Bayer officials reportedly agreed to pay an average of $220,000 per settlement resolving charges that Yaz and Yasmin birth control pills sometimes caused fatal blood clots in patients.

The U.S. Food and Drug Aministration (FDA) announced on April 10, 2012, that Bayer and other drug manufacturers who sell birth control pills containing drospirenone, a synthetic hormone linked to the blood clot side effects, must update their warning labels to reflect the possible blood clot risks associated with the drugs.

The revised labels will note, as reported by Law360, that some studies showed as much as a three-fold increase in the risk of blood clots for birth control pills containing drospirenone compared with products containing other synthetic versions of the female hormone progesterone, while other studies found no added risks, the FDA said.

An FDA-funded study published in October found women who took drospirenone-containing birth control pills were about 75 percent more likely to suffer from potentially fatal venous thromboembolism and similar conditions.

The study, which surveyed more than 835,000 birth control users, said the risk was higher among 10- to 34-year-olds, and that a spike in risk occurred for women using the drug for less than three months. The FDA said the study results provided “another positive finding to the increasing body of evidence linking drospirenone to increased risks” of blood clots relative to standard estrogen pills.

In December, an FDA panel recommended that Bayer revise the labels on its Yaz and Yasmin contraceptives to highlight the increased blood clot risks, with a majority of the the 26 panelists voting that the drugs’ labels did not contain enough warning to stress their increased risks of serious side effects including deep vein thrombosis or the formation of a clot in a deep vein.

In the letter, POGO called for a new, fully independent advisory committee to be convened to review the safety of Yaz and Yasmin:

We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded. A new advisory committee—without questionable impartiality or any conflicts of interest—should re-evaluate the safety of Yaz and Yasmin.

The committee voted 15-11 that the benefits of its oral contraceptives outweighed the risks of blood clots developing in women. All three of the doctors with ties to Bayer voted with the majority, though two of them later voted to encourage stronger labeling.

As noted in the Wall Street Journal article,

FDA advisory committees are designed to give the agency independent judgments on medical issues. The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to ‘ensure … transparency.’ However, committee members must disclose potential conflicts only to the FDA, which doesn’t generally make the information public.

Steven Nissen, a frequent FDA panel member and prominent Cleveland Clinic cardiologist, stated to the Wall Street Journal that, in general, if panelists have significant financial ties to a drug maker whose product is under review, it can “bias the proceedings.” He added, “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

The December hearing was filled with emotional testimony from patients and family members. Joan Cummins of Hackettstown, N.J., told of the death of her 18-year-old daughter, Michelle Pfleger, in 2010. Ms. Pfleger, a freshman at Elon University in North Carolina, was taking Yaz. She collapsed and died of cardiac arrest from a blood clot in her lung, her mother testified. Lieff Cabraser represents Ms. Cummins in a wrongful death lawsuit against Bayer charging that Yaz caused her daugther’s fatal blood clot.

The close vote of the FDA advisory committee that the benefits of Yaz and Yasmin outweighed the potential health risks has received substantial media attention after it was revealed that several of the doctors on the panel had ties with Bayer, the manufacturer of Yaz and Yasmin.

The Washington Monthly reports, “at least four of the advisory comittee members in this case have served as paid researchers,” “a fifth advisor agreed to serve as a consultant,” and “a sixth received consulting fees from a law firm representing Bayer.”

December 9, 2011

A Food and Drug Administration (FDA) advisory committee met yesterday to determine whether Yaz birth control should be packaged with a warning about the drug’s higher association with blood clot risks.

The hearing included discussion of conflicting medical studies conducted by Bayer Corporation, Yaz’s manufacturer, and by independent researchers. Bayer’s two studies found no increased risk of blood clots associated with its Yaz and Yasmin birth control drugs. However, three independent studies found evidence that drospirenone, a synthetic progestin used in Yaz and Yasmin, can increase the chances of developing a blood clot.

Joan Cummins, whose eighteen-year-old daughter Michelle Pfleger died from a blood clot allegedly caused by her Yaz birth control medication, testified at the hearing. WBALTV reports on her moving statement, in which she told the advisory committee, “I need my daughter back, and you can’t give her back. But you can, you absolutely can prevent other mothers from coming here with broken hearts.” 

