Recent Developments Since <i>Pliva v. Mensing</i>

Deferring to the FDA's interpretation of this regulatory scheme, Mensing concluded that federal law imposes a “duty of sameness” on a generic drug manufacturer, which is required to market its products with the same warnings and labelling approved by the FDA for use with the equivalent brand-name drug. The Mensing majority determined that this “duty of sameness” conflicted with any duty imposed under state tort law to provide a different warning. Because it was “impossible” for generic drug manufacturers to satisfy these conflicting state and federal obligations, Mensing concluded that the state law claims were impliedly preempted. Id. at 2575, 2577-78, 2581.

In reaching this conclusion, Mensing rejected arguments that generic drug manufacturers may change product warnings without the prior approval of the FDA. This included updates to the labeling of generic medications made under the FDA's Changes Being Effected (CBE) process. Whereas Levine determined that brand-name drug manufacturers could unilaterally update product labeling under CBE, Mensing found that the CBE process permits a generic drug maker only to “change[ ] its label to match an updated brand-name label or to follow the FDA's instructions.” Adopting the FDA's interpretation of the federal regulations, the Court concluded that generic manufacturers may not alter their products' labeling without FDA approval, as this “would violate the statutes and regulations requiring a generic drug's label to match its brand-name counterpart's.” Id. at 2575.

The Post-Mensing Landscape

Since Mensing, most federal courts have dismissed state law tort claims against generic drug manufacturers based on the conflict between state law obligations to provide greater warnings or a “safer” product and the federal duty of “sameness” in labeling and design. See Demahy v. Schwarz Pharma., 702 F.3d 177, 186 & n. 7-8 (5th Cir. 2012) (citing cases). Nevertheless, plaintiffs in generic drug cases have adopted various approaches to distinguish Mensing's preemption rule, with mixed results.

In some instances, plaintiffs have argued that Mensing should be read narrowly to require the dismissal of claims only to the extent that they assert a failure-to-warn under product liability law, and not where similar facts are pleaded under negligence, design defect, fraud, or breach of warranty. See, e.g., Strayhorn v. Wyeth Pharm. 887 F. Supp. 2d 799 (W.D. Tenn. 2012). Alternatively, plaintiffs have argued that Mensing does not preempt failure-to-warn claims where it is alleged that the generic manufacturer did not keep pace with FDA-approved changes to the labeling and warnings provided by the brand-name manufacturer. See, e.g., In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., No. 2:11-MD-2226, 2012 WL 718618, at *4 (E.D. Ky. Mar. 5, 2012). Finally, taking an approach widely rejected both before and after Mensing, plaintiffs in some cases have argued that the branded-drug manufacturer should be held liable for injuries to patients who consumed the generic version, in effect shifting liability from the manufacturer to a third party whose product the plaintiff never used. See Smith v. Wyeth, 657 F.3d 420, 423-24 (6th Cir. 2011).

Recent developments with respect to each of these approaches are considered below.

Claims Alleging Alternative Theories, Including Defective Design

Courts have generally held that claims against generic drug manufacturers sounding in failure-to-warn are preempted under Mensing, regardless of how such claims may be styled in pleadings. See Guarino v. Wyeth, — F.3d —, No. 12'13263, 2013 WL 3185084, at *3 (11th Cir. June 25, 2013); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013); Strayhorn v. Wyeth Pharm., Inc., 887 F. Supp. 2d 799, 817-19 (W.D. Tenn. 2012); Gross v. Pfizer, Inc., 825 F. Supp. 2d 654, 658 (D. Md. 2012). In such cases, courts have dismissed claims that generic companies failed to communicate warning information (through “Dear Doctor” letters, training programs for healthcare practitioners or patients, continuing healthcare education, prominent professional or public notifications, or specialized product packaging), concealed important safety information, failed to test and to inspect their products, breached product warranties, and were negligent in continuing to sell a product that was unreasonably dangerous, inadequately labeled, and/or not fit for the purpose for which it was sold.

