We have two things in common with the petitioner in Mancini v. Commissioner of Internal Revenue, No 16975-13, 2019 Tax Ct. Memo LEXIS 16 (U.S. Tax Ct. Mar. 4, 2019).  First, we both will be filing our 2018 tax returns in about a month from now, unless of course Mr. Mancini is more on top of things than we are and has already filed.  Second, neither of us will be deducting our net gambling losses, but for different reasons.  For our part, we don’t have any gambling losses of which to speak.  For Mr. Mancini, he will not be deducting net gambling losses for 2018 or any other year because the Tax Court has ruled that his gambling losses are not a “casualty loss” that would be fully deductible under the U.S. Tax Code.

Yes, you read that correctly.  We are blogging about a tax case, which might amuse our tax attorney colleagues, but may leave our faithful readers in the drug and medical device world scratching their heads.  There is, however, a compelling tie in:  The petitioner in Mancini was trying to deduct his gambling losses as a “casualty loss” under the Tax Code because they alleged resulted from compulsive gambling caused by his treatment with Parkinson’s disease medication.

Although the Tax Court rejected the petitioner’s attempt to recharacterize his gambling losses, impulse control disorders such as compulsive gambling, compulsive shopping, and hypersexuality are diagnosable conditions that are more common than you might think.  Be that as it may, the petitioner rolled snake eyes.  He was diagnosed with Parkinson’s disease and was treated with increasing doses of Pramipexole, a dopamine agonist used to treat the condition.  While on a relatively high dose, the petitioner started gambling more and more, resulting in substantial losses.  When his wife and daughter eventually intervened, his neurologist discontinued the medication, and his gambling diminished, except to a “limited extent.”  Id. at **2-**3.  He later tried to deduct his losses, but rather than limit his gambling loss deductions to his gambling winnings, he called them “casualty losses” and tried to deduct them in their entirety.

A casualty loss is a non-business loss that arises “from fire, storm, shipwreck, or other casualty, or from theft.”  You know, like when a tree falls on your house during a storm.  The petitioner claimed that his gambling losses were an “other casualty” because his compulsive gambling “manifested abruptly once his dosage reached a certain level, it was unexpected . . . , and it was unusual, even for Pramipexole takers.”  Id. at **18.

The Tax Court ultimately rejected the deduction, but in the part of the order that we find most noteworthy, the Court ruled (1) that Pramipexole was capable of causing compulsive gambling and (2) that it had actually caused compulsive gambling in the petitioner.  The Tax Court discussed these concepts in terms of “framework evidence” and “diagnostic evidence, but we know them more commonly as “general causation” and “specific causation.”

Whatever you call them, the Tax Court’s ruling was based on the slimmest of scientific evidence.  On general causation, the Tax Court relied on the plaintiff’s expert, whose “knowledge comes from reading published studies—he even directly cited one during his testimony.”  Id. at **12.  Significantly, the government did not offer contrary evidence, leaving the expert’s opinion on that Pramipexole could cause impulse control disorders essentially uncontested in a forum where the etiology of alleged drug side effects is rarely, if ever, considered.  If the government had dug into the published studies, we expect it would have found a considerably more nuanced situation, but the Tax Court will never know.

On specific causation, the same expert drew his conclusion from the petitioner’s medical records, which showed that his compulsive gambling occurred while he was on his peak dose.  Id. at **14-**15.  We know this as “challenge and de-challenge,” where the onset of a complication coincides with the beginning of therapy and the complication abates when therapy is discontinued.  The problem with drawing causation opinions from “challenge and de-challenge” is that it relies solely on temporal correlation and ignores other potential causes and/or risk factors.  Did the petitioner have more free time and access to gambling?  Did he experience a “big win” or a “near miss,” both well known risk factors for compulsive gambling?  Did the court take into account his family’s intervention, which can have a powerful impact on gambling behavior?  It appears other potential causes were neither raised nor considered, which causes us to question the Tax Court’s finding of a causal relationship.

In the end, the petitioner lost his deduction because he did not suffer a “casualty loss,” regardless of the cause of his compulsive gambling.  For one thing, there was no physical damage to property, which is required under “sixty-odd years of caselaw.”  Id. at **18-**21.  Further, the losses were not “sudden” or “immediate,” like a tree falling on your house.  As the Court put it, “These losses were necessarily the result of dozens or hundreds of individual gambling sessions and probably thousands of separate wagers.”  Id. at **23.

The upshot is that the Tax Court’s questionable conclusion on causation wound up being superfluous.  One footnote is that the petitioner did try to sue the drug manufacturer in a product liability lawsuit, but was found to be time barred.  Id. at **5.  Perhaps his tax strategy was his fallback position, and we don’t blame him for trying to manage his tax burden within the limits of the law.  I guess that makes three things we have in common.

Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices.  With those kinds of devices (and others), the hospital typically contacts the sales representative in advance, and he or she is charged with delivering the device in the specified size and providing any specialized instrumentation required for implantation.  The system is logical and effective, but it still comes as a surprise to many lay people that an industry representative is involved at all.  Plaintiffs’ attorneys sometimes emphasize this disconnect to suggest that something untoward is going on, although surgeons and nurses will tell you that a sales consultant’s presence in real time is an integral part of the process.  Many surgeons will tell you that they always expect the consultant to be there.

We were thus surprised to see the tables turned in Parker v. Orthofix Inc., No. 3:17-cv-248, 2019 U.S. Dist. LEXIS 24271 (D. Or. Feb. 14, 2019), where the plaintiff faulted the medical device sales representative for not being present for her surgical procedure.  At first blush, it seems like a damned-if-you-do-damned-if-you-don’t situation, but in the end the district court’s order rejecting the plaintiff’s claim came down to the evidence.  The court granted summary judgment for the manufacturer because the plaintiff could not produce evidence suggesting that the defendant’s representative should have been there (with instruments in tow), let alone that any duty existed or was breached.

Here is what happened.  The plaintiff underwent vertebral fusion surgery using the defendant’s plating system, but her pain persisted.  She therefore went to another surgeon, who determined that a second surgery was required to remove the defendant’s plate and re-perform the procedure using a competitor’s plate.  Id. at *4-*5.

