West Palm Beach Personal Injury Lawyer - bayer

Yaz Ads Were Deceptive and Profitable

Brenda Fulmer — Wed, 07 Oct 2009 13:41:11 GMT

Bayer was recently sued by a union’s health insurer in Pennsylvania who alleges that the German manufacturer of one of the top-selling birth control pills engaged in deceptive trade practices and a three-year racketeering scheme in order to sell its drugs to young women and induce their health insurers to pay for them. This latest lawsuit focuses on the time period from March 17, 2006, through March 31, 2009 and alleges that Bayer misled doctors, patients and others regarding the safety risks associated with Yaz and Yasmin. The health insurer seeks to disgorge profits made during that time period, when sales of Yaz and Yasmin grew 17% to approximately $1.8 billion according to Bloomberg.

You may recall some of the advertising employed by Bayer early on in their marketing of Yaz; they looked more like commercials for a wonder drug than a contraceptive:

www.youtube.com/watch

In the past several months, Bayer has faced the following:

Establishment of MDL 2100 for the national coordination of lawsuits in federal court over Yaz and Yasmin with hundreds if not thousands of lawsuits expected to be filed by women and young girls who suffered pulmonary emboli, DVT, heart attacks, strokes, or gallbladder disease while taking the popular birth control pills
Publication of an article in the British Medical Journal that notes significantly increased risks of blood clotting adverse events in women using Yaz and Yasmin, especially in the months following first use of the products.
Investigation by Swiss authorities into the September 2009 death of a young woman who suffered a fatal pulmonary embolism after taking Bayer’s Yaz for approximately 10 months.
Reached $20 million settlement with the California Attorney General over claims of deceptive advertising for Yaz, which includes requirement that Bayer run corrective advertising to correct previous misleading claims. Similar agreements have been reached with 29 other states as well.

In response to the union health insurer lawsuit, Bayer spokeswoman Rose Talarico commented in the Law 360 Product Liability Reporter: “Bayer reaffirms and stands behind the safety of its drospirenone-containing oral contraceptives.”

Originally posted at InjuryBoard by Brenda Fulmer

All That Yaz is Dangerous

John Hopkins — Mon, 05 Oct 2009 14:12:35 GMT

The US Drug Watchdog group has now issued a press release warning women who have taken the birth control drug, Yasmin or Yaz of the very serious side effects of these drugs. Our firm has been warning consumers for some time. The group points out that the manufacturer, Bayer, has done a poor job in informing women who may have taken these drugs of the potential side effects. The watchdog group goes so far as to characterize this situation as possibly “the most important pharmaceutical initiative” in which they have ever been involved. Yaz and Yasmin contain a synthetic progestin called drospirenone, which has never before been used in a birth control pill before. Bayer paid for a study that demonstrated Yaz a safe, but at least one other study sets forth that Yaz and Yasmin can cause a whole host of problems, including:

Venous thrombosis
Arterial thrombosis
Thromboembolic events
Myocardial infarction
Heart attack
Stroke
Thromboembolism
Hepatic neoplasia
Gallbladder disease
Hypertension
Blood clots
Deep Vein Thrombosis
Pulmonary embolism
Death

In October of 2008 the FDA sent Bayer one of the most strongly worded warning letters I have seen. Although that letter largely dealt with the advertising being used by Bayer, it chastised Bayer for making claims about the conditions for which Yaz was demonstrated as being effective. In addition, it warned Bayer that its advertising failed to sufficiently disclose the potential risks of Yaz. Bayer apparently has a penchant for overstatement. Complaints have been filed by various groups including, with the Federal Trade Commission, Better Business Bureau, and, as said, the FDA. Bayer has been accused of making claims without real foundation. For example, it claimed that its One-A-Day WeightSmart vitamins could help with weight loss; reportedly without any true scientific basis. They also claimed that their One-A-Day vitamins could prevent prostate cancer; again without true science. Bayer was told to stop advertising its All-Day-Energy vitamin as “All-Day”, because it likewise is not demonstrated to scientifically perform All-Day. Yaz and Yasmin advertising cost Bayer $20 million in corrective ads they are required to put on the airwaves. You have seen the ones; where the actress in a snazzy bar seems less than repentant about Yaz’s advertising and that, well, shucks, maybe we didn’t tell you guys everything quite as clearly as we could have about Yaz. She says that the FDA wants them to clear a few things up. Unfortunately, in my opinion, the corrective ad campaign cleared little up and the action taken to inform the public about Yaz was lackluster at best.