Even in cases that present a “pure” design issue, where the focus is not on the adequacy of warnings but the drug's ingredients and structure, most courts have found that Mensing controls. See Bartoli v. APP Pharms., Inc. (In re Pamidronate Prods. Liab. Litig.), 842 F. Supp. 2d 479, 484 (E.D.N.Y. 2012); Eckhardt v. Qualitest Pharm. Inc., 858 F. Supp. 2d 792, 801-02 (S.D. Tex. 2012). As noted by a New York federal district court:

In Mensing, the Supreme Court found that a generic drug is “designed to be a copy of a reference listed drug (typically a brand-name drug)” and it must be “identical in active ingredients, safety, and efficacy.” Thus, the “federal duty of 'sameness,'” also applies in the context of generic drug design, and federal law preempts state laws imposing a duty to change a drug's design on generic drug manufacturers.

Bartoli, 842 F. Supp. 2d at 484 (citations omitted).

Not every court has read Mensing to preempt defective design claims against generics, including in some cases where the alleged defect related not to the drug's design, but to the accompanying warnings and labeling information. However, the Supreme Court's recent decision in Mutual Pharm. Co. v. Bartlett, — U.S. —, 133 S.Ct. 2466 (2013), which reversed a key decision from the First Circuit permitting defective design claims under Mensing, should halt this trend.

Bartlett removes any doubt that the preemption holding in Mensing extends to state law claims that are framed, not as a failure to adequately warn consumers about the risks of a drug, but as defects in design. Bartlett thus should preclude the practice, seen in various generics cases since Mensing, of repackaging state law failure-to-warn claims as design defect claims. The Supreme Court's decision also leaves little room for “pure” defective design claims against generics, as the majority concluded that federal law prohibits the manufacturers of these medications from redesigning their products, which must incorporate the same chemical composition of the equivalent branded version.

But perhaps the most wide-sweeping implication of Bartlett is the Court's rejection of the First Circuit's “stop-selling” rationale as a basis for denying preemption defenses. Under this rationale, a product manufacturer that faces competing federal and state law obligations may, it is argued, comply with both requirements by simply withdrawing its products from the market, and therefore lacks a true conflict preemption defense. Numerous courts, before Bartlett was decided, had refused to impose liability based on a manufacturer's “failure-to-withdraw” generic drugs from the market. See Gardley-Starks v. Pfizer, Inc., 2013 WL 139900, at *5 (N.D. Miss. Jan. 10, 2013) (citing cases).

The Bartlett majority confirmed that this “stop-selling” rationale has no basis in its preemption jurisprudence, and in fact would mean that the vast majority ' if not all ' of the Court's impossibility preemption cases were wrongly decided. The Court's rejection of this approach should apply not only in cases involving generic (or branded) drug makers, but in product liability litigation generally.

Nevertheless, as with Mensing, some courts may construe Bartlett narrowly, including based on the majority's statement of its holding: that state-law design-defect claims “that turn on the adequacy of a drug's warnings”' are preempted by federal law under Mensing. Bartlett, 133 S.Ct. at 2470. The opinion, furthermore, points to potential exceptions to its holding where state tort law is intended solely to spread the cost of product-related injuries, requires a manufacturer to remove defective products from the market, or provides a basis for parallel state-law claims alleging “misbranding” of drugs under the FDCA. [Editor's Note: Next month's issue of LJN's Product Liability Law & Strategy will contain an article analyzing the Bartlett case in depth.]

For example, the Eighth Circuit recently reversed the dismissal of design defect claims so that the district court could consider Bartlett's implications where state law applied the consumers' expectations test to determine the existence of a product defect, rather than the risk-utility analysis at issue in Bartlett. See Fullington v. Pfizer, — F.3d —, No. 12'2945, 2013 WL 3491060, at *6 (8th Cir. July 15, 2013). Similarly, the Pennsylvania Superior Court held that it was error to dismiss all defective design claims against generics manufacturers, concluding that while such claims may be of the type held to be preempted in Bartlett, the dismissal was premature without the court's first conducting a careful analysis of the applicable state law. See Hassett v. Dafoe, — A.3d —, No. 81 EDA 2012, 2013 WL 3874882, at *11 (Pa. Super. Ct. July 29, 2013).

