Regulatory Controversies
Since early 2007 the company has received three Warning Letters from the Federal Drug Administration citing issues in compliancy. The first of these, a seven-page correspondence, named various issues at an Ireland-based manufacturing facility such as untimely fix of failures and procedural noncompliance in the testing of failed or otherwise problem-prone devices. The second, sent November 2007, cites issues at the firm’s Mahwah, N.J. facility including poor fixation of hip implant components, in some instances requiring mitigation by revision surgeries; exceeded microbial level violations in the cleaning and final packaging areas of the sterile implants; and failure to institute measures in prevention of recurrence of these and other problems. The final warning letter, sent April 2008, cites issues at the firm’s Hopkinton, MA biotechnology facility. Again, issues relate to quality and noncompliance including falsification of documents relevant to the selling of products to hospitals which are to be sold under a limited, government-mandated basis. Stryker maintains that employees involved in the falsification of documents have since been terminated.
In the Fall of 2007, Stryker, along with the related companies: Biomet, Zimmer Holdings, DePuy Orthopaedics and Smith & Nephew, were involved in civil ligation with the U.S. Department of Health and Human Services, Office of Inspector General. This litigation called for a net payout of $311 million as the governmental department maintains the aforementioned companies engaged in unlawful kickbacks to physicians who urged hospitals to purchase their respective products. Stryker, however, having cooperated early in the investigation, was not fined.
As of February 2008, a dispute exists between Stryker Corp. and the U.S. Department of Justice concerning a subpoena linking the company to aforementioned misconduct in sale of products. Since governmental filing of the injunction, Stryker notes that it has produced in excess of 300,000 pages of documentation in compliance with the mandate. U.S. Government counters, however, that the documentation was not proper in scope and format. Law officials expect the investigation to continue for several months.
On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. The devices are being recalled because Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. see info on the FDA website http://www.fda.gov/Safety/Recalls/ucm320958.htm
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