The U.S. District Judge presiding over all federal valsartan recall lawsuits has appointed two Special Masters to work with the parties on potential settlements that may resolve individual claims brought by former users diagnosed with cancer following exposure to the recalled versions of the hypertension drug.

There are currently several hundred product liability lawsuits filed throughout the federal court system, each involving similar allegations that former users of valsartan or other sartan-based medications were diagnosed with cancer due to exposure to N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and other chemical byproducts that resulted from changes to the generic drug manufacturing process.

The chemicals are known human carcinogens, which have been discovered in nearly all versions of the generic drug distributed prior to massive valsartan recalls issued in July 2018. High levels of the impurities were discovered in versions of the drug containing ingredients supplied by Zhejiang Huahai Pharmaceuticals in China, as well as other generic drug makers.

Lawsuits allege that long-term exposure to recalled valsartan pills have been linked to reports of stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer and other injuries which developed as the chemicals traveled through the digestive system.

Given common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the federal litigation has been centralized for pretrial proceedings before U.S. District Judge Robert B. Kugler in the District of New Jersey, as part of a multidistrict litigation (MDL), which currently includes at least 650 cases. However, as valsartan cancer lawyers continue to review and file claims in the coming months and years, it is widely expected that several thousand cases will ultimately be included in the proceedings.

On December 18, Judge Kugler sent a letter (PDF) to all counsel involved in the litigation, announcing the appointment of retired judges Gregory M. Sleet and Lawrence F. Stengel as Special Masters for Settlement. The two former judges were both Chief Judges in the District Courts of Delaware and Eastern Pennsylvania, respectively, before retiring from the bench.

The appointment of special masters means the court believes that a valsartan settlement may be negotiated to resolve large numbers of claims, potentially avoiding the need for the Court to prepare hundreds of individual cases for costly trials in the coming years.

On the same day, Judge Kugler issued an order (PDF) denying several motions to dismiss brought by defendant drug manufacturers, rejecting arguments that the claims should be preempted by federal law under the Federal Food, Drug and Cosmetic Act.

“Under defendants’ view of the Act, Congress would have barred most, if not all relief, for persons injured by defective pharmaceuticals,” Judge Kugler wrote. “Such a reading would ultimately preclude courts from affording state consumers any protection from defective drugs. The Court therefore finds this reading to be incorrect.”

Judge Kugler’s decision clears the way for discovery to proceed in the litigation, which is expected to continue through at least late 2021, before the first “bellwether” cases go before juries.

While the outcome of these early test trials will not be binding on other plaintiffs, they will be closely watched by parties involved in the litigation and may have a large influence on potential valsartan cancer settlements, providing a gauge for how juries may respond to certain evidence and testimony likely to be repeated throughout the claims.

Tags: Cancer, Drug Recall, Hypertension, NDMA, Valsartan