Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Back in 2008, the United States Supreme Court held, in Riegel v.

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Drug & Device Law

JANUARY 15, 2024

First , the none of what you just read about the Supreme Court decision in Sullivan is precedential in Pennsylvania. We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 3d 1245 (N.J.

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Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. label, he would still have prescribed [the drug] to [plaintiff]. . . .

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Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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Drug & Device Law

APRIL 21, 2022

Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. For example, the court took judicial notice of an FDA recall notice. In support of that allegation, plaintiffs pointed to a particular adverse event that was noted in a recall notice. 2022 WL 1076173, at *5.

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Drug & Device Law

JUNE 2, 2023

May 25, 2023), has nothing whatever to do with drugs, or devices, or product liability, but we bring it to our readers’ attention because of what it has to say about federal appellate procedure. 3d 411, 422-23 (2005). 2023 WL 3632755 (U.S. Varghese v. Honeywell International, Inc. , Not anymore.

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Drug & Device Law

FEBRUARY 13, 2023

Those allegations, Pietrantoni held, sufficed to state an unpreempted (because the PAC program was apparently not FDA required) claim for negligent performance of a voluntarily assumed duty. 2005) (emphasis original). In a lot of ways Pietrantoni is a pretty good case for the defendants. citations omitted). Robertshaw Controls Co. ,

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Drug & Device Law

FEBRUARY 2, 2023

Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d What’s really interesting about Atkinson is its holding that the other prerequisite to case-by-case application of comment k – that the product have “proper directions and warning” – was also satisfied as a matter of law. Genentech Inc.

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Drug & Device Law

JANUARY 25, 2024

In Watson , even though it was about FTC regulation, the Court took a shot at the notion that drug and device companies might try to remove their myriad product liability cases based on this statute if interpreted to cover mere regulation. That is how plaintiff bought his medical walker and why we are talking about federal officer removal.

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Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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Drug & Device Law

MARCH 28, 2022

In a recent post , we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.” Here, we’re focusing on expert opinions misusing these FDA terms of art. In Robinson v. Ethicon, Inc. 2022 WL 614919 (S.D. of Bexis’ book. In Sadler v.

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Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” July 3, 2019) (expert may not opine about “proximate cause”); Perez v. 2005 WL 730688, at *4 (E.D. March 29, 2005) (same). E.g. , Dalgic v. Townsend Engineering Co. ,

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Drug & Device Law

JULY 13, 2023

When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. The most famous of these is probably Bates v.

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Drug & Device Law

MARCH 7, 2024

We recall that FDA was so impressed with the first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication. The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat COVID-19.

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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Drug & Device Law

AUGUST 9, 2022

The first thing defendant asked the court to do was take judicial notice of the drug’s labels from the FDA website. The labels included warnings about the risk of bleeding and hemorrhagic events and information about adverse events related to the eye and vision. The court granted that request on two grounds.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. Mensing , 564 U.S. 604 (2011), and Mutual Pharm. Bartlett , 570 U.S. 472 (2013). 2023 WL 2386776, *3. citing Gross v.

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