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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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Issue #141, August 2019

FDA Says Twice-Daily Use of Xeljanz Can Cause Blood Clots, Death

The Food and Drug Administration has approved new warnings concerning an increased risk of blood clots and death associated with twice-daily 10 mg doses of Pfizer’s rheumatoid arthritis drugs Xeljanz and Xeljanz XR (tofacitnib) in patients with ulcerative colitis.


Allergan Initiates Worldwide Recall of Textured Breast Implants Amid Reports of Cancer Risk

Allergan, in response to a request by the Food and Drug Administration, has initiated a worldwide recall of its textured breast implants and tissue expanders due to reports of cancer and cancer-related deaths associated with the devices.


Warning Claim in Medtronic Pain Pump Case Preempted, Ala. Federal Judge Rules

Failure-to-warn claims asserted against Medtronic in a pain pump action are preempted because they improperly seek to hold the manufacturer liable for failing to make disclosures to the Food and Drug Administration, an Alabama federal judge has ruled.


Claim Preclusion Bars Generic Accutane Action, Kan. Federal Judge Rules

Claim preclusion bars a second lawsuit filed by a woman alleging injuries from generic Accutane because it arises from the same transaction at issue in the first action, and the defendants are in privity with one another, a Kansas federal judge has ruled.


Calif. Federal Court Allows Warning Claims to Proceed in Pelvic Mesh Case

Claims of failure to warn asserted against Boston Scientific Corp. in a lawsuit targeting its Obtryx Sling pelvic mesh device may proceed because the plaintiffs adequately alleged that the company failed to provide their doctor with adequate warnings, a California federal court has ruled.


Wright Medical Group Dismissed from Calif. Profemur Hip Case

A California federal judge has dismissed Wright Medical Group Inc. from a Profemur hip replacement case for lack of specific jurisdiction, ruling that the company does not has sufficient contacts with California on its own or that it purposefully availed itself to the state.


GSK Renews Summary Judgment Motion on Preemption Grounds in Zofran MDL

GlaxoSmithKline has renewed its motion for summary judgment on preemption grounds in the Zofran multidistrict litigation, arguing there is clear evidence that the Food and Drug Administration would have rejected enhanced warnings regarding the risk of birth defects.


Woman Says Pfizer’s Rheumatoid Arthritis Drug Caused Sepsis, Amputation of Limbs

A new lawsuit accuses Pfizer Inc. of failing to warn patients and doctors that its rheumatoid arthritis drug Xeljanz can cause sepsis in older patients, leading to necrosis and amputation.


6th Cir. Upholds Dismissal of Gardasil Vaccine Case Against Merck

A federal appeals court has upheld dismissal of a case accusing Merck & Co. of intentionally adding HPV DNA to its Gardasil HPV vaccine, ruling that the plaintiff failed to exhaust her administrative remedies as required by the Vaccine Act.


Causation Established in Pelvic Mesh Case, Wis. Federal Judge Says

A woman who suffered complications after being implanted with an Ethicon Prolift transvaginal mesh device has established a link between the company’s allegedly inadequate warnings and her injuries, a Wisconsin federal judge has ruled.


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