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Here is another guest post by Reed Smith‘s Kevin Hara examining the exclusion of a couple of slapdash expert witnesses, and the resultant grant of summary judgment. Since it is summer time, it is only fitting that he does so using baseball analogies. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.


Baseball has always held a special place in American society, and while it is no longer revered to the same degree as it once was, few things are more evocative of summer and tradition than this remarkable sport.  This guest blogger is admittedly biased, having spent the majority of his formative years in one of baseball’s true havens, St. Louis, Missouri, home of the team who wears the Birds on the Bat—the Cardinals.  Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention, a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams.  Remarkably, the Cardinals have not finished last in the National League in more than a century, since 1918, around the time World War I ended.  At its essence, success in baseball depends on preventing your opponent from scoring runs, relying on pitching and defense, and plating runs of your own based on your offense.  With the exception of this season, the Cardinals have generally excelled at the fundamentals, one of the reasons for their long-standing success. 

However, there is a truly spectacular story unfolding this year, as a phenomenal once-in-a-lifetime athlete, Shohei Ohtani of the Los Angeles Angels is in uncharted territory—as a dominant starting pitcher and nearly unstoppable hitter who just achieved the unparalleled feat of pitching a complete game shutout in the first game of a doubleheader and hitting two gargantuan home runs in the second.  Oh(tani), and in subsequent game he hit another home run.  He is, at the same time, a force in both run prevention and run creation, which combines, for this Cardinals fan, Albert Pujols and Bob Gibson.

This combination brings us to today’s case, MacSwan v. Merck & Co., 2023 U.S. Dist. LEXIS 103532 (W.D.N.Y. June 14, 2023).  While MacSwan may not be as sublime as the season Ohtani is enjoying, it is a best-of-both-worlds scenario, because the defendant successfully moved to exclude Plaintiff’s experts on causation and moved for summary judgment on Plaintiff’s failure to warn and breach of implied warranty claims, effectively playing both solid defense and winning offense in one fell swoop.  Incidentally, Fosamax litigation (a different MDL) has yielded some monumental decisions, including one of the worst cases of 2017 and the Supreme Court’s subsequent reversal.

Plaintiff ingested Fosamax, an oral bisphosphonate used to prevent and treat osteoporosis, and alleged it caused her to suffer osteonecrosis of the jaw (“ONJ”).  Id. at *1-2.  The court exercised its “gatekeeping” function under Rule 702 to assess whether the methodology underlying Plaintiff’s proffered expert testimony was “scientifically valid” and whether it could “be [properly] applied to the facts in issue.”  Id. at *3 (internal quotation marks and citations omitted).  Plaintiff had two experts, Dr. Morhaim, on causation and Dr. Merchant, a supposed treater.  Like Dr. Seuss, I’ll refer to them as M1 and M2, respectively.  Neither passed Rule 702 muster.  Id.

M1 was a periodontist with expertise in “oral implantology,” with a “full-time periodontal and implant practice,” and two decades as an expert legal consultant.  Id. at *6.  He opined Plaintiff’s “adverse dental condition was BRONJ, [ONJ associated with bisphosphonate use] and was directly due to her taking the oral medications Fosamax and Atelvia.”  Id. at *7.  M1 had read literature “pertaining to bisphosphonates,” and worked with patients taking such medications, requiring him to “understand and explain” the products’ risks and benefits—qualifying him to “opine generally regarding the diagnosis and treatment of ONJ.”  Id. at *8-10.  In addition to his general expertise, he sought to “offer general and specific causation opinions that Fosamax caused Plaintiff’s injuries.”  Id

However, M1 was the medical equivalent of a pinch hitter.  He “never treated or examined Plaintiff; . . .neither reviewed all of Plaintiff’s relevant medical and dental records, nor cite[d] to specific scientific studies or data to support his opinion.”  Id. at *7-8. (emphasis added).  In other words, M1’s opinion did not rest on sound methodology, leading the court to reject it:

[M1] testified in deposition that he had read relevant scientific literature during his career, including various articles mailed to his home, however, he could not cite any particular article and his report references no scientific literature or clinical data. This is not the level of scientific rigor that would be expected in his profession.

Id. at *12 (internal citations, brackets and quotation marks omitted).  His “informal discussions with colleagues and his diagnosis of ONJ in five patients taking bisphosphonates,” failed to provide a reliable basis for general causation because his experience was “confined” to those cases and entailed “diagnosing” the condition, not “ascertaining its causation.”  Id. at *12-13.  As the court aptly stated, his experience with any nexus between Fosamax and ONJ was “extremely limited.”  Id. at *13.  Plaintiff took a big swing and a miss on general causation for her first strike.

M1’s specific causation opinion was similarly suspect.  For instance, he reviewed only “some of Plaintiff’s medical records,” and did not review Plaintiff’s pre-2010 dental records, which documented she was already missing a number of teeth.  Id. at *13, 17.  Likewise, his conclusion that Plaintiff’s ONJ was “directly related to her bisphosphonate use” hinged on his theory that the “effects of Fosamax were present” in Plaintiff’s body for nearly 2 decades based on its lengthy half-life—an assertion for which he “fail[ed] to cite a source.”  Id. at *13.  M1 further admitted not knowing whether Fosamax remained pharmacologically active even if it remained buried in the bone for a prolonged period.  Id.  The court was unable to determine whether this half-life hypothesis was “based on sufficient facts or data.”  Id. at *14 (citation omitted).  M1’s reliance on his selective review of Plaintiff’s treatment records further undermined the reliability of his opinion that Plaintiff even had BRONJ, as did his failure to properly exclude potential alternative causes—such as a partial denture and smoking—which he admitted could cause dental infections.  Id.  at *17-18.  Nor did M1 adequately account for the effects of Atelvia, another oral bisphosphonate Plaintiff ingested, despite acknowledging it carried similar risks of ONJ.  Id. at *21.  He inexcusably saw “no reason to [rule out alternative causes],” based on his conclusory testimony that “if the patient is on [Fosamax] and there is clinical evidence of BRONJ, then it’s related and caused by that medication being in the patient’s system”—a BRONJ diagnosis “by definition.”  Id. at *19. (internal quotation marks and punctuation omitted).  This is quintessential ipse dixit testimony that falls far short of Rule 702 standards, and the court agreed, excluding all M1’s causation opinions because they lacked the requisite reliability, and allowing him to offer such opinions would be “highly prejudicial.”  Id. at *22-23.  After another swing and a miss on causation, Plaintiff was now down two strikes.

