Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

In re Lipitor (Atorvastatin Calcium) Marketing Sales Practices and Products Liability Litigation

United States District Court, D. South Carolina, Charleston Division

December 11, 2015

IN RE: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION

          For In the Matter of Lipitor (Atorvastatin Calcium) Marketing Sales Practices and Products Liability Litigation: H Blair Hahn, LEAD ATTORNEY, Richardson Patrick Westbrook and Brickman, Mt Pleasant, SC.

         For Plaintiffs' Lead H Blair Hahn, LEAD ATTORNEY, Christiaan A Marcum, Elizabeth Middleton Burke, Richardson Patrick Westbrook and Brickman, Mt Pleasant, SC.

         For Plaintiffs' Liason Mark Charles Tanenbaum, LEAD ATTORNEY, Mark C Tanenbaum Law Office, Charleston, SC.

         For Pfizer Inc., Defendant: Amanda S Kitts, John Mark Jones, David Eidson Dukes, LEAD ATTORNEYS, Nelson Mullins Riley and Scarborough, Columbia, SC; Karin Kramer, LEAD ATTORNEY, Quinn Emanuel Urquhart and Sullivan, San Francisco, CA; Kelly A Evans, LEAD ATTORNEY, Snell and Wilmer, Las Vegas, NV; Lee A Mickus, LEAD ATTORNEY, PRO HAC VICE, Snell and Wilmer, Denver, CO; Lyn Peeples Pruitt, LEAD ATTORNEY, Mitchell Williams Selig Gages and Woodyard, Little Rock, AK; Mara C Cusker Gonzalez, Mark Steven Cheffo, LEAD ATTORNEYS, Lincoln D Wilson, Sheila L Birnbaum, Quinn Emanuel Urquhart and Sullivan, New York, NY; Michael Tucker Cole, Rachel B Passaretti-Wu, LEAD ATTORNEYS, PRO HAC VICE, Nelson Mullins Riley and Scarborough, Charleston, SC; Amy Chung, Lucas Przymusinski, DLA Piper U.S. LLP, New York, NY; Brett M Collings, Theodore VH Mayer, Hughes Hubbard and Reed, New York, NY.

         For McKesson Corporation, Defendant: Emma E Garrison, Habib Nasrullah, Jeremy A Moseley, LEAD ATTORNEYS, Wheeler Trigg O'Donnell LLP, Denver, CO.

         For Greenstone LLC, Defendant: Carole W Nimaroff, George A Tsougarakis, LEAD ATTORNEY, Hughes Hubbard and Reed, New York, NY; Mark Steven Cheffo, LEAD ATTORNEY, Quinn Emanuel Urquhart and Sullivan, New York, NY; Brett M Collings, Theodore VH Mayer, Hughes Hubbard and Reed, New York, NY.

         For Pfizer International LLC, Defendant: Carole W Nimaroff, George A Tsougarakis, LEAD ATTORNEYS, Hughes Hubbard and Reed, New York, NY; Loren H Brown, LEAD ATTORNEY, DLA Piper U.S. LLP, New York, NY; Brett M Collings, Theodore VH Mayer, Hughes Hubbard and Reed, New York, NY.

         For Laura McCammon, Interested Party: John T Lay, LEAD ATTORNEY, Gallivan White and Boyd, Columbia, SC; Joseph D Cohen, LEAD ATTORNEY, PRO HAC VICE, Porter Hedges, Houston, TX.

         CASE MANAGEMENT ORDER NO. 55

          Richard Mark Gergel, United States District Judge.

         This Order relates to:

          Hempstead v. Pfizer, Inc., 2:14-cv-1879

         In this MDL, Plaintiffs allege that Lipitor caused them to develop Type 2 diabetes. To carry their burden, Plaintiffs must prove both general and specific causation. Westberry v. Gislaved Gummi AB, 178 F.3d 257, 263 (4th Cir. 1999). The Court will address Plaintiffs' general causation testimony by separate order. The Court makes no finding here as to whether the testimony of Plaintiffs' general causation experts is admissible or whether Plaintiffs can survive summary judgment on the issue of general causation in this particular case. For the purposes of this motion, the Court assumes that general causation can be established in this case and turns to Plaintiffs' specific causation expert testimony.

         Plaintiff has disclosed two case-specific expert witnesses in this bellwether case, Dr. Daniel Handshoe and Dr. Elizabeth Murphy. Both experts opine that Lipitor caused, or was a substantial contributing factor of, Ms. Hempstead's Type 2 diabetes. Pfizer has moved to exclude the testimony of both experts. (Dkt. Nos. 1004, 1006). Here, the Court addresses Pfizer's motion to exclude the testimony of Dr. Elizabeth Murphy. (Dkt. No. 1006).

