Heartburn drugs, bone fractures and a liability lawsuit- what do these 3 things have in common? Apparently, an Arizona woman by the name of Rebecca Smith-Lee.
Ms. Smith-Lee has filed a product liability lawsuit against the makers of several popular heartburn drugs, including Nexium, Protonix, Prevacid, Prilosec and Aciphex, alleging that use of the medications caused her to suffer multiple bone fractures.
But, what is the catch? Are these drugs actually linked to bone fractures? The answer is surprisingly, yes.
Actually, in May 2010, the FDA warned that there may be an increased risk of bone fractures from Nexium and the other proton pump inhibitors (PPI) medications.
That warning was updated by the FDA in March 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time. Over-the-counter versions of the drugs did not appear to be affected, according to the federal drug regulators.
Even the prominent consumer advocate group, Public Citizen, has called for black box label warnings to be added to all PPIs, alerting people that the drugs have been linked to bone breaks and can cause consumers to develop a dependency on the drugs.
As for Ms. Smith-Lee’s complaint, it was filed earlier this month in U.S. District Court for the Northern District of California. It names a number of drug manufacturers as defendants, including Astrazeneca, Janssen Pharmaceuticals, Pfizer, Novartis, and Takeda Pharmaceuticals, as well as McKesson Corporation, which distributes the drugs in Arizona and California.
Smith-Lee indicates that she took the various different heartburn drugs from 2007 through 2010. In December 2009, she experienced multiple fractures in her right foot, which required surgery. A month later, she suffered multiple fractures in her left foot.
According to the allegations raised in the lawsuit over the fractures, the manufacturers of Nexium, Protonix, Prevacid, Prilosec and Aciphex have known for years that the drugs could weaken bones, but failed to adequately warn doctors and consumers.
All of the drugs Smith-Lee used are part of a class of medications known as proton pump inhibitors (PPIs).
As surprising as this may be, Ms. Smith-Lee is not the first to allege this, as there have been a number of similar bone fracture lawsuits over Nexium and other heartburn drugs that have been filed in courts throughout the United States. The only difference between her complaint and others, is that most did not involve the use of this many different types of proton pump inhibitors. Which simply signifies to me that her heartburn must have been really bad, and she ultimately tried basically everything on the market!
Smith-Lee charges the manufacturers with negligence, designing and manufacturing a defective product, failure to warn, breach of warranty and fraud. She is seeking both compensatory and punitive damages.