Schedin v. Johnson & Johnson et al
Filing
292
MEMORANDUM OPINION AND ORDER denying defendant's 283 Motion for Relief from Judgment (Written Opinion). Signed by Judge John R. Tunheim on August 17, 2012. (DML)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
IN RE: LEVAQUIN PRODUCTS
LIABILITY LITIGATION
MDL No. 08-1943 (JRT)
This Document Relates to:
Civil No. 08-5743 (JRT)
JOHN SCHEDIN,
Plaintiff,
v.
MEMORANDUM OPINION AND
ORDER DENYING
DEFENDANT’S MOTION FOR A
RELIEF FROM JUDGMENT
ORTHO-MCNEIL-JANSSEN
PHARMACEUTICALS, INC.,
Defendant.
Ronald S. Goldser and David M. Cialkowski, ZIMMERMAN REED,
PLLP, 1100 IDS Center, 80 South Eighth Street, Minneapolis, MN 55402;
Mikal C. Watts, WATTS LAW FIRM, LLP, 555 North Carancahua, Suite
1400, Corpus Christi, TX 78478, and Lewis J. Saul and Kevin M.
Fitzgerald, LEWIS SAUL & ASSOCIATES, 183 Middle Street, Suite
200, Portland, ME 04101, for plaintiff Schedin.
John D. Winter, PATTERSON BELKNAP WEBB & TYLER, 1133
Avenue of the Americas, New York, NY 10036; James B. Irwin, IRWIN
FRITCHIE URQUHART & MOORE, LLC, 400 Poydras Street, Suite
2700, New Orleans, LA 70130; Tracy J. Van Steenburgh and Dana M.
Lenahan, NILAN JOHNSON LEWIS, PA, 120 South Sixth Street, Suite
400 Minneapolis, MN 55402; and John Dames and William V. Essig,
DRINKER BIDDLE & REATH LLP, 191 North Wacker Drive, Suite
3700, Chicago, IL 60606, for defendant.
Plaintiff John Schedin brought claims against defendant Ortho-McNeil-Janssen
Pharmaceuticals, Inc.1 for failure to warn about certain risks of using its drug, Levaquin,
1
Now Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC. (See
Pretrial Order 7a, Dec. 29, 2011, Docket No. 282.)
24
specifically the risk of tendon rupture. His case was the first tried in multi-district
litigation involving numerous plaintiffs.
The jury found for Schedin and awarded
compensatory and punitive damages. The Court denied Defendant’s post-trial motions,
and Defendant filed a still-pending appeal in the Eighth Circuit Court of Appeals.
Defendant now seeks relief from judgment pursuant to Federal Rule of Civil Procedure
60. Defendant contests that Schedin’s failure to disclose some calculations of his expert
witness, Dr. Martin Wells, entitles them to relief from judgment pursuant to
Rule 60(b)(2) and Rule 60(b)(3). The Court will deny Defendant’s Rule 60(b)(2) motion
because Defendant fails to demonstrate that the evidence is material and not merely
cumulative or impeaching or that the evidence is such that a new trial would probably
produce a different result. The Court will also deny Defendant’s Rule 60(b)(3) motion
because Defendant has not shown, by clear and convincing evidence, that Schedin
engaged in a fraud or misrepresentation that prevented it from fully and fairly presenting
its case.
BACKGROUND
Dr. Wells’ Expert Report
On October 13, 2009, Schedin served the Expert Report of Dr. Wells, a
biostatistician, in the multi-district litigation. (Aff. of Dana M. Lenahan, Ex. A., Expert
Report, Docket No. 286.)
The report criticized the validity of the Ingenix study,
Defendant’s epidemiological study that compared the risk of Achilles tendon rupture with
Levaquin and other fluoroquinolones. (See, e.g., id. ¶ 4.) Dr. Wells criticized numerous
aspects of the study (e.g., id. ¶¶ 11-16), and he performed new analyses on the underlying
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data. In Paragraph 28, Dr. Wells stated that the Ingenix study’s filtering of the data
resulted in underreporting of the risks of Levaquin compared to ciprofloxacin, another
fluroquinolone, in the Medicare population. (Id. ¶¶ 28, 31.) In Paragraph 32, Dr. Wells
also reported that he found an increased risk of Achilles tendon rupture in the entire
population of Levaquin-exposed individuals used as the basis for the Ingenix study. (Id.
