If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA’s rejection of the same proposed label, FDA’s statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA’s pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosamax decisions out of the District of New Jersey, which we touted not too subtly. Then the Third Circuit reversed, essentially holding that summary judgment cannot be granted for defendants under a Levine analysis because juries have to decide whether the clear evidence bar was met. We sharpened our proverbial pens to decry the reasoning of that decision, its impact on litigation, and its invitation for juries to second-guess FDA.

We have, of course, tracked the appeal of Fosamax to the Supreme Court, including the amicus brief of the Solicitor General and the oral argument. The Solicitor’s brief advocated that judges should decide preemption under Levine when interpreting the scope of an agency decision is required for the decision. Drawing on the Administrative Procedures Act, the brief argued that “[n]o sound reason exists for treating the meaning and effect of an FDA administrative determination differently” than other federal agency decisions, which are questions of law. Drawing on Supreme Court authority in the patent context, the brief reasoned that “[t]o the extent extrinsic evidence may sometimes be relevant in litigation between private parties to determine the meaning and effect of FDA’s agency action, the court’s evaluation of such subsidiary facts does not alter the ultimate legal character of the inquiry or the court’s exclusive authority to resolve it.” Cases are not exactly on hold while the Supreme Court mulls over what to do with the Fosamax appeal, so we were intrigued by the question certified on appeal in Rinder v. Merck Sharpe & Dohme Corp., — N.E. 3d –, 2019 IL App. (1st) 171969 (Ill. App. Jan. 23, 2019):

Under [Levine] federal law preempts state-law failure to warn claims related to the use of a prescription drug if there is “clear evidence” that the FDA would not permit the manufacturer to include the plaintiff’s requested warning in the drug’s labeling. Is the question whether the defendant has presented the necessary “clear evidence” one for resolution by the court or jury?

We will skip over the underlying facts of the case, but we can say there are multiple FDA decisions to be interpreted, it was pretty to clear to us that FDA would have rejected the label plaintiff wanted when they wanted it, and the plaintiff’s arguments seemed to hinge on after-the-fact evidence of causation. But here is where we come back to Fosamax. Although most published decisions involved the court deciding whether there was the clear evidence in the record required by Levine, the court identified Fosamax as the only relevant federal circuit decision and proceeded to follow it in rejected each of defendant’s arguments for why the court should decide the issue and find it was impossible to the defendant to have the label that plaintiff wanted. In essence, the Rinder court ruled that “the issue presented by the [Levine] inquiry is simply a particular application of the task juries regularly perform in tort cases, determining what the evidence shows probably would have happened if the allegedly wrongful conduct had not occurred.” Therefore, substantive Illinois law would require a jury to consider the defense of conflict preemption and summary judgment would be impossible in cases where plaintiff could come up with some arguments against defendant’s urged interpretation of the FDA’s decisions. Until Fosamax is reversed or at least rejected by other circuit courts, this is the sort of facile decision we will keep seeing.


An unexpected bit of good news as we go into November. Bexis will be presenting at the Reed Smith annual client CLE program on big-deal pending cases.  In preparation, he took a look at the SCOTUSBlog page for Merck Sharp & Dohme Corp. v. Albrecht, No 17-290 (that’s the Supreme Court name for In re Fosamax in the Third Circuit).  There’s a new entry from last Friday: “Justice Alito is no longer recused in this case.”  See also, from the Supreme Court’s official docket:

Oct 26 2018 Justice Alito is no longer recused in this case.

That’s good news for our side, because as we mentioned at the time certiorari was accepted:

We do note one unfortunate aspect of the order granting review: “Justice Alito took no part in the consideration or decision of this petition.” Since Justice Alito has historically supported preemption – he wrote the dissent in Wyeth v. Levine, 555 U.S. 555 (2009) – that means we’re short a vote.

Not any more. Our understanding, based on something we heard several years ago, is that Justice Alito at one time held stock in Merck. Evidently not any longer. While we’re not counting our chickens in Albrecht before they’ve hatched, we’re not playing a man short any longer, either. So we like our side’s chances in Albrecht even better now.

For more of our Albrecht/Fosamax coverage see here, here, here, and here.

