There’s an old saying, “bad things come in threes.” We don’t know where it comes from, and don’t even think it’s true, although a trio of new opinions in the ObTape MDL is making us reconsider.
Recently, a group of “Phase I Plaintiffs” (and their experts) survived summary judgment and Daubert attacks. These plaintiffs brought claims under Georgia law for design defect, manufacturing defect, failure to warn, and implied warranty. They claimed that the ObTape device, used to treat incontinence in women, caused serious complications, including infection and erosion of the device into body tissues.
The main opinion blew out the summary judgment arguments and core Daubert attacks on plaintiffs’ medical and design experts. See In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., 2010 WL 1664965 (M.D. Ga. Apr. 22, 2010). Sticking with the theme of threes, there were three different types of experts under attack.
First, of course, were the assorted medical experts – doctors specializing in OB/GYN or urogynecological surgery – who offered general and specific causation opinions based on their training and personal (anecdotal) experience with ObTape, and bolstered those opinions with medical records review as well as the infamous “review of relevant medical literature.” Id. at *3. The medical experts survived the Daubert challenge to their general cause opinions by heaping anecdotal evidence upon anecdotal evidence. The base of this anecdotal pyramid? Adverse event reports. Id. at *18. The court (correctly) noted that adverse events standing alone can’t prove general causation. See id. (“Adverse event data is generally regarded with caution, particularly in the context of a drug or device that is alleged to cause an injury that might otherwise occur for another reason.”). Layered on top of that anecdotal foundation were the doctors’ own anecdotal experiences with ObTape (the court used the sturdier-sounding phrase, “experiential conclusions.”). Id. And finally, the anecdotal capstone was the published literature on ObTape, primarily consisting of case reports and case studies. Id. at *19. Good ‘nuff, said the court. Similarly, the specific causation opinions of these experts – invoking the magic words “differential diagnosis” – were admissible because they considered alternate causes of the alleged injuries and “explained why, in their opinion, a defect in ObTape was the most likely cause of Plaintiffs’ complications.” Id. at *20. In finding these opinions admissible, the court had to address the 11th Circuit’s recent Daubert opinion knocking out experts in Guinn v. AstraZeneca Pharms. LP, 2010 WL 1286947 (11th Cir. Apr. 6, 2010) – a nice win for our colleague Steven Weisburd, who briefed and argued that case, by the way. Unfortunately for the defendant here, the ObTape court paid mere lip service to Guinn before rubber-stamping the differential diagnosis performed and concluding that the methodological approach of the ObTape experts was a “far cry from the haphazard approach” taken by the Seroquel experts. Id. at *21.
The second category of experts under attack were a couple of bioengineers the plaintiffs invited to the party; these doctors examined ObTape samples, tested those samples, and formulated opinions based on those observations, the experts’ training and experience, and “review of the relevant scientific literature.” Id. at *3. These experts appear to have survived primarily because they were bioengineers, which just sounds smart, and conducted fancy tests such as “differential scanning calorimetry” and “Fourier transform infrared analyses.” Id. at *22.
Finally, the piece de resistance – and every plaintiff’s dream – a turncoat former employee of the defendant who used to be in charge of the vigilance database, was responsible for evaluating adverse event reports relating to ObTape, and offered opinions relating to general causation and design defect. Id. at *2. The defendant faced an uphill battle trying to knock this “expert” out of the box, particularly where much of her testimony could double as lay testimony based on her personal experiences with ObTape during her time of employment. Id. at *16-17. And, of course, she was clearly credentialed enough to perform the same evaluation and analysis during the time she was employed.
There were a few miscellaneous experts who were limited (because the specific cause opinion offered either lacked a sufficient basis, id. at *21, or was too speculative, id. at *22), or subject to a further Daubert hearing (because the court was concerned the doctor in question was “simply parroting the medical literature” and did not base his opinion on any testing or clinical experience, id. at *23). That’s a silver lining for defense practitioners like us, because we all too often see “experts” who are mere document delivery vehicles. Overall, however, the cavalcade of experts offered by the plaintiffs largely survived attack, and the court went on to swiftly deny summary judgment on all claims (except that pesky implied warranty claim, id. at *14).
The second and third opinions in the trilogy are much shorter, and dealt with ancillary (but still important) experts and issues. The second opinion addressed three areas of proposed expert testimony:
1) Business ethics: Excluded, because the ethics professor proffered was not a physician, medical researcher, or medical ethicist, and had no expertise in the areas of what should be reported to the FDA (more on this later) or medical device industry standards for warning physicians and patients about potential adverse events. In re Mentor Corp. ObTape TransObdurator Sling Prods. Liab. Litig., 2010 WL 1727828, at *3-4 (M.D. Ga. Apr. 27, 2010).
2) Animal studies: Allowed. It is typically inappropriate to extrapolate animal study results to humans, and thus the court properly barred any testimony comparing animal study results with complications in humans. Id. at *4. Hooray! The court went on, however, to permit testimony on these studies to the extent they “should have caused Mentor to investigate further.” Id. at *5. Even more troubling, the court appeared to permit testimony that the defendant failed to provide these animal studies to the FDA, even though the plaintiffs (naturally) disavowed any preempted “fraud on the FDA” claim. Id. at *6. Again, more on this later, but for now, let us just say, boo.
3) “Legal duty” opinion testimony: Allowed. Yup, the ObTape experts will be allowed to walk the tight rope of telling the jury the warnings were inadequate, without making “legal conclusions that merely tell the jury what result to reach.” Id. at *7.
The final opinion in the ObTape trilogy related to the admissibility of evidence regarding the defendant’s regulatory compliance. Told you we’d get back to the issue. The court started by spelling out the plaintiffs’ concession: “Plaintiffs acknowledge that claims based solely on a company’s fraudulent representations to the FDA are preempted by federal law.” In re Mentor Corp. ObTape Obdurator Sling Prods. Liab. Litig., 2010 WL 1734638, at *1 (M.D. Ga. Apr. 23, 2010). The court went on to grapple with an issue that comes up repeatedly, with mixed results – given that there’s no claim for “fraud on the FDA,” may the plaintiffs nevertheless put on evidence that the defendant “engaged in a pattern of misrepresentation to the FDA” or “falsely represented to the FDA” information about the device at issue? Id. On this issue, the court got close to doing the right thing, but ultimately wobbled:
The Court is skeptical as to the relevance of this evidence to Plaintiffs’ claims. However, it will defer a final ruling on the admissibility of such evidence until it hears further from counsel at the pretrial hearing. The Court cannot presently conceive of how this evidence would be relevant to Plaintiffs’ design and manufacturing defect claims. [ed. note: Amen.] It is conceivable that Plaintiffs may be able to tie some of this evidence to their failure to warn claims, depending upon the nature of Mentor’s
defenses to those claims. At this time, the Court does not have sufficient information to rule in limine on this evidence and requires the parties to be prepared to address this issue at the pretrial hearing.
Id. at *2. Yup, it is a big old punt. Here’s hoping that Judge Land sees the light at that pretrial hearing, and doesn’t allow the plaintiffs to do the hokie pokie with preempted “fraud on the FDA” evidence.
So there you have it: a trilogy of tough opinions. We hate being the bearer of bad news, especially when it comes in threes.