United States: Plaintiffs’ Attorneys Keep Trying Novel Theories But Innovator Liability Is Still An Elusive Target


Over the past few years, three courts have overturned the fundamentals of tort law, holding that a manufacturer of a brand-name prescription drug can be subject to liability even when a plaintiff alleges that he or she was harmed by a generic drug made by the brand manufacturer's competitor. Most courts, including four federal courts of appeal and dozens of federal district and state trial courts, have rejected this expansion of tort law. This tension intensified after two U.S. Supreme Court rulings on the viability of state failure-to-warn claims against manufacturers of prescription drugs created different liability rules for generic manufacturers than for makers of brand-name drugs.

In the first case, the U.S. Supreme Court held that federal drug law does not preempt state failure-to-warn claims with respect to brand-name drugs;1 in the second case, it ruled that federal law does preempt failure-to-warn claims stemming from the use of generic products.2 As a result, the U.S. Supreme Court allowed users of brand-name drugs to potentially have an avenue for recovery not available to users of generic drugs.

The brand-name ruling came from the 2009 case Wyeth, Inc. v. Levine. The Court considered whether a plaintiff who had been administered brand-name Phenergan, an antihistamine used to treat nausea, could claim that its manufacturer, Wyeth, inadequately warned of the risk of developing gangrene when the drug is injected into a patient's vein rather than administered through an IV drip.3 At the time of the suit, the drug had long been available in generic form.4 In allowing the claim against Wyeth to go forward, the majority of the Court reasoned it was not impossible for Wyeth to comply with both federal labeling law and any state law warning requirements that would be derived if the litigation deemed its warnings inadequate.5 The majority opinion explained that Wyeth could have used the "changes being effected" (CBE) process to add the safety information required by the jury's determination and then seek FDA approval for that change.6 In order to demonstrate that FDA labeling law preempts a state failure-to-warn claim against a brandname manufacturer, the manufacturer must show "clear evidence that the FDA would not have approved a change to [the drug's] label."7 While Wyeth showed that the FDA had approved Phenergan's label and worked with the company to update the label several times, the Court said it did not show that the FDA would have prohibited the change required if the warning was deemed inadequate under a state's tort law.8 As a result, plaintiffs who take brandname drugs can generally move forward with state failure-to-warn claims against the drug's manufacturer.

Two years later, in PLIVA, Inc. v. Mensing, the Supreme Court faced the preemption issue, but this time with respect to generic drugs. In Mensing, two individuals who developed tardive dyskinesia claimed that the drug's manufacturer failed to adequately warn of this risk.9 Here, plaintiffs' doctors wrote the prescription for the brand-name version of the drug, Reglan.10 Pursuant to state substitution laws, the pharmacists filled the prescriptions with generic metoclopramide, manufactured by PLIVA.11 As in Levine, the Court applied the forward-looking "impossibility preemption" test. Here, though, the majority found that it would be impossible for PLIVA to adhere to both its federal labeling requirements to use the "same" warning approved for the brand-name drug and to change those warnings to cure any defect a jury in a state failure-to-warn suit determines to exist.12 Unlike the manufacturer of the branded drug, a generic drug maker cannot use the CBE process to change its labels; it can only request the FDA to make such a change.13

Thus, the primary distinction between the Levine and Mensing preemption rulings seems to hinge on the old adage about asking for forgiveness or permission. Brand manufacturers can change the label first and ask for permission second, while generics must ask for permission first and can only make a change once the FDA has agreed with the request. The sole issue related to the preemption analysis is whether the manufacturer had the ability to implement new labeling requirements. The Court held that brand manufacturers could do so, while generic manufacturers could not.14

No Post-Mensing "Innovator Liability" for Brand Manufacturers

After the Court decided Mensing in 2011, generic drug users were left searching for possible avenues of legal recovery after incurring injury. This controversial decision made the ability to bring a successful lawsuit against generic drug manufacturers near impossible. The theory of innovator liability, which holds the brand manufacturer responsible for injury resulting from the generic drug, has been tested as a work-around to the Mensing decision. Innovator liability has repeatedly been defeated in courts on many occasions, with the argument made that one company does not owe a duty to those taking a drug manufactured by an entirely different company. Since Mensing was decided, courts have declared that traditional product liability law remains unchanged under the laws of Arizona, Arkansas, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and West Virginia.15

