This post is from the non-Reed Smith side of the blog.
Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.
The product at issue is synthetic pelvic mesh. Plaintiff’s first challenged expert was a gynecologic surgeon. While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise. Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not. Starting with a different medical procedure altogether. “It is not an alternative design of any product. In fact, it is not a product at all.” Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022). Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.” Id. at *7. The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue. Id.
Next plaintiff’s expert wanted to testify that non-synthetic xenografts made from biological tissue are safer alternative designs. Acknowledging that courts to have considered the issue are split, the court drilled down on the question at issue—are the xenografts sufficiently similar to the mesh used in plaintiff’s surgery to be allowed to be used as comparator products in a design defect case. Answer: no. Id. at *9-10. The xenografts are natural fiber, they were not designed. As such, they are not governed by the same regulatory scheme as manmade products. Further, the choice between two classes of products is a matter of medical judgment, not alternative design. Id. at *11. Defendants have to be careful to not compare their product’s safety profile to these other medical options. As long as they don’t, the door to this testimony remains closed.
Plaintiff’s expert’s third alternative design was a synthetic product, but the product was not on the market at the time of plaintiff’s surgery and has never been approved by the FDA. The court said:
[I]n the field of prescription drugs and medical devices, FDA approval is the key to making such a device feasible and available for physicians to use outside of an experimental setting.Id. at *12.
If it is not feasible or available, it is not an alternative design under Texas law.
Moving away from alternative designs, plaintiff’s expert’s next opinion was that the manner in which the mesh was cut (mechanical or laser) makes the product unreasonably dangerous. First, plaintiff’s expert has testified that both methods carry risks, so his opinion is really that the device is defective no matter how it is cut, making how it is cut irrelevant. Second, and more importantly, “no one links any of the Plaintiff’s injuries to the manner in which the mesh was cut.” Id. at *14. Texas law requires that the defect that made the product unreasonably dangerous be the producing cause of the injury. Without that causal connection, plaintiff’s expert’s testimony is irrelevant. Id. The last two opinions excluded were beyond the expert’s area of expertise. He was not allowed to testify regarding adverse event reporting or defendants’ compliance with FDA requirements. He also could not testify about the level of training defendants provide to surgeons. It is not the manufacturer’s duty to train physicians—that’s what medical school, residency, etc. is for. And there are no allegations in the case that plaintiff’s surgeon’s treatment fell below the standard of care. So, how he was trained is irrelevant.
That brings us to expert number 2. Where most of the first expert’s opinions were excluded on relevance grounds, plaintiff’s pathologist’s opinions were excluded as unreliable and outside his area of expertise. His “bark” product degradation theory has never been reliably tested, is not supported by reliable evidence that this degradation actually occurs in humans and cannot be related to the product at issue. Pizzitola II, 2022 U.S. Dist LEXIS 184351, *4 (S.D. Tex. Oct. 7, 2022). To the extent his degradation opinion is based on other factors, it was not excluded. Id. Plaintiff also wanted this expert to testify about the adequacy of defendants’ warning. But as a pathologist, he lacked the qualifications. He is not a surgeon, has never reviewed the IFU, and has never drafted an IFU. Id. at *6.