Claims That Generic Makers Breached the Duty of 'Sameness'

To avoid preemption, plaintiffs often claim that the manufacturer's allegedly tortious conduct under state law involved a breach of federal regulations. There is no conflict for preemption purposes, it is argued, because federal and state laws impose parallel obligations to act in the same manner. Post-Mensing, plaintiffs in generic drug cases have argued that claims premised on breach of the manufacturer's duty of “sameness” are not preempted by the FDCA, a position recently followed by the Sixth Circuit in Fulgenzi v. PLIVA, Inc., 2013 WL 949096 (6th Cir. Mar. 13, 2013). [See "And Yet Another Twist in Product Liability Litigation, Preemption and Generic Drug Liability" on page 3 for a report of the Fulgenzi decision.]

Apart from the issue of preemption, claims that a generic manufacturer failed to update product labeling to match changes made by the branded manufacturer, such as those asserted in Fulgenzi, are still limited by state law requirements to prove proximate causation. This element may be difficult to establish where the branded medication, containing the updated warning that the generic drug defendant allegedly failed to include, is prescribed but substituted with a generic version at the plaintiff's pharmacy.

Claims Alleging Innovator Liability

For years before Mensing, plaintiffs in pharmaceutical cases have asserted, unsuccessfully, that the liability of brand-name drug manufacturers extends not only to persons injured from the use of their products, but to anyone who ingested the equivalent generic version. Under this theory of so-called innovator liability, a manufacturer's duty includes guarding against tortious conduct committed by a different company and, indeed, a competitor in the marketplace. In the leading case on this issue, Foster v. Am. Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994), the Fourth Circuit held that the manufacturer of a brand-name drug has no duty to patients who ingested only a generic version of the drug manufactured by the company's competitors, rejecting the plaintiff's negligent misrepresentation claims. See also Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 540-41 (E.D. Pa. 2006) (collecting cases), rev'd on other grounds, 521 F.3d 253 (3d Cir. 2008). But see Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008).

Foster found that there was “no legal precedent for using a name brand manufacturer's statements about its own product as a basis for liability for injuries caused by other manufacturers' products,”' and concluded that this would be “especially unfair” given that “the generic manufacturer reaps the benefits of the name brand manufacturer's statements by copying its labels and riding on the coattails of its advertising.” As the court noted, it is the brand-name manufacturers that undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information. Generic manufacturers, on the other hand, avoid such expenses by duplicating successful pioneer drugs and their labels. 29 F.3d at 170.

Plaintiffs have argued that Mensing's preemption rule justifies a fresh look at innovator liability, which they assert avoids unfairness to consumers whose claims are preempted under Mensing as the result of state requirements, or a pharmacists' choice, to fill prescriptions with generic medications. These arguments have, almost without exception, been rejected by the courts in the post-Mensing landscape. As the Sixth Circuit stated in Smith:

The plaintiffs' argument ' that the name-brand defendants' liability stems from the fact that the regulatory structure governing name-brand and generic drugs makes it foreseeable that patients and their physicians will rely on the name-brand labels to use and prescribe generic drugs ' has been rejected by all but one of the courts that have considered it.

657 F.3d at 423-24. See also Gardley-Starks, 2013 WL 139900, at *5.

The Alabama Supreme Court's recent opinion in Wyeth v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), is the only post-Mensing decision adopting a rule of innovator liability and, with the California Court of Appeal's 2008 decision in Conte, one of only two state court decisions shifting liability for injuries caused by generic drugs to the brand-name manufacturer.

The Weeks court concluded that, because of the duty of “sameness” recognized in Mensing, it is “questionable” whether generic drug manufacturers have an independent duty to advise of the risks associated with their products. 2013 WL 135753, at *9-11. On this basis, Weeks rejected as “flawed” the Foster court's reasoning that generic drug manufacturers are responsible for the representations they make in warning labels. Moreover, Weeks found that the analysis in Foster “confuses strict liability and tort law,” concluding that “the fact that a brand-name manufacturer did not produce the version of the drug ingested by the plaintiff” should not bar failure-to-warn claims “because a warning label is not a part of the manufacturing process.” Id. at *15.

As illustrated in cases such as Fulgenzi, however, a generic drug manufacturer remains responsible for its labeling under state law. Indeed, an independent state law duty to provide a different warning was necessary to the preemption finding in Mensing. Nothing in Mensing's preemption analysis, or the duty of “sameness” under federal law, would negate this necessary element of a state tort action. Moreover, Foster was not limited to strict liability principles, but considered traditional tort law questions such as foreseeability in determining a manufacturer's duty under state law. That Mensing recognized a conflict between federal and state obligations would thus seem to present no challenge to Foster's holding that a state law duty to guard against competitors' negligent misrepresentations stretches foreseeability “too far.”

