An oral acne treatment, Diane 35, manufactured by the German drug maker Bayer AG, and declared responsible for four deaths in France, has been cleared for use by the French Health Authority. Sales had been suspended there for eight months due to an inordinately high Diane 35 blood clot risk, but the European Commission declared it safe for use as an acne treatment.

However, Diane 35 has been regularly prescribed by physicians as an oral contraceptive despite not having been approved for that use. This “off-label” use has resulted in tragic consequences around the world.

Danger and risk from Diane 35 reverberates worldwide

A lawsuit was filed in Canada in December, 2013 by the parents of an 18 year old girl who had been using Diane 35 as an acne treatment. Feeling ill, she visited her prescribing physician who found nothing abnormal in her blood work. Despite those findings, she died days later from four cardiac arrests, a pulmonary embolism, and brain hemorrhaging. The suit was filed against Shoppers Drug Mart, a major Canadian prescription service, for failing to warn their daughter about Diane 35’s dangerous side effects. The girl became the thirteenth Canadian woman and the eighth under 21 whose deaths have been unofficially linked to Diane 35.

In Australia, Diane 35 (marketed there under the trade names Brenda 35, Juliet 35, Estelle 35, and Laila 35) continues to be prescribed as an oral contraceptive despite well-documented links to potentially fatal blood clots, or venous thromboembolism (VTE).

These clots usually occur in the leg, and can travel to the lung, where they become dangerous. Despite the Diane 35 blood clot risk, its one of the most common off label prescriptions for contraception because doctors feel it has fewer side effects than alternative birth control prescriptions. However, between 2010 and 2013 in Australia, there have been 61 adverse events including pulmonary embolisms, deep vein thrombosis, and one death.

Yaz and Yasmin blood clot risks spur litigation

Diane 35 is not available for sale in the United States, but Bayer manufactures two oral contraceptives for the US market that are also under fire. Yasmin, approved by the FDA in 2001, has been prescribed to more than 3 million women worldwide, but the product has come under heavy scrutiny lately for its dangerous side effects, prompting numerous ongoing lawsuits. In Canada, 23 deaths have been attributed to Yaz and Yasmin.

Its sister drug, Yaz, was approved by the FDA in 2006 with a formula designed to be more effective against the symptoms of PMS. However, Yasmin and Yaz side effects include an increased risk for blood clots, causing some women to develop DVT, strokes and pulmonary embolism.

Number of Yaz lawsuits climbs; settlements skyrocket

Because of the growing number of claims filed, the U.S. Judicial Panel on Multiditrict Litigation moved to consolidate qualified Yaz and Yasmin lawsuits to Illinois federal court in October 2009.

As of February 2012, there were more than 11,300 product liability claims filed, according to Bayer’s annual report. By August 2012, Bayer had settled nearly 1900 Yaz lawsuits amounting to $402.6 million. The most recent settlement statistics show that Bayer has settled 4,800 cases involving Yaz blood clot injuries totaling $1 billion with another $24 million set aside for gallbladder disease claims.