This is where things went off track.  The hospital’s supply office arranged to have the competitor’s replacement plate available (apparently delivered by the competitor’s sales consultant), but after the surgeon started the procedure, he realized that he did not have the specialized tool required to remove the defendant’s plate.  It is not entirely clear why.  The hospital’s clinic supervisor said she never requested the specialized tool because the surgeon did not note in his pre-surgery report that he intended to remove the defendant’s device.  Id. at *6-*7.  The surgeon wrote in his post-operative note (and later testified) that he believed that someone had contacted the defendant beforehand to secure the specialized tool and was told that the surgeon could use instruments from the hospital’s universal tray.  Id. *7.

Whatever occurred before the procedure, the evidence was uniform that the surgeon telephoned the defendant during the surgery and learned that he needed the specialized tool, resulting in the surgeon ending the procedure.  The plaintiff required a third surgery, which also failed to resolve her pain.  Id. at *7-*9.

The plaintiff sued only the medical device manufacturer, and instead of alleging the usual defect allegations against the defendant’s plating system, the plaintiff claimed only that the defendant “negligently misinformed [the hospital] and the surgical team before the unsuccessful surgery about the tool needed to remove the [plate] being contained within a universal tray” and that “this misinformation caused the surgical team to begin operating on Plaintiff without having the correct tool, resulting in the surgical team needing to abandon that surgery.”  Id. at *8-*9.

It turns out, however, that the plaintiff did not have admissible evidence that anyone had ever contacted the defendant before the surgery, which would explain why the defendant’s sale consultant was not there.  The surgeon wrote in his post-operative note that he believed that someone had contacted the defendant, only to be told that the universal tools would do.  But what “someone” was told is obvious hearsay, and there was no other evidence of that purported conversation.  Throughout discovery, no one could even identify the person who placed this call nor the person who received it.  Thus, while the surgeon’s post-operative note met the business-records exception to the hearsay rule, the plaintiff could not account for the second and third levels of hearsay.  Id. at *10-*15.  That is to say, writing down that “someone told me that someone told him or her” is not admissible evidence.  See Fed. R. Evid. 805 (separate exception required for each level of hearsay within hearsay).

The surgeon’s deposition testimony met the same fate:  “I can remember in this case someone telling me that they had talked to Orthofix, and . . . saying that . . . the plate was easy to take out . . . with what I believe is called a universal system.”  (Id. at *16-*17) (emphasis in original).  Again, hearsay within hearsay, as was the testimony of the competitor’s sales representative:  “I had spoken with [the surgeon] and it was his understanding that we would only need the universal system . . . he thought the hospital had contacted the Orthofix rep to get the product there.”  Id. at *20-*21.  This piling on did not help because hearsay problems cannot be cured with still more inadmissible hearsay.

Beyond that, the plaintiff opposed summary judgment with evidence of the contact made with the defendant during surgery.  But that evidence did not raise a dispute of material fact.  The plaintiff’s claim alleged that the defendant misrepresented the tools required to remove the defendant’s plate, which caused the surgical team to start and later abandon the second surgery.  Thus, undisputed evidence that the defendant provided information after the surgery commenced was irrelevant:

Because Plaintiff alleges that Defendant supposedly gave this misinformation to the surgical team before surgery, evidence of a statement made by an employee or agent of Defendant during the unsuccessful surgery would not provide support for Plaintiff’s claim or create a genuine dispute of material fact.  By that time, the surgery had begun and any misstatements made during that surgery cannot be the cause of that surgery having occurred.

Id. at *19-*20 (emphasis in original).  So something fell through the cracks here, and it was no fault of the plaintiff.  It was likewise not the defendant’s fault.  As the district court concluded, “[S]omeone dropped the ball . . . .  Whether that someone was [the surgeon], someone on his surgical team, someone working for [the hospital], someone working for Defendant, or someone else, the Court cannot determine, and on the evidence presented by Plaintiff neither can a jury.”  Id. at *22.  Summary judgment granted.

It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration.  We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights.  In commemoration, we light candles for eight nights. And we use oil.  Lots and lots of oil.  Like, eight dozen potato latkes-worth of oil.   Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.

In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana.  We love warnings causation, a potent doctrine too often rendered toothless by passive judges.  Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018).   In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava.  In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery.  Two years later, the plaintiff began to experience pain on the inside of her right thigh.  Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter.  The plaintiff was required to undergo open surgery to remove the rest of the filter.  The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.

The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries.  The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . .  the causal link is broken and the plaintiff cannot recover.”  2018 WL 6415585 at *3.  The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter.  His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.”  Id.    Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff.  The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims.  Id.  at *4.

The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to  perforate and fracture.  She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id.   The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier.  As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.”   Id.   Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.

We make these same arguments over and over and over again in our medical device cases.  We often don’t prevail, even on clear records.  We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed.  We will keep you posted on similar decisions.  And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.

This post comes from the Cozen O’Connor side of the blog only. 

 

Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage and again as a part of our preemption scorecardCanary was a winner.

That decision, however, dismissed only plaintiff’s product liability claims, letting her fraud claim move forward. Last month, the court issued a summary judgment decision on that fraud claim. Canary is not such a winner anymore.

Backing up a little bit, the product was Medtronic’s PrimeAdvanced spinal cord stimulator. It was implanted in plaintiff to address her neck and back pain. Canary v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 192794, at *2 (E.D. Mich. Nov. 13, 2018). Yet, after the surgery, plaintiff complained that she was experiencing hives all over her body, abdominal pain and bowel inflammation. Id. at *3-4. Almost a month later, she had the device removed. She claimed that her problems stopped. Id. at *4.

During discovery, however, plaintiff produced no causation opinion from an expert—to be clear, no expert on either general or specific causation. Instead, she relied exclusively on the testimony of her treating doctors. Their testimony, however, was only marginally helpful to her, as it was laced with words like “possible” and “plausible” and missing any declaration that the opinions were reached to a degree of medical certainty or even probability. Yet the court allowed her fraud claim to survive summary judgment.

