Products Liability Research Paper
Select a company that has been the subject of a product liability lawsuit in the last ten (10) years.
The Plaintiffs vs. Bayer Pharmaceuticals, the German manufacturer of the birth controls Yaz and Yasmin has landed themselves in hot water and is headed to the courts. Bayer Pharmaceuticals net worth is over a billion dollars and is still climbing. The use of the birth controls Yaz and Yasmin has sparked a lot of attention with claims of a number of dangerous side effects. This case has become very popular, with over 11,300 claims pending and the possibility of more to come, Bayer is expected to pay out about $110 Million in the Yaz case in an attempt to avoid being tried before a jury but that is only the beginning of a long list of active claims. The use of these birth controls are causing an increased number of blood clots in women as well as complications of blood disorders, problems of the heart, strokes, and in some cases even death. www.drugwatch.com the problem appears to be stemming from drospirenone (a progestin) that is found in the birth control pills. In the case of Shannon Landry of Louisiana she filed a complaint with the U.S. district Court for the Southern District of Illinois. In 2000 Landry began taking Yaz and continued until 2010, and shortly thereafter she began having severe side effects. She was later diagnosed with a gallbladder disease called biliary dyskinesia that resulted in surgery to have her gallbladder removed. Although her case is a little different from the usual side effects like blood clots it is one of the side effects that can occur from using Yaz, her side effects are the results of taking the same birth control which can also raise the levels of potassium and block the flow of the bile’s. The complaints are still coming in as more and more women are experiencing these side effects from increased blood clots that can cause women to lose twice as much blood through clotting but not all of the side effects are the same
The plaintiffs seem to feel that Bayer has downplayed the dangers and risks of the use of
Yaz and Yasmin and that the marketing approach used was over exaggerated. In some cases the plaintiffs have accused Bayer of a lack of proper medical research and failure to indicate the most dangerous risks associated with the use of these birth controls. It also appears that the manufacturer may have supplied medications with possible defects, flaws in the design, and warnings that were inadequate. The downfall to using Yaz and Yasmin is due to a number of deaths from 2004 to 2008 and the birth control needs to be taken off of the market. In 2012 Bayer settled the first of many cases that were pending that cost them $110 million to settle about 500 cases which netted the plaintiffs almost $220,000 each, but so far the total payout has been around $142 million. With the number of claims rising, Bayer is expecting to pay somewhere in the neighborhood of $2.6 billion by the time all of the cases have been settled.
As with many other cases no company wants to bear the blame when things go wrong and Bayer is no different. There is no amount of money that can cover the loss of a loved one from the use of a defective product, nor can it heal the internal wounds and scars that are left behind. It is so easy for a company to create a product and at the same time set money aside for a potential problem that may occur because they knowingly manufactured products under deceitful practices. The use of birth control is an old method for preventing pregnancy but companies are now trying to create multi-meds in the same manner that they do multi-vitamins. The manufacturers are finding ways to cut corners and minimize their production cost while they profit from the sales. In this case the purpose of the lawsuits are to instill into these manufacturers that they have to not only pay but also admit to liability and negligence. When a company has an opportunity to mass-produce a product the consumers are usually the ones who suffers.
Whenever a consumer knows about the risks and dangers of a product it gives them an opportunity to opt out and try something else or even choose to use a more practical cure or prevention. In the case with Bayer there is no indication of whether or not the plaintiffs are being compensated for punitive damages or if their cases are based on tort. The cases that were settled appears to be due to negligence, however there is no indication of how many of the families were paid in the death cases. The guidelines and safety standards needs to be reevaluated and strictly enforced and when cases like these comes up the products should be taken off of the markets for immediately for further evaluation.
Although the controversy with Bayer continues there has not been any removal of the birth controls Yaz and Yasmin from the market. As of April 2012 the information has been updated and the risk for blood clots has been added to the package inserts. But Bayer is not the only manufacturer that should be worried. There are also generic versions of Yaz and Yasmin being produced by companies like Teva Pharmaceuticals and Barr Laboratories, Watson Pharmaceuticals, and Sandoz, Inc., these companies should be worried about the possibility of future lawsuits and should consider the fact that generics usually contain similar ingredients to Yaz and Yasmin. If these birth control pills are causing side effects that could possibly lead to death, consumers have to wonder if this is an attempt to utilize the birth controls as a form of permanent sterilization in order to decrease the population. www.lawsuits.lawinfo.com in November 2009 33,000 boxes of Yaz were recalled, but they were not taken off of the market and no explanations were given as to why the recall had occurred. With the increased danger of side effects, there have been changes to Yaz advertising and prescriptions. Due to the lack of responsibility and liability Bayer has falsely mislead consumers and they are feeling the pain. There is no proof that these drugs were tested prior to going on the market and no one knows how dangerous these birth controls are or whether or not all of the ingredients are being listed. The listing of the side effects and the medical proof of known health scares for Yaz and Yasmin should be enough for the Food and Drug Administration (FDA) to pull the birth control off of the market. After Yaz and Yasmin were put on the market in 2006 the FDA had given Bayer several warnings for using advertisements that were considered to be slick.
