United States: Rafferty v. Merck Expands Potential Liability For Drug Manufacturers In Massachusetts

On March 16, 2018, Massachusetts's highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability risk exposure for pharmaceutical manufacturers in the state. In the case of Rafferty v. Merck & Co., SJC-12347 (March 16, 2018), the Supreme Judicial Court held that a user of a generic drug may not bring a simple negligence claim against the brand-name manufacturer for failure to warn, but the user could bring a failure to warn claim against the brand-name manufacturer if it could show that that the brand name manufacturer intentionally failed to update a label on its drug, "knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use." The Supreme Judicial Court's holding requires a plaintiff to show that the brand-name manufacturer's actions were reckless, as opposed to only negligent, which is a more stringent standard to prove. The Court's decision sought to balance protection for the consumers of generic drugs in light of the U.S. Supreme Court decision in Pliva Inc. v. Mensing,[1] while taking into account the burden on brand-name manufacturers. However, by its own admission, this latest decision from Massachusetts's highest Court stands in the minority of courts that have ruled on this issue. The decision is an important one, however, because brand-name manufacturers can now be held liable to the users of the generic versions of its drug under a theory of reckless failure to warn. It will be interesting to see if other jurisdictions that have not addressed the issue will follow the Massachusetts high court.

The Massachusetts Supreme Judicial Court also concluded that a plaintiff who is injured by a generic drug due to a failure to warn cannot bring a claim against a brand-name manufacturer under c. 93A, the Massachusetts Consumer Protection Statute, where the brand-name manufacturer did not advertise, offer to sell, or sell the drug.

In Rafferty, plaintiff Brian Rafferty was prescribed finasteride by his physician to treat an enlarged prostate. Merck & Co., Inc. (Merck) is the manufacturer of Proscar, an FDA-approved brand-name version of the drug finasteride. Rafferty began to experience side effects. He weaned himself off the drug but the side effects continued and worsened. He was diagnosed with hypogodanism and androgen deficiency allegedly induced by the drug. At the time plaintiff was prescribed the generic version of finasteride, the product label warned of the potential for side effects, but represented that these side effects would resolve after discontinuing use of the drug. This generic label conformed to Merck's label for Proscar, in accordance with federal law.

According to plaintiff, by the time he was prescribed finasteride, several reports and studies had already emerged suggesting that the side effects could in fact persist even after discontinuing use. He further alleged that Merck had changed the label for Proscar in certain foreign markets to include a warning about persistent side effects, but had not changed its label in the United States as of the time plaintiff had ingested the generic drug.

Plaintiff filed suit against Merck, alleging that, although he had never ingested Merck's brand-name version of finasteride, Merck owed him a duty to warn of its dangers because, under Federal law, Merck controlled the label on the generic version that plaintiff did in fact ingest. The first sentence of the Court's decision acknowledges that "[u]nder Federal law, a manufacturer of a generic drug must provide its users with a warning label that is identical to the label of the brand-name counterpart." Plaintiff asserted a negligence claim for failure to warn and a claim for violation of M.G.L. c. 93A, Section 9 (the Massachusetts Consumer Protection Statute). Merck moved to dismiss and the judge allowed the motion. Thus, the trial court judge ruled, with respect to the negligence claim, that Merck owed no duty of care to plaintiff in part because Merck did not manufacture the finasteride that allegedly caused plaintiff's injury. The judge further concluded that there could be no violation of the consumer protection statute where there was no duty of care owed to the consumer. Plaintiff appealed and the Supreme Judicial Court transferred the case from the Appeals Court on its own motion.

Plaintiff did not assert a products liability claim and did not contend that Merck owed him a duty to warn as a manufacturer. Rafferty conceded, as he must under Massachusetts's prevailing law, that Merck owed him no duty to warn under the law of products liability as a manufacturer may be found liable for failure to warn only where the product that caused the injury was made by that manufacturer. As noted by the Court, plaintiff brought a general negligence claim pursuant to the standard articulated in Jupin v. Kask, 447 Mass. 141 (2006). However, as recognized in Jupin, "even where the requirements of negligence are satisfied, there may nevertheless be a public policy justification for declining to impose a duty of care where the 'imposition of a precautionary duty is deemed to be either inadvisable or unworkable.'" In short, the existence of a duty is ultimately determined with reference to existing social values and customs, as well as social policy. Although this case was an "exception to the usual pattern" because the Hatch-Waxman amendments required that the warning label of a generic drug be identical to the warning label of its brand-name counterpart and because the U.S. Supreme Court interpreted the regulatory scheme in PLIVA (564 U.S. at 614-15) to forbid a generic drug manufacturer from independently revising its warning labels, the Court noted that it must nonetheless consider as a matter of public policy whether a duty should be imposed.

After analyzing the burden and potential chilling effect on drug innovation, the federal regulatory scheme, PLIVA's holding and the need to protect consumers, the Supreme Judicial Court concluded "as a matter of public policy that allowing a generic drug consumer to bring a general negligence claim for failure to warn against a brand-name manufacturer poses too great a risk of chilling drug innovation, contrary to the public policy goals embodied in the Hatch-Waxman amendments." However, it also concluded that "public policy is not served if generic drug consumers have no remedy for the failure of a brand-name manufacturer to warn in cases where such failure exceeds ordinary negligence, and rises to the level of recklessness." Thus, the Court held that a "brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury." The court concluded that "this recklessness standard strikes the most appropriate balance between competing public policy interests, limiting liability for brand-name manufacturers while also providing remedies for the most serious injuries and deterring the most dangerous forms of conduct." The Court acknowledged that by imposing a duty to warn generic consumers on brand-name manufacturers, it found itself in the minority of courts that have decided the issue. However, it is also the only court to limit the scope of liability to reckless disregard of the risk of death or grave bodily injury.

Finally, the Court held that where the failure to warn is with respect to a drug that Merck never advertised, offered to sell or sold, plaintiff could not assert a claim pursuant to the Massachusetts Consumer Protection Statute. In order to assert a claim pursuant to M.G.L. c. 93A, Section 9, a plaintiff must allege that the defendant committed an unfair or deceptive act or practice in the conduct of trade or commerce, causing injury to plaintiff. The act complained of must occur "in the conduct of any trade or commerce." To satisfy the "trade or commerce" requirement in a failure to warn claim, it is not necessary that plaintiff purchase the product directly from the defendant – plaintiff need only have used the product (even if sold by another) and have been injured as a result of the defendant's failure to warn. The Court held that "Merck's alleged unfair and deceptive action – the failure to warn Rafferty of the side effects of the drug – was not taken in the course of "any trade or commerce" because it was not taken in the course of the advertising, offer to sell or sale of any Merck product." Because c. 93A allows for attorneys' fees and double / treble damages, which would not otherwise generally be recoverable pursuant to Massachusetts law absent the assertion of the c.93A claim, the dismissal and view of the Court vis-à-vis the c. 93A claim is a positive outcome from a defense perspective for those subject to potential liability under Massachusetts law.

Footnote

[1] In PLIVA, the United States Supreme Court held that State tort law claims against generic drug manufacturers arising out of a failure to warn are preempted by federal law.

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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Reed Smith
Arnold & Porter
Wilson Elser Moskowitz Edelman & Dicker LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Reed Smith
Arnold & Porter
Wilson Elser Moskowitz Edelman & Dicker LLP
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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