We have reported periodically on rulings in the Aredia/Zometa litigation, including Daubert and summary judgment rulings by the MDL judge and choice of law rulings by Judge Arthur Spatt of the E.D.N.Y. in Deutsch v. Novartis Pharmaceuticals Corp., a case remanded for trial from the MDL. Judge Spatt has now decided Daubert motions in Deutsch and another remanded case, and his very long opinion is a bit like yesterday’s list of silly law songs: there is something in there for everyone. Deutsch v. Novartis Pharmaceuticals Corp., 2011 U.S. Dist. LEXIS 22755 (E.D.N.Y. March 8, 2011).
MDL rulings are law of the case. The MDL judge ruled on Daubert challenges to several plaintiffs’ experts. Novartis challenged those experts based both on arguments made to the MDL judge and on new arguments. Judge Spatt generally refused to consider the arguments previously decided by the MDL judge based on the law of the case doctrine, finding the doctrine particularly applicable when cases are transferred from an MDL. 2011 U.S. Dist. LEXIS 22755 at *18-21. “Reversing or otherwise undermining the decisions by the MDL court could lead to the type of inconsistent pretrial rulings that Congress sought to avoid [in the Multi-District Litigation Act], and therefore frustrate the very purpose of consolidation.” Id. at *21.
As a general matter, we agree that issues decided by the MDL judge should not be relitigated on remand. In Deutsch, however, the MDL rulings became the third rail, and anyone raising an argument that came within a few yards of an issue decided by the MDL court got zapped.
Reliability of opinions based on non-controlled epidemiologic studies. Novartis challenged many expert opinions because they were based only on epidemiologic studies rather than on randomized controlled clinical trials or studies. But the MDL court had rejected this argument, and Judge Spatt found that binding under the law of the case doctrine. Id. at *22. The Deutsch court, however, then went on to address this argument and agreed with the MDL judge, although it is hard to tell how much this decision was tilted by deference to the MDL court. Id. at *23-35. Score one for their side.
Challenges to opinions of experts ruled qualified in the MDL. After the MDL judge rejected Novartis’s Daubert challenges to certain plaintiffs’ experts, Novartis tried challenging those experts’ opinions that were not considered by the MDL judge. Again, Novartis hit the third rail. Because the MDL court found them qualified in certain areas, the Deutsch court allowed the experts to testify about additional scientific topics that were related to their areas of expertise. See, e.g., id. at *50-51. Score one for their side.
Opinions about Novartis’s corporate conduct. Plaintiffs wanted their medical and scientific experts to testify about Novartis’s corporate conduct. Judge Spatt ruled that the experts could explain Novartis internal documents, such as whether they indicated certain risks, but could not explicitly or implicitly testify about the intent, motivations, or state of mind of Novartis or its employees or whether Novartis acted in bad faith. Id. at *60-64, 77-78. Score one for our side.
Opinions based on a doctor’s personal experience. The court barred one of the plaintiffs’ experts from opining that, based only on his experience with his own patients, a reduced dosing regimen led to a lower incidence rate of ONJ. He had no data to support the reliability of his opinion, nor had he followed a particular methodology, and his personal observations were insufficient to support the conclusion he reached. Id. at *74. Score one for our side.
Adverse event reports. The MDL judge allowed an expert to testify about general causation, despite Novartis’s objection that his opinion was based on adverse event reports. Unfortunately, that was considered law of the case, which made adverse event reports another third rail. Novartis tried to challenge experts’ reliance on adverse events reports, but the Deutsch court zapped those arguments. See, e.g., id. at *85. We have previously explained that adverse event reports are not reliable evidence, and the court’s ruling is simply wrong. The court tried to soften its ruling by noting that the expert did not “cite un-reviewed [adverse event] reports for their truth, but rather for the accepted theory that a vast number of reports contributes to the plausibility of causation.” Id. at *85. Hogwash; even a vast number of unreliable reports do not amount to anything reliable. And we all know that this distinction will disappear when these opinions are trotted out to the jury. Score one for their side.