         I. Legal Standard

         Under Rule 104(a) and 702, " the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Thus, the trial court must ensure that (1) " the testimony is the product of reliable principles and methods," that (2) " the expert has reliably applied the principles and methods to the facts of the case," and (3) that the " testimony is based on sufficient facts or data." Fed.R.Evid. 702(b), (c), (d). " This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid," Daubert, 509 U.S. at 592-93, and whether the expert has " faithfully appl[ied] the methodology to facts." Roche v. Lincoln Prop. Co., 175 Fed.Appx. 597, 602 (4th Cir. 2006)

         Factors to be considered include " whether a theory or technique . . . can be (and has been) tested," " whether the theory or technique has been subjected to peer review and publication," the " known or potential rate of error," the " existence and maintenance of standards controlling the technique's operation," and whether the theory or technique has garnered " general acceptance." Daubert, 509 U.S. at 593-94; accord United States v. Hassan, 742 F.3d 104, 130 (4th Cir. 2014). However, these factors are neither definitive nor exhaustive, United States v. Fultz, 591 Fed.Appx. 226, 227 (4th Cir. 2015), cert. denied, 135 S.Ct. 2370, 192 L.Ed.2d 159 (2015), and " merely illustrate[] the types of factors that will bear on the inquiry." Hassan, 742 F.3d at 130. Courts have also considered whether the " expert developed his opinions expressly for the purposes of testifying," Wehling v. Sandoz Pharms. Corp., 162 F.3d 1158 (4th Cir. 1998), or through " research they have conducted independent of the litigation," Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317 (9th Cir. 1995) (on remand), and whether experts have " failed to meaningfully account for . . . literature at odds with their testimony." McEwen v. Baltimore Washington Med. Ctr. Inc., 404 Fed.Appx. 789, 791-92 (4th Cir. 2010).

         Rule 702 also requires courts " to verify that expert testimony is 'based on sufficient facts or data.'" E. E. O. C. v. Freeman, 778 F.3d 463, 472 (4th Cir. 2015) (quoting Fed.R.Evid. 702(b)). Thus, " trial judges may evaluate the data offered to support an expert's bottom-line opinions to determine if that data provides adequate support to mark the expert's testimony as reliable." Id. The court may exclude an opinion if " there is simply too great an analytical gap between the data and the opinion offered." Id. " The proponent of the [expert] testimony must establish its admissibility by a preponderance of proof." Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001).

         The Court is mindful that the Daubert inquiry involves " two guiding, and sometimes competing, principles." Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999). " On the one hand, . . . Rule 702 was intended to liberalize the introduction of relevant expert evidence," id., and " the trial court's role as a gatekeeper is not intended to serve as a replacement for the adversary system." United States v. Stanley, 533 Fed.Appx. 325, 327 (4th Cir. 2013) cert. denied, 134 S.Ct. 1002, 187 L.Ed.2d 852 (2014). On the other, " [b]ecause expert witnesses have the potential to be both powerful and quite misleading, it is crucial that the district court conduct a careful analysis into the reliability of the expert's proposed opinion." United States v. Fultz, 591 Fed.Appx. 226, 227 (4th Cir.) cert. denied, 135 S.Ct. 2370, 192 L.Ed.2d 159 (2015); accord Westberry, 178 F.3d at 261.

         II. Ms. Hempstead's Medical History and Diagnosis of Diabetes

         Juanita Hempstead began seeing primary care physician Dr. Lou Sabih in January of 1998. (Dkt. No. 1275-1 at 9). In March of 1998, Dr. Sabih ordered a lipid panel, which showed that Ms. Hempstead had total cholesterol of 243 mg/dL, LDL of 151 mg/dL, HDL of 41 mg/dL, and triglycerides of 255 mg/dL.[1] ( Id. ). In response to these labs, Dr. Sabih prescribed 20 mg of Lipitor daily. ( Id. ). Because of apparent concerns about possible liver toxicity, Ms. Hempstead did not start taking Lipitor at that time. ( Id. ).

         Over a year later in June of 1999 (and after adjustments to her blood pressure medication), Ms. Hempstead had another lipid panel, which showed Ms. Hempstead had a total cholesterol of 250 mg/dL, LDL of 175 mg/dL, HDL of 46 mg/dL, and triglycerides of 142 mg/dL. ( Id. at 10). Ms. Hempstead weighed 176 lbs at the time and had a body mass index (BMI) of 26.37.[2] ( Id. ). Her glucose measurement at the time was 97 mg/dL.[3] ( Id. ). Ms. Hempstead was again prescribed 20 mg of Lipitor daily. ( Id. ). Ms. Hempstead took Lipitor inconsistently over the next year. ( Id. ). Pharmacy records indicate that she did not refill the prescription at all between January and July of 2000. ( Id. ).

