Policy Prescription

JANUARY 31, 2022

While the drug companies, wholesalers, pharmacies and doctors, and federal regulators, such as the FDA and DEA, all point fingers at each other , it seems that the state boards of pharmacy are getting a pass that they don’t deserve.

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Codon

JULY 21, 2024

FAAH knockouts have been around since 2001, and since then, studies have indicated their potential as “a new mechanistic approach to anti-anxiety therapy.” .” Requests to use fewer animals would issue from Institutional Animal Care and Use Committees (IACUCs), which, at U.S.

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Codon

AUGUST 27, 2024

Doctors in training are told that when they hear hoofbeats, they should think horses, not zebras; rare diseases are the exception, not the rule. Nevertheless, the costs of DNA sequencing have dropped since 2001 , and since 2008 have decreased at a pace more rapid than that which Moore’s Law predicts for computing power.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

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Codon

DECEMBER 12, 2024

7 During the few years that thalidomide was available on the market — and before Australian doctor William McBride warned of its consequences in a letter published in The Lancet in 1961 — it affected more than 10,000 babies, killing about half of them within months after birth.

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PLOS: DNA Science

FEBRUARY 3, 2025

Her doctor said this was because she was 6 months pregnant. After doctors persistently attributed Diane’s fatigue, weakness, cough, and labored breathing to bronchitis, pneumonia, and a nebulous “virus,” she was finally diagnosed with dilated cardiomyopathy (an enlarged heart) at age 57. Her heart had stopped.

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Codon

NOVEMBER 24, 2024

Because the FDA has asserted since 2001 that modification of human embryos would require its permission, this effectively bans even the testing of such technology in the U.S. Jiankui, a Chinese scientist who had done his doctoral and post-doctoral training in U.S. while it proceeds elsewhere.

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Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

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Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. By the time, however, the cases progressed to summary judgment, the plaintiffs were not claiming any defect in TDF.

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Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 341 (2001). 2001), aff’d , 358 F.3d Camden County Board of Chosen Freeholders v.

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Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. Plaintiffs Legal Committee , 531 U.S. T]he studies or analyses. . .

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Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs point to no FDCA requirement that such information be included in an order for medicine to be delivered to the doctor who ordered it. Moreover, “it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.”

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Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

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Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

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Drug & Device Law

AUGUST 11, 2023

We’re not doctors, we just play them on TV.) 341 (2001), state tort claims are inappropriate vehicles for criticizing what the FDA considered in making a regulatory decision or the conclusion it reaches.) At least that was our take-away. Note: Don’t take medical advice from lawyers. Which brings us around to Novotney v.

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Drug & Device Law

JULY 24, 2023

341 (2001). Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.” It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony.

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Drug & Device Law

DECEMBER 9, 2022

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients. 2001), aff’d sub nom.

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Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 341 (2001). This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. Plaintiffs Legal Committee , 531 U.S. 2019 WL 6766574, at *3.

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Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.”

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” 2001), aff’d , 358 F.3d

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Drug & Device Law

MARCH 31, 2022

2001) (“irrespective of the theory of recovery. . . Thus, the two sides of the Baltimore opinion remind us of the classic “ The Strange Case of Doctor Jekyll and Mister Hyde.” E.g. , Ford Motor Co. General Accident Insurance Co. , 2d 362, 370 (Md. The first part is rational, restrained, and full in accord with governing precedent.

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Drug & Device Law

FEBRUARY 1, 2022

341 (2001) as impermissible attempts at private enforcement of the FDCA. The court did dismiss plaintiff’s breach of express warranty claim because plaintiff failed to allege that any of the “purported warranties” were made to her or her doctor and for lack of the required pre-suit notice. Plaintiffs’ Legal Comm. , The court agreed.

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