Products and Liability Research Paper
Steve Jackson
Strayer University
Legal 500
Professor Wendy White
June 10, 2014

Question # 1:
Describe the company and the product safety issue that led to the lawsuit.
Baxter Pharmaceuticals is a healthcare company located in Deerfield, Illinois which was founded in 1931 by Dr. Donald Baxter. Baxter Pharmaceuticals was the first manufacturer of commercially prepared intravenous solutions. The company primarily “focuses, develops, manufacture, and markets different healthcare products that are used to save and sustain the lives of people with immune disorders, hemophilia, infectious disease, and other chronic and acute medical conditions.” ("Corporate overview," 2013) Baxter has been known as a very global diversified healthcare company that has a great reputation for its safety and effectiveness since 1931. “The company also has expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.” ("Corporate overview," 2013)
On June 2009, there was a lawsuit placed again Baxter Pharmaceuticals (which is also known as Baxter Health Corporation) by Dennis Quaid and Kimberly Quaid. The Quaid’s filed suit against Baxter for liability and negligence for the “medical drug error” which nearly killed their twins. The Quaid twins (11 days old) were in admitted into Cedar-Sinai Medical Center to be treated for a staph infection. The doctor prescribe that the twins be given Hep- Lock 10 units/ml through continuous intravenous drip of antibiotics to cure there infection. The next day, a nurse came into the twins’ room to replace the empty bags of antibiotics. At this point, the twins were given 10,000 unit/ml vitals of Heparin instead of 10 unit/ml vitals Hep-Lock that is used to keep the twins intravenous lines clear. Hep-Lock is a lower dose of Heparin which was prescribed by the treating physician.
The nurse mistakenly injected the twins with a massive overdose of 10,000 units of Heparin (blood-thinning medication). Later on that day this step was repeated and within 48 hours of the twins being admitted. They were facing death from a condition they were not admitted for. The twin’s begin to bleed profusely because they were hemorrhaging through vein or artery which normally cause brain damage, organ failure, and/or can lead to death. In the end the twins were stabilized. The hospital investigation showed that the fatal mistake occurred when the bottle of Hep- Lock 10 units/ml and Heparin 10,000 unit/ml had similar labels with blue backgrounds that made the two hard to distinguish.
Question #2
Discuss the legal theories used by the plaintiff to recover in this lawsuit, how the lawsuit was resolved, and why you agree with the decision in the case.
In this case the plaintiff (the Quaids) filed two count complaint against Baxter for liability and negligence. The Quaid argued that Hep-Lock 10 unit/ml and Heparin 10,000 unit/ml are beyond dangerous condition because of the blue labels on the drug, which makes it overly hard to distinguish the two medications from one another. Baxter stated that the two medications should have been different vitals and should have been disguisable in shape and size.
The Quaid’s further argue the defend was negligent because they failed to recall or repackage the 10,000 units/ml vial of Heparin or issue some type of important warning to healthcare providers around the United States. When they had knowledge of infant deaths that were a result of the medication errors. The plaintiff also argued that Baxter sold different dosages with the same blue background and failed to issue urgent warning about the fatal medication errors that had occurred to health care providers who had already purchased the products. Baxter could not assure providers initiate mandatory education and implement safety measures are in place to prevent medication errors that happened to the twins. Baxter also failed to provide the adequate after-market solution to the existing vials and to assure that none of the existing vials were used or going to be until after a solution was in place and executed as safe and effective.
“The court rejected the plaintiff’s contention that the defendant’s failure to bring a third party complaint renders the issue premature and speculative. The decision to use a product that is mislabeled or contains inadequate warnings was made by a highly trained party is not subject to the court’s jurisdiction.” ("Quaid VS Baxter," 2008) Basically, the case was dismissed on forum non conveniens due to jurisdiction. I don’t agree with the court’s decision to dismiss on jurisdiction. I think the states should not matter when the manufacturer is based in another states. A person should be able to file a suit against them for wrong doing where ever they are. I don’t think the Quaid’s should have been filing a suit again Baxter. I believe if they were going to file suit again someone it should have been the hospital; because there employees are the ones that administered the drugs and made the mistake. I do believe this medication error could have been avoided if they would have just read the labels as they are required to do by the FDA and the policies and procedures of most hospitals. ("Quaid VS Baxter," 2008)
Question # 3
Describe the changes that have taken place in the company to ensure greater safety of this product or its products. On February 8, 2008, Baxter sent out an important medical safety alert to healthcare providers urging them to carefully read and check the product container labels for Heparin(10,000 units/ml) and Hep-Lock U/P (10 units/ml), which both use prominent blue background colors . They not only urge them to read and check those specific labels but check all labels on drugs that they will be administering. Baxter alert also stated that they were aware of fatal medication errors that have occurred because of the mix up. Basically, they were notifying providers what could happen if they do not pay attention.
