This Order relates to the cases listed in Appendix 1
Before the Court is Defendant’s Omnibus Motion for Summary Judgment, (Dkt.
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) eases. 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.,
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 eases. (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.
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.
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 anyclass 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 briefing Daubert and dispositive motions.
(Dkt. No. 1352). CMO 65 did not require any Plaintiff to marshal any evidence with
On June 9, 2016, the Court held a Status Conference to discuss proceeding with summary judgment. (Dkt. No. 1550). Plaintiffs, for the first time, had appellate counsel appear in front of the Court. (Id.). It was in this conference that Plaintiffs’ counsel indicated, for the first .time in this litigation, that some plaintiffs may possibly be able to survive summary judgment despite the Court’s Daubert rulings:
MR. HAHN: ... And by taking up 10, 20, and 40, your general causation opinions, and then Murphy’s specific causation opinion, I don’t think we can have a summary judgment as to all the other plaintiffs in the litigation, because those other plaintiffs, in some states you don’t have to have [an] expert—New Mexico is one—.... there may be other plaintiffs that have—haven’t had the opportunity, and plan to put up a specific causation expert that’s going to give an opinion that would get them to a jury.
THE COURT: No, no, I had—I entered an order, Mr. Hahn, in which I said if any of you don’t agree with the lead counsel’s position about specific causation, you need, by a designated date, to identify your case and provide me the names of your experts, so we can get on with discovery.
MR. HAHN: Yes, sir.
THE COURT: So I don’t think we’re out there with other potential cases. Now this issue of states that do not require expert testimony on causation, ... I wasn’t aware there were such states.
(Dkt. No. 1550 at 7). The Court went on to state: “let’s assume there are. Then the brief in opposition could say all claims from the following—from the State of New Mexico, we oppose it, because there’s not a[n expert] requirement .... the plaintiff would still have to make a showing of whatever is required under that law to establish causation, even if you don’t need an expert...” (Id. at 9). Thus, Court set a scheduling for briefing,on summary judgment, (CMO 79, Dkt. No. 1548), and Plaintiffs had an opportunity to come forward with evidence under this new theory in opposition to summary judgment.
However, when the deadline for opposition to summary-judgment came á month- and-a-half later, not a single Plaintiff came forward with evidence that she claimed precluded the entry of summary judgment. Instead, Plaintiffs argued that it was theoretically possible that some unidentified Plaintiff(s) may possibly have some unidentified circumstantial, non-expert evidence of specific causation. (Dkt. No. 1586). In this opposition, Plaintiffs readily acknowledged that any Plaintiff “who believed she could adduce a differential diagnosis that could survive Daubert notwithstanding the exclusion of Dr. Murphy’s expert testimony in Hempstead” should have come forward in response to CMO 65, (Dkt. No. 1586 at 13), but argued that Plaintiffs should be allowed to present non-expert testimony to transferor courts after remand.
Given this speculative response, the Court gave Plaintiffs a third opportunity to come forward if any thought her case could survive summary judgment. The
NOTICE IS HEREBY GIVEN that any Plaintiff who asserts that her case can survive summary judgment on specific causation even if the Court’s ruling in CMO 55 is upheld on appeal, must file a response to Defendant’s motion for summary judgment (Dkt. No. 1564) within fifteen (15) days of the date of this Order. Any such response must specifically identify the particular Plaintiff opposing summary judgment, identify the substantive state law that she contends applies to her claims, and include all evidence that she asserts precludes the entry of summary judgment in her case.
If any Plaintiff contends that she needs additional case-specific discovery to provide such evidence, she must comply with the requirements of Fed. R. Civ. P. 56(d) and identify the specific facts that are yet to be discovered. Should the claims of any Plaintiff survive summary judgment based on Rule 56(d), the Court will then promptly enter a scheduling order in each such case allowing for appropriate discovery and the filing of dispositive motions after discovery.
(Dkt. No. 1599 at 3-4). Again, not a single Plaintiff came forward with evidence of specific causation. Nor did a single Plaintiff make an individualized Rule 56(d) request.
Instead, Plaintiffs filed an omnibus response arguing that, other than the two bellwether Plaintiffs, no Plaintiff has had an opportunity to develop the facts of her case. (Dkt. No. 1611). Inexplicably, Plaintiffs argued that none of the Plaintiffs (other than the two bellwether Plaintiffs) have had an opportunity to “hire experts” or “prepare expert reports,” (Dkt. No. 1661 at 8), despite the fact that CMO 65 offered any Plaintiff the opportunity to do just that.
In the Rule 56(d) affidavit filed with Plaintiffs’ response, Plaintiffs stated that they needed an opportunity to seek (1) “[ejvidence, testimony, and (if necessary) third-party discovery from their treating physicians,” (2) “[ejxpert opinions regarding specific causation,” and (3) “their patient records.” (Dkt. No. 1611-1). Plaintiffs did not state any other information that they need to seek to defend against this motion for summary judgment.
Thus, the Court issued CMO 82. First, the Court held that the time for Plaintiffs to come forward and argue that they could produce expert testimony on specific causation had passed:
As an initial matter, the time for a Plaintiff to come forward and argue that she could produce an expert opinion on specific causation that would survive Daubert has passed. The Court issued an order to show cause on this seven months ago, and explicitly stated that it would allow any such plaintiff to proceed with discovery and pre-trial proceedings, and in the last seven months not a single Plaintiff has come forward. Plaintiffs’ Lead Counsel testifies that he understood his admission at the January 22, 2016 status conference as a confirmation “on the ability of Plaintiffs to survive the evidentiary standards for specific-causation expert evidence set forth in CMO 55” and that he understood CMO 65 to “relate to whether individual Plaintiffs believe their case could survive the Rule 702 expert standards in CMO 55.” (Dkt. No. 1611-1 at 6-7). Whatever the dispute about non-expert evidence, there can be no dispute, and according the Plaintiffs’ Lead Counsel’s affidavit, there is no dispute, that any Plaintiff who believed she could proffer expert evidence on specific causation that wouldsurvive Rule 702 and Daubert was required to come forward in response to CMO 65. (See also Dkt. No. 1611 at 17 (“CMO 65 directed any Plaintiff who thought they could survive summary judgment on specific causation in light of the Court’s exclusion of Dr. Murphy in CMO 55 (Doc. 1283) to come forward with new or additional expert evidence.”); Dkt. No. 1611 at 18 (“Plaintiffs continued to understand the Gourt’s order to relate to whether individual Plaintiffs believed their case could survive the Rule 702 expert standards in CMO 55, not the separate legal issue of whether the law of their state requires expert evidence.”)). No Plaintiff has done so. Therefore, Plaintiffs’ argument that they have not had an opportunity to seek specific causation expert testimony is meritless. The Court provided that opportunity in CMO 65, not a single Plaintiff came forward, and by not coming forward in response to CMO 65, Plaintiffs have waived that argument.
