FDA

05/27/2014

Transvaginal Mesh Risk Label May Be Heightened by FDA

Transvaginal Mesh Settlement Information

In the wake of mounting lawsuits against manufacturers of transvaginal mesh devices implanted in women to treat a litany of internal conditions, the U.S. Food and Drug Administration ("FDA") is now moving to heighten the risk label associated with transvaginal mesh specifically used to treat pelvic organ prolapse ("POP").  The risk label for mesh devices used to treat POP will be heightened from "low" to "intermediate." If the new standard is adopted after a mandatory 90-day public comment period, manufacturers of... Read More
01/23/2014

Underreported Da Vinci Robot Injuries Lead to More Injured Patients

Underreporting of da Vinci robotic surgeries may be contributing to increased incidence of injury to patients who elect the robotic procedures lacking an accurate understanding of inherent risks. Bloomberg recently published an unsettling news story recently about a 45-year old woman, Sheena Wilson, who underwent da Vinci robotic surgery for a hysterectomy believing it to be safe only to awake from the surgery with serious injuries leaving her disabled. As reported by Bloomberg, Ms. Wilson said if she had known others had... Read More
04/29/2013

FDA Pharmaceutical Approval Process: An Overview

FDA Pharmaceutical Approval Process

Mounting pressure from the pharmaceutical industry (Industry) has greatly influenced the drug approval process conducted by the U.S. Food and Drug Administration ("FDA").  This pressure has led to the question of who the FDA is actually serving, the health and safety of the public or the Industry? According to Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group, the Industry is exerting its influence on the FDA in three distinct ways: The Prescription Drug User Fee Act, passed in 1992, provides... Read More
04/17/2013

FDA Grapples With Social Media

FDA Social Media Issues

As businesses continue to capitalize on social media as an inexpensive and effective advertising tool, pharmaceutical companies are struggling to find ways to embrace this trend while abiding by FDA regulations, “…fear of offending the FDA has led pharmaceutical makers to be overly cautious and shy away from social media—even if they’re not violating the law.” Social media has existed as a platform for patients with health concerns since the 1990s. “Some people are surprised to learn that online discussion forums... Read More
02/19/2013

Mirena IUD Irresponsible Advertising Continues Despite Rising Lawsuits

The amount of money a pharmaceutical spends on advertising its products doesn’t necessarily mean its products are safe.  For example, drug giant Bayer, the maker of the Mirena IUD, has spent millions of dollars advertising its Mirena IUD contraceptive through TV and social media ads.  The advertising apparently works – Mirena IUD sales reportedly topped $700 million in 2010.   At the same time, women who have suffered serious complications after using the Mirena IUD including uterine perforation, miscarriage and... Read More
02/19/2013

Miscarriage and Infertility Linked to Mirena IUD Prompt Lawsuits

At Audet and Partners, LLP, we are currently investigating potential lawsuits on behalf of women who have suffered complications from the Mirena IUD (Intra-Uterine Device).   Sadly, there have been cases linking the Mirena IUD to miscarriage and infertility. Now women across the United States who have suffered adverse complications after using the device are now speaking out. Mirena IUD Serious Injuries Serious complications have been linked to the Mirena IUD including: Infection Uterine Perforation Ectopic Pregnancy Miscarriage Ovarian Cysts Pelvic Inflammatory Disease Infertility Mirena IUD Lawsuits Bayer marketed it as... Read More
12/05/2012

Fresenius Imperils Dialysis Patients Administered GranuFlo or Naturalyte

As reported by the New York Times earlier this year, Fresenius Medical Care failed to warn thousands of dialysis patients about the increased risk of cardiac arrest associated with the use of its products Granuflo and Naturalyte. Fresenius operates a number of dialysis clinics across the U.S., but it is also the leading supplier of dialysis products and equipment to other dialysis centers. In November 2011, Fresenius discovered a sharp increase in the number of patients suddenly... Read More
11/15/2012

Class Action Lawsuits Against Bayer in Connection With Mirena IUD Contraceptive Device

Mirena IUD, manufactured by Bayer, was approved by the FDA in 2000 as a contraceptive device recommended to women who have had at least one child. This small, t-shaped plastic device is inserted by a health care professional and can be left in place for up to five years. Among its marketing strategies for the Mirena IUD, Bayer held “Mirena Parties” for “busy moms” in connection with the social networking site Mom Central. At these gatherings, a representative from Mom... Read More
06/13/2012

