State-Law Design-Defect Claims Against Generic Drug Manufacturers Are Preempted

Mensing

Under the Supremacy Clause of the U.S. Constitution, “[w]here state and federal law 'directly conflict,' state law must give way.” Mensing, 131 S. Ct. at 2577. One circumstance in which state and federal law directly conflict is “where it is 'impossible for a private party to comply with both state and federal requirements.'” Id. (citation omitted). “The question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it.” Id. at 2579 (emphasis added).

The Court found it easy to “imagine that a third party or the federal government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.” Id. (emphasis in original). Accordingly, allegations that a party could “have started a Mouse Trap game that eventually led to a better label” by “ask[ing] the FDA for help” are not sufficient to defeat preemption. Id. at 2578. “[W]hen a party cannot satisfy its state law duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” Id. at 2581.

Because “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,” plaintiffs' failure-to-warn claims were preempted. Id. at 2578.

After Mensing, most courts rejected plaintiffs' “attempts to elude Mensing by clothing [their] allegations as” something other “than failure-to-warn claims.” Guarino v. Wyeth, LLC, No. 12-13263, 2013 WL 3185084, at *3 (11th Cir. June 25, 2013). For example, the Eleventh Circuit held that “'failure-to-communicate' claims” were preempted because “[n]o matter the garb in which [plaintiffs] attempt[] to present them,” claims that “are at bottom allegations regarding ' failure to warn ' cannot escape Mensing's grasp.” Id. Similarly, the Fifth Circuit rejected a claim that “generic defendants failed to test and inspect” as “yet another attempt to circumvent disfavored failure-to-warn claims.” Morris v. PLIVA, Inc., 713 F.3d 774, 778 (5th Cir. 2013). The First Circuit's decision in Bartlett, which held that a design-defect claim was not preempted, was against this trend.

Bartlett

The U.S. Supreme Court's decision in Bartlett leaves no doubt that “state-law design-defect claims ' that place a duty on [generic] manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling” and therefore preempted. 133 S. Ct. at 2479.

The plaintiff in Bartlett alleged injuries caused by sulindac, a generic pain medication. Despite the absence of a failure-to-warn claim, “allegations that sulindac's label was inadequate featured prominently at trial.” Id. at 2475. “To determine whether a product is 'unreasonably dangerous'” under New Hampshire law, courts apply “a 'risk-utility approach' under which 'a product is defective as designed if the magnitude of the danger outweighs the utility of the product.'” Id. at 2474. The relevant factors are “'the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.'” Id. at 2475 (citations omitted).

The Supreme Court explained that “[i]n the drug context, either increasing the 'usefulness' of a product or reducing its 'risk of danger' would require redesigning the drug: A drug's usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients.” Id. (emphasis added). But “redesign was not possible for two reasons.” Id.

“First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based.” Id. A manufacturer “'cannot legally make [a generic drug] in another composition'” ' if a drug's composition is changed, “the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce.” Id. (citation omitted). “Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned.” Id. (emphasis added).

“Because Mutual was unable to change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings.” Id. at 2470. Accordingly, Mensing controlled, and the plaintiff's state-law design-defect claim was preempted.

The Court rejected the First Circuit's attempt to distinguish Mensing “by arguing that generic manufacturers facing design-defect claims could simply 'choose not to make the drug at all' and thus comply with both federal and state law.” Id. at 2472 (quoting Bartlett, 678 F.3d at 37). “[A]dopting the Court of Appeals' stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.” Id. at 2470. Calling the “incoherence” of the theory “plain when viewed through the lens of [the Court's] previous cases” ' and citing Mensing as “an obvious example” ' the Court pointed out that “[i]n every instance in which the Court has found impossibility pre-emption, the 'direct conflict' between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.” Id. at 2477-78.

Mensing and Bartlett's Potential Impact

Bartlett is likely to bolster arguments that design-defect claims are generally inappropriate in the prescription drug context ' not only for generics, but also for brand-name drugs. Most pharmaceutical products are “chemically incapable of being redesigned.” Id. at 2475. “In cases where it is impossible ' in fact or by law ' to alter a product's design (and thus to increase the product's 'usefulness' or decrease its 'risk of danger'), the duty to render a product 'reasonably safe' boils down to a duty to [adequately warn].” Id. at 2480. That will be true in most cases.

