Mutual Pharmaceutical Co. v. Bartlett (2013)

by McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Building #1The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently.  (Although anyone familiar with recent Supreme Court patent jurisprudence would perhaps not be amiss in thinking the adage should be adapted to "Bad analogies make bad law.")  The current Court (or at least a 5-member majority) showed on Monday that it could be immune to these equities in reversing a $21 million judgment to a New Hampshire woman disfigured as a consequence of taking a generic formulation of sulindac, a non-steroidal anti-inflammatory drug (or NSAID).  Once again, the Court waded into the waters of drug regulatory law and the interplay between the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and Hatch-Waxman Act and state, common law products liability sounding in tort, with the Court deciding that state law was preempted (to the detriment of the patient's recovery for the "tragic circumstances" of her disfigurement).

The case arose from administration of a generic version of Clinoril (the branded version of the drug sulindac): Sulindacmade by Mutual Pharmaceutical to Respondent Karen L. Bartlett.  Ms. Bartlett suffered a known -- albeit rare -- side effect of sulindac administration (as well as other NSAIDs), toxic epidermal necrolysis, a skin hypersensitivity reaction.  The consequences for Ms. Bartlett were "horrific" according to the Court:  "[s]ixty to sixty-five percent of the surface of respondent's body deteriorated, was burned off, or turned into an open wound.  She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year.  She is now severely disfigured, has a number of physical disabilities, and is nearly blind."  Significant for the Court's decision, at the time she was administered the drug, the drug label did not contain any specific warning regarding this type of side effect (although the FDA later required the package insert to contain a warning regarding the risk of developing this condition); the Agency later required this warning to be on the drug label.

Ms. Bartlett sued in an action eventually transferred to Federal court under state law claims characterized by the Court as "both failure-to-warn and design-defect claims," but the District Court dismissed the former cause of action following her physician's admission that he had not read either the label or package insert.  Ms. Bartlett prevailed on her design defect claim, which under New Hampshire law "requires manufacturers to ensure that the products they design, manufacture, and sell are not 'unreasonably dangerous.'"  According to the Court:

New Hampshire imposes design-defect liability only where "the design of the product created a defective condition unreasonably dangerous to the user," citing Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181 (2001); Chellman v. Saab-Scania AB, 138 N. H. 73, 7, 637 A. 2d 148, 150 (1993).  To determine whether a product is "unreasonably dangerous," the New Hampshire Supreme Court employs a "risk-utility approach" under which "a product is defective as designed if the magnitude of the danger outweighs the utility of the product."  Vautour, supra, at 154, 784 A. 2d, at 1182 (internal quotation marks omitted).  That risk-utility approach requires a "multifaceted balancing process involving evaluation of many conflicting factors."  Ibid. (internal quotation marks omitted); see also Thibault, supra, at 809, 395 A. 2d, at 847 (same).

While the set of factors to be considered is ultimately an open one, the New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry:  "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."  Vautour, supra, at 154, 784 A. 2d, at 1182; see also Price, supra, at 389, 702 A. 2d, at 333 (same); Chellman, supra, at 77-78, 637 A. 2d, at 150 (same).

Moreover, according to the Court this form of liability, while being "strict" product liability is not "absolute" liability; the distinction is that the former imposes a "duty of care" on manufacturers as opposed to the latter form of liability, which is a way states can "spread the risk" of injury due to design or manufacturing defects.  This distinction is relevant, because the Court's determination that Mutual was under a common law-defined duty in New Hampshire implicated the three ways the company could comply with state law, and how two of the three were impossible under Federal law.

Supreme Court SealThe Court's opinion, by Justice Alito joined by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas, found that Mutual could comply with its state-law imposed duty either by making chemical changes to the drug or changing the drug label (here, by including the more stringent warnings from the package insert on the label, as the FDA was later to do).  The majority found that changing sulindac chemically was impossible both for reasons of "basic chemistry" (i.e., there is little that could be changed in the molecule without changing it into a different molecule) and FDA regulatory law, which required the generic compound to be a copy of the branded drug and to have certain pharmacological properties in common with the branded embodiment.  21 U. S. C. §§ 355(j)(2)(A)(ii), (iii) and (iv), 21 U. S. C. §§ 355(j)(8).  The impossibility of changing the label is a direct consequence of the FDA requirement that a generic drug have the same label as the branded version.  § 355(j)(2)(A)(v).  And a generic drug manufacturer is barred from unilaterally changing either the drug itself, its formulation or its label.  21 CFR § 314.70(b)(2)(i).  Generic manufacturers are also prohibited from making any unilateral changes to a drug's label.  See §§ 314.94(a)(8)(iii), 314.150(b)(10).  Thus, in this case there was a direct conflict between what was required to comply with the state-imposed duties under its tort law and the requirements of Federal drug regulatory law.

Under these circumstances, the Court held that Federal law prevails and preempts state tort liability, citing Maryland v. Louisiana, 451 U. S. 725, 746 (1981), for the principle that "[u]nder Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are 'without effect.'"  And the Court rejected the third possibility open to Mutual, which was to stop selling generic sulindac in New Hampshire, saying that if this were the law "impossibility preemption" would be "all but meaningless," citing its recent opinion in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), a case involving state law liability on "failure to warn" grounds.  The Court expressly rejected this alternative in the PLIVA case, saying that "[a]dopting the [appellate court's] stop-selling rationale would mean that not only PLIVA, but also the vast majority -- if not all -- of the cases in which the Court has found impossibility pre-emption, were wrongly decided."

