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Bone Medical Device Lawsuit Against Stryker Moves Forward

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On Monday, a Louisiana federal judge cleared the way for most of a suit alleging that Stryker Corp. promoted the off-label combining of its bone void filler Calstrux and OP-1 protein, despite knowing the high risk of side effects, to proceed in court.

The federal judge found that the Plaintiff’s claims under the Louisiana Products Liability Act (LPLA) were plausible. The judge found that the allegations against Stryker promoted the off-label combining of two prescription medical devices that were not approved by the U.S. Food and Drug Administration (FDA) were sufficient to survive the motion, according to Law360.

The Plaintiff’s fraud claim, however, was dismissed by the judge, who said the Plaintiff had acknowledged that it fell outside the scope of the LPLA, Law360 reported.

The Plaintiff alleged in the complaint that he suffered “debilitating injuries” after his surgeon used the Calstrux and OP-1 combination during his November 2006 spinal surgery because the products caused bone to grow in unintended areas of his body. The judge in the case found that the Plaintiff had proven that the combination of the bone void filler and protein was “unreasonably dangerous in design” because there was a viable alternate design, free of the same defects caused by the combination of devices. The judge also said Stryker could have chosen not to promote the unapproved off-label combination, according to Law360.

Stryker’s motion to dismiss a claim that the combination product was unreasonably dangerous due to inadequate warning was denied by the judge, who said the Plaintiff had demonstrated that the product caused damage and that Stryker knew the risks but illegally promoted the combination anyway, Law360 reported.

The Plaintiff’s claim was also supported by his allegation that Stryker recalled Calstrux only after the FDA performed an inspection and formally reprimanded the medical device maker over its illegal off-label promotion and its failure to report serious adverse effects associated with the Calstrux/OP-1 combination, according to Law360.

The judge also preserved the Plaintiff’s breach of express warranty claim, noting allegations that Stryker withheld information about the dangerous device combination from the medical community and actually promoted Calstrux as the “preferred” and “perfect carrier for OP-1,” which caused the Plaintiff’s botched surgery, Law360 reported.

The Plaintiff’s redhibition claim for future proceedings was also preserved and Stryker’s bid to dismiss his negligence claim was denied after the judge found that the Plaintiff’s petition clearly alleges that Stryker Corp., the parent company of Stryker Biotech, “informed, instructed, and recommended” certain actions to Stryker Biotech concerning how to move forward with the marketing of Calstrux/OP-1 and the issuance of warnings concerning the combination, according to Law360.

The Plaintiff brought the suit against Stryker Biotech LLC, Howmedica Osteonics Corp., and Stryker Corp. in Louisiana state court in June. It alleges that several Stryker employees and surgical consultants were aware of the adverse side effects associated with the combination and drafted a “proposed ‘Dear Doctor” letter warning surgeons not to mix Calstrux and OP-1. The Plaintiff alleged that the letter was never sent due to fears that it would hurt sales of OP-1, Law360 reported.

breakinglawsuitnews.com disclaimer: This article: Bone Medical Device Lawsuit Against Stryker Moves Forward was posted on Monday, December 29th, 2014 at 4:36 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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