Ronwin v. Bayer Corporation ( 2009 )

FILED
United States Court of Appeals
Tenth Circuit
UNITED STATES COURT OF APPEALS June 17, 2009
FOR THE TENTH CIRCUIT Elisabeth A. Shumaker
Clerk of Court
EDWARD RONWIN,
Plaintiff-Appellant,
v. No. 08-8089
(D.C. No. 2:01-CV-00172-WFD)
BAYER CORPORATION, an Indiana (D. Wyo.)
corporation, doing business as Bayer
Pharmaceutical Division,
Defendant-Appellee.
ORDER AND JUDGMENT *
Before KELLY, McKAY, and BRISCOE, Circuit Judges.
Edward Ronwin appeals pro se the district court’s grant of summary
judgment in favor of Bayer Corporation on his claims for negligence, strict
liability, and breach of implied warranty. Exercising jurisdiction under 28 U.S.C.
§ 1291, we affirm.
*
After examining the briefs and appellate record, this panel has determined
unanimously that oral argument would not materially assist the determination of
this appeal. See Fed. R. App. P. 34(a)(2); 10th Cir. R. 34.1(G). The case is
therefore ordered submitted without oral argument. This order and judgment is
not binding precedent, except under the doctrines of law of the case, res judicata,
and collateral estoppel. It may be cited, however, for its persuasive value
consistent with Fed. R. App. P. 32.1 and 10th Cir. R. 32.1.
Background
Dr. Ronwin filed a complaint against Bayer in September 2001, alleging
that he was injured by cerivastatin, a prescription drug in the “statin” family that
was manufactured and sold by Bayer under the name “Baycol.” The United
States Food and Drug Administration (FDA) first approved Baycol for the
treatment of high cholesterol in 1997. Plaintiff began taking Baycol for that
purpose on or about January 10, 2001, when he was almost 77 years old. He
alleges that a short time later he began experiencing a number of physical
symptoms, including pain in his left shoulder, thighs, and back, blurred vision,
and gait problems. He stopped taking Baycol on or about August 8, 2001. He
claims that his blurred vision and gait problems receded after he ceased taking
Baycol, but that his other symptoms persisted. Dr. Ronwin was diagnosed in
2003 with a torn left rotator cuff, which he had surgically repaired.
Bayer voluntarily removed Baycol from the market on August 8, 2001,
citing a risk of rhabdomyolysis 1 as a serious, potentially fatal adverse effect of the
drug. Dr. Ronwin and thousands of other plaintiffs sued Bayer, claiming that
various injuries resulted from their ingestion of Baycol. 2 As of 2003, Bayer had
1
“Rhabdo[myolysis] is an acute, fulminating, potentially fatal disease of the
skeletal muscle, which entails destruction of skeletal muscle.” In Re Baycol
Prods. Litig., 218 F.R.D. 197, 201 n.1 (D. Minn. 2003).
2
Plaintiff originally filed his complaint in state court in Wyoming. Bayer
removed the case to the United States District Court for the District of Wyoming.
(continued...)
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settled close to 1,000 of the claims involving Baycol. See In re Baycol Prods.
Litig., 218 F.R.D. 197, 210 (D. Minn. 2003).
In support of his claims, plaintiff proffered his own expert testimony and
the expert testimony of Dr. Raul G. Reyes, as summarized in expert reports
submitted to the district court. After discovery was completed, Bayer filed a
summary judgment motion arguing there was no evidence establishing that Baycol
caused plaintiff to suffer any injury. More specifically, Bayer contended that
plaintiff’s proffered expert testimony was inadmissible under Federal Rule of
Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579(1993), because neither witness was qualified to offer an expert opinion and their
methodologies were not reliable. The district court granted Bayer’s motion,
excluding plaintiff’s proffered expert testimony and granting summary judgment
in favor of Bayer on all claims.
Applicable Law and Standards of Review
In this diversity action “the substantive law of the forum state governs the
analysis of the underlying claims, including specification of the applicable
standards of proof, but federal law controls the ultimate, procedural question
2
(...continued)
In January 2002 the case was conditionally transferred by the Judicial Panel on
Multidistrict Litigation to the United States District Court for the District of
Minnesota (hereafter “MDL case”). After pretrial proceedings were completed,
including briefing on Bayer’s summary judgment motion, plaintiff’s case was
transferred back to the district court in Wyoming in 2007.