In particular, Plaintiff’s internal medicine doctor testified that the device was a possible cause, one of the top possibilities, and that allergy and skin testing was needed. But he offered no opinion to a reasonable degree of medical certainty:

Dr. Thammineni, the internal medicine doctor who treated Plaintiff when she was admitted to the intensive care unit on May 28, 2013, explained during his deposition that while he stated that Plaintiff had “contact dermatitis secondary to spinal cord stimulator” in his notes, he recommended that she get allergy and skin testing to ascertain exactly what caused the reaction. When Dr. Thammineni was asked if the spinal cord stimulator was more of a possibility than other causes, he responded with a “yes.” And when asked “[c]an you say to a reasonable degree of medical certainty that the hives were caused by the implantation of the spinal cord stimulator on May 16th and not some other source,” he stated that the stimulator was “one of the top possibilities.”

Id. at *6.

Plaintiff’s dermatologist testified that something at the time of the surgery triggered the hives, that the timing of the implant and removal created an “association,” but that there was no test to determine the cause of the hives:

There was something around the time of the surgery that triggered a hive-like reaction. The device was used, but other things were used at the time of the procedure, such as prep and — however, when the device was removed, her hives and itching in that area went away, so there’s an association with that. Unfortunately, there’s no test for [these types of] reactions in this situation.

Id. at *6-7. She did not testify on causation to a reasonable degree of medical certainty.

Finally, plaintiff’s allergist stated that it was “plausible” that plaintiff had an allergic reaction to the device, and later said that she “believed” the device caused the hives:

Q: You stated it was plausible that she had an allergic reaction to the device; is that correct?

A: I think everything is plausible, but, yes.

Q: Okay. The fact that she reported she had hives after the device, and her hives stopped after the device was removed, would that further support the conclusion that it was plausible that the device caused a reaction?

[Defense counsel]: Object to the form.

The witness: I would — yes.

[Plaintiff’s counsel]: And earlier you testified regarding the correlation and the difference between general hives versus local hives.

A: Yes.

Q: Do you believe the stimulator caused the local hives she reported to you?

A: Yes.

[Defense counsel]: Object to the form.

[Plaintiff’s counsel]: That was a yes?

A: Yes.

Id. at *7. Again, there is no indication that the allergist testified that her “belie[f]” was held to a reasonable degree of medical certainty, or to any degree of certainty or even probability.

The court, discussing two cases involving less complex science, one of which did actually involve a plaintiff’s general causation expert, held that this treater testimony, along with the general sequence of events, was enough. In fact, while Medtronic had two experts opine to a reasonable degree of medical certainty that the device did not cause the allergic reaction—the only two causation experts in the case—the court noted that these experts “did not eliminate the possibility that it could have done so.” Id. *15.

If the analysis comes down to this, it’s not clear that a defendant could ever win summary judgment. Almost any causation issue would be trial ready, despite what could be a lack of any real science behind it or an expert to opine on that science to a reasonable degree of medical certainty.

The Canary doesn’t look so good anymore. Time to get out of the coal mine.

We’ve written about a lot of Risperdal summary judgment wins. No medical causation, no warnings causation (learned intermediaries aware of risks), no alternative design, no fraud. So, when we see an opinion that overturns a plaintiff’s verdict on the grounds of (1) impossibility preemption; (2) clear evidence preemption; and (3) no evidence of general causation, we can’t help but wonder how it got to trial in the first place. So we decided to do a little digging. From our review of the case, it appears these issues were all raised at the summary judgment stage but denied. What changed before and after trial? Not the facts that support these arguments. The regulatory history hasn’t changed. The experts’ opinions haven’t changed. Yet, defendant had to go through an amateur-hour trial (we’ll tell you more about that later) and then wait over a year for these post-trial rulings granting judgment as a matter of law. Sure, better a late win then no win at all – but it certainly feels like this could have been avoided.

The case is Byrd v. Janssen Pharm, Inc., No. 1:14-cv-0820, slip op. (N.D.N.Y. Sep. 21, 2018) and, as mentioned above, involved Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism. Plaintiff alleged that his use of Risperdal caused him to develop abnormal breast tissue growth. The two claims that went to trial were negligent design, manufacturing, and warning defect and strict liability design, warning, and misrepresentation. Id. at 3.

The opinion methodically sets out both defendant’s arguments and plaintiff’s responses, but we’re going to jump right to the conclusions. First up was preemption. Standard plaintiff argument: defendant unilaterally should have changed its warning to include gynecomastia and was able to do it via the Changes Being Effected (“CBE”) regulations. Standard impossibility preemption defense: federal law prohibited defendant from changing the FDA-approved labeling and/or there is “clear evidence” that the FDA would have rejected the proposed labeling change. Id. at 12. The court was persuaded as to both impossibility and clear evidence. Defendant presented “clear evidence” that the FDA had rejected its request to add safety and dosing information for pediatric use of Risperdal. Id.

But the court spent most of its analysis on whether a CBE label change even was permissible under federal law. A CBE labeling change can only be made on the basis of new information concerning a serious risk. “[H]ere, the relationship between antipsychotics and [abnormal breast development] was not new information because it had been discussed in basic psychiatry textbooks for decades, and the FDA does not consider gynecomastia a serious adverse event.” Id. at 9. A “serious” adverse event is defined by federal regulations to be an event that either “resulted in inpatient hospitalization or required surgical intervention to prevent inpatient hospitalization.” Id. at 15. And, both plaintiff’s and defendant’s regulatory experts agreed that gynecomastia “would not be a serious adverse event.” Id. at 16-17. Now, plaintiff’s expert was Dr. Plunkett and she was quick to voice her personal disagreement with the FDA on this point – but that’s irrelevant (both to us and to the court). Id. at 17.

