Healthcare It News

FEBRUARY 20, 2024

Challenges in diagnosing sleep apnea and research that shows positive airway pressure treatment can lower healthcare costs motivate healthcare organizations and government agencies like the U.S. New FDA update on Philips Respironics' 2021 device recalls PAP machines which deliver oxygen through a mask, are one way to treat sleep apnea.

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Health Law Advisor

JANUARY 30, 2023

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

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Healthcare Law Blog

APRIL 14, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Following the U.S.

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Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

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Drug & Device Law

OCTOBER 23, 2023

Back in 2008, the United States Supreme Court held, in Riegel v. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. Medtronic, Inc. , Moreover, Martin was decided before Buckman Co. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. continue to be subject to Rule 407-based exclusion.

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Drug & Device Law

MAY 16, 2022

Fortunately for limited government everywhere, the private group lost in CCoC – unanimously. as the FDA acknowledged the warning might be. . . . [W]hen Put simply, no government may, consistent with the First Amendment require a private person to repeat governmentally endorsed false statements. Here’s how. CCoC , 29 F.4th

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Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. 1396r-8(k)(6). But it mattered to the folks that administered Medicare.

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Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 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. Kent , 552 U.S. Lohr , 518 U.S.

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Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008.

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Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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Drug & Device Law

JANUARY 16, 2023

As we’ve also discussed previously , the FDA imposes tight restrictions about anything that a regulated entity proposes to say about off-label uses in the label. 49603, 49605-06 (FDA Aug. 22, 2008)). at *4 (“plaintiffs focus their appeal on the three Japanese studies not originally submitted to the FDA”). quoting 73 Fed.

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Drug & Device Law

JULY 18, 2023

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since. 312 (2008).

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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. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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