Photo of Bexis

April Zambelli-Weiner is an epidemiologist (meaning she’s not an M.D.), on the plaintiffs’ side, who claims expertise in a wide variety of areas.  In addition to the Zofran (birth defect) litigation that prompted this (and a prior) post, her name pops up in litigation over leukemia, Walsh v. BASF Corp., ___ A.3d ___, 2020 WL 4135151, at *12 (Pa. July 21, 2020) (“no ruling with respect to whether [her] failure to opine on whether . . . specific products may cause leukemia precludes her use as an expert”); inflammatory bowel disease, In re Accutane Litig., 2020 WL 260901, at *8 (N.J. Super. App. Div. Jan. 17, 2020) (“her analysis did not conform to the scientific methodology”), certif. denied, 2020 WL 2555213 (N.J. May 12, 2020); strokes, Galinis v. Bayer Corp., 2019 WL 2716480, at *10 (N.D. Cal. June 28, 2019) (testified that “studies funded by or otherwise associated with” the defendant were less “reliable than an “FDA-funded study”); and uterine perforation, In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 482-88 (S.D.N.Y. 2016) (opinions “outside the scope of her expertise” and “not based on a sound methodology”).

We’ve already described the underlying dispute about her actions in our “Stupid Expert Tricks” post, so we won’t repeat that here.  Suffice it to say that some of the testimony she offered caused her own lawyer to “file[] an emergency motion to withdraw his appearance, notifying the Court that he had learned that ‘factual representations’ made in her affidavit were ‘inaccurate.’”  In re Zofran (Ondansetron) Products Liability Litigation, 392 F. Supp.3d 179, 183 (D. Mass. 2019) (“Zofran I”).  As we already blogged, Zofran I granted the defendant’s motion to compel additional discovery into the unusual plaintiff-side funding (to the tune of over $200,000) of a study that Zambelli-Weiner conducted while a plaintiffs’ “consultant” to support the plaintiffs’ allegations in the Zofran MDL litigation.

In the prior post, just about every one of the “stupid expert tricks” we recounted was accompanied by prolonged attempts to thwart discovery into the conduct of the experts at issue.  The Zofran MDL is no different.  After being compelled to turn over documents detailing how her study was conducted in collaboration with plaintiffs’ counsel from the outset, Zambelli-Weiner invalidly claimed that documents she thereby produced were “confidential” when they really weren’t.  Her further attempts at preventing public disclosure were rejected in In re Zofran (Ondansetron) Products Liability Litigation, 2020 WL 1550563 (D. Mass. April 1, 2020) (“Zofran II”).  Perhaps the MDL judge has a sense of humor – issuing this opinion on April Fools’ Day.

Four documents were “de-designated” in Zofran II.  They are now public, and we have them – so anyone can read them.  Here is the MDL court’s brief description of the procedural background:

April Zambelli-Weiner . . . is the co-author of an epidemiological study that plaintiffs cite as evidence that Zofran causes birth defects.  At the time she conducted the study, she was a paid consultant to plaintiffs’ counsel.  The study itself was funded by plaintiffs’ counsel in the amount of $210,000.  Dr. Zambelli-Weiner also participated, along with plaintiffs’ counsel, on a panel at a conference in Las Vegas concerning this litigation.

2020 WL 1550563, at *1.  Here are the documents, as described in Zofran II:

(1) a Zofran study protocol prepared by Dr. Zambelli-Weiner; (2) unpublished analyses that compared the birth defects risks associated with Zofran to those with other anti-emetic medications; (3) a draft of Dr. Zambelli-Weiner’s study prepared for submission to the New England Journal of Medicine; and (4) a “Causation Briefing Document” prepared for plaintiffs’ counsel by Dr. Zambelli-Weiner.

Id. (record citations omitted) (note: the Zofran II opinion numbers these documents differently from the exhibit numbers accompanying our versions).

“[N]one of the documents at issue are of the type ordinarily considered confidential,” id. at *2, so Zambelli-Weiner’s arguments ultimately fell on deaf ears.  As for the study protocol, her “research appears to be unrelated to any proprietary or business enterprise of any kind, except to the extent she is acting in her capacity as a paid consultant for plaintiffs’ counsel.”  Id.  We think that’s precisely right.  Zambelli-Weiner’s “enterprise” was to include junk science in the medical literature at the highest level – in the New England Journal of Medicine.  Id. at *3.  Assuming that to be the business justification for the confidentiality claim, it failed:

[Zambelli-Weiner’s] misrepresentations to the Court concerning the nature of that relationship at the very least diminish whatever discovery protections might otherwise apply.

Id. at *2.  Any resemblance to “future research” was coincidental at best.  Id. (Zambelli-Weiner’s future research claims “bear[] little resemblance” to the document in question).  Indeed, the study protocol specified that Zofran would be compared to other antiemetics, but that didn’t happen – we explain why in just a bit.  See Page 1 at “exposure definition.”

