Pfizer Could Face Lawsuits Over Birth Control Pill Recall

Pfizer, maker of 1 million recently recalled birth control pill packages, could be facing lawsuits. A packaging problem could cause women to take an inadequate dose of their birth control pills, increasing risks for accidental pregnancy.

According to experts familiar with the matter, women who become pregnant after taking the defective birth control pills could sue Pfizer for their unwanted pregnancies, and could sue big, wrote My Health News Daily.

Traditionally, said I. Glenn Cohen, assistant professor and co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, courts view these types of wrongful pregnancy cases in much the same way as they do medical malpractice, said My Health News Daily. For instance, people have been able to sue for unwanted pregnancies following botched vasectomies; one case involved a woman who successfully sued a pharmacist for her pregnancy resulting from errors in filling her birth control prescriptions, said Cohen.

Arthur Caplan, a bioethicist at the University of Pennsylvania, said that consumers’ best option would be to join in a class action lawsuit against Pfizer, which would enable the group to ask for significantly more money than in individual cases, and which would also be more attractive to attorneys. “I’m sure some enterprising lawyer is already thinking of bringing a class-action lawsuit … against the company,” Cohen said, wrote My Health News Daily. A class action also offers anonymity to individual children who should not learn that their only reason for existence was a defective pill, noted Caplan, who added, “Judges and juries don’t tend to want to say ‘You’d be better off if you didn’t exist,’” said My Health News Daily.

Awards depend on location. Cohen noted that 32 states recognize “wrongful pregnancy cases,” in which a healthy baby is born from an unwanted pregnancy. Most, said Cohen, allow damages related to the cost of the pregnancy; some consider emotional distress and lost time from work, and some allow for economic expenses related to raising the child for 18 years, which can translate into hundreds of thousands of dollars per case. Should such a class action be filed, “that’s a lot of money,” Cohen said, wrote My Health News Daily. Giving birth to an unhealthy baby due to the defective drugs could result in a “wrongful birth” lawsuit, wrote My Health News Daily.

A total of 14 lots each of Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets were involved; both are manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products under the Akrimax Pharmaceuticals brand. The recall followed Pfizer’s discovery that some packets contained too many, and others too few, of the active tablets. The packages should contain 21 active and 7 inactive sugar pills that, when taken correctly, regulate menstruation and provide contraception.

Pfizer said the issue was the result of mechanical and visual inspection failures that occurred on the packaging line, a problem Pfizer says has since been corrected. The recalled packages bear expiration dates from July 31, 2013 through March 31, 2014 and were distributed to warehouses, clinics, and retail pharmacies in the United States. The products are packaged in blister packs.

The U.S. Food and Drug Administration (FDA) stressed that the packaging error can impact the daily regimen for these oral contraceptives, rendering the regimen incorrect and leaving women with inadequate contraception protection. Patients in possession of the recalled birth control should utilize another form of birth control and notify their physicians.