Product Liability Research Paper
Michelle Wright
Professor Ellen Kapalko
Law Ethics & Corporate Governance

Yaz The Product Liability of Bayer Pharmaceuticals The Bayer Pharmaceuticals Company was founded in 1893 by Friedrich Bayer and Johann Wescott in Barmen, Germany. Bayer is known for their trademarked Bayer Aspirin which was created in 1899. Bayer spent decades marketing heroin worldwide as a cough medicine for children. The side effects of selling heroin to children were not a concern for them. Although they originated as a pharmaceutical company they turned their attention to manufacturing chemical weapons. Bayer formed a close relationship with German firms during the World War which formed the conglomerate called IG Farben. They became the largest donor to Hitler’s army. In the post-war years Bayer grew to become the third largest pharmaceutical company in the world. In the mid-1980s Bayer was one of the companies which sold a product called Factor VIII concentrate to treat haemophilia. Factor VIII turned out to be infected with HIV and in the U.S. alone; it infected thousands of haemophiliacs, many of whom died in one of the worst drug-related medical disasters ever. But it was only in 2003 that the New York Times revealed that Bayer had continued producing and selling this infected product to Asia and Latin America after February 1984 when a safe product had become available, in order to save money. Dr. Sidney M. Wolfe, who investigated the scandal, commented, "These are the most incriminating internal pharmaceutical industry documents I have ever “(Bayer:history,2012) Bayer has been a company with many unethical practices that have placed people at risk of serious infections and even death. In 2001 Bayer had to recall its anti-cholesterol drug Baycol/Lipobay, which was subsequently linked to over 100 deaths and 1,600 injuries. Germany's health minister accused Bayer of sitting on research documenting Baycol's lethal side-effects for nearly two months before the government in Berlin was informed ("Bayer:history," 2012) The immoral practices exercised by Bayer leads me to speak of one of the latest products that they have produced and caused serious illnesses and deaths. In the United States the Birth control market has changed drastically. While research is down, the numbers of companies have fallen off and for those that remain, it has been very profitable. Bayer pharmaceuticals have not necessarily been one of those companies that are enjoying this ride. Bayer Pharmaceuticals are the makers of the birth control Yaz. The YAZ birth control pill, manufactured and marketed by Bayer Pharmaceuticals has been linked to a number of serious, life-threatening side effects including but not limited to heart attack, stroke, DVT, pulmonary embolism, blood clots, abnormal heart rhythm, gall bladder injury, pancreatitis and death. (Schmidt & Clark, LLP, 2012) Yaz is short for the birth control Yasmine. It was created by Berlex Lavatories and was acquired by Bayer. This birth control contains the substance drospirenone and ethinyl estradiol. Yaz was created as a form of birth control but was also used for treatment of premenstrual dysphoric disorder and for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. (Freudenheim,1989) The Product safety issue that led to the vast amount of lawsuits towards Bayer was that the additional safety measures were not taken by Bayer. Studies showed that Yaz was the cause of blood clotting in woman and they carried the highest risk of all the other birth control contraceptives on the market. The major side effects of blood clots cause by Yaz is are effects on the blood stream and ventricle system of the body. These blood clots can lead to numerous injuries including Stroke, Pulmonary Embolism, DVTs, Heart Attacks and other injuries that can cause major medical problems and even death. The FDA Commissioner Dr. David Kessler has joined forces with lawyers suing the Bayer Company for concealing the health risks of using Yaz. "Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events," Kessler said in court documents, citing studies that Bayer itself conducted but allegedly misreported to regulators. (pearle, 2011) Bayer believed that its product was safe and effective and had a favorable benefit risk profile in accordance with their product labeling. Bayer is involved in thousands of law suits that I can not pin point one particular case. The numbers are so large that New Jersey has ordered that all pending and future New Jersey court actions arising out of the use of oral contraceptives Yaz, Yasmine, Ocella are designated as a mass tort for centralized case management purposes under the Supreme Court. Most lawsuits have been consolidated into a Federal Multi-District Litigation. The legal theory that caused the plaintiffs to recover in the law suits were the fact that Bayer was responsible for placing warning labels on the product indicating the risks and potential hazards to women. They failed to warn the public of known risks of taking the birth control and that the risks outweigh the benefits. The current ongoing Yaz Lawsuit is centered on Bayers failure to warn the public of the risks associated with Venous Thromboemolism Events (VTE) and other blood clot related side effects. The warning indicated that the greatest risk of suffering a VTE occurs in the first 6 months after beginning Yaz. The update warning did not indicate to what degree the risk was lessened after the first 6 month interval of taking Yaz. In May of 2011 the FDA issued a safety alert regarding birth control pills like Yaz, which contain Drosperidone which broadened the risk associated with Yaz and similar drugs to include deep vein thrombosis, pulmonary embolism and other blood clot related events. (best legal source, 2012) In the court hearings Bayer presented preselected data that withheld the information about the analysis that demonstrated the increase in the US reporting rate for VTE or clots that was originally in the 2004 review of Yasmine Saftey. Bayer was order by the FDA to place a more precise warning on Yaz in 2011 which cost them 20 million dollars in corrective advertising. Their job was to make the public educated and aware of the risks related to VTE. They failed to do so. Law suits all around the country started to form but the judge ordered a mediation that would allow Bayer to settle out of court in order to compensate the victims. After nearly six months of settlement negotiations, Bayer had reportedly reached agreements with approximately 33 different law firms to resolve at least 1,444 Yaz and Yasmin lawsuits. All of the claims were filed on behalf of women who suffered blood clot-related injures after taking the company’s blockbuster birth control pills. Despite the massive settlement agreement, Bayer still faces some 14,000 Yaz and Yasmin lawsuits involving injuries including pulmonary embolisms, deep vein thrombosis, heart attacks, strokes and gallbladder injuries. To date they have paid out more than 402.6 million dollars and has set aside 600 million for future cases. Although the most of the law suits were resolved by pay outs for damages it will never replace the lives that are gone, the permanent damages to people that are now deformed, blind, or paralyzed just to name a few. Bayer should have removed the Yaz from distribution all together until investigations were finished by the FDA. Regardless of how many warning you put on a label if a product is detrimental to anyone’s health with that many risks involved it should not be produced, marketed or sold. Product liability laws are designed to protect consumers from dangerous products, while holding companies responsible for marketing and selling a product that they know poses a risk to consumers.