The court didn’t stop there. Defendant also argued that plaintiff had failed to satisfy his burden of proof on causation. While defendant made arguments regarding both proximate and medical causation, the court focused its attention on the latter and specifically the lack of general causation evidence. Id. at 26. Starting with Dr. Plunkett who “admitted to not being a causation expert,” but opined on it anyway – the court found her opinion unsupported by the literature. Id. None of the three pieces of literature relied on by Dr. Plunkett included a control group, so at best they were evidence of an association, not a correlation. Dr. Plunkett’s reliance on this literature demonstrated a “disregard for the difference between an association between two things and a causal relationship between those two things.” Id. at 29; see id. at 30 (“a correlation between Risperdal and gynecomastia cannot be drawn without a control group”). The fact that these studies lack a control group was likely not “new” information at trial and again begs the question why this issue is only being properly addressed post-trial.

Plaintiff’s other causation expert likewise had no support for a general causation opinion. His conclusion was that plaintiff’s gynecomastia was “secondary at least in part to prolonged use of Risperdal.” Id. at 31. But, putting aside reliance on the same literature relied on by Plunkett, the only basis plaintiff’s second expert had for his general causation opinion was his differential diagnosis. A differential diagnosis, however, “generally does not prove general causation.” Id. at 33. It assumes general causation has already been proven. Without general causation, defendant was entitled to judgement as a matter of law.

Still, the opinion continues. The remainder of the decision addressed defendant’s alternative request for a new trial based on the inappropriate conduct of plaintiff’s counsel. The court did not need to decide this issue having already found two grounds to overturn the verdict and award judgement in defendant’s favor. Based on the description of plaintiff’s trial antics, however, we can only assume that the court wanted this opportunity to admonish plaintiff’s counsel. Defendant pointed out 23 separate incidences of plaintiff’s attorney’s misconduct in front of the jury. Id. at 34. In concluding that plaintiff’s counsel’s behavior did warrant a new trial, the court relied on:

(1) Plaintiff’s counsel’s self-deprecating tone of voice and posture when referring to his lack of professional skills and/or experience, (2) his helpless tone of voice and posture when referring to the fact that he was bullied as a child, (3) his alternating innocent and defensive tones of voice in response to an admonishment by the Court, (4) the sympathetic facial expressions of the jurors following the aforementioned acts and/or accompanying comments, (5) the credulous expressions of the jurors following Plaintiff’s counsel’s acts of asserting the truth of Plaintiff’s case and/or vouching for his witnesses, and (6) the jurors’ reactions following Plaintiff’s counsel’s acts of offering his personal opinions about the evidence and/or testifying when he could not otherwise introduce evidence.

Id. at 37-38. While this behavior more than justified a new trial – it wasn’t necessary because no childish antics could overcome the fact that plaintiff had failed to prove general causation and that defendant had clear evidence to support impossibility preemption. Both of those things were true a year ago too. But better late than never.

A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been the neighborhood fox, known to all for years (we live right next to Valley Forge National Park).  The conversation went back and forth for a while, eventually including descriptions of larger size, different coloration, and much longer legs than the fox’s.  We remained unconvinced.  Eventually, our neighborhood e-mail chain came alive with close-up photos of what was undeniably a coyote, taken a scant hundred yards away in a neighbor’s back yard.   Because we are law nerds, it occurred to us that coyotes are just like causation:  an expert can assert a causal link, and assert it again, but, ultimately, there has to be evidence to support the assertion.

As the court agreed in today’s case, a nice (albeit unreported) affirmance of a HUMIRA summary judgment victory out of Maryland’s Court of Special Appeals. In Larson v. Abbott Labs., Inc., 2018 WL 3479236 (Md. Ct. Spec. App. July 19, 2018), the plaintiff, a highly-educated space engineer who had been diagnosed as HIV-positive years before, alleged that the defendant’s psoriasis medication caused him to become sufficiently immunocompromised that he contracted progressive multifocal leukoencephaly (PML).  PML is an often-fatal viral brain disease that left the plaintiff physically disabled and cognitively impaired, and unable to care for himself.  PML is caused by a virus that that is present in the bodies of most adults in the United States but that generally remains inactive except in severely immunocompromised people. HUMIRA’s prescribing information warned that medications of its class had the potential to affect defenses against infection, and that the safety and efficacy of the medication in immunosuppressed patients had not been evaluated.  The warnings did not specifically mention HIV patients.

The plaintiff had been diagnosed as HIV-positive five years before he took HUMIRA. During that time, he treated his plaque psoriasis with home remedies.  When it worsened, he asked his treater about treatment with HUMIRA.  She sought information from the defendant, then referred the plaintiff to a physician who concluded from the information that, because the plaintiff’s HIV was well controlled and that he was not severely immunocompromised (and because a tuberculosis skin test came back negative), he was an appropriate candidate for the medication.  What was unknown to the doctor – and apparently to the plaintiff – was that recent lab results revealed progression of his HIV disease.   (The plaintiff’s infectious disease specialist had attempted to contact him with the results, but he hadn’t responded by the time he began his HUMIRA treatment.) Within three months after beginning his treatment, he began exhibiting headaches and extreme fatigue.  His condition worsened, and he was diagnosed with PML shortly thereafter.

The plaintiff filed suit, asserting the usual product liability claims. His primary causation expert was a “highly-regarded infections disease specialist with significant experience” treating HIV-positive patients. Larson, 2018 WL 3479236 at *7.  The defendant moved to exclude the expert’s opinion.  The trial court granted the motion, and, because the plaintiff was left without expert causation testimony, the court granted summary judgment for the defendant.  The plaintiff appealed.

The plaintiff presented several questions for the appellate court’s determination, including questions related to the trial court’s holdings about the adequacy of the product’s warnings. The appellate court found that it needed to consider only one question – whether the trial court erred in barring the testimony of the plaintiff’s general and specific causation experts and granting summary judgment – because a negative answer to that question obviated the need to consider any of the others.  In the process, the court rejected the plaintiff’s argument that the it needed to address the adequacy of the warnings whether or not the plaintiff could establish medical causation.  As the court explained,

Generally, the “proximate causation element” in a failure to warn case against a pharmaceutical manufacturer is established by proof that the allegedly inadequate warning was a substantial contributing factor to the plaintiff’s injury. . . . In certain product liability cases, however, such as the case before us, the parties disagree over whether sufficient evidence exists to show that the product, itself, can cause the specific injury alleged and, therefore, whether the manufacturer had a duty to provide different or additional warning to prevent the injury. . . . . What is often termed “general causation” is present “when a substance is capable of causing a given disease. . . . General causation, therefore, relates to the element of duty — i.e., whether the risk of the type of injury the plaintiff suffered was reasonably foreseeable, and therefore, whether the manufacturer had a duty to warn the prescribing physician in the first place. . . . Evidence demonstrating [medical] causation . . . must exist independent of whether the manufacturer’s allegedly defective warning label was a proximate cause of the injury. In other words, evidence of general and specific causation was necessary in this case to establish [the defendant’s] duty to warn . . . .

