STRIKE-THROUGH A number of surgeons complained that blood soaked through to their skin while wearing MicroCool Breathable High Performance gowns, which Kimberly-Clark marketed as being impermeable to blood and microbes.

For most Americans, the Kimberly-Clark brand is an icon of warmth, quality and family values. The maker of Kleenex, Huggies and Depends helps more than a billion people every day "cope, laugh, love and carry on with simple human dignity," the company's website says.

But inside the company's healthcare division, which made drapes, surgical gowns, exam gloves and sterile wraps, the scenario may have been quite different. According to depositions given by former employees as part of a lawsuit against Kimberly-Clark, the company experienced serious, persistent quality issues in all of its barrier protection products for as long as a decade. In the depositions, former employees alleged that the products consistently did not meet quality standards, and yet leaders ignored the problems. Because Kimberly-Clark was a market leader, the problems, if real, could have put thousands of patients and healthcare workers at risk.

In their depositions, former employees said aggressive cost-cutting measures meant quality took a back seat to profits, as K-C worked to compete with manufacturer/distributors like Cardinal and Medline that had their own private-label barrier products. The employees testified that although the quality problems were well known inside the company, executives chose to keep marketing the products and to not tell healthcare professionals or regulators.

K-C spinoff Halyard Health now faces investigations from the Department of Justice and the Department of Veterans Affairs. An FDA inspector reportedly visited Halyard this summer, inquiring about the company's gowns. In addition to the threat of a possible class action suit on the part of customers, Halyard also faces a possible shareholder suit over the gowns. The controversy was also the subject of a 60 Minutes investigation (osmag.net/HtAAf8) that aired in May.

The company admits no wrongdoing. It says it's cooperating with the government agencies and "vigorously" contesting the lawsuits. The company says it was "profoundly disappointed" with the 60 Minutes segment, calling it "inaccurate and misleading." A Halyard statement says, "Protecting healthcare workers and patients is our number one priority."

Not Cool
The revelations stem from a lawsuit filed in 2014 focused on the company's MicroCool Breathable High Performance gown: Hrayr Shahinian, MD vs. Kimberly-Clark Corp.

K-C introduced its MicroCool brand in 1998, and in 2012 it unveiled the MicroCool Breathable High Performance gown. The company claimed the gown met the requirements for the Association for the Advancement of Medical Instrumentation's Level 4 designation — completely impervious throughout the "critical zone" in the front of the gown. AAMI recommends Level 4 gowns for cases where the surgeon's hands are in a body cavity, for orthopedic procedures without tourniquets, open CV and thoracic procedures, trauma and cesarean sections.

Questions about whether the gowns actually met those standards surfaced soon after the product launch. According to a plaintiff's legal brief, K-C employees sent a batch of gowns — 3 lots of 32 each — to Intertek, 1 of 2 U.S. labs that tests AAMI Level 4 gowns. One of the 3 lots failed. That prompted a K-C scientist to instant message the manager of the plant in Honduras where the gowns were made. "We need to try and come up with a reason/rationale why only one lot of MicroCool had sleeve seam fails — which would justify testing it again. [S]omething anything so we can re-test and have a reason. Anything you can think of — doesn't have to be a proven reason. Just something to hang a re-test on. Know what I mean?" According to the brief, the manager responded, "We do not have that process (sleeve sealing) validated."

Despite the results, K-C continued to market the gowns. It would sell more than 50 million between February 2012 and January 2015.

Just as the gowns failed in-vitro tests, they started failing in-vivo tests. Surgeons started experiencing "strike-through," meaning that liquid permeated the gown and soaked through to their skin. How many did is a matter of dispute. According to deposition testimony from Bernard Vezeau, K-C's former global strategic marketing director for surgical and infection prevention, during that 3-year period, the company received large numbers of complaints about the gowns, enough to fill a printed spreadsheet hundreds of pages long. That document remains under seal. However, William Rutala, PhD, MPH, an expert witness for Halyard Health, testified that the company sold 55 million gowns between 2013 and 2015, and received only 45 complaints. Dr. Rutala, a renowned expert on infection, cited unpublished K-C data.

Rashel Campos, RN, administrator of the Bahamas Surgery Center in Bakersfield, Calif., which is a plaintiff in the case, testified in her deposition that in her center, surgeons experienced strike-through several times. "There were times when our surgeons had removed their gowns, and they were wet or bloody and then (had) to shower and put on new scrubs. They walked into my office to show me they were wet, and the fluid went through the gown."

Mr. Vezeau testified that surgeons also complained that the sleeves literally fell off the gowns during procedures. According to the plaintiff's legal brief, in summer 2012, a K-C sales rep wrote to the home office: I "would highly encourage you to re-examine the sleeves." ... Is "there any way to make them stronger" because "they do pull apart pretty easily."

According to the plaintiff's legal brief, K-C continued to test the gowns in the spring and summer of 2012, this time using another company. The results were similar, with at least 3 tests resulting in seam failure. The gowns stayed on the market.

