Q:\tracy\10-2125 final order & reasons daubert & sum judg.wpd
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UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA ANDREA FRISCHHERTZ, wife CIVIL ACTION of/and BRAD FRISCHHERTZ, individually and on behalf of the minor child, E.F. NO. 10‐2125 SMITHKLINE BEECHAM SECTION “C”(4) CORPORATION d/b/a GLAXOSMITHKLINE ORDER & REASONS
Before the Court are six motions: (1) Defendant GlaxoSmithkline LLC’s Motion to Exclude
the Testimony of Susan R. Andrews, Ph.D. Rec. Doc. 185; (2) Defendant GlaxoSmithKline LLC’s
Motion to Exclude the Testimony of Joseph A. Hirsch, Ph.D. Rec. Doc. 186; (3) Defendant
GlaxoSmithKline LLC’s Motion to Exclude the Testimony of Paul Goldstein, Ph.D. Rec. Doc. 187;
(4) Defendant GlaxoSmithKline LLC’s Motion to Exclude the Testimony of Shira Kramer. Rec.
Doc. 188; (5) Defendant GlaxoSmithKline LLC’s Motion to Strike the Testimony of Edward J.
Trapido, Sc.D. Rec. Doc. 190; and (5) Defendant GlaxoSmithKline LLC’s Renewed Motion for
Summary Judgment. Rec. Doc. 233. On October 3, 2012, the Court held a Daubert hearing where
oral argument was heard on motions (3) through (5). Rec. Doc. 229. The plaintiffs and defendant
also filed post-hearing briefs. Rec. Docs. 245, 246. The most significant motions in terms of impact
upon the case are Rec. Doc. 187 and Rec. Doc. 188 concerning the testimony of Paul Goldstein,
Ph.D. and Shira Kramer, Ph.D. and Rec. Doc. 233, the defendant’s renewed motion for summary
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judgment. For that reason the Court will address these only.
1. Defendant GlaxoSmithKline LLC’s Motion to Exclude the Testimony of Paul Goldstein,
2. Defendant GlaxoSmithKline LLC’s Motion to Exclude the Testimony of Shira Kramer
3. Defendant GlaxoSmithKline LLC’s Renewed Motion for Summary Judgment is
Plaintiffs Andrea Frischhertz and her husband Brad Frischhertz bring this claim on behalf
of their son, E.F., a minor (hereinafter collectively “plaintiffs”) against GlaxoSmithKline (“GSK”),
the manufacturer of Paxil. Plaintiffs concede that their only claim remaining is for inadequate
warning under the Louisiana Products Liability Act (“LPLA”). Rec. Doc. 139, p.1., n.1.
The petition for damages alleges that plaintiff, Andrea Frischhertz, took Paxil as prescribed
by her doctor while she was pregnant with E.F. Rec. Doc.1. Paxil is a Selective Serotonin Reuptake
Inhibitor (SSRI) commonly prescribed to treat depression. As a result of the medication, the petition
for damages and the first amended and supplemental complaint allege that E.F. was born with
“incomplete development of the cardiac septum, and irreversible birth defects” including cardiac
deformities and Holt-Oram Syndrome. (Rec. Doc. 64). Holt-Oram Syndrome is a heart-hand
syndrome that is characterized by hand abnormalities and an atrial septal defect. The defendant
contests whether E.F. has this syndrome. The parties agree that E.F. has a limb abnormality that
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makes his fingers on his right hand smaller than his left. E.F. was born March 30, 2005. Plaintiffs
allege that GSK had knowledge that Paxil caused birth defects while taken during pregnancy before
Mrs. Frischhertz took the medication during her pregnancy with E.F. but did not release this
II. LEGAL STANDARDS FOR ADMISSIBILITY–DAUBERT
The United States Supreme Court revised the standards for admitting scientific evidence
under the Federal Rules of Evidence in Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579,
113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The Court began with the “baseline” principle that “all
relevant evidence is admissible” unless excepted by the Constitution, a statute or rule and that the
standard of relevance “is a liberal one.” FED.R.EVID. 402; Daubert, 509 U.S. at 585-589, 113 S.Ct.
at 2793-94. The Court found that Rule 7021 obliges the trial judge to act as a “gatekeeper” and
screen scientific evidence for reliability and relevance. FED.R.EVID. 702; Daubert, 509 U.S. at
595, 113 S.Ct. at 2798. Regarding reliability, the Court said: “the subject of an expert’s testimony
must be ‘scientific . . . knowledge.’ The adjective ‘scientific’ implies a grounding in the methods
and procedures of science. Similarly, the word ‘knowledge’ connotes more than subjective belief
or unsupported speculation.” Daubert, 509 U.S. at 589-590, 113 S.Ct. at 2795.