Finally, as recognized in the Weeks dissent, even after Mensing, the vast majority of courts continue to follow the rationale embodied in Foster. As recently stated by the Eleventh Circuit:

[T]he overwhelming national consensus ' including the decisions of every court of appeal and the vast majority of district courts around the country to consider the question ' is that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of the generic form of a product.

Guarino, 2013 WL 3185084, at *6. See also Bell v. Pfizer, 716 F.3d 1087, 1092-3 (8th Cir. 2013).

Conclusion

With some exceptions, courts since Mensing generally have followed the Supreme Court's rationale that the duty of “sameness” conflicts with and thus preempts state law tort obligations in generic drug cases. If recent developments are any guide, however, plaintiffs ' and some courts ' will continue to try to find ways to distinguish the preemption holdings in Mensing and Bartlett.

Joseph G. Falcone is a litigator with Herbert Smith Freehills New York LLP, where he is a partner in the disputes practice. He can be reached at [email protected] or 917-542-7805. Michael R. Kelly is a senior associate in the firm's disputes practice, and can be contacted at [email protected] or 917-542-7819.

In PLIVA v. Mensing , 131 S.Ct. 2567 (2011), a 5-4 majority of the Supreme Court held that federal regulations applicable to generic pharmaceuticals preempt state law claims alleging that the manufacturers failed to warn consumers of the drug's risks. Together with Wyeth v. Levine , 555 U.S. 555 (2009), in which the Court allowed failure-to-warn claims to proceed against a manufacturer of brand-name medications, the Court's decisions have been interpreted to establish different preemption rules for generic- and branded-drug makers based on the different obligations these manufacturers face under federal law.

Background

To obtain federal approval to market a new drug, a manufacturer must prove that it is safe and effective and that the proposed label is accurate and adequate, a process involving lengthy and expensive product testing. In contrast, generic drug makers must establish the equivalence of their product to an existing FDA-approved medication (typically, the brand-name version), demonstrating that the generic version has the same active ingredients and effectiveness as the reference drug. Generics must also adopt the same FDA-approved labeling that accompanies the equivalent brand-name version. See Mensing, 131 S.Ct. at 2574-75. This abbreviated FDA-approval process permits generic drugs to be marketed inexpensively, without the same testing and clinical trials required for brand-name medications.

Deferring to the FDA's interpretation of this regulatory scheme, Mensing concluded that federal law imposes a “duty of sameness” on a generic drug manufacturer, which is required to market its products with the same warnings and labelling approved by the FDA for use with the equivalent brand-name drug. The Mensing majority determined that this “duty of sameness” conflicted with any duty imposed under state tort law to provide a different warning. Because it was “impossible” for generic drug manufacturers to satisfy these conflicting state and federal obligations, Mensing concluded that the state law claims were impliedly preempted. Id. at 2575, 2577-78, 2581.

In reaching this conclusion, Mensing rejected arguments that generic drug manufacturers may change product warnings without the prior approval of the FDA. This included updates to the labeling of generic medications made under the FDA's Changes Being Effected (CBE) process. Whereas Levine determined that brand-name drug manufacturers could unilaterally update product labeling under CBE, Mensing found that the CBE process permits a generic drug maker only to “change[ ] its label to match an updated brand-name label or to follow the FDA's instructions.” Adopting the FDA's interpretation of the federal regulations, the Court concluded that generic manufacturers may not alter their products' labeling without FDA approval, as this “would violate the statutes and regulations requiring a generic drug's label to match its brand-name counterpart's.” Id. at 2575.

The Post-Mensing Landscape

Since Mensing, most federal courts have dismissed state law tort claims against generic drug manufacturers based on the conflict between state law obligations to provide greater warnings or a “safer” product and the federal duty of “sameness” in labeling and design. See Demahy v. Schwarz Pharma. , 702 F.3d 177, 186 & n. 7-8 (5th Cir. 2012) (citing cases). Nevertheless, plaintiffs in generic drug cases have adopted various approaches to distinguish Mensing's preemption rule, with mixed results.

