We are no longer accepting OP-1 Putty medical device cases.

Stryker OP-1 PuttyStryker Biotech’s attempts to have an OP-1 Putty/Calstrux Medical Device case against it dismissed have failed in Louisiana. The Honorable Brian Jackson, Chief Judge of the Middle District of Louisiana, ruled on December 22, 2014 that Williams F. Boutte, Jr.’s case against Stryker Biotech, LLC (Boutte v. Stryker Biotech, LLC et al., Case No.14-00456-BAJ-SCR [M.D.La., Dec. 22, 2014]) can go forward.

This case is a medical device products liability action being handled by Baum, Hedlund, Aristei & Goldman, involving injuries sustained by the plaintiff following the off-label/unapproved implantation during spinal surgery of two medical devices (OP-1 and Calstrux) manufactured by defendant Stryker Biotech, LLC.

OP-1 is a Bone Morphogenetic Protein (BMP) that stimulates bone growth. In his complaint/petition, Plaintiff, Mr. Boutte, alleges that Stryker induced surgeons, including his surgeon, to combine OP-1 with another device, Calstrux (both devices are powdered material). The combined use of OP-1 with Calstrux had never been approved by the FDA, thus the combined use of these two devices was an off-label/unapproved use. The off-label promotion of medical devices by a device manufacturer is generally prohibited by law and Stryker Biotech was criminally indicted for its off-label promotion of OP-1/Calstrux. In January 2012, Stryker pled guilty and paid a $15 million criminal fine.

Mr. Boutte specifically alleges that Stryker engaged in the off-label promotion of OP-1 with Calstrux notwithstanding its knowledge of risks associated with this combinatory use, and that Stryker failed to issue appropriate warnings that, when these two devices are combined with one another, they could migrate away from the surgical site causing bone formation in unintended areas of the body – which, as alleged in the complaint, is exactly what occurred following plaintiff’s surgery.

Mr. Boutte filed a complaint against Stryker Biotech, LLC under the Louisiana Products Liability Act (LPLA) for inter alia (among other things), design defect, breach of warranty, failure to warn and redhibition (Wiki: a civil action available under Louisiana law against the seller and/or manufacturer of a defective product, similar to the lemon laws more familiar to common law jurisdictions in other U.S. states.) Mr. Boutte also filed a negligence claim against Stryker Corporation, the parent company of Stryker Biotech, LLC. Stryker moved to dismiss all claims and the Court addressed each cause of action in substantial detail.

The Court rejected Stryker’s arguments and held that Mr. Boutte has alleged valid causes of action under the LPLA against Stryker Biotech for design defect, failure to warn, breach of warranty and redhibition. The Court also held that Mr. Boutte has alleged a valid negligence cause of action against Stryker Corporation (the corporate parent for Stryker Biotech).

This is one of the few cases specifically addressing the interplay between the Louisiana Products Liability Act and a medical device products liability action arising out of off-label promotion of a medical device. The ruling is significant as there are currently hundreds of medical device and pharmaceutical products liability cases filed nationally arising out of the off-label promotion of medical devices and pharmaceuticals.

In discussing the decision, plaintiff’s counsel, Bijan Esfandiari, stated, “We are pleased with Judge Jackson’s well-reasoned ruling denying Stryker’s motion to dismiss. The court’s ruling confirms that plaintiff, Mr. Boutte, has asserted valid claims against Stryker under Louisiana law arising out of the serious injuries he sustained as a result of the alleged defectively designed and labeled OP-1/Calstrux devices. The ruling is a victory for all consumers in that it confirms that medical device manufacturers must ensure that their conduct and devices are in compliance and in conformity with the law.”

Baum, Hedlund, Aristei & Goldman has successfully represented thousands of people in pharmaceutical product liability cases. The firm is listed in the 2014 Top Ranked Law Firms™, U.S. News & World Report Best Lawyers® 2014 Best Law Firms, The Best Lawyers in America®, and Martindale Hubbell’s Bar Register of Preeminent Lawyers.

Read more about off-label use of Stryker OP-1 Putty and Calstrux