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whether [summary judgment] is appropriate.” Specialty Beverages, L.L.C. v.
Pabst Brewing Co., 537 F.3d 1165, 1175 (10th Cir. 2008). Thus, we apply
federal law in reviewing de novo the district court’s grant of summary judgment
in this case. See Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1214
(10th Cir. 2002). Summary judgment is appropriate “if the pleadings, the
discovery and disclosure materials on file, and any affidavits show that there is no
genuine issue as to any material fact and that the movant is entitled to judgment
as a matter of law.” Fed. R. Civ. P. 56(c).
The district court’s grant of summary judgment in favor of Bayer rested on
two antecedent rulings. First, the district excluded the testimony of both of
plaintiff’s experts. “The admissibility of expert testimony is governed by Rule
702 of the Federal Rules of Evidence.” United States v. Benally, 541 F.3d 990,
994 (10th Cir. 2008), cert. denied, 129 S. Ct. 1020 (2009).
We review de novo the question of whether the district court
performed its gatekeeper role and applied the proper legal standard in
admitting an expert’s testimony. We then review for abuse of
discretion the trial court’s actual application of the gatekeeper
standard in deciding whether to admit or exclude an expert’s
testimony.
Miller v. Pfizer, Inc., 356 F.3d 1326, 1335 (10th Cir. 2004) (quotation and
brackets omitted). In reviewing a district court’s application of the second step of
this standard, we afford substantial deference to a court’s exclusion of expert
opinion evidence under Daubert. Hollander, 289 F.3d at 1204. “Under the abuse
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of discretion standard, a trial court’s decision will not be disturbed unless the
appellate court has a definite and firm conviction that the lower court made a
clear error of judgment or exceeded the bounds of permissible choice in the
circumstances.” Id. (quotation omitted). 3
In its second ruling leading to its grant of summary judgment, the district
court held that, under Wyoming law, plaintiff was required to present expert
testimony in order to establish that Baycol caused his injuries. Plaintiff does not
challenge the district court’s application of Wyoming law in deciding this issue.
Exclusion of Expert Testimony
The proponent of expert testimony bears the burden of showing that its
proffered expert’s testimony is admissible. Ralston v. Smith & Nephew Richards,
Inc., 275 F.3d 965, 970-71 n.4 (10th Cir. 2001). F.R.E. 702 “imposes upon the
trial judge an important ‘gate-keeping’ function with regard to the admissibility
of expert opinions.” Ralston, 275 F.3d at 969. In this role, a district court should
apply a two-step analysis, determining first whether an expert is qualified to
render an opinion by “‘knowledge, skill, experience, training, or education,’” and
3
Plaintiff contends that we should apply a de novo standard of review to the
district court’s exclusion of expert testimony because the court’s evidentiary
ruling served as the definitive ground for its grant of summary judgment. The
Supreme Court rejected a similar argument in General Electric Co. v. Joiner,
522 U.S. 136, 142-43 (1997), holding that a district court’s decision on the
admissibility of expert testimony is reviewed for an abuse of discretion, even
where that ruling is “outcome determinative” for purposes of summary judgment.
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second, whether the expert’s opinions are “‘reliable’” under Daubert. Id.(quoting F.R.E. 702). “Reliability is determined by assessing whether the
reasoning or methodology underlying the testimony is scientifically valid.”
Hollander, 289 F.3d at 1204 (quotation omitted).
Trial courts generally apply four factors in assessing the reliability of an
expert’s methodology:
(1) whether the opinion at issue is susceptible to testing and has been
subjected to such testing; (2) whether the opinion has been subjected
to peer review; (3) whether there is a known or potential rate of error
associated with the methodology used and whether there are
standards controlling the technique’s operation; and (4) whether the
theory has been accepted in the scientific community.
Id. at 1205. These factors are nonexclusive, “and district courts applying Daubert
have broad discretion to consider a variety of other factors.” Id. But
[r]egardless of the specific factors at issue, the purpose of the
Daubert inquiry is always the same: to make certain that an expert,
whether basing testimony upon professional studies or personal
experience, employs in the courtroom the same level of intellectual
rigor that characterizes the practice of an expert in the relevant field.
Id. at 1205-06 (quotation and brackets omitted).
