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Using Work Hours as Volunteer Hours Becoming Part of Corporate Culture

The hip shoe and sunglasses company TOMS has set the bar for giving back to the community through its One for One movement. The Southern California-based business helps someone in need for every product it sells and, since...more

9/24/2014 - Corporate Culture Corporate Social Responsibility Philanthropy Retailers Toms of Maine Volunteers

Ongoing Reglan Litigation — New Appellate Ruling

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

8/29/2014 - Appeals FDA Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Preemption Warning Labels

DePuy Pinnacle Litigation Update

The coordinated litigation over Pinnacle metal-on-metal hip implants pending before Judge Kinkeade is also known as MDL No. 2244. The MDL was established in May of 2011. Since then, more than 60 million pages of documents...more

8/15/2014 - Bodily Injury DePuy Hip Replacement

Oregon, Washington, Vermont Join 33 States Suing over 5-Hour Energy Drink

Oregon, Washington State and Vermont say the slogans for 5-Hour Energy drink are hype that is misleading. Last week the Attorneys General of all three states filed lawsuits against the drink’s maker, Living Essentials LLC and...more

8/14/2014 - False Advertising Food Labeling Misleading Statements

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

8/4/2014 - Clinical Trials Draft Guidance Drug Manufacturers Fast Track Process FDA Manufacturers Medical Devices Pharmaceutical Pharmaceutical Manufacturers Premarket Approval Applications Prescription Drugs Risk Assessment Risk Mitigation Technology

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

7/25/2014 - Drug Manufacturers FDA Free Speech GlaxoSmithKline Healthcare Healthcare Facilities Hospitals Johnson & Johnson Medical Devices Medicare Off-Label Promotion Off-Label Use Pharmaceutical Prescription Drugs

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

7/18/2014 - FDA Guidance Update Internet Marketing Medical Devices Pharmaceutical Prescription Drugs Social Networks

Searcy Denney Files Additional Lawsuits Over Defective DePuy Pinnacle Metal-on-Metal Hip Implants

Searcy Denney’s Mass Tort Unit recently filed two new individual lawsuits on behalf of clients who have suffered personal injuries as a result of their defective DePuy metal-on-metal hip implants. The first case was filed on...more

7/10/2014 - Bodily Injury DePuy DePuy Hip Replacement Johnson & Johnson

FDA Warning on Hysterectomy Procedure Raises Awareness of Cancer Risk

A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure. ...more

7/3/2014 - Cancer FDA FDA Warning Letters Healthcare

Testosterone Claims Consolidated in Chicago

The judicial panel on multidistrict litigation (JPML) has created an MDL to hear product liability lawsuits filed against the makers of prescription low testosterone products. Lawsuits involving testosterone replacement...more

6/26/2014 - FDA Side Effects

GlaxoSmithKline Fined Again – The Cost of Doing Business?

It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop? That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more

6/20/2014 - Compliance GlaxoSmithKline Off-Label Promotion Off-Label Use Pharmaceutical Popular Prescription Drugs

City of Chicago Sues Big Pharma Over Opioid Marketing Campaign of Deception

Opioids are frequently prescribed to ease the pain for those suffering from cancer but the city of Chicago believes the drug use has gone above and beyond cancer pain and it’s suing Big Pharma for aggressively pushing the...more

6/12/2014 - False Statements FDA Popular

NuvaRing Settlement Update

Merck announced on June 4, 2014, that it would be funding the $100 million dollar NuvaRing settlement announced in February of this year, as the 95% plaintiff participation threshold required by the Settlement Agreement has...more

6/5/2014 - Judicial Settlement Agreements Medical Devices Merck Multidistrict Litigation Qualified Settlement Funds

More Lawsuits Filed Against American Medical Systems, Inc.

American Medical Systems, Inc. (“AMS”) is a Minnesota based manufacturer of transvaginal mesh medical devices, which are support systems that are designed to correct stress urinary incontinence and pelvic organ prolapse....more

5/22/2014 - Bodily Injury Healthcare Medical Devices Transvaginal Mesh

DePuy ASR Litigation Update

In late 2013, a $4 billion settlement program was announced by Johnson & Johnson. This settlement covers more than 8,000 plaintiffs with lawsuits or unfiled claims who have undergone revision surgery due to a defective DePuy...more

5/21/2014 - Johnson & Johnson Settlement

FDA Rallies Around Pradaxa with New Study, Still No Antidote

A review by the FDA finds no additional risk of myocardial infarcation (MI) or a heart attack when Pradaxa (dabigatran) is compared to Coumadin (warfarin). An MI occurs when blood suddenly stops flowing to parts of the heart...more

5/20/2014 - Bodily Injury FDA Pradaxa

$100 Million for Victims of Meningitis Outbreak

We’ve previously written about the 2012 meningitis outbreak caused by contaminated drugs originating from the New England Compounding Pharmacy (NECC). The meningitis outbreak from these tainted steroids was linked to 64...more

5/19/2014 - Drug Compounding FDA Fungal Meningitis Pharmacies

AAOS Demystifies Metal on Metal Hips

The American Academy of Orthopaedic Surgeons (AAOS) recently published an “information statement” for patients who have been affected by the recent metal-on-metal (MoM) hip disaster. The statement is not a rigorous academic...more

5/16/2014 - Healthcare Medical Devices

CDC: Multistate Outbreak of Salmonella Linked to Foster Farms Chicken

It has been one year since an outbreak of Salmonella Heidelberg was first identified and linked to Foster Farms raw chicken and since then the numbers of individuals affected keeps growing. Last month, an additional 43 people...more

5/1/2014 - CDC Food Contamination Salmonella

Palm Beach County United for Children with Pinwheels

On any given day in the state of Florida, there are approximately 750 children ready to be adopted from foster homes with no identifiable family. There are also over 50,000 children in Florida who are neglected or abused,...more

4/14/2014 - Adoption

Weight Loss Supplement Alli Recalled Nationwide

Just to be safe, drugmaker GlaxoSmithKline (GSK) Consumer healthcare will remove all of its weight loss drug alli from stores shelves in the U.S. and Puerto Rico due to fear of contamination. There have been at least 20...more

4/9/2014 - FDA Food Labeling GlaxoSmithKline Weight-Loss Products

Harvard Researchers Take FDA Approval of Implantable Cardiac Devices to Task

Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to...more

4/8/2014 - FDA Medical Devices

Congressional Hearing on Proposed FDA Rule Change

Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling....more

4/3/2014 - FDA Generic Drugs Pharmaceutical Prescription Drugs

When Money Influences Medicine

The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson....more

3/28/2014 - Conflicts of Interest Ethics Healthcare

J&J Gets $1.2 Billion Pass on Risperdal Fine

Two years ago, healthcare giant Johnson & Johnson was facing a $1.2 billion judgment after a jury determined J&J concealed the risks of its antipsychotic drug Risperdal while it aggressively and improperly marketed it...more

3/28/2014 - Civil Monetary Penalty Fines Fraud Fraudulent Concealment Healthcare Johnson & Johnson Pharmaceutical Prescription Drugs

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