A subsequent event got the attention of K-C executives. Cardinal Health, which distributed the MicroCool gown as well as its own AAMI Level 4 gown, the "Smartgown," claimed that the Cardinal gown was the "only breathable, fully impervious gown in the industry." K-C sued, and as the legal battle progressed, late in 2012, Cardinal sent several batches of MicroCool High Performance gowns to Intertek. Again, the gowns flunked the tests. In 2 of the tests of 32 gowns, more than half exhibited liquid or viral penetration. In 2 additional tests of 36 gowns each, more than half failed. Cardinal supplied the results to K-C, and 6 weeks later, according to a plaintiff's legal brief, the lawsuit settled.

Keith Edgett, who was Kimberly-Clark's global director of surgical and infection prevention until October 2013, testified that "none of these results was surprising" to his team. "We had cost-optimized performance out of K-C's products." Mr. Edgett did not return a call from Outpatient Surgery.

At a subsequent meeting, K-C Healthcare President Joanne Bauer expressed frustration about the quality problems Cardinal had found and about the continuing quality problems across all product lines over the previous decade, according to Mr. Edgett's deposition. She asked Mr. Edgett to find the solution. Mr. Edgett testified that he believed the gowns should have been removed from the market until the problem was resolved. But sales continued. In her deposition, Ms. Bauer, who is now retired, testified that she didn't recall if she ever considered recalling, or stopping the sales of, the MicroCool gowns.

Mr. Edgett testified that he dispatched Mary Weber, a biologist on his team, to visit K-C's manufacturing plant in Honduras. She found serious manufacturing problems. According to Mr. Edgett's testimony, the seaming devices were outdated and running too fast. The operators were poorly trained. Mr. Edgett testified that he learned that K-C's Honduras team had known about the gown manufacturing problems for years. Meanwhile K-C continued to test the gowns, with the same results. By the end of 2013, according to the plaintiff's brief, K-C's quality department acknowledged that the bar "sealing technology of gown sleeves is inadequate to meet the AAMI requirement for barrier performance."

Mr. Edgett testified that his team recommended changes to the gown material and replacement of the seaming machines. "But they were incorrectly implemented and the defects remained. They were overheating gown sleeve seams, resulting in a brittle seam that would eventually crumble." He testified that the problems were not resolved when he left the company in 2013 to take another job.

Given the problems, how did the MicroCool High Performance gowns ever achieve FDA approval as an AAMI Level 4 product? Mr. Edgett testified that he didn't believe the gowns tested for that application were "representative of the gowns in the market." He speculated that the company cherry-picked the gowns it used for testing. "When you look at the way K-C validates new designs, they do it under ideal conditions. As soon as the eyes were off that process, it goes back to normal state and the product is not the product you tested. That was a consensus amongst the engineers and scientists."

MicroCool gowns today
Is the problem fixed yet? It's hard to say. In testimony, K-C scientist Jascomb said the problems were fixed by late 2014 or early 2015. But Halyard Health declined to provide evidence to Outpatient Surgery that the gowns now meet the AAMI standards, citing ongoing litigation.

In January 2016, Halyard filed an adverse event report with FDA: "I was called to a room to speak to a resident involved in a trauma case. The resident reported to me that during surgical intervention, the patient's blood permeated the resident's surgical gown (AAMI 4 obtained from the multi trauma pack, from Kimberly-Clark) via the sleeves. The blood ran down her arms and entered her gloves."

According to Halyard expert witness Dr. Rutala, whatever the performance of the gowns, no harm was done. He testified that there were "no instances in the peer-reviewed literature of gown failure resulting in transmission of a bloodborne pathogen The risk of transmission of HIV, HBV and HCV as well as Ebola via a surgical gown is essentially zero even if there was some failure. (That's because) the factors necessary for disease induction include: dose, a portal of entry, susceptibility of the host, virulence and a pathogen. The bloodborne pathogens have been demonstrated to be transmitted to HCP via percutaneous injury or mucosal exposure. Healthy, intact skin does not allow viruses to get into the body."

"There are no reports of infection due to a breach in barrier protection from any surgical gown," says Halyard's statement. Since the gowns were introduced, "we have sold over 65 million ... without a single complaint of injury due to barrier protection. MicroCool gowns continue to have an extraordinary safety record and an incredibly low complaint history."

More than just gowns?
According to the testimony of Messrs. Edgett and Vezeau, the high-performance gowns were not the only problems. The company also allegedly experienced persistent, unresolved seaming problems with its drapes, seaming and pinhole problems with its sterile wraps, and pinholes in its masks. It experienced problems with other gowns as well.

"It was not just limited to gowns, it was on every business that we had," testified Mr. Vezeau. "We had a problem with our surgical wrap having pinholes. When you have pinholes, that allows bacteria to settle on the instruments. Face masks also had pinholes, which would enable bacteria to flow through the mask when the surgeon wore them. Exam gloves, pinholes." Mr. Vezeau died of a heart attack in 2016.

In his deposition, Mr. Edgett expressed frustration that the products were not removed from the market until the problems could be solved. "The organizational behavior was not consistent with what I would consider to be an ethical organization," he testified. "I was shocked when I learned about the extent of the issues. I believe (the company's leaders) were putting customers in harm's way. We were tracking HAIs as well as new viruses globally and I felt we were misleading our customers." OSM