Merck & Co. v. Garza and Product Liability Lawsuit

Describe the company and the product safety issue that led to the lawsuit

In the beginning of 1999, the Food and Drug Administration (FDA) approved for sale to market the drug “Rofecoxib”, popularly marketed as Vioxx, in the United States (Russo, 2012, p. 220). Vioxx functioned as a drug aimed at relieving pain from arthritis and quickly became a highly prescribed medication in the country. The company responsible for designing and supplying the drug was the New Jersey-based Merck & Co., Inc., a massive pharmaceutical company and medical giant famous for its innovative and effective vaccines and treatments. Vioxx catapulted Merck to the forefront of arthritis medication in the United States and for several years the company profited greatly from the sale of its “wonder drug”. Lacking the negative side effects of other medication, users of Vioxx reported far less stomach pain and other associated negative results of strong pain medication, making it a hotly traded and marketed prescription medication in the American market. 

Vioxx, despite its approval from the FDA, was not without its downsides. Vioxx users, when compared to the leading benchmark medication Naproxen, “had a greater chance of having a heart attack” (Ludwig, 2011, p. 1133). Naproxen, the drug previously popularized to treat arthritis pain and used as the benchmark medication for analyses and tests regarding improvements in quality of care, maintained an “ability to block platelet aggregation—a quality that Vioxx did not share” (p. 1135).  Merck argued that Vioxx did not increased the risk of heart attack insomuch as Naproxen maintained an unintended benefit of reducing heart attacks. Therefore, as Merck argued, Vioxx did not increase the risk of heart attack at all; instead, the risk was the same, just that Naproxen contained an “added benefit” (p. 1135). The lawsuit itself originated in 2001, when a “group of plaintiffs sued Merck on a products liability claim that Vioxx users were four times more likely to suffer a heart attack than naproxen users” (p. 1135). Thus, the so-called “naproxen hypothesis” would claim that a 2000 study entitled “VIGOR”, which analyzed the effects of Vioxx and related medication, supported only the “absence of a benefit conferred by naproxen rather than a possible problem with Vioxx” (Russo, 2012, p. 220).  

On November 6, 2003, “respondent investors filed a securities fraud action” under the power of the Securities Exchange Act of 1934, stating that Merck had “knowingly misrepresented the heart-attack risks associated with its drug Vioxx” (FindLaw, 2013). Following the publication of another study illustrating the dangerous effects of Vioxx on the risk of heart attack and mitral valve prolapses, Merck pulled the drug from the shelves in September of 2004. In the subsequent investigation, it was found that Merck researchers and project leads had sent emails to their departments instructing employees not to discuss the risks to user’s cardiovascular health, and that the company deliberately attempted to keep “safety concerns from destroying the drug’s commercial prospects” (Russo, 2012, p. 221). The securities fraud action of 2003 stated that Merck had commenced illegal marketing of Vioxx and “intentionally downplayed its risks” as well as stressing that the company’s sales campaign was “false, lacking in fair balance, and otherwise misleading” (FindLaw, 2013). Thus, the securities fraud action centered around the fact that Merck had deliberately misled the public and investors regarding the true health effects of the drug in order to increase the drug’s commercial profitability. However, the claim would be dismissed, as the investor’s claim violated a two-year statute of limitations regarding the time limit needed to properly allow the plaintiffs notification of the suit. This dismissal, however, would be overruled by the United States Court of Appeals. The Supreme Court affirmed the ruling of the Court of Appeals following Merck’s subsequent appeal and clarified the “essential principles for applying” the law to “securities fraud claims” (Russo, 2012, p. 223). 

