We like it when our readers contact us, even when it’s only to tell us that we made a mistake. At least they’re paying attention. But we like it most when our readers send us new opinions of interest − especially good ones. The rapid exchange of information helpful to the defense of prescription drug
News Flash: Texas Adopts Learned Intermediary Rule; Rejects DTC Exception
In his role as amicus curiae for the Product Liability Advisory Council (“PLAC”) Bexis is now two for two since moving to Reed Smith – of course that also means that somebody else is doing the really heavy lifting, in this case Randy Roach of Roach & Newton and Gene Williams and Manuel Lopez of Shook Hardy. Today the Texas Supreme Court, in a landmark (there goes Bexis breaking his arm patting himself on the back again) 55-page unanimous decision, the Texas Supreme Court held the following:
(1) the learned intermediary doctrine generally applies within the context of the physician-patient relationship, and a prescription drug manufacturer fulfills its duty to warn its product’s end users by providing an adequate warning to the prescribing physician; (2) the [lower court] erred by adopting a DTC advertising exception to the doctrine; (3) the learned intermediary doctrine is not a common-law affirmative defense, but a common-law rule and its applicability was not waived by [defendant]; (4) [a] non-prescribing, treating physician, owed no duty to warn [plaintiffs] of the risks associated with [the drug] beyond the risks directly attributable to the infusion process; (5) because all of [plaintiff’s] claims are premised on [defendant’s] alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) [plaintiffs] failed to introduce any evidence that the allegedly inadequate warning was the producing cause of [plaintiffs’] purported injuries.
Centocor, Inc. v. Hamilton, No. 10-0223, slip op. at 55 (Tex. June 8, 2012).Continue Reading News Flash: Texas Adopts Learned Intermediary Rule; Rejects DTC Exception
Ugly Texas Decision Ignores Erie, Tramples State Law
T for Texas
A couple of Texas Supreme Court developments of interest. (1) the court reversed the adverse Vioxx decision in Garza – holding that the plaintiffs did not provide sufficient epidemiological evidence in a low dose case. A copy of the opinion, which requires two epidemiological studies showing a relative risk of 2 or more, is available…
Mirapex – Rule 702 Inapplicable To Toll Statute of Limitations
We don’t generally cover statute of limitations-type issues (except for class action tolling) because they tend to be too state-specific and fact-bound to be of much general use. We’re making an exception for today’s decision in Gazal v. Boehringer Ingelheim Pharmaceuticals, No. 10-3129, slip op. (8th Cir. July 28, 2011), because it decides a…
Restatement (3d) §6(c) By Any Other Name….
Seems to be Texas law.
The Third Restatement of Torts – controversially – includes an extremely limited form of “design defect” claim that it would allow against manufacturers of drugs and medical devices. That doesn’t really make sense in the drug context because, with some minor exceptions (such as quantity of active ingredient per dose,…
Warning Causation to the Rescue
The Fifth Circuit affirmed summary judgment in Pustejovsky v. Pliva, Inc., 09-10983, slip op. (5th Cir. Oct. 8, 2010), the other day. We covered the original summary judgment, here. The defendant, a generic manufacturer of metoclopramide, first lost on preemption. Slip op. at 5. That’s not a surprise since generic preemption’s been…
Notes on Informal Physician Interviews
A couple of readers dropped us notes after reading yesterday’s post about the situation with informal treating physician interviews in New Jersey.
Brad Wolff at Swift Currie kindly updated us on Georgia, which isn’t as much of a lost cause as we thought. While the recent Georgia Supreme Court opinion in Baker v. Wellstar Health …
Learned Intermediary Causation – Lights Out In Georgia And A Texas Two-Step
Whether additional warnings would have made a difference to learned intermediary physicians was the issue to be decided in two appellate decisions handed down this week. On facts that weren’t all that much different – at least as far as the prescribers were concerned (hold that thought for later) – the courts came to diametrically…
Merck Wins Vioxx AG Case In Texas
Bexis can’t say much anyway, since his firm’s involved in Vioxx, and neither of us have seen the opinion, but Merck announced today that it was granted summary judgment today in the Texas state AG consumer protection litigation. Here’s a link to Merck’s press release. When we get a copy of what promises to…