Stryker Settles Dangerous Device Lawsuit Involving Unapproved Knee Replacements with DOJ
Stryker will reportedly pay $80 million to the federal government to settle both criminal and civil claims that the manufacturer’s subsidiary, OtisMed, sold devices used for knee replacements to surgeons and hospitals without prior approval from the Food and Drug Administration. OtisMed’s chief executive, Charlie Chi, pleaded guilty in federal court to putting the unapproved knee replacement devices on the market on Monday, December 8th.
The dangerous devices were sold by OtisMed prior to 2009, before Stryker purchased the company. However, the parent company is now liable for $34.4 million, criminal forfeiture of $5.16 million and a civil settlement of $40 million, according to the U.S. attorney’s office.
The knee surgery devices were cutting guides, designed to help surgeons make accurate bone cuts during knee replacement surgery. Between May 2006 and September 2009, the company sold 18,000 units of the dangerous devices, and made $27 million in revenue. In September 2009, the FDA denied OtisMed’s application for approval of the devices, but the company shipped 200 units anyway.
Dangerous Devices Can Lead to Serious Personal Injury
When defective medical devices become available to the public, problems associated with them can generally be described in one of three ways:
- Device Issues — defects from the fabrication process, mechanical or electrical malfunctions, or faulty material used to manufacture the device. Producers of that defective device or the corporation who lends its name to the device could potentially be held liable for any injuries suffered by individuals if they can prove that the damage is directly attributable to the instrument itself.
- Usage Difficulties– This can be caused by design irregularities, incorrect labeling, poor or confusing instructions, or inadequate packaging.
- Clinical Errors — This is the hardest scenario to prove since a patient’s preexisting medical disorder (e.g., allergy) might trigger the device to do more harm than it does to benefit that individual.
The Strom Law Firm Protects Citizens Harmed by Dangerous Devices
The attorneys at the Strom Law Firm keep a close watch on recalls of dangerous devices and defective product recalls in the US. We aim to protect our clients’ health and safety, and hold manufacturers to the highest possible standard of safety. If you or a loved one have experienced severe, life-limiting side effects from a defective product or drug, and believe that your pain stems from a product recall that came too late, you may be entitled to compensation. The Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.