Once again, this discussion of a decision in the Pelvic Mesh litigation comes only from the Dechert side of the blog.

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As part of our continuing discussion of the pelvic mesh MDL court’s recent pre-trial decisions, today we discuss the court’s Daubert opinion, which addresses many experts and many of the key expert issues that we ordinarily see in drug and device mass-tort litigation. To review all of the court’s rulings, feel free to read the opinion, which is quite long.  It can be found at: In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012; 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 78061 (S.D.W.V. June 4, 2013) (“Daubert Opinion”).  There’s also a short reconsideration opinion:  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012; 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 84133 (S.D.W.V. June 44, 2013) (“Reconsideration Opinion”).  For now, we’re going to discuss some of the rulings that we find particularly interesting.  The defense did well:

Relationship Testimony

The plaintiffs offered what were called “relationship experts.”  They were really damages experts.  They offered opinions on “the impact of the bellwether plaintiffs’ loss in terms of body image, self-esteem, confidence, sexual drive and the ability to maintain an affectionate sexual relationship.”  Id. at *23.  There were a number of problems with these experts.  See id. at *23-29.  The most obvious was that a jury doesn’t seem to really need an expert’s help with this.  Once the plaintiffs testified on these subjects, jurors should be fully equipped to reach conclusions.  The court thought so too:

Expert testimony which “merely regurgitates factual information that is better presented directly to the jury rather than through the testimony of an expert witness” is properly excluded.  Parts of the Relationship Experts’ expert reports merely state what the plaintiffs told them.  Such testimony is better presented directly to the jury via the bellwether plaintiffs themselves.  . . . [E]xpert testimony on this issue is unnecessary because it is understandable to the average juror.  To the extent that the bellwether plaintiffs may be uncomfortable speaking to the jury about the personal issues and the impact that these issues have had on their relationships and lives, the average juror will also understand.

Id. at *29-30.  We’ll also note that the use of such experts could be, more than anything, an effort to put this type of information before the jury for a second time.  That seems not just inefficient, but unduly prejudicial.  The opinions were excluded in their entirety.

Corporate State of Mind and Intent

We’ve addressed many times that a plaintiff’s expert has no particular ability to read the mind of a corporation and announce what it was thinking or intending.  Jurors should review the evidence and make their own determinations.  That’s their job, not an expert’s.  The pelvic mesh plaintiffs had a number of experts who intended to do just this, and the court didn’t allow it:

While an expert may testify as to a review of internal corporate documents solely for the purpose of explaining the basis for his or her opinions–assuming the opinions are otherwise admissible–Bard’s knowledge, state of mind, alleged bad acts, failures to act, or other matters related to corporate conduct and ethics are not appropriate subjects of expert testimony because opinions on these matters will not assist the jury.

Id. at *37-38.  Applying this reasoning, the court excluded such testimony from a number of plaintiffs’ experts.

Warnings

The court excluded a “warnings adequacy” opinion from plaintiffs’ urogynecologist expert, Dr. Shull.  Dr. Shull lacked familiarity with the process of developing product warnings, and this doomed his opinion:

Despite his stellar qualifications as a urogynecologist, Dr. Shull is unqualified to testify on the specific issue of product warnings, as evidenced by his lack of familiarity with the process. To the extent that Dr. Shull seeks to opine that surgeons did not receive adequate warnings from Bard, he is similarly unqualified to do so.

Id. at *35.  We’ve seen a number of courts allow “warnings adequacy” testimony simply on the basis of the expert being a medical doctor.  No particular understanding of how warnings language is developed or why was needed.  But just being a doctor doesn’t qualify someone to draft product warnings. This ruling recognizes that.

Causation

General Causation

The court excluded the general causation opinion from a Dr. Zolnoun, a medical doctor and epidemiologist.  The court found that Dr. Zolnoun didn’t present enough science or a reliable scientific method to support her opinion.

Plaintiffs tried to save her opinion by arguing that, like with cigarette smoking and lung cancer, the proposition that transvaginal mesh products cause nerve problems is generally accepted by the scientific community.  Id. at *11.  Plaintiffs pointed the court to internal Bard documents and an FDA document to demonstrate this.  Interestingly, Dr. Zolnoun hadn’t read those documents, making it hard to see how they could form the basis of her opinion.  Id.  Setting that aside, however, the court held that the documents didn’t demonstrate scientific consensus:

While these documents may certainly suggest that Dr. Zolnoun’s general causation opinions are true, it does not appear from these documents that the medical community generally recognizes them as true to the same extent that the medical community recognizes that cigarette smoke causes cancer.

Id. at *11-12.

Unable to sway the court with materials that Dr. Zolnoun didn’t review, plaintiffs argued that her opinion was based on a proper methodology because she relied on “clinical experience and relevant, peer-reviewed literature” that she actually had reviewed.  Id. at *12.  But the court didn’t find that to be true and found, instead, that her opinions were simply ipse dixit.  Id.

Dr. Zolnoun’s first general causation opinion is . . .  based on nothing more than her personal, unscientific observation and opinion that “it’s obvious” that mesh arms are sharp and can serrate or tear nerves. This is the type of “subjective, conclusory approach that cannot reasonably be assessed for
reliability” and that Rule 702 is designed to exclude.  . . .

Dr. Zolnoun’s second general causation opinion . . . is similarly lacking in any reliable basis and methodology and is simply an ipse dixit opinion. For example, she testified:

“As you stated, I’m not an expert in mesh and traction and contraction. So I cannot possibly be an expert in amount of scarring because of mesh because that’s not what I do. But if you ask me as a pain person, then this contraction happens, it’s obvious. Scarring happens and it happens differently in different setting in different context.”