Id., at *9-10. And so the court proceeded to determine whether the trial court had erred in excluding the plaintiff’s causation experts. The plaintiff’s causation theory was that “the immunosuppressant effect of HUMIRA permitted the ‘unmasking’ of [the virus that causes PML], despite the fact that” the plaintiff was not as immunosuppressed as HIV-positive patients who develop PML” even in light of his most recent lab results.  Id.  Maryland is a Frye state.  Under that standard, as the court explained, an expert’s opinion is admissible only if the basis of the opinion is “shown to be generally accepted as reliable within the expert’s particular scientific field.” Id. at *12 (internal punctuation and citations omitted). The standard applies equally to new scientific techniques and to accepted methods applied to support novel theories.

With respect to plaintiff’s main causation expert, the trial court had held that his causation conclusions “[had] not been sufficiently tested and proven to qualify as reliable forensic conclusions rather than scientific hypothesis.” Id. at *13.   The expert’s primary contention was that, “in addition to general HIV disease progression, some additional functional immune deficit must be present for PML to occur,” and that HUMIRA caused that deficit in the plaintiff. Id.   The trial court held that the expert had not considered other potential contributing factors, and that he could not provide a sufficient factual basis for his opinion that HUMIRA was “the missing link.” Id. at *14.

The appellate court stated that, “to constitute a sufficient basis for his general causation opinion, Dr. Jacobson needed to provide support for his contention that” the class of drugs was “known to be associated with an increased risk of PML” at the time the plaintiff took the drug. Id. The plaintiff contended that this support was to be found in the expert’s reference to the drug’s black-box warning about opportunistic pathogens coupled with “well-documented reports of PML occurring in patients who had received” this class of drugs.” Id. But, the court pointed out, the expert did not discuss the “well-documented reports of PML” or explain how the reports helped form the basis of his opinion.   The plaintiff also asserted that the expert relied on “peer reviewed studies, reviews of other biologicals, and FDA Adverse Event Reporting data,” but, the court found, he did not explain how the existence of case reports demonstrated a causal connection, and, the one article he cited related to a drug with a different mechanism of action than HUMIRA’s.

The court echoed the trial court’s holding that there “is sound scientific reasoning to suggest that [the drug’s immunosuppressive effect] could be a factor, but it falls short of showing with any degree of reliability that it is a factor, much less a substantial contributing cause” of the plaintiff’s PML. Id. at *15 (emphasis in original).   The court also reviewed the depositions of the plaintiff’s other experts, and held that, although they “believed that [the plaintiff’s] use of HUMIRA likely contributed to his immunological decline, none could provide a sufficient factual basis for that conclusion. . . . Indeed, [one] conceded that a scientifically reliable causal association” had not been established, id., and another stated “more unequivocally that he believed that [the plaintiff’s increased immunosuppression]” occurred “independent of HUMIRA, representing progression of his HIV disease.”  The same expert discussed an article establishing “the theoretical possibility” that the class of drugs was associated with PML, but explained that “it [didn’t] necessarily establish causation . . . .” Id.

The court commented that it agreed with the trial court that “it may well be that additional research will confirm some or all of [the expert’s] hypotheses. What is determinative in this case, however, is that those causal theories have not been established now nor were they established” when the plaintiff took the drug.  The court also acknowledged that there were ethical obstacles to conducting controlled studies on HIV-positive individuals, and that, because PML is a rare disease, “the amount of epidemiological data that could be useful is limited.”  But this didn’t excuse the experts’ theoretical causation opinions.  The court concluded, “We hold that [the plaintiff’s] experts’ opinions were not grounded on an adequate supply of data, and, therefore, the circuit court properly excluded their testimony.” Id. at *16,

We love a good expert exclusion. BTW, the coyote pictures are really cool.  E-mail us, and we will send them to you.

 

 

Today’s case has a little bit of everything – choice of law, statutory compliance, alternative design, warnings causation. So, the decision is a bit of “grab bag” in addition to being a “mixed bag.”

The case is Hyde v. C.R. Bard, Inc., 2018 WL 3586404 (D. Ariz. Jul. 26, 2018). To begin with, plaintiff voluntarily withdrew several claims – manufacturing defect, breach of express warranty, failure to recall, and breach of implied warranty. Id. at *2. Defendant did not move for summary judgment on negligent design defect, negligence per se, or punitive damages – so those claims remain. That left failure to warn, misrepresentation and fraud, and strict liability design defect. Of those, only strict liability design defect survived. Id.

The court first had to decide which state’s law applied. Plaintiff was living in Wisconsin when she had the IVC filter implanted but did not experience any complications until after moving to Nevada. Plaintiff argued that Nevada law should apply as the location where the injury occurred. The court disagreed. Wisconsin, the forum state, applies a two-step analysis for choice of law questions. First, are one state’s contacts so minimal that applying that state’s law would be “officious intermeddling.” Id. The court found both states to have significant contacts with the case and so moved on to step two. This consists of the analysis of 5 factors. The court found three factors (maintenance of interstate order, simplification of the judicial task, and application of the better rule of law) to be neutral. Id. at *3-4. And the remaining two favored Wisconsin. As to predictability, the IVC filter was sold in Wisconsin, implanted in Wisconsin, and defendant’s interactions with the implanting surgeon took place in Wisconsin. So, defendant could reasonably expect Wisconsin law to apply to any products liability claims arising from the use of the filter. Id. at *4. As to the forum state’s interest, Wisconsin “has a strong interest in having its laws applied to corporations transacting business with the state. Id.

