Product Liability Update
August 2016In This Issue:
Foley Hoag LLP publishes this quarterly Update concerning developments in product liability
and related law of interest to product manufacturers and sellers.
Massachusetts Superior Court Rejects “Innovator Liability” Failure-
to-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed
No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That
Copied Defendant’s Labeling But Defendant Did Not Make Or Sell
In Rafferty v. Merck & Co., 2016 Mass. Super. LEXIS 48 (Mass. Super. Ct. May 23, 2016),
plaintiff sued his prescribing physician and a pharmaceutical manufacturer for injuries
allegedly suffered from use of the drug nasteride, the generic equivalent of a brand
name medication manufactured by defendant. Plaintiff brought claims for negligence and
violation of Mass. Gen. Laws Ch. 93A (the state’s unfair and deceptive practices statute),
alleging defendant failed to warn that sexual dysfunction was a potential side effect.
Defendant moved to dismiss, arguing Massachusetts does not recognize an “innovator
liability” theory that would extend a brand name, i.e., innovator, drug manufacturer’s duty
to warn beyond users of its product to individuals who use a generic equivalent that copies
the manufacturer’s labeling.
The court acknowledged that this was an issue of rst impression in Massachusetts.
The court noted that the federal Food, Drug and Cosmetics Act (“FDCA”) established
an “onerous and lengthy” process for the approval of a new branded drug by the
United States Food & Drug Administration (“FDA”), including approval of its label, while
a chemically and biologically equivalent generic drug may be approved through an
abbreviated process so long as its label follows that of the branded drug. And under the
United States Supreme Court’s rulings in PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011)
(see July 2011 Foley Hoag Product Liability Update), and Mut. Pharm. Co. v. Bartlett,
133 S. Ct. 2466, 2476 (2013) (see July 2013 Foley Hoag Product Liability Update),
failure-to-warn and design defect claims against generic manufacturers are preempted
because the FDCA prohibits the manufacturer from departing from the FDA-approved
branded drug’s design and labeling, leaving the branded manufacturer as the only
possible defendant.
Against this background, the court concluded that holding defendant liable as an innovator
would be inconsistent with fundamental principles of Massachusetts product liability law,
under which a plaintiff must prove that the product he claims caused his injury is traceable
to the defendant. Merely issuing instructions about how to use a category of products is too
attenuated a relationship to warrant imposing liability. Although defendant generated the
information used in the generic drug’s warning label, defendant did not afrmatively supply
that information to the generic manufacturer, which merely copied the information on its own.
In addition, defendant’s warning label could be analogized to a non-defective component
part, and in Massachusetts manufacturers are not liable for a failure to warn of risks created
◼ Massachusetts Superior Court Rejects “Innovator
Liability” Failure-to-Warn Claim, Holds Branded
Pharmaceutical Manufacturer Owed No Duty to
Plaintiff Alleging Injury From Equivalent Generic
Drug That Copied Defendant’s Labeling But
Defendant Did Not Make Or Sell
◼ First Circuit Afrms Exclusion of Expert Opinion
That Benzene Caused Leukemia Due to Failure to
Explain Discounting of Conicting Epidemiologic
Studies and Circular Analysis Purporting to Exclude
Idiopathic Causation Based on Possibility of
Benzene Causation
◼ Massachusetts Federal District Court Holds
Defendant Not Subject to Personal Jurisdiction On
Out-of-State Plaintiffs’ Claims as Defendant Was Not
At Home in State, Appointment Of Agent For Service
Did Not Consent to General Jurisdiction There And
Plaintiffs’ Claims Had No Nexus to Defendant’s
In-State Activities
◼ Massachusetts Federal Court Holds Res Ipsa
Loquitur Permits Inference of Manufacturing Defect
in Cardiac Guide Wire Based on Lack of Evidence
of Negligent Handling and Physicians’ Testimony
Spontaneous Breakage Was Rare; Off-Label Use
No Bar To Claim Where Use Was Foreseeable
And Not Shown To Impose Greater Stress Than
On-Label Use
◼ First Circuit Afrms Dismissal of Claims Against
Biologics Manufacturer For Lack of Standing Where
Plaintiffs Failed to Allege Particularized and Concrete
Harm From Defendant’s Alleged Failure to Sell
Sufcient Product in FDA-Approved Dose to Meet
Market Demand
◼ First Circuit Holds Jurisdictional Transfer Statute
Permits Transfer To Proper Court To Cure Lack of
Either Personal or Subject Matter Jurisdiction
