United States: Product Liability Update: October 2017


Massachusetts Federal Court In Multi-District Litigation Holds Under Six States' Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required To Adopt Branded Manufacturer's Allegedly Inadequate Warnings

In In re Zofran (Ondansetron) Products Liability Litigation, 2017 U.S. Dist. LEXIS 130965 (D. Mass. Aug. 4, 2017), a multi-district litigation ("MDL") in the United States District Court for the District of Massachusetts, parents and guardians of children with birth defects sued the manufacturer of a brand-name prescription anti-nausea drug, asserting claims for misrepresentation and negligent undertaking in promoting the drug off-label for pregnancy-related nausea and not adequately disclosing birth defect risks. A number of plaintiffs alleged maternal exposure only to generic equivalents of the brand-name drug, but asserted the branded or innovator manufacturer was liable as it had "created a market" for pregnancy use, should have known generic alternatives would enter that market and knew generic manufacturers were legally required to copy the branded manufacturer's labeling. Defendant moved to dismiss these "innovator liability" claims on the ground that its product had not caused plaintiffs' harm.

The court first noted that none of the highest courts in the six states whose law governed plaintiffs' claims—Georgia, Indiana, Kentucky, Massachusetts, New York and Oklahoma—had directly ruled on the issue. On the other hand, the overwhelming majority of courts, "including all seven federal circuits to have addressed the issue," have held that a brand-name manufacturer cannot be held liable for injuries caused by a generic equivalent. Moreover, the general tort law jurisprudence of the states in question supported adherence to the majority position and hence dismissal of plaintiffs' claims.

Regarding plaintiffs' request at least to certify the question to the highest courts of the states that have a certification procedure (all but New York), the court found certification unnecessary under Georgia law because an intermedi ate appellate court had directly decided the issue, or under the laws of Indiana, Kentucky and Oklahoma because the Sixth and Tenth Circuits had decided the issue under those states' laws without requesting certification. While there was "some su perficial appeal" to certifying the question to the Massachusetts Supreme Judicial Court ("SJC"), two Massachusetts trial courts had recently followed the "overwhelming and well-reasoned majority view" and hence the MDL court concluded it could make an informed and intelligent prediction that the SJC would do likewise. The court expressed awareness that its ruling would leave consumers injured by generic drugs without a remedy, because the United States Supreme Court had held claims against generic manufacturers preempted by the federal law requirement that their labeling be identical to that of the brand-name manufacturer. Nonetheless, just because Congress had exempted generic manufacturers from liability, it did not follow that branded manufacturers should bear that liability.

Massachusetts Federal Court Holds Medical Device Distributor Not Fraudulently Joined As Design Defect and Failure-to-Warn Claims Not Preempted by FDA Regulations That Do Not Prohibit But Merely Require Notification of Design or Labeling Changes, and Distributor May Be Liable On Implied Warranty Claims Even Without Taking Title to Product

In In re Stryker LFIT V40 Femoral Head Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 140808 (D.Mass., Aug. 31, 2017), plaintiffs in three state court actions brought claims against two out-of-state manufacturers and a Massachusetts distributor for breach of the implied warranty of merchantability (the Massachusetts nearequivalent of strict liability) for injuries allegedly caused by a hip replacement device based on design defect and failure-to-warn theories. The manufacturers removed the actions to the United States District Court for the District of Massachusetts, where a related multi-district litigation was pending, asserting diversity jurisdiction and alleging the non-diverse distributor was fraudulently joined. Plaintiffs moved to remand to state court.

In opposing plaintiffs' motion, the manufacturers first argued plaintiffs' claims against the distributor were preempted by 21 C.F.R. §§ 807.81 and 807.20(a)-(c), United States Food and Drug Administration ("FDA") regulations which the manufacturers asserted prohibited a medical device distributor from altering the design or warnings of FDAregulated devices. The court found, however, that the plain language of the regulations required a distributor to register and submit a premarket notification before repackaging or relabeling a device, but did not prohibit those actions. Accordingly, a distributor's position differs from that of a generic pharmaceutical manufacturer, whose labeling federal law unequivocally requires be identical to that of the corresponding FDA-approved brand-name drug, and plaintiffs' claims against the distributor were not preempted.

The manufacturers next argued the distributor could not be liable for breach of warranty, as it never actually took title to the hip implants but merely acted as a "conduit" in their sale. The court noted that Massachusetts Supreme Judicial Court ("SJC") precedent cited by the manufacturers merely addressed whether a product sale had occurred, and not whether it was necessary for a warranty claim that defendant have held title. Moreover, Mass. Gen. L. ch. 106, § 2-318 eliminates any requirement of privity in breach of warranty actions against a "manufacturer, seller, lessor or supplier of goods," suggesting possession of title was not required. And other SJC rulings had specifically held distributors may be liable for implied warranty product liability claims. As there was a reasonable legal basis for plaintiffs' claims against the distributor, the court granted plaintiffs' motion to remand.