         In July of 2000, Ms. Hempstead began taking Lipitor regularly. ( Id. at 11). In the fall of 2000, Dr. Michael Ausmus became Ms. Hempstead's primary care physician. ( Id. at 10-11). Two years later, in September of 2002, a lipid panel showed Ms. Hempstead had total cholesterol of 179 md/dL, LDL of 111 mg/dL, HDL of 40 mg/dL, and triglycerides of 139 mg/dL. ( Id. at 10). She had an abnormal glucose reading of 114 mg/dL. ( Id. ). She had gained a total of 13 pounds since starting Lipitor in 1999, resulting in a total weight of 184 and a BMI of 27.57. ( Id. ).

         In the fall of 2003, Ms. Hempstead stopped taking Lipitor for three weeks due to abdominal pain. ( Id. at 11). A lipid panel taken after being off Lipitor for approximately three weeks showed Ms. Hempstead's blood lipid levels had risen. She had total cholesterol of 258 mg/dL, LDL of 173 mg/dL, HDL of 46 mg/dL, and triglycerides of 194 mg/dL. ( Id. at 10). Her glucose reading after three weeks off Lipitor was 122 mg/dL. ( Id. ). Three months later, after resuming Lipitor, her lipid levels came back down, with total cholesterol of 176 mg/dL, LDL of 103 mg/dL, HDL of 37 mg/dL, and triglycerides of 179 mg/dL. ( Id. at 10, 11).

         In February of 2004, Ms. Hempstead was seen in the emergency room and diagnosed with colitis. ( Id. at 11). She had a random blood glucose reading of 214 mg/dL, but there was no diagnosis of diabetes. ( Id. ). On May 14, 2004, Ms. Hempstead was admitted to the hospital with a blood glucose level of 613 mg/dL and diagnosed with new-onset diabetes. ( Id. ). She was two weeks shy of her sixtieth birthday. (Dkt. No. 1094 at 8). Ms. Hempstead's weight was not properly recorded during her hospital stay. However, her weight a couple of weeks prior to the hospital stay was 191 pounds, with a BMI of 28.6, and her weight at her first follow-up appointment after the hospital stay was 180 pounds, with a BMI of 27. (Dkt. No. 1275-1 at 10, 11).

         III. The Role of Relative Risk in General and Specific Causation

         Before addressing Dr. Murphy's opinion, it is helpful to review the difference between general and specific causation and how each is proven. " [I]n order to carry the burden of proving a plaintiff's injury was caused by exposure to a specified substance," a plaintiff must demonstrate general and specific causation. Westberry v. Gislaved Gummi AB, 178 F.3d 257, 263 (4th Cir. 1999); Zellers v. NexTech Ne., LLC, 533 Fed.Appx. 192, 196 n.6 (4th Cir. 2013) cert. denied, 134 S.Ct. 911, 187 L.Ed.2d 780 (2014). " General causation is whether a substance is capable of causing a particular injury or condition in the general population and specific causation is whether a substance caused a particular individual's injury." Norris v. Baxter Healthcare Corp., 397 F.3d 878, 881 (10th Cir. 2005). " Plaintiff must first demonstrate general causation because without general causation, there can be no specific causation." Id. ; accord Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 351-52 (5th Cir. 2007).

         The parties agree that epidemiologists use a two-step process for establishing general causation. (Dkt. No. 972 at 27-28; Dkt. No. 1053 at 13); see also Ambrosini v. Labarraque, 101 F.3d 129, 136, 322 U.S.App.D.C. 19 (D.C. Cir. 1996). First, studies must establish an association or correlation between two variables, here, Lipitor and diabetes. If two variables correlate, the incidence of one variable (diabetes) changes with the incidence of another (Lipitor). In other words, one variable (Lipitor) increases the risk of the other (diabetes). Once an association is established, epidemiologists apply the " Hill factors" to evaluate whether an association is causal. Reference Manual on Scientific Evidence 600 (3d ed. 2011); In re Zoloft (Sertraline Hydrochloride) Products Liab. Litig., 26 F.Supp.3d 449, 454-55 (E.D. Pa. 2014), recon. denied, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015).

         However, even if Plaintiffs establish that there is an association between Lipitor and diabetes (i.e., that Lipitor increases the risk of diabetes) and that Lipitor is capable of causing diabetes, it does not necessarily follow the Lipitor caused the development of diabetes in a particular plaintiff. For specific causation, the plaintiff must " demonstrate[] that the substance actually caused injury in her particular case." Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1249 n.1 (11th Cir. 2010). Under a preponderance-of-evidence burden, a plaintiff must show, more likely than not, the substance caused, or was a substantial contributing factor to, her particular injury.

