A budding class action suit seeking $5 million in damages for a similar recall could have a significant impact on what the big pharmaceutical firm pays out.
Pharmaceutical giant Pfizer recently announced it's recalling one million packets of birth control medication because it mixed up the order of the hormone-containing pills with placebos during packaging, putting an unknown number of women at risk for unintended pregnancies. While news of this error spread quickly, the question of Pfizer's liability in this incident and how it delayed to notify the public has received scant attention.
* * *
If women end up pregnant because of this production debacle, what is Pfizer's legal responsibility? The cost of terminating the pregnancy or carrying the child to term? Physical and mental health issues related to the pregnancy? Rearing the child? Adverse outcomes during childbirth? Or are corporations such as Pfizer shielded by the law from facing substantive damages?
In interviews with legal experts in reproductive rights and product liability, and an examination of related case law, we have found that the answer to this question is largely determined by the state in which a potential defendant resides.
About three-quarters of the states in this country recognize "wrongful pregnancy," also known as "wrongful conception," in which damages can be recovered for use of faulty contraception or a failed sterilization. But recoverable damages in such cases vary from state to state.
The most common allowable damages in wrongful pregnancy cases cover the expense of the pregnancy and childbirth, which can also include related costs such as mental or physical injury and loss of wages. A much smaller fraction of the states that recognize wrongful pregnancy permit for damages that include the cost of rearing the child, but this is offset by what the courts deem as the value of having a healthy child.
Only a few states allow for the full damage rule in wrongful pregnancy cases, which says that all damages caused by the injurious act are recoverable, including the cost of raising and educating a child without being offset by the emotional benefits of having a healthy child.
Recovering the cost of an abortion, however, is generally not sought in a wrongful pregnancy suit because the expense of going to trial would exceed that of the procedure. And in "wrongful birth" cases -- in which medical professionals failed to detect or tell the patient that the fetus showed some kind of anomaly that led to a birth defect -- liability would fall to the physician or hospital but almost certainly not to the distributor of the negligent birth control.
Legal experts also pointed out that the right for women to bring wrongful pregnancy lawsuits is still in its relative infancy, so to speak, going back only a few decades. And the majority of these cases have been due to failed sterilization procedures, such as a tubal ligation that afterward still led to pregnancy.
It once was the case -- and still is in about a quarter of the states -- that the emotional and spiritual benefits of having a child trumped any negligent act, such as failed contraception or sterilization, which led to an unintended pregnancy.
But while these wrongful pregnancy lawsuits are now recognized in the majority of states in this country, they remain the only type of tort -- civil cases in which damages can be sought by an injured party for a wrongful act -- in which the plaintiff is not guaranteed the right to seek damages for all related injuries.
Caitlin Borgmann, CUNY law professor and reproductive rights expert, said that by not allowing recovery for the costs of raising a child, the vast majority of courts are just carving out this one area and cutting off this source of recovery. "There's something about pregnancy that makes courts want to treat it differently," she said. "Normally, if someone causes you a harm that's recognized in law as a tort -- if they did it negligently, not intentionally -- then they're responsible for anything foreseeable resulting from that conduct."
Historically, with regards to cases of wrongful pregnancy, the courts argued that this would be speculation. But today, Borgmann said, the arguments against this view are much more convincing. She pointed out that not only is it now a self-evident fact that raising a child is incredibly expensive, it's especially persuasive if the injured party was using the contraception in the first place because they couldn't afford to have a child.
Borgmann and other legal experts only found one precedent directly involving birth control pills that led to an unintended pregnancy, Troppi vs. Scarf, a 1971 case in which a pharmacist accidentally filled a birth control pill prescription with tranquilizers. Originally the judge dismissed the case, ruling the benefits of the child far outweighed the damages. But the plaintiffs, who already had seven children, won on appeal and were awarded damages that included the cost of rearing the child, but which were offset by the benefits of parenthood.
But a budding class action lawsuit against another pharmaceutical company, which recently recalled birth control pills for the same type of packaging defect as seen in the Pfizer recall, might have a significant impact on what Pfizer could be liable for in the future.
* * *
In September 2011, Qualitest Pharmaceuticals issued a recall of 1.4 million birth control pills that, as with the Pfizer recall, had been packaged in the wrong order, misplacing the placebos and the pills containing hormones.
Two weeks later, a proposed nationwide class-action lawsuit was filed, with Lauren Betancourt as the first plaintiff to be named in the complaint. Betancourt claims the defectively packaged pills led to her pregnancy.
The class action is seeking more than $5 million in damages. According to the complaint (available in full here), "the plaintiff is pregnant and she has suffered and may suffer bodily injury resulting in pain and suffering, mental anguish, loss of capacity for the enjoyment of life, expensive health care and treatment, loss of earnings, and a loss of ability to earn money."
Attorney Keith Bodoh, lead counsel on this class action, told us that since the initial court filing many other women have joined the suit, with so far about 70 in total, and he keeps receiving new calls every day. Bodoh, and his co-counsel attorney Steve Beard, are now representing clients across the country, including women in California, Texas, Kentucky, North Carolina, South Carolina, Florida, Michigan, New York, Nevada, Washington, and Oregon.
He noted that over 200 women have contacted him and over 98 percent of them claim they are pregnant because of Qualitest's defective packaging. "So it's a serious blunder," he said. "It wasn't just one or two here or there. It looks to me, based on the telephone calls that I've received, that there are maybe thousands of people that are pregnant because of this with Qualitest."
Several women have already contacted Bodoh regarding the Pfizer birth control recall, but he said that it's too early in the process to assess how many people may be affected.
