Health Products Liability

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FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more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

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

What's in the Box? FDA Proposes Revisions to Nutrition Facts

On February 27, 2014, the U.S. Food and Drug Administration proposed three rules that would make landmark revisions to the iconic black and white Nutrition Facts panel if finalized. The proposed changes affect all packaged...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

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

Healthcare Law -- Jul 15, 2013

How Does the DOMA Defeat Impact Healthcare Reform and Health Insurance Access? - NOTE: The Supreme Court's 5-4 decision to invalidate the Defense of Marriage Act (DOMA) will affect more than 1,000 federal statutes—and...more

Infuse Bone Graft Lawsuit Website Launched By Hissey Kientz, LLP Law Firm

The law firm of Hissey Kientz, LLP announces the launch of its new website, Medtronic Bone Graft Lawyers (http://medtronicbonegraftlawyers.com/). A Yale University Study has linked the Medtronic Infuse Bone Graft to severe...more

BOOK REVIEW: An Excellent Resource for Litigators Preparing for Depositions

This Book Review by Northeastern Pennsylvania insurance defense attorney of the Scranton, PA law firm of Foley, Comerford & Cummins appeared in the July 2013 edition of the Pennsylvania Lawyer Magazine. The review analyzes...more

Does Corn By Any Other Name Taste As Sweet?

Genetically modified organisms (GMOs) have received much attention in recent years, yet the concept of genetically engineering (GE) food is not new – U.S. farmers began growing GMOs in 1994 and now plant about 165 million...more

Mirena IUD linked to serious complications

The Mirena IUD has been linked to ectopic pregnancy, uterine perforation, pelvic inflammatory disease, device migration and other serious side effects....more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Supreme Court Denies Certiorari in MAO’s Double Damages Case

On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

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