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. Some advocates say these pills simply do not bring that level or risk.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Medicare Medicare 52

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

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. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , at 1206.

FDA 59

FDA Governance Nurses Hospitals 59

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. Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects.

FDA 52

FDA Governance 52

Drug & Device Law

MARCH 13, 2023

Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally. 393, 400 (2010). Coloplast Corp. , 3d 448 (W.D. E.g. , Lewis v. Coffing Hoist Division , 528 A.2d

FDA 59

FDA Compliance Governance Doctors 59

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. . .

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

JANUARY 24, 2023

Plaintiff’s purported nationwide class was dismissed for failure to plead what state law governs her common law claims and the court “reminded” her that a California plaintiff lacks standing to assert claims under the laws of other states.

Fraud 59

Fraud FDA Governance 59

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. at *4 (“plaintiffs focus their appeal on the three Japanese studies not originally submitted to the FDA”). quoting 73 Fed. 22, 2008)).

FDA 72

FDA Governance 72

Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs). Tootsie Roll Indus. LEXIS 982 (Cal.

FDA 59

FDA Compliance Governance 59

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). 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. , 316, 328-29 (D. 2013) (Painter); McClellan v. I-Flow Corp. , 2d 1092, 1119-25 (D. Tennessee Gas Pipeline Co.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

AUGUST 8, 2022

Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 2010); In re Welding Fume Products Liability Litigation , 526 F.

Doctors 52

Doctors Fraud Licensing Compliance 52

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. May 20, 2010). See , e.g. , Yates v.

FDA 52

FDA Governance 52

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.

FDA 52

FDA Governance 52

Drug & Device Law

FEBRUARY 3, 2022

Redick’s implant, that he was familiar with the Australian registry data, and that he did not recall reading the 2010 label, which was available online and contained the risk information about females and patients needing smaller head sizes. No proof on reliance or proximate cause, no basis for a new trial.

FDA 59

FDA Public Health Doctors Governance 59