In some instances, plaintiffs have argued that Mensing should be read narrowly to require the dismissal of claims only to the extent that they assert a failure-to-warn under product liability law, and not where similar facts are pleaded under negligence, design defect, fraud, or breach of warranty. See, e.g., Strayhorn v. Wyeth Pharm . 887 F. Supp. 2d 799 (W.D. Tenn. 2012). Alternatively, plaintiffs have argued that Mensing does not preempt failure-to-warn claims where it is alleged that the generic manufacturer did not keep pace with FDA-approved changes to the labeling and warnings provided by the brand-name manufacturer. See, e.g., In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., No. 2:11-MD-2226, 2012 WL 718618, at *4 (E.D. Ky. Mar. 5, 2012). Finally, taking an approach widely rejected both before and after Mensing, plaintiffs in some cases have argued that the branded-drug manufacturer should be held liable for injuries to patients who consumed the generic version, in effect shifting liability from the manufacturer to a third party whose product the plaintiff never used. See Smith v. Wyeth , 657 F.3d 420, 423-24 (6th Cir. 2011).

Recent developments with respect to each of these approaches are considered below.

Claims Alleging Alternative Theories, Including Defective Design

Courts have generally held that claims against generic drug manufacturers sounding in failure-to-warn are preempted under Mensing, regardless of how such claims may be styled in pleadings. See Guarino v. Wyeth, — F.3d —, No. 12'13263, 2013 WL 3185084, at *3 (11th Cir. June 25, 2013); Morris v. PLIVA, Inc. , 713 F.3d 774, 777 (5th Cir. 2013); Strayhorn v. Wyeth Pharm., Inc. , 887 F. Supp. 2d 799, 817-19 (W.D. Tenn. 2012); Gross v. Pfizer, Inc. , 825 F. Supp. 2d 654, 658 (D. Md. 2012). In such cases, courts have dismissed claims that generic companies failed to communicate warning information (through “Dear Doctor” letters, training programs for healthcare practitioners or patients, continuing healthcare education, prominent professional or public notifications, or specialized product packaging), concealed important safety information, failed to test and to inspect their products, breached product warranties, and were negligent in continuing to sell a product that was unreasonably dangerous, inadequately labeled, and/or not fit for the purpose for which it was sold.

Even in cases that present a “pure” design issue, where the focus is not on the adequacy of warnings but the drug's ingredients and structure, most courts have found that Mensing controls. See Bartoli v. APP Pharms., Inc. (In re Pamidronate Prods. Liab. Litig.), 842 F. Supp. 2d 479, 484 (E.D.N.Y. 2012); Eckhardt v. Qualitest Pharm. Inc. , 858 F. Supp. 2d 792, 801-02 (S.D. Tex. 2012). As noted by a New York federal district court:

In Mensing, the Supreme Court found that a generic drug is “designed to be a copy of a reference listed drug (typically a brand-name drug)” and it must be “identical in active ingredients, safety, and efficacy.” Thus, the “federal duty of 'sameness,'” also applies in the context of generic drug design, and federal law preempts state laws imposing a duty to change a drug's design on generic drug manufacturers.

Bartoli, 842 F. Supp. 2d at 484 (citations omitted).

Not every court has read Mensing to preempt defective design claims against generics, including in some cases where the alleged defect related not to the drug's design, but to the accompanying warnings and labeling information. However, the Supreme Court's recent decision in Mutual Pharm. Co. v. Bartlett, — U.S. —, 133 S.Ct. 2466 (2013), which reversed a key decision from the First Circuit permitting defective design claims under Mensing, should halt this trend.

Bartlett removes any doubt that the preemption holding in Mensing extends to state law claims that are framed, not as a failure to adequately warn consumers about the risks of a drug, but as defects in design. Bartlett thus should preclude the practice, seen in various generics cases since Mensing, of repackaging state law failure-to-warn claims as design defect claims. The Supreme Court's decision also leaves little room for “pure” defective design claims against generics, as the majority concluded that federal law prohibits the manufacturers of these medications from redesigning their products, which must incorporate the same chemical composition of the equivalent branded version.