In a recent innovator liability ruling, the Eleventh Circuit in Guarino v. Wyeth rejected the theory of liability where the plaintiff admitted she was harmed by generic metoclopramide manufactured and distributed by a company other than the brand defendants.16 The brand defendants moved for summary judgment arguing that, as a matter of Florida law, they were not liable for plaintiff's injuries because plaintiff did not ingest a product manufactured by them. Specifically, the brand defendants contended that Florida law prevents consumers from suing brand-name manufacturers for injuries arising from use of a generic equivalent. The district court granted summary judgment on behalf of the brand defendants.17 On appeal, the panel of judges affirmed the district court's grant of summary judgment.- The court relied heavily on well-settled state law that recognized that no cause of action existed against the brand manufacturer of a drug when a plaintiff admits to having only taken the generic equivalent.19 Specifically, the court noted:

Every court in Florida to consider the question has concluded that the brand manufacturer of a prescription drug cannot be held liable for injuries suffered by consumers who ingested only the generic form of a drug[...]. As one court explained, '[i]t is well-settled under Florida law that a plaintiff may only recover from the defendant who manufactured or sold the product that caused the injuries in question.' We see no reason to doubt this interpretation of the law.20

In further justification of its holding, the Eleventh Circuit noted that a "mountain of authority" from across the country "steels us in our determination" that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of a generic form of a product.21

Attempts to Circumvent Mensing and Hold Generic Manufacturers Liable Have Failed

Despite the clear and unmistakable holding in Mensing, plaintiffs have continued to challenge the adequacy of generic labels. Some have done so by making the same claims and arguments squarely rejected in Mensing. Others have tried to challenge the label by arguing that their claims, such as strict liability, design defect, negligence, breach of express and implied warranties, fraud, misrepresentation, unfair trade practices, etc., are not failure-towarn claims; rather, they are distinct causes of action not addressed in Mensing. The generics manufacturers have maintained that Mensing preempts any claim that relates to the generic drug label regardless of the name given the claim. Courts across the country have routinely ruled that claims related to the generic drug label are preempted under Mensing.22 As one judge has explained in dismissing such claims, "Mensing means what it says: all failure-to-warn claims against generic drug manufacturers are preempted if generic manufacturers cannot independently alter their warning labels."23

The First Circuit, however, created a stir when it allowed a case to proceed against a generic manufacturer on a design defect theory for simply selling the drug. The First Circuit stated that "while the generic maker has no choice as to label[,] the decision to make the drug and market it [...] is wholly its own."24 The court suggested that a jury should be able to "second-guess the FDA"25 and determine that the drug's "risks outweighed its benefits making it unreasonably dangerous to consumers, despite [the FDA] having never withdrawn its statutory 'safe and effective' designation."26 The court stated it was willing to redefine the relationship between state liability law and federal drug laws because it did not believe a plaintiff should lose the right to recover "by the mere chance of her drugstore's selection of a generic."27 The First Circuit then urged the Supreme Court to take the case and review its novel design defect theory, noting that "the Supreme Court has yet to decide" it, but that it "needs a decisive answer from the only court that can supply it."28

On June 24, 2013, the U.S. Supreme Court rejected the First Circuit's ruling that design defect claims against generic drug companies are not preempted by Mensing on the grounds that the defendant could simultaneously comply with both state and federal law by choosing not to sell the medication altogether. As Justice Alito explained for the majority, the Court's "pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability," for "if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be 'all but meaningless.'"29

It was this understanding that the Bartlett decision was predicated on, with five of the nine justices finding that the same preemption standard under Mensing held for design defects as well. The Supreme Court held that the plaintiff's "stop selling" theory is "incompatible" with its preemption jurisprudence, which "presume[s] that an actor seeking to satisfy both his federal- and statelaw obligations is not required to cease acting altogether" in order to avoid liability.30

The Court's opinion in Bartlett marks a decisive victory for generic pharmaceutical manufacturers who, despite Mensing, have continued to face personal injury lawsuits on the grounds that they could have stopped selling the medications at issue. Following this ruling, it would appear that attorneys representing individuals who claim to be injured by generic drugs may be forced to turn to legislative and regulatory avenues to address the broad reach of federal preemption of warning and design defect claims. At the close of the majority opinion, the Court stated that it "would welcome Congress' 'explicit' resolution of the difficult pre-emption questions that arise in the prescription drug context."31

Defending Against Innovator Liability

Despite the "mountain of authority" from across the country rejecting innovator liability, the issue still persists. With courts faithfully applying Mensing and dismissing claims against generic manufacturers, brand manufacturers must be prepared to defend against claimed innovator liability.

