In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig.

Decision Date03 January 2017
Docket NumberMDL No. 2:14–mn–02502–RMG
Citation227 F.Supp.3d 452
Parties IN RE: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION
CourtU.S. District Court — District of South Carolina

This Order relates to the cases listed in Appendix 1

Richard Mark Gergel, United States District Court Judge

Before the Court is Defendant's Omnibus Motion for Summary Judgment, (Dkt. No. 1564).1 For the reasons stated below, the motion is GRANTED IN PART.2

I. Background
A. Procedural History

On February 18, 2014, the Judicial Panel on Multidistrict Ligation created this MDL, centralizing cases where female plaintiffs "allege that they have developed type 2 diabetes

as a result of taking Pfizer's cholesterol-lowering drug Lipitor." (Dkt. No. 1 at 1). Plaintiffs allege that Defendant failed to warn physicians and consumers adequately of the risk of developing Type 2 diabetes from taking Lipitor, knew or should have known that taking Lipitor increased the risk of developing Type 2 diabetes, and negligently, recklessly, and carelessly marketed Lipitor without adequate instructions or warnings. (See id ., Dkt. No. 160).

This Court held an initial status conference on March 27, 2014, and, after a second status conference on April 25, 2014, discovery commenced when the Court entered CMO 4, which among other things, set forth an initial discovery plan. (Dkt. No. 101 at 17–24). This plan provided for certain document production by Pfizer (including electronic discovery), interrogatories served by Plaintiffs on Pfizer, and depositions of Pfizer and its current and former employees. (Id .) On May 2, 2014, the Court entered CMO 5, which required Plaintiffs to serve Plaintiff Fact Sheets and certain mandatory disclosures on Pfizer. (Dkt. No. 110).

With discovery underway, the Court turned to the process for selecting a bellwether case for trial. Under Amended CMO 6, entered on May 22, 2014, the Plaintiffs' Steering Committee (PSC) and Defendant each selected seven (7) cases for the Discovery Pool in June of 2014. (Dkt. No. 148 at 4). More in depth case specific discovery was taken in these 14 cases in the Fall of 2014, including the propounding of written discovery on Discovery Pool Plaintiffs, depositions of Discovery Pool Plaintiffs, immediate family members and healthcare providers, depositions Pfizer sales representatives, and completion of a Defendant Fact Sheet by Pfizer. (Id . at 5).

On January 30, 2015, the Court convened the parties to randomly select the first cases for bellwether trials from the Discovery Pool cases. (Dkt. No. 739). By stipulation, the parties narrowed the fourteen (14) Discovery Pool cases to four (4) cases. The Court then randomly selected the first bellwether trials from these four (4) cases. The first case selected was Daniels v. Pfizer , Case No. 2:14–cv–01400, and the second case selected was Hempstead v. Pfizer , Case No. 2:14–cv–01879. Thereafter, the parties conducted additional case-specific discovery in these two cases. (See CMO 29, Dkt. No. 746; CMO 30, Dkt. No. 790).

From the beginning of this MDL, the parties have agreed that Plaintiffs must prove both general and specific causation as elements of their claims and have litigated this case as if expert testimony is needed to prove both. General causation is whether a substance is capable of causing a particular injury or condition (in this instance, whether Lipitor

is capable of causing diabetes ); specific causation is whether the substance caused the injury of the particular plaintiff at issue (in this instance, whether Lipitor caused Ms. Hempstead's diabetes ). E.g.,Norris v. Baxter Healthcare Corp ., 397 F.3d 878, 881 (10th Cir. 2005). "Plaintiff[s] must first demonstrate general causation because without general causation, there can be no specific causation." Id . Here, if Lipitor

is not capable of causing diabetes, it follows that it is not the cause of diabetes in particular plaintiffs.

The parties served common expert disclosures, including general causation experts, in March and April of 2015. (See CMO 29, Dkt. No. 746). Over Defendant's objection, the Court allowed Plaintiffs to supplement these disclosures in May of 2015 "to ensure this Court has the best information possible when addressing Daubert motions." (CMO 34, Dkt. No. 869 at 2). The parties then served specific causation expert disclosures in the two bellwether cases, in May and June of 2015. (See CMO 29, Dkt. No. 746; CMO 34, Dkt. No. 869). The Court allowed Plaintiffs to serve a rebuttal report by one of these case specific experts, again over Defendant's objection. (See CMO 38, Dkt. No. 967).

