Three immunology experts testified. The testimony of the first was allowed on reliability factors. Another was allowed on reliability factors, but denied on experiential grounds. A third (for defendant) was allowed on reliability grounds.
Facts: This case (Hovey v. Cook – U.S. District Court of West Virginia – March 26th, 2015), is one of 70,000 cases pulled together into seven in the Judicial Panel on Multidistrict Litigation, involves the implanting of the Stratasis TF Urethral Sling, a pelvic repair product used to treat stress urinary incontinence (SUI). The plaintiff, Mary Hovey, was implanted with the Strasis and claims that she suffers from physical and mental disabilities due to the deleterious product. She sued for failure to warn, liability, negligence, breach of warranty, violation of consumer protection laws, and more. The parties retained many immunology experts to put forth their opinions on various matters and this opinion is the result of the many “Daubert” challenges therein. Only the experts in immunology are discussed in this summary.
The plaintiff’s first expert, Dr. Donald Kreutzer, testified that the Stratasis manufactured by Cook causes excessive scarring and inflammation. Cook moved to exclude this opinion in that none of the medical studies cited by the expert show excessive or scarring of the tissue and thus, there is no scientific foundation for these conclusions. Cook also argues that Dr. Kreutzer did not provide opinions that are generally accepted by the scientific community.
Cook also filed a motion to exclude the testimony of Lisa Morici, Ph.d for similar reasons as Dr. Kreutzer. They maintain that Morici’s testimony should be excluded because her opinions are not supported by the medical literature that she cited and that these same studies were performed on animals, not humans. Cook states that the results of animal studies, in this instance, do not lead to the same conclusions in humans.
The third expert in immunology was proffered by the defendant. Hovey filed a motion to exclude the opinions of Dr. Dennis Metzger, who stated that there is no evidence, based on the literature and his own studies, that SIS can cause numerous medical afflictions, such as graft-hose disease or hypersensitivity. The defendants challenge these opinions based on reliability of the evidence as well as relevancy of the studies.
Discussion: The court first looked at the testimony of Dr. Kreutzer. While it could be concluded that the literature and studies analyzed could come to different conclusions as to causation, the role of Daubert is not to opine on proving cause and effect, but to touch upon the validity of methodology. Here, Dr. Kreutzer’s opinions could be deemed as useful in this case.
As to Dr. Morici, the similar theories are in effect. While she relies on animal studies to reach the medical conclusions, courts have indicated that, in some cases, animal studies backed up by similar data in humans are admissible under Daubert. In the instant case, Dr. Morici provided sufficient evidence that the cited animal studies, backed up by other peer-review studies, can be used for her medical opinions. In addition, the defendants filed a motion to exclude Dr. Morici’s testimony on the manufacturing and preparation of Cook’s products. There was no objections raised by the plaintiffs to this motion.
Last, Hovey objected to the testimony of Dr. Metzger as irrelevant, as the studies performed by the expert were not designed to reach the stated opinion, which is that SIS causes inflammatory responses. Dr. Metzger found that SIS induces immune responses. The court noted that the terms immune response and inflammatory response are used interchangeably throughout the studies and that there is relevancy to this particular case. As to the plaintiff’s contention that the opinions are not reliable as they are based on animal studies, the same conclusions are made as those regarding Dr. Morici.
Held: The motion to exclude the testimony of Dr. Kreutzer was denied. The motion to exclude the testimony of Dr. Morici was partially granted and partially denied. The motion to exclude the testimony of Dr. Metzger is denied.