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Lawsuit over Evra contraception patch settled

-CTV.ca

02/28/2009- Janssen-Ortho Inc. has agreed to settle a class-action lawsuit started by Canadian women who claimed they were injured by the Evra contraceptive skin patch.

The women alleged that Janssen-Ortho failed to adequately warn them and their doctors about Evra's association with an increased risk of developing blood clots, pulmonary embolisms, strokes, heart attacks and deep vein thrombosis.

On Friday, Janssen-Ortho agreed to settle the claims on an individual basis, without admitting liability. They are also prepared to settle any other valid claims that are brought forward.

Michael Peerless, a partner at Siskinds, LLP, the law firm that handled the class action, said: "Janssen-Ortho Inc. should be commended for taking proactive steps at resolving individual claims and not dragging their heels or these claimants through a long, drawn-out litigation process."

Evra was first approved for marketing and sale in Canada as a contraceptive in 2002.

Since then, at least 16 cases of blood clots and one heart attack among users have been reported. Two patients died, including a 16-year-old girl, according to Health Canada.

Janssen-Ortho released new safety information about Evra in November 2006 through Health Canada. The statement said women wearing the patch should avoid saunas and whirlpool baths, due to a "theoretical risk of unintentional increase in estrogen exposure from the patch."

It added that the patch should be discontinued at the earliest sign of blood clots, including pain in the calf, shortness of breath, chest pain or coughing blood.

Janssen-Ortho noted the results of a U.S. study indicated that women using the patch had an increased risk of blood clots in the legs and lungs compared to women using an oral contraceptive. Another study, however, indicated no difference in the risk of these blood clots.

The statement noted that the version of Evra marketed in Canada is manufactured differently and contains less estrogen than the U.S. product, Ortho-Evra.

In November, 2006, a group of 43 U.S. women sued Ortho-McNeil Pharmaceutical Co. (a subsidiary of Johnson & Johnson), alleging they suffered blood clots and other health woes after being placed on Ortho-Evra. That legal action is ongoing.

Janssen-Ortho maintains that the use of any combination hormonal contraceptives, whether in pill or patch form, is associated with increased risks of serious conditions including blood clots.

The risk of adverse events is small in healthy women but increases significantly if associated with the presence of other risk factors such as obesity, or cigarette smoking, the company says.

One of the Canadian women who died while using the patch was a "heavy" woman and a smoker in her early 30s, the adverse reaction report said.

The other person who died was a 16-year-old girl, who began using the patch shortly after delivering a baby by caesarean. The product insert warns that women "should be encouraged to use" a non-hormonal form of contraception in the three months following delivery.

If you or someone you love has used the Ortho Evra Birth Control Patch and has experienced side effects such as: heart attack, stroke, blood clots, or deep vein thrombosis (DVT) you need to know your legal rights. Call our Ortho Evra side effects lawyers for a free legal consultation or to ask questions about a possible Ortho Evra lawsuit or Ortho Evra recall.