After full discovery, Defendant filed motions to exclude Plaintiffs' general causation expert testimony as well as Plaintiffs' specific causation expert testimony in the two bellwether cases. (Dkt. Nos. 972, 1004, 1006). As more fully explained below, after extensive briefing and oral argument, the Court ultimately excluded Plaintiffs' expert testimony on general causation with respect to dosages of less than 80 mg. (See CMO 49, Dkt. No. 1197; CMO 68, Dkt. No. 1469). The Plaintiffs at issue here all ingested dosages of Lipitor

less than 80 mg.3 Thus, the Plaintiffs here do not have admissible expert testimony on general causation.

As explained in more detail below, the Court also excluded the expert testimony of Dr. David Handshoe and Dr. Elizabeth Murphy, the two specific causation experts in the bellwether cases because their opinions were based on nothing more than an increased risk and temporal association. (CMO 55; Dkt. No. 1283; CMO 76, Dkt. No. 1517). However, Plaintiffs noted that in the SPARCL study, patients with certain characteristics and taking 80 mg of Lipitor

had a relative risk ratio of developing diabetes greater than 2.0, meaning it was more likely than not that these individuals would not have developed diabetes in the absence of Lipitor.4 Thus, it was possible that Plaintiffs with such characteristics and taking 80 mg of Lipitor might be able to proffer a specific causation expert opinion that would survive Daubert , even if the Court's ruling in CMO 55 was correct, and the Court entered a scheduling order to identify and take to trial such a case. (See CMO 61, Dkt. No. 1323).

However, in a hearing on the matter on January 22, 2016, Plaintiffs' Lead Counsel stated that there was no plaintiff in the MDL that met those criteria. (Dkt. No. 1347 at 5). Thus, the Court turned to where that left the MDL proceedings:

THE COURT: Let's talk for just a minute about where that leaves us .... let me ask this first from the plaintiffs: Is there any reason to believe that if we picked a 20– or 40– milligram case to try as a bellwether that you would have any class of cases or factual presentation or new theory that might survive specific causation, assuming the correctness of the Murphy order? Mr. Hahn?
MR. HAHN: The short answer is no, sir, Your Honor, we don't. Given the Murphy order and the Court's reading of the medicine, we are not going to be able to get a differential diagnosis that's going to survive.
THE COURT: Well, it's not a differential diagnosis, you've got to show specific causation more likely than not. And you have an opinion to that ....
But if we assume for a minute that the critical question then is whether the Court is correct regarding the standard, if you are telling me, Mr. Hahn, that if I'm correct, then you're not going to have a case that survives summary judgment?
MR. HAHN: Yes, Sir.

(Dkt. No. 1347 at 9–10). The Court went on to discuss with counsel options for proceeding within the MDL. Defendant's Lead Counsel suggested the Court issue an order to show cause to see if any Plaintiff could differentiate her case and then, if not, grant summary judgment in all cases, and Plaintiffs' Lead Counsel agreed:

MR. CHEFFO [Defendant's Lead Counsel]: ... So I think what is most efficient for this litigation ... is to have that ultimately reviewed, right? And I think that what other courts in similar situations have done is they have basically said, just issue an order to show cause and said, look, you know, if anybody thinks that they are differently situated or has some kind of different argument or something else, they can come forward; if not, what we are going to do is we are going to grant judgment on that.
.... they would then ... presumably get appealed to the Fourth Circuit and the Circuit Court would do what it's going to do. And I think that's the appropriate ... remedy in an MDL.
.... the most efficient way is to expeditiously grant summary judgment for all the cases on that ground, and anything else, get to the Fourth Circuit and have the Court review it.
THE COURT: Mr. Hahn, what your thoughts?
MR. HAHN [Plaintiffs' Lead Counsel]: Judge, I—I believe that Mark was cheating and reading off of my notepad. We basically agree .....

(Dkt. No. 1347 at 11–13).

The Court took counsel's suggestion and issued CMO 65, which stated,

NOTICE: THIS ORDER CONTAINS AN IMPORTANT DEADLINE FOR ALL PLAINTIFFS .
Lead Plaintiffs' counsel advised the Court in an on the record telephone conference of January 22, 2016, that, if the Court's ruling excluding the expert testimony of Dr. Elizabeth Murphy (CMO 55, Dkt. No. 1283) is correctly decided, then none of the cases now pending in the MDL will be able to survive summary judgment on the issue of specific causation. Notice is hereby given that any Plaintiff who disputes the position taken by Plaintiffs' Lead Counsel and asserts that her case can survive summary judgment on specific causation even if the Court's ruling in CMO 55 is upheld on appeal, such Plaintiff shall provide notice to the Court within 15 days of this order and set forth with specificity how her case is distinguished from the Court's ruling in CMO 55. The Court will then promptly set a schedule in each such case for identifying expert witnesses, submitting expert reports, deposing identified experts, and
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