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The drug maker AstraZeneca has agreed to pay the federal government $7.9 million to resolve allegations that the company paid kickbacks to encourage use of its blockbuster heart burn drug Nexium.
According to a Department of Justice press release issued on February 11, AstraZeneca gave the pharmacy benefit manager Medco Health Solutions discounts on other drugs, such as Prilosec, Toprol XL and Plendil, as long as Medco made Nexium the “sole and exclusive” drug of its kind on certain formularies and other marketing activities.
The marketing scheme violated the Federal Anti-Kickback statute, according to the Justice Department, resulting in false claims being submitted for Nexium to the Retiree Drug Subsidy Program.
“We will continue to pursue pharmaceutical companies that pay kickbacks to pharmacy benefit managers,” Acting Assistant Attorney General Joyce R. Branda said in the press release. “Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs.”
The Nexium settlement came following a whistleblower lawsuit filed under the qui tam provision of the False Claims Act. Former AstraZeneca employees Paul DiMattia and F. Folger Tuggle will receive more than $1.4 million from the settlement, as a result of bringing the illegal marketing to the attention of the federal government.
Nexium belongs to a class of drugs known as proton pump inhibitors (PPIs). It is the most widely used medication from this class, generating an estimated $6 billion in annual sales before it became available over the counter and as a generic.
Nexium Health Concerns
Although Nexium is widely used, concerns about potential side effects have emerged in recent years, including claims that AstraZeneca failed to adequately warn about potential risks.
One of the emerging concerns have been that Nexium increases the risk of infections, particularly Clostridium difficile infections (CDIs). Another concern has been over an increased risk of bone fractures.
CDIs can lead to Clostridium difficile-associated diarrhea (CDAD), causing persistent diarrhea, water stool, abdominal pain and fever. It can eventually lead to more severe intestinal problems if not treated in a timely manner.
The FDA first warned of the link between drugs like Nexium and Prilosec and CDIs in a drug safety communication in February 2012. The agency required new warnings be placed on the drugs at that time and warned doctors to be aware of the potential connection when presented with patients taking heartburn medications whose diarrhea did not improve.
The agency added further warnings in late October for CDAD and other health risks associated with the medications. The label changes also include new warnings about how long PPIs should be taken to treat gastroesophageal reflux disease (GERD), vitamin B 2 deficiency, and acute interstitial nephritis.
In 2010, the FDA required the manufacturers of all other proton pump inhibitor (PPI) medications to update the warning labels, adding information about a potential risk of fractures and bone problems from side effects of Prilosec, Nexium and other drugs in the same class.
That warning was updated again by the FDA in 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, which is exactly the kind of prescribing behavior the study found happens far too often. Over-the-counter versions of the drug did not appear to be affected, according to federal drug regulators.
A number of former users have pursued Nexium lawsuits after suffering bone fractures, alleging that AstraZeneca withheld information about the risks associated with long term use of the heartburn drug.