• 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

• 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:

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.