We immediately called for the further appeal and reversal of the hideous decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, we’re just bloggers.  Thus, we were greatly pleased when the United States Supreme Court, on December 8, 2017, requested the views of the Solicitor General on whether to grant certiorari in the Fosamax appeal, now known as Merck, Sharp & Dohme Corp. v. Albrecht, No. 14-1900 (U.S.).

We’re even more pleased, now that we have read the Solicitor General’s responsive brief, which we have just received.  Getting right to the point – the bottom line:

In the view of the United States, the petition for a writ of certiorari should be granted.

United States Amicus br. at 1.  Even though “[n]o circuit conflict yet exists,” the issue in its MDL context is sufficiently “significant” to grant certiorari now.  Id. at 12.

Although the question is close, . . . this Court should grant certiorari.  The underlying issue in this preemption case is a significant one:  whether the meaning and effect of an FDA labeling decision is a question of law for courts to resolve or a question of fact for lay juries to determine.  The petition cleanly presents that issue in an MDL context in which hundreds of separate cases . . . turn on its proper resolution.

Id. at 22-23.

First, the Solicitor General believes that preemption is a legal issue, not one for the jury, as the Third Circuit held in its unprecedented ruling:

The court of appeals erred in holding that a jury must determine whether FDA’s . . . decision − which declined to approve petitioner’s proposal to revise [the drug’s] Warnings and Precautions section . . . − preempted respondents’ state-law failure-to-warn claims arising from that same type of injury.  Where, as here, FDA renders a decision declining to approve a drug-labeling change, the interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve, not factual questions for a jury.

Id. at 12.  “The meaning and effect of such agency action is a legal question within the exclusive province of a court.”  Id. at 13.  “Judges, rather than lay juries, are best suited to evaluate the scope of an agency’s legal determination in light of the relevant statutory and regulatory context.”  Id. at 14.

Second, the Solicitor General believes that the FDA’s rejection of the defendant’s request for a label change was “clear evidence” supporting preemption:

[B]ecause FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting petitioner’s impossibility-preemption defense.

Id. at 12.  “Nothing is ‘hypothetical’ about FDA’s actual 2009 decision in this case.”  Id. at 16.

[Levine] did not resolve how to determine the meaning and effect of an actual FDA labeling-supplement decision. . . .  [T]he court of appeals erred in transplanting [Levine’s] discussion about a hypothetical regulatory scenario to support a requirement for “clear evidence” about the scope and effect of the actual agency labeling decision in this case.

Id. at 16-17 (emphasis added).  The FDA was not quibbling about language when it rejected the label change at issue, but instead the “FDA’s decision thus was based on the lack of adequate data to support a warning.”  Id. at 21.  “Indeed, nearly a year later, FDA announced − after reviewing further data − that it had yet to find any ‘clear connection’” between the drug and the alleged risk.  Id. at 22.

Third, “clear evidence” was used in Levine “not in its ‘strict evidentiary sense’ but merely as a ‘useful reminder’ that a general presumption concerning a legal interpretation should control if substantial doubt exists.”  Id. at 18.  Thus, the Third Circuit’s “clear and convincing” evidentiary gloss in Fosamax was also error.  Rather, “to establish impossibility preemption, a name-brand drug manufacturer cannot rely on speculation or merely plausible interpretations of ambiguous features of FDA’s regulatory framework and practices.  Id. at 18-19.

Now we wait. If the Court grants review, Albrecht will likely be the most significant preemption decision since Levine itself.

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug’s manufacturer warned about the risk of plaintiff’s ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy (“PML”), a condition about which the drug’s labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug’s Risk Evaluation and Management Strategy (“REMS”) program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff’s remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before.  Because this was under the NJPLA, the first issue was whether the “super-presumption” of the adequacy of the PML warnings would apply given plaintiff’s argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of “manipulation of the post-market regulatory process,” the basis of the so-called “McDarby exception,” noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians’ decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug’s label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer’s preemption defense, which argued that the proposed changes to the drug’s label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine’s once-novel “clear evidence” standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found “There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay.” FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.


