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 find this update useful, please encourage your colleagues and contacts to also register with us on our website. As always, you can access all of our publications at https://foleyhoag.com.
Included in this Issue:
MASSACHUSETTS
- First Circuit Holds Failure-To-Warn Claims Against Drug
Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act
Because Animal Studies Cited By Plaintiffs Did Not Demonstrate
Risks Beyond Those In Studies Already Submitted To FDA And Hence
Were Not "Newly Acquired Information" Permitting
Defendant To Change Its FDA-Approved Labeling, And There Was
"Clear Evidence" FDA Would Have Rejected Labeling Change
Because It Later Rejected Similar Labeling With Awareness Of The
Cited Studies
- Massachusetts Federal Court Holds Jurisdiction Over
Non-Resident Branded Drug Manufacturers Satisfies Long-Arm Statute
And Due Process Despite Possibility Plaintiff Took Generic Drug
In-State, As Defendants' Out-Of-State Labeling Could Have
Harmed Plaintiff In-State Since Generic Labeling Must Follow
Branded, And Claims Were "Sufficiently Related" To
Defendants' In-State Sales Of Branded Drug; Design Defect
Claims Preempted By Federal Food, Drug, and Cosmetic Act Because
Defendants Could Not Have Modified Drug's Active Ingredient
Without FDA Approval
- In Putative Class Action For Reduced Vehicle Value Caused By
Allegedly Defective Hoods, Massachusetts Federal Court Dismisses
Magnuson-Moss Warranty Act Claims Despite Viable Express Warranty
Claim, Holding Plaintiff Cannot Use Broader Jurisdictional
Provisions Of Class Action Fairness Act To Evade Magnuson-Moss'
Jurisdictional Requirement Of At Least One Hundred Named
Plaintiffs, Dismisses Fraud By Omission Claims For Failure To
Plausibly Allege Hood Condition Was Essential To Purchase, And
Dismisses Tort-Based Implied Warranty Claims Because Alleged
Damages Were Purely Economic
- Massachusetts Federal Court Holds Plaintiff Failed To Prove
Personal Jurisdiction Over Surgical Mesh Manufacturer's Parent
Or Distributor, As Plaintiff Could Not Prove Manufacturer Was So
Dominated By Parent As To Be Its Alter Ego And Hence Impute Its
In-State Conduct To The Parent, And Affidavit Established
Distributor Did Not Sell Mesh Product In Massachusetts Until After
Plaintiff's Surgery; Plaintiff Pleads Adequate Design Defect
Claim By Identifying Other Mesh Products As Feasible Alternative
Design, But Not Manufacturing Defect Claim For Failing To Identify
Any Departure From Product's Intended Design
- In Putative Class Action Alleging Diminished Value Of Pet Food Based On Levels Of Heavy Metals And BPA, Massachusetts Federal Court Dismisses Plaintiffs' Fraud-Related Claims For Lack Of Plausible Allegation Of Objective Injury Where Product Complied With FDA Standards, Express Warranty Claim For Lack Of Allegation Of Promise Made Part Of Basis Of Bargain And Implied Warranty And Unjust Enrichment Claims Where Dogs Ate Food Without Harm So Plaintiff Received Full Benefit Of Bargain
NEW YORK/NEW JERSEY SUPPLEMENT
- In Case of First Impression, New York Federal Court Holds
Claims Involving Class II Medical Device Undergoing FDA "De
Novo" Review Because Not Substantially Equivalent To Marketed
Devices And Hence Subjected To FDA Special Controls Not Expressly
Preempted By Food, Drug, And Cosmetic Act Because Controls Did Not
Impose Specific Requirements On Device; Plaintiff's Claim For
Failure To Warn Physicians About Adverse Events Properly Includes
Claim Based On Failure To Report Events To FDA As Required By
Act
- New York First Department Holds Plaintiff Injured By Store Display Fitness Band Failed Adequately To Plead Claims For Breach Of Express Warranty Where He Did Not Allege He Saw Representations On Packaging From Which Product Had Been Removed, Implied Warranty Of Fitness For Particular Purpose Where He Did Not Allege Any Purpose For Product Other Than Its Ordinary One Or Implied Warranty Of Merchantability Where He Did Not Allege Any Deficiency In Product Itself But Rather That It Was Compromised By Repeated Customer Use
Excerpt:
First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In Studies Already Submitted To FDA And Hence Were Not "Newly Acquired Information" Permitting Defendant To Change Its FDA-Approved Labeling, And There Was "Clear Evidence" FDA Would Have Rejected Labeling Change Because It Later Rejected Similar Labeling With Awareness Of The Cited Studies
In Perham v. GlaxoSmithKline LLC (In re Zofran Ondansetron Prods. Liab. Litig.), 57 F.4th 327 (1st Cir. 2023), plaintiffs brought failure-to-warn claims against a pharmaceutical manufacturer in a multi-district litigation centralized in the United States District Court for the District of Massachusetts after being prescribed defendant's drug off-label to prevent nausea and vomiting while pregnant. Plaintiffs alleged the drug caused a variety of birth defects, and that it should have had a Pregnancy Category C label warning because there were animal data suggesting adverse fetal effects.
Download the April 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.