The panel voted twice during the day; a first vote determined, 15-11, that the benefits of Yaz and Yasmin outweigh the potential harm that the drugs cause. Huffington Post reports, “the majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug’s overall benefit, citing numerous alternatives available.” Mark Woods of New York University School of medicine stated, “I can see no real group of patients that this drug benefited over existing alternatives. Without any clear benefit, and given the potentially catastrophic risk, I voted no.“ 

The second vote determined, 21-5, that Yaz and Yasmin labels should be changed to note “that the evidence about blood clots is conflicting.” While there is no timetable for Bayer to make changes in Yaz and Yasmin warning labels, the FDA panel agrees that new labeling should clearly state the potential risks of blood clots. 

Independent studies have found a two to three times greater risk of blood clots for women taking birth control drugs containing drospirenone than earlier generation birth control drugs. These earlier generation birth control drugs do not contain drospirenone and are just as effective in preventing pregnancy.

Ms. Cummins told the FDA panel:

My name is Joan Cummins. My daughter Michelle was an amazing young woman. Vivacious, beautiful, accomplished. She was looked up to by her peers and cherished by her family. Michelle was extremely intelligent and an exceptional student.

At eighteen, she was just starting her freshman year at Elon University in North Carolina, when she collapsed on the way to one of her morning classes on a day I will never forget, September 24, 2010. She was rushed to the hospital by paramedics, but died from cardiac arrest from a pulmonary embolism.

My daughter was on Yaz. One day she was a healthy eighteen-year-old full of life with a promising future ahead of her, the next she was gone. Because she has been robbed of her voice, others must speak for her and for all of the others who are still taking these Yaz pills.

Do you all think this is some kind of academic debate?

Are you seriously debating whether independent studies are trumped by Bayer studies? If there is even a question that there is more risk with these pills, we needed all of this? If there are so many questions about whether these pills are more dangerous, what are we doing here? Because of all of the alternative pills, the questions alone tell us that these pills must be removed.

In my mind, these drugs should be removed from the market tomorrow. By leaving them on the market, you are confusing the situation. My daughter is dead because Bayer confused the situation. Please fix this.

No one would think that responsible scientists would allow that. It is worse than insanity. It is a sickness called greed.

My daughter did not need Yaz. Bayer needed Yaz.

As for me, I need my daughter back. You can’t give her back. But you can, you absolutely can prevent other mothers from coming here with broken hearts.

Please remove these drugs! If you don’t, you will answer for it.

Lieff Cabraser represents Joan Cummins in her wrongful death lawsuit against Bayer Corporation. Learn more about Yaz lawsuits and victims’ rights.

According to ABC News, independent studies have found that Yaz patients have two to three times the risk of developing blood clots than do patients taking other forms of birth control. Dr. Susan Jick of the Boston University School of Medicine authored an independant study showing the increased risk of blood clots for patients taking Yaz.

Some patients, like former pediatric nurse Carissa Ubersox, profiled in the ABC News report, experienced negative health side effects from Yaz including life-threatening VTE (venous thromboembolism).

Blood clots formed in Ubersox’s legs and traveled to her lungs, stopping her heart for four minutes and eventually blinding her. Ubersox and other alleged victims of Yaz are suing Bayer for concealing its knowledge of the increased risk of blood clots associated with Yaz.

Bayer was aware of “an increase in the U.S. reporting rate” for blood clots, and it was also aware of of “spontaneous reporting data” that signaled “a difference in the VTE [venous thromboembolism, blood clots occurring in veins which can travel to the heart or lungs] rates for Yasmin” and other birth control pills. However, Kessler says, “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

Bayer currently faces over 10,000 Yaz and Yazmin lawsuits  for injuries caused by their birth control pills. From 2004 to 2008, there are at least 50 reported deaths. Plaintiffs charge Bayer with negligence in warning patients of health risks, and with marketing Yaz and Yasmin for unapproved uses such as treating PMS and acne. One instance of Bayer’s aggressive off-label marketing campaign is their $450,000 contract with a well known women’s health blogger, Judith Reichman, who mentioned off-label benefits of Yaz in her book.

In light of the growing evidence that Yaz and other birth control drugs containing the synthetic hormone drospirenone may increase the risk of blood clots, the FDA may require new warning labels for these higher risk pills. On December 8, the FDA will hold a hearing on Yaz and Yasmin birth control to determine their safety and effectiveness.

Units of Bayer AG (BAYN), Germany’s largest drugmaker, may have sought to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks the drug posed, according to company e-mails.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to company files provided to lawyers for women suing Bayer. U.S. regulators approved Yaz only for the most severe form of PMS. Salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz.

“This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women battling premenstrual dysphoric disorder, the most severe form of PMS, wrote Matt Sample, a Berlex sales consultant, according to a copy of the e-mail produced as evidence.

Read the full article here. Learn more about Yaz birth control litigation and victims’ rights.