Thanks to Terry Henry at Blank Rome for sending along today’s preemption decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), No. 12-2250, slip op. (3d Cir. April 30, 2014), affirming the dismissal of so-called “design defect” claims against generic drug manufacturers under the laws of 28 states.  Essentially, the Third Circuit did what the Pennsylvania Superior Court should have done in its metoclopramide appeals, but didn’t.  The Third Circuit held each and every “design defect” claim preempted under multiple state laws because the plaintiffs could articulate no theory of liability that didn’t depend on one of three preempted things:  (1) changing warnings; (2) changing design; or (3) stop selling the product altogether:

When we pressed [plaintiffs] at oral argument to give an example of a strict-liability design-defect claim under any relevant state regime that would not ultimately result in some combination of the same three options for the Generic Defendants – i.e., changing the labeling . . ., changing the design of the drug, or pulling the drug from the market – they were unable to identify such a claim . . . .  Therefore, it is unnecessary for us to embark on a 28-state tour of strict-liability design-defect law.

In sum, Mensing and Bartlett recognize that manufacturers have no control over the design or labeling of generic drugs.  Short of exiting the market – which Bartlett rejects – [plaintiffs] have failed to identify anything the Generic Defendants can do to reconcile their conflicting duties under state and federal law.  Therefore, [plaintiffs’] strict-liability design-defect claims are pre-empted.

Fosamax, slip op.
at 33-34 (citations and footnotes omitted). The Third Circuit thus joins every court to have analyzed the practical question:  take away warnings, design, and removal from the market, and there’s nothing left upon which to base liability, short of a true manufacturing defect claim, which are downright rare in our neck of the woods.

Fosamax also held that the Restatement sections argued by the plaintiffs, Restatement (Second) of Torts §402A, comment k (1965) and Restatement (Third) of Torts, Products Liability §6(c) (1998) did not avoid preemption.  Comment k would necessarily require a change of a drug’s warnings or design.  Fosamax, slip op. at 29-30 n.26.  Section 6 (c) involved “a risk/utility theory” of the sort addressed by BartlettSlip op. at 18 n.16 (lots of footnotes in Fosamax).

In Fosamax “the bottom line is that [plaintiffs] placed their bets on the First Circuit’s Bartlett decision. and they lost.”  Slip op. at 17 n.15 (citation and quotation marks omitted).  The Third Circuit did not allow plaintiffs to “shape shift” their claims on appeal after the Supreme Court reversed Bartlett. Slip op. at 15.  That’s good for defendants, but not so good for us bloggers, since we’d love to report that the Third Circuit also blew out the other side’s post-Bartlett salami slicing.  Fosamax does take pains to point out that, by not addressing waived arguments, it should not be seen as endorsing them (something we wish the Supreme Court in Riegel had done with respect to parallel claims):

Our lack of comment is not a tacit endorsement of the Appellants’ negligence theory.  We have yet to hear how the Generic Defendants’ duties under negligence-based design-defect claims would be any different from their duties, discussed below, under strict-liability design-defect claims, i.e., changing the labeling, changing the composition, or removing the product from the market.

Fosamax, slip op. at 19 n.17.  We think that’s right.  As we pointed out at the time, the negligence-based stop selling theory in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), should likewise be preempted under Bartlett as the action required by state law is the same as for any strict liability design defect theory. Once a drug is approved, its design cannot be changed in any way that affects safety or effectiveness without prior FDA approval.

For the same reasons the Third Circuit refused to allow the Fosamax plaintiffs to shift their arguments towards an “absolute liability” theory after Bartlett – not that any state in the country recognizes such liability.  Fosamax, slip op. at 31-32 n.28.

Now that the Third Circuit has spoken on generic preemption, the Pennsylvania Superior Court’s unartful dodging of the same issues in the Reglan/Metoclopramide litigation is looking every bit as shaky as we thought it would.  In preemption cases,

When the Third Circuit has spoken on a federal issue . . . it is appropriate for this Court to follow Third Circuit precedent in preference to that of other jurisdictions.  Whenever possible, Pennsylvania state courts follow the Third Circuit so that litigants do not improperly “walk across the street” to achieve a different result in federal court than would be obtained in state court.

