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Is Multidistrict Litigation in Need of Reform?

In recent years, multidistrict litigation increasingly has been the subject of criticism. Critics charge that, by aggregating claims in a single proceeding, the MDL process encourages the filing of meritless claims. The proliferation of claims is accompanied by increasing pressure to settle and a lack of scrutiny given to individual claims.

Such criticisms have resulted in calls for reform of the MDL process. Congress has taken notice and has included proposals for reform to address certain of these excesses in the Fairness in Class Action Litigation Act of 2017.[1]

Among other things, the proposed law would require plaintiffs in MDL proceedings to provide evidence of their alleged injury within days of being transferred to a multidistrict proceeding.[2] It would increase appellate involvement in the MDL process by providing appellate jurisdiction over orders that may materially advance the ultimate termination of one or more civil actions in the proceedings.[3] And it would prohibit trials in multidistrict proceedings unless all parties to the civil action consent.[4]

However, recent experience suggests that in many instances the MDL process is functioning well to effectively and efficiently resolve complex cases. Indeed, there arguably has been a trend among MDL courts in granting dispositive motions addressing common issues that resolve all, or large categories, of claims.

In the Mirena MDL litigation, for example, the court granted defendants’ omnibus motion for summary judgment on the issue of causation after issuing rulings excluding plaintiffs’ expert evidence as unreliable under Rule 702 and Daubert.[5]

The Mirena litigation involved a plastic intrauterine device that delivered a hormone to prevent pregnancy for up to five years. Plaintiffs alleged that the device was defectively designed, and as a result, perforated, became embedded in, or migrated from plaintiffs’ uteruses. The court excluded the opinions of plaintiffs’ experts on general causation, laying the basis for granting summary judgment on the asserted claims.

After an extensive analysis, the court concluded that plaintiffs’ theory regarding the mechanism by which Mirena allegedly caused secondary perforation was simply unreliable. The court noted that plaintiffs’ theory had never been tested and that plaintiffs’ experts lacked supporting data at several steps of their analysis.[6]

Moreover, the court concluded that the experts’ analysis was largely results-oriented and lacked the intellectual rigor necessary for admissible expert testimony.[7] The court’s rulings on the issue of general causation, a fundamental requirement for all of the asserted claims, effectively resolved the litigation.

In the Lipitor litigation the court addressed claims that a statin medication used to treat high cholesterol increased patients’ risk of developing type 2 diabetes. There was a significant background rate of diabetes in the population that was prescribed Lipitor.

The question before the court was whether the medication increased this background risk. Like the court in the Mirena litigation, the court in Lipitor issued rulings on dispositive motions for summary judgment and to exclude expert evidence under Rule 702 and Daubert that largely resolved the litigation.

As the court observed in its ruling on plaintiffs’ scientific evidence, the studies that examined whether there was an increased risk of type 2 diabetes examined the effects in patients taking various dosages, ranging from 10 mg to 80 mg. The studies generally found no association between the medication and diabetes at lower dosages. The only statistically significant results occurred in patients taking the 80 mg dose.

After evaluating this evidence, the court excluded expert testimony regarding general causation in patients taking doses below 80 mg.[8] The court reasoned that, because epidemiologic studies using the lower doses found no statistically significant increased risk, expert opinions that general causation was established at these lower doses were “not based on sufficient facts and data.” [9]

These rulings were largely dispositive of the litigation, given that plaintiffs’ counsel had difficulty coming up with any plaintiffs who had actually taken the 80 mg dose.

Finally, in Incretin-Based Therapies, the MDL court granted defendants summary judgment with respect to claims alleging that various pharmaceuticals used to treat diabetes increased the risk of pancreatic cancer.[10] The court agreed that the claims were preempted, finding that the U.S. Food and Drug Administration had specifically considered pancreatic cancer risk, commented publicly that the labeling for these products was adequate, and stated that evidence of a causal association between the products and pancreatic cancer had not been established.[11]

Based on this record, the court determined that there was “clear evidence” that the FDA would have rejected proposals to add warnings regarding the risk of pancreatic cancer to product labeling, and thus plaintiffs’ claims were preempted by federal law.

These and other recent rulings illustrate that courts presiding over MDL proceedings have in many instances utilized available procedures to effectively and efficiently resolve thousands of asserted claims. The MDL process is specifically designed to allow federal courts to address such “common issues” in complex litigation involving multiple, similar claims.[12]

In these recent examples, MDL courts have taken up this charge and used omnibus motion practice to largely resolve litigation through resolution of such fundamental issues.

That said, there may also be case-specific issues that are dispositive of large numbers of claims in an MDL proceeding. These should not be ignored. Rather, there should be a parallel process to address such issues on a case-by-case basis.

Such procedures can take many forms. In many cases, defendants and plaintiffs may be able to informally resolve such issues. It is standard practice in large MDLs to require plaintiffs to submit fact sheets, provide document discovery and submit additional information that can be utilized to identify claims that lack merit.

Once such information is provided, it can be analyzed by the parties, and defendants may informally request that plaintiffs’ counsel voluntarily dismiss cases that lack merit. In those cases where plaintiffs refuse, defendants can file case-specific dispositive motions that can be resolved by the MDL court on a rolling basis.

Such procedures were utilized effectively in the Heparin MDL proceedings to resolve numerous asserted claims based on lack of product identification evidence and other grounds.[13]

More formalized procedures can also be employed. For example, some MDL courts have issued Lone Pine or show cause orders that require plaintiffs to provide certain basic information supporting their claims, or have them subject to dismissal.[14]

Such parallel procedures to address case-specific issues are critical, and may go a long way to address the concerns of the critics of the MDL process, who believe that aggregation leads to the filing of large numbers of claims that simply have no merit.

While reform of MDL procedures may have a beneficial effect by providing courts and parties additional tools to resolve litigation, in many instances MDL courts have effectively used the existing tools to weed out weak or meritless claims.

Doug Smith is a partner in the Chicago office of Kirkland & Ellis LLP. He has litigated cases at both the trial and appellate stage in state and federal courts throughout the country, including commercial, mass tort, product liability, securities, bankruptcy, environmental and intellectual property cases.

Disclosure: The author was counsel of record in the Heparin MDL proceedings and has represented certain of the companies that are defendants in the cases discussed in this article in other matters.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] Fairness in Class Action Litigation Act of 2017, H.R. 985, 115th Cong. (Mar. 13, 2017).

[2] Id. § 105.

[3] Id.

[4] Id.

[5] In re Mirena IUD Prods. Liab. Litig., 202 F. Supp. 3d 304 (S.D.N.Y. 2016).

[6] In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 429-30 (S.D.N.Y. 2016).

[7] Id. at 430.

[8] See In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Prods. Liab. Litig., — F. Supp. 3d —, 2017 WL 87067, at *2 (D.S.C. Jan. 3, 2017).

[9] Id. at *8.

[10] In re Incretin-Based Therapies Prods. Liab. Litig., 142 F. Supp. 3d 1108 (S.D. Cal. 2015).

[11] Id. at 1112.

[12] See 28 U.S.C. § 1407(a).

[13] See generally In re Heparin Prods. Liab. Litig., 803 F. Supp. 2d 712 (N.D. Ohio 2011).

[14] See In re Zimmer NexGen Knee Implant Prods. Liab. Litig., 2016 WL 3281032 (N.D. Ill. June 10, 2016); In re Fosamax Prods. Liab. Litig., 2012 WL 5877418 (S.D.N.Y. Nov. 20, 2012); In re Rezulin Prods. Liab. Litig., 2005 WL 1105067 (S.D.N.Y. May 9, 2005).