That, of course, would never do.  As a consequence, Ms. Bartlett is without a remedy against the generic drug manufacturer, an outcome the majority regrets but does not use to come to a different conclusion:

This case arises out of tragic circumstances.  A combination of factors combined to produce the rare and devastating injuries that respondent suffered:  the FDA's decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent's physician to prescribe sulindac despite its known risks, and Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings.  Respondent's situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.

Four Justices dissented.  Justice Breyer, joined by Justice Kagan, writes that there is a fourth alternative, that is for a company to shoulder the burden of "paying a sizable damages" award as a remedy in instances where a rare side effect causes harm to a patient.  This opinion is informed, in part, by an amicus brief submitted by two former FDA Commissioners, who inform the Court that "the FDA has long believed that state tort litigation can 'supplemen[t] the agency's regulatory and enforcement activities.'"  Justice Sotomayor, joined by Justice Ginsburg, is more vociferous, accusing the majority of unnecessarily crafting a rule that "immunize[d] generic drug manufacturers from state-law failure-to-warn claims" in PLIVA v. Mensing and, here, "unnecessarily and unwisely extend[ing] its holding in Mensing to pre-empt New Hampshire's law governing design-defects with respect to generic drugs."  "Of greater consequence," the Justice writes:

[T]he Court appears to justify its revision of respondent Karen Bartlett's state-law claim through an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability.  Remarkably, the Court derives this proposition from a federal law that, in order to protect consumers, prohibits manufacturers from distributing new drugs in commerce without federal regulatory approval, and specifically disavows any intent to displace state law absent a direct and positive conflict.

The majority has gone astray, according to the dissent, for failing to apply the "two cornerstones of our pre-emption jurisprudence":  to discern the "purpose of Congress" in enacting the statute, and to require a "clear and manifest" Congressional intention to supersede the "historic police powers of the States" as embodied in the type of common law tort liability at issue in this case.  The Justice sees this decision as being in contrast to the Court's (correct) decision in Wyeth v. Levine, where state tort law liability was not preempted by Federal drug regulatory law.  State tort law is a complement to Federal drug law in protecting consumers, a situation Congress has not seen fit to alter or correct:

Congress' preservation of a role for state law generally, and common-law remedies specifically, reflects a realistic understanding of the limitations of ex ante federal regulatory review in this context.  On its own, even rigorous preapproval clinical testing of drugs is "generally . . . incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in the studies," citing Kessler & Vladeck, A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 471 (2008); see National Academies, Institute of Medicine, The Future of Drug Safety: Promoting and Protecting the Health of the Public 37-38 (2007).

Her dissent also notes that "the FDA, which is tasked with monitoring thousands of drugs on the market and considering new drug applications, faces significant resource constraints that limit its ability to protect the public from dangerous drugs," citing Levine, 555 U. S., at 578-579, and n. 11, and that "[t]ort suits can help fill the gaps in federal regulation by 'serv[ing] as a catalyst' to identify previously unknown drug dangers," citing Bates v. Dow Agrosciences LLC, 544 U. S. 431, 451 (2005).

Under these circumstances this dissent finds the facts of this case to be far from the "strict standard for impossibility" that should be required for Mutual to avoid state law tort liability.  And as in Justice Breyer's dissent, Justice Sotomayor did not see Mutual's alteratives to be limited to those "impossible" under Federal law:

A manufacturer of a drug that is unreasonably dangerous under New Hampshire law has multiple options:  It can change the drug's design or label in an effort to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business.  If federal law or the drug's chemical properties take the redesign option off the table, then that does not mean the manufacturer suddenly has a legal obligation under state law to improve the drug's label.  Indeed, such a view of state law makes very little sense here because even if Mutual had strengthened its label to fully account for sulindac's risks, the company might still have faced liability for having a defective design.  . . .  When a manufacturer cannot change the label or when doing so would not make the drug safe, the manufacturer may still choose between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product.

And while these alternatives may be "unwelcome" from a manufacturer's prospective, "it is a choice that a sovereign State may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation."

Ironically, the majority, usually so quick to rely upon Federalism (or "states' rights") principles in other contexts finds state tort law liability to be preempted while the traditionally "liberal" members of the Court would hew to basic Federalism principles in permitting states to protect their citizens under common law tort law.  While the majority "saves for another day the question whether a true absolute-liability state-law system could give rise to impossibility pre-emption," it seems that states adopting an "absolute liability" regime that imposes no affirmative duties contrary to Federal law but merely "spreads the risk" might be one way for the states to regain their traditional right to employ the sovereign police powers to impose tort liability that would escape the wide latitude of preemption embodied in the Court majority's decision.

Mutual Pharmaceutical Co. v. Bartlett (2013)
Opinion by Justice Alito, joined by Chief Justice Robefrts and Justices Scalia, Kennedy, and Thomas; dissenting opinion by Justice Breyer, joined by Justice Kagan; dissenting opinion by Justice Sotomayor, joined by Justice Ginsburg


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.