A little over a year ago, we discussed one of the best decisions we had ever read on why comparative risk claims – premised on a manufacturer’s alleged failure to warn that a competing product was supposedly “safer” – are both statistically invalid and practically impossible. That decision, Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343 (S.D. Miss. 2021), explained at length both how product “comparisons,” if based on the FDA’s voluntary “MAUDE” adverse event reporting system are inherently suspect due to “informational bias,” id. at 355, and, if based on non-public information, would require access to unavailable information about competitors’ products. Id. at 354-55.
We are watching the post-MDL-remand Bard IVC filter litigation with interest. It bears some resemblance to the Bone Screw litigation of the late 1990s/early 2000s (except in Bone Screw, there was no MDL settlement) in that the targeted defendant is engaged skirmishes across the country. In mass torts, the plaintiffs have the benefit of…
The Ninth Circuit’s Booker Decision
The decision in In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) (“Booker”), is yet another reminder that multidistrict litigation as it is currently conducted is a fundamentally flawed process, dedicated more to forcing settlements than to any of the goals envisioned by Congress when it passed…
Preemption (and Other Things) Defanging Depakote Claims
It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial. What’s left doesn’t strike us as a very good warnings case. Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects. Make no mistake about it, Depakote has a known association with such injuries. First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:
there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
21 C.F.R. §201.57(c)(9)(i)(A)(4). Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect. For details, see 2015 WL 4743056, at *2-3.
Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies. Id. at *1. On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it. Id. Her allegations did try to change the subject, however. In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.” Id. at *5.…
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More On Aredia/Zometa – Innovator Drug Preemption
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.
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The big developments – the Caronia opinion, and the Supreme Court’s grant of certiorari in Bartlett – along with other distractions, such as our ABA Blawg 100 award, have left us with a pile of unblogged stuff that we think is of interest to our readers.
Today we’re taking a crack at that pile. We apologize in advance if these discussions aren’t as detailed (and thus aren’t as useful) as our usual posts.
California Leans Daubert
California has long gone its merry, idiosyncratic way in the Daubert/Frye wars. The California Supreme Court has fashioned something called “Kelly/Leahy”
after the names of the two most important opinions. However, in Sargon Enterprises, Inc. v. University of Southern California, ___ P.3d ___, 2012 WL 5897314 (Cal. Nov. 26, 2012), the court spoke about California expert admissibility with a distinct Daubert accent. Sargon (great name – it evokes space aliens, unknown elements, or even ancient Sumer) is a drug/medical device case only in the loosest sense. It’s about an alleged “breach of a contract
for the [defendant] to clinically test a new implant the [plaintiff] had patented.” Id. at *1. The expert testimony at issue involved lost profits. Id. at *2. The testimony was vague and tautological, involving the expert’s supposition that the defendant, because it was “innovative,” would have joined the “big six” dental implant manufacturers. But he measured “innovation” according to “the proof is in the pudding” – successful companies were “innovative,” less successful ones less so. Why was the plaintiff company “innovative” even though it was small? That opinion was a bunch of gobbledygook and jargon amounting to “because I think so.” See Id. at *3-5. The trial court threw the expert out. The Court of Appeals reversed and found the testimony admissible, then the
California Supreme Court granted review.
This blog doesn’t care all that much about the ins and outs of calculating lost profits, but we do care about the standards for expert admissibility. Sargon is
noteworthy for the court’s repeated reliance on the federal precedent that we have (usually) come to know and love, starting with “[u]nder California law,
trial courts have a substantial ‘gatekeeping’ responsibility.” Sargon, 2012 WL 5897314, at *14 (footnote citing Joiner and Kuhmo Tire omitted). That leads to “[e]xclusion of expert opinions that rest on guess, surmise or conjecture is an inherent corollary to the foundational predicate for admission of the expert testimony.” Id.
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Rule 702 Decision in Baycol Raises Interesting Legal Points
We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.…