Meta-analysis. The court did a thorough analysis of one expert’s testimony about his meta-analysis of epidemiologic studies and allowed some opinions and barred others. Id. at 87-113. In doing this analysis, the court was mindful of the “strong risk of prejudice if a Court permits testimony based on an unreliable meta-analysis because of the propensity for juries to latch on to the single [risk] number” resulting from the meta-analysis. Id. at *106. Tie.
Opinions expressed not included in expert report but stated at expert’s deposition. One well-known danger of deposing an expert is that he or she will offer opinions beyond those stated in the expert report and then will be allowed to testify about them at trial. That happened here – Novartis moved to exclude the opinions not stated in the report; and the court denied the motion, saying that “Novartis cannot claim surprise by any of Prof. Ray’s opinions that it elicited and questioned him on at length.” Id. at *113. Score one for their side.
Alleged “cover up” activity after plaintiffs were treated. Plaintiffs offered an expert to opine that Novartis meddled with the conclusions in a scientific article published in 2008. The court rejected this testimony as irrelevant because the plaintiffs were treated long before 2008 and the article could have not influenced their care. Id. at *118-19. Score one for our side.
Dr. Suzanne Parisian. There must be a page in the plaintiffs’ manual directing counsel to try in every single case to use Dr. Suzanne Parisian, called by this court a “seasoned veteran of product liability litigation.” Id. at *125. The court split the baby here, allowing her to testify about FDA regulatory requirements but barring her testimony about corporate state of mind, pharmaceutical industry standards, ghostwriting, causation, and diagnosis. Id. at *125-41.
Dr. Parisian was also offered to testify about the reasonableness of Novartis’s conduct in complying with FDA regulations and interacting with the FDA. We think allowing that sort of testimony is a big, big mistake. But the court was indulgent. The court found that her report discussed her experience and FDA regulations and subsequently offered conclusions without analysis connecting it all together. Although recognizing that “other courts have excluded Dr. Parisian’s testimony based on the disconnect between her analysis and opinions,” id. at *132 (citing cases), the court decided to have a Daubert hearing to determine whether she employed a reliable methodology. Id. at *136. We think a judge should not convene a hearing to bail out an expert who could not prepare a proper report. What’s worse, the hearing also will consider whether “Dr. Parisian can testify as to her opinions within the confines of certain limitations so as to avoid prejudice to Novartis.” Id. at *136-37. In other words, a hearing to decide whether, as we put it before, “the notoriously hard-to-control Dr. Parisian” will behave herself on the witness stand. That sounds crazy to us. We predict the witness will say whatever the court wants to hear at the Daubert hearing and whatever plaintiffs want the jury to hear at trial. More or less a tie, but anything Parisian is allowed to testify to is junk.
Causation testimony by treating physicians. The court excluded two of plaintiffs’ treating physicians’ testimony on specific causation because they were not experts in the disease or its causes and did not perform a proper differential diagnosis, as they did not analyze or rule out other causes. Id. at *152-58. Another, more qualified treater was allowed to opine about specific causation as long as he limited his opinion to his experience as the patient’s treating physician and his opinions based on that treatment. Id. at *163-64. Score one for us.
Fair enough. But the court really stumbled in its very last ruling on plaintiffs’ treaters, a Dr. Gelfman. This doctor testified that he performed a differential diagnosis but could not “remember what factors he considered at the time . . . or what specific literature he relied upon outside of various case reports.” Id. at *165. He also acknowledged being unaware of certain risk factors. Id. at *166. That should have been the end of Dr. Gelfman, as a plaintiff has the burden of establishing the reliability of her experts’ testimony, and plaintiff here could not establish that the forgetful Dr. Gelfman did a proper differential diagnosis. The court, however, let him testify, ruling that these defects could be explored on cross-examination. No, no, no, no. A proper foundation for admissibility is required before anyone ever gets to cross-examination, and all the cross in the world can’t make up for that. Score one for their side.
Final score, 4-5-2. It’s pretty certain this poor jury will be sifting through a lot of garbage.