Suit: 113 pregnancies after birth control pill mix-up

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A 2011 FDA recall of Endo birth control pills was triggered by blister packs rotated 180 degrees, reversing the weekly tablet orientation.

More than 100 women who became pregnant after allegedly taking mispackaged birth control pills filed suit in Philadelphia last week against Qualitest Inc., a subsidiary of the Irish drug-maker Endo Pharmaceuticals Inc., which has its U.S. headquarters in Malvern.

The case seeks millions in damages, including in some cases the costs of delivering, raising, and educating the children borne of the unplanned pregnancies.

The discovery of the mispackaged contraceptives prompted the FDA in 2011 to issue a recall notice for 3.2 million blister packs, according to court filings.

The suit in Philadelphia Court of Common Pleas also names Vintage Pharmaceuticals LLC, Endo Health Solutions Inc., and Patheon Inc., which either made or packaged the recalled contraceptives.

Representatives for Endo and Patheon, citing the litigation, declined to comment.

After lawyers in Atlanta originally sought class-action status for potential victims, a federal judge in Georgia rejected their request Nov. 4. Lawyers for the women refiled in state court in Pennsylvania, where Endo has its U.S. headquarters.

The FDA recall was triggered when a Kansas City woman returned a package to her pharmacist after noticing the blister pack had been rotated 180 degrees, reversing the weekly tablet orientation, according to the suit filed in Philadelphia Court of Common Pleas.

With the order reversed, a woman's chances of getting pregnant skyrocket.

Keith Bodoh, the lead attorney on the case based in Atlanta, declined to comment on the case, as did co-counsel Walter Z. Steinman of Wyncote.

In a 2012 interview with the Atlantic, Bodoh described the defective packaging as "a serious blunder" and the repercussions "heart-wrenching."

Bodoh told the magazine that one client in the military gave her child up for adoption because she was getting ready to be deployed. Other clients were forced to drop out of law school and nursing school. At least two 17-year-olds became pregnant and another client was due to have twins. One of the women lived in central Pennsylvania.

According to the court order issued in Georgia on Nov. 4, Bodoh represents 117 women from 26 states. Of Bodoh's clients, 113 became pregnant and 94 carried their babies to term.

The birth control trademarks named in the suit include Cyclafem 1/35, Cyclafem 7/7/7, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem. There is no evidence that the packaging problem has recurred.

Editor's Note: This story was revised to reflect that the suit was refiled in state court in Pennsylvania, not the Eastern District of Pennsylvania, which is a federal designation.

samwood@phillynews.com

215-854-2796 @samwoodiii

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