Adverse Event Reporting

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Our recent post on the outcome of the plaintiffs’ in limine motions in the Guenther Aredia/Zometa case prompted a volcanic retort from one of the plaintiffs’ counsel (who will remain anonymous) that “all was not beer and skittles” (yech – not an appetizing combination) for the defense, specifically listing the court’s rejection of a defense “paper storm” and “preemption based in limines.” Attached to counsel’s emails were an order striking an original set of defense in limines as too darn long and a second order resolving a choice of law dispute in favor of Florida, rather than Georgia, law.  Why a plaintiff would prefer Florida law in prescription drug product liability litigation case escapes us; some of us remember the excellent Florida law on causation and the learned intermediary rule that led to huge defense wins in the Seroquel litigation.

At about the same time as that email, one of our automatic searches pulled up the opinion on the Guenther defense in limines, which counsel had referenced but did not attach.  See Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013).  Because (as counsel noted) we are interested in preemption issues – even hard ones for our side, which certainly includes preemption in innovator drug cases post-Wyeth v. Levine, 555 U.S. 555 (2009) – we took a look. Hmmmm.

For a post-Levine decision, we actually don’t think the rulings are all that bad.  In fact, since the opinion provides a road map for possible future preemption inroads, we think this Guenther decision is worthy of comment.Continue Reading More On Aredia/Zometa – Innovator Drug Preemption

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One of the remand courts in the Aredia/Zometa litigation recently issued a decision on various motions in limine.  See Brown v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 104985 (E.D.N.C. July 27, 2012).  Here’s the rundown of the “good,” the “not-so-good,” and the “it depends.”
The good:
·                     Post-injury label changes: The court

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We’ve been reading the Keith Richards autobiography, Life, and it made us think about the past. The Rolling Stones were formed 50 years ago, in April 1962. We were Beatles fans in the 1960’s. (Still are). When the Rolling Stones showed up on The Ed Sullivan Show they seemed sort of terrifying. (Still are.)

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A topic of repeated interest for us is how courts treat evidence of adverse event reports.  And we haven’t been shy about how we feel — AER’s should not be used in a civil trial.  AER’s are voluntary, biased (sometimes litigation-generated), and should not be used to calculate incidences of drug risk. AER’s are not the stuff of good science.  We’ve even put together an Adverse Event Report Cheat Sheet  filled with cases laying out compelling reasons for excluding AER’s.
So, why are we re-hashing this already well trod ground?  Well because in railing against the use of AERs in the courtroom, we’ve often distinguished the FDA’s reliance on AERs on the basis that the FDA can act in the public interest on a lower quantum of evidence than is necessary to establish causation in a products liability suit.  A recent report by the FDA, however, has left us wondering just how helpful AERs are to even the FDA.  The purpose of the report, entitled Understanding Barriers to Medical Device Quality was “to assess and understand gaps in medical device quality.”  FDA Report at 3.  While the FDA didn’t rely exclusively on AERs, they were a driving factor in the FDA’s apparent conclusion that medical device quality has significantly lagged behind medical device technology.  While we will leave a more thorough discussion of the four corners of the report to our friends at the FDA Law Blog, we thought it worthwhile to point out how even the FDA’s use of voluntary AERs can lead to false conclusions.Continue Reading More Reasons to Discount Adverse Event Reports

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So says the unanimous Supreme Court today in Matrixx Initiatives, Inc. v, Siracuso, 09-1156, slip op. (U.S. March, 22, 2011).  We’re not securities lawyers, so we’re primarily concerned with how Matrixx could affect product liability litigation.
We don’t think it will have all that much, since the court makes pretty sure that “materiality” for …

