Posted on: 7/17/2012
Steven M. Thomas, Jennifer Stonecipher
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A recent decision by the California Supreme Court may signal the end of so-called "innovator liability" under Conte v. Wyeth. The Conte decision arguably has spent three years on the ropes, with a long list of courts declining to hold brand-name manufacturers liable for injuries allegedly caused by generic-equivalent drugs. Nevertheless, undeterred litigants clinging to the California Court of Appeal's 2008 decision in Conte have continued to push for expanded tort-law duties in drug products litigation. The California Supreme Court's decision in O'Neil v. Crane Co., 266 P.3d 987 (Cal. 2012), however, could be the blow that puts Conte on the canvas.
Conte's Expansive Duty of Care
In Conte v. Wyeth, 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008), the plaintiff alleged injuries relating to her use of metoclopramide, a generic version of Reglan. She sued Wyeth, the brand-name manufacturer, as well as three generic manufacturers, and the trial court granted summary judgment in favor of all defendants. Id. at 304. The appellate court affirmed as to the generic manufacturers, agreeing that the plaintiff had failed to demonstrate that she or her physicians had relied on the generic labels. Id. However, the court allowed the plaintiff to go forward with her negligence claims against Wyeth. Id.
Because the claims sounded in negligence rather than strict liability, Conte's reasoning turned on whether Wyeth owed a duty to consumers who received a generic drug. For the Conte court, foreseeability made all the difference. The court explained that a brand-name manufacturer's duty is not limited to consumers of its own product. Instead, the duty extends to "those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug." Id. at 304-05. Because the court found it foreseeable that a physician would prescribe a generic version in reliance on Wyeth's representations about Reglan, the court allowed the negligence claims against Wyeth. Id. at 313.
More than Foreseeability Under O'Neil
O'Neil involved allegations that the death of a Navy officer had been caused by exposure to asbestos fibers while working aboard a ship. The officer's family sued several companies that supplied products to the Navy, asserting claims based on strict liability and negligence. O'Neil, 266 P.3d at 993. Defendants Crane and Warren manufactured valves and pumps that were used in the ship. Id. at 991. While the defendants' valves and pumps did not contain asbestos, they often incorporated other vendors' asbestos-containing gaskets and packing materials into the parts that they supplied, as directed by the Navy's specifications. Id. at 992. The original asbestos-containing gaskets and packing materials were replaced many years before the decedent worked aboard the ship. Id. at 993.
The plaintiffs argued that, even if the decedent had not been exposed to asbestos from the defendants' products, they were nevertheless responsible for the injuries because their products originally included asbestos-containing components and because it was foreseeable that their products would be repaired with additional asbestos-containing components in the future. Id. The trial court dismissed all claims against Crane and Warren, but the Court of Appeal reversed. Notably, it found that the defendants could be strictly liable for the dangerous products with which its own products "will necessarily be used." Id. at 994.
The Supreme Court of California reversed, concluding that the defendants were not strictly liable for the decedent's injuries because any defect in the defendants' own products did not cause the alleged injury and they "had no duty to warn of risks arising from other manufacturers' products." Id. at 995.
In evaluating the negligence theories and whether the defendants owed a duty of care to prevent the injury, the court explained that "foreseeability alone is not sufficient to create an independent tort duty." Id. at 1006. Instead, the court followed the reasoning announced in Rowland v. Christian, 443 P.2d 561 (Cal. 1968), that foreseeability of harm is only one of several factors that a court must consider in deciding the existence and scope of duty. Rowland also instructs courts to consider the degree of certainty that the plaintiff suffered injury, the closeness of the connection between the defendant's conduct and the injury, the moral blame attached to the defendant's conduct, the policy of preventing future harm, the extent of the burden to the defendant and consequences to the community of imposing a duty, and the availability, cost, and prevalence of insurance for the risk involved. Rowland, 443 P.2d at 582 (the "Rowland factors").
The O'Neil court concluded that the above-referenced factors did not support a duty of care. O'Neil, 266 P.3d at 1007. "[E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law." Id. The court reversed and remanded the case for entry of judgment in favor of Crane and Warren.
O'Neil raises serious doubts as to whether Conte remains good law. First, O'Neil underscores the view that a manufacturer's liability under strict products liability is limited to defects in the products that it manufacturers or distributes. Id. at 995. Second, Conte's reasoning under negligence theories is equally vulnerable. Conte focused almost exclusively on foreseeability and brushed aside the additional Rowland factors—citing a limited factual record. Conte, 85 Cal. Rptr. 3d at 314. But, in O'Neil, those factors tipped the scales against imposing a duty of care. O'Neil reemphasizes the multifaceted approach required in determining the limits of a manufacturer's duty and highlights the flaws in Conte's elevation of foreseeability at the expense of important policy goals.
