United States District Court, D. South Dakota, Southern Division
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For Deane Berg, Plaintiff: Gregory Alan Eiesland, LEAD ATTORNEY, Johnson, Eiesland Law Offices, PC, Rapid City, SD; R. Allen Smith, Jr., LEAD ATTORNEY, PRO HAC VICE, The Smith Law Firm, PLLC, Ridgeland, MS.
For Johnson & Johnson, Johnson & Johnson Consumer Companies, Inc., Defendants: Gene M. Williams, Kathleen Anne Frazier, LEAD ATTORNEYS, PRO HAC VICE, Shook, Hardy & Bacon, LLP, Houston, TX; J. Crisman Palmer, LEAD ATTORNEY, Gunderson, Palmer, Goodsell & Nelson, LLP, Rapid City, SD.
For Luzenac America, Inc., Defendant: J. Lee Gray, LEAD ATTORNEY, PRO HAC VICE, Holland & Hart LLP, Greenwood Village, CO; Steven W. Sanford, LEAD ATTORNEY, Cadwell, Sanford, Deibert & Garry, LLP, Sioux Falls, SD; William W. Maywhort, LEAD ATTORNEY, PRO HAC VICE, Holland & Hart LLP, Colorado Springs, CO; Keeya M. Jeffrey, PRO HAC VICE, Holland & Hart LLP, Denver, CO.
For Exponent, Inc., Interested Party: Daniel R. Fritz, II, LEAD ATTORNEY, Lindquist & Vennum LLP, Sioux Falls, SD; James J. Ficenec, PRO HAC VICE, Archer Norris, Walnut Creek, CA.
KAREN E. SCHREIER, UNITED STATES DISTRICT JUDGE.
MEMORANDUM OPINION AND ORDER
Defendants Johnson & Johnson and Johnson & Johnson Consumer Companies, Inc. move for summary judgment on all of plaintiff's claims (Docket 149) and also move to exclude the testimony of four of plaintiff's experts (Dockets 140, 143, 145, and 147). Defendant Luzenac America, Inc. joins in the motions (Dockets 151, 153, 155, 156, and 157). For the following reasons, defendants' motions to exclude are granted in part and denied in part. Defendants' motion for summary judgment is denied.
Berg was diagnosed with ovarian cancer in December of 2006. She was 49 years old at the time. Prior to her diagnosis, Berg used Johnson & Johnson products--Johnson's Baby Powder and Shower to Shower--to dust her perineum for feminine hygiene purposes. She applied the products on a daily basis from 1975 until 2007.
Talc is one of the main ingredients in Johnson's Baby Powder and Shower to Shower. Talc is a naturally occurring mineral that is mined from the ground and used in various applications. Luzenac supplies talc to Johnson & Johnson.
Research has been ongoing studying how talc affects the female reproductive system for a number of years. For example, Dr. Daniel Cramer, one of Berg's proposed experts, published a study in 1982 that found that an association existed between the application of talc to a woman's genital area and the development of ovarian cancer. Defendants stayed current on the various studies that analyzed any potential hazards associated with talc.
Berg alleges that her application of talc to her perineum caused her ovarian cancer and brought this product liability action against defendants because their products did not include any warnings regarding the possible hazards of applying talc to a woman's perineum. Berg has identified four expert opinions in support of her claims.
First, Dr. Cramer is an epidemiologist and is prepared to testify that talc use in the genital area has a strong causal association with ovarian cancer. Further, Dr. Cramer's opinion is that Berg's frequent application of talc to her genital area was " the major cause of her invasive serous ovarian cancer[.]" Docket 148-1 at 18.
Second, Dr. Gary Rosenthal is a toxicologist and is prepared to testify about talc's immunotoxic potential and how such potential relates to ovarian cancer. His opinion is that Berg's frequent talc use " played a role in disease processes leading to her ovarian cancer." Docket 144-1 at 11.
Third, Dr. John Godleski is an expert in microscopy, and he examined tissues taken from Berg's reproductive system following her diagnosis of ovarian cancer. He is prepared to testify that talc particles were present in Berg's tissues.
Fourth, Dr. David R. Lenorovitz and Dr. Edward E. Karnes are experts in the field of forensic human factors and warnings. Their designation as experts is to: (1) ascertain if talc posed a hazard to the populace; (2) ascertain if any such hazard was open and obvious to a reasonable user; (3) determine if there was a feasible way to place a warning on the talc product; and (4) determine if there was a financially and
technically reasonable alternative to talc. Docket 173 at 2.