Plaintiff’s Proffered Expert Testimony
Plaintiff proffered Dr. Reyes and himself as expert witnesses on causation.
Although Dr. Reyes is a surgeon with over fifty years of experience, he admitted
in his deposition that he had never prescribed statin drugs and that he was
unaware of any published medical literature linking statins, or Baycol in
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particular, to rotator cuff injuries. After reviewing a small portion of plaintiff’s
medical records, Dr. Reyes submitted an expert report concluding that:
The medical records clearly reveal that Dr. Ronwin suffered a left
shoulder rotator cuff tear which required corrective surgery and, in
view of the undisputed propensity of Baycol to disrupt body function
along with an absence of any other traumatic event in Dr. Ronwin’s
case, it is my medical opinion that in view of the lack of medical
history of any injury to this shoulder that there is a high probability
that this injury was caused by Baycol ingestion for a period of seven
(7) months.
Aplee. App., Vol. I at 286. 4
Dr. Ronwin purports to be an expert on the biochemical composition of
Baycol and its effect on the human body. He received B.S. and M.S. degrees in
chemistry in 1949 and 1950, and a Ph.D. in biochemistry in 1952. He worked in
the fields of chemistry and biochemistry until 1971, during which time he
authored or co-authored numerous published scientific papers. He entered law
school in 1971, then practiced law for twenty years. At the time he submitted his
expert report in opposition to Bayer’s summary judgment motion, Dr. Ronwin had
not actively worked as a scientist in more than 30 years, but he had maintained
his memberships in three major scientific societies, he continued to read scientific
publications, and he taught one chemistry overview course in 2001.
4
With respect to plaintiff’s other claimed injuries, Dr. Reyes’s expert report
concluded only that his symptoms “may be related to his ingestion of Baycol.”
Aplee. App., Vol. I at 286.
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In his expert report Dr. Ronwin concluded that the injuries he suffered “are
related to and caused by [his] ingestion of Baycol whose chemical structure can
give rise to flouride ion which can, in turn, cause injury to numerous body
components, proteins and tissues including the protein collagen in tendons and in
rotator cuff tendons.” Aplee. App., Vol. II at 509. In support of this theory, he
cited a book and a number of scientific papers addressing the effects of
flouridated drinking water on various parts of the human body. In addition to
these writings, he also based his opinion on his “general store of personal,
biochemical knowledge.” Id. at 507.
Expert Qualifications
Applying the first step of the Rule 702 analysis, the district court held that
Drs. Reyes and Ronwin were not qualified by their knowledge, skill, experience,
training, or education to testify regarding a causal connection between Baycol
ingestion and plaintiff’s shoulder injury. The court noted Dr. Reyes’s lack of any
practical experience or training with respect to Baycol or statins in general and
Dr. Ronwin’s “lengthy departure from active research, publication, and teaching.”
Aplee. App., Vol. II at 803. A district court has “wide discretion” in determining
whether a witness’s experience is sufficient to qualify him as an expert. United
States v. Arney, 248 F.3d 984, 991 (10th Cir. 2001). Dr. Ronwin contends that
Dr. Reyes’s extensive orthopedic surgery experience qualifies him to opine on the
cause of plaintiff’s rotator cuff tear. But we have specifically rejected the
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contention that surgical experience alone is sufficient to qualify an expert to
testify regarding an issue “not within the reasonable confines of her subject area.”
Ralston, 275 F.3d at 970 (holding district court did not abuse its discretion in
excluding testimony by board-certified orthopedic surgeon where she had no
practical, research, or publication experience regarding the subject matter of her
proffered expert testimony, see id. at 969-70). Nor did the district court abuse its
discretion in holding that Dr. Ronwin’s relevant practical experience in
biochemistry was too stale to qualify him to give an expert causation opinion in
this case. See Meyerhoff v. Michelin Tire Corp., 70 F.3d 1175, 1182 (10th Cir.
1995) (upholding exclusion of expert testimony based, in part, on proffered
witness’s absence from the relevant industry for over 30 years). Applying the
proper standard, we cannot conclude that the district court abused its discretion in
concluding that Drs. Reyes and Ronwin were not qualified to testify regarding
whether Baycol caused plaintiff’s injuries.