NuvaRing Contraceptive Ring Lawsuits & Investigations

NuvaRing Birth Control

NuvaRing is the trade name for a combined hormonal contraceptive vaginal ring manufactured by Merck (formerly Schering-Plough, formerly Organon), that is available by prescription. It is a flexible plastic (ethylene-vinyl acetate copolymer) ring that releases a low dose of a progestinand estrogen over three weeks. It is considered to be a “third-generation” birth control method. Numerous lawsuits have been filed against the manufacturers, distributors, and marketers of the NuvaRing birth control vaginal ring, and recent court cases are now allowing these... Read More
04/20/2012

About Yaz, Yasmin, and Ocella (Drospirenone) Litigation

78431709

Some of the newest birth control pills -- Yaz, Yasmin, and Ocella -- are the subject of over 1,000 lawsuits that claim the medications increase the risk of blood clots and stroke and cause other health problems in women who take them. Litigation focuses on Bayer Healthcare's failure to disclose the risks of taking these fourth generation combination birth control pills. Recent research regarding Yaz and blood clots prompted the FDA to require Bayer to add warnings to the drug... Read More
04/20/2012

Yaz, Yasmin, Beyaz, and Ocella Birth Control Pills

yasmin-box-blister

Yasmin is the brand name for a birth control pill that is generically known as drospirenone.  It is also a treatment for moderate acne and premenstrual dysphoric disorder (PMDD) in women.  It is produced by Bayer Healthcare.  Bayer Healthcare also manufactures “Yaz” birth control pills. The main difference between Yaz and Yasmin is in the level of estrogen contained in each pill compared to the level of progestins. Yasmin has brought Bayer Healthcare $487 million in sales in the US alone with $1.5... Read More
11/30/2011

Plavix Linked To Life Threatening Blood Disorder

The anti-platelet medication, Plavix (clopidogrel), has been linked to a deadly blood disorder, Thrombotic Thrombocytopenic Purpura. TTP is rare blood disorder in which blood clots form throughout the body’s small blood vessels, explained NewInferno. These clots can lead to significant problems if blood vessels are blocked and blood flow becomes limited to major organs, such as the brain, kidneys, and heart. Plavix is manufactured by Bristol-Myers Squibb. Read the rest of the article here: http://www.americas-watchdog.com/plavix-linked-to-life-threatening-blood-disorder/ If you or someone you or a loved one... Read More
11/21/2011

FDA Pulls Avastin From the Market

On Friday, November 18, 2011 US Food and Drug Administration (FDA) announced that it had pulled from the market the drug Avastin.  Avastin is used for treatment of patients with metastatic breast cancer, however there is no evidence the drug is safe and effective for that use. Researchers said Avastin may increase a cancer patient's risk of having a fatal reaction to treatment when it is added to chemotherapy. Please visit our website www.Audetlaw.com for additional... Read More
04/20/2010

FDA says studies on triclosan, used in sanitizers and soaps, raise concerns

FDA says studies on triclosan, used in sanitizers and soaps, raise concerns: "The Food and Drug Administration said recent research raises 'valid concerns' about the possible health effects of triclosan, an antibacterial chemical found in a growing number of liquid soaps, hand sanitizers, dishwashing liquids, shaving gels and even socks, workout clothes and toys."... Read More
03/08/2010

McCormick & Company Issues Recall for Salmonella

McCormick & Company Issues Recall for Salmonella: "McCormick & Company, Incorporated is initiating a recall of products manufactured with HVP (hydrolyzed vegetable protein) that were supplied by Basic Food Flavors of Las Vegas, Nevada, the U.S. Food and Drug Administration (FDA) just announced. The recall is being implemented because the ingredient has the potential to be contaminated with Salmonella."... Read More
02/19/2010

FDA comments on denture paste poisoning reports

FDA comments on denture paste poisoning reports | Dallas - Fort Worth News | wfaa.com | Health News: "A spokesperson with the Food and Drug Administration now says they became concerned about the potential of zinc overload from denture adhesives early last year.The news comes after a five-year News 8 investigation into denture paste poisoning in which the FDA was contacted numerous times."... Read More