But perhaps the most wide-sweeping implication of Bartlett is the Court's rejection of the First Circuit's “stop-selling” rationale as a basis for denying preemption defenses. Under this rationale, a product manufacturer that faces competing federal and state law obligations may, it is argued, comply with both requirements by simply withdrawing its products from the market, and therefore lacks a true conflict preemption defense. Numerous courts, before Bartlett was decided, had refused to impose liability based on a manufacturer's “failure-to-withdraw” generic drugs from the market. See Gardley-Starks v. Pfizer, Inc ., 2013 WL 139900, at *5 (N.D. Miss. Jan. 10, 2013) (citing cases).

The Bartlett majority confirmed that this “stop-selling” rationale has no basis in its preemption jurisprudence, and in fact would mean that the vast majority ' if not all ' of the Court's impossibility preemption cases were wrongly decided. The Court's rejection of this approach should apply not only in cases involving generic (or branded) drug makers, but in product liability litigation generally.

Nevertheless, as with Mensing, some courts may construe Bartlett narrowly, including based on the majority's statement of its holding: that state-law design-defect claims “that turn on the adequacy of a drug's warnings”' are preempted by federal law under Mensing. Bartlett, 133 S.Ct. at 2470. The opinion, furthermore, points to potential exceptions to its holding where state tort law is intended solely to spread the cost of product-related injuries, requires a manufacturer to remove defective products from the market, or provides a basis for parallel state-law claims alleging “misbranding” of drugs under the FDCA. [Editor's Note: Next month's issue of LJN's Product Liability Law & Strategy will contain an article analyzing the Bartlett case in depth.]

For example, the Eighth Circuit recently reversed the dismissal of design defect claims so that the district court could consider Bartlett's implications where state law applied the consumers' expectations test to determine the existence of a product defect, rather than the risk-utility analysis at issue in Bartlett. See Fullington v. Pfizer, — F.3d —, No. 12'2945, 2013 WL 3491060, at *6 (8th Cir. July 15, 2013). Similarly, the Pennsylvania Superior Court held that it was error to dismiss all defective design claims against generics manufacturers, concluding that while such claims may be of the type held to be preempted in Bartlett, the dismissal was premature without the court's first conducting a careful analysis of the applicable state law. See Hassett v. Dafoe, — A.3d —, No. 81 EDA 2012, 2013 WL 3874882, at *11 (Pa. Super. Ct. July 29, 2013).

Claims That Generic Makers Breached the Duty of 'Sameness'

To avoid preemption, plaintiffs often claim that the manufacturer's allegedly tortious conduct under state law involved a breach of federal regulations. There is no conflict for preemption purposes, it is argued, because federal and state laws impose parallel obligations to act in the same manner. Post-Mensing, plaintiffs in generic drug cases have argued that claims premised on breach of the manufacturer's duty of “sameness” are not preempted by the FDCA, a position recently followed by the Sixth Circuit in Fulgenzi v. PLIVA, Inc., 2013 WL 949096 (6th Cir. Mar. 13, 2013). [See "And Yet Another Twist in Product Liability Litigation, Preemption and Generic Drug Liability" on page 3 for a report of the Fulgenzi decision.]

Apart from the issue of preemption, claims that a generic manufacturer failed to update product labeling to match changes made by the branded manufacturer, such as those asserted in Fulgenzi, are still limited by state law requirements to prove proximate causation. This element may be difficult to establish where the branded medication, containing the updated warning that the generic drug defendant allegedly failed to include, is prescribed but substituted with a generic version at the plaintiff's pharmacy.

Claims Alleging Innovator Liability

For years before Mensing, plaintiffs in pharmaceutical cases have asserted, unsuccessfully, that the liability of brand-name drug manufacturers extends not only to persons injured from the use of their products, but to anyone who ingested the equivalent generic version. Under this theory of so-called innovator liability, a manufacturer's duty includes guarding against tortious conduct committed by a different company and, indeed, a competitor in the marketplace. In the leading case on this issue, Foster v. Am. Home Prods. Corp. , 29 F.3d 165 (4th Cir. 1994), the Fourth Circuit held that the manufacturer of a brand-name drug has no duty to patients who ingested only a generic version of the drug manufactured by the company's competitors, rejecting the plaintiff's negligent misrepresentation claims. See also Colacicco v. Apotex, Inc. , 432 F. Supp. 2d 514, 540-41 (E.D. Pa. 2006) (collecting cases), rev'd on other grounds, 521 F.3d 253 (3d Cir. 2008). But see Conte v. Wyeth, Inc. , 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008).