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

Merck & Co. v. Garza came about as one of many lawsuits brought against Merck for the use of Vioxx as a medication to treat arthritis pain. Garza, age seventy-one at the time of death, had a “history of heart problems” (Merck, Cases and Code, 2013). Mr. Garza had been prescribed Vioxx as medication appropriate for treating his repeated complaints of pain in his left arm, numbness, and physical weakness. Given a prescription for Vioxx on March 27, 2001, Garza began the medication regime and died of a heart attack three weeks later on April 21st.  Survived by his wife and children, Merck was sued by the family on the basis of the “design and marking defect[s] [and] strict liability claims based on allegations that Vioxx caused Garza’s death.” (Merck, 2008). By claiming that “Vioxx had caused his heart attack”, the Garzas “attempted to prove general causation by introducing epidemiological studies, including clinical trials, as well as deposition testimony” that would justify that the drug was a contributing factor in Garza’s death, or that Vioxx itself in any way “confers an increased risk of serious adverse cardiovascular events” (Merck & Co., Inc., v. Garza, 2011, p. 4).  If the plaintiffs could prove a causal link between the use of Vioxx and the direct result of Garza’s heart attack, a plausible case could make that would support the idea that Vioxx was responsible for the death of the plaintiff’s family member. 

The family attempted to prove “specific causation” by bringing in testimony of Dr. Americo Simonini, “who opined that Vioxx caused Mr. Garza’s heart attack” in that, since Garza’s “cardiac status was stable” prior to the administration  of Vioxx, the development of two blood clots within such a short time must be the result of the medication (Merck, 2011, pg. 5). However, the Texas Supreme Court agreed with the lower court ruling that the Garza family did not present adequate scientific evidence that the clots were particularly unusual for an individual like Garza, a man who had a long history of poor health and consciously chose to smoke, not engage in exercise, and continue living an unhealthy lifestyle. Moreover, the Court found that the Garzas had not offered proper scientific evidence that Vioxx use for the short period in which Garza was administered the drug could be responsible for the formation of blood clots. Despite the lack of evidence, the lower Texas state trial court returned a jury vote that sided with the plaintiffs, which Merck promptly appealed. The appeal reversed the lower court ruling and sided against the plaintiffs, who then appealed that ruling, which was then decided in favor of the plaintiffs. The case was then taken for review by the Texas State Supreme Court. 

The lawsuit was resolved in favor of Merck, which reversed the Court of Appeals earlier ruling. Arguing that the precedent case of Merrell Dow Pharmaceuticals, Inc. v. Havner, which held that “a causation opinion based on epidemiological evidence is scientifically reliable only when supported by at least two statistically significant studies demonstrating that a substance more than doubles the risk of injury at issue at the plaintiff’s dose and duration”, the Supreme Court maintained that the Garzas had failed all accounts to provide such evidence and that the lower courts had, in fact, ignored the FDA’s conclusions based on the same evidence (Merck, 2011, p. 6). The claims by the Garza family that Vioxx more than doubled the risk of heart attack were not justified by scientific evidence, and the Court made a specific point to state that “a plaintiff cannot prove causation by presenting different types of unreliable evidence” (Merck, 2011, p. 9). Thus, the lawsuit was decided in favor of Merck. 

I agree with the decision in the case. The Garza family attempted to include extrapolative evidence as justification for the death of their family member, which is scientifically and logically unsound, as one cannot justify the death of Garza based on studies that have widely different doses and durations of treatment. Moreover, the claims that Merck had deliberately misled the public about the dangers of Vioxx are, though somewhat grounded in reality, nonetheless insufficient to afford legal blame for the death of Garza. The medication clearly stressed the danger of cardiovascular strain and the approval of the drug by the FDA found no substantive evidence that prescribed use of Vioxx presented a more that acceptable level of risk. Furthermore, I agree with the decision in the case in that the tightening of the rules of applying epidemiological evidence is something I approve of, as the inclusion of scientific evidence in favor of the plaintiff would constitute an improper application of only marginally related studies that would cloud and pollute the correct ruling in the case. 

