The largest medical device lawsuit ever awarded might surprise you. The award happened in May 2017, to the tune of $454 million. It was not a faulty imaging device or elaborate robotic surgery apparatus, rather a seemingly low-tech piece of equipment; surgical gowns. In this case, the 
surgical gown was made by Halyard Health, a former subsidiary of the Kimberly-Clark Corporation.
Halyard manufactured a gown called the MicroCool gown which by all standards is a medical device. The technology behind the gown is such that it was guaranteed to be cool, comfortable and most importantly, impermeable to infectious agents such as the Ebola virus and HIV. A medical device gown that can prevent workers from contracting a deadly disease while at the same time maintaining its comfort requires a sophisticated manufacturing process, enabling a microscopically small weave.
Medical Device Flawed Manufacturing?
Behind the scenes of the manufacturing process (which took place in Honduras), company employees of Halyard Health were blowing whistles. Email and documents from employees to management and to each other indicate whistleblowing attempts and continuing dissatisfaction with the medical device manufacturing process. The communications indicate the gowns may not have been impermeable to deadly viruses and that quality control may be suspect.
The company allegedly responded by firing the whistleblowers, refusing to recall the allegedly defective gowns and possibly worse, they continued to market and promote the gowns as being impermeable. The company knew about the manufacturing problems going back to 2012 but did nothing about it. Their decision was to conceal the truth. In doing so, thousands of healthcare providers lives were put at risk each and every day.
In 2014, a lawsuit was filed by more than 400 hospitals and healthcare systems in the State of California claiming that the company had failed to alert customers the medical device gowns might not have been impermeable, and that while they should have recalled the gowns they did not. The jury awarded the healthcare system.
Halyard Health issued the following press release soon after the $454 million was awarded to the complainants:
“Nearly 70 million MicroCool gowns have been sold without a single complaint of an injury. The company believes the jury’s verdict is contrary to the evidence presented at trial and that its punitive damages award is baseless, excessive and not consistent with California and federal laws. The company therefore intends to challenge the verdict in post-judgment motions in the district court and, depending upon the rulings on those motions, to appeal to the United States Court of Appeals for the Ninth Circuit.”
Though the Kimberly-Clark Corporation spun off Halyard Health long before the lawsuit took place, they are jumping back into the fight, one would presume in order to save their reputation.
What Wasn’t Said
The internal memos stated the medical device manufacturing process was “crap,” and while we don’t know what was meant by that statement or why whistleblowers were fired, what wasn’t said in the official release does raise a few flags.
It is “good to know” that 70 million MicroCool gowns were allegedly sold without a single complaint, my question is: “How would they know?” Were there lesser disease agents or other problems occurring among healthcare professionals that were attributed to factors other than the gowns? After all, who thinks to blame a gown as the first culprit? How much of it was due, simply to luck?
Of those 70 million how many are still in inventory? It’s an interesting question. The number sold is a sales statistic. If 50 million are still in inventory and obviously have not been used, how would the company know that those items are safe?
Then there is the matter of chance. Under most circumstances, gowns are not worn in U.S. hospitals for suspected Ebola cases and the like. Gowns are used for more innocuous purposes. We are told (though it’s a scary thought), that passenger planes can be flown without the need for pilots, that most flights are routine events. Pilots are essential when things go wrong, for that one time in 10,000 or whatever it may be, when there is a problem. Why wouldn’t an impermeable gown be thought of in the same way?
The press release fails to address the simplest of all accusations, quality assurance or whatever they wish to call it. I would feel a lot more comfortable with their press release had they said something to the effect that they extensively tested thousands of gowns and they re-confirmed, over thousands of lots, that the gowns are absolutely impermeable to Ebola, HIV and all disease agents. It was not stated.
What we do know is that the company never reported problems but long-fired employees did. What we know as well, that for now the jury found enough reasons, $454 million of them, to be exact, to not believe the company’s bluster.
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