The Bartlett Court also noted that it “is not unusual” for a pharmaceutical manufacturer's “liability [to] turn[] on the adequacy of [its] warnings” because “a large majority of States” have “adopted comment k to ' 402A of the Restatement (Second) of Torts, which recognizes that it is 'especially common in the field of drugs' for products to be 'incapable of being made safe for their intended and ordinary use.'” Id. at 2476 n.2 (quoting Restatement 2d, at 353). “Under comment k, '[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.'” Id. (emphasis in original) (quoting Restatement 2d, at 353-54). Thus, manufacturers usually do “'not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings.'” Id. (citation omitted). See also Restatement (Third) of Torts ' 6(c) (no design-defect claim as long as drug provides benefits to “any class of patients”). To the extent any States still allow design-defect claims against pharmaceutical manufacturers, there is now additional precedent to change that rule.

After Mensing, some plaintiffs' lawyers argued that brand-name companies should be liable for injuries allegedly caused by ingesting generic products. They may point to Bartlett now as well, but efforts to alter state law to recognize this new theory have been decisively rejected. Following Mensing, “the 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 (citing cases). Accord Bell v. Pfizer, Inc., 716 F.3d 1087, 1092 (8th Cir. 2013) (“'overwhelming majority of courts'” have rejected argument that “brand defendants are liable for ' injuries because the generic manufacturers copied the brand defendants' ' labeling.”).

Against this overwhelming post-Mensing weight of authority, the lone holdout is the Supreme Court of Alabama, which recently held that “a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.” Wyeth, Inc. v. Weeks, __ So. 3d __, No. 1101397, 2013 WL 135753 (Ala. Jan. 11, 2013). Notably, however, on June 13, 2013, in response to a rehearing petition, the Court granted oral argument and left the rehearing petition open pending argument.

Plaintiffs also have attempted to avoid preemption by bringing “failure-to-update” claims ' claims that generic manufacturers failed to update their labeling quickly enough after the brand-name manufacturer has made a change. Most courts have rejected those attempts. Morris, 713 F.3d at 777 (failure-to-update claim preempted and “logically incoherent” because plaintiffs faulted defendants for failing to adopt an allegedly inadequate label); Fullington v. Pfizer, Inc., No. 12-2945, 2013 WL 3491060, at *6 (8th Cir. July 15, 2013) (“failure to update claim” failed as a matter of law because plaintiff's physician “had independent knowledge of the risk” from “information provided by the manufacturer of the reference listed drug”). But see Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (failure-to-update claim not preempted, but it “must pass through the 'narrow gap' between Mensing and Buckman [Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001)], and will be constrained as a result”).

There also may be attempts to change federal law so that it is no longer impossible for generic manufacturers to change the labeling of their drugs. Under current CBE (changes-being-effected) regulations, brand-name manufacturers, but not generic manufacturers, are permitted to make temporary changes to labeling to reflect new safety information. See Mensing, 131 S. Ct. at 2575, 2581 & n.8. The FDA has signaled its intention to consider a proposed rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs)” to ' among other things ' “create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.” RIN 0910-AG94. Whether FDA will in fact adopt an amendment, and whether any amendment will affect Mensing and Bartlett remains to be seen.

Wendy S. Dowse is a senior associate in Kaye Scholer LLP's Product Liability Group. Steve Glickstein, a member of this newsletter's Board of Editors, is a partner at the firm.

In 2011, the U.S. Supreme Court held that federal law prohibits generic pharmaceutical manufacturers from independently changing the labeling of their drugs ' the labeling must be the same as the labeling for the brand-name drug to which the generic is equivalent. PLIVA, Inc. v. Mensing , 131 S. Ct. 2567, 2574-77 (2011). State-law claims based on the failure to provide different warnings for generic drugs conflict with this “federal duty of 'sameness'” and are therefore preempted. Id. at 2575.

