Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege that the drug poses a multitude of serious risks, which Bayer downplayed in its Yaz marketing campaigns.

The U.S. Food and Drug Administration admonished Bayer in October 2008, citing the company for “significant deviations” in its promotion of Yaz. The complaint largely centered on the understatement of the drug’s risks and the overstatement of its benefits, including the treatment of conditions for which the drug was not approved. The misleading marketing campaign is frequently cited in lawsuits brought against Bayer by former Yaz users.

Some of the most serious side effects associated with Yaz include stroke, heart arrhythmia cardiac arrest, deep vein thrombosis and other forms of blood clotting, pulmonary embolism, gallbladder disease, kidney damage or failure, and sudden death.

Judge Herndon told Southwestern Illinois’ Belleville News-Democrat that he may also conduct bellwether trials, a cluster of cases selected because they reflect the charges and allegations of the other lawsuits. The outcome of bellwether trials helps establish guidelines for other cases.

When a significant number of similar lawsuits, such as those being brought against Bayer over Yaz injuries, accumulate in federal courts, the Judicial Panel on Multidistrict Litigation normally moves to consolidate them in one U.S. District Court to avoid redundant efforts and inconsistent pre-trial rulings. The dynamics of these representative trials will then be considered in the evaluation of other cases.

SOURCE: Yaz Lawsuit › Southern Illinois district court to handle Yaz lawsuits

The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg.

Deep vein thrombosis (DVT) is a very serious type of blood clot that can lead to serious complications and death if not treated properly. Clots that form a DVT can become dislodged, traveling through the bloodstream to the lungs and causing a pulmonary embolism, resulting in permanent damage to the lung. DVT can also cause stroke, cardiac arrest, and other potentially deadly conditions.

Yaz contains drospirenone, a synthetic progestin used in Yaz, Yasmin, and Ocella, which is a generic form of Yasmin. Drospirenone has been shown to increase potassium levels in some women who take the drug, which can lead to DVT and affect the function of several organs, including the heart.

The Ohio plaintiff’s lawsuit was filed in New Jersey Superior Court. The suit alleges that the plaintiff’s injuries were the result of Bayer’s failure to adequately warn consumers of the drug’s risks. Her attorney claims that Bayer knew Yaz to be more dangerous than other birth-control pills, but chose to downplay the drug’s hazards.

SOURCE: Yaz Lawsuit › Ohio mother sues Bayer, alleging Yaz caused blood clot

The plaintiff began taking Yaz after her gynecologist reassured her of the drug’s benefits and safety. After weeks of using Yaz, however, the woman began experiencing severe pain that sent her to the emergency room twice for general treatment and CT scans.

It took 13 hours for doctors to finally discover the problem. According to the Times, “In her left lung, the pulmonologist told her, was the largest blood clot they had ever seen and there were others in her right lung as well.”

The woman spent 6 days in the hospital as she was treated with 2 types of blood thinners to dissolve the clots in her lungs. Doctors expected a good recovery but told her that she might never be completely the same . Two weeks after the treatment, she told the Times that she is “incredibly tired most of the time.”

The plaintiff said that a couple of days after the treatment the severity of her situation suddenly hit her. “Wow, I almost died,” she told the Times. Now she strives to tell others about how Yaz affected her and has put the lives of so many other women in danger.

“It’s not just about women who are my age,” she told the Times, adding that lots of younger women are being seriously injured by the drug.

“There’s no reason for blood clots to be forming except for this pill and it’s a very scary situation,” she said.

Bayer has defended itself and Yaz against the allegations, pointing to the two Bayer-funded studies that showed the drug had a safety profile similar to other, more traditional oral contraceptives.

Another Yaz study, not funded by Bayer, found women who took Yaz to be more at risk for blood clots, heart attacks, and strokes. Those results were echoed by a more recent study published by the British Medical Journal in August.

SOURCE: Yaz Lawsuit › Recovering Maryland woman sues Bayer after Yaz nearly killed her

“She was short of breath. She was having severe chest pains and her face was changing colors,” Kraus told WTAE.

