Appeals court upholds dismissal of whistleblower suit against Stryker

From Westlaw Journal Medical Devices: A Missouri federal judge properly rejected a whistleblower suit against Stryker Corp. and other pain pump makers because its allegations were based on information that had already been made public, a federal appeals court has ruled.

The 8th U.S. Circuit Court of Appeals rejected orthopedic surgeon and former Stryker consultant Dr. Lonnie Paulos’ allegation that his False Claims Act suit against Stryker and two other pain pump manufacturers should proceed because his allegations against them are based on firsthand, previously unknown information.

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Woman claims Sanofi fertility drug caused son’s birth defects

From Westlaw Journal Pharmaceutical: A Utah woman and her adult son have filed a failure-to-warn and fraud lawsuit alleging he was born with birth defects because drugmaker Sanofi and its predecessors hid the dangers of Clomid, a fertility drug the woman took prior to pregnancy.

In a complaint filed in the U.S. District Court for the District of Utah, Victoria Cerveny and her son Alexander allege that low levels of Clomid (clomiphene citrate tablets USP) she took in 1992 stayed in her system during her pregnancy, causing him to be born with malformations in his left hand and elbow.

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Texas federal judge halts DePuy’s move to derail Pinnacle implant MDL

From Westlaw Journal Medical Devices: The federal judge overseeing consolidated litigation over the DePuy Pinnacle hip device has denied a wave of defense motions designed to have the cases thrown out of court, clearing the way for a Sept. 1 start to the first of the trials.

In three opinions U.S. District Judge Ed Kinkeade of the Northern District of Texas denied DePuy’s summary judgment motions on five issues in the suits filed by Toni Lay and Kathleen Herlihy-Paoli, rejected DePuy’s effort to exclude testimony by six plaintiffs’ witnesses, and killed its motion to quash the plaintiffs’ depositions for two orthopedic research physicians.

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Judge voids veteran’s negligence suit over failed spinal cord stimulator

From Westlaw Journal Medical Devices: A Utah federal judge has dismissed a veteran’s suit claiming medical device maker St. Jude Medical Inc.’s negligence led to the failure of two spinal cord stimulator procedures within a 12-month period.

U.S. District Judge Ted Stewart of the District of Utah said plaintiff Richard McCartney offered insufficient evidence that St. Jude representatives present at the two procedures advised the surgeon on the stimulator’s placement or that the surgeon actually followed that advice.

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Supplement maker agrees to recall, destroy product

From Westlaw Journal Pharmaceutical: Nutritional supplement maker Triceutical Inc. must recall and destroy all dietary supplements it has produced since February 2012 under a consent decree entered by a New York federal judge.

The agreement is the latest development in an investigation that dates to May 2012, when the Food and Drug Administration found various regulatory violations at the company’s Farmingdale, N.Y., production facility.

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Defect and warning claims to proceed in bone-cement suit

From Westlaw Journal Medical Devices: DePuy Orthopaedics Inc. must face state-law claims for defect and inadequate warning by a woman who had corrective surgery after the bone cement used during her knee replacement failed, a Cincinnati federal judge has ruled.

U.S. District Judge Michael R. Barrett of the Southern District of Ohio rejected all of DePuy’s arguments in support of its motion to dismiss Myrtle Thompson’s suit, including its claim that she had not pleaded enough details to make her allegations plausible.

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8th Circuit restores suit over tainted baby formula

From Westlaw Journal Products Liability: The 8th U.S. Circuit Court of Appeals has revived a product liability suit alleging bacteria-tainted Enfamil baby formula severely damaged an infant’s brain.

The appeals court panel ruled that the trial judge abused her discretion by excluding expert testimony from three physicians because they could not rule out other possible sources for the boy’s infection.

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Covidien seeks to halt sale of ‘infringing’ Ethicon surgical tool

From Westlaw Journal Medical Devices: Covidien has filed suit in a Connecticut federal court to halt the sale of a new ultrasonic surgical tool by Ethicon Endo-Surgery Inc., which Covidien says infringes the patents on its similar implements.

In a complaint filed in the U.S. District Court for the District of Connecticut, Covidien Sales LLC and corporate relative Covidien LP say Ethicon debuted its Harmonic ACE+7 Shears with Advanced Hemostasis at a May medical conference.

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Testosterone replacement therapy suits consolidated in Chicago

From Westlaw Journal Pharmaceutical:  A federal judge in Chicago will oversee consolidated pretrial proceedings for suits claiming testosterone replacement therapy products increase users’ risk of strokes and heart attacks.

In an order issued June 6, the Judicial Panel on Multidistrict Litigation assigned 45 testosterone replacement therapy cases to U.S. District Judge Matthew F. Kennelly of the Northern District of Illinois.  Of the cases filed to date, 37 are already in that court, it noted.

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Suit over leaky breast implants is preempted, judge finds

From Westlaw Journal Medical Devices:  Mentor Worldwide LLC has won dismissal of a lawsuit accusing it of negligently providing a California woman with saline breast implants that leaked, causing a mycobacterial infection.

U.S. District Judge Jeffrey S. White of the Northern District of California dismissed Edna Malonzo’s product liability suit May 28, agreeing with Mentor that the Medical Device Amendments to the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, preempt all her claims.

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