Although attempts to avoid Mensing have been largely unsuccessful, in Bartlett v. Mutual Pharm. Co., the First Circuit held that a design-defect claim against a generic manufacturer was not preempted under Mensing because it could simply “choose not to make the drug at all.” 678 F.3d 30, 37 (1st Cir. 2012). In June, the Supreme Court reversed, holding that “state-law design-defect claims ' that place a duty on [generic] manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling.” Mutual Pharm. Co. v. Bartlett , 133 S. Ct. 2466, 2479 (2013).

This article discusses Mensing and Bartlett and their potential impact. For an analysis of the other related decisions, see “Recent Developments Since Pliva v. Mensing” in the September issue of this newsletter (http://bit.ly/17Rqoyu).

Mensing

Under the Supremacy Clause of the U.S. Constitution, “[w]here state and federal law 'directly conflict,' state law must give way.” Mensing, 131 S. Ct. at 2577. One circumstance in which state and federal law directly conflict is “where it is 'impossible for a private party to comply with both state and federal requirements.'” Id. (citation omitted). “The question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it.” Id. at 2579 (emphasis added).

The Court found it easy to “imagine that a third party or the federal government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.” Id. (emphasis in original). Accordingly, allegations that a party could “have started a Mouse Trap game that eventually led to a better label” by “ask[ing] the FDA for help” are not sufficient to defeat preemption. Id. at 2578. “[W]hen a party cannot satisfy its state law duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” Id. at 2581.

Because “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,” plaintiffs' failure-to-warn claims were preempted. Id. at 2578.

After Mensing, most courts rejected plaintiffs' “attempts to elude Mensing by clothing [their] allegations as” something other “than failure-to-warn claims.” Guarino v. Wyeth, LLC, No. 12-13263, 2013 WL 3185084, at *3 (11th Cir. June 25, 2013). For example, the Eleventh Circuit held that “'failure-to-communicate' claims” were preempted because “[n]o matter the garb in which [plaintiffs] attempt[] to present them,” claims that “are at bottom allegations regarding ' failure to warn ' cannot escape Mensing's grasp.” Id. Similarly, the Fifth Circuit rejected a claim that “generic defendants failed to test and inspect” as “yet another attempt to circumvent disfavored failure-to-warn claims.” Morris v. PLIVA, Inc. , 713 F.3d 774, 778 (5th Cir. 2013). The First Circuit's decision in Bartlett, which held that a design-defect claim was not preempted, was against this trend.

Bartlett

The U.S. Supreme Court's decision in Bartlett leaves no doubt that “state-law design-defect claims ' that place a duty on [generic] manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling” and therefore preempted. 133 S. Ct. at 2479.

The plaintiff in Bartlett alleged injuries caused by sulindac, a generic pain medication. Despite the absence of a failure-to-warn claim, “allegations that sulindac's label was inadequate featured prominently at trial.” Id. at 2475. “To determine whether a product is 'unreasonably dangerous'” under New Hampshire law, courts apply “a 'risk-utility approach' under which 'a product is defective as designed if the magnitude of the danger outweighs the utility of the product.'” Id. at 2474. The relevant factors are “'the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.'” Id. at 2475 (citations omitted).

The Supreme Court explained that “[i]n the drug context, either increasing the 'usefulness' of a product or reducing its 'risk of danger' would require redesigning the drug: A drug's usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients.” Id. (emphasis added). But “redesign was not possible for two reasons.” Id.

“First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based.” Id. A manufacturer “'cannot legally make [a generic drug] in another composition'” ' if a drug's composition is changed, “the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce.” Id. (citation omitted). “Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned.” Id. (emphasis added).

“Because Mutual was unable to change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings.” Id. at 2470. Accordingly, Mensing controlled, and the plaintiff's state-law design-defect claim was preempted.

The Court rejected the First Circuit's attempt to distinguish Mensing “by arguing that generic manufacturers facing design-defect claims could simply 'choose not to make the drug at all' and thus comply with both federal and state law.” Id. at 2472 (quoting Bartlett, 678 F.3d at 37). “[A]dopting the Court of Appeals' stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.” Id. at 2470. Calling the “incoherence” of the theory “plain when viewed through the lens of [the Court's] previous cases” ' and citing Mensing as “an obvious example” ' the Court pointed out that “[i]n every instance in which the Court has found impossibility pre-emption, the 'direct conflict' between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.” Id. at 2477-78.

