Stryker Employees Admit Wrongdoing in Marketing of Human Bone Growth Products

Two former sales associates for medical-device maker Stryker Corp. have pleaded guilty to charges they falsified company documents and promoted unapproved, off-label uses of company products they knew had caused earlier problems in patients.

The guilty pleas came as the U.S. Justice Department investigates allegations that Stryker, a leading maker of hip replacements and other medical devices, had misused an exemption in Food and Drug Administration rules which allow companies to sell limited quantities of products for “humanitarian” reasons.

Two Stryker products, called OP-1 and OP-1 putty, are used by surgeons to promote the growth of bones that fail to heal properly on their own. OP-1 is a naturally occurring protein known for its ability to aid new bone growth, and the putty form of the drug is a moldable compound which includes the bone-growing protein, officials said.

Not FDA Approved, but Waivers Granted

Neither Stryker device has been approved by the FDA for use in patients, but the agency has an exemption in its rules which allow certain unapproved products to be used for humanitarian reasons. Such waivers are granted when the FDA is convinced that a small group of people might benefit from treatment by a drug which has not been fully evaluated or approved by the agency. Devices granted such waivers can be used in up to 4,000 patients each year.

In 2001 and 2004, the FDA granted humanitarian-device exemptions to the Stryker for the products, allowing them to be used in patients who had undergone failed spinal-fusion surgeries.

FDA Exemption Abused?

Stryker is accused of abusing the FDA’s humanitarian waivers for the OP-1 and OP-1 putty products by promoting the products for non-humanitarian uses. An investigation into the alleged abuse began in 2007, officials said, and centered on the company’s biotech division.

One former Stryker sales associate recently pleaded guilty and admitted that paperwork saying clinical trials of the devices had been completed were falsified. The falsified documents reportedly were presented to the Medical College of Wisconsin in Milwaukee. Another former Stryker company sales representative has admitted promoting unapproved uses of the company’s bone-growth products.

Earlier Investigations

The new federal inquiry into abuse of the FDA’s humanitarian exception is just the latest hurdle for Stryker. The company is already under close federal oversight after an earlier investigation found the company paid kickbacks to doctors who used the company’s artificial hips and knees.

Also, Stryker products have been recalled for various reasons. In January 2008, two models of the Trident Acetabular PSL Cup and the Trident Hemispherical Cups were recalled after the FDA uncovered unsanitary conditions at two Stryker manufacturing plants. Patients had complained of persistent pain broken hip replacement parts, migration of hip parts, loosening of the hip cups, squeaking, grinding, and crunching of their new hips while walking. In some cases, painful and costly additional revision surgeries were required to fix the problems.

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