         Some courts have held that one way that a plaintiff can meet her burden of production on specific causation is to have an expert witness testify to specific causation based on epidemiologic studies that find a relative risk of injury of 2.0 or higher and what is referred to as " the logic of the effect of doubling of the risk." Reference Manual on Scientific Evidence 612 (3d ed. 2011); see also Marder v. G.D. Searle & Co., 630 F.Supp. 1087, 1092 (D. Md. 1986) (" In epidemiological terms, a two-fold increased risk is an important showing for plaintiffs to make because it is the equivalent of the required legal burden of proof--a showing of causation by the preponderance of the evidence or, in other words, a probability of greater than 50%." ).

         The relative risk ratio is the risk of disease or injury among people exposed to an allegedly harmful substance divided by the risk of the disease among those not exposed to the substance. Reference Manual on Scientific Evidence at 627. For instance, if the risk of developing diabetes while on Lipitor is 6% and the risk of developing diabetes not on Lipitor (i.e., in a placebo group) is 4%, then the relative risk of developing diabetes for Lipitor is 6/4 or 1.5.[4] A relative risk of 1.0 indicates no difference between the two groups in risk. The risk in the two groups is the same (e.g., 5% divided by 5% or 20% divided by 20%).

         Assuming no confounding factors, bias, etc., a statistically significant relative risk ratio between 1.0 and 2.0 can be used, in conjunction with the " Hill factors," to establish general causation but cannot be used, by itself, to establish specific causation. A relative risk ratio in this range suggests that while some people exposed to the substance developed the disease due to exposure (i.e., there is the potential for the substance to cause the disease), most would have developed the disease anyway. Take the example above with a relative risk ratio of 1.5,[5] where 4% of the placebo group and 6% of the Lipitor group develop diabetes. In a group of 100 people all taking Lipitor, six of them will develop diabetes. Four of these people (4% of 100) would have developed diabetes regardless, as in the placebo group. The other two diabetics (2% of 100) would not have developed diabetes but for Lipitor. In other words, two-thirds of the people who take Lipitor and develop diabetes would have done so regardless, and one-third of people who take Lipitor and develop diabetes would not have developed diabetes but for the Lipitor. For this minority (the one-third), Lipitor is a substantial contributing factor to their diabetes. Thus, to establish specific causation with a relative risk between 1.0 and 2.0, an expert--utilizing a valid methodology, applying it reasonably and relying on sufficient data to support her opinions--must opine to a reasonable degree of medical certainty that the particular plaintiff is in the minority of those that developed the disease due to exposure to a particular drug or substance rather than in the majority that would have developed the disease regardless.

         A relative risk ratio greater than 2.0, however, suggests that of the people exposed to a substance who developed the disease, most of them developed the disease due to the exposure. For example, if the relative risk of diabetes due to Lipitor were 3.0,[6] then two-thirds of those on Lipitor who develop diabetes would not have developed diabetes but for the drug. An example of this would be if, in a randomized study, 6% of the Lipitor group developed diabetes and 2% of the placebo group developed diabetes. In this example, six out of a hundred people on Lipitor would develop diabetes. Of these six, two would have done so regardless and four would develop diabetes only because they took Lipitor.

         Thus, for a relative risk ratio above 2.0, there is a " probability of greater than 50%" that the substance at issue caused the disease or injury. Marder, 630 F.Supp. at 1092 . In other words, it is more likely than not that the substance caused the injury or disease. This logic does have its limitations. It relies on studies " identifying a genuine causal relationship and a reasonably reliable measure of the increased risk." Reference Manual on Scientific Evidence at 612. If confounding factors, bias or random error is the source of the association, rather than a true causal relationship, the logic falls apart. Id. at 612-13. Thus, a finding of statistical significance is very important, and observational studies with the potential for confounding and bias may not be sufficient for this theory of specific causation. Randomized controlled trials may be required to show an actual doubling of the risk exists (i.e., to show a valid relative risk ratio). Even with randomized controlled trials, this logic is based on the assumption that the plaintiff at issue is similar to the study subjects and has the same amount of exposure to the substance as the study subjects. Id. at 613.

         Turning to the actual case at hand, Dr. Murphy determined that " the most reliable data suggests the [relative] risk ratio is somewhere around 1.6." [7] (Dkt. No. 1006-3 at 49). Thus, using her estimate of relative risk, most of the people who develop diabetes while on Lipitor would have done so anyway, and she cannot use the logic of " doubling the risk" to provide a specific causation opinion. Using her estimate, 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.[8] The question then becomes ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.