Describe the changes that have taken place in the company to ensure greater safety of this product or its products

As a medication, Vioxx has been removed from the market starting in 2004. The removal of the drug for public consumption or prescription use is the primary change made by the company to ensure greater safety of its product line, as there no other effective options with regards to the safety results of a potentially harmful drug. Merck reports increased efforts at screening future medications for dangerous side effects and potential elevation of particular health markers such as heart disease, but the company’s insistence that Vioxx is a drug safe for public consumption has been reinforced in the Martin Report, a document assembled in 2005 by Debevoise & Plimpton LLP to address concerns about the marketing and development of Vioxx. More recently, Merck plead guilty to a federal charge of marketing across interstate lines and with the U.S. Attorney’s Office to avoid further civil litigation. The cost of these lawsuits approaches nearly $1 billion

Discuss which regulatory agency oversees the particular industry the company is in

The Food and Drug Administration is the primary regulatory agency that oversees the industry in which Merck is involved in. As a federal agency, the FDA has complete control over the proper authorization and testing of all medications issued in the United States (Pitts, 2008, p. 515). While the FDA mandates the testing requirements and has the power to order withdrawals of drugs, it is important to note that Merck initially removed Vioxx from purchase by the public as a voluntary measure and not as federally mandated command. Moreover, the FDA, as Pitts (2008) points out, has an incredibly length bureaucratic backlog as a result of inefficacies and redundancies, though the need to guarantee that medications are safe for public use outweighs the cost of time delays on approving new drugs. 

Make recommendations to the company about avoiding future lawsuits

Avoiding future lawsuits is something Merck will find easier in the future, given the lessons it learned from Vioxx. First, Merck would do well to avoid stating in any explicit terms the need to falsify or mislead the public with regards to the safety of its product. By keeping incriminating documents, internal memos, and emails that discuss plans by company executives fully cognizant of the dangers of their product, and their subsequent refusal to take action in the name of profit, the company runs the risk of future lawsuits that will have substantial amounts of evidence to support the plaintiffs. Secondly, Merck should commence better and more thorough testing of its medication and ensure that patients do not run the risk of hidden dangers, as seen with Vioxx. Though Vioxx was labeled as being known to have caused increased heart disease, Merck could have avoided a great deal of civil litigation and saved immense sums of money if it had clearly stated the dangers of the medication and not have attempted to lie and manipulate its marketing campaign into presenting an unfair and imbalanced approach to the drug. Thus, I argue that Merck can avoid future lawsuits if it maintains better security and awareness of its own internal communications, as well as guaranteeing the safety of its product through more rigorous internal testing. Lastly, by stressing the importance of safety and transparent marketing, Merck can avoid lawsuits in the future by removing the ability of plaintiffs to claim damages based on misinformation, misrepresentation of facts, and potentially harmful product.

References

Ludwig, J. (2011). Merck & C. v. Reynolds: Sarbanes-Oxley's Perplexing Statute of Limitations. Loyola Of Los Angeles Law Review, 44(3), 1133-1144.

Merck & Co. v. Reynolds: Sarbanes-Oxley's Perplexing Statute Of Limitations. (2011).

Merck & Co., Inc., et al. v. Reynolds et al.. (n.d.). FindLaw: Cases and Codes. Retrieved June 13, 2013, from http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=US&vol=000&invol=08-905

Merck & Co., Inc., et al. v. Garza et al. (2011, August 28). Petition for Review. Retrieved June 11, 2013 www.supreme.courts.state.tx.us/ebriefs/09/09007304App.pdf

Pitts, P. J. (2008). FDA and the Critical Path to Twenty-first-century Medicine. Journal of Medicine & Philosophy, 33(5), 515-523. 

Pringle, Evelyn. “FDA Shields Drug Companies from Lawsuits”. March 1, 2006. http://www.opednews.com/articles/genera_evelyn_p_060301_fda_shields_drug_com

Russo, A. (2012). The Aftermath of Merck: D&O Insecurity in the Security Fraud Arena. Pace Law Review, 32(1), 217-238.