Hall Render

NOVEMBER 17, 2023

Grifols gets FDA approval for new facility in Clayton Invitae pledged $115M, 374-job investment in North Carolina. Million Individuals Affected by MOVEit Hack MARYLAND Adventist HealthCare, Montgomery College form partnership to address need for qualified nursing workforce Harford Memorial Hospital closing set for Feb. Many more are waiting.

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Hall Render

FEBRUARY 10, 2023

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

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Hall Render

NOVEMBER 3, 2023

Joe’s among busiest hospital ERs in nation, poll reveals New ASC, medical building proposed in New Jersey New Jersey hospital innovation director appointed to FDA committee New Jersey hospital rebuffs criticism from US senator Nurses testify that N.J. Then Prospect Medical took over.

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Drug & Device Law

DECEMBER 4, 2023

2016) (quoting Mayer v. CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. We saw more of the same with the discussion of consumer fraud claims in CPAP II. Johnson , 2016 WL 3055875, at *7 (N.D.

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Drug & Device Law

MARCH 3, 2022

The MDL was established in June 2016. That discussion did not, for instance, tout a non-existent presumption against preemption or suggest that Buckman only limited claims titled as “fraud-on-the-FDA,” mistakes we have seen from other judges. The first is pace. The briefing on motions to dismiss was complete in September 2017.

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Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. 2016) (association’s “adoption of rules, policies, and procedures. . . Such power rests solely with the FDA.” Typically overblown MDL claims for “fraud” and “conspiracy” also failed. Reynolds Tobacco Co. , 3d 168, 170-71 (5th Cir.

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Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

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Drug & Device Law

APRIL 21, 2022

The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud. 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.

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Drug & Device Law

FEBRUARY 2, 2023

Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2016) (applying the Texas warning presumption to a generic drug eluting patch). manufacturer, . .

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Drug & Device Law

MARCH 7, 2022

Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., at *8 (agreeing with Bouncing Angels, Inc. 2, 2020). “In

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Drug & Device Law

MAY 26, 2022

9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake. Under Fed.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. 2022 WL 4237528 (D.

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Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our 1938 (2016), but the lack of a presumption meant plaintiff’s claim was preempted. Contraceptive devices without a pharmacologic action have not avoided litigation.

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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

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. The court held that the presumption applied because it was “undisputed that the [device] is subject to FDA oversight.”

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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. Mensing , 564 U.S. Lohr , 518 U.S. Lohr , 518 U.S.

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Drug & Device Law

JUNE 5, 2023

April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible. at *2 (citations omitted). Bard, Inc. ,

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Stryker Corp. ,

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Drug & Device Law

OCTOBER 12, 2022

The complaint included causes of action for negligence, strict liability, breach of various warranties, violation of the New Hampshire consumer protection statute, and common law fraud. Buckman preempts FDA-related claims when they would not exist if the FDCA did not exist. Goodbye, fraud. So far, so good. .

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Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 4th 210 (5th Cir.

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