Litigation

This Week’s Life Science Headlines

February 28, 2014
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Design Defect FDA Litigation Medical Device News Pharmaceuticals Product Liability Recalls Regulatory
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Life Science Matters

Litigation

J&J, Ethicon Sued Over Surgical Stapler Misfire (subscription required)
GSK Can’t Shake Calif. County’s Avandia False Ad Claims (subscription required)
Pradaxa Lawsuits Raise Questions Over Clinical Trial Data Accuracy
Firms Kick Off Benicar Diarrhea Suits Against Daiichi (subscription required)
Mirena Birth Control Lawsuit Filings Approach 1,000 Cases
Boston Scientific Obtryx Sling Lawsuits Consolidated for Trial
Zoloft False Ad Suit Time-Barred, Judge Finds (subscription required)
J&J Hid Topamax Birth Defect Risks, Philly Jury Hears (subscription required)
Total, Endo Units Hit With

Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

February 27, 2014
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Duty to Warn Labeling Litigation Pharmaceutical/Medical Device/Biotechnology Warnings/Instructions
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admin

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…
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Last Week’s Important Life Science Headlines

February 25, 2014
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Class Action Design Defect FDA Litigation Medical Device News Pharmaceuticals Product Liability Recalls Regulatory
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Life Science Matters

Litigation

Xarelto Lawsuit Filed Over Uncontrollable Internal Bleeding
Neomedic Cases Added to Vaginal Mesh Litigation in W.Va. Federal Court
Endo Puts Aside $520M for Vaginal Mesh Litigation (subscription required)
9^th Circ. Refuses to Revive Novartis Jaw Injury Litigation (subscription required)
FTC Bags $2M False Ad Win Against Diabetes Supplement Co. (subscription required)
J&J Mesh Suits Belong in Federal Court, 10^th Circ. Told (subscription required)
New Philly Mass Tort Program Created for Pelvic Mesh Suits (subscription required)
J&J Wins 1

This Week’s Life Science Headlines

February 14, 2014
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FDA Litigation Medical Device News Pharmaceuticals Preemption Product Liability Recalls Regulatory Settlements
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Life Science Matters

Litigation

Mich. Drug Companies Now Less Immune Under Tort Reform (subscription required)
9^th Circ. To Reconsider Its Remand of Teva Painkiller Suit (subscription required)
Medtronic Tells 10^th Circ. Bone Device Suit is Preempted (subscription required)
Unilever to Pay $10M Over Hair Loss Tied to Suave Product (subscription required)
Expert Testimony Barred in Denture-Adhesive Mass Tort (subscription required)
Roche Looks to Sink $2M Accutane Verdict on Appeal (subscription required)
Pfizer Says 2^nd Circ. Can’t Review Lipitor FCA Suit (subscription

This Week’s Life Science Headlines

February 6, 2014
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FDA IP Litigation Medical Device News Nutritional Supplements Pharmaceuticals Product Liability Recalls Regulatory Settlements
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Life Science Matters

Litigation

Abbott Hit with 5 AndroGel Suits in FDA Probe’s Wake (subscription required)
Pradaxa Litigation Fines Upheld, Non-Monetary Sanctions Overturned
J&J Punished for Losing Evidence in Vaginal Mesh MDL (subscription required)
Negligent Drug Design Claims May Increase in Pa. (subscription required)
9^th Circ. Urged to Reinstate Expert in Novartis Jaw Injury Suit (subscription required)
Deferred Sanctions Leave Hope for Takeda in Actos MDL (subscription required)
1^st Circ. Holds FCA Relator’s Feet to Rule 9(b) Fire (subscription required)
Biomet To

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

February 5, 2014
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Class Action Design Defect Litigation Medical Device News Pharmaceuticals Product Liability Regulatory
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Life Science Matters

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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Court Reverses Preemption of Medical Injury Suit

February 4, 2014
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Litigation Pharmaceutical/Medical Device/Biotechnology Regulatory Compliance
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Michael P. Luongo

A California Appellate Court recently ruled in Coleman v. Medtronic, Inc. that state law tort claims against medical device manufacturers are not preempted by federal law. Medtronic manufactures and sells a medical device called Infuse that is used in spinal surgery. The U.S. Food and Drug Administration granted premarket approval of Infuse for use in certain types of spinal surgery where the incision is made on a patient’s abdomen, but did not approve the device for spinal surgeries where the incision is made on a…
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New Alternative Causation for Pharma Defendants in Surgeon General’s Smoking Report?

H. Lockwood Miller III

Last week, the Office of the Surgeon General of the U.S. Department of Health and Human Services released a new report on the health consequences of smoking on the 50th anniversary of the first Surgeon General’s report on smoking and health. The report is available, click here. The 2014 report – entitled “The Health Consequences of Smoking—50 Years of Progress” – adds colorectal and liver cancer to the list of cancers causally linked to smoking. The report also adds several non-cancers to the list of…
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