United States: PML Valsartan Order

Last Updated: September 13 2019
Article by Stephen J. McConnell

Few things raise our blood pressure as much as the MDL process. MDL stands for Multi-District Litigation, but the M might as well stand for Mutilating and the D for Distorting. One-sided discovery, wholesale parking of 'shotgun' complaints, made-up spoliation issues, and bellwether trial programs that produce results representative of nothing other than plaintiff lawyer dreams all wreak havoc on our systolic and diastolic numbers. For a while we harbored hopes that the Joint Panel on Multidistrict Litigation might be clamping down on creating drug and device MDLs, or at least narrowing them down.

Now? Not so much.

Let's push the salt shaker away, ignore the latest demand for money from the heirs, count to ten, and take a look at In re: Valsartan N-Nitrosodimethylamine Ndma Contamination Prods. Liab. Lit., 2019 U.S. Dist LEXIS 24045, (JPML February 14, 2019), to see how the JPML ruled regarding creation of an MDL for valsartan, a medication indicated for treating hypertension. The litigation arises out of an investigation by the FDA into impurities found in drug products containing valsartan. Purchasers of recalled lots of generic valsartan subsequently filed actions alleging economic losses. The initial wave of consumer class actions was followed by actions alleging personal injuries from the ingestion of affected valsartan medications, as well as other related litigations.

After enough (query what is really "enough") actions were filed, the MDL dance commenced. First, there were plaintiff purchasers suing for economic damages and related injunctive relief. They moved to centralize 10 actions in the District of New Jersey. Then came 30 "related" actions: 17 for personal injury and the remainder were putative class actions on behalf of consumers and third-party payors. Different parties plumped for different jurisdictions. Surprisingly, not everyone yearns for New Jersey. Other suggested districts were the Northern District of California, the Northern District of Florida, the District of Massachusetts, the District of Minnesota, and the Western District of Texas. Notice that none of these jurisdictions is likely to receive a Chamber of Commerce Award for Niceness to Corporate Defendants. Plaintiffs in two of the actions supported centralization only of the consumer class actions and sought the District of New Jersey. A plaintiff in one potential tag-along action on behalf of third-party payors sought inclusion of its action and requested the Southern District of Florida or the District of New Jersey.

The principal common defendants in this litigation supported centralization of the 10 actions in the District of New Jersey. They asked the Panel to limit the scope of the MDL solely to consumer class actions. Some defendants opposed inclusion of any of the actions against them, and certainly actions involving personal injuries, and alternatively, requested the District of New Jersey or the Northern District of West Virginia. Other responding defendants opposed certain permutations of centralization, suggesting that an MDL may not be warranted on the ground that alternatives to centralization exist, particularly transfer under Section 1404(a).

The JPML ruled that all the valsartan actions involved common factual questions arising out of allegations that plaintiffs purchased or used generic formulations of valsartan medications containing certain impurities possibly presenting risks of cancer and liver damage; and that defendants knew or should have known, of the impurities as early as 2012. All actions stemmed from the same FDA investigation and voluntary recall. Accordingly, the JPML reasoned that centralization would eliminate duplicative discovery; prevent inconsistent pretrial rulings, including with respect to class certification and Daubert motions; and conserve the resources of the parties, their counsel, and the judiciary.

The primary dispute hovered around whether the personal injury claims should be lumped in with the economic claims (both the direct and third-party payor cases). It is not hard to think of why those claims should be treated separately. But the JPML believed that the "core factual issues in the personal injury actions will be the same as in the consumer class actions." Those issues included the cause of the alleged impurities; the nature and extent of the health risks they posed; the defendants' knowledge of the alleged impurities; and the impact of any findings made by the FDA.

The JPML expressed no opinion as to whether this MDL "will grow to include actions involving other medications in the same class as valsartan." Yikes. This could get messy. The court rejected Section 1404 transfer as a practicable alternative to centralization, "given the number of actions, districts, and counsel for plaintiffs and defendants. There are presently a total of 40 related actions pending in 22 districts, which involve over a dozen district slates of plaintiffs' counsel and some 20 defendants, most of whom do not share counsel. These circumstances portend significant inefficiencies and obstacles to Section 1404 transfer if the related actions to a single district."

After seeing above how many of the parties smiled on the Garden State, you will not be surprised to learn that the JPML deemed the District of New Jersey as an appropriate transferee district for this litigation. Five actions on the motion and seven potential tag-along actions were already pending there. Many of the defendants have their U.S. headquarters in New Jersey.

Congrats, valsartan litigants. Make sure you find your way to Jimmy Buff's for Newark hotdogs. They might not be good for your blood pressure, but they sure are good eating. Or say hello to our friends at Star Tavern in Orange. We bet you'll like Jersey thin pizza more than you'll like Jersey discovery rulings.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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