To us the most interesting point in the study protocol was the confirmation on page 2 that the drug “Diclegis” “currently is the only FDA-approved treatment for nausea and vomiting due to pregnancy.”  That drug used to be called “Bendectin,” and it “was safe, but discontinued . . . in the face of prohibitive insurance and legal costs.”  For years, we worked on Bendectin litigation – it was always based on junk science (Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), was a Bendectin case).  It’s gratifying to have a plaintiffs’ expert, who is trying to do the same to Zofran, being compelled to make that admission public.

Document number two consists mainly of “the unpublished analyses comparing Zofran’s birth-defect risks to those of other anti-emetic medications.”  Zofran II, 2020 WL 1550563, at *2.  Zambelli-Weiner tried her best to keep these numbers under wraps, even deflecting scientific inquiry after her article was published (not in NEJM, as she hoped, but in Reproductive Toxicology, a less prestigious journal):

[T]he Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency specifically asked Dr. Zambelli-Weiner whether she had performed such analyses [of other antiemetics].  In her response to PRAC, she did not reveal that these unpublished analyses existed.  Two months later, PRAC recommended a change to Zofran’s label, relying in part on her study.

Id. at *3 (record citations omitted).  Particularly given the result of this concealment, it is a good thing that this tangled web has become public.

Dr. Zambelli-Weiner herself has stated that information comparing the risk of birth defects from ingesting Zofran to that of other antiemetic medications, such as that contained in this document, is the type of important public-health information that ordinarily should be shared.

Id. (record citations omitted).

Further, based on our own review, we invite those with a statistical bent to look at the charts of relative risk and confidence intervals on pages 5 and 6 of this document.  Most of the relative risks are below one, all are below two (analogous to “more likely than not”), and the higher purported risks tend to have wider confidence intervals – indicative of smaller sample size.  The farthest right column (Exposure 4) compares Zofran to the other antiemetics − all the relative risks are either at or below 1.00, with two of them showing Zofran having a statistically significant decreased risk.  That, we think, is why none of the head-to-head product comparisons saw the light of day in Zambelli-Weiner’s published article.  In light of all this hidden data, as the MDL court stated, “[t]he unpublished analyses that compare the risk of ingesting Zofran to the risk of ingesting other anti-emetic medications thus seem to be potentially material omissions from her published study.”  Id.

Document number three (which our copy has as “Exhibit 4”) is a preliminary draft of the Zambelli-Weiner study eventually published in the Reproductive Toxicology.  It’s long and we don’t have the inclination to put it side-by-side with the final study and run a fine-toothed comb comparison – but we know who will.  As for confidentiality, Zambelli-Weiner “does not explain how any differences between this draft and the study as it was later published could constitute proprietary business information, or describe any actual prejudice that might result from its disclosure.”  Zofran II, 2020 WL 1550563, at *3.

The final document was a memo from Zambelli-Weiner to plaintiffs’ counsel in the Zofran MDL from early 2015.  The opinion describes it as “a research brief prepared for plaintiffs’ counsel by Dr. Zambelli-Weiner . . . pursuant to a consulting arrangement with the law firm of Grant & Eisenhofer, P.A., which is counsel to plaintiffs in this matter.”  Id.  As such, it was “plausibly proprietary.”  Id.  However, it proposed exactly the type of study that counsel subsequently funded and Zambelli-Weaver authored:

Nested case-control study of administrative claims database to contribute US-based data with the power to examine specific cardiac birth defects

Zambelli-Weaver memo, at “Additional Avenues for Inquiry” (unnumbered page 11).  “[S]cientists and regulatory authorities evaluating” Zambelli-Weiner’s published article:

would likely consider it material that four years before the study’s publication, and as part of a paid consulting arrangement with plaintiffs’ counsel, she proposed conducting a similar study.

Zofran II, 2020 WL 1550563, at *3.  While Zambelli-Weiner argued that “her financial relationship with plaintiffs’ counsel was sufficiently disclosed,” Zofran II took a more jaundiced view:

[Zambelli-Weiner’s] statement was only one sentence long, and indicated only that her organization had received funds from plaintiffs’ counsel.  It did not state or suggest that Dr. Zambelli-Weiner had consulted with counsel as to the nature of the study itself, or provide any detail about the extent of that relationship.  This document sheds additional light on that relationship and therefore its disclosure will also be permitted.

Id. (record citation omitted).

We are shocked, shocked to find that plaintiffs’ experts think they are entitled to act in this fashion, and then prevent discovery of those very actions.  Indeed, we find it highly ironic that Zambelli-Weiner would purport to pontificate on the “reliability” of research “associated with” a defendant, given her own conflicts of interest just described.  Galinis, 2019 WL 2716480, at *10.  We can only wonder how many times the other side has gotten away with similar shenanigans in other mass torts.