Included In This Update:
- Massachusetts Superior Court Holds Claims Against Generic Drug Manufacturer Not Preempted by Federal Law Because Manufacturer Could Have Applied to FDA to Change Drug’s Labeling
- Massachusetts Superior Court Holds Pharmacy Violates Unfair Trade Practices Act by Mailing Informational Letter to Pharmacy Customers Without Disclosing Small Profit, Dismisses Claims for Breach of Privacy and Patient Confidentiality
- Massachusetts Federal District Court Holds Manufacturer of U.S. Navy Aircraft Not Entitled to Federal Forum for Acting Under Federal Officer Where Manufacturer Did Not Show Navy Controlled Content of Warnings or Manufacturer was Performing Governmental Function
- Massachusetts Appeals Court Holds Value of Defendant’s Contribution Claim Against Third Party, Assigned to Plaintiff in Addition to Monetary Payment as Part of Settlement, Is Not Part of Joint Tortfeasors’ Common Liability, Hence Monetary Payment Discharges Such Liability and Permits Contribution Claim
- Massachusetts Federal District Court Dismisses Failure-to-Warn Claim Against Chemical Manufacturers and Suppliers Because Decedent’s Employer Was “Sophisticated User,” Holds Defendants’ Mere Membership in Trade Group Does Not Create Liability for Group’s Alleged Misrepresentations
Excerpt:
Massachusetts Superior Court Holds Claims Against Generic Drug Manufacturer Not Preempted by Federal Law Because Manufacturer Could Have Applied to FDA to Change Drug’s Labeling
In Kelly v. Wyeth, No. 20033314F, 2007 WL 1302589 (Mass. Super. 2007), plaintiff took a generic drug and subsequently suffered from depression and akathisia, two side effects acknowledged in the drug’s labeling. Plaintiff sued the drug manufacturer for negligent failure to warn, breach of express and implied warranties relating to merchantability and fitness for a particular purpose, and violation of Mass. Gen. L. ch. 93A (Massachusetts’ unfair and deceptive trade practices statute) based on the alleged warranty violations. Defendant moved for summary judgments on all counts.
Defendant first argued all of plaintiff’s claims were preempted because federal law conflicted with state law such that defendant could not comply with both. To secure FDA approval of a generic drug, the manufacturer must demonstrate that the drug is the bio-equivalent of the related branded drug and submit a proposed label that is identical to that of the branded drug. Defendant argued that, because no statute or regulation permits a manufacturer to change the generic drug’s labeling independent of the branded drug manufacturer and/or FDA, federal law conflicted with Massachusetts tort law. The Massachusetts Superior Court, however, concluded that—even if defendant could not unilaterally change the generic drug label—defendant could apply to the FDA for a labeling change. The court moreover concluded that a generic drug manufacturer is independently obligated under state law to warn of dangers associated with its drug, notwithstanding warnings associated with the branded drug. Because defendant had the option and obligation to seek a labeling change, state and federal law did not conflict and plaintiff’s claims were not preempted.
The court also denied summary judgment specifically against plaintiff’s failure-to-warn claim, concluding a genuine factual dispute existed regarding, among other things, whether the label conveyed a "fair indication of the nature and extent" of the risk of depression and akathisia. The court, however, granted summary judgment against plaintiff’s breach of warranty claim, concluding plaintiff had identified no language in the label explicitly or implicitly promising depression and akathisia would not occur, nor language warranting a specific result from taking the drug. Finally, the court granted summary judgment against plaintiff’s ch. 93A claim because it was "premised on the same facts and circumstances as [plaintiff’s] breach of warranty claim."
For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.