Lawsuits Allege Birth Control Patch Causes Harmful Blood Clots

On March 1, 2006 U.S. District Judge David A. Katz, of the Northern District of Ohio, was selected to oversee the federal court Ortho Evra Multidistrict Litigation (MDL).  See In re Ortho Evra Products Liability Litigation, No. MDL-1742, 2006 WL 538724, transfer order issued (J.P.M.L. Mar. 1, 2006). 

Judge Katz, who holds court in Toledo, Ohio, is already handling the first federal court lawsuit filed concerning an injury caused by the birth control skin patch called Ortho Evra; that case is called Bernard v. Ortho-McNeil Pharmaceuticals.  With this MDL assignment, Judge Katz is now in charge of overseeing consolidated pretrial proceedings in all of the current 67 federal court lawsuits that have been filed against Ortho-McNeil regarding its Ortho Evra contraceptive patch.

These Ortho Evra cases generally allege that the Ortho Evra patch was defectively designed.  Furthermore, plaintiffs allege that Ortho-McNeil inadequately warned doctors and patients of harmful blood clots — possibly resulting in pulmonary embolisms, heart attacks, and strokes — that have been associated with use of the Ortho Evra birth control patch.  The typical lawsuit includes various different legal liability theories such as negligence, breach of warranty, and misrepresentation regarding the risks of serious side effects.  Late in 2005, a motion was filed with the Judicial Panel on Multidistrict Litigation (JPML) by a plaintiff’s lawyer requesting the consolidation of all federal court lawsuits alleging injury or death due to use of the Ortho Evra birth control patch.

The Ortho Evra skin patch combines a progestin, norelgestromin, and an estrogen, ethinyl estradiol, in a transdermal delivery system.  Based on reports made to the FDA MedWatch program, the Ortho Evra patch has been linked to an increased risk of pulmonary embolism, heart attack, and stroke in women, especially those who smoke cigarettes or who are more than 35 years-old.

In November 2005 the FDA ordered Ortho-McNeil to put a bolded warning on the Ortho Evra label, or package insert, to inform doctors and patients that the Ortho Evra patch exposes users to estrogen levels some 60 percent greater than found in a typical oral contraceptive, or birth control pill. In turn, it is this increased dosage of estrogen that is associated with the increased risk of developing harmful blood clots.

(Posted by: Tom Lamb)