In defending such claims, the procedural history of Mensing could 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. Additionally, the recent Supreme Court opinion in Bartlett is another arrow in the quiver of pharmaceutical companies defending suits on preemption grounds.


1 See Wyeth, Inc. v. Levine, 555 U.S. 555, 558-59 (2009).

2 See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011).

3 Levine, 555 U.S. at 558.

4 Id. at 561.

5 Id. at 573.

6 Id.

7 Id. at 571.

8 Id. at 568-73.

9 Mensing, 131 S. Ct. at 2572-73.

10 Id. at 2573.

11 Id.

12 Mensing, 131 S. Ct. at 2579.

13 Id.

14 Id. at 2581.

15 See Demahy v. Schwarz Pharm., Inc., 702 F.3d 177 (5th Cir. 2012) (applying Louisiana law); Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011) (applying Kentucky law); Hogue v. Pfizer, Inc., 893 F.Supp.2d 914 (S.D. Ohio 2012); Baymiller v. Ranbaxy Pharmaceuticals, Inc., 894 F.Supp.2d 1302 (D. Nev. 2012); Phares v. Actavis-Elizabeth, LLC, 892 F.Supp.2d 835 (S.D. Tex. 2012); Strayhorn v. Wyeth Pharmaceuticals, Inc., 882 F.Supp.2d 1020 (W.D. Tenn. 2012); Lashley v. Pfizer, Inc., 877 F.Supp.2d 466, 471-73 (S.D. Miss. 2012); Guarino v. Wyeth, LLC, 2012 U.S. Dist. LEXIS 55665 at *1-2 (M.D. Fla. April 3, 2012); In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 856 F.Supp.2d 904, 910-13 (E.D. Ky. 2012) (applying Georgia, Indiana, Louisiana, Minnesota, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Texas law); Moore v. Mylan, Inc., 840 F.Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012); In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012) (applying Arizona, Florida, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and West Virginia law); Del Valle v. PLIVA, Inc., 2012 WL 4747259, at *5-8 (S.D. Tex. Sept. 12, 2012); Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1294 (M.D. Fla. Nov. 18, 2011); Madden v. Teva Pharmaceuticals, USA, Inc., 2012 Phila. Ct. Com. Pl. LEXIS 293 (Pa. C.P. 2012) (applying Washington law); Condouris v. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012).

16 Guarino v. Wyeth, LLC, 2013 U.S. App. LEXIS 12966, at *2-*3 (11th Cir. June 25, 2013).

17 Id.

18 Id. at *18.

19 Id. at *14-*15.

20 Id. at *14-*15 (citations omitted).

21 Id. at *21.

22 Demahy v. Schwarz Pharma, Inc., No. 11-31073, 2012 WL 5261492, at *6 (5th Cir. Oct. 25, 2012); Gaeta ex rel. A.G. v. Perrigo Pharm. Co., 469 Fed.Appx. 556, 557 (9th Cir. 2012); Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011), cert. denied, 132 S.Ct. 2103 (2012); Bell v. PLIVA, Inc., 845 F.Supp.2d 967, 970-71 (E.D. Ark. 2012); Moretti v. Mutual Pharm. Co., 852 F.Supp.2d 1114, 1118 (D. Minn. 2012); In re Pamidronate Prod. Liab. Litig., 842 F.Supp.2d 479, 484 (E.D.N.Y. 2012).

23 Strayhorn, 11-2058-STA-cgc, 2012 WL 3261377, at *10 (W.D. Tenn. Aug. 8, 2012) (Order Granting Generic Defendants' Motion to Dismiss).

24 Bartlett v. Mut. Pharm. Co., 678 F. 3d 30, 38 (1st Cir. 2012), cert. granted, 133 S. Ct. 694 (2012).

25 Id. at 38. The trial would presumably consider whether all versions of sulindac, including the innovator drug, are defective in design, even though the FDA approved the branded-drug-specific design and warning.

26 Id. at 34.

27 Id. at 38.

28 Id. at 36, 38.

29 Mutual Pharm. Co. v. Bartlett, 2013 U.S. LEXIS 4702, at *27 (U.S. June 24, 2013) (quoting Mensing, 131 S. Ct. 2567 (slip op., at 14)).

30 Id. at *28.

31 Id. at *36.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions