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Drugs & Medical Devices

Get ready for the next wave of pharmaceutical litigation with HarrisMartin's Drugs & Medical Devices. This reporter will keep you one step ahead of drug and medical device litigation with in-depth investigations, guest commentaries and objective courtroom coverage on today's and tomorrow's hottest drugs and supplements.


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Ga. Woman Says Mentor Breast Implants Caused Her Bio-Toxin Disease in New Lawsuit

A Georgia woman alleges in a new federal lawsuit that defective, leaking Mentor saline breast implants caused her to develop bio-toxin disease and mold infection.


Concentric Awarded Summary Judgment in N.Y. Merci Retriever Action

A New York judge has awarded summary judgment to the manufacturer of a device used to remove foreign objects from the brain, ruling that the defendant’s expert affidavits established that the Instructions For Use conveyed to doctors the most current knowledge available concerning the potential risk of device fracture.


Failure-To-Warn Claim Against Abilify Makers Time-Barred, 5th Cir. Affirms

A failure-to-warn claim asserted against the makers of Abilify is time-barred because the plaintiff knew as early as April 2013 that the drug may be linked to his tardive dyskinesia, yet failed to file suit until more than a year later.


Ind. Federal Judge Dismisses Negligence Per Se Claim in Cook Medical IVC Filter MDL

The federal judge overseeing the Cook Medical Inc. inferior vena cava filter multidistrict litigation docket has dismissed plaintiffs’ negligence per se claims, finding they impermissibly seek to create a private right of action for violations of the Food, Drug and Cosmetic Act.


Ind. Federal Judge Remands Biomet M2a Hip Case, Says Distributors May be Liable for Failure to Warn

An Indiana federal judge has remanded a Biomet M2a-Magnum hip implant case to Louisiana state court, ruling that the plaintiffs may have viable failure-to-warn claims against the non-diverse distributor defendants.


Lialda Kidney Damage Lawsuit to Proceed Against Shire in Alabama Federal Court

State law claims accusing the maker of Lialda of failing to recommend monthly testing of kidney function are not preempted because there is evidence that the label could have been changed without FDA approval, an Alabama federal judge has ruled.


FDA Says Invokana Poses Increased Risk of Leg, Foot Amputations

Based on new data from two large clinical trials, the Food and Drug Administration has concluded that type 2 diabetes drug Invokana (canagliflozin) poses an increased risk of leg and foot amputations.


Negligence Claims Against Generic Cordarone Makers Not Preempted, Texas Federal Judge Rules

Claims based on generic drug manufacturers’ failure to provide a plaintiff or his physician with FDA-approved warnings concerning the risks of amiodarone allege a violation of both state and federal law and are therefore not preempted by federal law, a Texas federal judge has ruled.


Risperdal Makers Not Liable for Injuries Allegedly Caused by Generic Counterpart, N.Y. Federal Judge Rules

A New York federal judge has awarded summary judgment to the makers of Risperdal in a gynecomastia case, predicting that the state’s highest court would rule that where a manufacturer had no oversight over the manufacturing of a generic drug, it cannot be held liable for injuries allegedly caused by that drug.


N.C. Federal Judge Dismisses Essure Birth Control Action on Preemption Grounds

A North Carolina federal judge has dismissed a lawsuit involving Bayer’s Essure permanent birth control device, finding the plaintiffs’ claims of failure-to-warn, manufacturing defect, breach of warranty, and fraud are expressly or impliedly preempted by federal law.


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