Schedin v. Johnson & Johnson et al
Filing
263
MEMORANDUM OPINION AND ORDER denying defendant's 219 Motion for Judgment as a Matter of Law; denying defendant's 224 Motion for New Trial (Written Opinion). Signed by Judge John R. Tunheim on August 26, 2011. (DML)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
JOHN SCHEDIN,
Civil No. 08-5743 (JRT)
Plaintiff,
MEMORANDUM OPINION AND
ORDER
v.
ORTHO-MCNEIL-JANSSEN
PHARMACEUTICALS, INC.,
Defendant.
Mikal C. Watts, WATTS LAW FIRM, LLP, 555 North Carancahua, Suite
1400, Corpus Christi, TX 78478; Ronald S. Goldser, ZIMMERMAN
REED, PLLP, 651 Nicollet Mall, Suite 501, Minneapolis, MN 55402; and
Lewis J. Saul, LEWIS SAUL & ASSOCIATES, 183 Middle Street, Suite
200, Portland, ME 04101, lead counsel for plaintiff Schedin.
John Dames and William V. Essig, DRINKER BIDDLE & REATH LLP,
191 North Wacker Drive, Suite 3700, Chicago, IL 60606; William H.
Robinson, Jr., LECLAIR RYAN, 1100 Connecticut Avenue N.W., Suite
600, Washington, DC 20036; and Tracy J. Van Steenburgh, NILAN
JOHNSON LEWIS, PA, 400 One Financial Plaza, 120 South Sixth Street,
Minneapolis, MN 55402, lead counsel for defendant.
Plaintiff John Schedin brought claims against defendant Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (“Ortho-McNeil”) for failure to warn about certain risks he was
taking in using its drug, Levaquin, specifically the risk of tendon rupture. Schedin’s
action was the first case tried from many plaintiffs whose claims have been consolidated
for coordinated pretrial proceedings in multi-district litigation.
The jury found for
Schedin and awarded compensatory and punitive damages. Ortho-McNeil now moves
for a new trial claiming the verdicts are against the clear weight of the evidence and that
21
the defendant was denied a fair trial by erroneous evidentiary rulings and improper
closing arguments by Schedin. Ortho-McNeil also moves for judgment as a matter of
law (”JMOL”) on substantially the same issues as those raised in the motion for a new
trial.1
Ortho-McNeil argues the recent Supreme Court decision in PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567 (2011), should control the Court’s analysis on these motions.
Because the Court finds that Mensing is inapplicable to a brand-name manufacturer such
as Ortho-McNeil, that the verdicts were not against the clear weight of the evidence, and
that Ortho-McNeil was not denied a fair trial, the Court denies the motion for a new trial.
Further, because the standard of review for JMOL is more stringent than that for a new
trial, the Court denies the motion in so far as it rests on the same arguments as the motion
for a new trial. As far as the JMOL rests on pre-emption arguments, the Court finds no
pre-emption and denies the motion.
BACKGROUND
Plaintiff John Schedin was prescribed Levaquin for an upper respiratory infection
in February of 2008 and, after eight days of consuming the drug, he suffered bilateral
Achilles tendon ruptures. (Compl. ¶ 108, Docket No. 1.) At the time Schedin was
prescribed Levaquin, the drug contained a warning regarding tendon rupture that stated:
Tendon effects: Ruptures of the shoulder, hand, Achilles tendon, or other
tendons that required surgical repair or resulted in prolonged disability have
been reported in patients receiving quinolones, including levofloxacin.
Post-marketing surveillance reports indicate that this risk may be increased
in patients receiving concomitant corticosteroids, especially in the elderly.
1
The JMOL motion is Ortho-McNeil’s third. The Court denied its two previous motions.
(Docket Nos. 179, 196.)
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(Def. Trial Ex. 12.) Schedin brought claims against Ortho-McNeil, arguing the label was
inadequate to warn his physician of the risks of Levaquin related to tendon injuries.
Schedin sought both compensatory and punitive damages. He also alleged violations of
Minnesota’s Consumer Fraud Act. See Minn. Stat. § 325F.69. On December 8, 2010, a
jury found for Schedin on his failure to warn claim – awarding him compensatory
damages of $700,000 and punitive damages of $1,115,000. (Docket Nos. 183, 184.) The
jury found for Ortho-McNeil on the consumer fraud claim.
ANALYSIS
I.
