Second Stryker Warning Letter Cites Bacterial Contamination, Other Problems at Hip Replacement PlantJan 17, 2008 | Parker Waichman LLP
Stryker Corp., a maker of hip and other joint replacement components, has received a second warning from the Food & Drug Administration (FDA) to correct bacterial contamination issues and other problems at its New Jersey manufacturing facility. In a warning letter dated November 28, 2007, the FDA said that deficiencies at the plant had led to the manufacture of defective hip replacement components and other medical devices. Those problems had resulted in injuries to patients who had received the faulty components, and in some cases forced them to undergo additional surgeries.
According to the FDA warning letter, Stryker has been receiving complaints about components made at the New Jersey factory, including hip joints that did not fit properly, since 2005. Patients had been complaining about a range of problems, including pain, difficulty walking and "squeaky" joints, and some have had pieces of implant parts break off or wear down unevenly.
The warning letter was issued to Stryker after FDA officials had spent 6 weeks inspecting the plant over the summer. During that inspection, the FDA found a range of problems. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.
This is the second time that Stryker has been warned by the FDA as a result of the inspection that took place last summer. The current FDA warning letter chastises Stryker for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007. The latest warning letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems." For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”
The November 28 FDA letter warns Stryker that if it does not provide an adequate response to the problems cited by the agency, the FDA could act without notice and seize property, levy fines and seek injunctions. The letter also notes that the FDA will not approve sale of certain new Stryker medical devices until the violations are fixed and that it will notify federal agencies about the warning letter, so they can consider it when awarding contracts.
For its part, Stryker insists that it is working to fix the deficiencies uncovered by the FDA. In a statement released to the Associated Press, Stryker said “We have been working diligently for the past several months to respond to the FDA and will continue to work closely with them to address these matters."
The recent FDA warnings have not been Stryker’s only brush with federal regulators this year. According to the Associated Press, Stryker was among five companies that make joint replacements in the US that agreed in September to pay a $310 million fine and accept federal monitors to settle allegations they gave doctors kickbacks to use their products.