(Dkt. No. 1616 at 7-8 (emphasis in original)).
The Court went on to provide Plaintiffs with a fourth and final opportunity to come forward with non-expert evidence:
With regard to non-expert evidence, in an abundance of caution, the Court will provide Plaintiffs with a fourth and final opportunity to come forward. Plaintiffs have argued that 15 days is not sufficient time to marshal their evidence. Thus, the Court will afford them an additional 60 days. The Court notes that the only facts that Plaintiffs have stated they may need to discover (other than expert testimony) to defend against summary judgment is information from their own treating physicians and their own patient records. (Dkt. No. 1611-1 at 5). They have not requested any discovery from Defendants or other third-parties.
Given the nature of the evidence that Plaintiffs claim they need time to marshal, specifically their request to marshal their own medical records and information from their own treating physicians, the Court finds 60 days sufficient.
(Id. at 8).
In response to CMO 82, no Plaintiff made a Rule 56(d) motion. Thus, the additional 60 days did prove sufficient. In addition to the omnibus responses to summary judgment filed by the Plaintiffs’ Steering Committee, (Dkt. Nos. 1586, 1611, 1684), two sets of Plaintiffs filed responses to CMO 82. Thirty-four Plaintiffs (“the Hayes Law Firm Plaintiffs”) submitted their Plaintiff Fact Sheets (PFSs) and certain medical records. (Dkt. Nos. 1670, 1682, 1686, 1687, 1688). They contend that (1) they were not diabetic before taking Lipitor, (2) they were diagnosed with diabetes after taking Lipitor, and (3) they did not have certain risk factors for diabetes, even though they had others. (See Dkt. No. 1670 at 17-39). At oral argument counsel stated this was “the best thing 1 could come up with with nonexpert evidence,” that “[tjhey are not diabetic before taking the medication, they took Lipitor and then they became diabetic.” (Dkt. No. 1727 at 24).
The Douglas & London Plaintiffs did not initially submit any evidence to the Court and simply argued that summary judgment was precluded by:
(a) their respective health history and conditions as documented in their medical records, pharmacy records and/or other relevant records;
(b) their respective Plaintiff Fact Sheets (“PFS’s”) that have already been servedon Defendants and any and all amendments thereto;
(c) the general causation evidence identified and discussed in Plaintiffs’ Opposition to Defendants’ Omnibus Motion for Summary Judgment dated July 22, 2016 [Dkt. 1686]; and
(d) the substantive state law that applies to each D&L Plaintiffs respective claims.
(Dkt. No. 1689 at 5 (footnotes omitted)). The Court entered a text order stating that these Plaintiffs must submit to the Court any evidence that they wished to the Court to consider. (Dkt. No, 1695). In response, Plaintiffs literally dumped boxes upon boxes of documents on the Court, with no discernment or suggestion as to which documents they claimed precluded summary judgment. (Dkt. Nos. 1698, 1700, 1701, 1702, 1703, 1704, 1705, 1706). Nevertheless, the Court reviewed these documents as well, almost all of which were completely irrelevant. For example, the documents include pictures from colonos-copies, EKGs, and pap smear results.
The Court held oral argument on the omnibus motion on November 1, 2016, and the matter is now before the Court for a decision.
B. The Court’s Daubert Rulings
1. General Causation
On September 24-25, 2015, the Court heard extended oral argument on Defendant’s motions to exclude common expert witnesses, including Plaintiffs’ general causation experts. (Dkt. Nos. 1147, 1148). One of the primary issues raised both in briefing and at oral argument was the importance of dosage.
Lipitor is prescribed in four different doses: 10 mg, 20 mg, 40 mg, and 80 mg. Plaintiffs’ general causation experts initially “opine[d] that Lipitor can cause diabetes, without specifying the precise dose at which this effect begins.” (Dkt. No. 1159 at 26). If a study suggested an increased risk of diabetes, the experts “ascribe[d] the risk to all doses.” (E.g., Dkt. No. 972 at 269). However, Pfizer argued that “[d]ose is critical to proving general causation,” and that Plaintiffs lacked reliable evidence that Lipitor causes diabetes at doses less than 80 mg. (Id. at 49).
After reviewing the studies relied on by the experts and their opinions, the Court was concerned about whether Plaintiffs’ experts had sufficient facts and data to support their causation opinions at all doses of Lipitor, and even whether the experts would be willing to offer an opinion at low doses, given the available data. See In re Seroquel Products Liab. Litig., No. 6:06-MD-1769-ORL-22D,
After a thorough review of relevant caselaw and the expert opinions at issue, the Court issued an order on October 22, 2015, holding that “at least where the experts agree that there is a dose-response relationship and where there is evidence that an association no longer holds at low doses, dose certainly matters, and Plaintiffs must have expert testimony that Lipitor causes, or is capable of causing, diabetes at particular dosages.” (CMO 49, Dkt. No. 1197 at 11). Over Defendant’s strenuous objections, the Court re-opened expert discovery and allowed additional time for Plaintiffs to serve supplemental reports offering opinions as to whether Lipitor causes diabetes at dosages of 10 mg, 20 mg, 40 mg, and 80 mg. (See id.). The parties served supplemental expert reports on general causation in December of 2015 and January of 2016, and then filed' supplemental briefs on Pfizer’s motion to exclude Plaintiffs’ general causation expert testimony in February of 2016. (See CMO 50, Dkt. No. 1230; CMO 60, Dkt. No. 1318). The Court heard additional oral argument on March 18, 2016. (Dkt. No. 1460).