Werner v. Plater-Zyberk, 799 A.2d 776, 782 (Pa. Super. 2002); (citing Cellucci v. General Motors Corp., 676 A.2d 253, 255 n.1 (Pa. Super. 1996), aff’d, 550 Pa. 407, 706 A.2d 806 (1998)) (both addressing federal preemption issues).

Last July we discussed a rare event, a preemption win for an innovator drug under the  Wyeth v. Levine, 555 U.S. 555 (2009), “clear evidence” standard.  However, that case, In re Fosamax Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. June 27, 2013), occurred in the peculiar context of a preemption motion granted after the defendant won a trial of the same case.  Given that the plaintiff was extremely likely to lose anyway, given the verdict, that case was never appealed.

Now the Fosamax preemption ruling has been extended to other, similarly situated cases in the MDL.  See In re Fosamax (Alendronate Sodium) Products Liability Litigation, No. 3:08-cv-00008-JAP-LHG, slip op. (D.N.J. March 26, 2014).  The court disposed of the MDL plaintiffs (mostly) procedural arguments against preemption and applied its earlier ruling to all cases in the MDL with injury dates before Sept. 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change. Slip op. at 7.

The court found no reason not to apply its preemption ruling to other similarly situated plaintiffs because: (1) the case in question had been selected as a bellwether; (2) preemption had been thoroughly briefed; and (3) plaintiffs had been repeatedly instructed to come forward with all their preemption related evidence.  Slip op. at 9-13.  The “newly discovered” evidence that the plaintiffs predictably asserted after they lost didn’t change anything.  It was an expert opinion based on the same facts that existed when the court decided the original bellwether preemption motion.  Slip op. at 15.  Further, all the expert testimony in the world about what might have happened, did not change the undisputed regulatory facts about what actually did happen. Slip op. at 19-20.  The court pointed out (with a useful collection of cases) that preemption had repeatedly been addressed in similar fashion in other MDLs.  Slip op. at 16-17.

Plaintiffs attempted to claim that design defect claims were different and couldn’t be preempted.  The court again disagreed.  There was no way to change the chemical composition of Fosamax, so the “design” claims were merely warning claims in disguise.  Slip op. at 21-22.

After disposing of various arguments rehashing what had already been decided, the court disposed of the plaintiffs’ final argument that “if fully informed” the FDA might have acted differently.  That claim was merely warmed over fraud on the FDA:

[T]o the extent that Plaintiffs claim that [defendant] withheld information from the FDA and clear evidence does not exist as to whether the FDA, if fully informed, would have rejected a stronger label, this does not defeat Defendant’s showing that it is entitled to judgment as a matter of law on preemption grounds. . . .  [E]ven assuming [defendant withheld information], Plaintiffs have failed to show that providing such information to the FDA would have changed the FDA’s conclusion that a Precaution was not warranted.  Instead, Plaintiffs’ contention appears to be a fraud-on-the-FDA theory which was rejected by the Supreme Court in [Buckman], or alternatively, is based largely on speculation and cannot defeat summary judgment.

Slip op. at 29 (citations omitted).

So this time, it appears, there is likely to be a Fosamax preemption appeal.  As we pointed out in our first post, the regulatory facts supporting preemption look quite strong.  Thus, another avenue for eventual reconsideration of Levine – or at least some of its loopier aspects – appears to be presenting itself.

Thanks to Terry Henry at Blank Rome for sending this decision along to us.

Schadenfreude – That probably best describes how we felt when we read Secrest v. Merck, Sharp & Dohme Corp., No. 11-4358, slip op. (2d Cir. Jan. 30, 2013).  We’ve seen time and time again how plaintiffs attempt to manipulate treating physician testimony, usually but not always cloaked by biased judicial rulings that prevent one side – our side – from talking to treaters informally, while giving plaintiffs full reign to subject treaters to all manner of persuasion.

That evidently happened in Secrest, and produced contradictory treater testimony so grotesque that the Second Circuit recoiled, calling it a “sham” in a for-publication decision.

