Stryker Corp. receives subpoena in New Jersey probe of medical device makers

Stryker Corp. has received a subpoena from the Attorney General of New Jersey related to an investigation of financial relationships between companies that make medical products and surgeons that use them.

Stryker, the Kalamazoo-based medical device maker, disclosed the May 7 subpoena for “various documents related to the financial interests and arrangements of physicians participating in certain clinical trials for or on behalf of the company” in a filing Monday with the U.S. Securities and Exchange Commission.

New Jersey AG Anne Milgram last week announced a settlement with Stryker competitor Synthes, a maker of artificial spinal disks, that requires Synthes to disclose all payments to doctors involved in researching its products and stop paying doctors in stock or stock options.

Milgram’s office also said it had issued subpoenas to five other device makers, but declined to name the companies.

Stryker’s Orthopaedics division is based in Mahwah, N.J.

Also in Monday’s filing, Stryker said it had received a warning letter from the U.S. Food and Drug Administration on May 5 related to facial-implant products it previously sold through its Portage distribution facility.

The company received three warning letters in 2007 and 2008 regarding quality or regulatory-compliance issues at other facilities. Stryker has said it will spend at least $50 million this year and next to improve the quality and consistency of its plants.

Warning letters are informal advisories, according to the FDA, issued for “significant regulatory violations that require prompt and adequate corrective actions.”

Source:  Kalamazoo Gazette

Share your thoughts

Your email address will not be published. Required fields are marked *