Kimberly-Clark Under Investigation
If there is one thing that you should have learned by reading our blog posts, it is that no one is immune to Cal-OSHA, California Labor Laws or the penalties and lawsuits that companies will run into if you don’t abide by the state guidelines. Major, multinational corporations are no exception.
You may have heard of Kimberly-Clark in the past and possibly know of them as one of the biggest manufacturers of supplies in the medical industry as well as textiles and paper products.
A class action lawsuit is making its way through the US District Court of Central California regarding cost cutting measures implemented by Kimberly-Clark in their medical gowns which, in turn, rendered their material less effective. By reducing the integrity of their medical gowns, many individuals were put at undue risk and, surprisingly enough, this class action lawsuit was not brought by Cal-OSHA, but rather the workers who recognized the degradation of their medical gowns. In this case, the employees knew the guidelines implemented by the Occupational Safe and Health Administration and did the job of Cal-OSHA for them.
Kimberly-Clark Knowingly Broke the Law
In this case, the plaintiff, Bahamas Surgery Center LLC, is suing both Kimberly-Clark and Halyard Health Inc., alleging that the two companies knowingly manufactured a medical gown called MicroCool that did not hold up to the AAMI 4 Medical Safety Standard that regulates pathogen barriers. Essentially, this medical gown did not meet medical standards that are in place to ensure workplace safety for surgeons and nurses, with the goal of warding against infectious material passing through and affecting the individual wearing it.
The gowns that are at the forefront of this class action lawsuit were sold between February 2012 and January of 2015, so this lawsuit could implicate hundreds of more facilities that haven’t been alerted of the class action suit. It is likely that we are just seeing the beginning of individuals and institutions jumping on board with this lawsuit. Violating Cal-OSHA (or just OSHA standards for that matter) is nothing to scoff about – it can lead to serious legal consequences and negative press.
Falsifying FDA 510(k) Information
In addition to producing a garment that did not meet Cal-OSHA standards, there is a more nefarious story behind these medical gowns! Apparently, these medical gowns were fast-tracked through the approval process by the FDA in what is known as an FDA 510(k). But, the real twist is that it appears that Kimberly-Clark falsified information provided to the FDA in order to get this garment to market faster than it normally would have been.
Even scarier for medical professionals is that in a round of testing of 96 gowns, 48 failed and 32 failed catastrophically. In may cases, these medical gowns are the last line of defense against pathogens such as Ebola. It is imperative that, in order to protect our medical professions, these medical gowns are created with the highest integrity.
The result of these failed medical gowns still remains to be seen, but we can expect a major fine levied against the manufacturing giant Kimberly-Clark as well as a tarnished reputation in the medical industry. Stay tuned to CES Today for additional information on this Cal-OSHA and FDA compliance case.