the drug. Consequently, Wyeth was amenable to suit for negligent misrepresentation because the plaintiff allegedly relied on Wyeth’s warning label which also appeared on the generic version that allegedly injured the plaintiff. Weeks, 2013 Ala. LEXIS at *19. Notably, the Alabama Supreme Court agreed to conduct a rehearing in Weeks; oral arguments occurred in September of 2013.
FDA Rule Proposal
Although outside the scope of this article, a recent rule proposal by the FDA may substantially impact innovator liability. According to the FDA, “The proposed rule would enable [generic drug manufacturers] to update product labeling promptly to reflect certain types of newly acquired information related to drug safety, irrespective of whether the revised labeling differs from that of the [brand-name].” Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67985 (proposed Nov. 13, 2013). If enacted, the rule would allow generic drug manufacturers to unilaterally update warning label information. This may undermine one of the foundations of innovator liability claims—brand-name manufacturers should foresee reliance on their warning labels because federal law requires generic drug manufacturers to exactly replicate the brand-name warning labels. However, it remains to be seen whether this proposed rule will be enacted and if so, what effect it would have in jurisdictions which recognize innovator liability claims.
With the trial court’s decision in Weese, New York added its name to the growing list of jurisdictions that have declined to recognize innovator liability. Notwithstanding the U.S. Supreme Court decision in PLIVA v. Mensing, supra, holding that state tort law claims against generic manufacturers are preempted under federal law, the majority of state and federal courts have still declined to recognize this theory of recovery against brand-name manufacturers.
Those few jurisdictions that do recognize the theory see foreseeability as the primary issue, i.e., it is foreseeable that users and prescribers would rely on the warning label of brand-name drugs because federal law mandates the brand-name label appear on the generic version. Those that reject innovator liability argue that foreseeability of injury is not enough to make out a tort claim if there is not a corresponding duty to warn, i.e., regardless of foreseeability, manufacturers do not have a duty to consumers injured by the products of a competitor. It is possible that this split in jurisdictions will one day lead to further appellate, and potentially, Supreme Court review.
Kelly E. Jones is a partner at Harris Beach. Andre J. Major, an associate at the firm, assisted in the preparation of this article.