A month’s supply of diapers: $100. A month’s supply of formula: $125. Crib: $150.
When you take a look at the numbers, babies are expensive. The U.S. Department of Agriculture estimates that a typical middle-income family will spend $226,920 to raise a child born in 2010 from birth to age 18. The approximation doesn’t include the cost of college, either.
For parents who are unprepared, for whatever reason, to assume these costs, having a child can be financially and emotionally stressful. One such woman, Lauren Betancourt, unexpectedly became pregnant despite the fact that she regularly took birth control pills.
Betancourt sued birth control pill manufacturer Qualitest Products Inc. over her unintended pregnancy two weeks after the company announced a voluntary nationwide product recall of 1.4 million packages of pills. According to a press release from Qualitest, packages for eight brands of its oral contraceptive products were misaligned during production, meaning pills were placed out of order. Women who took the medication may have taken placebo pills on days they should’ve been taking active pills, leaving them at risk for becoming pregnant.
Although the company issued a recall as soon as it discovered the problem, the notice didn’t come quickly enough for Betancourt, who claims she became pregnant because of the manufacturing error. She is seeking more than $5 million in damages and is pursuing class certification.
Nicole Nehama Auerbach, a partner at Valorem Law Group, finds Betancourt’s lawsuit interesting because it focuses on the pill packaging rather than the pills. “It’s not that often that you actually see a package being dangerous in and of itself as opposed to the product being dangerous,” she says.
Betancourt filed a wrongful pregnancy lawsuit, also called a wrongful conception lawsuit, against Qualitest. This type of suit is one of three common unintended pregnancy suits.
In a wrongful birth lawsuit, parents sue a doctor, geneticist or hospital for allegedly failing to perform adequate tests in order to diagnose or prevent a birth defect.
“The parents are basically saying that if they had found out about this horrible birth defect, they would’ve terminated the pregnancy,” explains Lauren Tulli, a member at Cozen O’Connor.
Parents also can bring a wrongful life lawsuit on behalf of their child.
“The presumption is the same: ‘Had my parents known that I was going to have these horrible deformities, I wouldn’t have been born, so my life is wrong,’” Tulli says.
Wrongful pregnancy lawsuits are less morally controversial. They allege a medical provider performed a sterilization procedure that didn’t work and made conception possible. In Betancourt’s case, she claims Qualitest’s error caused her to conceive.
Almost all courts have said that, unlike plaintiffs in wrongful birth and wrongful life cases, plaintiffs in wrongful pregnancy cases cannot recover the costs of raising unwanted but healthy children through the age of 18. They can only obtain damages for pre-birth costs, such as pain and suffering related to pregnancy and labor, time off work, prenatal medical costs and the cost of the failed contraceptive measure.
“The claim is that a healthy child is a blessing, so you can’t recover for that,” Auerbach says. “To me, that’s a fascinating concept. I have three boys of my own, and each one is a blessing on many days—but they’re expensive. It’s one thing if you planned for your baby, but it’s another if somebody negligently caused you to get pregnant.”
Auerbach says she knows of just one exception to this widely held stance among the courts. In 1982, the Supreme Court of Connecticut ruled in Ochs v. Borrelli that parents who conceived after a failed sterilization procedure could recover pre-birth damages as well as damages for raising their unwanted child through the age of 18. The court reasoned that although the defendants in the case asserted that public policy required the court to hold that the birth of a healthy child is a blessing and should offset financial burdens associated with raising the child, “public policy cannot support an exception to tort liability when the impact of such an exception would impair the exercise of a constitutionally protected right.” In this case, the parents had a constitutionally protected right to use contraception to limit the size of their family.
Although Betancourt, who decided not to terminate her unwanted pregnancy, could cite Ochs v. Borrelli in her case, experts say the courts’ mostly uniform stance on damages in wrongful pregnancy cases indicates it isn’t likely that Qualitest will have to pay Betancourt or other potential class members’ damages related to raising their children through their teenage years. The company also may be able to limit the damages it must pay because of its swift, Food and Drug Administration-compliant recall.
Pharmaceutical industry lawyers agree it’s important for drug manufacturers and other consumer products companies to establish recall plans of action.
“When a company faces a recall that poses significant risk for the patient, you can’t get into a reactive mode—you have to be prepared,” says James Wood, a partner at Reed Smith. “Companies must have a worldwide proactive plan in place so that communications are instantaneous and coordination is done in one place.”
Wood recommends that in-house lawyers study global recall regulations when developing their companies’ recall plans. In particular, they should focus on rules and guidelines issued by the FDA, the World Health Organization, the European Union and Canada.
“Then you’re ready to conduct a recall anywhere in the world and get the product back very quickly,” Wood says.
Experts stress that it’s in companies’ best interest to partner with the FDA when conducting recalls. The FDA has a guidance document called “Guidance for Industry: Product Recalls, Including Removals and Corrections,” which is a step-by-step recall procedure the agency endorses.
“The FDA really spells it out for companies as to how to proceed through this recall process,” Tulli says. She notes that the FDA will even draft press releases for companies, like the one Qualitest issued, to ensure the recall happens properly and speedily. Additionally, following the process “will prevent the FDA from coming at companies with regulatory offenses,” Tulli says.
General counsel mustn’t forget about other internal duties during a recall. For instance, they should be closely involved in public relations efforts.
“There has to be very quick action on the part of GCs to make sure they completely understand what the facts are before getting misinformation out into the public,” Auerbach says. “There needs to be coordination within the company at the highest levels to open as many lines of communications as necessary for the public to understand the issue and take the appropriate action.”
Additionally, GCs should ensure employees retain all documents in case of litigation, inform insurance companies about the error and recall, report the incident to the board and consult with outside counsel.
Finally, it’s important to have outside consultants evaluate the company’s quality control processes to avoid future problems.
“The minute that you lose quality control in a substance that is being ingested by humans, the ramifications are obvious and can cause huge amounts of liability, and potentially even cost the company itself,” Auerbach says. “Consultants must determine what happened, how it happened, why it happened, whether there is internal responsibility, and whether there needs to be personnel or processing changes.”
Companies also should adhere to the FDA’s Current Good Manufacturing Practices (cGMPs), which ensure drugs are manufactured in a safe and effective manner.
“By way of best practices, a company like Qualitest is best served to follow these cGMPs because that’s going to be their first line of defense—‘We’ve been compliant all this way, our facility is in good condition, our equipment is well-maintained and we have all of the proper quality control processes in place,’” Tulli says.