Pharmaceutical

Panel discusses consolidation of ‘nightmarishly complex’ PPI litigation

PPI proton pump inhibitor Panel discusses consolidation of nightmarishly complex PPI litigationAccording to Law360, when plaintiffs in lawsuits against the makers of acid-reducing proton pump inhibitors, or PPIs, filed for consolidation in October there were 15 federal cases pending. Now there are more than 100 cases with plaintiffs’ attorneys reviewing thousands more potential cases of alleged kidney injuries caused by PPI use that could be filed in the coming months.

In 2011 concerns were brought to the U.S. Food and Drug Administration (FDA) about PPIs potentially having the dangerous side effect of harming users’ kidneys. These were brought by consumer advocacy group Public Citizen, according to the patients’ multidistrict litigation (MDL) brief.

In 2014, the FDA acknowledged possible kidney risk associated with long-term use of the drugs, and required the manufacturers to include warnings about risks of acute interstitial nephritis. Last year, new research was published linking PPI use to a 20 to 50 percent higher risk of chronic kidney disease and linking PPI use to renal failure.

Pfizer, which holds the license to distribute over-the-counter Nexium, claims that there are 69 prescription products made by 35 manufacturers. Often patients took more than one kind of PPI during the course of their treatment.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) during a hearing Jan. 26 discussed various concerns such a complex situation presented; for example, they questioned if trade secrets might be revealed during discovery if competitors were in the same litigation, and they expressed concern over the amount of time that would end up being dedicated to Daubert hearings to review the admissibility of scientific expert witness testimony for such a large number of products.

The panel attempted to come up with a structure for consolidating the cases, including possibly splitting the cases into multiple simpler, more efficient MDLs. However, every way they suggested splitting the cases the possibility remained that defendants might end up having to participate in multiple MDLs.

“It just seems to me to be nightmarishly complex,” U.S. District Judge Sarah Vance, one of the seven member JPML, said at one point during the oral arguments, according to Law360.

The defendants, which include AstraZeneca Pharmaceuticals, Takeda Pharmaceuticals USA Inc., Pfizer Inc. and Procter & Gamble Co. oppose consolidation. The plaintiffs’ attorneys, who filed for consolidation, favor a single MDL instead of multiple, smaller MDLs.

Also discussed was potential venues, should the JPML decide to consolidate the cases. The Middle District of Louisiana and the District of New Jersey were both mentioned. Both already have PPI cases pending. Also mentioned were the Southern District of Illinois; the District of Kansas; the Western District of Louisiana; and the Central District of California.

Source: Law360