Here’s an outline.  Plaintiff took Fosamax over a period of years prescribed by Dr. X and then Dr. Y.  Dr. Y apparently did not testify, or at least his testimony was considered irrelevant by both sides.  Dr. X testified as a fact witness that at the time plaintiff suffered her injury (bone deterioration in the jaw – “ONJ”) he (Dr. X) “was not aware” that plaintiff continued to take Fosamax (then being prescribed by Dr. Y).  Secrest, slip op. at 5.

Then the defendant moved for summary judgment against the warning claim on causation grounds – because if Dr. X didn’t know about plaintiff’s Fosamax use, he couldn’t have been affected by an allegedly inadequate warning.  Why would a treater say anything about the risks of a drug that s/he didn’t know that the plaintiff was taking?

After the motion was filed, up popped Dr. X again – this time serving as the plaintiff’s expert.

To any naif out there, that means Dr. X was now on the plaintiff’s payroll.

Predictably, Dr. X has changed his tune, offering utterly contradictory testimony in a second expert deposition that he actually did know about plaintiff’s Fosamax use during the critical time.  Specifically:

By contrast, in his [second]  deposition, Dr. [X] testified that he “knew
she was on [Fosamax]” in [the critical time] and that, had [defendant] warned him about the
risk of ONJ, he would have recommended that [plaintiff] stop taking Fosamax.

Secrest, slip op. at 5.  As the court pointed out “[o]nly after he was designated as plaintiff’s expert” did Dr. X experience an epiphany of recollection that led to this contradictory testimony.

Neither the district court (which granted summary judgment anyway) nor the Second Circuit was having any part of Dr. X’s changed testimony.

It was a “sham.”

[C]onsidering Dr. [X]’s clearly contradictory testimony . . .
we hold that the District Court was entitled to disregard Dr. [X]’s new testimony
relating to his knowledge based on the “sham issue of fact” doctrine, which
prohibits a party from defeating summary judgment simply by submitting an
affidavit that contradicts the party’s previous sworn testimony.  Although we have typically applied the sham
issue of fact doctrine where a party submits an affidavit that contradicts the
party’s own prior statements, it may also apply when a party attempts to use
evidence from an expert witness to defeat summary judgment.

Secrest, slip op. at 7.  The subsequently procured “expert” testimony could be disregarded “where the relevant contradictions between the first and second depositions are unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and are central to the claim at issue.”  Id. at 8.
Moreover, the plaintiff “ha[d] not proffered a plausible explanation” for Dr. X’s testimonial gymnastics, but only argued that “credibility determinations are left to the jury.”  Id. at 9.  The timing – after the filing of a summary judgment motion – was also extremely suspect.  Id. at 10.  Thus summary judgment was affirmed.

That’s as close as you’ll see an appellate court come to calling a witness a liar without actually doing so.

Schadenfreude – it feels good.

For the record, after summary judgment was granted on the warning claims in Secrest, non-warning claims (design defect) were tried to a jury and plaintiff lost again.  The Second Circuit also summarily affirmed the jury verdict in a second, unpublished opinion, here.