In a forty-page order issued on March 30, 2016, the Court ultimately excluded Plaintiffs’ expert opinions on general causation, except for the opinion of Plaintiffs’ epidemiologist, Dr. Singh, that Lipitor 80 mg causes diabetes. (CMO 68, Dkt. No. 1469). The Court found "Dr, Singh’s 10 mg opinion was not based on sufficient facts and data and that Dr. Singh did not reliably apply the epidemiological/Bradford Hill method because this method requires a statistically significant association be established through studies and such studies do not exist for Lipitor 10 mg. (Dkt. No. 1469 at 15-16). Plaintiffs conceded that Dr. Singh could not offer an opinion at Lipitor 20 mg or Lipitor 40 mg if the Court excluded his opinion regarding Lipitor 10 mg. (Id. at 24).
The Court also excluded the opinions of Dr. Quon, an endocrinologist who ostensibly reached his conclusion via a literature review but who admittedly cherry-picked studies to support his conclusion rather than considering the totality of the literature, (id. at 27-34); Dr. Roberts, a cardiologist, who claimed' in her report to use the Bradford Hill method used by epidemiologists but who seemed to misunderstand the methodology’s basic premise in deposition, who cherry-picked studies for consideration and failed to consider contrary evidence, and who failed' to provide any analysis of'particular dosages as required by CMO 49, (id. at 34-38); and Dr. Gale, who faded to provide any analysis of particular dosages as required by CMO 49 and who ascribed the risk observed at Lipitor 80 mg to all dosages of Lipitor. (Id. at 38-39). Thus, the only admissible opinion on general causation is Dr. Singh’s opinion regarding Lipitor 80 mg.
2. Specific Causation
Diabetes is a complicated and progressive disease, and a number of factors, including genetics, diet, exercise, age, and weight play a significant role in the development of new onset diabetes. (See, e.g., Dkt. No. 972 at 16-22, Dkt. No. 1047 at 9-12; Dkt. No. 1004-3 at 325-26). This makes teasing out the role of Lipitor, if there is one, in the development of a particular patient’s diabetes difficult. Interestingly, none of Plaintiffs’ general causation experts could think of a method to determine whether a particular patient’s diabetes was caused by Lipitor or caused by other risk factors and testified that they themselves could not determine whether a particular patient’s diabetes was caused by Lipitor. Plaintiffs’ specific causation experts have never diagnosed a patient with
Plaintiffs in this MDL are not the first to grapple with the problems of proving causation where the alleged injury is a complicated, progressive, multi-factor disease like diabetes. In Guinn v. AstraZeneca Pharm. LP,
Similarly, in Haller v. AstraZeneca Pharm. LP,
The first bellwether Plaintiff, Plaintiff Daniels, proffered the testimony of Dr. David Handshoe on the issue of specific causation. The second bellwether Plaintiff, Plaintiff Hempstead proffered the testimony of both Dr. Handshoe and Dr. Murphy on the issue of specific causation. Pfizer moved to exclude the testimony of both experts, (Dkt. Nos. 1004, 1006), and the Court held two separate days of oral argument on these motions in October and December of 2015. (Dkt. Nos. 1196, 1273).
On December 11, 2015, the Court issued CMO 55, excluding the testimony of Dr. Murphy. (Dkt. No. 1283). Dr. Murphy determined that the most reliable data suggested a relative risk ratio of developing diabetes while taking Lipitor to be around 1.6. (Dkt. No. 1006-3 at 49). Using this estimate of relative risk, 63% of the people who take Lipitor and develop diabetes would have done so in the absence of Lipitor, whereas 37% of the people who take Lipitor and develop diabetes did so only because they took Lipitor.
Dr. Murphy testified that Plaintiff Hempstead’s BMI, adult weight gain, family history, age, and hypertension were all significant or substantial contributing factors in Plaintiff Hempstead’s development of diabetes. (Dkt. No. 1275-2 at 185, 186, 247). Dr. Murphy’s opinion that Lipitor was also a substantial contributing factor
On May 11, 2016, the Court issued CMO 76, excluding the testimony of Dr. Hand-shoe in both this case and the Daniels case. Dr. Handshoe testified that the best estimate of the relative risk ratio for diabetes associated with statin use was 1.25. (Dkt. No. 1004-6 at 238-39). Using this estimate of relative risk, 80% of the people who take Lipitor and develop diabetes would have done so in the absence of Lipitor, whereas 20% of the people who take Lipitor and develop diabetes did so only because they took Lipitor. Thus, the Court turned to Dr. Handshoe’s methodology for concluding that Plaintiffs Daniels and Hempstead were in the 20% that developed diabetes due to Lipitor, rather than the 80% that would have done so regardless. (Dkt. No. 1517 at 7-8). Interestingly, Dr. Handshoe testified that if he walked into a room of 100 patients with diabetes, he could not pick out which ones would have “statin induced diabetes” as opposed to “non-statin induced diabetes.” (Dkt. No. 1004-6 at 163). He testified he could not do this with ten people or with two people. (Id.). Thus, the Court was curious how he accomplished it in the cases of Ms. Daniels and Ms. Hempstead.