“We believe we have made appropriate provisions for most of the cases we consider to be worthy of settlement with these accounting measures,” Bayer officials said in an e-mailed statement. (feeley, 2012) Bayer has made what they feel is appropriate changes to the labels and set aside a substantial amount of money for pending a future lawsuits. This means that although we know we are damaging the lives of others, causing people to become ill; as long as we have money set aside for those that want to sue, we will continue to sell this product and not make any more changes to what we have. We will not only sell Yaz but make a similar product with the same ingredients and call it Yasmine as a new improved item and hope that the negative publicity goes away. Bayer is projected to have an increase in sales of 5 percent in sales. From what I have studied on this case Bayer has not made any drastic changes. FDA recently warned Bayer about poor quality control at a German Plant that still produces Drospirenone used in Yaz which is the cause of the blood clots. Bayer continues to lack concern for the welfare of the public. The change in the label, which took Bayer an entire year to change, was nothing specific to the Bayer birth control pills. The new changes pertained to all combined oral contraceptives, or birth control pills. They added 4 sentences that did not reference Yaz at all and was identical to the first change in 2011. The FDA is the governing agency that regulates Bayer Pharmaceuticals. The Food and Drug Administration is responsible for examining every drug before its place into the public sector to make sure it’s safe. Drugs are scrutinized from the design to the use to the marketing and advertisement by the FDA. The FDA must determine the side effects to the conditions un- der which the drug is manufactured. In order to avoid future law suits; it must first start with the FDA. When faced with the false ads that Bayer has run; the FDA should review all advertising before they are made public and meet FDA standards. Warning letters are placed on the website of the FDA when there is a major concern with the product but there is no vehicle to take those to the site if they are not looking for a problem. A national bulletin should be made to make people aware for those that are not internet savvy. This will avoid many potential lawsuits or digression in someone’s health by them discovering a problem a head of time. FDA needs to take a stronger approach to the regulations that are placed before new products are put on the market. FDA has completed 6 published studies on the evaluation of the blood clotting and review of preliminary data and still has not reached a decision to pull this item off the market. More than 9000 women would have to prescribe to the birth control in order to observe a difference of one case of thromboembolism. Bayer Pharmaceuticals should not wait until the FDA pulls the plug on Yaz. To avoid future lawsuits they need to pull the item from distribution. They know what this drug is doing; they created it. They should improve a new birth control based upon current birth control pills and expound on it. Bayer has caused enough lives to be ruined.

References
Bayer:history. (2012). Retrieved from http://www.gmwatch.org/gm-firms/11153-bayer-a-history

Best legal source. (2012). yaz lawsuit info . Retrieved from http://www.yazlawsuitsinfo.com/yaz-class-action-lawsuit-news/ Dinger JC, Heinemann LA, Kühl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007; 75:344-54
Feeley, J. (2012, july 13). bayers yasmine lawsuits rise to 402 million dollars. Business Week . Retrieved from http://www.businessweek.com

FREUDENHEIM, M. (1989, FEBRAURY 2). Birth control industry is being transformed. NEW YORK TIMES. Retrieved from http://www.nytimes.com/1989/02/22/business/birth-control-industry-is-being-transformed.html

Pearle, L. (2011, 06 12). Fda to review safety issues surrounding leading birth control pill yaz. Retrieved from http://abcnews.go.com/Health/fda-discuss-safety-issues-surrounding-leading-birth-control/story?

Pitcher, A. (2012). Fda sues bayer over birth control pill ads. Retrieved from http://www.policymic.com/articles/2525/fda-sues-bayer-over-birth-control-pill-ads&referral=category_list

Schmidt & Clark, LLP. (2012). Bayer settles 1444 yaz, yasmine blood clot law suites. Retrieved from http://www.schmidtandclark.com/bayer-yaz-yasmin-blood-clot-lawsuits-settlement

Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM. Risk of thromboembolism

in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet

Gynecol 2007; 110(3):587-93