1A witness who is qualified as an expert by knowledge, skill, experience, training, or
education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific,technical, or other specialized knowledge will help the trier of fact to understand the evidence orto determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) thetestimony is the product of reliable principles and methods; and (d) the expert has reliablyapplied the principles and methods to the facts of the case.
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The Court suggested several factors in determining reliability. Of particular importance is
whether “the theory or technique . . . can be (and has been) tested.” Daubert, 509 U.S. at 593, 113
S.Ct. at 2796. Another factor is whether the theory or technique has been subjected to evaluation
by peer review and publication. A third factor is the known or potential rate of error in the technique
and the existence and maintenance of standards governing its operation. A final consideration is
whether the theory or technique has been generally accepted in the scientific community.
The Court stressed that the standard under Rule 702 is a “flexible one.” The Court
emphasized also that the focus of the inquiry is “solely on principles and methodology, not on the
conclusions that they generate.” Daubert, 509 U.S. at 595, 113 S.Ct. at 2797.
The Court favored admission of evidence on the borderline. “Vigorous cross-examination,
presentation of contrary evidence, and careful instruction on the burden of proof are the traditional,
and appropriate means of attacking shaky but admissible evidence.” Daubert, 509 U.S. at 596, 113
S.Ct. at 2798. At the same time, the Court recognized the significant difference between the “quest
for truth in the courtroom and the quest for truth in the laboratory.” Daubert, 509 U.S. at 596-97,
113 S.Ct. at 2798. Scientific inquiry must necessarily be broad and far-reaching, with the reliability
of theories under continuous study and revision. Resolution of a legal dispute, on the other hand,
involves binding, final judgments that cannot be based on conjecture. Consequently, there may well
be “authentic insights and innovations” of science that are nonetheless inadmissible in a court of
law. Daubert, 509 U.S. at 595-99, 113 S.Ct. at 2798-2799.
III. ADMISSIBILITY OF EXPERTS
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A. Testimony of Paul Goldstein, Ph.D.
Dr. Goldstein is a toxicology and genetics expert. He has a Ph.D. in genetics from York
University in Toronto. Rec. Doc. 211, Exh. A. At the time Dr. Goldstein received his Ph.D., there
was no formal toxicology degree available. Rec. Doc. 211. Despite that, his research and teachings
demonstrate his qualifications in toxicology. Defendant wishes to exclude him based on his lack
of training in epidemiology, pharmacology and teratology and the fact that he does not have a formal
degree in toxicology. Rec. Doc. 187. Dr. Goldstein, a toxicologist, has the relative expertise to
opine on the toxicological effects of Paxil. He is not disqualified from rendering a causation opinion
because he does not have a medical degree. In re Fema Trailer Formaldehyde products LiabilityLitigation, No. 07-1873, 2009 WL 4508546 (E.D. La. Nov. 24, 2009).
However, Dr. Goldstein’s methodology does not meet the requirement for scientific
knowledge under Daubert. 509 U.S. at 589-590, 113 S.Ct. at 2795. Dr. Goldstein bases his general
causation opinion on the “Sloot Paper.” Dr. Anthony Scialli testified at the Daubert hearing. He
is a physician and board certified in OB-GYN and is the director of the Reproductive Toxicology
Center, which provides information to physicians and others on the effects of chemicals on
reproduction. Rec. Doc. 239, pp.56-60. At the Daubert hearing, Dr. Scialli testified in detail
regarding the Sloot Paper. He opined that Whole Embryo Cultures as described in the article are
inappropriate for assessing what is a teratogen in human risk assessment. He in fact wrote a letter
to the journal criticizing the article which was subsequently published as well. As a result of the
article, the authors clarified that Whole Embryo Culture tests are not intended to identify teratogens.