Methodologies
The district court also excluded plaintiff’s experts’ testimony on the
independent basis that their methodologies failed to satisfy any of the four
Daubert factors and were therefore not scientifically valid or reliable. First, we
reject plaintiff’s argument that his experts’ theories have been peer reviewed. His
primary contention, however, is that the district court erred in choosing to apply
the Daubert factors. Specifically, he argues that, because of the short time that
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Baycol was sold, there will never be sufficient research to support a causation
conclusion, and further that “‘[t]he first several victims of a new toxic tort should
not be barred from having their day in court simply because the medical
literature, which will eventually show the connection between the victims’
condition and the toxic substance, has not yet been completed.’” Aplt. Opening
Br. at 18 (quoting Hollander, 289 F.3d at 1211). The record belies plaintiff’s
assertions: thousands of plaintiffs filed suits asserting that Baycol caused their
injuries; the district court in the MDL case required each plaintiff to submit an
expert report in support of his claim of causation; and plaintiff’s case had been
pending for seven years at the time the district court excluded his proffered expert
testimony. We cannot conclude that the district court exceeded the bounds of
permissible choice in deciding to apply the four Daubert factors in assessing the
reliability of Dr. Reyes’s and Dr. Ronwin’s methodologies.
Because the district court has discretion to consider a variety of
factors [in] assessing reliability under Daubert, and because, in light
of that discretion, there is not an extensive body of appellate case
law defining the criteria for assessing scientific reliability, we are
limited to determining whether the district court’s application of . . .
Daubert manifests a clear error of judgment or exceeds the bounds of
permissible choice in the circumstances.
Hollander, 289 F.3d at 1206.
Plaintiff asserts that the district court should have admitted Dr. Reyes’s
testimony, despite its failure to satisfy any of the Daubert factors, because a
reasonable differential diagnosis may be sufficient to validate a causation
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opinion. 5 See id. at 1211-12. 6 Bayer argues that Dr. Reyes did not do a
differential diagnosis ruling out all other plausible causes of his shoulder injury,
including those that were identified by plaintiff’s own treating physicians.
Plaintiff responds that Dr. Reyes implicitly did such an analysis with respect to
degenerative changes and his advanced age as likely causes of his rotator cuff
tear. He asserts that Dr. Reyes reviewed his medical records related to the
shoulder injury and was aware of his age, therefore Dr. Reyes must have
considered and ruled out these other factors as the cause of his injury, as opposed
to simply ignoring or overlooking them. But plaintiff admits that Dr. Reyes did
not rule out a third potential cause, and he fails to show that Dr. Reyes ruled in
Baycol as a scientifically plausible cause based upon reliable evidence. We
conclude that the district court did not abuse its discretion in failing to admit
Dr. Reyes’s expert testimony based upon his “implicit” differential diagnosis.
5
Dr. Ronwin does not contend that he performed a differential diagnosis, or
even that he would be qualified to do so.
6
“‘Differential diagnosis’ refers to the process by which a physician ‘rules
in’ all scientifically plausible causes of the plaintiff’s injury. The physician then
‘rules out’ the least plausible causes of injury until the most likely cause remains.
The remaining cause is the expert’s conclusion.” Hollander, 289 F.3d at 1209(citation and quotation omitted). We have emphasized that the remaining cause
must have been “ruled in” as scientifically plausible based upon reliable evidence.
See id. at 1211. And this court has recognized that deficiencies in a particular
differential diagnosis can support a district court’s decision to exclude expert
testimony. See id. at 1212.
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Absent indicia of reliability based upon the Daubert factors or a valid
differential diagnosis, all that is left to support plaintiff’s experts’ causation
conclusions is their own ipse dixit. See Gen. Elec. Co., 522 U.S. at 146(“[N]othing in either Daubert or the Federal Rules of Evidence requires a district
court to admit opinion evidence that is connected to existing data only by the ipse
dixit of the expert.”). The district court did not abuse its discretion in excluding
plaintiff’s proffered expert testimony.
Grant of Summary Judgment
Having excluded plaintiff’s proffered expert testimony, the district court
held that he presented no evidence demonstrating a causal link between his
ingestion of Baycol and his alleged injuries. In reaching this conclusion, the
court applied an earlier ruling in the MDL case that, because the Baycol litigation
involves complicated causation issues, all plaintiffs were required to present
expert testimony to prove injury and a causal connection. See In re Baycol Prods.
