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From Health Law Daily, August 6, 2014

Spinal fusion device is pain in the neck for manufacturer

By Lisa A. Weder

Medtronic, Inc., a medical device manufacturer and retailer, filed motions to strike and dismiss patient Laura Blankenship’s assertions that its spinal fusion medical device caused her permanent disabilities due to the device’s alleged design defects, the company’s failure to warn, knowledge of the product’s adverse effects, and the company’s intentional misrepresentation. The device had been used in her cervical region, which was not approved by the FDA. The Missouri district court denied Medtronic’s motions to strike and dismiss Blankenship’s claims, but dismissed her untimely filed claim that the fraudulent activity violated the Missouri Merchandising Practices Act (Blankenship v MedtronicInc., August 4, 2014, Jackson, C).

Background. Medtronic made a spinal fusion medical device designed to help patients with degenerative disc disease, which was approved by the FDA in 2002. In September 2007, InFUSE™ BoneGraft/LT-CAGE™ Lumbar Tapered Fusion device (Infuse) was used in Blankenship’s cervical diskectomy and fusion procedure on three discs. The procedure was performed “off-label” because using the device for cervical placement had not been approved by the FDA. The procedure allegedly resulted in Blankenship’s permanent disability.

Blankenship contended that Medtronic knew of the device’s adverse side effects, edited medical literature to downplay its effects, and that the company used royalty agreements with doctors to use the device. In March 2013, she filed a second amended complaint alleging the device’s design defects, the company’s failure to warn and intentional misrepresentation, and violation of California’s unfair competition law, and while the court denied Medtronic’s motion to dismiss, the court granted Blankenship leave to amend her fraud and intent to misrepresent claims in March 2014 because she had not plead the claims following the particularity requirements of the Federal Rule of Civil Procedure 9(b) (Rule 9(b)).

Blankenship filed her third complaint in April 2014, which included an alleged violation of the Missouri Merchandising Practices Act, against which Medtronic moved to dismiss, based on the same Rule 9(b) requirements. In May 2014, Blankenship filed her response and included 4 exhibits. Included in these exhibits were a staff report based on Medtronic’s influence on InFUSE’s clinical studies and various letters to senators, which Blankenship felt satisfied the Rule 9(b) particularity requirements because they were adequately referenced in her complaint. The letters sparked a 16-month long investigation into Medtronic’s practices.

Arguments for the court. Medtronic moved to strike against her third and fourth exhibits in June, stating that they are not subject to judicial notice. The court accepted Blankenship’s claims as relevant in showing that Medtronic was perpetuating fraudulent activity. The court denied Medtronic’s move to strike the exhibits. The court also dismissed Medtronic’s motion to dismiss Blankenship’s third complaint regarding fraud and intentional misrepresentation based on her overabundant fulfillment of the particularity requirements of Rule 9(b). Medtronic stated that Blankenship left out an attending doctor’s false statement in her complaint, and while she did not produce the exact statement, she proved that the doctor was a paid consultant of Medtronic. The court ruled that Blankenship had answered the “who, what, when, where, why, and how” of the company’s fraudulent behavior. The court dismissed Blankenship’s Count II claim that was based on the Missouri Merchandising Practices Act because she had missed the amended pleading deadline to include it.

The case number is 413-CV-1087(CEJ).

Attorneys: Christopher J. Quinn (Driscoll Firm, PC) for Laura Blankenship. Martin J. Buckley (Buckley and Buckley, LLC) and Michael K. Brown (Reed Smith LLP) for Medtronic Inc., Medtronic Sofamor Danek USA, Inc., Medtronic Vertelink Inc., Medtronic Sofamor Danek, Inc., and Warsaw Orthopedic Inc.

Companies: Medtronic Inc.; Medtronic Sofamor Danek USA, Inc.; Medtronic Vertelink Inc.; Medtronic Sofamor Danek, Inc.; Warsaw Orthopedic Inc.

MainStory: TopStory MDeviceNews FraudNews MisbrandingNews PLDeviceNews MissouriNews

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