Regulatory

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…
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January 31, 2014
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Design Defect FDA Litigation Medical Device News Nutritional Supplements Pharmaceuticals Product Liability Regulatory
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Litigation

Byetta Thyroid Cancer Lawsuit Centralization Request Filed with JPML
MDL Arguments Over Centralization of Lipitor Diabetes Cases Postponed
Top DOJ Atty Outline Pharma Fraud Enforcement (subscription required)
Possible Sanctions for Takeda in Actos Bladder Cancer MDL (subscription required)
Hydroxycut False Ad Claims Must Be Clarified, Judge Says (subscription required)
GNC Hit with Suit Claiming Diet Pills Led to Liver Damage (subscription required)
J&J Beats $258M Risperdal Verdict in Split La. High Court (subscription required)
Calif. Court Reverses Preemption of Medtronic

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January 23, 2014
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Class Action Design Defect FDA Litigation Medical Device News Nutritional Supplements Pharmaceuticals Preemption Product Liability Recalls Regulatory Supplements
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Litigation

Pharma Can Be Liable for Design Negligence: Pa. High Court (subscription required)
Pfizer Escapes Whistleblower Suit Over Lipitor Marketing (subscription required)
23andMe Faces Suit Over Recently Banned DNA Tests (subscription required)
Claims and Classes in Medical Monitoring Cases (subscription required)
Boston Scientific Mesh Lawsuit to Move Forward After SOL Challenge
Motion Filed to Centralize OxyElite Pro Lawsuits in MDL
6^th Circuit Revives Mylan Wrongful Death Suit (subscription required)
Jury Clears Abbott In Tainted Formula Injury Suit (subscription required)
Ethicon

Claims Regarding Post-FDA Approval Problems Not Preempted

January 23, 2014
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Design Defect FDA Litigation Medical Device News Preemption Product Liability Recalls Regulatory
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While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims. In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body. The product was removed from the market in 2010, a warning letter was…
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Life Science Matters An inside look at the latest legal developments involving medical devices, pharmaceuticals, and more

Regulatory

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Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

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Claims Regarding Post-FDA Approval Problems Not Preempted

Multicounty Litigation Order in New Jersey Provides No Guidance to Practitioners June 23, 2021

New Multicounty Litigation Application in New Jersey June 8, 2021

Lack of Agreement to Arbitrate Dooms Bid to Compel Arbitration May 26, 2021

Mixed Bag in New Jersey Medical Device Preemption Opinion May 12, 2021

First Circuit Agrees Pharmacists Provide Services, Not Sell Goods April 27, 2021