With regard to Ms. Hempstead, Dr. Handshoe stated that he felt her overweight BMI was “not clinically significant given that ... she had multiple normal blood sugars even with this weight.” (Dkt. No. 1004-42 at 109). He testified that he did not know whether adult weight gain increased a patient’s risk of diabetes and, therefore, did not consider it. (Dkt. No. 1004-42 at 109, 110). Dr. Handshoe acknowledged that Plaintiff Hempstead’s ethnic background and age increased her risk of diabetes but summarily dismissed these as potential causes of her diabetes based on his “clinical judgment.” (Id. at 142,144, 206-08). Dr. Handshoe simply did not consider other risk factors that he testified were independent risk factors for diabetes, such as hypertension, elevated triglycerides and low HDL. (Id. at 181, 194). In the Daniels case, Dr. Handshoe testified that the diabetes risk factors were additive: “you have this risk, you have that risk, I think the risks are additive. I mean, how can you tease out that only one thing caused’ somebody’s diabetes ...” (Dkt. No. 1004-6 at 134). However, Dr. Handshoe took the opposite position in his deposition in this case. He testified that Lipitor was “the only factor” in Ms. Hemp-stead’s development of diabetes, finding that all other factors were “not significant to my clinical judgment.” (Id. at 236, 237). He testified that his analysis was based solely on temporal relationship: Ms. Hempstead took Lipitor and developed diabetes after taking Lipitor. (Id. at 145-46). The Court excluded Dr. Handshoe’s testimony as unreliable for multiple reasons in CMO 76. (Dkt. No. 1517).
In their response to this summary judgment motion and in response to the summary judgment motions filed in the two bellwether eases on the same day in this MDL, Plaintiffs raise for the first time the argument that they can survive summary judgment on both general and specific causation without expert testimony. Plaintiffs argue that Defendant has admitted that Lipitor can cause Type 2 diabetes at doses lower than 80 mg and that these alleged admissions are competent evidence of general causation. (Dkt. No. 1586 at 15-26). With regard to specific causation, Plaintiffs argue that they may be able to survive summary judgment with some evidence other than expert testimony and argue that the Court should remand all of the cases in the MDL back to the transferor courts for those courts to take up the issue on specific causation. The Court addresses each argument in turn.
II. Legal Standard
Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Only material facts-those “that might affect the outcome of the suit under the governing law”—will preclude the entry of summary judgment. Anderson v. Liberty Lobby, Inc.,
At the summary judgment stage, the court must “construe the evidence, and'all reasonable inferences that may be drawn from such evidence, in the light most favorable to the nonmoving party.” Dash v. Mayweather,
Ill, Discussion
Here, Defendant has moved for summary judgment on the basis that Plaintiffs have no evidence to support two essential elements of her claims—general and specific causation. “Rule 56(c) mandates the entry of summary judgment ... against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett,
A. General Causation
As explained above, th’e Court 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). Because Plaintiffs at issue here were prescribed and ingested Lipitor is dosages of less than 80 mg prior to their diabetes diagnosis, they have no admissible expert testimony regarding general causation. However, Plaintiffs argue that alleged admissions by Defendant are sufficient to survive summary judgment.
Specifically, Plaintiffs argue that four pieces of evidence constitute admissions by Defendant that Lipitor can cause diabetes at dosages less than 80 mg:
(1) An email from Senior Vice President David DeMicco;
(2) the U.S. Lipitor label stating that “[ijncreases in HbAlc and fastingserum glucose levels have ^ been reported with [statins], including LIP-ITOR”;-
(3) Parke-Davis’s9 New Drug Application (NDA) data showing that Lipitor was associated with increases in blood glucose levels;
(4) The official Lipitor website, which states that “[e]levated blood sugar levels have been reported with sta-tins, including LIPITOR”; and
(5) Pfizer’s Japanese label insert for Lipitor.
(Dkt. No. 1586 at 16). Plaintiffs argue that these pieces of evidence are admissible under Rule 801(d)(2) for the truth of the matter asserted. Except for the Japanese label, Pfizer does not dispute the admissibility of the evidence put forward by Plaintiffs.
1. Eñe Question
Plaintiffs generally argue that state substantive law controls whether expert evidence of causation is needed to survive summary judgment in products liability cases.
“Under the familiar Eñe doctrine, [courts] apply state substantive law and federal procedural law when' reviewing state-law claims.” Kerr v. Marshall Univ. Bd. of Governors,
The substantive elements of a state claim, including the applicable standard of care, whether the standard has been violated, and whether the alleged violation is
In other words, while the question of whether evidence is sufficient to survive summary judgment is generally a matter of federal procedural law, “the ‘expert testimony’ rule” may be “so closely interrelated with the substantive cause of action ... that federal courts sitting in diversity cases should apply the state rule in order to fully realize state substantive policy.” Hemingway v. Ochsner Clinic,
To the extent that state substantive law requires causation to be established by expert testimony, it is also a question of state substantive law whether party-opponent admissions can substitute for expert evidence of causation. In re Mirena,
2, Expert Testimony is Required Under State Substantive Law.
As an initial matter, Plaintiffs dispute whether state substantive law requires expert testimony in this instance. Plaintiffs argue that state law “reflects a spectrum of subtly varying rules” that ranges from the requirement of expert testimony to no requirement at all. (Dkt. No. 1586 at 27). The variance is not nearly as great as Plaintiffs would have the Court believe.