We have reported periodically on rulings in the Aredia/Zometa litigation, including Daubert and summary judgment rulings by the MDL judge and choice of law rulings by Judge Arthur Spatt of the E.D.N.Y. in Deutsch v. Novartis Pharmaceuticals Corp., a case remanded for trial from the MDL. Judge Spatt has now decided Daubert motions in Deutsch and another remanded case, and his very long opinion is a bit like yesterday’s list of silly law songs : there is something in there for everyone. Deutsch v. Novartis Pharmaceuticals Corp., 2011 U.S. Dist. LEXIS 22755 (E.D.N.Y. March 8, 2011).
MDL rulings are law of the case. The MDL judge ruled on Daubert challenges to several plaintiffs’ experts. Novartis challenged those experts based both on arguments made to the MDL judge and on new arguments. Judge Spatt generally refused to consider the arguments previously decided by the MDL judge based on the law of the case doctrine, finding the doctrine particularly applicable when cases are transferred from an MDL. 2011 U.S. Dist. LEXIS 22755 at *18-21. “Reversing or otherwise undermining the decisions by the MDL court could lead to the type of inconsistent pretrial rulings that Congress sought to avoid [in the Multi-District Litigation Act], and therefore frustrate the very purpose of consolidation.” Id. at *21.
As a general matter, we agree that issues decided by the MDL judge should not be relitigated on remand. In Deutsch, however, the MDL rulings became the third rail, and anyone raising an argument that came within a few yards of an issue decided by the MDL court got zapped.Continue Reading A Grab Bag Of Rule 702 Rulings In A Remanded Aredia/Zometa Case

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The Monday curse continues! Another bad case that makes us feel so disappointed, so cheated, so sad, so … Monday.
We have blogged on the Bartlett case before. We did it here. And here. And here. And here. And that’s not all. It’s been the gift that keeps on giving. Though, as was the case over the holidays, some of those gifts were items we’d just as soon return. Make no mistake about it, Judge LaPlante works hard and writes lengthy, scholarly opinions. He seems thoughtful and diligent. Some of what he wrote we liked a lot. Some — not so much. Being thoughtful and diligent doesn’t always make you right. (And sometimes one can be thoughtless and lazy and still be utterly right. Every day we bank on that possibility.)
In the Bartlett case the plaintiff suffered truly horrific injuries, claiming they were the result of a generic anti-inflammatory drug called Sulindac. The details are in our earlier posts, so let’s get right to the bottom line: the jury returned a verdict of $21 million. The defendant filed a motion for judgment as a matter of law and, in the alternative for a new trial. Last week, Judge LaPlante denied those motions. Bartlett v. Mutual Pharmaceutical Co., 2010 WL 5494053 (D. N.H. Jan. 5, 2010).
The coverage we’ve seen so far of this decision emphasizes the defendant’s claims that the trial was unfair because the plaintiff lawyer inserted all sorts of prejudicial stuff (including putting up on the screen a precluded question about the company’s net sales — supposedly an accident due to a computer “glitch”) as well as the defendant’s claim that the judge seemed biased because he said a few things that defendant construed as rooting for the plaintiff, and also appeared to get teary-eyed during emotional testimony (the Judge told the jury the next day that it was only an allergy).Continue Reading The Bartlett Saga Continues: Reversal Bait

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Last year the Ninth Circuit, in a case called Siracusano v. Matrixx Initiatives, 585 F.3d 1167 (9th Cir. 2009), issued a really troubling decision, holding that reports of adverse product events – although not even the plaintiff claimed that they were statistically significant – were enough to get past a motion to dismiss in…

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A lot of things about that recent Gadolinium opinion ticked us off.  But one of the lowest of many low points was when the court ruled a causation opinion based upon FDA adverse event reports (“AERs”) was admissible in a civil trial because the FDA used AERs to assess causation administratively.  In re Gadolinium-Based …

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Yes, Virginia, the FDA’s regulations requiring redaction of physician identifying information from Adverse Drug Event (“ADE”) reports are mandatory – even if plaintiffs obtain them … well … irregularly.
That’s the lesson of a brand new discovery decision in In Re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 4:08-MD-2004, slip op. (M.D. Ga.…

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