“She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They eventually had to do emergency surgeries because they noticed there were two huge blood clots, one in each pulmonary artery,” Kraus said.

Kraus said that because of Yaz, her daughter now faces possibly lifelong struggles with pancreatitis, liver function problems, and acute kidney failure. Kraus and the other plaintiffs have requested a jury trial, more than $150,000 in compensation, attorney fees, court costs, and punitive damages.

Bayer Corporation, which is headquartered in Pittsburgh, defended itself from the allegations in a statement to WTAE.

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives. Bayer will defend itself vigorously against these lawsuits,” a company spokesman said.

The lawsuit, however, alleges that Bayer grossly downplayed the risks of Yaz in its advertising campaigns and that the number of adverse events caused by Yaz is at least 10 times more than the number reported incidents, possibly 100 times more.

“I just don’t want anybody else to see their child go through anything like this ever again,” Kraus told WTAE.

Source: http://www.thepittsburghchannel.com/

SOURCE: Yaz Lawsuit › Mother says Yaz nearly killed her daughter

When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear in the search results. Some sponsored links will appear at the top of the results in a yellowish box. One of the links will lead to Bayer’s website for Yaz and will contain a gray-text notice: “Click to see full safety and prescribing information, including boxed warning.”

Why is Bayer using this new format for Yaz? Because the U.S. Food and Drug Administration has warned pharmaceutical companies about using the text promos for drug advertising since they do not contain any warnings or disclaimers to customers about possible side effects, health risks, and other drawbacks.

Bayer clashed with the FDA last year over its Yaz advertisements. The company aired a couple of television commercials titled “Not Gonna Take It” and “Balloons” that promoted the drug for unapproved uses, downplayed its risks and side effects, and used competing music and visual to draw the viewer’s attention away from the safety information. The FDA ordered the ads off the air and requested that Bayer spend a minimum of $20 million on a “corrective” ad campaign.

Other drug companies, anxious to promote their drugs through Google’s sponsored links without being called out by the FDA, will no doubt keep a watchful eye on the agency’s reaction to the new Yaz links.

SOURCE: Yaz Lawsuit › Bayer tests Google’s new ad format for Yaz promotion

Development of gall stones and gall bladder disease are among the serious risks associated with the oral contraceptive Yaz. The drug has also been blamed for elevating the risk of cardiac arrhythmias and heart attack, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, hepatic adenomas and sudden death.

According to the lawsuit, 50 deaths attributed to the use of Yaz and Yasmin were reported to the U.S. Food and Drug Administration between the first quarter of 2004 and the third quarter of 2008.

The lawsuit alleges that Bayer markets Yaz and Yasmin “as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits,” rather than the higher risks the drugs pose.

“The foreseeable risks of the product exceeded the benefits associated with its design or formulation. Or they were more dangerous than an ordinary consumer would expect,” the lawsuit states.

The plaintiff seeks compensatory and punitive damages, medical expenses and economic damages, and attorney’s fees. Because Bayer ran a deceptive ad campaign for Yaz, hailing the drug for uses unapproved by the FDA while downplaying its risks, the plaintiff also seeks an unspecified amount of punitive damages.

Source: http://www.chicagonow.com/

SOURCE: Yaz Lawsuit › Chicago woman sues Bayer over Yaz-related injuries

“Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form of bouncing water balloons; in another, people are made of pipes. After all, cute, cartoon-like illustrations help lighten ads for drugs that pose very serious side effects for some people.

Amusing as Haskins’ Target episode is, it effectively illustrates just how outlandish and just plain silly some pharmaceutical advertising can be.

It’s also not the first time that Haskins has featured drug commercials on Target: Women. Last year, she spoofed big pharma television ads for birth control drugs, noting how they are touted as a way to have fewer periods more than anything else.

“Fewer periods! Yay! Now we don’t have to leave the tribe and go sit in that hut for a week. That was a bummer,” Haskins says.

Drugs developed for one thing but marketed as a treatment for something else is a common ruse employed by some pharmaceutical companies to make their products more enticing. Negative disclosures about the drugs, such as the legally required information about side effects, may be washed out with distracting music and visuals. That was how Bayer advertised Yaz last year, before the Food and Drug Administration cited the company for false and misleading advertising and ordered a redo.