While the specific language used by courts vary to some degree, all jurisdictions require expert testimony at least where the issues are medically complex and outside common knowledge and lay experience. See, e.g., Ex parte Trinity Indus., Inc.,
(expert testimony required where “lay jurors are ill prepared to evaluate complicated technical data for the purpose of determining ... whether there is a causal relationship between the violation of a duty and an injury to the patient”), aff'd, 79 Hawai’i 362,
(“Expert opinion is required to prove causation if the issue is outside the realm of common knowledge.”); Walton v. Jones,
(“Except as to questions of cause and effect which are so apparent as to be matters of common knowledge, the issue of causal connection between an injury and a specific subsequent physical disability involves a scientific inquiry and must be established by the opinion of medical witnesses competent to express such opinion.”) (emphasis in original); Hollander v. Sandoz Pharm. Corp.,
To be sure, Plaintiffs are correct that there are instances where expert testimony is not required to prove causation, but those circumstances—where a lay juror can infer causation from common knowledge and lay experience—are not present here. Such circumstances include an immediate onset of symptoms that naturally follow from an accident or a complete lack of any other possible cause. E.g., Turner v. Iowa Fire Equip. Co.,
On the other hand, the effects of drugs on the human body and the causation of a complicated, progressive diseases like diabetes do require expert testimony. See, e.g., Hollander,
Here, expert testimony is certainly required. Diabetes is a complicated, pro
3. Admissions Cannot Substitute for Expert Testimony When Required Under State Law.
The Court can find no state law cases that shed light on the question of whether party opponent admissions can substitute for expert testimony when it is normally required. Thus, the Court turns to few cases in the county to have addressed the issue.
This “novel argument” that party opponent admissions can substitute for expert testimony was raised in the Meridia MDL and “ereate[d] an issue of first impression” for the Meridia MDL court. In re Meridia Prod. Liab. Litig.,
With regard to blood pressure, the label stated “MERIDIA SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS .." Id. at 810. The Meridia court held this language constituted “admissions of Meridia’s potential to cause substantial increases in blood pressure in some patients” and held this was sufficient to survive summary judgment on general causation. Id. (emphasis in original). Importantly, however, the Meridia court went on to hold that:
The insert lists the other conditions as being “associated” with Meridia. Such admissions of temporal associations (or reports of temporal associations) are insufficient to create admissions of causation. Therefore, Plaintiffs have met their burden of showing a genuine issue of material fact only with respect to Meri-dia’s capacity to cause substantial increases in blood pressure. For all other conditions, Plaintiffs have not met their burden. The Court therefore GRANTS Defendants’ motion for summary judgment with regard to all tort claims involving harms not related to increased blood pressure.
Id. The Meridia court went on to grant summary judgment with regard to the blood pressure claims, holding that the language with regard to increased blood pressure was a ■ sufficient warning as a matter of law. Id. at 814.
The Sixth Circuit’s affirmance in the Meridia ease found “no fault with the district court’s treatment of the causation factor.” Meridia Prod. Liab. Litig. v. Abbott Labs.,
A review of the cases cited by Plaintiffs—as well as common sense—suggest that if it is conceivable at all that a statement by a party opponent could be used in place of expert testimony to prove causation, the circumstances in which this might occur would be exceedingly rare, especially in the pharmaceutical or medical contexts .... the most that can be wrung from the authority cited by Plaintiffs is that if admissions could ever substitute for expert testimony in a complex case that requires expert testimony as to causation under state law, those admissions would have to be clear, unambiguous, and concrete, rather than an invitation to the jury to speculate as to their meaning.
In re Mirena IUD Prod. Liab. Litig., No. 13-MC-2434 (CS),
no court has held that admissions can substitute for required expert testimony, and this Court will not be the first. Such a ruling would disregard the purpose of the requirement for expert testimony, leaving jurors to speculate, and would chill free and frank discussion by manufacturers of drugs or devices.
Id. at 320,
there may be myriad reasons, including an abundance of caution or the avoidance of lawsuits, why a manufacturer may warn of a possible phenomenon without being convinced that it is a genuine risk, and permitting the label to substitute for expert testimony here would present a wholly conjectural basis for a jury to determine general causation. And allowing a label to substitute for expert testimony would discourage manufacturers from exercising caution, providing potential users with less information rather than more where the science is debatable, a result mimical to the public health.
Id. at 323,
Defendants’ labeling changes and notification letters merely relayed information about a possible association between their drug and optic neuropathy. Spontaneous reporting by a pharmaceutical company should be encouraged; it serves “as a signaling system for adverse drug reactions that may not have been detected during pre-market testing.” Haggerty v. Upjohn Co., 950 F.Supp. 1160 , 1164 (S.D.Fla.1996). Such reporting does not, however, indicate causation.
Nelson v. Am. Home Prod. Corp.,
4. DeMicco Email
The primary piece of evidence relied on Plaintiffs is a one-sentence email by Pfizer VP, Dr. DeMicco sent on September 27, 2009. On September 25, 2009, Dr. DeMicco sent an earlier email to Dr. David Waters at the University of California, San Fransi-co, with the statistical analysis for the occurrence of diabetes in SPARCL.
I would draw these conclusions based on this data:
1. Atorvastatin increases the risk of developing diabetes.
2. The risks of 10 and 80 mg are similar.
3. Fasting blood sugar and features of the metabolic syndrome are strong predictors of the development of diabetes in both populations.
First, this email is, at best, evidence of an association, not causation. An association does not equal causation, and epidemiologists engage in a rigorous analysis of multiple factors to determine whether an association is causal.
Plaintiffs argue that the statement “increases the risk” is synonymous with “causes,” and thus, they argue, Dr. DeMic-co’s statement, “I concur with your assessment” is an admission that Lipitor causes diabetes. Plaintiffs are “follow[ing] human nature, which is to confuse association and causation.” Siharath v. Sandoz Pharm. Corp.,
These emails discuss a statistical analysis that, as the later published article on the data states, found that the 80 mg dose of Lipitor “is associated with a slightly increased risk of new-onset [type 2 diabetes].” (Dkt. No. 972-29 at 2) (emphasis added). This increased statistical risk was shown by a hazard ratio of 1.37, with a 95% confidence interval of . 1.08 to 1.75. (Id.). A hazard ratio, like a relative risk ratio or odds ratio, is a “measure of association used in epidemiology.” RSME at 295 (defining relative risk) (emphasis added); see also RSME at 291 (defining odds ratio and describing it as a “measure of association, often used in epidemiology”). As a statistical analysis comparing two groups, all it can show is an association, i.e. a correlation or increased risk; it cannot show causation. See In re Neurontin Mktg., Sales Practices, & Prod. Liab. Litig.,
Explained in another way, “risk” is “[a] probability that an event will occur.” RSME at 627. An “increased risk” is an “increased probability that an event will occur.” Here, diabetes is more probable, more likely to occur, in the group taking Lipitor. This is the very definition of an association, and says nothing about causation. See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod.