Rec. Doc. 239, pp. 77-81. Dr. Goldstein agreed that Whole Embryo Cultures are not a basis for
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predicting human risk. He stated that such studies are of value in generating a hypothesis, which
he agreed was just the “first step in that process.” Rec. Doc. 187, Exh. 2, depo. Goldstein, pp. 138-
Dr. Goldstein’s causation analysis also did not meet the required level for peer review or the
standard that is accepted in his professional community, and he appears to have inappropriately
applied the Bradford-Hill criteria for both general and specific causation. The Bradford-Hill criteria
can only be applied after a statistically significant association has been identified. Federal Judicial
Center, Reference Manual on Scientific Evidence, 599, n.141 (3d. ed. 2011) (“In a number of cases,
experts attempted to use these guidelines to support the existence of causation in the absence of any
epidemiologic studies finding an association . . . . There may be some logic to that effort, but it does
not reflect accepted epidemiologic methodology.”). See, e.g., Dunn v. Sandoz Pharms., 275 F. Supp.
2d 672, 678 (M.D.N.C. 2003). Here, Dr. Goldstein attempted to use the Bradford-Hill criteria to
prove causation without first identifying a valid statistically significant association. He first
developed a hypothesis and then attempted to use the Bradford-Hill criteria to prove it. Rec. Doc.
187, Exh. 2, depo. Goldstein, p. 103. Because there is no data showing an association between Paxil
and limb defects, no association existed for Dr. Goldstein to apply the Bradford-Hill criteria. Hence,
Dr. Goldstein’s general causation opinion is not reliable.
The defendants offered Dr. Goldstein as an expert on general and specific causation, meaning
that the plaintiffs allege Dr. Goldstein is an expert who can opine on (1) whether Paxil can cause
birth defects at all and (2) whether Paxil caused the birth defects in this instance. Dr. Goldstein
stated at his deposition that he no longer held the view that E.F. had a heart defect. Rec. Doc. 233,
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Exh. S, depo. Goldstein, pp. 131-32. Dr. Goldstein’s specific causation opinion as to limb defects
must be excluded because it is not based on reliable scientific analysis or evidence. Dr. Goldstein
testified to specific causation based on the fact that he believes Paxil is a teratogen and he believes
that if a teratogen is present “it could possibly affect the developing cells in the–either the hand
limb–or hand bud . . . .” Id., p. 104. However, Dr. Goldstein also conceded that he knew of no
evidence in humans or animals that demonstrates that Paxil is a limb teratogen, and he does not
know if it is. Id., p. 114. Hence, his hypothesis is pure speculation.
The Supreme Court requires that “an expert . . . employ in the courtroom the same level
of intellectual rigor that characterizes the practice of an expert in the relevant field.” In re SilicaProds. Lab. Lithog., 398 F. Supp. 2d 563, 639 (S.D. Tex. 2005) (quotingKuhmo Tire Co., Ltd. V.Carmichael, 526 U.S. 137, 152 (1999)). Dr. Goldstein has demonstrated that his causation analysis
did not meet the required level for peer review or the standard that is accepted in his professional
B. Testimony of Shira Kramer, Ph.D.
Dr. Shira Kramer offers testimony on general causation such as whether a pregnant woman’s
ingestion of Paxil during the first trimester of pregnancy can cause limb or heart defects. Dr.
Kramer’s report did not offer an opinion as to specific causation. Rec. Doc. 233, Exh. U, depo.
Kramer, pp. 44-45. Dr. Kramer’s general causation opinion is that (1) Paxil affects levels of
serotonin in the developing embryo, and (2) this effect can cause limb defects. Rec. Doc. 233, Exh.
Dr. Kramer is not qualified to offer an opinion based on serotonin’s impact on limb defects.
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While she theorizes about “perturbation of serotonin levels,” Id., pp. 81-86, 92-93, Dr. Kramer is
an epidemiologist and is not qualified to make the reaching arguments she makes about serotonin
levels during pregnancy. Indeed, she has in other litigation conceded she is not an expert in
serotonin. Rec. Doc. 188, Exh. 19, p. 81. Dr. Kramer cites to numerous epidemiological studies in
her report, Rec. Doc. 188, Exh. 3, p. 31-55, but admits that this literature is “more or less
noncontributory” to the correlation between Paxil exposure and limb defects. Rec. Doc. 233, Exh.
