Administrative Agency Health Products Liability

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FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

Confounding Issues about Compounding Pharmacy Regulation

Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012 New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more

Health Reform + Related Health Policy News - October 17, 2012

In This Issue: - Top News…1 - State News…5 - Regulatory News…8 - Additional Reading…8 - Federal Register…9 - For More Information…12 - Excerpt From Top News: Congress, FDA Weigh...more

Pharmaceutical Law Update -- October 2012: New Jersey Court Grants Summary Judgment Based on Lack of Warning Causation

A New Jersey federal court granted summary judgment to Baxter Healthcare Corporation (Baxter) last month based on a familiar legal concept rarely applied in the Garden State – warning causation. In Baker et al. v. APP...more

Hydraulic Fracturing: A Future Source of Silicosis Claims?

In April 2012, Eric Esswein, an industrial hygienist from the National Institute for Occupational Safety and Health, made a statement at a conference sponsored by the Institute of Medicine that was guaranteed to attract the...more

The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit

The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more

China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports

China’s State Food and Drug Administration recently issued draft guidance on drafting and preparing Periodic Safety Update Reports for drugs and is seeking comments from the public until 16 April 2012. China’s State Food...more

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more

Medical Device Patient Safety Act Proposes Two-Step Change to Oversight of Devices

In mid-December of 2011, following the recommendation of the Government Accountability Office (GAO), a bipartisan group of senators introduced the Medical Device Patient Safety Act.  According to the GAO, the Food...more

Par Pharmaceutical vs USA - Off-Label Promotion and the First Amendment

Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early...more

HCG Marketers Face Hot Pursuit by FDA, FTC

Putting a snag in New Year’s resolutions for pound-shedding, the FDA and the FTC recently sent out warning letters to several companies that sell HCG-based diet products online. (These companies include Nutri-Fusion Systems...more

Presumption-of-Adequacy Defense Is Clarified and Reinforced

On Sept. 29, the Appellate Division took a significant step forward in clarifying and reinforcing the presumption-of-adequacy defense provided to manufacturers of prescription drugs under the New Jersey Product Liability Act...more

Illegal Clinical Trials of Bone Cement Sends Executives to Prison

Four ex-officers of a Pa.-based manufacturer of a bone cement product were sentenced to prison for an unapproved trial that led to three deaths. Each pled guilty to a single misdemeanor count of shipping adulterated and...more

There'll Always Be Posner: Double-header

A great Chicagoan, Ernie Banks, was famous for saying “Let’s play two” – an expression of pure joy about the game of baseball. Another great Chicagoan, Judge Richard Posner, recently came out with a pair of opinions that...more

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more

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