A Quick Boles Update

            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 II.  Douglas 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!

Fosamax MDL Preps for Fourth Bellwether Case

            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.

Fosamax and the Risk/Benefit Analysis

            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 Appeal.  In 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.