Post-Mensing Rejection of Innovator Liability
Despite the determined efforts of plaintiffs' attorneys, courts have routinely rejected the expansion of a brand-name manufacturer's duty of care announced in Conte, even characterizing the decision as "anomalous," Burke v. Wyeth, Inc., No. G-09-82, 2009 WL 3698480, at *3 (S.D. Tex. Oct. 29, 2009), and "the lone outlier against the overwhelming weight of authority." Dietrich v. Wyeth, Inc., No. 50-2009-CA-021586 XXX MB, 2009 WL 4924722, at *5 (Fla. Cir. Ct. Dec. 21, 2009). While numerous courts have declined to impose liability on a brand-name manufacturer for injuries allegedly caused by another manufacturer's generic version, it appears that only one reported decision has embraced Conte-type liability. Compare Kellogg v. Wyeth, 762 F. Supp. 2d 694, 696-97 (D. Vt. 2010) (agreeing with Conte), with In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., MDL No. 2226, 2012 WL 716132, at *5 (E.D. Ky. Mar. 5, 2012) (noting that 55 decisions from across the country have rejected innovator liability).
While Conte may have seemed destined to fade into the background, the Supreme Court's decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), sparked renewed attempts to assign responsibility to brand-name manufacturers. If federal law preempted failure-to-warn claims against generic manufacturers, as the Court concluded in Mensing, who would be responsible for injuries when the consumer received a generic medication? The Court acknowledged the "unfortunate hand" that federal regulations had dealt to the Mensing plaintiffs—and possibly to the three-quarters of consumers whose prescriptions are filled with generics.
Mensing recognized that Congress or FDA could "change the law and regulations if they so desire," id. at 2581, but a legislative or regulatory response may be easier said than done. In August 2011, Public Citizen filed a petition requesting that FDA implement regulatory changes to allow generic manufacturers to independently revise their labels. But as of April 2012, FDA had taken no action. In April, legislators in the House and Senate introduced the Patient Safety and Drug Labeling Improvement Act, a bill that would similarly allow revisions to generic labels. Despite the recent attention, legislators likely face an uphill battle in enacting such changes during an election year.
Following Mensing, courts have continued to reject the expansion of tort-law duties based on Conte. See Smith v. Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011); Metz v. Wyeth LLC, --- F. Supp. 2d ---, 2011 WL 5826005, at *2 (M.D. Fla. Nov. 18, 2011). The plaintiffs' bar may sense the weakness of innovator liability theories, as they have employed new strategies aimed at avoiding the preemptive effect of Mensing – for example, recasting failure-to-warn claims as breach of warranty claims or even as claims for failure to send "Dear Doctor" letters consistent with FDA-approved labeling. See, e.g., In re Darvocet, 2012 WL 718618, at *4 n.9, 5-6 (E.D. Ky. Mar. 5, 2012). Nevertheless, the issue of innovator liability persists. In fact, the Alabama Supreme Court is considering a similar issue in a certified question from the federal court in Weeks v. Wyeth, Inc., No. 1:10-CV-602, 2011 WL 1216501 (M.D. Ala. Mar. 31, 2011), certified by No. 1101397 (Ala. Oct. 17, 2011) (certifying the question of whether a manufacturer can be liable for fraud or misrepresentation based on statements made in connection its brand-name drug when the plaintiff claims injury from another manufacturer's generic version).
Defending Against Innovator Liability After O'Neil and Mensing
In light of O'Neil, Conte does not seem to be a viable basis for holding a brand-name manufacturer liable for injuries allegedly caused by a generic-equivalent drug. Even so, with many courts faithfully applying Mensing and dismissing claims against generic manufacturers, brand-name manufacturers must be prepared to defend against claimed innovator liability.
In addressing such claims, counsel should note that Conte justified its quick disposal of the Rowland factors based on a limited factual record. Thus, developing a factual record to demonstrate the policy considerations weighing against an extension of duty, including the potential costs and insurance implications, may be persuasive in California and other jurisdictions. Public policy reasons, which were overlooked in Conte, provide additional strong support for rejection of innovator liability. The procedural history of Mensing could also be useful to counsel in showing that the Supreme Court's decision does not justify a departure from the overwhelming majority of authority rejecting innovator liability. Before it reached the Supreme Court, the Eighth Circuit affirmed the dismissal of the claims against the brand-name manufacturers, which was not at issue before the Supreme Court. See Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009), rev'd on other grounds, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Nothing in Mensing requires imposing a new duty on brand-name manufacturers.
Following Mensing, brand-name manufacturers may seem like attractive potential targets for creative opponents. But O'Neil may be a sign that Conte's days are numbered. The decision provides strong support against innovator liability. Practitioners should be mindful of this and other emerging cases that reject the expansion of a manufacturer's duty.
Steven M. Thomas is a partner in the Kansas City, Missouri, office of Shook, Hardy & Bacon L.L.P. Steve's practice focuses on complex, national product liability litigation, with an emphasis on representation of manufacturers of prescription drugs, biologics and medical devices. He has served as national and regional counsel for major pharmaceutical companies and has substantial experience with all aspects of personal injury and multidistrict litigation. firstname.lastname@example.org
Jennifer Stonecipher Hill is an associate in the Kansas City, Missouri, office of Shook, Hardy & Bacon L.L.P. She focuses her practice on the defense of pharmaceutical and medical device manufacturers engaged in product liability litigation. In addition, Jennifer advises clients on issues governed by the Food and Drug Administration, including product labeling, regulatory compliance and risk evaluation and management. email@example.com