Originally posted at InjuryBoard by John Hopkins

Yaz Problems Continue to Arise

Laurie Briggs — Fri, 02 Oct 2009 16:13:00 GMT

Lawsuits against Bayer, the manufacturer of Yaz, continue to be filed across the United States by women who have suffered serious health issues, which may have been caused by the drug. Yaz is a combination hormone contraceptive containing the hormones ethinyl estradiol (estrogen) and drospirenone which is a synthetic form of progestin. In the drug world, Yaz is commonly referred to as “fourth generation” birth control pill, because of its composition, and is markedly different from its earlier counterparts because it contains drospirenone.

These lawsuits follow warning letters from the Food and Drug Administration to Bayer in 2008 concerning false claims being made in their advertising (Bayer agreed in February 2009 to spend $20 million on a corrective ad campaign to address the FDA concerns), admonishments to fully disclose risks associated with the use.

While Bayer vigorously defends its product (why wouldn’t it, when Yasmin, Yaz and Yasminelle contraceptives brought in $1.86 billion for Bayer in 2008 alone), their legal woes continue to mount. Yaz has recently been tied to an increase in the risk of several health issues, including blood clots (deep vein thrombosis and pulmonary embolism), gallbladder problems, heart attacks and strokes for women using the pill.

Many of the lawsuits have been filed by women who have suffered from blood clots; gallbladder problems including gallstones, infection, inflammation (cholecystitis), obstructions and even gallbladder removal (cholecystectomy) are being more frequently reported in recent months. Symptoms of gallbladder disease include abdominal pain, chest pain under the breastbone, fever and chills, heartburn, nausea and vomiting.

It is still unknown whether it is the combination of estrogen and drospirenone which is causing the problem or it if is the drospirenone itself which is the culprit. While it has long been known that the use of oral contraceptives can lead to an increased risk in clotting, the reports from women who have experienced health issues while taking Yaz are arising in otherwise healthy women with no other risk factors and the problems are appearing following a relatively short period of use.

Two medical research studies, conducted in the Netherlands and Denmark and recently published in the British Medical Journal, appear to support the hypothesis that use of oral contraceptives leads to increased risk of blood clots – particularly where the levels of estrogen are higher. The only study which contradicts the conclusions of these researchers is one sponsored by, and paid for, by Bayer itself. Yaz uses drospirenone as its progesterone ingredient and the Dutch study found that there was a 6.3-fold increase in VT risk for drospirenone.

The problems associated with Yaz are not limited to women in the United States. The death of a Swiss woman, who died from complications arising from a pulmonary embolism while taking the birth control pill Yaz, is being investigated by the government of Switzerland. Swissmedic, the central supervisory authority for therapeutic products in Switzerland, making it the Swiss equivalent to our Food and Drug Administration, announced earlier this week that it is investigating the “sudden” death of a woman who had been taking the contraceptive for less than one year.

Originally posted at InjuryBoard by Laurie Briggs

An Aspirin is an Aspirin; Or is It?

Armand Rossetti — Tue, 28 Oct 2008 14:38:02 GMT

Today, the FDA released information concerning Bayer HealthCare's illegal marketing of two aspirin based drugs: Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium. It is well known in the health care field that a doctor recommended, daily low dose aspirin regimen (81 mg) can aid in preventing long term cardiovascular disease. However, by adding what would ordinarily be considered non-regulated dietary supplements to aspirin to arrive at Heart Advantage and Women's Low Dose, Bayer has gone a step further and created two entirely new drugs.

Bayer Heart advantage combines aspirin and phytosterols (for cholesterol reduction), and Bayer Women's combines aspirin and calcium carbonate (to fight osteoporosis). Whenever a manufacturer combines nutrients such as calcium or phytosterols with aspirin, those new combinations result in the creation of entirely new drugs that must undergo FDA approval. According to the FDA, Bayer is marketing products that claim to lower blood cholesterol, and that consumers may use thos new drugs to prevent or treat coronary heart disease. Therefore, Bayer cannot legally market these new over the counter (OTC) drugs to consumers without first submitting an approved FDA new drug application.

In addition, the FDA noted that Bayer's Heart Advantage and Women's Advantage both have inadequate and misleading directions and warnings. Without proper directions, consumers are not able to use those drugs safely for their intended purpose, and without supervision of a health care professional.

Bayer is not the first company to receive warning letters for combining drugs with nutrients and marketing them without FDA approval. Recently, the FDA issued warning letters to manufacturers of joint pain medications that marketed those products without first seeking FDA clearance. In a clear statement concerning manufacturer failure to seek preapproval before marketing new combination drugs, the FDA stated the following:

"Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States."

Originally posted at InjuryBoard by Armand Rossetti