Drug & Device Law

DECEMBER 21, 2023

Never mind that, since Bausch the Supreme Court has entertained preemption issues under Rule 12(b)(6) on multiple occasions, including the Mensing ( 2011+1 ) prescription drug preemption decision. If Bausch was ever a correct statement the law, it has since been impliedly overruled.

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Drug & Device Law

NOVEMBER 27, 2023

Thus, when the other side inveigles one of ours to switch sides – usually with the promise of a lot more money for a lot more testimony – the result can be a lot of collateral litigation. We’ve blogged a couple of times before about turncoat experts, so the recent decision in Hawkins v. DePuy Orthopaedics, Inc. 2023 WL 7292164 (D.D.C.

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Drug & Device Law

OCTOBER 30, 2023

This medical causation theory was outlined in a 2011 memo authored by the defendant’s then-chief medical officer, which touched off the ensuing storm of litigation. As to the first causation point, the 2011 memo was limited to certain arrhythmias. G/N , 2023 WL 5807340, at *1.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. 1 (highlights). 3d at 1247. For one thing, plaintiffs changed their tune.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 604 (2011), and Mutual Pharm. Wyeth Ayerst Pharms. , 3d 364 (1st Cir. 3d 1034 (S.D.

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Drug & Device Law

MARCH 9, 2023

Citing a range of Tennessee cases, the Campbell court rejected plaintiff’s argument with “it is only the Plaintiffs who are required to present expert testimony to establish causation in cases where the plaintiff has suffered a complex medical injury.” A relative risk of exactly 2.0 But we digress from our digression. LEXIS 31015, *5-6.

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Drug & Device Law

FEBRUARY 20, 2023

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. His testimony is thus irrelevant and inadmissible.

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Drug & Device Law

FEBRUARY 14, 2023

Plaintiff had hip replacement surgery in 2011 with a ceramic-on-ceramic hip replacement system. Defendant, of course, argued a lack of causation based on plaintiff’s surgeon lack of reliance on or even reading of any of defendant’s warnings or labeling and his testimony that he performed the surgery based on his own experience and training.

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

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Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

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Drug & Device Law

FEBRUARY 28, 2022

at 287 (citing transcript of expert’s testimony). [A]t A]t first blush, [the expert’s] testimony. No other witness offered testimony on these unidentified standards. An excellent example is the Sherman case, which involved junk science causation testimony in what we call a “toxic soup” chemical exposure case.

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Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). Notice how admissibility of expert testimony under Fed. 19-2899 (8th Cir. filed Sept.

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