[t]he degree of statistical relationship between two or more events or variables. Events are said to be associated when they occur more or less frequently together than one would expect by chance. Association does not necessarily imply a causal relationship.
RMSE at 619.
The Reference Manual on Scientific Evidence provides an analogous example. Studies found that women with herpes were more likely to develop cervical cancer than other women. RMSE at 219. In other words, herpes increased the risk of cervical cancer; having herpes increased' the probability that women would develop cervical cancer. Some assumed this association was causal. However, “[ljater research showed that the primary cause of cervical cancer was a human papilloma virus (HPV),” and that herpes was simply a marker of sexual activity, not the cause of cervical cancer. Id.
Here, viewing the evidence in the light most favorable to Plaintiffs,
Furthermore, even if the one-sentence email indicated that Dr. DeMicco thought
Finally, in Meridia, the court assumed state law did not require expert testimony. Id. at 802. By contrast this Court has found that state substantive state law requires expert testimony to prove general causation in this case. “[A] federal court in the exercise of its diversity jurisdiction should act conservatively when asked to predict how a state court would proceed on a novel issue of state law.” Rhodes,
5. Evidence Regarding Blood Glucose
The next three pieces of evidence are (1) statements of association only and (2) statements regarding blood glucose, not diabetes. The U.S. Lipitor label states that “increases in HbAlc and fasting serum glucose levels have been reported with [statins], including LIPITOR.” (Dkt. No. 1586-9). This statement never mentions diabetes, only blood glucose levels, and the two are not synonymous. (See Dkt. No. 1159 at 12 stating that “diagnosis of diabetes requires more than a single elevated plasma glucose level”). Furthermore, the language “have been reported” indicates temporal association, not causation. For both reasons, it fails to create a genuine issue of material fact as to whether Lipitor causes diabetes in dosages less than 80 mg.
Next, Plaintiffs point to the NDA data allegedly showing that Lipitor was associated with increases in blood glucose levels. Again, increased blood glucose levels are not synonymous with full blown diabetes, and the data only indicates, at best, an association, not causation.
6. Japanese Label
Finally, Plaintiffs point to the Japanese label insert for Lipitor. The Japanese label states that “[h]yper-glycemia and diabetes melitis may occur .... ” (Dkt. No. 1586-5 at 4). Again, this is not a clear statement that Lipitor causes diabetes, like in Meridia, but an acknowledgement of a possible association. See In re Zoloft,
Regardless, it cannot be used to replace state substantive law requiring expert testimony. Unlike the U.S. label in Meridia, the Japanese label change at issue here was ordered by Japanese officials, specifically Japan’s Ministry of Health Labor, and Welfare (MHLW), “without even discussing it with [the Japanese lieensee/dis-tributor of Lipitor].” (Dkt. No. 1761-3 at 193). There is no evidence in the record that Pfizer had any input regarding the inclusion, or wording of, the statement placed on the Japanese label or that Pfizer manifested a belief in its accuracy. Indeed, as Plaintiffs point out, Pfizer disagreed with the label change, but it went into effect anyway. (Dkt. No. 1181 at 5; Dkt. No. 1761-2 at 9-10). In short, the statement is one by MHLW, not Pfizer, and is not an admission by Pfizer.
While such a label change may have relevance to Pfizer’s knowledge of adverse events, the purpose for which Plaintiffs’ originally intended to introduce it,
B. Specific Causation
1. Expert Testimony is Required.
As explained above, all jurisdictions at issue here require expert testimony at least where the issues are medically complex and'outside common knowledge and lay experience. Courts have held that effects of drugs on the human body and the causation of a complicated, progressive diseases like diabetes do require expert testimony.
Here, expert testimony is certainly required. Diabetes is a complicated, progressive disease with a number of risk factors. Plaintiffs general causation experts cannot even figure out how to determine whether an individual’s diabetes was caused by Lipitor or other factors, and Plaintiffs specific causation expert cannot determine which people in a room of 100 people or 10 people had “statin-induced” diabetes as opposed non-statin-induced diabetes. (Dkt. No. 1004-1 at 210-11; Dkt. No. 1004-4 at 162; Dkt. No. 1004-5 at 71; Dkt. No. 1004-6 at 163). If these experts cannot make this determination, it is certainly not within the common knowledge of a lay person. A jury’s finding of causation in the absence of any expert testimony would be based on impermissible speculation or conjecture. Dash,
2. Expert Testimony on General Causation Combined with Non-expert Evidence
Plaintiffs next argue that in some jurisdictions, a plaintiff can survive summary judgment with a combination of (1) specific causation expert testimony that a substance is a possible cause of a plaintiffs injury and (2) “non-expert evidence.” (Dkt. No. 1586 at 29). Again, this statement is true as far as it goes, but is not applicable here. See, e.g., Benkendorf v. Advanced Cardiac Specialists Chartered,
The non-expert evidence present in these cases is probative of causation and, at least in combination with expert testimony on a “possible causes,” is sufficient for a jury to infer causation without engaging in speculation; indeed, this non-expert evidence often consists of the same type of evidence that is sufficient to get to a jury without any expert testimony, such as in the case of immediate onset of symptoms. See, e.g., Smith v. Hines,
However, for the cases at issue here, Plaintiff have not produced any expert evidence at all, not even expert evidence that Lipitor is a possible cause of diabetes. To the extent Plaintiffs attempt to rely on relative risk estimates of Dr. Murphy and Dr. Handshoe, Plaintiffs never disclosed
Furthermore, even if Plaintiffs had such expert testimony, they have not pointed to any probative, non-expert evidence to combine with it. Plaintiffs first state that “the MDL includes numerous patients with no history of diabetes prior to their initial Lipitor exposures.” (Dkt. No. 1586 at 39). This is undoubtedly time. It is impossible that Lipitor would have caused a Plaintiffs diabetes if she developed the disease prior to ever taking the drug. However, the converse of this statement is not true. Plaintiffs may have developed diabetes after taking Lipitor, after having a grandchild, after tasting creme brulee for the first time, or after she turned 65. However, the fact that Plaintiff developed diabetes after these events does allow a reasonable jury to infer causation, without speculation and conjecture. See Westberry v. Gislaved Gummi AB,
“[Depending on the circumstances, a temporal relationship between exposure to a substance and the onset of a disease or a worsening of symptoms can provide compelling evidence of causation.” Westberry,
But such circumstances are not present here. Plaintiffs here developed diabetes months or years after taking Lipitor and while they had other substantial risk factors for the disease.
