The Pharma Data

MAY 13, 2021

Testimonials are not necessarily representative of all of those who will use our products. Some of our testimonials are provided by customers who have received promotional offers in exchange for their participation. The testimonials displayed are given verbatim except for correction of grammatical or typing errors. 2018 Mar 11.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Weve railed against passage of the BLOCKING Act since February 2018 when it was made as a legislative proposal in the first Trump Administrations Proposed Fiscal Year 2019 Budget (pages 22 and 51)including in blog posts ( here , here , here , here , and here ) and in Congressional testimony as antithetical to a primary goal of the Hatch-Waxman Amendments: (..)

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Agency IQ

JULY 13, 2023

In June, the House Committee on Energy and Commerce (E&C) held a hearing on the House’s initial proposal , featuring testimony from witnesses and some legislative proposals for discussion. Congress is already working on the reauthorization process.

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Drug & Device Law

MARCH 4, 2024

Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” His inability to produce admissible expert testimony is due to his own actions, namely the failure of his proposed experts to test their alternatives. Weisgram v.

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Drug & Device Law

JANUARY 19, 2024

We’ve been posting about decisions from In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation , MDL 2775, since 2018. Its preemption ruling on defendant’s motion to dismiss made the list of ten worst decisions from 2018 , and a subsequent preemption decision reflected more MDL madness.

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Drug & Device Law

JANUARY 5, 2024

Because such a claim did not share “common core of facts” with the original alleged injury—a 2018 stroke—the claim did not relate back to the original complaint and thus was time-barred. Plaintiffs had no evidence to rebut the treater’s clear testimony. 2023 WL 8717570, *3.

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Drug & Device Law

DECEMBER 26, 2023

Testimony by expert witnesses. First, the Committee found it necessary to “emphasize” both the court’s role and the burden of proof. “[E]xpert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule.”

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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

JULY 24, 2023

See , e.g. , In re Thalomid & Revlimid Antitrust Litigation , 2018 WL 6573118, at *4 (D.N.J. 30, 2018); In re Skelaxin (Metaxalone) Antitrust Litigation , 299 F.R.D. It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony. 555, 565 (E.D.

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Drug & Device Law

JUNE 23, 2023

2018) (all substantive law); McCarrell v. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years. That court ruled, in effect, that when mass tort litigation tourists come to New Jersey to sue a New Jersey company, they may only do so under New Jersey law.

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Drug & Device Law

JUNE 20, 2023

Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts.

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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). There was a similar endorsement in 2018.

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Drug & Device Law

NOVEMBER 28, 2022

2018) (Etminan); Gerke v. Because the facts of [plaintiff’s] case paralleled the description of [the pseudonym] in Dr. Moline’s congressional testimony, [defendant] suspected that [she] was one of the thirty-three anonymous individuals that the article had studied. 2019) (Zambelli-Weiner); In re 3M Bair Hugger Litigation , 924 N.W.2d

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Drug & Device Law

AUGUST 26, 2022

The court did not mention that the manufacturer was sold in 2018.) Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) Plaintiff sued the US manufacturer, its US parent (at the time of the implant), and its parent’s Swedish parent (at the time of the implant). (The

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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

APRIL 18, 2022

2018), as “ The Best Wisconsin Law Decision We’ve Ever Seen, Affirmed.” The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. 2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” 3d 746 (7th Cir.

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Drug & Device Law

MARCH 28, 2022

2018 WL 3649714 (S.D. April 19, 2018). The Federal Rules of Evidence do not permit an expert to render conclusions of law, because such testimony cannot properly assist the jury in understanding the evidence or determining a fact in issue. So we ran a search. High on the list was Tsao v. Ferring Pharmaceuticals, Inc.

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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. 2018 WL 1440608, at *5 (W.D. at *3 (quoting expert’s testimony). 2018 WL 4286197 (N.D. 7, 2018), reached essentially the same result.

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Drug & Device Law

FEBRUARY 3, 2022

Litigation over this PMA device has produced two separate preemption decisions that we deemed among our ten worst of the particular year ( #6 in 2018 and #6 in 2021 ). First, plaintiffs complained about allegedly undisclosed opinion testimony offered by a defense expert. We will trust you to fill in the blanks.

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Drug & Device Law

JANUARY 28, 2022

Clearly, given Dr. Rosenzweig’s meat-axe testimony that all mesh products made from polypropylene are unsafe and unsuitable for implantation in the human body, Plaintiffs’ proposed alternative design (TVTs in general) was dead on arrival, which the opinion recognized. 3:14-cv-00549 (VLB), 2018 WL 1525709, *25 (D. newsflash! )

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