Apotex sued over problems on contraceptive packaging line

The recall last month of Alysena 28 birth control pills by generic drugmaker Apotex was the most recent in a series of manufacturing issues faced by the Canadian drugmaker. But the mistake has given birth to an $800 million lawsuit only 6 weeks after the company said it put too many placebos in more than half a million packages of contraceptives.

Forty-five women are seeking $800 million (U.S. $778.8 million) in a class-action lawsuit filed Friday, claiming a packaging foul-up by Apotex led them to take placebos instead of the active birth control pills. Four of them had abortions, according to the Agence France-Presse. "Raising a child today costs millions of dollars," Sandy Zaitzeff, a lawyer for the women, told the news service. "In this modern world, people enter into relationships and don't necessarily want to have a child and so should not be burdened with the costs of raising a child."

Elie Betito, director of public and government affairs for Apotex, said today, "It is a legal matter so unfortunately, there is nothing we can say."

Last month Health Canada issued an alert for the Alysena 28 birth control pills made by Apotex after it was discovered that some packages contained 14 active contraceptive pills and 14 placebos instead of the 21 active and 7 placebos that they should contain. Apotex has encountered troubles with the FDA for a number of years. In March, the agency issued a warning letter to two Apotex plants in Canada, noting that some of the problems had come up in previous inspections. In 2011, the FDA lifted an import ban against Apotex that had been in place for about two years for problems outlined in warning letters issued in 2009 and 2010. Apotex had complained to international authorities that the ban violated the North American Free Trade Act.

But Apotex is not the only company to have problems with packaging contraceptives. Endo Health Solutions has been sued by a number of women who got pregnant when that company got birth control pills and placebos out of order in 2011. And other companies, including Novartis' ($NVS) Sandoz unit, Pfizer ($PFE), and Glenmark Pharmaceuticals, have all had to recall contraceptives for similar packaging problems.

- read the Agence France-Presse story