MOTIONS TO EXCLUDE EXPERT TESTIMONY
In this diversity action, federal law governs whether expert testimony is admissible. Wagner v. Hesston Corp., 450 F.3d 756, 760 (8th Cir. 2006). Rule 702 of the Federal Rules of Evidence governs the admissibility of expert testimony. Russell v. Whirlpool Corp., 702 F.3d 450, 456 (8th Cir. 2012). The rule provides:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
Fed. R. Evid. 702. In applying Rule 702, the trial judge becomes a " gatekeeper" who screens evidence to ensure its reliability and relevance. Russell, 702 F.3d at 456. " The rule clearly is one of admissibility rather than exclusion." Sappington v. Skyjack, Inc., 512 F.3d 440, 448 (8th Cir. 2008). An expert's opinion should be excluded " only if it is so fundamentally unsupported that it can offer no assistance to the jury." Id.
The district court applies a three-part test when screening proposed testimony for experts under Rule 702:
First, evidence based on scientific, technical, or other specialized knowledge must be useful to the finder of fact in deciding the ultimate issue of fact. This is the basic rule of relevancy. Second, the proposed witness must be qualified to assist the finder of fact. Third, the proposed evidence must be reliable or trustworthy in an evidentiary sense, so that, if the finder of fact accepts it as true, it provides the assistance the finder of fact requires.
Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir. 2001). To satisfy the reliability requirement, the party offering the expert testimony must show by a preponderance of the evidence " that the methodology underlying [the expert's] conclusions is scientifically valid." Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010). In making the reliability determination, the court may consider: (1) whether the theory or technique can be or has been tested; (2) whether the theory or technique has been subjected to peer review or publication; (3) whether the theory or technique has a known or potential error rate and standards controlling the technique's operations; and (4) whether the theory or technique is generally accepted in the scientific community. Russell, 702 F.3d at 456. Additional factors to consider include: " whether the expertise was developed for litigation or naturally flowed from the expert's research; whether the proposed expert ruled out other alterative explanations; and whether the proposed expert sufficiently connected the proposed testimony with the facts of the case." Polski v. Quigley Corp., 538 F.3d 836, 839 (8th Cir. 2008). " This evidentiary inquiry is meant to be flexible and fact specific, and a court should use, adapt, or reject" these factors as the particular case demands. Russell, 702 F.3d at 456.
When making this inquiry, the court should focus on " principles and methodology, not on the conclusions that they generate." Kuhn v. Wyeth, Inc., 686 F.3d 618, 625 (8th Cir. 2012) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 595, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). At times, conclusions and methodology are not entirely distinct from one another, and
the court " need not completely pretermit judicial consideration of an expert's conclusions." Id. With these principles in mind, the court will now address defendants' motions to exclude expert testimony.
I. Dr. Daniel Cramer
Defendants' sole argument in support of their motion to exclude Dr. Cramer's testimony goes to the issue of whether his testimony is reliable.  Defendants attack Dr. Cramer's testimony regarding both specific causation and general causation, arguing that the testimony put forth to support each is not reliable. For purposes of defendants' motion to exclude Dr. Cramer's testimony, the court only considers whether the testimony is admissible and does not consider whether it is sufficient to prove an element in plaintiff's case.  See Daubert, 509 U.S. at 596 (noting the difference between admissibility and sufficiency).
Dr. Cramer is the Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School and is a practicing obstetrician and gynecologist. He has a doctorate degree in epidemiology from the Harvard School of Public Health.
Dr. Cramer's expert report relies on epidemiology  to address two issues: (1) " the association between use of cosmetic talc powders in the genital area and ovarian cancer with regard to the likelihood that this is cause-and-effect" and (2) " the possible relevance of talc use to the occurrence of ovarian cancer in the specific case of Ms. Deane Berg[.]" Docket 148-1 at 3. The report concludes by opining that (1) there is a causal association between the use of talc and ovarian cancer, and (2) chronic talc use was the major cause of Berg's invasive serous ovarian cancer. Id. at 18.