            When last we left Boles v Merck, the case had been tried twice and the trial court had certified for appeal its decision denying defendant’s motion for judgment as a matter of law or in the alternative for a new trial.  In denying the defense motion, the court saw fit to reduce the verdict, which the plaintiff rejected in favor of seeking a new trial.  See posts here and here.
While we are still waiting to see if the Second Circuit will accept that appeal, it did have something to say about plaintiff’s counsel’s attempt to appeal the order imposing minimal sanctions against him for his outrageous conduct in Boles IIDouglas v. Merck & Co., Inc., No. 10-4196-cv, slip op. (2d Cir. Jan 23, 2012) .  They quashed it and told Douglas he had to wait until the trial court’s decision to reduce the verdict was before the appellate court – something we hope happens sooner rather than later.
And, while this is really a non-event, what it reminds us is that we needn’t be talking about appeals of remittiturs and sanctions – what we should really be seeing is a new trial.  So, since it is a slow news days, we’ll take a minute to stand on our soap box and once again advocate that courts should be more willing to toss out verdicts that are a product of juror passion and prejudice rather than simply remitting them.  Just looking at Boles II as an example, in ruling sua sponte on remittitur, the court said that it “believes the $8 million verdict is unreasonably high, but cannot point definitively to anything in the records that caused the surplus.” In re Fosamax Products Liability Litigation, 742 F. Supp. 2d 460, 484 (S.D.N.Y. 2010) If the jury awarded the plaintiff over five times the maximum amount of justifiable compensatory damages, isn’t that sufficient proof that the verdict was tainted?   And where there is taint, a new trial should follow.
We understand that new trials based on attorney misconduct and subsequent jury passion are rare because generally courts afford lawyers latitude when representing their clients.  But lawyers need to be held accountable when they go too far.   There is a limit to what lawyers can do in the courtroom when advocating on behalf of their clients.  When plaintiffs’ attorneys – in pursuit of excessive verdicts — are allowed to vilify defense witnesses, attack defense counsel and distort and mischaracterize the evidence to the jury, the basic tenets of fairness and impartiality in litigation go out the window. 
Jurors are people too.  As such they, we all know that they are influenced by things like whether they connect to a particular witness, fun demonstratives, and well even if their seats are comfortable.  All that aside, juries primarily should be focused on the facts and their verdicts should be supported by the facts in evidence.  When they aren’t, new trials are warranted.  That should be true if the evidence just isn’t there or if the evidence has been so diluted by attorney misconduct that that misconduct affected the outcome of the trial.    
Where an excessive verdict is given under the influence of passion and prejudice (which seems to have been the conclusion of the trial court in Boles II), remittitur isn’t enough.  The misconduct should be seen as not simply tainting the amount of the verdict, but indeed the finding of liability itself.  Boles itself proves this point considering that without the disingenuous antics of plaintiff’s counsel, the jury in Boles I found in favor of the defendant.  While remitting the verdict helps, it doesn’t take away the bad precedent set by a plaintiff verdict in any amount.
Also, Happy Birthday Bexis!
            Trial in the fourth Fosamax MDL bellwether case, Secrest v. Merck, is scheduled to begin today.  So, we thought it appropriate to discuss the MDL court’s recent summary judgment and Daubert decisions in that case.  Secrest also interests us because it involves Florida law and the only claims now left for trial are strict liability and negligent design defect.   Where have we seen this before?  It’s beginning to look a lot like the unfortunate case of Boles v. Merck, in which we are still waiting to see if the Second Circuit will take the interlocutory appeal of the trial court’s denial of defendant’s motion for judgment as a matter of law following an $8 million plaintiff verdict (check out our prior post here).
             In Secrest, both parties filed multiple Daubert challenges and Merck filed a motion for summary judgment.  While the decision initially may be viewed as Solmonesque – all of the motions were granted in part and denied in part – Merck was clearly the victor, with its experts coming out unscathed and winning summary judgment on all but plaintiff’s design defect claims.  In re: Fosamax Products Liability Litigation (Secrest v. Merck), 2011 U.S. Dist. LEXIS 97075 (S.D.N.Y. Aug. 30, 2011).  Here are our highlights of the various rulings:
            Plaintiff’s Daubert Challenges:  Plaintiff sought to partially exclude the testimony of two of Merck’s experts.  While these motions were granted in part, they were only granted as to topics on which Merck conceded the experts would not testify.   Id. at *33-37.  We call that a win.
            Defendant’s Daubert Challenges:  Merck sought to exclude the testimony of three of plaintiff’s expert witnesses on a variety of topics – they won some and lost some.  For example, one of plaintiff’s experts was precluded from testifying about bone mineral density because he “relied solely” on other physicians’ calculations.  Id. at *32.  That same expert, however, as a treating physician, would be permitted to testify about “his clinical experience with certain medical options . . . and making recommendations to patients.”  Id. at *33. 
While we won’t go through each of Merck’s expert challenges, we found one particularly interesting, and not in a good way.  Merck sought to exclude the case-specific causation testimony of plaintiff’s lead expert based in part on lack of evidence of plaintiff’s continuous use of Fosamax.  Id. at *26.  As in many pharmaceutical products cases (Vioxx and hormone therapy come to mind), the “science” relied on by plaintiffs to establish causation is limited by a length-of-use threshold for development of the alleged injury (it is limited in other ways too, but that’s a topic for another day).  In Fosamax, that temporal threshold is three years of continuous use.  Id. at *16-17.  While Plaintiff Secrest’s medical treatment records reference that her physicians were prescribing her Fosamax from 1998 to 2004, her pharmacy records show large gaps during which she never filled a Fosamax prescription.  Id. at *26-27. 
As defense counsel, we routinely rely on pharmacy records to demonstrate that a plaintiff was not actually taking the drug prescribed to her – in other words pharmacy records trump treatment records.  Right?  Well, the Fosamax MDL court isn’t so sure about that: 

