Health Law Advisor

JULY 21, 2023

3] The FDA created the voluntary Breakthrough Devices Program to expedite the development, assessment, and review for premarket approval, 510(k) clearance, and de novo marketing authorization for devices designated as “breakthrough devices” to improve timely access for patients and providers. [4]

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Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. Black’s Law Dictionary, “chattel,” at 251 (rev. 19, comment f.

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Drug & Device Law

FEBRUARY 25, 2022

Courtesy of the Second Circuit, as we blogged here , Connecticut will be the second state high court to determine whether state law allows a “warning” claim based on another of the other side’s favorite preemption avoidance theories ? filed Jan. case ( Conte ) in 2009. Bausch & Lomb, Inc. , SC20607 (Conn. State ex rel.

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Drug & Device Law

MARCH 3, 2022

Our methodology was to try to find decisions she has authored, either at the district or circuit level, that address product liability, preemption, personal jurisdiction, or some other issues that pop up frequently in our posts. It was also fairly systematic in matching up record citations with the cited law in conducting the analysis.

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. 2023) (en banc) (no presumption against preemption; “force of law” of agency ruling a non-issue in express preemption) ( here ); In re Ford Motor Co. 4th 315 (6th Cir.

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Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. 2010) (applying TwIqbal because “[p]unitive damages are never awarded as a matter of right, are disfavored by the law”). But even before that was done, Poozhikala v. Medtronic Inc. 2022 WL 610276 (C.D. Corrections Corp. ,

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Drug & Device Law

MARCH 31, 2022

This post is from the non-Dechert side of the blog. Thus, the Standard Oil court rejected the government’s “tort law analogy” as a basis for “establishing. . . The Generic Manufacturer Defendants here were prohibited by federal law from changing the design or labeling of [their products]. . . . fiscal and regulatory policies.”

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. 2d 397 (6th Cir.

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Drug & Device Law

APRIL 10, 2023

Keeton, Prosser & Keeton on the Law of Torts , at 165 (5th ed. That’s why this defense oriented blog has inveighed against claims solely for “ medical monitoring ” ever since it was founded. Having no law and no facts in their favor, the Brown plaintiffs instead tried to pound the drum of “public interest.” Prosser & P.

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Drug & Device Law

AUGUST 14, 2023

True, if you turn to Creazzo in the Atlantic Reporter you will find, under “attorneys and law firms,” the following: “Ronnie L. We know the other side reads the blog – so after today we submit any such assertions made in future cases would not merely be false but would presumably become frauds on whatever court to which they might be made.

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Drug & Device Law

MARCH 17, 2022

Plaintiffs’ argument was based on a supposed difference between the “Due Process guarantee” of the Fifth Amendment, governing federal law, versus the Fourteenth Amendment governing the states. But the Convention does not authorize nationwide service ? Here’s another example. LG Chem, Ltd. 2022 WL 274498 (11th Cir. citations omitted).

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Drug & Device Law

JUNE 28, 2022

At least one state already has such a law. A State may not evade the pre-emptive force of federal law by resorting to. . . This logical contradiction posed a significant “obstacle” to the exercise of the FDA’s authority to approve the products it regulates for marketing. Roe , 429 U.S. 589, 597 (1977); Robinson v. 393(b)(2)(B).

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Drug & Device Law

MARCH 2, 2023

Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. In deciding specific personal jurisdiction, it relied almost exclusively on pre- Bauman/Walden authority, much of which is probably not good law anymore. The recent decision in Blevins-Ellington v. CooperSurgical, Inc. ,

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Drug & Device Law

DECEMBER 11, 2023

As a result, the Court has the authority to sever the claims against the two groups of defendants. 826 (1989), made clear that any federal court, even an appellate court, “has the authority to dismiss a dispensable nondiverse party by virtue of Rule 21.” at 707 (footnote omitted). See also Todd v. Merrell Dow Pharmaceuticals, Inc.,

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Drug & Device Law

JUNE 6, 2023

A little less than three years ago we posted about a decision by a federal court in Pennsylvania that twisted Texas and Supreme Court precedent to find an independent claim for failure to test under Texas law. So, we could not resist blogging about a Texas court reaching the exact opposite conclusion. Ethicon Inc.,

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Drug & Device Law

FEBRUARY 8, 2024

As insightful and modest as the Blog can be, we are not infallible. So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor. So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor. The MDL in which Hinton v.

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