DUTY TO WARN AFTER MENSING
As an initial matter, Ortho-McNeil submitted a letter to the Court arguing that the
Supreme Court decision in Mensing, issued after briefing on the instant motions, should
dictate the outcome of these motions. (Docket No. 257.) Mensing discussed pre-emption
in the context of prescription drugs. Pre-emption is the application of the Supremacy
Clause of the U.S. Constitution,2 resulting in the rule that any “state law that conflicts
with federal law is without effect.” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516
(1992) (internal quotation marks omitted). “Preemption is disfavored in areas of historic
importance to the states’ police powers – areas such as public health and safety.” In re
St. Jude Med., Inc. Silzone Heart Valves Prods. Liab. Litig., No. 01-MDL-1396, 2004
2
The Supremacy Clause provides that “the Laws of the United States . . . shall be the
supreme Law of the Land . . . .” U.S. Const. art. VI, cl. 2.
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WL 45503, at *5 (D. Minn. Jan. 05, 2004) (citing Kemp v. Medtronic, Inc., 231 F.3d 216,
222 (6th Cir. 2000)).
Pre-emption can be either express or implied. Express pre-emption is found when
Congress “pre-empt[s] state law by so stating in express terms.” Hillsborough Cnty., Fla.
v. Automated Med. Labs, Inc., 471 U.S. 707, 712-13 (1985) (citing Jones v. Rath Packing
Co., 430 U.S. 519, 525 (1977)). Express pre-emption is not at issue in this case.
However, where Congress has not expressly pre-empted state law, a court will
infer implied pre-emption “where it is impossible for a private party to comply with both
state and federal law, and where under the circumstances of a particular case, the
challenged state law stands as an obstacle to the accomplishment and execution of the full
purposes and objectives of Congress.” Crosby v. Nat. Foreign Trade Council, 530 U.S.
363, 372-73 (2000) (alterations, citations, and internal quotation marks omitted).
Therefore, “a conflict arises when compliance with both federal and state regulations is a
physical impossibility . . . .” Automated Med. Labs, Inc., 471 U.S. at 713 (internal
quotations omitted). “Impossibility pre-emption is a demanding defense.” Wyeth v.
Levine, 555 U.S. 555, 129 S. Ct. 118, 1199 (2009).
The Mensing Court held that a generic drug manufacturer meets the burden of
impossibility pre-emption for state failure to warn claims by showing that it could not
“independently satisfy those state duties” due to its position in the Food and Drug
Administration’s (“FDA”) regulatory scheme. Mensing, 131 S. Ct. at 2581. Under
Mensing, Ortho-McNeil argues Schedin’s claims against it are pre-empted since they
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required “independent action” by the FDA.
This “independent action” standard of
Mensing, however, is not controlling for several reasons.
First, the Supreme Court noted that its finding of impossibility pre-emption of
state law failure to warn claims for generic manufacturers did not apply to brand-name
manufacturers. Rather, the Mensing Court explicitly affirmed its previous ruling in
Wyeth that failure to warn claims against brand-name manufacturers are not pre-empted.3
Mensing, 131 S. Ct. at 2581 (“We recognize that from the perspective of [plaintiffs],
finding pre-emption here but not in Wyeth makes little sense. Had [plaintiffs] taken . . .
the brand-name drug prescribed by their doctors, Wyeth would control and their
lawsuits would not be pre-empted.”) (emphasis added). Since Levaquin is a brandname drug, the pre-emption analysis of Wyeth, not Mensing, controls.
Secondly, the manner in which the Mensing Court defined the duty of generic
manufacturers – to maintain exactly the same label as the brand-name product – implies a
heightened duty for brand-name manufacturers since the brand-name manufacturers are
the only entities that ever would be able to initiate a label change during the relevant time
periods. In both Wyeth and Mensing, as in the instant case, the FDA regulations at the
time of the contested prescription did not empower the FDA to require label changes of
manufacturers. See Mensing, 131 S. Ct. at 2588 n.9 (Sotomayor, J., dissenting). In 2007,
the FDA was given that authority. Pub. L. 110-85, § 901, 121 Stat. 924-26. However,
under the pre-2007 statutory framework applicable to Wyeth, Mensing, and this case, a
3
Had the Mensing Court not expressly affirmed Wyeth, the Court still would be obliged
to read them in concert with each other; the cases were decided a mere two years apart.
