Suit: AstraZeneca Negligent in Marketing Nexium

Kathy Craft of Houston, who had been taking Nexium for indigestion, was walking at a normal pace when, she said, her leg suddenly broke, throwing her to the ground and causing her to break her ankle and displace a cervical disc.

Craft is one of 34 people, most of them women, who say in a lawsuit filed in Harris County, Texas, that AstraZeneca's heartburn drug caused them to suffer bone deterioration, leading to fractures and osteoporosis.

A similar suit was filed by an Ohio woman in April. Ginny Begin of Toledo said she “was simply walking when a bone in her leg suddenly broke in half." 

The Texas suit alleges that the drug causes "severe bone deterioration and unexpected bone fractures."

Nexium is a proton pump inhibitor which reduces heartburn, ulcers and acid reflux and similar conditions by reducing the production of acid in the stomach. However, it also reduces calcium absorption, which can decrease bone density.

FDA Warnings

The plaintiffs, mostly women from the Houston area, note that the Food and Drug Administration issued an alert in March 2011, warning that Nexium and similar drugs caused an increased risk of bone fractures and osteoporosis. In May 2010, the FDA required manufacturers to place stronger warnings on labels and patient information packets.

Although the FDA did not act until 2010, the suit cites studies as early 2006 that showed the increased risk of bone problems, particularly in women over 50 years of age.

More recently, the FDA warned in March that Nexium and other proton pump inhibitors could cause low magnesium levels.

The plaintiffs are not all women, however. One is a nine-year-old boy, Cole Williams, who says he suffered a severe fracture of the right hand after taking Nexium as prescribed for 18 months.

Besides AstraZeneca, the suit names Ghadeer Rafeedie, who was the company's sales representative in Houston, responsible for “educating and enlightening” health care professionals about Nexium.

The suit charges that AstraZeneca and Rafeedie were negligent in selling and promoting the drug, the third-largest-selling drug in the world, with sales of $5.2 billion in 2008.

It seeks damages for mental anguish, disfigurement, medical expenses, pain and suffering, legal expenses and related items.