 Wisconsin’s product liability statute provides a presumption that a product is not defective if it complied with relevant standards or specifications approved by a state or federal agency – such as the FDA. Defendant therefore argued that because the IVC filter was cleared by the FDA via the 510(k) process, the presumption applied. The court however, refused to apply the statutory compliance presumption because the 510(k) process is not a safety review and therefore defendant was not entitled to the non-defectiveness presumption. Id. at *6.

Another defense to strict liability claims in Wisconsin is that the harm was caused by a known and inherent risk. Defendants argued, citing to publications, FDA documents, and plaintiff’s surgeon’s testimony, that the very complication suffered by plaintiff was well known in the medical community. Id. at *7. Plaintiff countered that while the general risk may be known, the fact that defendant’s filters had a higher adverse event rate than other filters was not known. The court decided that any challenge as to incident rates is a triable issue of fact for the jury. Id.

Turning to plaintiff’s burden of proof, to maintain a claim for strict liability design or warning defect, plaintiff has to establish that the risk of harm could have been “reduced or avoided” with a “reasonable alternative design or warning.” Id.   In this case, plaintiff’s expert pointed to anchors that were added to other of the defendant’s IVC filters as a specific and available alternative design. Defendant argued that plaintiffs in the litigation claim that those other IVC filters also are defective. Essentially plaintiff relied on an allegedly defective design as the alternative to the allegedly defective design at issue. Id. That feels like it should be a non-starter. But the court said that the alternative design only has to “reduce” the risk of harm. Id. So, if the alternative is slightly less defective that appears to be enough. Again, a bit of a head scratcher.

Moving on to failure to warn, the court found plaintiff’s claim failed for lack of evidence of causation. The court skirted the issue of learned intermediary, on which the Wisconsin Supreme Court has not ruled, finding that plaintiff identified no evidence that either plaintiff or her surgeon would have changed his/her decision regarding implanting the device. Id. at *8-9. In fact, plaintiff’s surgeon testified that he didn’t recall which filter was used or who made the decision to use that filter. He further testified that he trusted the FDA, the device was meeting the expectations of the FDA, and he wouldn’t have deferred implanting the filter where it was medically necessary. Id. at *9. Put all together, there was nothing in the record to establish that a warning about greater risks would have affected either the surgeon’s or the plaintiff’s decision to use the product.

That same rationale carried over to plaintiff’s misrepresentation and fraud claims where reliance is an essential element. Plaintiff never received any independent information from the defendant nor did she point to any information from the defendant on which her surgeon relied. Id. at *10.

So, the case remains although substantially cutback. Just two quick observations from reading between and outside the lines of the opinion as to negligence per se, on which defendant did not move for summary judgment. First, if 510(k) clearance doesn’t involve “safety,” how can negligence per se apply? It would seem that following the court’s logic, the 510(k) process does not rise to the level of a substantive standard of care that can support plaintiff’s negligence per se claim. Second, back in March we reported on another partial summary judgment win in the Bard IVC Filter MDL. In that case, this same court granted summary judgment on negligence per se finding that the claim could not be based on alleged FDCA violations because there is no private right of action to enforce the Act. See prior post here. From an outsider’s perspective, it feels like negligence per se should be out of this case as well.

This post is from the non-Reed Smith side of the blog only.

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA. It is a claim that should not survive either express or implied preemption.

But, some courts do allow it, such as Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018). Now, we think the Bull court is overstating when it says “most courts” to have considered a failure to report claim have found it to be a parallel claim. We refer you to our PMA Preemption scorecard which clearly shows this is an issue on which courts are split. Nor is the reasoning of the opinion anything new. Defendant had a duty under state law to warn physicians and a duty under federal law to comply with adverse event reporting requirements and those two requirements aren’t in conflict with each other. Id. at *8. But just because two roads don’t intersect doesn’t mean they are parallel.

And, because Pennsylvania doesn’t recognize a state law failure to report claim, any such claim exists solely as a result of the FDCA and therefore should also be impliedly preempted. Again, having concluded there are parallel duties, Bull also concludes no implied preemption. The court found that plaintiff alleged a valid state law failure to warn claim that was based on a failure to comply with its federal duty to report adverse events to the FDA. Id. at *9.

We don’t like those conclusions, but it’s also not the first time we’ve seen them. Where we usually take solace is that more often than not a finding that a failure to report claim is not preempted is followed by a finding that it is also not adequately pleaded. We refer you back again to the PMA Preemption scorecard for the many, many decisions reaching that conclusion. The primary reason the claim fails TwIqbal – failure to sufficiently plead causation.

Unfortunately, the court in Bull gave plaintiff a pass on pleading physician-specific warning causation. The complaint “does not even allege that [plaintiff’s] doctors consulted the [FDA adverse event] database, or any other source of . . . adverse event reports, when making their treatment decisions.” Id. But the court found that unnecessary. Instead, all that was required was an allegation that prior to the implantation of the device in plaintiff, defendant failed to disclose adverse events that if disclosed may have led her doctor’s not to use the device. Id.

That shouldn’t be enough. Even Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which allowed a failure to report claim, acknowledged that causation is a particularly problematic hurdle for plaintiffs:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Therefore, the causal chain requires both that the FDA would do something differently (such as make the adverse events public), and that that hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. Plaintiff’s allegations in Bull, as set forth in the opinion, are much too vague to support a plausible causation claim.

And the analysis shouldn’t have stopped there. The opinion actually sets forth sufficient facts that were pleaded to support reaching just the opposite conclusion on causation.

First, would the FDA would have done something differently? Plaintiff had the device implanted in 2010 and began experiencing problems with it in 2015. Bull at *5. Per the facts alleged, in 2009 the FDA conducted an inspection of defendant’s manufacturing facility. Id. at *2. The report of that inspection included information about Medical Device Reports (MDRs) that were either untimely or not submitted to the FDA. Id. at *3. It also included an analysis of MDRs both at the company and within the FDA’s database. Id. at *2-3. So, what the facts establish is that the FDA became aware of these adverse events a year before plaintiff received the device and at no time prior to plaintiff’s surgery did the FDA require defendant to take any further action to warn physicians beyond the existing labeling and warnings. So there is no causal nexus between the alleged failure to report and plaintiff’s injury.

