C&M Health Law

JANUARY 25, 2023

Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024. Section 3604 of the Act requires FDA to issue a report on an annual basis, beginning two years after the Act’s enactment, that summarizes its diversity action plans.

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Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. And this is “Climavores,” a show about eating on a changing planet.

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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. 2010), which is undoubtedly the worst post- Riegel appellate PMA preemption decision of all. 341 (2001), which put an end to any doubt about this proposition. Medtronic, Inc. ,

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Drug & Device Law

DECEMBER 4, 2023

2010) (citations and quotation marks omitted). “[W]e have exercised restraint” and “opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the affected state] decides differently.” 2010). “[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . .,

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

NOVEMBER 10, 2023

Two of your intrepid bloggers took shots at writing blogposts about Valsartan shortly after it was decided – but found the opinion simply too complicated, verbose, and depressingly wrong for us to wrap our hands, or our brains, around. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug.

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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

AUGUST 8, 2022

Recently, we have become concerned about personal injury plaintiffs deciding to sue these kinds of organizations because they don’t like some standard that stands between them and the pot of gold at the end of the litigation rainbow. Smith, LLC , 2010 WL 11566367, at *7 (N.D. Such power rests solely with the FDA.”

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Drug & Device Law

FEBRUARY 3, 2022

1407, talks about “pretrial proceedings” only—have been quite plaintiff friendly. It was presumably a bellwether, as those are the only kinds of cases MDL courts can try, even among the most expansive interpretation of § 1407, and we do not know much about the merits other than the defendant won a jury verdict. (We

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Drug & Device Law

NOVEMBER 28, 2022

2010) (Matsen); Nelson v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). On the “strength” of this article, Dr. Moline not only set out to become a repeat P-side asbestos expert, but also “testified to Congress about her findings” using “a pseudonym. . . 316, 328-29 (D.

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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

JANUARY 24, 2023

Almost a year ago we wrote a post called Learned Intermediary – Not Just for Failure to Warn about a California putative economic loss class action that was dismissed for failing to plead any allegations about whether the drug manufacturer had adequately warned plaintiff’s prescribing physician.

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Drug & Device Law

MARCH 7, 2022

2010) (applying TwIqbal because “[p]unitive damages are never awarded as a matter of right, are disfavored by the law”). These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., That’s a start, but what about the federal courts of appeals? Corrections Corp. ,

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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

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. 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Wyeth , 619 F.3d 3d 632 (6th Cir. 3d 434 (Pa.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. The two of us recently wrote about the issue of retroactivity of Michigan S.B. Nothing about retroactivity. 410 repeal in Law360 (i.e.,

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Drug & Device Law

AUGUST 25, 2023

As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. Litigation began over alleged birth defects in 2015 and whether the manufacturer should have added warnings about that issue. Albrecht, 139 S. 1668 (2019)and Wyeth v. Levine , 555 U.S. 555 (2009).

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Drug & Device Law

JANUARY 16, 2023

The claims in Zofran concerned plaintiffs’ demands for warnings about the off-label use of this product for relief of morning sickness during pregnancy. 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.

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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

DECEMBER 7, 2023

In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges. Yates , 2010 WL 503061, at *1 (E.D. Shinette , 2018 WL 4929736, at *5 (E.D.

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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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