¶ 32.) Dr. Wells did not report the relative risk of Achilles tendon rupture for patients
taking ciprofloxacin in the entire population. The failure to report this information (the
ciprofloxacin odds ratio) and the underlying calculation (the ciprofloxacin calculation) is
the basis of each of Defendant’s arguments.
Defendant’s Requests and Dr. Wells’ Testimony
On November 24, 2009, Defendant noticed the deposition of Dr. Wells and
requested that he produce “[a]ll data and other information received or reviewed in
connection with the formation of your opinions, whether or not you relied on that data or
information.” (Lenahan Aff., Ex. B., Dep. Notice.) On December 10, 2009, Defendant
took Dr. Wells’ deposition. During this deposition, Defendant did not specifically ask
Dr. Wells for the calculation and data underlying paragraph 32. (See id. 144:5-146:7.)
Dr. Wells testified during Schedin’s trial (in November 2010) about the flaws of
the Ingenix study. He also testified that in the Medicare population there was a
significant association between Levaquin and Achilles tendon rupture but that the same
association was not seen with ciprofloxacin. (Lenahan Aff., Ex. E., Schedin Trial Tr.
582:3-17.) Defendant did not ask, and Dr. Wells did not disclose the comparative risks of
Levaquin and ciprofloxacin for all patients in the dataset.
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In May 2011, Defendant sent a letter requesting the “production of the calculations
performed by Martin Wells using the Ingenix data and discussed in Wells’ Expert Report
. . . .” (Lenahan Aff., Ex. X.) Schedin’s counsel responded by e-mail, “You have all
there is. Any calculations that Dr. Wells did were on his computer and there is no record
of the calculations.” (Lenahan Aff., Ex. I.)
During the second trial in this multi-district litigation (in June 2011), Christensen
v. Johnson & Johnson, Defendant again questioned Dr. Wells about paragraph 32 and the
underlying calculations.
Defendant asked whether Dr. Wells compared the risk of
Achilles tendon rupture for patients taking Levaquin with the risk for patients taking
ciprofloxacin in the entire population, he testified, “Yeah, I probably did. I probably
did.” (Lenahan Aff., Ex. J, Christensen Tr. 761:21-762:13.) When asked where the
results of those calculations were, Dr. Wells said they were “probably still in the
computer.” (Id. 761:15-15.) When asked why the calculation had not been produced,
Dr. Wells said that when he did the calculations they printed out on the screen and to
record them he wrote them down. (See id. 766:7-767:10.) Dr. Wells also noted that the
dataset he used to do the calculation was “available” to Defendant. (Id. 767:1-4.)
Dr. Wells next testified during the first trial of the New Jersey consolidated
Levaquin litigation proceedings (in September 2011).
Prior to that trial, Dr. Wells
produced some of the Expert Report’s underlying calculations to the New Jersey
plaintiff’s counsel. (See Lenahan Aff., Ex. K 103:6-15.) In response to questions about
the calculations underlying paragraph 32, Dr. Wells testified that even though they were
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not in his report he “must have” calculated the risk of Achilles tendon rupture for patients
taking ciprofloxacin. (Id. 105:6-9.)
Immediately after Dr. Wells’ testimony in the New Jersey trial, Defendant’s
counsel sought access to the calculations that Dr. Wells had produced in the New Jersey
litigation. (Lenahan Aff., Ex. L.) On October 24, 2011, Schedin’s counsel produced the
calculations, but no explanation of the calculations was included. (Lenahan Aff. Ex. M.)
On October 25, 2011, Defendant’s counsel asked for an explanation of how the
calculations related to Defendant’s May 2010 request. (Lenahan Aff., Ex. N.) Schedin’s
counsel responded that “[t]he calculations provided . . . are the calculations you
requested” and that Dr. Wells had redone the calculations at the request of New Jersey
counsel. (Id.) Schedin’s counsel did not explain which calculations produced results
referenced in the Expert Report.