Moreover, to the extent plaintiff relies on a 2011 FDA Safety Officer Report and a 2012 483 Inspection, those took place after plaintiff was implanted with the device and if they involve allegedly unreported events after 2010 – they can have no bearing on causation. To establish causation plaintiff should be required to prove (and plead) that had the adverse events been properly reported to the FDA, the information would have reached plaintiff’s physician in time to prevent the alleged injuries.

Second, would plaintiff’s doctors have done something differently? Well, because the FDA didn’t take action the answer is there is nothing to trigger plaintiff’s doctors doing anything different either. But, there is also the added fact that in this case after the events were reported and the FDA did require some additional warnings and even after the FDA recalled the device – plaintiff’s doctors did not explant the device. Id. at *5. While we are only privy to what’s reported in the complaint, we think the second link in the causal chain is likely broken as well.

We have a hard time imagining this case getting beyond summary judgment on causation based on what we see as the regulatory history from the opinion. We’ve talked in greater detail about this causation hurdle in failure to report cases here. So, while defendant lost at this stage, we are optimistic about a win in the future.

This post comes solely from the Cozen O’Connor side of this blog.

 

Last week, the Judge in the Testosterone Replacement Therapy (TRT) MDL threw out an over $140 million jury verdict. In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 2018 U.S. Dist. LEXIS 111724 (N.D. Ill. July 5, 2018). It wasn’t the first time that the testosterone MDL court did something like that. Last December, it threw out a $150 million verdict. That’s almost $300 million in verdicts total. It’s got to take some strength to toss such hefty verdicts—testosterone or not.

In each instance, the court found the jury’s verdict to be so internally inconsistent that it required a new trial. In the verdict tossed last week, the jury found for the defendants on a failure to warn claim based in strict liability claim but found for the plaintiff on a failure to warn claim based in negligence. That sure does seem inconsistent.

Each claim turned on the same two disputed elements: (i) whether the TRT product, AndroGel, was unreasonably dangerous and (ii) whether its unreasonable dangerousness was a cause in fact and legal cause of the plaintiff’s injury (a heart attack). Id. at *419. In an attempt to save the verdict, plaintiff’s attorneys tried to reconcile these two findings. They argued that the strict liability claim had a different focus from the negligence claim. The strict liability claim focused on the AndroGel product itself and whether its deficient warnings caused plaintiff’s heart attack, while the negligence claim focused on defendants’ conduct and whether their negligence caused plaintiff’s heart attack. Id. at *420.

Um . . . . Okay. That does describe a different focus. But, either way, whether viewed as a product with deficient warnings or as defendants who negligently provided deficient warnings, the jury was ultimately answering the same question: did the AndroGel cause the heart attack? The causation questions were precisely the same:

[Plaintiff] has not articulated any theory, supported by evidence, of how [defendants’] breach of its duty of care could have been the cause in fact and legal cause of [Plaintiff’s] heart attack unless AndroGel itself was a cause in fact and legal cause of the heart attack. As [defendants] put the point in [their] reply, regardless of what the elements of each claim “focus on,” the claims share an essential causation question—whether AndroGel caused [plaintiff’s] heart attack.

Id. at *422. The court threw out the jury’s verdicts on both claims:

The verdicts on these claims are inconsistent under the instructions given to the jury. When this happens, the Court cannot accept one of the two inconsistent verdicts while discarding the other; both of them have to go.

Id. at *424-25.

But the jury also found for plaintiff on a misrepresentation claim, and that claim did not require a finding of “unreasonable dangerousness,” be it through deficient warnings or otherwise. Accordingly, the court found that this particular pro-plaintiff verdict was not necessarily irreconcilable with the jury’s finding against plaintiff on the strict liability claim. Id. at *425. Yet the court ordered a new trial on the misrepresentation claim too. It was not sufficiently distinct and separable from the other claims to protect against injustice resulting from two separate trials with separate verdicts. In particular, the jury received a single causation instruction for all claims:

[T]he Court does not believe that it can appropriately order a new trial limited to the negligence and strict liability claims while keeping the misrepresentation verdicts intact. A court may order a partial new trial only if “it clearly appears that the issue to be retried is so distinct and separable from the others that a trial of it alone may be had without injustice.” In this case, one of the key disputed issues was causation, specifically whether AndroGel cased [plaintiff’s] heart attack. The jury was given a single causation instruction that covered all of the claims. Thus the issue of causation on the two claims that have to be retried due to the inconsistency of the jury’s verdicts is anything but “distinct and separable” from the issue of causation on the misrepresentation claims. For this reason, the Court concludes, it would be impossible to limit a new trial to the inconsistent claims “without injustice.” The appropriate remedy for the jury’s inconsistent verdicts on the strict liability and negligence claims is “[a] new trial on all claims.”

Id. at *426-27.

So out goes another hefty jury verdict in the testosterone MDL. The last time the MDL court did this, when it tossed out the $150 million verdict in December 2017, the jury at the second trial awarded $3.2 million. That’s not a small verdict, but it’s almost $147 million smaller than the first verdict. That’s a pretty significant, as they say, delta. So let’s see what happens in the new trial this time.

It has been said, with maybe a bit of sarcasm, that a company developing a drug hopes that its drug will become successful enough to attract frivolous lawsuits.  OK, so maybe only outside lawyers have offered such an aphorism, but bear with us.  Imagine that a drug is developed to treat a really common condition, like high cholesterol, it becomes accepted as a first-line treatment, and becomes one of the most widely used prescription drugs of the last few decades.  Imagine then that the patient population that would take this drug has lots of co-morbidities and that, while the drug is being used on a long-term basis, some predictable portion of the drug’s users will develop a new condition, like diabetes.  Imagine then that, because the drug has been widely used for so long, there are lots of studies, published and unpublished, that look at measures like blood glucose and new diagnosis of diabetes, among many other things.  It should not be hard to imagine that thousands of the patients taking the drug would develop diabetes on the drug in the absence of any relationship and that plaintiff lawyers would round many of them up to sue based on the expectation that the lawyers and their favorite experts could gin up proof of causation that would survive a Daubert challenge if the manufacture did not pay to get rid of the litigation first.  This is hardly fancy as we have posted on multiple orders from Lipitor MDL (here, here, and here) that excluded plaintiffs’ causation experts and then granted summary judgment for the manufacturer across the board.

