The Purple Pill in the Red Zone

Unaware of the potential life-threatening side-effects allegedly linked to the proton-pump-inhibitor (PPI) group, coupled with the ease of availability over the counter, millions of people throughout the country have used this group of drugs to treat dyspepsia, peptic ulcer disease, and gastroesophageal reflux disease. PPIs differ in their drug interactions and the way they are broken down by the liver.

Nexium is the brand name for esomeprazole used to treat a number of stomach-related problems by blocking a proton pump and reducing the production of acid in the stomach. Due to its property of interfering with calcium absorption, Nexium has been linked to increased risk of osteoporosis and/or bone fractures, Chronic Kidney Disease (CKD), acute kidney injury, interstitial nephritis, and other kidney problems. What started as only a handful of lawsuits that had failed to qualify for MDL formation in February 2017, has now acquired the desired status owing to the increasing number of lawsuits. Other PPIs (Prilosec, Prevacid, Protonix, etc.) face similar allegations in litigation.

FDA Warnings

In 2010, the FDA released a safety communication based on results from studies conducted to test the link to bone fractures of the hip, wrist, or spine. The following year, the FDA ruled that the warning was only for the prescription-based long-term use of Nexium and required no label warnings for the OTC variety. In 2014, another safety warning was released for acute interstitial nephritis, a condition, if remained untreated, may become chronic leading to further complications that might require life-long dialysis treatment or a kidney transplant. However, no black-box warnings have been required yet.

Nexium: Important Lawsuits/Settlements/Fines

• AstraZeneca is facing a lawsuit pending since 2014, in re: Nexium (Esomeprazole) Antitrust Litigation MDL No. 2409 as a non-settling defendant along with Ranbaxy in the U.S. District Court for the District of Massachusetts, for violating federal and state antitrust laws by excluding generic competition for Nexium. Filed against four defendants: AstraZeneca, Ranbaxy, Teva, and Dr. Reddy’s, the MDL was left with two non-settling defendants in October 2015, when Teva opted to pay $24 million and Dr. Reddy’s agreed to help the drug buyers at the trial against the other defendants.
• In early 2015, AstraZeneca was asked to pay $20 million for promoting Nexium as a more effective choice for treating acid reflux as compared to Prilosec its nearly identical but less expensive sister drug. It also faced several lawsuits alleging that the company’s marketing campaigns tricked them into buying Nexium over Prilosec.
• In 2015, the Justice Department announced that AstraZeneca had agreed to pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium.
• Mid 2015, the Justice Department also announced that AstraZeneca agreed to pay the U.S. and participating states a total of $46.5 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program.

Nexium Bone Injury Lawsuit

The FDA warnings, research studies, and growing awareness resulted in the filing of several Nexium lawsuits. A multi-district litigation (MDL): 2404 in the U.S. District Court for the Central District of California presided over by Judge Dale S. Fisher was established in December 2012, for bone injury cases. However, this was closed in October 2014, with the judgment passed in favor of manufacturer defendant.

Nexium Kidney Damage Lawsuit

In August 2017, realizing the growing size of Nexium mass tort claims, centralization of all the Nexium, Prilosec, and Prevacid alleged kidney injury cases resulted in the formation of MDL 2789 presided by Hon. Claire C. Cecchi, U.S.D.J. and Hon. Mark Falk, U.S.M.J. Plaintiffs allege that the drug-makers knew or should have known about the severe side-effects of the drugs in question and that they withheld information from the medical community and consumers. More than 275 lawsuits have been centralized; the count is expected to grow eventually. The District of New Jersey was selected as the venue of choice as lawsuits were already pending there, and it was convenient for most plaintiffs including the defendant manufacturers. The MDL is now in discovery stage that began with a case management meeting this October to discuss details required to advance the litigation necessary for pretrial discovery. The litigation will soon witness selection of Bellwether cases.

This article was submitted by Neural IT. Neural IT provides cost-effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email them at [email protected] or call +1-844-NIT-TEAM (648-8326).

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