Foley Hoag LLP publishes this quarterly Update primarily
concerning developments in product liability and related law from
federal and state courts applicable to Massachusetts, but also
featuring selected developments for New York and New Jersey. If you
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can access all of our publications at https://foleyhoag.com.
Included in this Issue:
MASSACHUSETTS
- Massachusetts Federal Court Holds State Law Claims Alleging Misleading "Rapid Release" Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets' Dissolution Rate Met FDA Regulations and Guidance For "Immediate Release" And "Rapidly Dissolving," Verbatim Language Was Not Required For Preemption And Tablets' Slower Dissolution Than Non-"Rapid Release" Tablets Was Irrelevant
- Massachusetts Federal Court Holds: (1) Prescription Drug Failure-To-Warn Claims Preempted By Federal Food, Drug, And Cosmetic Act (FDCA) Because Reported Adverse Events Were Not "Newly Acquired Information" Permitting Manufacturer To Alter Its FDA-Approved Labeling; (2) Claims For Failure to Report Adverse Events To FDA Not Preempted Pending Massachusetts Supreme Judicial Court Ruling Whether State Law Recognizes Such Claims Independent Of FDCA; And (3) Plaintiff Adequately Pled Manufacturer Assumed Duty To Monitor Plaintiff By Assigning Patient Care Advocate And Negligently Failed To Address Plaintiff's Adverse Symptoms
- First Circuit Court of Appeals Holds Plaintiffs In Putative Class Action Alleging Misrepresentation Of Child Booster Seat Safe Weight Have Standing To Sue, As Overpayment Constitutes Concrete Economic Injury And Plaintiffs Plausibly Pled They Would Not Have Bought New Seat At All Absent Misrepresentation
- Massachusetts Superior Court Excludes Interventional Radiologist's Design Defect And Failure-To-Warn Opinions Regarding IVC Filter As Expert Was Not Engineer, Had No Medical Device Design Or Labeling Experience And Did Not Explain How Warning Was Inadequate; Plaintiff Also Lacked Actual Injury As Alleged IVC Perforation Caused No Symptoms Or Additional Medical Treatment
NEW YORK/NEW JERSEY SUPPLEMENT
- New York Appellate Division Holds Third-Party Claims Against Car And Tire Manufacturers "Aris[e] From" New York Marketing And Sales Activities Under Long-Arm Statute Based On "Substantial Relationship" To Claims Even Though Design, Manufacturing And (As To Car Manufacturer) Sale Of Particular Products At Issue Occurred Out-Of-State, And Applies New York Court Of Appeals Rather Than United States Supreme Court Precedent In Finding Jurisdiction Satisfies Due Process
- New York Appellate Division Holds Evidence Distributor Affixed Warning Labels To Some But Not All Asbestos-Containing Pipes At Most Constituted Negligence, But Not Malice Sufficient To Justify Punitive Damages
Excerpt:
Massachusetts Federal Court Holds State Law Claims
Alleging Misleading "Rapid Release" Labeling Of OTC
Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic
Act, As Tablets' Dissolution Rate Met FDA Regulations and
Guidance For "Immediate Release" And "Rapidly
Dissolving," Verbatim Language Was Not Required For Preemption
And Tablets' Slower Dissolution Than Non-"Rapid
Release" Tablets Was Irrelevant
In Sapienza v. Albertson's Co., Inc., No.
22-10968-RGS, 2022 U.S. Dist. LEXIS 217368 (D. Mass. Dec. 2, 2022),
plaintiff brought a putative class action in the United States
District Court for the District of Massachusetts against the
manufacturer and distributors of over-the-counter ("OTC")
acetaminophen tablets, asserting among other claims negligent
misrepresentation, fraud, breach of the implied warranty of
merchantability (the Massachusetts near-equivalent of strict
liability) and violation of Mass. Gen. L. ch. 93A (the state unfair
and deceptive trade practices statute). Plaintiff alleged the
medication's "rapid release" labeling was misleading
because the tablets actually dissolved more slowly than
defendants' less expensive non-"rapid release"
tablets, and this misrepresentation caused her and other consumers
to buy the former tablets at a premium. Defendants moved to
dismiss, arguing plaintiff's claims were preempted by the
National Uniformity for Nonprescription Drugs provision of the
Federal Food, Drug, and Cosmetic Act ("FDCA"), which
prohibits states from establishing any requirement that is
"different from or in addition to, or . . . otherwise not
identical with" those imposed by the FDCA.
Download the January 2023 Foley Hoag Product
Liability Update (pdf).
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.