The Complex Legacy of Boivin v. Merrell Dow Pharmaceuticals: A $7.5 Million Settlement and the Bendectin Controversy
In 1992, the case of Boivin v. Merrell Dow Pharmaceuticals resulted in a $7.5 million settlement for birth defects allegedly caused by the drug Bendectin. This case is a significant part of the broader, decades-long controversy surrounding Bendectin, a medication prescribed to pregnant women for morning sickness. While this settlement might suggest a clear link between the drug and birth defects, the reality is far more nuanced. Understanding the full context of this case requires exploring the history of Bendectin, the scientific evidence (or lack thereof) linking it to birth defects, and the legal battles that ensued.
Bendectin: A History of Hope and Controversy
Bendectin was introduced in 1956 as a treatment for nausea and vomiting during pregnancy, commonly known as morning sickness. It was a combination of doxylamine succinate (an antihistamine), pyridoxine hydrochloride (vitamin B6), and, originally, dicyclomine (an antispasmodic). The formulation changed over time, but the drug remained a popular choice for pregnant women seeking relief.
However, in the late 1970s, concerns began to surface regarding a potential link between Bendectin and birth defects. These concerns led to a wave of lawsuits against Merrell Dow Pharmaceuticals, the manufacturer of Bendectin. Despite numerous studies failing to establish a definitive causal relationship, the legal challenges and negative publicity led Merrell Dow to voluntarily withdraw Bendectin from the market in 1983. The cost of insurance almost equaled the entire income from the sale of the drug.
The Science (or Lack Thereof) Behind the Claims
It’s crucial to understand that, despite the numerous lawsuits and settlements, the overwhelming scientific consensus is that Bendectin does not cause birth defects. Meta-analyses of numerous cohort and case-control studies have found no statistically significant association between Bendectin exposure during the first trimester of pregnancy and an increased risk of congenital malformations.
One meta-analysis examined 16 cohort and 11 case-control studies, estimating the relative risk of malformation at birth associated with Bendectin exposure. The analysis revealed a pooled estimate of the relative risk of any malformation at birth in association with exposure to Bendectin in the first trimester was 0.95 (95% Cl 0.88 to 1.04). Separate analyses were undertaken for cardiac defects, central nervous system defects, neural tube defects, limb reductions, oral clefts, and genital tract malformations. In these categories, the pooled estimates of relative risk ranged from 0.81 for oral clefts to 1.11 for limb reductions, with all 95% confidence intervals enclosing unity. This means that the data did not support a link between Bendectin and birth defects.
Boivin v. Merrell Dow: A Closer Look
Given the scientific evidence, the $7.5 million settlement in Boivin v. Merrell Dow Pharmaceuticals might seem surprising. It’s important to remember that settlements don’t necessarily indicate guilt or causation. They can be strategic decisions made by companies to avoid the high costs and risks associated with protracted litigation.
Several factors could have contributed to the settlement in the Boivin case:
- The cost of defense: Defending against lawsuits, especially those involving complex scientific and medical issues, can be incredibly expensive.
- Public relations concerns: Negative publicity surrounding the lawsuits could damage Merrell Dow’s reputation, regardless of the scientific evidence.
- Uncertainty of jury outcomes: Jury decisions can be unpredictable, and companies might choose to settle rather than risk a large adverse verdict.
It’s also worth noting that the legal landscape surrounding Bendectin was complex and evolving during this period. Cases like Daubert v. Merrell Dow Pharmaceuticals (1993) significantly impacted how scientific evidence is admitted in court.
Daubert v. Merrell Dow Pharmaceuticals: A Landmark Case
The Daubert case, which went to the Supreme Court, established the Daubert Standard for evaluating the admissibility of scientific evidence in federal courts. This standard requires judges to act as “gatekeepers,” ensuring that scientific evidence is reliable and relevant before it can be presented to a jury. The court held that the enactment of the Federal Rules of Evidence implicitly overturned the Frye standard; the standard that the Court articulated is referred to as the Daubert standard.
The Daubert case itself involved claims that Bendectin caused birth defects. The Supreme Court reversed a lower court decision that had excluded expert testimony supporting the plaintiffs’ claims. However, on remand, the Ninth Circuit Court of Appeals upheld the original grant of summary judgment for Merrell Dow, finding that the plaintiffs’ evidence did not meet the Daubert standard.
The “Tortogen” and the Aftermath
The Bendectin litigation had a chilling effect on the pharmaceutical industry. The term “tortogen” was even coined to describe products that generate litigation but don’t actually cause harm. The Bendectin case highlights the potential for mass tort litigation to drive beneficial drugs off the market, even in the absence of sound scientific evidence of harm.
Interestingly, in 2013, the FDA approved a new drug called Diclegis, which is a reformulated version of Bendectin (doxylamine and pyridoxine). The approval of Diclegis suggests that the FDA, after reviewing the available evidence, considers this combination of drugs to be safe and effective for treating morning sickness.
Statute of Limitations in Birth Defect Cases
It’s important to be aware of the statute of limitations in birth defect cases. The statute of limitations is the time limit within which a lawsuit must be filed. These laws vary significantly by state. For example, in Illinois, a medical malpractice lawsuit must generally be filed within two years from the date of the injury or the date the injury should reasonably have been discovered, with a maximum of four years after the negligent act. However, there are exceptions for minors, allowing them to file a claim up to eight years after the date of injury, but before the age of 22. In California, a lawsuit must be filed within one year of discovering the injury or three years from the date of the injury, whichever comes first. For children, the law generally allows until they are 8 years old to file a lawsuit.
Given the complexities of these cases, it is important to consult with an attorney as soon as possible to ensure that your rights are protected.
Seeking Legal Advice
If you believe that your child’s birth defects may be due to a medication taken during pregnancy or any other form of medical negligence, it is crucial to seek legal advice from an experienced personal injury attorney. A lawyer can evaluate your case, explain your legal options, and help you navigate the complex legal process. They can also help you understand the statute of limitations in your state and ensure that you file your claim within the appropriate timeframe.
While the case of Boivin v. Merrell Dow Pharmaceuticals resulted in a settlement, it is essential to understand the broader context of the Bendectin controversy. The scientific evidence does not support a causal link between Bendectin and birth defects, and the drug has even been reintroduced to the market in a reformulated version. However, if you have concerns about a medication taken during pregnancy and its potential impact on your child’s health, seeking legal and medical advice is always the best course of action.