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On this week of Martin Luther King Day and the PresidentialInauguration, we start this post with some regrets. We regret that we lack theeloquence to offer a sufficiently meaningful link between the cases we discussand the inspiration that Dr. King has provided to so many, even after hisbrutally untimely death. We regret thatany homage we pay to our nation and its democracy might come across asfluff. In our day job, we are happy totake on tough cases, depositions, motions, whatever. Here, the wiser choice seems to be to declinethe challenge of trying to establish a link. We might offer the familiar quote that “Injustice anywhere is a threatto justice everywhere. We are caught inan inescapable network of mutuality, tied in a single garment of destiny. Whatever affects one directly, affects allindirectly” and argue that justice to manufacturers of drugs and devices in thecourts of our nation is included. Nah. We like when courts get the law right andhold plaintiffs to their proof. We decry when courts tilt the table forwhatever reason. We will not, however, cheapen the real struggles in thecountry or the importance of our democratic ideals usually winning out bymaking comparisons to the cases we are discussing. At least not this week. We makeno promises for the next post. We mightjust hum “Abraham, Martin and John” or “Renegades of Funk” as we type.
We do notregret the decisions in Begley v.Bristol-Myers Squibb Co., No. 06-6051 (FLW), 2103 US. Dist. LEXIS 4849(D.N.J. Jan. 11, 2013), and LaBarre v.Bristol-Myers Squibb Co., No. 06-6050 (FLW) (D.N.J. Jan. 11, 2013), eachgranting summary judgments on all claims in cases alleging bleeding from Plavixbased principally on lack of evidence that the warning was inadequate as tobleeding. If this sounds familiar, itshould. Two weeks ago, we posted on the Solomon decision from the same judge. So, why are we posting on more of the same? Well, Solomon applied Texaslaw, while Begley applied Illinoislaw and LaBarre applied Floridalaw. Also, the decisions brushed asidesome different arguments from the various plaintiffs, even though they wererepresented by the same firm and relying on the same expert—we will get to themlater. Why are we justifyingourselves? Read or read not. There is no why. (A little pre-CGI Yoda.)
As wouldbe expected, each decision is well thought out and systematic. We particularly appreciate the restraintshown in each for a federal court to resist making new state law. We also appreciate the efficiency in each ofdenying a “negligence claim [that] is nothing more than a restatement of herdefective design, defective manufacturing, and failure-to-warn claims” and indenying Rule 56(d) requests for more discovery on subjects that are “neitherrelevant nor probative Plaintiff’s claims.” Particularly on the former point, we have seen some courts take a claimfor “negligence” in a drug case as encompassing any conduct that can becriticized; the more sensible view is that negligence claims are still reallyclaims based on warnings, design, or manufacturing, but requiring additionalproof beyond strict liability. Forinstance, that the Defendant was negligent in failing to provide inadequatewarnings. We also enjoyed the clearrejection that arguments as to the efficacy of the product have anything to dowith whether the warnings were adequate, at least under Illinois and Floridalaw. There may be claims in some statesbased on overstating the efficacy of a drug, but failure to warn claims inIllinois and Florida are about “the product’s known dangerous propensities” and“any danger or harm that may result from ingesting the drug,” respectively. Begley,*17; LaBarre, *22. We also liked the simple recognition that theadoption of Comment k in Illinois and Florida meant that the design defectclaims fell with the lack of proof of inadequate warnings and that amanufacturing defect claim fails when there is no allegation that theplaintiff’s drug “deviated from the construction or specifications ofPlavix.” Begley, **27-28; LaBarre,**32-34.
