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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 Edgett's testimony, the seaming devices were outdated and running too fast.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 quali- ty department acknowledged that the bar "sealing technology of gown sleeves is inadequate to meet the AAMI requirement for barrier per- formance." 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 appli- cation were "representative of the gowns in the market." He speculat- ed 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 S E P T E M B E R 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 2 7