Plaintiff attempted to have her treating infectious disease specialist M2 offer an opinion based on his treatment that plaintiff had osteomyelitis and that her CT scan showed ONJ, but like M1 (in addition to not being disclosed under Rule 26), that opinion was riddled with unreliability.  For instance, ONJ is not an infectious disease, and M2 had neither researched nor lectured regarding oral bisphosphonates, and had no training as a dentist or oral surgeon.  Id. at *23.  Nor did he review Plaintiff’s medical or dental records or speak to Plaintiff’s dentists.  That’s a lot of “nots,” but the worst was that M2 was “unaware of when, how long, and what dosage” of Fosamax Plaintiff ingested.  Id. at *24.  M2 admitted Plaintiff was diagnosed with BRONJ prior to his examination, and he examined Plaintiff only twice.  Id. at *25.  Therefore, the court limited any testimony to his treatment of Plaintiff on those occasions, including review of CT scans and lab records and his observations of such information.  Id. at *27.  However, recognizing treating physicians attempting to offer causation opinions are subject to Rule 26, the court prohibited M2 from so opining—“including any opinion in Plaintiff’s medical records that she had BRONJ” which would “impermissibly allow him to serve as a conduit for another witness’s testimony.”  Id. at *28 (emphasis added).  This was Plaintiff’s third strike on causation, and in baseball terms, she—and any expert causation testimony—was now out.

Next, it was the defendant’s turn to step to the plate, moving for summary judgment.

Although there were disputed facts regarding the timing and duration of Plaintiff’s Fosamax use, they were not material to Plaintiff’s claims regarding the adequacy of the warning label, the alleged failure to warn Plaintiff’s prescribing physician, or breach of the implied warranty of merchantability.  Id. at *41-42.  Plaintiff asserted negligence and strict liability failure to warn claims, which are analyzed identically under New York law, under the standard of what a reasonable manufacturer knew or should have known.  Id. at *42.  To prevail on a failure to warn claim, Plaintiff had to prove that the defendant’s warning to the prescribing physician was inadequate and that such inadequacy caused her alleged injuries.  Id. at *43.

Plaintiff started taking Fosamax in 2001, and he argued Defendant’s failure to update its warning label to include information about the risk of ONJ until 2005 was actionable.  Id. at *45.  Putting aside that defendant could not unilaterally alter its label using the FDA’s Changes Being Effected regulation, based on the court’s exclusion of M1’s and M2’s testimony, Plaintiff could offer “no admissible expert testimony regarding a causal association between Fosamax and ONJ” prior to 2005.  Id. at *48-49.  Nor could Plaintiff fill that void by relying on expert testimony from other cases.  Id. at *49.  Expert testimony was necessary to address complex issues including the “causal relationship between Fosamax and ONJ” before 2005.  Id. at *50.  Absent such evidence, Plaintiff could not show any warning inadequacy in the Fosamax label, negating an essential element of her failure to warn claim.  Id.  So medical causation was absent.

However, even if the pre-2005 Fosamax label’s warning were inadequate, Plaintiff still “must demonstrate that had a different, more accurate warning been given, her physician would not have prescribed the drug in the same manner.”  Id. (internal quotation marks, punctuation and citations omitted).  Plaintiff failed to produce evidence that her prescribing dentist would have changed or discontinued her Fosamax if the drug had carried a different warning.  Id. at *50-51.  Rather, Plaintiff admitted her treater continued to prescribe Fosamax after the 2005 ONJ warning label update, and in 2007 her dentist knew about the “association between oral bisphosphonates and ONJ, but he also did not advise Plaintiff to cease taking them.”  Id. at *51.  As such, the failure of Plaintiff’s physicians to change their prescribing behavior, despite knowledge of the purported risks of ONJ meant Plaintiff could not prove any warning inadequacy proximately caused her alleged injuries.  Id.  Accordingly, the court granted summary judgment because there was no triable issue of fact “as to the adequacy of Defendant’s pre- or post-2005 warnings and whether Plaintiff’s treatment providers altered their prescribing decisions if a different [warning] was provided.”  Id. at *52.  Warning causation failed as well.

Plaintiff’s breach of implied warranty claim required her to establish “the product was not minimally safe for its expected purpose—without regard to the feasibility of alternative designs or the manufacturer’s reasonableness” in marketing the product.”  Id. at *53 (internal quotation marks and punctuation omitted).  Plaintiff produced no evidence that Fosamax was not “minimally safe,” as M1 admitted the risk of Plaintiff developing ONJ was “very low,” and that Fosamax’s benefits exceeded its risks.  Id. at *54.  The court granted summary judgment on Plaintiff’s implied warranty because she failed to show Fosamax was not “minimally safe.”  Id. at * 55.

In addition to pitching a shut out by successfully moving to exclude Plaintiff’s expert testimony on general and specific causation, Defendant successfully went to bat and hit a game-winning summary judgment home run.  As the Cardinals’ long-time Hall of Fame broadcaster Jack Buck used to declare at the end of every triumph, “That’s a winner!”