Much like the Zoloft MDL affirmance we lauded last year, all of this went up on appeal to either revive or affirm the end of an entire litigation.  We are pleased to say that In re Lipitor (Atorvastatin Calcium) Mkt’g, Sales Pracs. & Prods. Liab. Litig. (No. II), MDL No. 2502, — F.3d —, 2018 WL 2927629 (3d Cir. June 12, 2018), did the latter.  Without repeating the history of all of the decisions below that we detailed previously, there were five basic issues on appeal, the admissibility of each of the three experts plaintiffs offered, whether plaintiffs could use other evidence to establish causation without experts, and whether plaintiffs’ responses to show cause orders were sufficient to avoid summary judgment.  Each deserves some attention.

Plaintiffs’ statistician was up first.  His approach was to re-analyze clinical trial data to suggest that there was an increase in blood glucose levels and infer that as proof of causation for diabetes.  The disconnect here is fairly obvious, but the statistician compounded the problem by including both patients with a single instances of elevated glucose levels during the trials and patients with elevated glucose levels before the study began. Id. at *4.  Plaintiffs, their statistician, and other experts had agreed that a single increased glucose level did not indicate diabetes. Id. The statistician also agreed, as the MDL court put it, that he “lacked the expertise to opine about any implications that single glucose readings might have about the possibility of new-onset diabetes.” Id. This might have been enough to exclude his opinions, but he also relied on one test of statistical significance after the standard test failed and presented calculations of average blood glucose increases in a misleading and result-driven fashion. Id. at **5-6.  He also re-analyzed a study that had found no increased in the rate of diabetes with the drug compared to placebo based on a applying a new definition of diabetes after the fact and by someone who lacked relevant expertise. Id. at **6-8.  The Fourth Circuit affirmed the exclusion of his opinion, noting that the MDL court “properly discharged its gatekeeping duty” by weighing “classic concerns regarding reliability and relevance.” Id. at *6.

Plaintiffs also offered an internist to interpret the medical literature and perform meta-analysis of select studies, which he attempted to dress up with a purported application of the Bradford Hill criteria.  Noting the importance of dose to these analyses, the MDL court asked the internist to provide an analysis specific to each commercially available dose of the drug.  The MDL court ultimately excluded his causation opinion as to all but the highest dose because he acknowledged there was not a statistically significant increased risk of diabetes for the other doses. Id. at *9.  On appeal, plaintiffs challenged that their internist could not just lump all the doses together and offer a single causation opinion.  Given the facts here—like a 10 mg low dose, a 80 mg high dose, and studies specific to each dose—we do not think this requirement should have been the least bit controversial.  The Fourth Circuit, however, while holding that the MDL court did not “abuse its discretion in asking the expert to produce a dose-by-dose analysis,” cautioned that this was not a new requirement for all cases. Id. at *10.  The more serious, and recurring, issue was whether statistical significance was required for a causation opinion based on epidemiologic evidence and the Bradford Hill criteria.  Again, we think the Fourth Circuit could have gone a little farther—like you always or almost always need epidemiologic evidence as a starting point for causation in a product liability case and epidemiologic evidence must be statistically significant (with multiple studies with an increased risk greater than 2.0) to count—but its conclusion that the MDL court had not abused its discretion on the record here was good enough.  Specifically, the internist’s purported application of the Bradford Hill criteria and failure to establish that reliance on non-statistically significant results was accepted by epidemiologists were enough for the court to find his causation opinions unreliable. Id. at *12.

Plaintiffs also offered another internist to opine on specific causation for one of the bellwether plaintiffs.  While the plaintiffs touted that this expert had used a differential diagnosis to come to her opinion, the expert herself did not say that she did and claimed to use a methodology for her opinion in litigation that she had never used in her own practice. Id. at *13.  She also could not rule out other causes like the plaintiff’s weight and weight gain and relied too heavily on the post hoc ergo prompter hac fallacy. Id. at *15.  Again, this exclusion was within the MDL judge’s discretion.

Like the MDL court, the Fourth Circuit did not a bright line rule on whether general medical causation for product liability cases involving a pharmaceutical could ever be established without any expert testimony from the plaintiff.  We think the better approach, as spelled out in some state’s law, is to require expert testimony on these issues.  However, the Fourth Circuit’s conclusion that the specific non-expert evidence offered by plaintiffs—principally snippets from U.S. and foreign labeling—was not enough to establish causation is fine by us.  The causation issues are “complex and manifold” and the non-expert evidence from plaintiffs “isn’t especially strong.” Id. at *17 (contraction in the original).  So, the bottom line was more than fine by us:  “To hand to the jury the evidence here and ask it to reach a conclusion as to causation with any amount of certainty would be farcical and would likely result in a verdict steeped in speculation.” Id. Put another way, if a court is supposed to be the gatekeeper for expert evidence on key issues, it cannot just allow dubious non-expert evidence to suffice on an issue that would require an expert under Rule 702.

The last issue for the Fourth Circuit to address was whether the MDL court could require the remaining plaintiffs to come forward with evidence showing they could prove specific causation after the Daubert and summary judgment orders.  Plaintiffs’ argument on this was essentially that the MDL should have remanded all the cases rather than fulfilling the mission of the MDL court to decide common pretrial issues.  This argument was a bit disingenuous, because the plaintiffs surely would have been comfortable with summary judgment or Daubert motions being denied across the board had the rulings on the bellwether cases gone their way.  “Here, it was the district court’s prerogative to determine whether it could dispose of the cases before it on the merits.” Id. at *18.  We may not always be a fan of the direction MDL courts have taken in the last decade or so, but they are supposed to do what the MDL court did here.  At the end of the day, this MDL court “discharged [its] duties meticulously and thoughtfully” an ended a litigation as it should have been – with the manufacturer winning without facing the uncertainty of jury trials or succumbing to the pressure of a large number of pending cases.