Bayer referred to the birth control as a cure for all female problems caused by their menstrual conditions. They were also warned about using low quality ingredients that were found when a routine inspection was conducted in 2009 at their plant in Germany. These findings were due to failure to test final products before they were shipped to the U.S. and the use of equipment that was unclean. The cycle of producing and distributing drugs has become the go to method for every ache and pain complaint. The manufacturers are working closely with the physicians and hospitals to push these drugs and increase their product usage by indicating the multitude of advantages. The first round of introduction to these drugs comes from the samples that manufacturers are dishing out to physicians and hospitals for free. The problem that consumers have is that they are struggling to survive and more and more medications and medical supplies are being recalled for possible dangers.
The worst part about the situation is that paying has not deterred Bayer from continuing to profit from the use of the birth control pills. The FDA has regulations that are set into place based on the intended use of a medication before they will approve it. However, the FDA has no interest in approving the chemical compounds that are used, they are only concerned with the use of that chemical compound for a specific condition and its dosage which is what the FDA reviews. One of the tactics that manufacturers will try to use are the ‘off-label ‘uses that have not been approved or has not been submitted to the FDA. The promotion of non-approved drugs are prohibited by the FDA and Bayer violated that regulation by promoting Yaz and Yasmin off-label for unapproved uses which has been proven to be an ineffective medication.
The use of the marketing technics that were used by Bayer was a misrepresentation of what the products side effects were and how deadly that product could be to consumers. The FDA is not responsible for product safety or any of their promotion campaigns but they do require manufacturers to maintain accurate study practices of their products and report the unadvertised side effects. Although the FDA is a regulatory agency, they cannot monitor every move that a manufacturer makes. The idea that Yaz and Yasmin can be used for multiple problems makes them the top selling drugs for Bayer. But the FDA should also consider reviewing the side effects for the generic version of the birth control Ocella, which can cause deep vein thrombosis (DVT) also known as a pulmonary embolism.
The possibility of mass tort is prominent amongst law firms and the lawyers are looking for ways to up the ante in any lawsuit against major manufacturers. There are often times when the attorneys have altered the results of medical tests and created new results by using their own independent medical examiners. This is a tactic where lawyers have recreated the level of illness and will request the plaintiffs to demand more from the company. There are numerous law firms advertising the risk involved with birth controls and other medications. With the economy at an all-time low consumers are willing to have their voices heard in court if it will produce a check and the lawyers are willing to oblige them. As we all know talking to a lawyer initially is free and being able to target the complaint is the job of the lawyers whereas they are like dogs hovering over the same flavor of bone and looking for the cases that will produce the most revenue.
Sometimes manufacturers have too much on their plates and they try to mass produce products and the possibilities of mixing the wrong ingredients can be fatal to the consumers. A good recommendation to Bayer is that they focus more on the actual production process to ensure that the drugs that they are producing are made with quality ingredients and put less focus on their profitable benefits. The Bayer manufacturer has an obligation to list all of the risks associated with the drugs that they produce, and the possibility that the drug could be life threatening. Because birth control is one of those prescriptions that is strongly recommended for the prevention of pregnancy, tighter regulations are needed so that the drugs can perform properly and hopefully lessen the list of side effects.
The biggest recommendation for the Bayer manufacturer is for them to take the Yaz and Yasmin birth control pills off of the market immediately. This will allow for them to be able to settle all of the claims that are still pending and hopefully put an end to any future claims. The Bayer manufacturer will also have to consider the amount of negative publicity that is taking place. If they choose to continue promoting these forms of birth control they will need to reevaluate the uses to determine the best safety measures to use when advertising. By now Bayer should have learned that spending $20 million on commercials to advertise is a total waste of money when the product is essentially a death pill. The most important aspect for Bayer is that they promote medication that is used for shorter periods that will decrease the side effects but do the job that it is intended to do. Otherwise, Bayer will be labeled as the “Killer Company”, but they are not far from that theory. References
Herbert, T., & Ingulli, E. (2012). Law and ethics in the business environment (7th ed.). Mason, OH: South-Western Cengage Learning.
Retrieved on March 10, 2013 from- http://www.drugwatch.com/yaz/lawsuit.php
Retrieved on March 11, 2013 from- http://lawsuits.lawinfo.com/Yaz/index.html