U, depo. Kramer, p. 117. Dr. Kramer relies on “biological plausibility and temporality” to support
her hypothesis that Paxil can cause limb defects. Id., p. 119. However, beyond this assertion, Dr.
Kramer does not offer any articles supporting her serotonin theory. Indeed, plaintiffs’ own expert
pharmacologist, Dr. Joseph Hirsch, acknowledged that nothing in his review of the scientific
literature indicated that Paxil administered to pregnant animals disrupts embryonic serotonin. Rec.
Furthermore, Dr. Kramer’s methodology does not meet the required standard. Dr. Kramer
“lumps” all congenital malformations together to make her analysis. Rec. Doc. 188, Exh. 3, p. 30.
This technique is not generally accepted by the scientific community and is unreliable. Chambersv. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000), aff’d, 247 F.3d 240 (5th Cir. 2001)
(unpublished). Dr. Kramer has not demonstrated by a statistically significant measure that Paxil
could be a general cause of limb or heart defects if ingested during the first trimester of pregnancy.
While plaintiffs contend the fact that no epidemiology exists that provides a statistically significant
association between Paxil and E.F’s hand malformation is excused by the “rarity of E.F.’s
malformation,” the law cannot leap ahead of the science. Rec. Doc. 246, p. 4. Wells v. SmithKline
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Beecham Corp., 601 F.3d 375, 381 (5th Cir. 2010). IV. SUMMARY JUDGMENT A. Plaintiffs’ claims under the Louisiana Products Liability Act
Under the LPLA, there is a two-pronged test for inadequate-warning claims when the learned
intermediary doctrine is applicable. The plaintiff must show (1) that the defendant failed to
adequately warn the physician of a risk associated with the product that was not otherwise known
to the physician; and (2) that this failure to warn the physician was both a cause in fact and the
proximate cause of the plaintiff’s injury.” Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254,
265-266 (5th Cir. 2002) (citing Willett v. Baxter Int’l Inc., 929 F.2d 1094, 1098 (5th Cir. 1991)).
B. Standard of Review
Rule 56 of the Federal Rules of Civil Procedure states: “The Court shall grant summary
judgment 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. When considering whether any
genuine issues of material fact exists, courts view the evidence and inferences drawn from that
evidence in the light most favorable to the non-moving party. United States ex re. Reagan v. EastTexas Medical Center Regional Healthcare System, 384 F.3d 168, 173 (5th Cir. 2004) (citingDaniels v. City of Arlington, Texas, 246 F.3d 500, 502 (5th Cir. 2001)).
An issue is material if its resolution could affect the outcome of the action. Wyatt v. HuntPlywood Co., Inc., 297 F.3d 405, 409 (5th Cir. 2002) (citing Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248, 106 S.Ct. 2502, 91 L.Ed.2d 202 (1986)). A factual dispute precludes summary
judgment if the evidence would permit a reasonable jury to return a verdict for the nonmoving party.
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Hunt v. Rapides Healthcare Sys. LLC, 277 F.3d 757, 762 (5th Cir. 2001).
The party moving for summary judgment bears the initial burden of “informing the district
court of the basis for its motion, and identifying those portions of [the record] which it believes
demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317,
322 (1986). “If the moving party meets the initial burden of showing that there is no genuine issue
of material fact, the burden shifts to the non-moving party to produce evidence or designate specific
facts showing the existence of a genuine issue for trial.” Engstrom v. First Nat’l Bank of Eagle Lake,
47 F.3d 1459, 1462 (5th Cir. 1995) (citing Celotex, 477 U.S. at 322-24). In order to satisfy its
burden, the nonmoving party must put forth competent evidence and cannot rely on “unsubstantiated
assertions” and “conclusory allegations.” See e.g., Hopper v. Frank, 16 F.3d 92 (5th Cir. 1994);
Lujan v. Nat’l Wildlife Federation, 497 U.S. 871, 871-73 (1990). The mere argued existence of a
factual dispute will not defeat an otherwise properly supported motion. See Anderson v. LibertyLobby Inc., 477 U.S. 242, 247-48 (1996). “If the evidence is merely colorable, or is not significantly
probative,” summary judgment is appropriate. Id. at 249-50.
