Michelle Pfleger's Mother sues drug company after teenage daughter 'collapses and dies while on Yaz birth control pill'
When Joan Cummins said goodbye to her 18-year-old daughter before her first term at university, she consoled herself by thinking she'd be back for Christmas. But Michelle Pfleger never did come home. Instead, after less than a month at Elon University, North Carolina, she collapsed and died from a massive blood clot - after taking the birth control pill to treat her acne. Now Mrs Cummins is taking German pharmaceutical firm Bayer to court, claiming the contraceptive pill Yaz contributed to her daughter's death. Her case has been bolstered by the Federal Drug Administration, after it announced it was reviewing a range of oral contraceptives, including Yaz, which contain a form of the hormone progestin known as drospirenone.
In the lawsuit Mrs Cummins writes: 'One day she was a freshman at college so full of hope and promise and the next she was gone.'
The pretty blonde student, who lived in the small town of Great Meadows, New Jersey, collapsed suddenly last September, when she was on her way to class.
Miss Pfleger, who had taken Yaz for about a year, suffered a cardiac arrest and died in hospital after a massive blood clot reached her lungs.
Her room is still full of the ribbons she won has a champion horse rider, and her mother said she was in good health when she left for college in August.
She told CBS: 'Instead of her coming home and being part of life here again, she came home and I had to bury her. 'It's just horrible. I don't want to have anybody I know to have to go through this. It just is not fair.'
Her lawyer, Wendy Fleishman, described Yaz as 'a dangerous prescription drug sold without adequate warnings about the risks of serious and fatal injuries'. The suit claims companies violated consumer protection laws in New Jersey and North CAROLINA by 'knowingly and falsely representing that Yaz was fit to be used for the purpose for which they were intended, when in fact the drugs were defective and dangerous.' It alleges drospirenone, which is used in contraceptives including Yaz, Yasmin, Beyaz and Safyral, is potentially deadly and has caused at least 50 reported deaths between 2004 and 2008.
Two studies, published in the British Medical Journal in April, suggested the substance could increase the risk of a deep vein thrombosis by up to two or three times more than other oral contraceptives, which use a form of progestin known as levonorgestrel instead.
In a statement on its website, the FDA said: 'Other studies have not reported an increase in risk. 'The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.'
The BMJ studies emphasized the risk of a blood clot is still low, and said women didn't need to stop taking the pill unless they have checked with their doctor or start having symptoms of a blood clot like leg or chest pain.
According to gynecologist Dr Jennifer Ashton, the channel's medical correspondent, blood clotting is a possible side effect of all birth control pills, but just eight out of every 10,000 women taking them will have a 'clothing event'.
In a statement to MailOnline, Bayer said: 'Patient safety is Bayer’s top priority. Bayer’s oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used as directed and according to product labeling and good clinical practice. 'The lawsuits filed by plaintiffs focus on side effects that are warned about in the labeling for Yaz and Yasmin. Bayer will defend itself vigorously against these lawsuits.'
The firm told CBS it is working closely with the FDA on the subject, and said scientific evidence shows its birth control pills are as safe as others on the market.
Dr Ashton said: 'I spoke to the vice president and the medical director of the Women's Health Division at Bayer, and he told me that the studies do not show their pills to be more dangerous than other pills.