Suit seeks $80 million over boy’s injury from Ninja Turtle watch

From Westlaw Journal Products Liability: A New York woman is seeking $80 million in a lawsuit alleging a Teenage Mutant Ninja Turtles wristwatch leaked a corrosive material on her 6-year-old son’s arm, causing severe burns.

In a complaint filed in the U.S. District Court for the Eastern District of New York, Shelley Standish-Pociejowski asserts multiple causes of action against watch manufacturer M.Z. Berger & Co. and retailer Toys R Us Inc. for what she says was the failure of her son’s watch within days of its purchase.

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Mirena IUD migrated from uterus, Iowa woman says

From Westlaw Journal Medical Devices: Bayer Healthcare Pharmaceuticals is the target of a federal negligence and fraud suit by an Iowa woman who says she was injured when her Mirena intrauterine device migrated from her uterus to her rectum.

Jennifer Martin says the IUD was discovered in her rectum during an October 2012 exploratory procedure just three months after it was inserted.

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Smith & Nephew to pay Uncle Sam $8.3 million for trade law violation

From Westlaw Journal Medical Devices: Smith & Nephew Inc. will pay the federal government $8.3 million to settle a whistleblower’s claim that the company violated the Trade Agreements Act by selling medical devices to the government that were not manufactured in the United States or a specially designated trade partner nation.

The agreement resolves a qui tam suit filed in 2008 by former Smith & Nephew employee Samuel A. Cox III, who said the company  had violated both the Trade Agreements Act, 19 U.S.C. § 2501, and the False Claims Act, 31 U.S.C. § 3729, through the improper sales.

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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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