3. Hayes Law Firm Plaintiffs
These Plaintiffs submitted their Plaintiff Fact Sheets (PFSs) and certain medical records. (Dkt. Nos. 1670, 1682,
4. Douglas & London Plaintiffs
These Plaintiffs did not initially submit any evidence to the Court and simply submitted a separate brief that argued that summary judgment was precluded by.
(a) their respective health history and conditions as documented in their medical records, pharmacy records and/or other relevant records;
(b) their respective Plaintiff Fact Sheets (“PFS’s”) that have already been served on Defendants and any and all amendments thereto;
(c) the general causation evidence identified and discussed in Plaintiffs’ Opposition to Defendants’ Omnibus Motion for Summary Judgment dated July 22, 2016 [Dkt. 1586]; and ■
(d)the substantive state law that applies to each D&L Plaintiffs respective claims.
(Dkt, No. 1689 at 5 (footnotes omitted)). The Court entered a text order stating that these Plaintiffs must file any evidence that they wished to the Court to consider. (Dkt. No. 1695). In response, Plaintiffs literally dumped boxes upon boxes of documents on the Court, with no discernment or suggestion as to which documents they claimed precluded summary judgment. (Dkt. Nos. 1.698, 1700, 1701, 1702, 1703, 1704, 1705, 1706). Nevertheless, the Court reviewed these documents as well, almost all of which were completely irrelevant. The Court has found nothing in these records that would create an issue of fact as to causation, and Plaintiffs have pointed to none. Therefore, the Court enters summary judgment as to these Plaintiffs as well.
C. The Court Need Not Suggest Remand
The PSC and the specific Plaintiffs who responded to CMO 82, complain that the Court has overstepped its role as- an MDL court by addressing specific causation; Plaintiffs cite MDL courts that have declined to address “cumbersome, case-specific legal issues.” In re Phenylpropanolamine Prod. Liab. Litig., No. MDL 1407,
However, it is equally clear that “[a]n MDL transferee judge has authority to dispose of cases on the merits-for example, by ruling on motions for summary judgment.” Manual for Complex Litigation, § 22.36 (4th ed. 2004); accord In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig.,
As the United States "Supreme Court recently noted in a unanimous decision, “Congress anticipated that, during the pendency of pretrial proceedings, final decisions might be rendered in one or. more of the actions consolidated pursuant to § 1407,” by specifying that “ ‘at or before the conclusion of .,. pretrial proceedings,’ each of the transferred actions must be remanded to the originating district ‘unless [the action] shall, have been previously terminated.’ ” Gelboim v. Bank of Am. Corp., — U.S. -,
In considering whether the Court should rule on such motions prior to transfer, the Court considers the “aims” of Section 1407 to “eliminate duplication in discovery, avoid conflicting rulings and schedules, reduce litigation cost, and save the time and effort of the parties, the attorneys, the witnesses, and the courts.” Gelboim,
IV. Conclusion
For the reasons stated above, Defendant’s Omnibus Motion for Summary Judgment, (Dkt. No. 1564), is GRANTED IN PART. The Court GRANTS Defendant’s motion as to Plaintiffs’ claims listed in Appendix 1, and these claims are DISMISSED WITH PREJUDICE.
AND IT IS SO ORDERED.
Appendix 1
Notes
. Unless otherwise stated, the docket numbers in this Order refer to the MDL Docket, Case No. 2:14-cv-2502.
. This Order addresses the motion with regard to Plaintiffs who allegedly ingested dosages of Lipitor less than 80 mg. The claims of other Plaintiffs are addressed in CMO 99.
. In most of these cases, the parties agree, for the purposes of this motion only, that these Plaintiffs ingested Lipitor in dosages of less than 80 mg prior to diagnosis of diabetes. (Dkt. Nos. 1658, 1680, 1748). In other cases, the parties agree that Plaintiffs allege preexisting diabetes, i.e., that Plaintiffs were diagnosed with diabetes prior to taking Lipitor. (Dkt. No. 1680). For the cases where the parties agree that Plaintiffs were diagnosed with diabetes prior to ingesting Lipitor, it is impossible that Lipitor caused their diabetes, and the Court grants summary judgment on this ground as well.
. For an in depth discussion of relative risk and its' implications, see CMO 55, Dkt. No. 1283.
. The Court also noted that Plaintiffs had not "stated how long they need to marshal this evidence or suggested any proposed timeline for obtaining it.” (Id. at 8 n.5).
. See CMO 68, Dkt. No. 1469, for a full description of the data and studies relied upon by Plaintiffs’ experts.
. For an in depth discussion of relative risk and its implications, see CMO 55, Dkt. No. 1283. For purposes of the motion to exclude Dr. Murphy’s testimony, the Court assumed that general causation could be established. (Dkt. No. 1283 at 1).
. Ms. Hempstead began taking Lipitor in 1998 and was diagnosed with diabetes in 2004. (Dkt. No. 1004-34 at 4, 5).
. Parke-Davis is the predecessor of Pfizer.
. Pfizer has filed a motion in limine to exclude the Japanese label. (Dkt. No. 1163).