Thisbrings us to the meat of the decisions, which was whether there was evidence toraise a genuine issue of material fact as to the adequacy of the Plavix warningsfor the risk of bleeding. Afterrecognizing that Illinois and Florida require expert testimony where there areallegations that the extensive warnings provided were not good enough, thecourt turned to what plaintiffs had to offer. It is not clear why the plaintiff in Begleyhad more criticisms of the Plavix label than the plaintiff in LaBarre did or why the plaintiff in LaBarre also pointed to at least one company document to support herargument. Our friends at the Miller firm,who represented these plaintiffs, surely know from many summary judgmentdecisions on warnings in diet drug cases in the Philadelphia Court of CommonPleas, if from nowhere else, that it is important to generate evidence of afailure to warn and an impact of that failure to warn on the prescriber’sdecision to prescribe. (Rumor has itthat we once handed over a stipulation of dismissal to one of their lawyers inthe middle of a deposition based on the expectation that they understood theconsequence of not getting magic words. We cannot confirm or deny that rumor.) Regardless, the real problem with plaintiff’swarnings case was that they relied on a single expert, our old friend, LemuelMoye, M.D., Ph.D., to establish the inadequacy of warnings and he neverarticulated what different warnings as to a risk of bleeding should havesaid. We are not sure if this came up,but Dr. Moye was on the Cardiovascular and Renal Drugs Advisory Committee whenit recommended approval of Plavix in 1997 and he was the only one who votedagainst it. Back then, he had concernsabout proof of efficacy—not safety—so it is not surprising that his opinions asan expert in litigation over Plavix continued to focus on efficacy. Since the court had already determined thatrisk of the injury that plaintiff suffered, not whether the drug works for itsindication, is the focus, it was pretty easy to see that Dr. Moye’s opinions onthe treatment of efficacy in the Plavix label went nowhere. He did have some opinions about the risk ofbleeding of the product, but never offered “how Plavix’s warning label shouldhave reflected the duration of therapy and the impact of a long term therapy onthe risk of increased bleeding.” LaBarre, *28.
This begsthe question why plaintiffs would get through expert discovery and summaryjudgment briefing without an expert who would say that the warning of the riskat issue should have been revised in a particular way to make it adequate. At what point was it apparent that they couldnot find an expert who would actually say what is typically required to get bysummary judgment? We would expect thatthis shortcoming will cripple quite a few of these plaintiffs, at least if theyonly have Dr. Moye to carry the water. While the court notes that it is proceeding with summary judgmentmotions one by one in these “related cases”—footnote 2 in each decision—therecertainly will be a point where summary judgment on some or all these cases canbe decided in one fell swoop. In Begley, the court did not reach theissue of proof of proximate cause for a failure of warn, but, in LaBarre, it reached the issue as anadditional ground for summary judgment. A pretty easy conclusion where, as would be expected given the lack ofwarnings evidence, the prescribers “both represented that they would have notchanged their prescription for Mr. LaBarre even understanding the additionalrisk or questions of efficacy Plaintiff has raised in this litigation.” LaBarre,*32. Of course, courts do like to limitthe chance of successful appeal by offering alternative grounds, but everyplaintiff is going to fail proximate cause for failure to warn when there is nofailure to warn. It seems like a lot ofwork for the court to keep writing detailed decisions when the common failingsof plaintiffs’ proof should submarine a bunch of their cases.
If the court had really wanted to beefficient, though, these plaintiffs would not have been allowed to re-pleadfrom New Jersey law to their home state law after “two separate decisionsrendered by the New Jersey Supreme Court in 2007.” Begley,*1 n.1; LaBarre, *1 n.1. Presumably the cases were two of the ones discussedhere http://druganddevicelaw.blogspot.com/2008/06/ebb-and-flow-of-law-new-jersey-edition.html and not miscites to the later powerful DeBoard and Bailey decisions that made New Jersey law lessplaintiff-friendly. Plaintiffs obviouslypicked New Jersey law when they filed back in 2006 because they thought itwould give them a better shot than their home state law. They had active complaints asserting NewJersey claims for three years before reversing field. Without belaboring the standards for allowingplaintiffs to amend their complaints well after filing or many times, it doesseem that the amendments here forestalled the inevitable summary judgment andjust forced the court to issue separate decisions where a single ruling that noplaintiff could satisfy the requirements of the New Jersey Product LiabilityAct that they had pled was once possible. We will take separate decisions when the end result is the same andjust.
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