On November 25, 2011, Defendant’s counsel again asked Schedin’s counsel to
explain the relationship between the calculations produced in the New Jersey trial and the
calculations discussed in paragraph 32 of Dr. Wells’ Expert Report. (Lenahan Aff.,
Ex. O.) Schedin’s counsel responded on December 2, 2011, and provided the odds ratio,
that is the risk of Achilles tendon rupture for patients taking ciprofloxacin. (Lenahan
Aff., Ex. P.) The risk of Achilles tendon rupture for the entire population of the Ingenix
study was higher in patients taking ciprofloxacin than in patients taking Levaquin.2
Counsel provided the information, not Dr. Wells. (See id.)
2
The odds ratio for ciprofloxacin exposure is 1.755 (95% CI: 1.371-2.247). (Lenahan
Aff., Ex. P.) The odds ratio for Levaquin exposure is 1.606 (95% CI: 1.086-2.306).
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Defendant noticed a second deposition of Dr. Wells on January 3, 2012 and
requested that he produce “all documents that constitute, reflect, or relate to the
calculations underlying paragraphs 28 and 32” of the Expert Report and all documents
that relate to the calculation of the odds ratios for the risk of Achilles Tendon rupture for
ciprofloxacin. (Lenahan Aff., Ex. R.) On January 5, 2012, Schedin’s counsel produced
the calculations used to create the ciprofloxacin calculation of paragraph 28 only. (See
Lenahan Aff., Ex. S.) The deposition took place on January 6, 2012. (Goldster Aff., Ex.
3, Second Dep. of Martin T. Wells.) Dr. Wells testified that he could not remember if he
had previously calculated the risk of Achilles tendon rupture for the entire population of
the Ingenix study in patients taking ciprofloxacin. (Id. 22:17-22.) He further testified
that when Defendant had previously asked for the calculation he did not have it (id. 58:46) but that he had re-done the calculations in early December of 2011 (id. 58:15-19).
Defendant also requested that Dr. Wells produce the calculations underlying the
ciprofloxacin odds ratio provided by Schedin’s counsel on December 2. (Id. 10:1011:20, 13:4-10.) Those calculations were produced on January 9, 2012.
On January 10, 2012, Dr. Wells testified in the third trial in this multi-district
litigation, Straka v. Johnson & Johnson. (Lenahan Aff., Ex. V, Straka Tr.) During this
testimony, Dr. Wells indicated that he had not provided all of the data he had created in
December 2009 because he had been advised by Schedin’s counsel that he did not need
to do so. (Id. 1059:11-1061:2.)
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ANALYSIS
I.
STANDARD OF REVIEW
Under Rule 60(b) a party can seek relief from judgment for:
(2)
newly discovered evidence that, with reasonable diligence,
could not have been discovered in time to move for a new trial under
Rule 59(b); [or]
(3)
fraud (whether previously called intrinsic or extrinsic),
misrepresentation, or misconduct by an opposing party . . . .
Fed. R. Civ. P. 60(b).3 “The rule ‘provides for extraordinary relief which may be granted
only upon an adequate showing of exceptional circumstances.’”
Jones v. Swanson,
512 F.3d 1045, 1048 (8th Cir. 2008) (quoting United States v. Young, 806 F.2d 805, 806
(8th Cir. 1986)). Defendant seeks relief under both Rule 60(b)(2) and (b)(3).
II.
DEFENDANT’S RULE 60(b)(2) MOTION
A.
Standard of Review
“Motions under Rule 60(b)(2) on the ground of newly discovered evidence are
viewed with disfavor.” Haigh v. Gelita USA, Inc., 632 F.3d 464, 472 (8th Cir. 2011)
(quoting U.S. Xpress Enters., Inc. v. J.B. Hunt Transp., Inc., 320 F.3d 809, 815 (8th Cir.
2003)). To prevail on a Rule 60(b)(2) motion Defendant must show that (1) the evidence
was discovered after trial; (2) they exercised due diligence in discovering it; (3) the
evidence is material and not merely cumulative or impeaching; and (4) the evidence is
such that a new trial would probably produce a different result. Id. Defendant alleges
3
“A motion . . . must be made within a reasonable time – and for reasons . . . (2), and (3)
no more than a year after the entry of the judgment or order or the date of the proceeding.” Fed.
R. Civ. P. 60(c). The motion was timely made.
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that the ciprofloxacin odds ratio and the ciprofloxacin calculation are newly discovered
evidence that meets the standards of Rule 60(b)(6).
B.
Due Diligence
First, Defendant must demonstrate that they exercised due diligence in discovering
the new evidence.
Id.
