This post is a little different. For one thing it’s more or less a rehash of a post by Jeff Orenstein, one of Reed Smith’s regulatory enforcement types, on one of the firm’s “branded” blogs. DDL by contrast, is notoriously unbranded, since we have bloggers from different law firms.
Still, when we heard Jeff give
Ever since Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), was decided, we’ve pointed out at every opportunity that its basic principle – that an immediate state-law “duty” is incompatible with an FDA pre-approval requirement, and therefore subject to impossibility preemption – should apply to any FDA (and probably other government agency) pre-approval requirement for any product, not just generic drugs.
We’ve highlighted some success, see Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014) (non-generic dosage claim preempted); Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013) (non-generic black box, dosage, comparative labeling claims either preempted or probably preempted), but we hadn’t seen any case actually taking on a design defect claim in the non-generic context. Now we have. See Cassel v. ALZA Corp., 2014 WL 856023 (W.D. Wis. March 5, 2014). While Cassel contains some hopeful signs, the bottom line was not good – preemption motion denied. However, in order to avoid preemption, Cassel was forced to contort state law in novel ways that we don’t think most courts would countenance.
Cassel involved a peculiar sort of non-generic drug – at least that’s what we glean from the opinion – a fentanyl analgesic patch. Such a product has some of the characteristics of a drug, in that there’s fentanyl in it, and that’s a substance that meets the observation in Bartlett that “as a matter of “basic chemistry,” “because of [the drug’s] simple composition, [it] is chemically incapable of being redesigned.” 133 S. Ct. at 2475. On the other hand, the product’s mode of administration, being a patch, is capable of being redesigned, and in fact had been. See Cassel, 2013 WL 4648449, at *1 (discussing 2009 design change).Continue Reading Nice Try, But No Brass Ring
This post is from the non-Reed Smith side of the blog.
Have you ever told someone, “I’ll put it in the vault” or “not that there’s anything wrong with that”? Or yelled “Serenity Now!” in a chaotic situation. How about offered someone a “you are so good looking” after a sneeze? If not,
Maybe I can start a class action. I mean, I find it annoying that convenience stores don’t carry cold 12-ounce soda cans anymore. They don’t even carry the 16-oz bottles that existed years ago. Nowadays, everything’s in a 20-ounce bottle. But I don’t need 20 ounces of soda. A twelve-ounce can is fine. Heck, sometimes
We have been informed that Judge Carol Higbee, long-time Mass Torts judge for Atlantic County, announced yesterday that, effective sometime in late April/early May, she was being temporarily assigned to the Appellate Division of the New Jersey Superior Court. It is possible that the assignment could become permanent, with that decision being made in or
Safe harbor. We like the sound of that. The term connotes a level of calmness and predictability that we find appealing in the regulation of drugs and medical devices, and we find ourselves writing about safe harbors a lot lately. Bexis recently gave us his survey of safe harbors against state consumer fraud claims, and
Howard v. Zimmer is an old case. It was filed in the Northern District of Oklahoma in 2002 and got transferred to the Northern District of Ohio for the Sulzer Hip and Knee MDL. In 2010, after not participating in a class action settlement in 2003 and having plaintiff’s claims carved up on summary judgment
We will not be the first to comment on the Eighth Circuit’s affirmance earlier this week of summary judgment in Boehm v. Eli Lilly & Co., 2014 WL 904202 (8th Cir. March 10, 2014), nor will we be the last. The case is that good and that important. (And, unlike some of the recent
This guest post is from Reed Smith’s Lindsey Harteis, who as always gets all the credit and shoulders all the blame for what follows. Her post is about the First Amendment implications of the FDA’s recent draft guidance on manufacturer distribution of scientific articles and textbooks, a proposal that alters, but does not fundamentally change
Here’s another “little list” that came about because of Bexis updating chapter two (information-based claims) of his book. This one includes all cases where, due to the ordinary burden of proof, warning claims were dismissed on causation grounds where there was simply no evidence in the record about the prescribing physician’s actions. The reasons for the prescriber’s unavailability differ. S/he could be dead, disappeared, or for whatever reason never deposed.
Obviously, the rationale of these cases doesn’t fly in jurisdictions where a “heeding presumption” puts the onus on the defendant to come up with affirmative proof of lack of causation.
First, some cases from Texas, one of a few states that has addressed this issue repeatedly. In Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court pointed out that the plaintiff’s questioning of the prescriber was simply inadequate. “Instead of proving that greater risk of [the condition would have changed [the prescriber’s] decision to prescribe [the drug], [plaintiffs] elicited no evidence to that effect.” Id. at 172. Also under Texas law, the Fifth Circuit in Pustejovsky v. PLIVA, Inc., made clear that the party with the burden of proof loses when the prescriber simply doesn’t remember anything:
[Plaintiff] has not carried her burden. As [plaintiff] admits, [the prescriber] did not recall ever reading the package insert for the drug or consulting the Physician’s Desk Reference. Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden.
Lacking any evidence that [the prescriber] was aware of [defendant’s] warnings, [plaintiff] instead speculates about other ways an adequate warning might have reached [the prescriber] and altered her decision. . . . Certainly, these scenarios are possible. Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities. . . . While [plaintiff] can imagine any number of scenarios to fill the gaps in [the prescriber’s] memory, she has provided evidentiary support for none of them. Accordingly, [plaintiff] fails to demonstrate a genuine issue of material fact regarding causation.
Continue Reading Little Lists 2 – Warning Causation Dismissal Where Prescriber Not Deposed