C. Law and Analysis
Defendants move for summary judgment on plaintiffs claim under the LPLA on the basis that
neither of Drs. Paul Goldstein nor Shira Kramer provide admissible expert testimony on general or
specific causation. Rec. Doc. 233, p. 2. Therefore, defendants argue that plaintiffs have failed to
establish the effect of Paxil on E.F. during Mrs. Frischhertz’ pregnancy. Id.
Under Louisiana jurisprudence, the plaintiff in a personal injury suit, including suits under
the LPLA, bears the burden of proving by a preponderance of the evidence that there was a causal
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relationship between his or her injury and the accident or use of the product. Maranto v. GoodyearTire & Rubber Co., 650 So.2d 757, 759 (La.2/20/95). The test for determining the causal
relationship between the accident and subsequent injury is whether the plaintiff proved through
medical testimony that it is more probable than not that the subsequent injuries were caused by the
Proof of causation has two components, general and specific. See Pick v. American MedicalSystems, Inc., 958 F. Supp. 1151, 1164 (E.D. La. 1997); Kemp v. Metabolife International, Inc., No.
00-3513, 2004 WL 2095618 (E.D. La. Sept. 13, 2004). General causation deals with whether the
substance at issue can cause diseases or disorders in people in general. Pick,958 F. Supp. at 1164.
Specific causation focuses upon whether the substance was in fact the cause of the ailments or
symptoms in the particular patient. Id. An inability to establish specific causation is fatal to
plaintiffs’ claim. Id. at 1163.
Plaintiffs respond to defendant’s argument that summary judgment should be granted in
favor of defendants based on plaintiffs’ inability to establish specific causation in one paragraph.
Rec. Doc. 244, p. 20. Plaintiffs submit that their experts should be permitted to testify as explained
in their opposition to the four motions to exclude testimony, but plaintiffs do not address the merits
Plaintiffs needed both specific and general causation testimony to meet their burden of proof.
Dr. Kramer offered testimony on general causation. Rec. Doc. 233, Exh. U, depo. Kramer, pp. 44-
45. Her opinion did not pass the Daubert test and must be excluded. Dr. Goldstein also offered
testimony on general causation. Rec. Doc. 233, Exh. S, depo Goldstein. Of plaintiffs’ experts, only
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Dr. Goldstein’s testimony provided an opinion on specific causation.2 Id. In particular, he needed
to offer an opinion on whether Mrs. Frischhertz’ alleged ingestion of Paxil while pregnant caused
E.F.’s limb and alleged heart deformities. Dr. Goldstein’s testimony has been excluded. Because
the Court has excluded the testimony of Drs. Paul Goldstein and Shira Kramer, the plaintiffs have
no expert testimony establishing general or specific causation and cannot meet their burden of
establishing either general or specific causation from the ingestion of Paxil for the alleged birth
The Court refrains from re-addressing Mrs. Frischhertz’ prescribing physician, Dr. Kongara’s
testimony and its significance under the learned intermediary doctrine because it finds that the
plaintiffs cannot establish specific or general causation. Rec. Doc. 233.
IT IS ORDERED that defendant GlaxoSmithKline LLC’s Motion to Exclude the Testimony
of Paul Goldstein, Ph.D. is GRANTED. Rec. Doc. 187
IT IS FURTHER ORDERED that defendant GlaxoSmithKline LLC’s Motion to Exclude the
Testimony of Shira Kramer is GRANTED. Rec. Doc. 188.
IT IS FURTHER ORDERED that summary judgment on Louisiana Products Liability Act
claim is GRANTED in favor of the defendant and against the plaintiffs. Rec. Doc. 233.
IT IS FURTHER ORDERED, considering that plaintiffs have conceded that all other claims
are dismissed and the Court having granted this motion for summary judgment, that judgment be
2Additionally, Dr. Goldstein’s testimony was only related to specific causation on E.F.’s
limb defect and not on his alleged congenital heart defect. Dr. Goldstein testified that E.F. didnot have a congenital heart defect.
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ENTERED in this matter dismissing all of plaintiffs’ claims with prejudice. Rec. Doc. 159.
New Orleans, Louisiana, this 21st Day of December, 2012. HELEN G. BERRIGAN UNITED STATES DISTRICT JUDGE
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