“You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads,” the presenter in the revised commercial says.

The Yaz advertisements spawned a number of video skits lampooning the drugmaker’s claims and the style in which they are presented: a group of girlfriends in a lively bar discussing side effects in a way that would never happen in real life. One woman, who says she “didn’t go to med school for nothing,” gives her friends an off the cuff and very clinical rundown of the drug’s risks while her friends listen intently.

Inserting herself into this scenario, Haskins asks “Does anyone think Stephanie is acting super weird right now?”

For all the risks attached to some blockbuster drugs, it’s good to see that the absurdity of drug advertising isn’t sliding by unnoticed.

SOURCE: Yaz Lawsuit › Comedian lampoons the absurdity of drug ads

The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA never tested or approved Yaz.

In October 2008, FDA officials warned Bayer that its Yaz ads intentionally mislead and confused viewers by overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating the drug’s potential for serious side effects, including blood clots, cardiac arrest, and gallbladder disease. According to the FDA, the commercials used distracting visuals, multiple scene changes, and background music that effectively interfered with the audio presentation about the serious risks associated with the drug.

“Bayer promoted Yaz with the slogan ‘the difference a little chemistry can make,’” the plaintiff said. “What Bayer did not disclose was how negative that difference can be. Yaz gave me life-threatening injuries that have forever altered my life.”

After several months of Yaz therapy, the plaintiff developed an acute pain in her left shoulder and had difficulty breathing. A visit to the doctor revealed the plaintiff had developed blood clots in both her lungs. She was hospitalized immediately and treated successfully, but just one month later she developed gallstones and had to undergo surgery for their removal.

The plaintiff alleges that she “suffered months of anxiety and nausea related to (the) medical procedures and drugs given to treat the adverse side effects (she) developed from taking Yaz.”

The complaint charges that had Bayer properly warned patients about the dangers of using Yaz strictly as an acne treatment, the plaintiff could have avoided serious injury.

The lawsuit was filed in the Superior Court of New Jersey, where Bayer’s American operations are based. The plaintiff seeks an unspecified amount of compensatory damages.

SOURCE: Yaz Lawsuit › Injured by Yaz, SC nurse files lawsuit against Bayer

Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a link between the Yaz ingredient drosperinone and a higher occurrence of blood clots than in women who took traditional contraceptives containing levonorgestrel.

A spokesperson for Bayer said that the company is cooperating with the investigation, but that it stood by the safety of its drug.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Bayer spokesman, told Bloomberg. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Of course, Bayer’s spokesperson dismisses the results of the two independent clinical trials and focuses on the more favorable outcome the Bayer-funded clinical test, which suggested the risks of Yaz were similar to those of traditional birth control therapies.

As the top selling oral contraceptive in the world, Yaz is big business for Bayer. The drug brought in $1.86 billion just in the first quarter of 2009.

SOURCE: Yaz Lawsuit › Switzerland investigates the death of young Yaz user

The New York Times recently published a report about the dangers frequently associated with Yaz and other oral contraceptives. The article observes that one Bayer-sponsored European study involving tens of thousands of women found no difference in the level of cardiovascular problems or death between women taking Yaz and women who took levonorgestrel, a much older progestin-based drug.

However, the results of two other studies conducted in Denmark and the Netherlands and published in the British Medical Journal last month, showed that women who took Yaz and other newer progestins had a higher risk of blood clots, which can adversely affect the heart.

One doctor quoted in the New York Times report theorized that Yaz and other newer forms of birth control may have a different affect in European populations versus the more racially diverse and genetically mixed American population.

However, Dr. Frits Rosendaal, a clinical epidemiologist at Leiden University Medical Center in the Netherlands, told the New York Times that patients taking Yaz should switch to birth control drugs containing levonorgestrel. “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he told the New York Times.

Both Bayer and the FDA are conducting ongoing studies designed to measure the safety risks of Yaz and Yasmin against drugs that do not contain drospirenone.

SOURCE: Yaz Lawsuit › Yaz health risks: better safe than sorry?