January 28, 2011: A 62 year old Indiana woman filed suit today in Orange County California Superior Court against the manufacturer of OsmoPrep®, a drug that has been widely used as a bowel cleaning agnet for patients undergoing colonoscopies and other gastroenterology procedures. The lawsuit filed by The Senators (Ret.) Firm of Newport Beach, California, on behalf of Margarette Fields and her husband Ray, contends that Salix Pharmaceuticals Inc. and Salix Pharmaceuticals LTD, the makers of the drug, failed to provide proper warnings about the propensity of the drug to cause or contribute to the dev elopement of severe kidney dysfunction. Mrs. Fields developed life-threatening kidney failure in late 2007 after she used OsmoPrep® as directed by her physican.
OsmoPrep® contains sodium phosphate which has been implicated as a cause of a serious kidney disease known as Acute Phosphate Nephropathy. In 2008, over-the-counter oral sodium phosphate bowel prep products, including Fleet PhosphoSoda®, were withdrawn from the market based on numerous reports of Acute Phosphate Nephropathy associate with those medications. OsmoPrep®, and another Salix product called Visicol®, is ingested by patients in tablet form prior to colonoscopy procedures. While the FDA has not banned OsmoPrep® and Viscol®, the agency, required the manufacturer to place special warnings about the products in a “black box” on labeling provided to clinicians. Sales of OsmoPrep® have plummeted since the labeling change as doctors have switched their patients to bowle preps that do not contain oral sodium phosphate.
The complaint filed on behalf of the Fields’ alleges that Salix “failed to adequately warn prescribing physicians, including Plaintiff’s prescribing doctor, of the risks associated with use of the drug, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk of morbidity associated with Osmo-Prep®-induced adverse events.” In addition, the plaintiffs claim that Salix’ conduct in the marketing and promotion of the drug to patients and clinicians “overstated the drug’s benefits while downplaying the nature and extent of the risks, with the result that any warnings or precautions that were stated in the labeling for OsmoPrep® were consequently overshadowed, diluted, and rendered ineffective.”