Id. at *15.

The court excluded her opinions in their entirety.  We should note that the court also excluded medical causation opinions from David Kessler, the former FDA Commissioner.  Id. at *92.

Specific Causation

Dr. Zolnoun’s specific causation opinions – that each bellwether plaintiff’s nerve problems were caused by the transvaginal mesh – fared no better.   They were based on her general causation theories, and the court therefore found them to also be unreliable.  Id. at *16.

The court also rejected Dr. Zolnoun’s “bedside sensory test,” which she used to reach her specific causation opinions.  The court found that her use of the test suffered from the logical fallacy of “post hoc ergo propter hoc” reasoning.  Having dusted off our Black’s Law Dictionary (where Latin phrases always send us) and consulted Google, we now know what that means: “after this, therefore because of this.”  Ah.  We’ve seen that bad reasoning before.  As the court put it, Dr. Zolnoun’s opinion was improperly “based on the idea that because each bellwether plaintiff suffered pain after the mesh surgery, then the mesh must have caused the pain.” She used the wrong test to draw unreliable conclusions:

A review of Dr. Zolnoun’s expert report and deposition reveals that the bedside sensory testing she conducted is designed only to find the location and nature of the pain, not the cause, and that she did not perform a reliable differential diagnosis. Again, this is the type of “subjective, conclusory approach that cannot reasonably be assessed for reliability” that Rule 702 is designed to exclude.

Id. at *17-18 n.4.

The court, however, allow the specific causation opinions from other plaintiffs’ experts.  Plaintiffs’ pathologist expert, Dr. Klosterhalfen, can still give the opinion that the plaintiffs’ pain and other problems were caused by the Avaulta mesh product.  Id. at *67-70.  And plaintiffs’ urogynecologist expert, Dr. Hoyte, can also give a specific causation opinion.  His experience with mesh complications, review of the bellwether plaintiffs’ medical records, and use (what we’d call misuse) of a “differential diagnosis” method was sufficiently reliable for the court.  Id. at *78-80.

The court also held that pathologist expert, Julia Babensee, Ph.D., could give the following quasi-specific causation opinion as to each bellwether plaintiff:

It is my opinion that if an Avaulta device has been implanted in a woman, and the woman develops complaints such as pain, dyspareunia, infection, vaginal shortening, scarification and urinary and defecatory dysfunction, that more likely than not, to a reasonable degree of scientific probability, the Avaulta device(s) is a contributing factor of the problems.

Id. at *124-25.  Dr. Babensee could pair this opinion with her finding that the bellwether plaintiffs actually had these types of symptoms.  Id. at *125.  This seems to us like a specific causation opinion without an actual opinion, and it presents tricky testimony for the defense to deal with at trial.

Additionally, in its reconsideration opinion, the court allowed a specific causation opinion from plaintiffs’ biomedical engineer expert, Ahmed El-Ghannam, Ph.D.  He can testify that swelling of fibers in the mesh product “would have” caused inflammation in three bellwether plaintiffs because he examined the mesh products removed from those plaintiffs.  He couldn’t testify, however, that their implanted mesh products “actually did” have that effect.  He was either unqualified, had not reviewed the medical records, or both.  Reconsideration Opinion at *12.  Regardless, this sounds like another tricky opinion for the defense to deal with.

Treating Physicians

The court also addressed opinions of treating physicians, something that arises in many drug and device mass-tort litigation.  The court ruled that treating physicians can offer “causation” opinions if those opinions were “formed in the course of treatment of the bellwether plaintiffs.” Id. at 50.  That’s not an unusual ruling at all, though establishing whether the opinion was truly formed as part of treatment is another matter. The court also addressed whether treaters should have prepared FRCP 26(a)(2)(B) expert reports for opinions that they formed outside their treatment of the plaintiffs.  Id. at *49.  The court seemed to believe that the treaters should have, but allowed their testimony anyway.  The court held that their failure to prepare reports was harmless because they had already been deposed, and those depositions occurred before the expert-report deadline.  Id.

Opinions on FDA Regulations

An issue that often arises in our litigations is whether an FDA expert can testify on whether a company satisfied or violated FDA regulations. This court said no.  Dr. Kessler, plaintiffs’ FDA expert, cannot “testify that Bard violated FDA regulations.  The court held that “such testimony would be drawing legal conclusions.”  Id. at *87.  Dr. Kessler also cannot offer broad legal conclusions, such as “Bard failed to adequately disclose” or “Bard failed to warn on its label.”  Id. at *85.  Those are ultimate conclusions for the jury, not experts.  Id.  The court, however, did allow Dr. Kessler to make fact conclusions about, for instance, what Bard did or did not disclose and then to add his opinion on whether that information should have been disclosed.  Id. at *86-87.  That’s another fine line for trial, one that will almost certainly lead to a lot of sidebars and argument.

Experts Giving Factual Narratives and Lawyer Arguments 

The plaintiffs filed a Daubert motion of their own.  The court’s rulings are unremarkable.  We’ll note, however, that the court did exclude defendants’ experts from giving opinions that are more like lawyer argument and from presenting factual narratives that are not the bases for their expert opinions.  Id. at *132-36, *137-39.  These rulings appear as if they will have little effect on the testimony of the defense’s experts.  And we like them.  Many of us have seen these problems – argument and storytelling – from plaintiffs’ experts.  This is another helpful opinion on why courts shouldn’t allow it.