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The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

New Jersey Court Turns the Screws on the Insured, Holding That “Your Product” Exclusion Bars Coverage For Defective Product Claim

In Titanium Industries, Inc. v. Federal Ins. Co., No. A-1922-12T1, 2014 WL 4428324 (N.J. Super. Ct. App. Div. Sept. 10, 2014), the court held that the commercial general liability policy issued by defendant Federal Insurance...more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

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

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...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

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

Drop-down Menus: The Pitfalls of Electronic Medical Records, Part II

In an earlier blog post, I discussed the importance of time stamps and signatures in electronic medical records (EMRs). A potential pitfall in using EMRs is the prevalence of drop-down menus....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

Your smartphone is NOT a medical device

Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

Pro Te: Solutio Vol. 6 No. 2

In This Issue: - Forum Non Conveniens: How To Avoid The Tide of Lawsuits Brought by Foreign Nationals - Pro Te Solutio: Product Defense And FDA Compliance - Health Care Strike Force: Uncovering Fraud In The...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

DTSC Releases Initial Proposed “Priority Products” List for Safer Consumer Products Regulations

On March 13, 2014, the California Department of Toxic Substances Control (DTSC) released its initial proposed list of “Priority Products” for regulation under DTSC’s Safer Consumer Products program. The three categories of...more

Food And Beverage News And Trends

Food industry proposes front-of-package nutrition information. In the wake of the recently proposed changes to the Nutrition Facts panel labeling, the Grocery Manufacturer's Association proposed its own front-of-package...more

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...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

Food Labeling Client Alert: FDA Proposes Changes to Iconic Nutrition Facts Label

The U.S. Food and Drug Administration (FDA) recently proposed an update to the iconic Nutrition Facts label for packaged foods. In light of new scientific evidence about human health and nutrition, dietary recommendations of...more

FDA Proposes Overhaul of Nutrition Facts Labeling

The first major overhaul of the Nutrition Facts panel in more than 20 years focuses on serving sizes, calories, and a refreshed design. The Food and Drug Administration (FDA or the Agency) on February 27 announced the...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more

Transvaginal Mesh Studies Report Serious Complications

In early 2012, the Food and Drug Administration (FDA) ordered 33 transvaginal mesh manufacturers to conduct three years of trials on the safety and effectiveness of their implants. The required mesh patch studies came as a...more

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

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