Dallas, TXFor the past three years, attorney and physician Dr. Shezad Malik has been working on Yasmin/Yaz lawsuits and his firm is involved in the federal MDL litigation which has been centralized in the Southern District of Illinois, in East St. Louis. "The first bellwether trials, which will take place in January 2012, will start with the pulmonary embolism cases, in April gallbladder cases, and DVT (deep vein thrombosis) cases will follow next summer," says Dr. Malik.
Dr. Malik believes that recent research indicating drospirenone-based birth control pills pose an even greater threat than previously believed will affect the outcome of the Yasmin and Yaz lawsuits.
The latest FDA report states that women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, and researchers report in the Canadian Medical Association Journal (November 2011) that drospirenone-based birth control pills increased the risk of venous thromboembolism by as much as 65 percent.
"An FDA conference scheduled December 8 is going to examine and address the health risks associated with birth control pills Yaz and Yasmin, and that too will likely have profound implications and affect the outcome of the Yaz lawsuits," adds Dr. Malik. He opines that the FDA may revise the drug labels again (revised in 2010 and 2011), or issue stricter warnings regarding the birth control bills—a black box warning—or it may even ban the pills from the market altogether due to the dangers of Yaz blood clots, but he believes that the latter is "highly unlikely."
How do you have a case against Bayer when the company has already slapped warnings signs on its products? Dr. Malik's case is focused on "Failure to Warn." Bayer allegedly up-played the benefits, such as clear skin and decreased swelling, and downplayed the side effects. "So you have a new drug—this fourth generation oral contraceptive—that is arguably more dangerous, but the public hasn't been warned about the difference, as compared to the older contraceptive pills currently on the market," Dr. Malik explains.
"It is common knowledge that all contraceptives have known risks of venous thromboembolism, (VTE), but the risk profile is supposed to be reduced as time goes on," Dr. Malik adds. "These pills have a diuretic function and also an anti-mineralocorticoid function, which is designed to improve swelling, bloating and premenstrual tension, associated with periods. We believe there is an increased risk with the interaction of these diuretic effects and hormonal effects."
Thousands of patients have already filed a Yaz or Yasmin lawsuits against Bayer Corporation, claiming that the manufacturer highlighted the birth control pills' benefits while minimizing the serious side effects such as Yaz deep vein thrombosis, pulmonary embolism, stroke and death. "A number of these women have suffered debilitating strokes, permanent damage to their veins and respiratory system, and some have died," says Dr. Malik.
One of his clients went into a coma and is now blind (see the video above). "This woman, who is in her mid-40s, took the pill because of menstrual problems," says Dr. Malik. "She was found unresponsive one night by her husband. He performed CPR (which likely saved her life) and called 911: en route to hospital the paramedics shocked and revived her multiple times; they got her to ER very quickly, but because she was so unstable, they put her in an ice bath and a medically induced coma to prevent brain damage. When she awoke from the coma, she had severe neurological damage and ended up blind."
Dr. Malik is also seeing many young women, some as young as 16, who had their gallbladders removed. "That just doesn't happen in young women," explains Dr. Malik. "We typically see gallstones with the 'Four F's': fat, female, fertile and over 40. Clearly gallbladder problems are also linked to Yasmin and Yaz."
Bayer is strongly denying any problems and will vigorously defend themselves, but Dr. Malik is confident that justice will prevail.
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