Bodoh filed his nationwide class action against Qualitest in Georgia, where he practices, but other proposed class actions against Qualitest are also popping up in different parts of the country, including California and Texas.
Bodoh called the stories of his clients affected by Qualitest's defective packaging "heart-wrenching." He described one client in the military who will have to give up her baby for adoption because she was getting ready to be deployed. He noted as well that there are 17-year-olds who became pregnant, other women who had to drop out of law school and nursing school, and another client in Oregon who's pregnant with twins. (Fortunately for that client, Bodoh pointed out, Oregon happens to be one of the few states in the country where the cost of rearing the child is recoverable.)
"The lives of these people have just been turned upside-down because of this," he said.
A few of Bodoh's clients, he said, have already had the children after becoming pregnant because of the Qualitest defect. According to his research, while the Qualitest recall was announced in September 2011, some of the birth control pills may have been on shelves for up to ten months before Qualitest figured out that there was defective packaging.
"When they sell the pills to the public, they're supposed to have adequate safety measures in place so that no defective products reach the shelf," Bodoh said. "But it makes it more egregious when you learn that the products were on the shelf for at least 10 months in some cases."
This kind of negligent response time is another alarming similarity between the Qualitest and Pfizer birth control recalls.
* * *
Pfizer not only took as long as a year before realizing the packaging defect in its birth control pills -- which a customer had to point out to them -- but it also waited a month to notify the public that a recall had been issued, we confirmed with the Food and Drug Administration (FDA).
According to FDA spokeswoman Shelly Burgess, who tracked down the dates after we put in a request, the defective birth control packets were distributed to pharmacies between January 1, 2011, and December 28, 2011.
Pfizer, with the FDA's knowledge, issued the voluntary recall in late December of 2011. On January 31, 2012, one month later, it sent out a press release notifying consumers and the media. When we first asked the FDA about these dates, the agency said that it had no idea how long these pills had sat on the shelves and that only Pfizer would have that information.
It's important to note that, with the exception of limited recall authority for devices, the FDA does not have the authority to require companies to issue a recall. Rather, the FDA only has the power to advise a company to perform a recall and, if rebuffed, it could threaten seizure of the product.
What might be even more surprising is that the FDA doesn't even have the authority to require a company like Pfizer to notify the public once a recall has been issued. Again, it can only advise the company to alert the public. Yet in the case of Pfizer's voluntary birth control recall, the FDA failed to advise Pfizer to notify consumers and the media until a month after the recall had been issued.
When we asked Burgess of the FDA why the agency waited so long, she replied in an email: The "FDA evaluates the information associated to a recall submitted by a company to assure a recall is addressed adequately. After this evaluation and requesting additional information FDA determined that press was appropriate in this situation."
"That doesn't make any sense," said Dr. Sidney Wolfe, director of the Health Research Group at the non-profit watchdog Public Citizen. "The recall is either valid or not. If it's valid, the FDA should be doing whatever they can to announce it. It's inexcusable and it's a betrayal of the fact that the FDA is a part of the public health service."
George W. Conk, an adjunct professor at Fordham University School of Law and a products liability expert, agreed that both the FDA and Pfizer should have acted sooner to alert the public "because it would've had an immediate effect."
Asked why Pfizer waited a month after the recall to alert consumers and the media, Kristen Neese, the company's senior director of corporate communications and external affairs, responded via email. Pfizer "acted promptly, and at all times appropriately" to execute the recall "based on the very low level of the defect and our health hazard assessment, which indicated a low risk to patient safety," she said.
But public health and product liability experts noted that while these pills didn't contain dangerous, life-threatening chemicals, women who may become pregnant as a result probably won't find this defect "low level" or the effects on their bodies, psyches, and lives merely "low risk."
"If it's so low risk, why did they even recall it?" Wolfe said. "There is some risk for obvious reasons, and that's not really an acceptable excuse for delaying the notification." He added: "A preventable pregnancy because someone was too sloppy on the quality control side to put the pills in the right sequence -- that to me is an arrogant judgment to say that's low risk."
Based on its own internal investigation -- or more precisely "statistical sampling," as Neese called it -- Pfizer has also claimed that only about 30 of these one million recalled birth control packets may have been defective.
Asked why Pfizer would recall one million packets if it thought that only about 30 were affected, Neese responded, "Because of our high quality standards, should we identify even one package that does not meet our high standards, we will voluntarily recall the entire lot."
Keith Bodoh of the Qualitest class action found this hard to believe. "If there were only 30 packets that had the defective packaging," Bodoh said, "then you might recall maybe 100, or maybe 1,000, but to recall one million ... it doesn't ring true to me."
Wolfe, who co-founded the Health Research Group with Ralph Nader in 1971 and has served as a prominent FDA watchdog for 40 years, didn't buy Pfizer's explanation either. "If they knew when it happened, they could in a more surgical way say, 'We're gonna, with a safety margin, recall the ones that were affected,'" he explained. "They obviously don't have a clue and if they don't have a clue, how do they know that it's only 30? It's a contradictory piece of thinking."
Wolfe also pointed out that of all criminal and civil penalties paid by drug companies in this country over the last 20 years, Pfizer ranks toward the top, and about half to two-thirds of these penalties have been in just the last five years.
"There's a huge rash of illegal activity, repeated illegal activity, to try and keep their piece of the market or keep their margin as high as it is," he said. "And you can't say that that's not one of the pieces of thinking here."
Images: 1. Brendan McDermin/Reuters; 2. Francois Lenoir/Reuters.