To demonstrate “due diligence,” Defendant must offer a
“‘justifiable excuse’ for not discovering the material in a timely manner.” Scott v. Apfel,
194 F.R.D. 655, 658 (N.D. Iowa 2000) (citing Alpern v. UtiliCorp United, Inc., 84 F.3d
1525, 1537 (8th Cir. 1996)). Defendant claims they could not perform the same analysis
required to calculate the ciprofloxacin odds ratio because they did not know Dr. Wells’
methodology. Although the Court is not convinced that Defendant was unable to recreate
this calculation before trial,4 it will assume for the purposes of this motion that Defendant
exercised due diligence.
C.
Cumulative or Impeaching
Defendant must also establish that “the evidence is material and not merely
cumulative or impeaching[.]” Haigh, 632 F.3d at 472. Both the ciprofloxacin odds ratio
and the fact that Dr. Wells had performed the underlying calculation could be used for
impeachment.
But Defendant argues that the calculation had broader implications
because Dr. Wells’ testimony at trial “went to the substantive issue of whether the risk of
4
Defendant suggested at oral argument that the Court should not deny the motion simply
because the evidence was available through another avenue. Defendant offered no support for
this proposition. Cf. Baxter Int’l, Inc. v. Morris, 11 F.3d 90, 93 (8th Cir. 1993) (“The court also
pointed out that [Plaintiff] had other avenues to discover the [evidence]. We agree.”); Pri-har v.
United States, 83 F. Supp. 2d 393, 401 (S.D.N.Y 2000) (“Expert reports . . . based upon evidence
available to the defense at trial[] do not constitute new evidence.”).
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[Achilles tendon rupture] is greater with Levaquin® than other fluoroquinolones
including ciprofloxacin.” (Def.’s Mem. in Supp. at 25, Mar. 5, 2012, Docket No. 285).
While the ciprofloxacin odds ratio might have provided Defendant with slightly
more support for their case, the Court finds that the evidence is cumulative. Defendant
offered other expert testimony that Levaquin is no more tendon toxic than other
fluoroquinolones. Cf. Rosebud Sioux Tribe v. A & P Steel, Inc., 733 F.2d 509, 516
(8th Cir. 1984) (finding the newly discovered evidence was not cumulative when it was
the only “concrete” – not circumstantial – evidence). Defendant also offered evidence at
trial that the methodology of the Ingenix study was sound.
The Court therefore
concludes that the evidence was merely cumulative or impeaching.
D.
Different Result
Even if Defendant exercised due diligence and the evidence was material,
Defendant must also show that the evidence “is such that a new trial would probably
produce a different result.” Haigh, 632 F.3d at 472. Defendant asks the Court to assume
that Dr. Wells’ testimony was key to the case,5 but the Court is not convinced. Even if
Dr. Wells was a critical witness, his criticisms of the Ingenix study were broad and would
not be wholly undermined by the ciprofloxacin calculation.6 Moreover, “admission of
5
Defendant argues that Dr. Wells’ testimony regarding the flaws of the Ingenix study
was critical to Schedin’s case, that Dr. Wells’ ciprofloxacin calculation would have demonstrated
to the jury that the Ingenix study did not skew the results, and that the evidence would have cast
doubt on Schedin’s comparative toxicity theory.
6
For example, Dr. Wells suggested that the Ingenix study underreported the risks of
Levaquin in the Medicare population. Data demonstrating that Levaquin was not more
dangerous than other fluoroquinolones in the study’s total population does not contradict
Dr. Wells’ conclusion that the study underrepresented the drug’s risks in some sub-populations.
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the evidence would not produce a different result because liability rested not only on
[Dr. Wells’] testimony, but on the record as a whole.” Greyhound Lines, Inc. v. Wade,
485 F.3d 1032, 1037 (8th Cir. 2007).
Defendant tries to draw parallels to Rosebud Sioux Tribe, but unlike that case, “the
entire complexion of the case” has not changed. 733 F.2d at 516. The ciprofloxacin
calculation does not “contradict any testimony at trial.” Baxter Int’l, Inc. v. Morris,
11 F.3d 90, 93 (8th Cir. 1993) (distinguishing Rosebud Sioux Tribe). In sum, the Court
will deny Defendant’s Rule 60(b)(2) motion because the newly discovered evidence was
merely cumulative or impeaching and Defendant has not demonstrated that it was
probable it would produce a different result.