Litig., 321 F. Supp. 2d 1118, 1125-26 (D. Minn. 2004) (citing Sayer v. Williams,
962 P.2d 165, 167 (Wyo. 1998)). 7 Plaintiff does not identify any error in the
district court’s conclusion that, absent expert testimony on causation, summary
7
In that decision the district court specifically addressed plaintiff’s claims,
stating that “[c]ontrary to Plaintiff Ronwin’s assertions, whether Baycol caused
such injuries is beyond the understanding and experience of a lay person, and will
require a differential diagnosis.” In re Baycol Prods. Litig., 321 F. Supp. 2d at
1126-27.
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judgment was appropriate. But he argues that summary judgment should be
reversed because the district court did not grant his request for oral argument on
Bayer’s motion. He contends that the court’s failure to grant him an oral hearing
is a violation of his rights under the First and Seventh Amendments.
Denial of Oral Argument
“The law is well-settled that summary judgment does not violate the
Seventh Amendment.” J.R. Simplot v. Chevron Pipeline Co., 563 F.3d 1102,
1117 (10th Cir. 2009). Nor does a “hearing” on a summary judgment motion
necessarily require oral argument. “Rather, the parties’ right to be heard may be
fulfilled by the court’s review of the briefs and supporting affidavits and
materials submitted to the court.” Geear v. Boulder Comm. Hosp., 844 F.2d 764,
766 (10th Cir. 1988). Plaintiff does not cite in his opening brief any case law
holding that a district court’s grant of summary judgment without an oral hearing
is constitutionally infirm, or otherwise denying a district court discretion to
decide a summary judgment motion without oral argument. 8
8
The cases from other circuits that plaintiff cites for the first time in his
reply brief do not squarely support that proposition in the context of this case.
Therefore, in addition to being tardy, they are not persuasive. See Season-All
Indus., Inc. v. Turkiye Sise Ve Cam Fabrikalari, A.S., 425 F.2d 34, 39-40 (3d Cir.
1970) (holding that summary judgment should not be granted on the briefs
without oral argument unless court makes clear that affidavits must be filed with
the briefs); Ga. S. & Fla. Ry. Co. v. Atl. Coast Line R.R. Co., 373 F.2d 493,
496-98 (5th Cir. 1967) (addressing final judgment granted after court, without
prior notice, converted motion to dismiss into summary judgment motion and
(continued...)
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In Geear we addressed the sufficiency of the parties’ written materials in
the absence of an oral hearing:
[T]he district judge examined the briefs and supporting materials to
evaluate the merits of the motion for summary judgment. Nothing in
the record suggests that the issues and evidence presented in this case
could not be addressed adequately in the form of written briefs with
accompanying affidavits, depositions and similar exhibits. Based
upon its review of the submitted materials, the court found that entry
of judgment was appropriate because there was no genuine issue of
fact, and the Defendant was entitled to judgment as a matter of law.
Thus, the court satisfied the “hearing” requirement of Rule 56.
844 F.2d at 766. The same reasoning applies here. Plaintiff does not identify any
legal or factual issue that he was unable to present sufficiently in his 71-page
brief in response to Bayer’s motion, such that oral argument was essential. We
conclude that the district court’s decision not to grant a hearing on Bayer’s
summary judgment motion was not an abuse of discretion. We therefore affirm
the district court’s grant of summary judgment in favor of Bayer. 9
8
(...continued)
granted summary judgment after preliminary injunction hearing); Dredge Corp. v.
Penny, 338 F.2d 456, 461-62 (9th Cir. 1964) (holding that district court could not
apply local rule to preclude oral argument); see also Stump v. Gates, 211 F.3d
527, 533 (10th Cir. 2000) (stating “court does not ordinarily review issues raised
for the first time in a reply brief”).
9
Plaintiff raises two additional “issues” in his opening brief, which we
decline to address in detail. Whether Bayer “deliberately lie[d] to the court
below” and whether Bayer is a “criminal organization,” Aplt. Opening Br. at 2,
have no bearing on the basis for the district court’s grant of summary judgment in
Bayer’s favor.
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Conclusion
The judgment of the district court is AFFIRMED.
Entered for the Court
Paul J. Kelly, Jr.
Circuit Judge
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