This morning, our commuter train was packed with overjoyed Villanova students headed for the NCAA Championship Victory Parade. It was the second time in a few months that our fair city has been lifted by a huge sports triumph. And, though our heads were ringing by the time we reached our stop ("Indoor Voice" is apparently not a course offered at Villanova), we love the infectious joy of these victories.
We also love a good Daubert victory, like today's decision. In Tsao v. Ferring Pharms., Inc., 2018 U.S. Dist. LEXIS 49173 (S.D. Tex. Mar. 26, 2018), the defendant manufactured a drug designed to stimulate women's ovaries to produce eggs to be used for in vitro fertilization ("IVF"). The plaintiff, an oncologist, underwent fertility treatments using the defendant's drug. Alleging that she purchased "defective, adulterated, and misbranded" vials of the drug, she sued the defendant for economic damages for breaches of express and implied warranties and violations of the Texas Deceptive Trade Practices Act. The defendant had earlier voluntarily recalled certain lots of the drug because routine stability testing indicated that the lots "did not meet potency specifications and were out of specification . . . at the time of testing (twelve months or more into their shelf life." Tsao, 2018 U.S. Dist. LEXIS 49173 at *1. The plaintiff "complain[ed] that [the defendant] failed to inform her that [the drug] lacked the potency described in the drug's Prescribing Information" and that she would not have purchased and used [the drug] had she known it did not meet those product specifications." Id. at *3. Claiming that the reduced potency adversely affected her fertility treatments, she sought recovery of money she spent to purchase the drug, money she spent on other medications used in conjunction with the drug, and the costs of her IVF treatments.
Among her designated experts, the plaintiff designated herself to offer a number of opinions, among them opinions related to the alleged "sub-potency" of the drug she purchased, the likelihood that this "sub-potency" would cause her IVF treatments to fail, and multiple issues related to ovarian stimulation, including the "usual" period of stimulation, the "prolonged" period necessary because the drug was "sub-potent," and the supposed negative effects of this "prolonged stimulation." The plaintiff also designated a regulatory expert to testify about causation as well as the defendant's "alleged lack of compliance with FDA regulations regarding drug recall and misbranded or adulterated drugs." Id. at *11. The defendant moved to exclude the plaintiff's "expert" testimony and the testimony of her regulatory expert.
Motion to Exclude the Plaintiff's Expert Testimony
The defendant moved to strike the plaintiff's expert testimony on the grounds that: 1) she was not qualified as a reproductive endocrinologist; and 2) her opinions lacked the indicia of reliability required for medical expert testimony. The court resoundingly agreed. First, the court held that the plaintiff had "failed to demonstrate knowledge, skill, experience, training, or education with respect to reproductive endocrinology and drug recalls . . . ." Id. at *17. To wit, the plaintiff testified in deposition that "many of her opinions regarding [the drug] and reproductive endocrinology [were] based on internet research that she conducted using Google and Wikipedia" as well as "the websites of different fertility clinics and online patient forums to research the average stimulation period" for women undergoing this type of therapy. Id. at *17-18. In addition, the plaintiff testified that her opinions about issues related to the drug's recall were "based on her general understanding of ow pharmaceutical companies work. Id. at *19 (internal punctuation omitted). And so, the court found, the plaintiff had not met her burden to demonstrate that she was qualified to offer her expert opinions.
Because it had excluded the plaintiff's opinions based on her lack of qualifications, the court emphasized that it didn't need to reach issues related to the reliability of her opinions. But it stated for the record that the plaintiff's own opinion that she would have produced more eggs if the drug were "fully potent" was not reliable because: 1) it "did not "fit" with the scientific literature, the data contained in the medical record, or her treating physicians' testimony," id. at *21; 2) was not the product of the same rigor the plaintiff would use in her own practice (the court commented that it "[didn't] believe that [the plaintiff ] would base her opinions regarding treatment of an oncology patient on Wikipedia research"); id. at *24-25; and 3) her repeated deference to her treating physicians confirmed her lack of expertise in reproductive endocrinology. Id. at *26.
And so, while the plaintiff was obviously permitted to testify about her own experience, she was not permitted to offer her own "expert" opinions.
Motion to Exclude Regulatory Expert
The defendant challenged the testimony of the plaintiff's designated regulatory expert on three topics: 1) the potency of the drug purchased and used by the plaintiff; 2) FDA labeling requirements; and 3) the recall of the drug. After recounting the expert's qualifications at length, the court held that she was generally qualified to testify as an expert, and, specifically, was qualified to testify about FDA regulations and recalls. But the court held that the expert's opinions that the drug was "misbranded" and "adulterated" were impermissible legal conclusions and were contrary to FDA regulations. Specifically, the FDA had set a potency range within which the drug was required to fall – 80% to 125% of the labeled potency — and the drug was not "misbranded" or "adulterated" or "out of specification," according to FDA regulations, as long as it fell within this range. And there was no evidence that any lots of the drug that the plaintiff used were "out of specification" at the time she used them. As such, the expert's opinion that certain vials of the drug "may have" fallen out of specification by the time the plaintiff used them was "speculative, contrary to the evidence, and inadmissible ipse dixit." Id. at *37. Finally, the court held that the expert's opinion that the drug's potency was a key factor affecting the quality of retrieved eggs was unreliable because it was "contrary to the labeled indications for [the drug], her own deposition testimony, and the testimony of Plaintiff's treating physicians." Id. at *43.
Regular readers are familiar with our frustration with the too-frequent admission of expert testimony that should never see the light of day. While many of the challenges to the Tsao opinions were, dare we say, a slam-dunk, it's still nice to see an opinion come out the right way. Let's hope for more, and, on the day of the Phillies' 5-0 victory in their home opener, hope springs eternal that they can harness some of the city's "sports karma" for the long upcoming season.
This article is presented for informational purposes only and is not intended to constitute legal advice.