Mensing and Bartlett's Potential Impact

Bartlett is likely to bolster arguments that design-defect claims are generally inappropriate in the prescription drug context ' not only for generics, but also for brand-name drugs. Most pharmaceutical products are “chemically incapable of being redesigned.” Id. at 2475. “In cases where it is impossible ' in fact or by law ' to alter a product's design (and thus to increase the product's 'usefulness' or decrease its 'risk of danger'), the duty to render a product 'reasonably safe' boils down to a duty to [adequately warn].” Id. at 2480. That will be true in most cases.

The Bartlett Court also noted that it “is not unusual” for a pharmaceutical manufacturer's “liability [to] turn[] on the adequacy of [its] warnings” because “a large majority of States” have “adopted comment k to ' 402A of the Restatement (Second) of Torts, which recognizes that it is 'especially common in the field of drugs' for products to be 'incapable of being made safe for their intended and ordinary use.'” Id. at 2476 n.2 (quoting Restatement 2d, at 353). “Under comment k, '[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.'” Id. (emphasis in original) (quoting Restatement 2d, at 353-54). Thus, manufacturers usually do “'not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings.'” Id. (citation omitted). See also Restatement (Third) of Torts ' 6(c) (no design-defect claim as long as drug provides benefits to “any class of patients”). To the extent any States still allow design-defect claims against pharmaceutical manufacturers, there is now additional precedent to change that rule.

After Mensing, some plaintiffs' lawyers argued that brand-name companies should be liable for injuries allegedly caused by ingesting generic products. They may point to Bartlett now as well, but efforts to alter state law to recognize this new theory have been decisively rejected. Following Mensing, “the 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 (citing cases). Accord Bell v. Pfizer, Inc. , 716 F.3d 1087, 1092 (8th Cir. 2013) (“'overwhelming majority of courts'” have rejected argument that “brand defendants are liable for ' injuries because the generic manufacturers copied the brand defendants' ' labeling.”).

Against this overwhelming post- Mensing weight of authority, the lone holdout is the Supreme Court of Alabama, which recently held that “a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.” Wyeth, Inc. v. Weeks , __ So. 3d __, No. 1101397, 2013 WL 135753 (Ala. Jan. 11, 2013). Notably, however, on June 13, 2013, in response to a rehearing petition, the Court granted oral argument and left the rehearing petition open pending argument.

Plaintiffs also have attempted to avoid preemption by bringing “failure-to-update” claims ' claims that generic manufacturers failed to update their labeling quickly enough after the brand-name manufacturer has made a change. Most courts have rejected those attempts. Morris, 713 F.3d at 777 (failure-to-update claim preempted and “logically incoherent” because plaintiffs faulted defendants for failing to adopt an allegedly inadequate label); Fullington v. Pfizer, Inc. , No. 12-2945, 2013 WL 3491060, at *6 (8th Cir. July 15, 2013) (“failure to update claim” failed as a matter of law because plaintiff's physician “had independent knowledge of the risk” from “information provided by the manufacturer of the reference listed drug”). But see Fulgenzi v. PLIVA, Inc. , 711 F.3d 578 (6th Cir. 2013) (failure-to-update claim not preempted, but it “must pass through the 'narrow gap' between Mensing and Buckman [ Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341 (2001)], and will be constrained as a result”).

There also may be attempts to change federal law so that it is no longer impossible for generic manufacturers to change the labeling of their drugs. Under current CBE (changes-being-effected) regulations, brand-name manufacturers, but not generic manufacturers, are permitted to make temporary changes to labeling to reflect new safety information. See Mensing, 131 S. Ct. at 2575, 2581 & n.8. The FDA has signaled its intention to consider a proposed rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs)” to ' among other things ' “create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.” RIN 0910-AG94. Whether FDA will in fact adopt an amendment, and whether any amendment will affect Mensing and Bartlett remains to be seen.

Wendy S. Dowse is a senior associate in Kaye Scholer LLP's Product Liability Group. Steve Glickstein, a member of this newsletter's Board of Editors, is a partner at the firm.