[Drug and Device Law] A Black Friday for Plavix Plaintiffs
We expect that most of our readers enjoyed yesterday with the American rituals of gluttony, football, and traffic. For some, today is an opportunity to see if doing nothing is the best way to combat lingering indigestion. For others, it may be that the lure of transforming scattered leaves into tidy piles of leaves—tidy, that is, until wind or youthful leaps disturb them—is enough to separate butts from sofas. For yet others, there will be an urge to shop for presents for upcoming—or, in an incredibly rare calendar quirk, on-going—holidays. (Yes, celebration of the festival of lights has been known to include the giving of socks, something probably not common with Saturnalia or its cultural descendants.) To encourage shopping, the marketers have dubbed this day Black Friday. Although we have heard it for a while, we have not really understood why this moniker would encourage people to spend money. The same name has been given to a number of deadly historical events. The Black Tuesday stock market crash of 1929 was hardly a spur to reckless spending. Other days of the week have been dubbed "Black" to commemorate a range of bad happenings. We are not marketers or shoppers by profession, so, to us, the term Black Friday bespeaks of something bad happening on a Friday.
What is bad, of course, depends on viewpoint. The three NFL games yesterday were each good or bad depending on which team's fans are asked. That extra slice of chocolate pecan pumpkin cream pie last night may have been really good as you were eating it, but really bad as you realized that the practice of unbuckling your belt after a meal was not just something only other people did. The decision from two weeks ago—a Friday—in LaBarre v. Bristol-Myers Squibb Co., No. 13-1405, 2013 U.S. Dist. LEXIS 23215 (3d Cir. Nov. 15, 2013), was good for the defendant drug manufacturers and for product liability defendants in the affected jurisdictions, but bad for the two plaintiffs on appeal and the other Plavix plaintiffs in the pipeline. One of our first posts was on the district court's grant of summary judgment against the two plaintiffs in LaBarre, one of severalposts that have appeared here on good results from the Plavix litigation. While we marvel at the speed of an appeal that produced an affirmance a little more than ten months after summary judgment, we are equally satisfied with the logic of the decision.
In our post on the summary judgment decisions, we started with an expression of regret—in contrast to or conformity with yesterday's gratitude depending on your perspective—but lauded the court's "well thought out and systematic" decisions. In short, summary judgment was granted on all claims brought by two plaintiffs, one under Florida law and one under Illinois law. Each plaintiff experienced bleeding (cerebral hemorrhage for one and rectal and gastrointestinal for the other) while on Plavix and aspirin for acute coronary syndrome and asserted failure to warn, design defect, manufacturing defect and negligence claims. Each plaintiff failed to come forward with expert testimony that the extensive warnings as to the risk of bleeding were inadequate or that the product's risks exceeded its benefits. In connection with the summary judgment motions, the court stayed discovery and refused to re-open discovery as to the product's efficacy. For some reason, the second plaintiff appealed only the discovery limit ruling, but LaBarre also appealed the merits of summary judgment. The first issue up on appeal was whether additional discovery should have been permitted before ruling on summary judgment. As with the plaintiffs' gaffe in not offering any expert testimony on some basic issues, the plaintiffs' failure to follow a clear Rule of Civil Procedure made this issue an easy one for the appellate court. Fed. R. Civ. P. 56(d) requires parties who want more discovery to oppose a motion for summary judgment to "show[] by affidavit or declaration that, for specified reasons, it cannot present facts essential to justify its opposition." The plaintiffs submitted an affidavit saying they wanted more information on the efficacy of Plavix—the denial of which they did not contest on appeal—but "did not state they sought additional time to obtain expert testimony about warnings." Id. at *10. As a "procedural matter alone," this portion of the appeal was toast. Maybe plaintiff could have come forward with an affidavit saying additional efficacy discovery would have allowed their expert, our old friend Dr. Moye, to offer a stronger opinion on design defect, but that did not happen. Maybe this is because Dr. Moye had the rare realization that he would not be able to offer the opinion plaintiffs needed no matter how much discovery on efficacy was obtained.
A failure to warn claim, as we have said a few times, should be the only potentially viable claim in almost all prescription drug cases because of how drugs are actually prescribed. These warnings claims, in turn, properly hinge on prescriber testimony about whether a different warning would have changed what the prescriber did with the plaintiff. While the substance of their testimony is not discussed on appeal, it is obvious that the defendants' motions to stay discovery and for summary judgment were filed right after the depositions of the prescribing physicians for a reason. If the prescribers had testified "despite all the information in the label about the bleeding risk, I did not appreciate it and a stronger warning would likely have caused me to prescribe something else," then there would have been very different cases. That would have been surprising testimony where the plaintiff's decedent was being prescribed a drug to alter his coagulation after a heart attack in the hopes of avoiding another heart attack. Doctors, and most heart patients, understand that the risks of clots and bleeds are inversely related. As it was, plaintiff claimed she could make out a failure to warn claim based on allegedly inadequate warnings as to the product's efficacy. "Under Florida law, a manufacturer's duty to warn physicians only extends to the risks or dangers posed by a drug." Id. at **12-13. With a nice little discourse on judicial restraint for courts sitting in diversity, the appellate court refused to extend Florida law to make a claim for failure to warn about the prescription drug's efficacy. Id. at **10 n.7 & 13. In addition, because plaintiff offered no expert on any aspect of the drug's label, she could not make a claim for failure to warn, whether based on efficacy or the risk of bleeding. Id. at **13-14. Summary judgment on failure to warn affirmed. The appeal as to the design defect claim also turned on the lack of pertinent expert opinion testimony for plaintiff. Florida follows comment k as an affirmative defense to strict liability design defect claims. Because the defendants supported their summary judgment motion with testimony from two treating physicians to the effect that the benefits of Plavix exceeded its risk of bleeding for plaintiff's decedent and patients like him, the burden shifted to plaintiff to come up with some evidence that the drug's benefits did not exceed its known risks. Id. at **17-18. Instead, the report from Dr. Moye confirmed a "clear" benefit of the drug and did not weigh that benefit against any risks. Id. at **18-19. Again, this may be the product of questionable lawyering or of an expert's honest limits on what he could say. We do not know. Either way, summary judgment on design defect affirmed.
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Posted By Eric Alexander to Drug and Device Law at 11/29/2013 06:43:00 AM --
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