Defendants make two arguments in support of their motion to exclude Dr. Cramer's testimony.  First, they argue that Dr. Cramer's report is inadmissible because it fails to rule out alternative causes of Berg's cancer. Second, they argue that Dr. Cramer's report is inadmissible because the odds ratios established in the report and Dr. Cramer's interpretations of those odds ratios stem from unreliable methods.
A. Ruling Out Alternative Causes
Defendants argue that Dr. Cramer's methodology is not reliable because he fails to rule out alternative causes of Berg's cancer. Defendants rely on these four Eighth Circuit Court of Appeals opinions to support their proposition that Dr. Cramer was required to rule out alternative causes of Berg's cancer: Barrett, 606 F.3d 975; Bland v. Verizon Wireless, (VAW) L.L.C., 538 F.3d 893 (8th Cir. 2008); Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748 (8th Cir. 2006); and Turner v. Iowa Fire Equip. Co., 229 F.3d 1202 (8th Cir. 2000). None of these cases, however, require an epidemiologist to rule out all
alternative causes in order for his testimony to be admissible.
In Barrett, the Eighth Circuit found that the district court did not abuse its discretion when it limited the expert testimony of a toxicologist and a treating physician. 606 F.3d at 981-82. The toxicologist conceded that she lacked " significant scientific knowledge underpinning [her] opinion and that she did not rule out alternative causes of [plaintiff's] injury. . . . Her opinion . . . was admittedly based on assumption, without any scientific testing or exposure analysis." Id. at 981. The treating physician was not allowed to testify about the cause of the plaintiff's toxic exposure because he " assumed that [plaintiff] had been injured by hydrogen sulfide gas exposure without any scientific verification and without considering any alternative causes." Id. at 982. Neither expert witness was offering epidemiologic evidence. Both experts had glaring deficiencies in their opinions because they failed to do any scientific verifications, relied on unsupported assumptions, and did not consider alternative causes.
In Bland, the Eighth Circuit found that the district court did not abuse its discretion by excluding a treating physician's expert testimony. 538 F.3d at 897-98. The treating physician intended to testify about the differential diagnoses that he conducted. Id. at 897. " A differential diagnosis is a technique that identifies the cause of a medical condition by eliminating the likely causes until the most probable cause is isolated." Bland, 538 F.3d at 897. The treating physician's differential diagnosis was inadmissible because he failed to eliminate other possible causes. Id. The very nature of a differential diagnosis requires a consideration and elimination of other possible causes. By failing to consider other causes, a differential diagnosis cannot, by definition, be reliable. Thus, Bland stands for the proposition that an admissible differential diagnosis requires the expert to consider and eliminate other possible causes. Bland does not stand for the proposition that an expert offering epidemiologic evidence must rule out all other possible causes for his testimony to be admissible.
In Marmo, the Eighth Circuit found that the district court acted within the bounds of discretion when it precluded a toxicologist from testifying. 457 F.3d at 758. The toxicologist did not examine the plaintiff, did not inquire about other toxic exposures, did not exclude confounding factors, and " admitted that the causation standard she employed was not subject to expression in terms of a potential rate of error and was a much lower standard than medical causation." Id. Marmo does not support defendants' proposition that an expert offering epidemiologic evidence must rule out all other possible causes for his testimony to be admissible.
Lastly, in Turner the Eighth Circuit concluded that the district court did not abuse its discretion by excluding a treating physician's expert opinion. 229 F.3d at 1208-09. Just as in Bland, the treating physician's opinion was based on a differential diagnosis in which he " admitted that he made no attempt to consider all the possible causes, or to exclude each potential cause until only one remained, or to consider which of two or more non-excludable causes was the more likely to have caused the condition." Id. at 1208. Again, failing to properly administer a differential diagnosis resulted in an inadmissable differential diagnosis. But Turner does not require that an epidemiologist perform a differential diagnosis, which would require consideration of other possible causes.
After a review of these cases, the appropriate legal proposition created from these opinions is that an expert witness who performs a differential diagnosis must
consider all other possible causes and exclude each potential cause until only one remains, or consider which of two or more non-excluded potential causes was the more likely to have caused the condition. Dr. Cramer, however, does not claim to have performed a differential diagnosis. Indeed, his testimony is based on epidemiology. Moreover, Dr. Cramer's report indicates that he did in fact consider other possible causes of Berg's cancer. Therefore, Dr. Cramer's opinion will not be excluded on the basis that he failed to rule out all alternative causes. See In re Prempro Prods. Liab. Litig., 586 ...