Product Liability Update - January 2014

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In this Issue:

..Massachusetts Federal Court Rejects Exception to “Learned Intermediary” Rule for Prescription Drug Advertised Directly to Consumers, and Excludes Expert Opinion of Inadequate Warnings as Unqualified and Unreliable Where Expert Was Not a Physician or Behavioral Specialist and Cited No Studies or FDA Regulations in Support of Opinion

..Massachusetts Federal Court Denies Summary Judgment for Obesity Drug Manufacturer, Finding Factual Dispute Regarding Whether Different Warnings to Plaintiff’s Physician Would Have Changed His Prescribing Decision

..Massachusetts Appeals Court Reverses Dismissal of Plaintiff’s Claims Against Pelvic Mesh Manufacturers, Holding Allegations that Defendants’ Devices Included Mesh with Propensity to Erode and FDA Had Reported Over 1,000 Injuries Associated with Similar Devices Plausibly Suggested Entitlement to Relief

..First Circuit Holds Allegations in Complaint Supporting Inference of Omitted Essential Element Sufficient to Avoid Dismissal, Especially Where Relevant Facts are in Defendant’s Control and “Modest” Discovery May Reveal Same

..Massachusetts Federal Court Holds Lack of Expert Testimony Regarding Existence of Defect Warrants Summary Judgment Against Plaintiff’s Claim Based on Allegedly Faulty Operation of Airbag System

..Massachusetts Federal Court Holds Plaintiff’s Expert Testimony Regarding Cause of Water Filtration System Failure Admissible and Sufficient to Avoid Summary Judgment Where Expert Performed Two Rounds of Testing, Considered and Purported to Exclude Defendant’s Causation Theory and Identified Feasible Alternative Design

..Massachusetts Appeals Court Holds Statute of Limitations Bars Negligent Design Claim Against Pipe Liner Engineer Because Plaintiff Was on Notice of Possible Design Defect More than Three Years Before Suit, Even Though Expert Did Not Deliver Supporting Report Until Later

- Excerpt from Massachusetts Federal Court Rejects Exception to “Learned Intermediary” Rule for Prescription Drug Advertised Directly to Consumers, and Excludes Expert Opinion of Inadequate Warnings as Unqualified and Unreliable Where Expert Was Not a Physician or Behavioral Specialist and Cited No Studies or FDA Regulations in Support of Opinion:

In Calisi v. Abbott Laboratories, 2013 U.S. Dist. LEXIS 139257 (D. Mass. Sept. 27, 2013), plaintiff developed lymphoma after approximately four years of taking an arthritis drug manufactured by defendant. Plaintiff sued the manufacturer in the United States District Court for the District of Massachusetts for breach of the implied warranty of merchantability (the Massachusetts near-equivalent of strict liability) and negligence, asserting defendant failed adequately to warn about the alleged risk of lymphoma from the drug.

Please see full issue below for more information.

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Topics:  Advertising, FDA, Inadequate Warning, Learned Intermediary, Medical Devices, Prescription Drugs, Transvaginal Mesh

Published In: Civil Procedure Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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