Stryker, Medtronic lose preemption bids in OP-1, Calstrux and Infuse lawsuit

Stryker, Medtronic lose preemption bids to toss bone protein case

A California state court ruled out a series of motions seeking to dismiss a lawsuit filed over bone proteins made by Stryker and Medtronic, ruling that federal law does not preempt the case from going forward.

April Cabana sued the medical device companies for alleged off-label promotion of the bone growth products, as well as a hospital and surgeon Dr. Ali Mesiwala for failing to inform her that they were using the experimental products. Cabana allegedly received Stryker’s OP-1 Putty in combination with its Calstrux bone-filler during surgery to relieve her back pain. Stryker’s OP-1 Putty had clearance under a humanitarian-use exemption, which requires hospital board authorization prior to use. The combination of the putty and Calstrux bone-filler had never been examined or approved by the FDA, according to the complaint.

In a 2nd, corrective procedure, surgeons removed the excess bone and fused the remainder using Medtronic’s Infuse bone graft, again in an off-label manner, according to legal documents. Infuse had FDA clearance for use during an anterior procedure, but Cabana claims her surgeon opted for a posterior procedure.

Cabana claims the mixture of the 2 products caused excessive bone growth in her lower back, resulting in nerve compression and debilitating pain that required additional surgery.

After a Sept. 9 hearing, Judge Terry Green of the California Superior Court for Los Angeles County shot down the companies’ motions to dismiss on preemption grounds, ruling that Cabana presented adequate evidence that Stryker promoted the off-label combination of the OP-1 and Calstrux putties strong enough to allow a trial on her claims of liability failure to warn, negligence, negligence per se, breach of warranty and fraud, according to court documents. Citing evidence produced that Medtronic allegedly knew of but did not disclose problems with the Infuse product, Green also allowed Cabana’s claims of negligence, negligence per se, breach of warranty and fraud against that company to go to trial, slated for Feb. 10, 2014, according to the documents.

Last year Stryker copped to a misdemeanor and paid $15 million to settle charges that the company ran an off-label promotion scheme, including falsifying hospital records to authorize use of the OP-1 products, which were cleared only for humanitarian use. Stryker later sold its OP-1 assets to Olympus (TYO:7733).

Medtronic was cleared of wrong-doing just months later, when the U.S. Justice Dept. closed the books on its investigation into Infuse.

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