Vascular Solutions’ sale of vein treatment device lacked FDA approval, feds say

From Westlaw Journal Medical Devices: Vascular Solutions Inc. and its chief executive officer are charged in a federal criminal indictment with selling a varicose vein treatment system for uses not approved by the Food and Drug Administration.

An indictment filed in the U.S. District Court for the Western District of Texas charges both Minnesota-based VSI and CEO Howard C. Root with one count of conspiracy and eight courts of introducing adulterated and misbranded medical devices into interstate commerce, the U.S. Justice Department announced Nov. 13.

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4th Circuit backs dismissal of suit claiming injury from high-strength tape

From Westlaw Journal Products Liability: A federal appeals court has affirmed the dismissal of a failure-to-warn suit against the maker of Gorilla Tape, finding that the company had no duty to warn the plaintiff against the unforeseen use of the high-strength adhesive on his skin.

The 4th U.S. Circuit Court of Appeals called appellant Frankie Rocchetti’s informal, pro se appellate brief “conclusory.”

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9th Circuit says Target need not supply in-store defibrillators

From Westlaw Journal Medical Devices: A federal appeals court has ruled that Target Corp. has no duty to equip its stores with automatic external defibrillators, upholding a ruling against the family of a shopper who went into cardiac arrest at a Target store in 2008.

The 9th U.S. Circuit Court of Appeals decision comes four months after a California Supreme Court opinion announcing that state law “does not include an obligation to acquire and make available an AED for the use of its patrons in a medical emergency.” Verdugo et al. v. Target Corp., No. S207313, 59 Cal. 4th 312 (Cal. June 23, 2014) see Westlaw Journal Medical Devices, Vol. 21, Iss. 9).

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Montana Supreme Court orders new trial in suit over fingernail product

From Westlaw Journal Products Liability: The Montana Supreme Court has ordered a new trial in a suit by a woman who says she suffered boils, rashes and respiratory problems from exposure to an acrylic fingernail polish product.

The high court ruled unanimously that a judge in the state erred by admitting expert defense testimony during trial on Ronda Kenser’s claims against Premium Nail Concepts Inc. and then denying her request for cross-examination.

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Mexico sues over excessive device costs stemming from Orthofix bribery scheme

From Westlaw Journal Medical Devices: A Mexican government agency is suing Orthofix International for fraud and racketeering, alleging the company made “obscene profits” by bribing Mexican health officials to boost its medical device sales there.

Instituto Mexicano del Seguro Social, the agency that administers the country’s Social Security program and provides medical care to most Mexican citizens, says that between 2003 and 2007, Orthofix maintained a scheme to pay cash bribes to the purchasing officials at two major hospitals.

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Negligence, warning claims stand in Colorado man’s suit over allergy to Stryker knee implant

From Westlaw Journal Medical Devices: A federal judge in Denver has ruled that a Stryker knee implant recipient can proceed with his claim that the company should require implantation candidates to be tested for metal allergies before such procedures occur.

The ruling by U.S. District Judge R. Brooke Jackson of the District of Colorado was entered in response to Stryker’s motion to dismiss Edward Haffner’s multi-count suit alleging he had to have his Stryker Triathlon total knee system removed after 10 months due to his severe cobalt and nickel allergies.

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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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