Injury suit over off-label use of Infuse system federally preempted

From Westlaw Journal Medical Devices: A Michigan man’s claim that he was injured from Medtronic Inc.’s off-label marketing of the Infuse bone growth system is federally preempted, a federal judge in the state has ruled.

U.S. District Judge Janet T. Neff of the Western District of Michigan granted Medtronic’s motion to dismiss Clinton Thorn’s failure-to-warn and negligence claims, rejecting his assertion that any promotion of off-label medical device usage violates federal law.

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Florida couple says bed design caused daughter’s death

From Westlaw Journal Products Liability: A Florida furniture chain is facing a wrongful-death lawsuit by parents who say their daughter died after becoming entrapped between the mattress and footboard of their king-sized bed.

In a complaint filed in the Duvall County Circuit Court, Karen and Garvin Thomas accuse furniture chain owner W.S. Badcock Corp. of negligent design, manufacture and sale of its Empire Collection king-sized bed set.

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Discovery limits set in Minnesota surgical stapler injury suit

From Westlaw Journal Medical Devices: Ethicon Endo-Surgery Inc. must produce adverse incident reports and other documents related to its TX model surgical stapler in a suit that alleges a woman was injured when one of the tools malfunctioned during a throat operation.

U.S. District Judge John R. Tunheim of the District of Minnesota ordered Ethicon to produce data related to problems with the entire line of TX surgical staplers, which dates back to 1996, for plaintiff Susan Webb.

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Fiskars unit to pay $2.6 million penalty for failing to promptly report axe defect

From Westlaw Journal Products Liability: Gerber Legendary Blades, a division of Fiskars Brands Inc., has agreed to pay a $2.6 million federal civil penalty to settle claims that it failed to promptly tell the government about injury reports from numerous users of its Gator Combo axe.

In a complaint filed in the U.S. District Court for the District of Oregon, the U.S. Department of Justice said Gerber began receiving reports of severe injuries related to the axe in 2005 but did not notify the Consumer Product Safety Commission for nearly five years.

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OtisMed Corp. to pay $80 million to settle claims over improper sales of surgical product

From Westlaw Journal Medical Devices:  OtisMed Corp. and its former CEO have pleaded guilty in federal court to selling unapproved surgical cutting guides, with the company agreeing to pay more than $80 million to resolve all related criminal and civil charges.

OtisMed, acquired by Stryker Corp. in November 2009, sold more than 18,000 OtisKnee orthopedic cutting guides between May 2006 and September 2009, according to the settlement agreement approved Dec. 8, by a federal judge in the U.S. District Court for the District of New Jersey.  Investigators said the sales netted OtisMed about $27.1 million in revenue.

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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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