III.
DEFENDANT’S RULE 60(b)(3) MOTION
A.
Standard of Review
To prevail on a Rule 60(b)(3) motion, Defendant must show, by clear and
convincing evidence, that the opposing party engaged in a fraud or misrepresentation that
prevented them from fully and fairly presenting their case.7 United States v. Metro.
St. Louis Sewer Dist., 440 F.3d 930, 935 (8th Cir. 2006).
It is within the Court’s
discretion to determine “whether the Rule 60(b)(3) test has been met . . . .” Id.
B.
Misconduct, Fraud, or Misrepresentation
Defendant argues that Schedin’s attorneys withheld expert discovery materials and
so have engaged in misconduct under Rule 60(b)(3). Even assuming that withholding
7
Defendant suggests that the Rule 60(b)(3) standard is more lenient than the
Rule 60(b)(2) standard. It provides no Eighth Circuit authority to support this proposition.
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expert discovery can be misconduct under Rule 60(b)(3),8 the Court finds that there was
no violation of the Rule.
Dr. Wells testified that he did his calculations on a computer program that did not
retain the results unless he saved or printed them. (See Second Wells Dep. 10:6-9, 12:59, 12:25-13:2.) Dr. Wells did not recall doing the calculation for the ciprofloxacin odds
ratio, and if he did, apparently did not save it because he had to recreate it before it was
eventually produced. If Schedin’s attorneys, in fact, advised Dr. Wells that he did not
have to produce a calculation that he did not remember doing and of which he had no
record, they were not withholding discovery materials. See Helmert v. Butterball, LLC,
No. 4:08CV00342, 2011 WL 3157180, at *2 (E.D. Ark. July 27, 2011) (holding that
while the opposing party was entitled to the underlying data used by an expert, the expert
did not have to produce all of his notes and calculations); Flebotte v. Dow Jones & Co.,
No. Civ.A. 97-30117, 2000 WL 35539238, at *7 (D. Mass. Dec. 6, 2000) (“Therefore,
neither the plain language of [Rule 26] nor its purpose compels disclosure of every
calculation or test conducted by the expert during formation of the report.”).
Defendant argues that the failure to produce the calculations was particularly
egregious in light of the Court’s other pretrial orders. The Court did conclude that
another expert witness should have disclosed her consideration of a database analysis and
produced that underlying data. (MDL Docket No. 2277 at 5-6.) In contrast, Dr. Wells
8
Other circuits have held that withholding discovery from an opposing party constitutes
misconduct under Rule 60(b)(3). See, e.g., Abrahamsen v. Trans-State Express, Inc., 92 F.3d
425, 428 (6th Cir. 1996); Anderson v. Cryovac, Inc., 862 F.2d 910, 923 (1st Cir. 1988). See also
Rauenhorst v. United States, 104 F.R.D. 588, 598 (D. Minn. 1985) (Rule 60(b)(3) may be
properly applied to misconduct in withholding information called for by discovery).
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disclosed what data he used and that data was available to both parties – he not only used
data from Defendant’s Ingenix study but the calculation that Defendant claims was not
disclosed was performed on an identified subset. The Court concludes that Defendant
failed to demonstrate that Schedin’s attorneys or Dr. Wells engaged in misconduct
sufficient to support application of Rule 60(b)(3).
C.
Defendant’s Inability to Fairly Present Their Case
Defendant also contends that the lack of the ciprofloxacin odds ratio data
prevented them from fairly presenting their case. The Court finds that the lack of the
calculation did not prevent Defendant from mounting a vigorous (and in the case of
Christensen wholly successful) defense.
While Defendant might have been
inconvenienced, any misconduct does not warrant a new trial. The Court will, therefore,
deny Defendant’s Rule 60(b)(3) motion because Defendant has not shown that the
opposing party engaged in a fraud or misrepresentation that prevented them from fully
and fairly presenting their case.
ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that Janssen Pharmaceuticals, Inc.’s Motion for Relief from
Judgment Pursuant to Rule 60(b) [Docket No. 283] is DENIED.
LET JUDGMENT BE ENTERED ACCORDINGLY.
DATED: August 17, 2012
at Minneapolis, Minnesota.
____s/
____
JOHN R. TUNHEIM
United States District Judge
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