United States: Product Liability Update: April 2019

Last Updated: May 14 2019
Article by David R. Geiger, Richard G. Baldwin and Peter Ellis

Included in this Issue:

MASSACHUSETTS

  • First Circuit Holds Subsequent FDA Approval Of Drugs For Pediatric Use Not Conclusive Proof Of Effectiveness At Time Of Sale So As To Preclude Fraudulent Marketing Claims, And Individualized Proof Of Causation Of Prescriptions And Drugs' Ineffectiveness Not Required Where Claims Supported By Medical Literature And Expert Testimony
  • First Circuit Holds Due Process Permits Personal Jurisdiction Over Foreign Manufacturer Selling In Massachusetts Through Out-of-State National Distributor, Concluding Acceptance Of Customers' Orders And Requirement That Distributor Provide Defendant's Direct Contact Information Supported Finding Defendant Purposefully Availed Itself Of Privilege Of Conducting Activities In State
  • Massachusetts Federal Court Holds (1) Related Corporations' Use of Common Website And Conclusory Deposition Testimony That Entities Were Not Separate Did Not Demonstrate Pervasive Control Needed To Pierce Corporate Veil, (2) Expert Testimony Regarding Design Defect Created Triable Issue On Implied Warranty Of Merchantability, And (3) Whether Literature Representations Were "Puffery" Or Were Relied Upon Created Triable Issues On Misrepresentation
  • Massachusetts Supreme Judicial Court Holds Statute Of Repose For Tort Claims Arising Out Of Deficiencies Or Neglect In Improvements to Real Property Applies Even If Claim Involves Disease with Extended Latency Period
  • Massachusetts Federal Court Holds Pharmaceutical Failure-To-Warn Claims Not Preempted, As Manufacturer's Literature And Adverse Event Disclosures To FDA Could Be Found Inadequate, Permitting Manufacturer Unilaterally To Add Pregnancy Warning And Rendering FDA Rejection Of Warning Not Conclusive Proof Agency Would Have Rejected Warning With Full Disclosure

NEW YORK/NEW JERSEY SUPPLEMENT

  • Second Circuit Holds Pharmaceutical Failure-to-Warn Claims Preempted Where Plaintiffs Did Not Sufficiently Allege Newly Acquired Information Permitting Manufacturers To Change Warnings Without FDA Approval, And Joinder Of In-State Defendant Did Not Prevent Removal To Federal Court Where Defendant Had Not Been Served As Of Time Of Removal

Excerpt:

First Circuit Holds Subsequent FDA Approval Of Drugs For Pediatric Use Not Conclusive Proof Of Effectiveness At Time Of Sale So As To Preclude Fraudulent Marketing Claims, And Individualized Proof Of Causation Of Prescriptions And Drugs' Ineffectiveness Not Required Where Claims Supported By Medical Literature And Expert Testimony

In Painters & Allied Trades Dist. Council 82 Health Care Fund v. Forest Pharms., Inc., 915 F.3d 1 (1st Cir. 2019), numerous individual purchasers and third-party payors sued multiple antidepressant manufacturers in the United States District Court for the District of Massachusetts in a putative class action, alleging they misrepresented the drugs' efficacy in marketing them for the non-FDA-approved or "off label" use of treating depression in multiple pediatric age groups, causing physicians to prescribe and plaintiffs to pay for ineffective drugs. Plaintiffs sought refund of the drugs' full price through claims under the federal Racketeer Influenced and Corrupt Organizations Act ("RICO"), 18 U.S.C. § 1962, for harm caused by "a pattern of racketeering activity" that included violation of the federal mail and wire fraud statutes, 18 U.S.C. §§ 1341 and 1343, the Minnesota Unfair Trade Practices Act, which prohibits deceptive commercial acts, and the similar Minnesota Consumer Fraud Act, which forbids misrepresentation to consumers. The district court granted summary judgment, holding the RICO claims lacked evidence of injury and the state law claims were derivative of the RICO claims.

Download the April 2019 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.

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