Actonel Lawsuit Filed Over Sudden Femur Fracture

A Louisiana woman has filed a lawsuit against Procter & Gamble, Aventis and Warner Chilcott alleging that side effects of Actonel, an osteoporosis drug, caused her to suffer a sudden femur fracture.

The Actonel femur fracture lawsuit (PDF) was filed by Anita Baudean on July 3, in the U.S. District Court for the Eastern District of Louisiana.

According to the complaint, Baudean used Actonel for at least nine years to treat osteoporosis before she suffered a spontaneous femur fracture, which required surgical repair to place rods and pins.

The allegations contained in the complaint are similar to claims made in hundreds of femur fracture lawsuits involving Fosamax, which is a similar oral bisphophonate medication prescribed for treatment of osteoporosis.

The entire class of bisphosphonate medications has been linked to a risk of atypical femur fractures, which typically occur with little or no trauma at all.

FDA Warning About Femur Fractures from Actonel

In October 2010, the FDA required new warnings about the risk of thigh fractures from Actonel and other bisphosphonate medications.

During a review of the potential health risk, the FDA determined that the risk of fractures of the thigh bone may be connected to long-term use of bisphosphonates, and the FDA has recently suggested that users may be able to reduce their risk, while still maintaining the benefits of the drug, if they stop using the medications after three-to-five years.

Recent research has suggested that side effects of Actonel and other oral bisphophonates may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a complete fracture occurring under circumstances where the femur would not typically be expected to break, such as while taking a step or falling from standing height or less.

Failure to Warn About Risk of Femur Fractures from Actonel

Baudean alleges that the drug makers knew or should have known about the risk of Actonel femur fractures as early as 2005.

The complaint indicates that Baudean and other consumers were placed at an unreasonable increased risk of of problems when the medication was taken as directed. Had Baudean known about the increased risk of fracturing her femur while using Actonel she claims that she never would have taken the drug.

New warnings placed on the medication after Baudean’s injury occurred now inform consumers that they should contact their physician if they experience groin pain or discomfort, which may be an early sign of problems before a complete fracture while using Actonel occurs.

The lawsuit charges the companies with designing, marketing and manufacturing a defective product, failure to warn, breach of warranty and violating consumer protection laws.