Drug & Device Law

DECEMBER 4, 2023

On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. Undisputedly, the complaint at issue “allege[d] no specific facts about any specific plaintiffs or specific injuries.” 662, 679 (2009). 28, 2023) (“ CPAP II ”), is entirely Mr. Hyde. 2023 WL 7019287, at *3.

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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. 662, 684-85, 686 (2009) (citations, including to Twombly , omitted). That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he

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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

MAY 11, 2023

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

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Drug & Device Law

FEBRUARY 25, 2022

case ( Conte ) in 2009. allegations of failure to report adverse events to the FDA. PLAC argued that the FDA’s pre-authorization requirements for any statement in product labeling about off-label uses preempted state-law claims demanding such statements. The appeal remains pending. Bausch & Lomb, Inc. , SC20607 (Conn.

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Drug & Device Law

FEBRUARY 3, 2023

In 2009, a detailed warning was added to the “Precautions” section of the label. The court emphasized that preemption did not extend to claims about the “manner or method of publication” of the warning. Haddad , 2022 WL 18397392 at *3. This is important – stay tuned. The court continued: The.

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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

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. 14, 2022), leaves us scratching our heads. 379r(e).

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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

MARCH 7, 2022

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? 662 (2009). The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. 544 (2007), and Ashcroft v. Iqbal , 556 U.S.

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Drug & Device Law

APRIL 21, 2022

662 (2009), which together stand for the proposition that to state a claim and avoid dismissal a plaintiff must allege facts that plausibly suggest that the defendant is liable. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. Twombly , 550 U.S. Iqbal , 556 U.S.

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” Jacob , 40 F.4th

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Drug & Device Law

JUNE 6, 2022

2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. 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. . . at 1150 (citations omitted). Hoffmann-La Roche, Inc. 3d 75 (Fla.

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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

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

FEBRUARY 26, 2024

With about three minutes to go and Rutgers up 6-0, Rutgers fans swarmed the field and tore down both sets of goalposts. We blogged about this outcome in the district court, and its precedential affirmance is even more significant. 555, 573 (2009), and these antivaxxers didn’t come close. CHDI , 2024 WL 637353, at *5.

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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. 2009) (citations omitted).

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Drug & Device Law

DECEMBER 19, 2022

We last mentioned the Blackburn litigation, here , where we were not very happy about the Alabama Supreme Court’s loosening of the warning causation standard applicable that state’s learned intermediary rule. 555 (2009), relied upon to limit impossibility preemption. (B) 2022 WL 16729466 (11th Cir. 2022 WL 16729466, at *3.

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. This internal FDA decision was one of the reasons that preemption prevailed in Pfaff. T]he FDA responded. However, the FDA concluded that. . . [it

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Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 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. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. Levine , 555 U.S.

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Drug & Device Law

MAY 4, 2023

25, 2023), is one we have been talking about for a long time. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own.

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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. 555 (2009). Albrecht, 139 S. 1668 (2019)and Wyeth v. Levine , 555 U.S.

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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

JANUARY 10, 2023

Singulair was approved by the FDA in 1998 and its active ingredient is montelukast. Plaintiff was prescribed and took Singulair to treat his asthma from 2000 to 2009 and alleges he now suffers from depression and social anxiety as a result. Plaintiff’s lawsuit makes two design defect claims – strict liability and negligence.

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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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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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