1/31/18 Documents Find Bad Quality Control at M2a Production Plant
Mctlaw and its partner Nash & Franciskato are the ONLY law firms in the country to demand and get access to internal Biomet documents showing dangerous quality control issues at the plant where Biomet made the M2a Hips.
Uncovering the Full FDA Inspection Report of Biomet’s Warsaw Facility
In the fall of 2016, the FDA released a site inspection report of the Biomet facility in Warsaw, Indiana where all M2a metal on metal hip replacements were made. The FDA refers to this type of report as a “Form 483” report.
Where Form 483 reports are typically somewhere between 1-4 pages, the FDA’s Form 483 report based on its’ Fall 2016 inspection was historic in length. It was 58 pages long. It detailed serious problems with how Biomet handled product complaints and the internal investigation procedures for those complaints.
It also listed disturbing shortcomings in the design of the plant as well as poor air and water quality issues. As one example, the design of “clean rooms” (where employees would need to be gowned in order to work in a germ-free environment) requires employees coming to work in their street clothes to walk through the clean room in order to access the gowning area.
In certain areas, the only border between a clean area and a non-clean area was a piece of tape on the ground used as a marker. Workers were observed in street clothes walking within feet of items intended to be in a clean environment.
A heavily redacted version of this report is publicly available below.
Zimmer Biomet’s Response to the FDA’s Inspection
Even more disturbing than the FDA’s observations was Biomet’s 287-page response to the observations. Now owned by Zimmer and operating under the new company name of “Zimmer Biomet,” the first two pages of this response letter admits the existence of “systemic issues” at the facility, including issues affecting the “quality culture” at the facility.
Zimmer Biomet explained that at the time Zimmer purchased Biomet, it performed certain investigations of its own before the FDA’s inspection of the site. Zimmer Biomet claims that the internal investigations it conducted “self-identified major compliance-related issues in areas such as design controls, sterile packaging, complaint handling, nonconforming material, and CAPAs.” CAPA stands for “Corrective Action Preventive Action” and is a set of protocols companies take in order to address any potential problems with their products (hopefully before they result in safety concerns for patients).
The effect of the FDA’s Form 483 observations at the Biomet immediately resulted in Zimmer Biomet shutting down activities at the plant. A small number of employees were fired in order to make an example of those employees. Those employees thereafter filed wrongful termination lawsuits against Zimmer Biomet. As a result of the allegations in those wrongful termination lawsuits, certain Zimmer Biomet investors then filed “investor fraud” lawsuits against Zimmer Biomet. They claimed that the corporate leadership of Zimmer Biomet lied to the investors about just how bad the conditions at the plant were. Following the investor fraud lawsuits, Zimmer Biomet replaced its CEO.
Mctlaw Forces Biomet to Turn Over Internal Investigation Documents
Mctlaw is aggressively pursuing all documents related to Zimmer Biomet’s internal investigations regarding the Biomet plant where the M2a products were made and where complaints regarding M2a products were processed. As part of this pursuit, we requested that Biomet produce unredacted versions of the FDA inspection report, Zimmer Biomet’s response letter, and all internal investigations cited in the 287-page letter to the FDA. Biomet fought hard not to produce any of these documents. However, the Court issued an order wholly agreeing with our clients and forced Biomet to hand over these very important documents.
If not for mctlaw’s aggressive investigation, this information would remain hidden from the world.
Read the “Motion to Compel” Order