Merck urges the Court to assume that these medical records lack probative value simply because no corresponding pharmacy records have been located during discovery, but the Court cannot say that Secrest’s medical records have no probative value on the issue of Secrest’s Fosamax use, even if they are apparently contradicted by gaps in the pharmacy records. In this case, these medical records create a genuine dispute of fact regarding the duration of Secrest’s Fosamax use.

Id. at 27-28.  Really?  So, if plaintiff didn’t fill a prescription, where did she get the Fosamax?  Did she borrow it from a friend?  Buy it online from Mexico?  Strike a deal on a street corner?  Shouldn’t plaintiff have to come up with something better than the equivalent of my dog ate my pharmacy records?  We think so.
            Summary Judgment:   Since the court wasn’t willing to exclude plaintiff’s case-specific causation expert, which would have ended the case in its entirety, it next turned to Merck’s summary judgment motion on plaintiff’s particular causes of action.  First up, failure to warn.  Plaintiff had no evidence that her prescribing physician would have changed his decision to prescribe Fosamax if Merck had given a different warning.  Id. at *39-40.  A summary judgment slam dunk.  But plaintiff wasn’t going down without a fight, so she argued that her non-prescribing treater would have recommended she stop taking Fosamax if he had been informed of the risks by Merck.  Under Florida’s learned intermediary doctrine, “it is the prescribing physician’s course of conduct that is most relevant to proximate cause in the prescription drug context.”  Id. at *41 (citation omitted).  But,

other courts have recognized that proximate causation can be satisfied for purposes of the Learned Intermediary Doctrine where a non-prescribing physician testifies that the physician was aware of the patient’s use of a given drug and would have recommended taking the patient off of that medication if a different warning had been given.

Id. at *41-42 (citation omitted).  We’ve discussed this sort of learned intermediary situation before, here, and the key for the defendant is to keep asking questions.  That’s exactly what happened here.  Plaintiff Secrest couldn’t satisfy even this more liberal proximate causation standard because, as it turned out, her supposedly critical treater wasn’t even aware she was taking Fosamax – so any assertion that he would have warned her to stop taking it if there had been a different warning on the label “is purely speculative.”  Id. at *43.  No proximate cause, no failure to warn.
            Next, punitive damages.  The MDL court has previously thrown out plaintiffs’ punitive damages claims in the other Fosamax bellwether cases, id. at *44, so Plaintiff Secrest had to try a different approach.  She argued that because her injury date was later than the other bellwether plaintiffs, Merck had more information available to it.  Id. at *44-45.  So?  Fortunately, the court asked the same question:

Plaintiff has failed to introduce any evidence suggesting that Merck acted in a grossly negligent fashion in response to the available information. Rather than offering “clear and convincing evidence” that Merck reacted to the information that became available between October 2003 and her injury date in an intentionally wrongful or grossly negligent fashion, Plaintiff asserts in a conclusory fashion that, given the information available, Merck had a duty to add a warning about a possible connection between Fosamax and ONJ to the Fosamax label, and that its breach of this duty constitutes gross negligence. . . .Plaintiff has offered no evidence suggesting that Merck engaged in intentionally wrongful or grossly negligent conduct by delaying a label change until it had worked out language with the FDA.