Foster found that there was “no legal precedent for using a name brand manufacturer's statements about its own product as a basis for liability for injuries caused by other manufacturers' products,”' and concluded that this would be “especially unfair” given that “the generic manufacturer reaps the benefits of the name brand manufacturer's statements by copying its labels and riding on the coattails of its advertising.” As the court noted, it is the brand-name manufacturers that undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information. Generic manufacturers, on the other hand, avoid such expenses by duplicating successful pioneer drugs and their labels. 29 F.3d at 170.

Plaintiffs have argued that Mensing's preemption rule justifies a fresh look at innovator liability, which they assert avoids unfairness to consumers whose claims are preempted under Mensing as the result of state requirements, or a pharmacists' choice, to fill prescriptions with generic medications. These arguments have, almost without exception, been rejected by the courts in the post-Mensing landscape. As the Sixth Circuit stated in Smith:

The plaintiffs' argument ' that the name-brand defendants' liability stems from the fact that the regulatory structure governing name-brand and generic drugs makes it foreseeable that patients and their physicians will rely on the name-brand labels to use and prescribe generic drugs ' has been rejected by all but one of the courts that have considered it.

657 F.3d at 423-24. See also Gardley-Starks, 2013 WL 139900, at *5.

The Alabama Supreme Court's recent opinion in Wyeth v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), is the only post-Mensing decision adopting a rule of innovator liability and, with the California Court of Appeal's 2008 decision in Conte, one of only two state court decisions shifting liability for injuries caused by generic drugs to the brand-name manufacturer.

The Weeks court concluded that, because of the duty of “sameness” recognized in Mensing, it is “questionable” whether generic drug manufacturers have an independent duty to advise of the risks associated with their products. 2013 WL 135753, at *9-11. On this basis, Weeks rejected as “flawed” the Foster court's reasoning that generic drug manufacturers are responsible for the representations they make in warning labels. Moreover, Weeks found that the analysis in Foster “confuses strict liability and tort law,” concluding that “the fact that a brand-name manufacturer did not produce the version of the drug ingested by the plaintiff” should not bar failure-to-warn claims “because a warning label is not a part of the manufacturing process.” Id. at *15.

As illustrated in cases such as Fulgenzi, however, a generic drug manufacturer remains responsible for its labeling under state law. Indeed, an independent state law duty to provide a different warning was necessary to the preemption finding in Mensing. Nothing in Mensing's preemption analysis, or the duty of “sameness” under federal law, would negate this necessary element of a state tort action. Moreover, Foster was not limited to strict liability principles, but considered traditional tort law questions such as foreseeability in determining a manufacturer's duty under state law. That Mensing recognized a conflict between federal and state obligations would thus seem to present no challenge to Foster's holding that a state law duty to guard against competitors' negligent misrepresentations stretches foreseeability “too far.”

Finally, as recognized in the Weeks dissent, even after Mensing, the vast majority of courts continue to follow the rationale embodied in Foster. As recently stated by the Eleventh Circuit:

[T]he overwhelming national consensus ' including the decisions of every court of appeal and the vast majority of district courts around the country to consider the question ' is that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of the generic form of a product.

Guarino, 2013 WL 3185084, at *6. See also Bell v. Pfizer , 716 F.3d 1087, 1092-3 (8th Cir. 2013).

Conclusion

With some exceptions, courts since Mensing generally have followed the Supreme Court's rationale that the duty of “sameness” conflicts with and thus preempts state law tort obligations in generic drug cases. If recent developments are any guide, however, plaintiffs ' and some courts ' will continue to try to find ways to distinguish the preemption holdings in Mensing and Bartlett.

Joseph G. Falcone is a litigator with Herbert Smith Freehills New York LLP, where he is a partner in the disputes practice. He can be reached at [email protected] or 917-542-7805. Michael R. Kelly is a senior associate in the firm's disputes practice, and can be contacted at [email protected] or 917-542-7819.