. Indeed, one of the reasons Plaintiffs argue that the Court should suggest remand of all cases to their transferor courts for resolution of specific causation issues is that state law controls this question. (Dkt. No. 1586 at 35-43).
.Indeed, this is the standard cited by the Court above as the legal standard governing the motion at issue.
. See, e.g., Lewis v. Johnson & Johnson,
. If the Court's ruling is incorrect, and Plaintiffs are correct that Fed. R. Civ. P. 56 supersedes any state law on what type of evidence is required to survive summary judgment, then that rule would also apply here. Federal law, under Rule 56, would govern whether expert testimony is required to survive summary judgment, and the Court need not engage iri the 53 jurisdiction analysis below but simply rely on the ample federal precedent that expert testimony is required when medical causation is outside the common knowledge of lay jurors. See, e.g., Chapman v. Procter & Gamble Distrib., LLC,
. Plaintiffs rely heavily on New Mexico, pointing to one products liability cases that survived summary judgment without direct expert testimony on specific causation. This case, Carter Farms Co. v. Hoffman-Laroche, Inc.,
. In Meridia, ”[r]ather than undertake an analysis of all fifty states’ laws to determine which do and which do not require expert testimony on the issue of general causation,” the court assumed “arguendo that no states’ laws erect such a requirement.” Id. at 802.
. Such substantive policy implications reinforces the Court's conclusion that to the extent substantive state law requires expert testimony to prove a particular element of claim, state law also determines whether alleged admissions can substitute for such expert testimony.
. The other two cases cited by Plaintiffs are inapposite. In Westberry v. Gislaved Gummi AB,
the issue was not whether the MSDS statement could substitute for expert testimony. Rather, the comment regarding the MSDS was made in the context of evaluating whether the plaintiffs’ expert had a sufficient basis for his specific causation opinion. The Westberry court's discussion shows no more than that an MSDS is properly considered by an expert. Nothing in West-berry suggests that a manufacturer’s statement suffices to defeat summaiy judgment in the absence of expert testimony.
Mirena,
In Lewis v. Johnson & Johnson,
. SPARCL was a randomized clinical trial that tested whether Lipitor was effective for reducing the incidence of stroke in patients who had previously had a stroke or TIA. (Dkt. No. 972-28). Participants were randomly assigned to 80 mg of Lipitor or a placebo. (Id. at 2). Diabetes was not an endpoint in this study, but adverse event information was collected, and Pfizer conducted a post hoc analysis of the data. (Dkt. No. 972 at 24). A post hoc analysis of data from the clinical trial found a statistically significant increase in the risk of diabetes for patients randomized to 80 mg of Lipitor versus those on placebo. (Dkt. No. 972-29 at 2).
. These factors are (1) strength of the association, (2) replication of the findings, (3) specificity of the association, (4) temporal relationship, (5) dose-response relationship (aka biological gradient), (6) biological plausibility, (7) consistency with other knowledge (aka coherence), (8) consideration of alternative explanations, and (9) cessation of exposure. Reference Manual on Scientific Evidence 600 (3d. ed. 2011); see also Sir Austin Bradford Hill, The Environment and Disease; Association or Causation?, 58 Proc. Royal Soc’y Med. 295, 295-300 (1965)), available at Dkt. No. 972-32.
. Later in this opinion, the Court stated that Dr. Murphy's opinion was “based only on (1) the fact that Lipitor increases the risk of diabetes (general causation) and (2) that Ms. Hempstead developed diabetes after taking Lipitor.” Id. at 652. With this parenthetical, the Court was emphasizing that information regarding an increase in risk went to the matter of general causation, not specific causation. It was not equating the phrase "increased risk” with general causation.
. Viewing the evidence in the light most favorable to Plaintiff does not require the Court to conflate association and causation. See Llewellyn v. Allstate Home Loans, Inc.,
.Courts have occasionally used “increased risk” as shorthand for general causation when differentiating general causation from specific causation. See Jenkins v. Slidella L.L.C., No. CIV.A.05-370,
. Plaintiffs acknowledge that the U.S, label’s language "is not as supportive of our position” and may not be sufficient alone to survive summary judgment, (Dkt. No. 1634 at 47).
. Whether the data even indicates this is disputed by the parties. However, for the purposes of this motion, the Court assumes the NDA data does indicate an association between Lipitor usage and increased blood glucose levels.
. See Dkt. No. 1181.
. If the mythic state existed that allowed pharmaceutical products liability cases to go to a jury without any expert testimony on causation, it would be a black hole for all such cases. Plaintiffs have not cited a single case in any jurisdiction that has allowed a case to survive summary judgment in circumstances analogous to the ones here.
. Plaintiffs point to one jurisdiction—Pennsylvania—-that has found in medical malpractice cases that expert evidence of an "increased risk of harm” along with evidence that the harm in fact occurred is sufficient to warrant a jury trial. (Dkt. No. 1586 at 33). The Pennsylvania Supreme Court first found such evidence sufficient in a medical malpractice case in Hamil v. Bashline, relying on Section 323 of the Restatement of Torts, a.k.a., the Good Samaritan Rule.
. Every Plaintiff who submitted case-specific evidence in response to Pfizer’s omnibus motion has at least one other, and often multiple other, risk factors for diabetes according the evidence submitted by her.
. The facts listed in Plaintiff’s brief do not . always correspond to the information in the PFS, and the facts in the PFSs (such as Plaintiff’s weight) are often contradicted by Plaintiff’s medical records.
. This decision is in the court’s discretion. Some MDL courts have chosen to address case specific causation issues with regard to motions for summary judgment and suggest remand only after a case has survived a motion for summary judgment. In In re: Asbestos Products Liability Litigation (No. VI), MDL No. 875, the MDL court has addressed at least 791 separate motions for summary judgment in individual cases from a variety jurisdictions. (See http://www.paed.uscourts.gov/ documents/MDL/MDL875/MASTER% 20Ro-