On February 29, 2008, Baxter did an urgent Product recall on many doses of Hep-Lock (Heparin Lock Flush Solution, USP) and Hep-Lock (Preservation-Free Heparin Lock Flush Solution, USP) as a precaution. These products used the same pharmaceutical ingredient API from China just like the Heparin injection single and multi- dose vital. Baxter decided to recall the product because there were a negative impact and events that had happened with the multi-does product. They decided to recall any remaining heparin flush products that were currently on the market.
Baxter decided to use 20% larger font size, tear off cautionary labels, and different colors to distinguish different drugs and doses. This made it clear to see what strength was in the container. Baxter did this as a requirement from the FDA due to all the cases of mixes up with Heparin and Hep-Lock. The FDA notified providers and people of the United States that there was going to be a change to the container and carton labels of the heparin products in December of 2012. “The label change will required manufacturer like Baxter to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL).”("FDA drug safety," 2012) The FDA and Baxter both knew this was to reduce the risk of medication errors that were happening in society at the time.
Question # 4:
Discuss which regulatory agency oversees the particular industry the company is in.
“The Department of Health and Human Services is the principal agency for protecting the health of the American people and providing essential human services, especially for those who are least able to help themselves.” ("About HHS," 2013) The department is comprised of the Office of the Secretary and the working 11 operating divisions. The agencies (also known as divisions) perform a variety of different tasks and services which are very broad that includes research, food and drug safety, public health, grants/funding, health insurance, and etc. ("About HHS," 2013) HHS also has 14 staff divisions that fall under the operating divisions that provides leadership, direction, and policy and management guidance to the Department. Overall, the department of health and human service’s 300 programs provide adequate equitable treatment to beneficiaries nationwide. ("About HHS," 2013) The Food and Drug Administration (FDA) is the regulatory agency that ensures the safety and effectiveness of drugs sold in the United States. The FDA is an agency within the Department of Health and Human Services. The FDA regulate food, drugs, medical devices, radiation emitting products, vaccines, blood, biologic, animal and veterinary, cosmetics, and tobacco products; which are products we use every day in several different ways. The FDA is divided into two different phases which are called preapproval (pre-market) and post approval (post market) for all products especially drugs. All drugs has to go through this application review process if they wish to market their drugs in the US. Drugs cannot be manufactured or sold in the United States unless it has FDA approval. “Congress expanded and refined the FDA’s roles regarding drug approval and regulation according to the Food and Drug Act of 1906.” ("FDA Summary," 2013)
“The FDA reviews the NDA with three major concerns: safety and effectiveness, appropriate labeling, and adequate manufacturing method to assure the drug identity, strength, and quality.” ("FDA Summary," 2013) FDA continues to address drug production, distribution, and use even after the NDA approval of the drug. They just like to make sure that the drug benefit continues to outweigh the risk for its proposed use by monitoring its performance in a number of ways. Centers for Drug Evaluation and Research address the safety of drug supply. The primarily focus of activity is the Office of Drug and Safety (known as Office of Surveillance and Epidemiology). OSE uses reports of adverse events to identify drug safety concerns and advise ways to improve product safety and ways to protect public health. Overall, the goal of the FDA is to protect the people of America. ("FDA Summary," 2013)

Question # 5:
Make recommendations to the company about avoiding future lawsuits. Baxter should re-evaluate their containers and labels and ensure that clearly can be read and distinguished from any other drug that is similar that made cause medication errors. Baxter should make providers who buy their product take a training course on how to prevent medication errors and read label and important notices. Baxter should also have a requirement that every 2 years providers take an education and competency class to get some type of certification acknowledging they know how to read the labels and know how to prevent medication errors. There should be a safe initiative in place for providers who have participate in the annual training course. I also think Baxter needs to have a risk management and quality process department that will oversee providers who buy there drugs to ensure they are using them as instructed and safely. Baxter also needs to send out communications for drugs that have a bad impact on patients or any medication errors that have occurred that way others are aware of the issue and errors can prevented
Reference:
(2008). Quaid vs Baxter health corporation –State of Illinois ( No. 1-08-2727). Retrieved from website: www.state.il.us/court/opinions/appellatecourt/2009/../1082727.pdf Corporate overview. (2013). Retrieved from http://www.baxter.com/about_baxter/company_profile/corporate_overview.html
The Food and Drug Administration, (2012). FDA drug safety communication: Important change to heparin container labels to clearly state the total drug strength. Retrieved from website: http://www.fda.gov/Drugs/DrugSafety/ucm330695.htm
The Food and Drug Administration, (2013). FDA Summary. Retrieved from website: http://www.fda.gov/Drugs/default.htm
U.S Department of Health and Human Services, (2013). About HHS. Retrieved from website: http://www.hhs.gov/about/