Halyard Health’s Response to Allegations in Lawsuit Referenced in 60 Minutes Program
The lawsuit mentioned in the 60 Minutes show is Prime Healthcare Centinela, LLC, et. al. v. Kimberly-Clark Corporation and Halyard Health, Inc., which is pending in the United States District Court for the Central District of California. The lawsuit claims that Kimberly-Clark Healthcare (now Halyard Health, Inc.) misrepresented the quality or performance capabilities of our MicroCool High Performance Gowns, and that the gowns are unsafe. The Plaintiffs claim that our gowns never met the AAMI Level 4 standards, that we have been deceiving our customers for years, and that the gowns are dangerous. The lawsuit is not about personal injuries – none of the plaintiffs claim that they or any other identified individual has actually been harmed by using our gowns. Rather, the lawsuit alleges that the plaintiffs paid “too much” for the gowns which generally cost only a few dollars apiece. Halyard stands behind the quality and safety of its MicroCool High Performance Gowns and denies the allegations in the lawsuit. Below are specific allegations made in the lawsuit by the Plaintiffs and Halyard’s response to them:
The Plaintiffs claim that Halyard misrepresented to its customers and the general public that the MicroCool gown provides effective barrier protection when treating patients with infectious diseases, despite knowing that the gowns are unsafe and pose a great risk of bodily harm to patients and healthcare workers.
The MicroCool gowns have an extraordinary safety record. Halyard has sold over 58 million MicroCool gowns, and there has not been a single incident where a person has claimed that they contracted a virus or infection as a result of a gown failure. Not one.
The Plaintiffs claim that since at least as early as 2012, Halyard’s MicroCool gowns have failed an industry standard test and therefore do not meet the relevant standards for gowns represented to be AAMI Level 4.
The MicroCool gowns have been tested extensively, both before and following FDA clearance in 2010 to market the gowns as meeting the AAMI Level 4 standard. The gowns passed several such tests prior to clearance and several additional tests after clearance and prior to launching the gowns in the market. Since that time, the gowns have been tested under the revised AAMI Level 4 standard. Along with passing results, there have been individual test failures. However, individual test failures or other product nonconformance do not mean that the gowns do not meet the standards applicable to their FDA-cleared claim. If a testing result or product quality issue arises, Halyard investigates the issue and takes appropriate action to address the safety or efficacy risks associated with the issue, if any. Here, the Company carefully and thoroughly evaluated the risks to safety associated with the testing data and properly determined that there was no risk to healthcare workers or patients that would warrant a recall or other notice. The gowns have a remarkable safety record, and the clinical performance of the gowns in the field over the past four years establishes that the Company made exactly the right decision.
The Plaintiffs claim that Halyard received test results in early 2013 that show approximately 50% of the gowns tested failed to meet the AAMI Level 4 standards. 60 Minutes in their program stated that this test showed 77% of the gowns failed the test.
This test referenced by the Plaintiffs and 60 Minutes was not conducted by or at the request of Halyard. Rather, it was conducted at the request of a competitor of Halyard that was engaged in litigation with Halyard at that time. The results of that test were an extreme outlier; Halyard’s own testing results both before and after that test were completely different. The results of the test conducted by the competitor were also inconsistent with the actual performance of tens of millions of gowns in the field. There has never been any signal arising from the actual use of the gowns in the field consistent with the results of this test.
The Plaintiffs claim that once Halyard had failing test results, it failed to notify the FDA or customers or recall its gowns.
Halyard thoroughly evaluated the test results and determined that there was no safety or health risk with respect to the gowns in the market place. As a result of that evaluation and determination, no product recall or FDA notification was required or appropriate. Halyard believes that its quality review and product safety evaluation process was consistent with FDA standards and industry expectations. As noted above, the remarkable safety record and clinical performance of the gowns in the field over the past four years establish that the Company’s process was sound and its judgment correct.
The Plaintiffs claim that Halyard chose profits over quality and the protection of healthcare workers by using contract workers in its quality control function.
The quality and safety of our products is always priority number one. The contract workers and Halyard’s other employees were properly trained and qualified to perform their responsibilities.
Please direct all media inquiries to:
Media Relations, Halyard Health