Id. at *45-46. 
            Finally, the court struck plaintiff’s fraudulent misrepresentation claim.  Plaintiff alleged that Merck intentionally defrauded her prescriber by misrepresenting the risk/benefit profile of Fosamax, but plaintiff “fails to allege that Merck was aware of the FDA report, or the information contained therein” that forms the basis for the alleged misrepresentation.  Id. at *47-48. 
            Since plaintiff didn’t oppose Merck’s summary judgment motion on her express or implied warranty claims, plaintiff is left with only design defect claim (how can you “redesign” Fosamax and still have Fosamax?) for trial.  Having been here before, we can only hope for a better result than in Boles.  With two other defense wins in bellwether cases and a judge familiar with and hopefully prepared to combat the type of unprofessional and outrageous conduct exhibited by plaintiff’s counsel in Boles, we sit and wait with cautious optimism.
            As millions of aspiring witches and wizards line up for the opening of the last installment of the Harry Potter series, we bring you the latest – but likely not the final – chapter in the Fosamax litigation and specifically the twice-tried case of Boles v. Merck.  We’ve previously discussed the disheartening events in Boles here but here is a quick recap:
  • Book 1-Fosamax and the Prisoners of the Jury Box: The Hung Jury:  jury failed to reach a verdict (7-1 in favor of defendant)
  • Book 2-Fosamax and the Closing Argument of Fire: Outrageous Misconduct: the second trial, due to plaintiff’s counsel’s outrageous and unprofessional conduct, resulted in an $8 million verdict
  • Book  3-Fosamax and the Order of Remittitur:  The court denied defendant’s motions for judgment as a matter of law and for a new trial but reduced the verdict to $1.5 million (by the way, plaintiff rejected the reduced verdict and requested a new trial on damages)
The stage is now set for Book 4-Fosamax and The Half-Allowed Interlocutory AppealIn re Fosamax Products Liability Litigation (Boles), 2011 U.S. Dist. LEXIS 72123 (S.D.N.Y. Jun. 29, 2011).  The decision being appealed can be found at  In re Fosamax Products Liability Litigation, 742 F. Supp. 2d 460 (S.D.N.Y. 2010) and the single question certified for appeal is whether under Florida law:

a plaintiff [may] establish that a prescription drug is defective by showing that its risks outweigh its benefits for a subset of the patient population for whom the drug is indicated, regardless of the risk-benefit calculus for the indicated patient population as a whole?

In re Fosamax, 2011 U.S. Dist. LEXIS 72123, at *26.  Now the Second Circuit has to be persuaded to hear the appeal.

In the Boles II trial, plaintiff’s only remaining claims were for negligent and strict liability design defect.  Id. at *7.  Following the verdict for plaintiff, the court held that “a jury could find in favor of Boles if the jury determined that Fosamax’s risks outweigh its benefits, or lack thereof, when used as indicated for the prevention of osteoporosis.”  Id. at *13 (citation and quotation marks omitted).  Defendant argued that under Florida law, for plaintiff to recover for design defect, she must show that

the risks of a product outweigh its benefits from an objective standard–from the perspective of the population at large and not merely from the perspective of a particular user or group of users.

Id. at *15.  The court, hoping that “a third Boles trial will be the final Boles trial,” id. at *26, decided to seek guidance from the Second Circuit on the scope of the risk/benefit analysis.  In addition to finding this to be a controlling question of law that would impact hundreds of cases pending in the Fosamax MDL involving Florida plaintiffs, the court also found it was a contestable issue because defendant’s objective standard was supported by authority but was not a question on which the Florida Supreme Court had ruled.  Id. at *19-20.
                     So, while not quite an epic battle between good and evil and certainly not this summer’s biggest legal blockbuster, the continuing saga of Boles and the proper application of the risk/benefit analysis under Florida law – specific-user standard v. objective standard –  is one we’ll watch with keen interest. 
And now, after the Supreme Court has clarified the scope of Wyeth v. Levine, 555 U.S. 555 (2009), in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), and reminded everyone that Levine turned on the difference between a prior FDA approval requirement as opposed to a mere post facto FDA veto (rarely, if ever, exercised), we expect to see preemption return as a defense to design-related claims where the kind of loophole to prior FDA approval does not exist.  Since even the dissent in Mensing did not undertake to defend the lower court’s “it’s not impossible because you can just stop selling the FDA-approved drug” argument, 2011 WL 2472790, at *17 n.8, we look forward to an eventual Book 5–Fosamax and the Chamber of Preemption.