Massachusetts Federal Court Holds Commercial Breach of Implied Warranty Claims For Purely Economic Loss Require Contractual Privity

In Organic Mulch & Landscape Supply of New Eng., LLC v. Probec, Inc., 2017 U.S. Dist. LEXIS 113716 (D. Mass. July 21, 2017), a corporation asserted a claim for breach of the implied warranties of merchantability and fitness for a particular purpose against the manufacturer of allegedly defective industrial ice-bagging equipment sold to plaintiff by a distributor, whom plaintiff also sued after the distributor refused to remove the equipment, refund the purchase price and pay consequential damages. The manufacturer moved for judgment on the pleadings based on lack of contractual privity with plaintiff.

Plaintiff argued the motion should be denied because the Massachusetts legislature unambiguously abolished the privity requirement through the enactment of Mass. Gen. Laws ch. 106, § 2-318, which provides that "[l]ack of privity between plaintiff and defendant shall be no defense in any action brought against the manufacturer" of goods for breach of warranty. In the alternative, plaintiff asked the court to certify the question of whether privity was required to the Massachusetts Supreme Judicial Court ("SJC").

The court denied the request for certification and granted the manufacturer's motion. The court first pointed to a line of SJC cases recognizing certain distinctions under section 2-318 between contract-based and tort-based warranty claims, and quoted SJC dicta that "contract-based warranty claims involving commercial transactions may generally call for different treatment than tort-based warranty claims." Then, citing opinions by four different federal district court judges, the court asserted that based on the SJC authority "courts have since uniformly held that a contract-based breach of warranty claim arising in a commercial context requires a showing of privity of contract." In light of this uniformity, there was no need to certify the question.

First Circuit Rejects Fraud And Unfair And Deceptive Practices Claims Based On Allegedly Inflated "Compare At" Price Tag For Lack of Actual Injury Where No Allegation Product Was Not Worth Price Paid; Unjust Enrichment Claim Fails Due To Existence Of Sales Contract

In Shaulis v. Nordstrom, Inc., 865 F.3d 1 (1st Cir. 2017), plaintiff filed a putative class action in Massachusetts Superior Court against a clothing retailer alleging fraud, breach of contract, unjust enrichment and violations of the Code of Massachusetts Regulations ("CMR"), Federal Trade Commission Act ("FTCA") and Mass. Gen. Laws ch. 93A, the Massachusetts unfair and deceptive practices statute. Plaintiff purchased a sweater from the retailer with a "Compare At" price on its tag that purported to identify a 77% savings, but plaintiff asserted the tag was deceptive as the retailer never sold the sweater at that price and absent the tag she would not have purchased the sweater.

Defendant removed the action to the United States District Court for the District of Massachusetts and moved to dismiss, arguing plaintiff failed to allege a legally cognizable injury under any theory. The district court agreed. Plaintiff did not allege the sweater was worth less than she paid, and her disappointment concerning the bargain she was receiving did not suffice. Further, although the "Compare At" tag violated both the CMR and FTCA, neither regime provided a private right of action.

On plaintiff's appeal as to her Chapter 93A and common law claims, the United States Court of Appeals for the First Circuit affirmed. The court first noted that the Massachusetts Supreme Judicial Court's ("SJC") recent decisions under Chapter 93A held that a plaintiff cannot rely on a "per se" theory of injury but rather must show "real economic damages." Here, plaintiff failed to allege any damages beyond being induced to make a purchase she would not have made, which impermissibly merged the alleged deception with the injury. Plaintiff also lacked any objective claim she expected to receive a higher quality product than she did. Plaintiff's argument that her travel costs to and from the retailer constituted actual injury also failed, as she had not alleged the price tag induced her travel.

Regarding plaintiff's common law claims, her fraud claim failed for the same reasons as her ch. 93A claim. There was no breach of contract claim as plaintiff agreed to pay the stated price. Nor could she recover for unjust enrichment, as under Massachusetts law that equitable remedy cannot override an otherwise valid contract.

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.

Events from this Firm
1 Feb 2018, Seminar, Boston, United States

Foley Hoag LLP and Crowe Horwath invite you to a luncheon on Thursday, February 1, 2018, at Foley Hoag’s New York office prior to the start of SBIA’s Northeast Private Equity Conference.

1 Feb 2018, Webinar, Boston, United States

Protecting the value of your corporate brand is a critical mission. As companies are increasingly asked to make disclosures regarding their efforts to address social and environmental risks, these disclosures create both opportunities and challenges for those entrusted with protecting a company’s intangible assets.

8 Feb 2018, Seminar, New York, United States

Recent high-profile sexual harassment scandals have prompted renewed discussions about sexual harassment in the workplace. Join us for a breakfast seminar focused on these issues from a legal and crisis response perspective.

In association with
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