Administrative Law, Health Law, Products Liability

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

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

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

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

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

by James A. Hoover | Burr & Forman on 12/6/2012

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

by Mari Spears | Sedgwick LLP on 12/4/2012

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

by Dinsmore & Shohl LLP on 10/22/2012

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

by Dinsmore & Shohl LLP on 10/22/2012

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

by Mintz Levin - Health Law on 10/18/2012

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

by Polsinelli on 10/18/2012

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

by Sedgwick LLP on 10/4/2012

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

Criminal Drug Company Glaxo is Slapped on the Wrist

by Lawyers.com on 7/5/2012

After six years of bribing American doctors, pushing antidepressants on children and hiding the heart attack risk of a diabetes drug, the British drug Company GlaxoSmithKline LLC got a slap on the wrist yesterday....more

Hydraulic Fracturing: A Future Source of Silicosis Claims?

by Sedgwick LLP on 6/12/2012

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

by Sedgwick LLP on 5/14/2012

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

by McDermott Will & Emery on 4/11/2012

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

by Morgan Lewis on 4/3/2012

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

by Sedgwick LLP on 2/22/2012

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

by Michael Walsh on 2/13/2012

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

by Jeff Ifrah on 1/9/2012

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

by Duane Morris LLP on 12/20/2011

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

by Sheppard Mullin Richter & Hampton LLP on 12/20/2011

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

by Dechert LLP on 12/5/2011

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

by Dechert LLP on 10/21/2011

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

Successful Class II Medical Device Preemption Decision

by Dechert LLP on 9/29/2011

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more

Turkey Salmonella Outbreak

by Howard Ankin on 9/1/2011

The Centers for Disease Control and Prevention (CDC) is working with public health officials across the country and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) to determine the cause of...more

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

by Morgan Lewis on 8/10/2011

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more

No Preemption for the Common Cold Remedy

by Dechert LLP on 8/3/2011

Since the first sneeze, people have been trying to cure the common cold. While the cure remains elusive, everyone has a remedy for its symptoms – chicken soup, salt water gargle, fresh chopped garlic on crackers and, our...more

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Administrative Law › Health Law › Products Liability

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

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

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

FDA Unveils New System to Track Medical Devices

FDA Unveils New System to Track Medical Devices

Confounding Issues about Compounding Pharmacy Regulation

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

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

Criminal Drug Company Glaxo is Slapped on the Wrist

Hydraulic Fracturing: A Future Source of Silicosis Claims?

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

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

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

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

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

HCG Marketers Face Hot Pursuit by FDA, FTC

Presumption-of-Adequacy Defense Is Clarified and Reinforced

Illegal Clinical Trials of Bone Cement Sends Executives to Prison

There'll Always Be Posner: Double-header

There They Go Again

Successful Class II Medical Device Preemption Decision

Turkey Salmonella Outbreak

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

No Preemption for the Common Cold Remedy

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