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brand-name manufacturer was the only entity in the trifecta of actors (the FDA, the
brand-name manufacturer, and the generic) that could strengthen an inadequate label.4
Congress and the FDA have always been clear, however, that they want warnings
strengthened when necessary. The FDA requires that warnings “shall describe adverse
reactions and potential safety hazards [and] limitations in use imposed by them . . . .” 21
C.F.R. § 201.57(e) (2001). Manufacturers are required to develop post-market risk
identification and analysis systems.
21 U.S.C. § 355(k).
Furthermore, since risks
associated with a drug may accumulate over time, manufacturers
must keep records of clinical experiences . . . [,] record and report certain
adverse events to FDA, and must also annually report a “summary of
significant new information from the previous year that might affect the
safety, effectiveness, or labeling of the drug product” and a “description of
actions the applicant has taken or intends to take as a result of this new
information.”
Brief for the Unites States as Amicus Curiae Supporting Respondents at *5-6, Mensing,
131 S. Ct. 2567 (Nos. 09-993, 09-1039, 09-1501), 2011 WL 741927 (2011) [hereinafter
“U.S. Amicus Brief”] (citing various applicable FDA regulations).
Unlike these clear mandates applicable primarily to brand-name manufacturers,
the Mensing Court found the FDA regulations only empowered a generic manufacturer to
ask the FDA to ask the brand-name manufacturer to change the label. Since “requesting
FDA assistance would have satisfied the [generic m]anufacturers’ federal duty [to advise
the FDA of adverse events, but] would not have satisfied their state tort-law duty to
4
The FDA, prior to 2007, could withdraw the permission to market a brand-name drug if
it believed the labeling was inadequate. 21 U.S.C. § 355(e) (2006); Mensing, 131 S Ct. at 2588
n.9 (Sotomayor, J., dissenting).
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provide adequate labeling[,]” claims premised on the manufacturers’ failure to make such
a request were pre-empted. Mensing, 131 S. Ct. at 2578.
Brand-name manufacturers
under the FDA’s pre-2007 regime, however, did not face the same constraints since they
could strengthen a label without prior FDA approval. “It is beyond dispute that the
federal statutes and regulations that apply to brand-name drug manufacturers are
meaningfully different than those that apply to generic drug manufacturers.” Id. at 2582.
As a result, “[t]he need for [subsequent] FDA approval of the label change [for brandname manufacturers] did not make compliance with federal and state law impossible in
every case.” Id. at 2588 (Sotomayor, J., dissenting).
Given the power to initiate a label change that a brand-name manufacturer had in
the pre-2007 FDA regulatory scheme, the Wyeth Court held that a brand-name
manufacturer had to demonstrate by “clear evidence” that the FDA would not have
approved a change to the label in order to demonstrate impossibility pre-emption. Wyeth,
129 S. Ct. 1198. While the Wyeth Court did not elaborate on what type of evidence
would clearly establish the FDA would not approve a label change, the Mensing Court
noted that the brand-name manufacturer in Wyeth “could have attempted to show, by
‘clear evidence,’ that the FDA would have rescinded any change in the label and
thereby demonstrate that it would in fact have been impossible to do under federal law
what state law required.” Mensing, 131 S. Ct. at 2581 n.8 (emphasis added) (citing
Wyeth, 129 S. Ct. 1198). Taken together, Wyeth and Mensing stand for the proposition
that to trigger pre-emption, a brand-name manufacturer must show that the FDA would
not have approved a proposed label change that is the basis for a state law failure to warn
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claim; indeed, the brand name manufacturer likely must proffer evidence of the FDA’s
rejection of an actual label change. See id. Such a rejection was not in evidence in
Wyeth, nor in the instant case.
Ortho-McNeil, in its post-briefing letter to the Court, submitted for the first time
a letter from the FDA dated April 20, 2008, that it claims is clear evidence that the FDA
would not have approved a label change prior to Schedin’s prescription. (Letter, Ex. 2,
Docket No. 257.)
The letter, not in evidence at trial, is a response to a May 2005
Citizen’s Petition to strengthen the label of Levaquin regarding tendon rupture and
summarizes the literature review of three studies conducted between 2005 and 2007
(including the Ingenix study in which Ortho-McNeil participated). In the letter, the FDA
concludes that “these 3 studies do not provide data to suggest a robust difference in the
risk for tendon rupture between [fluoroquinolones].” Id. at 1. However, that letter was
written at a time when the FDA had the authority to require a label change.
Furthermore, it was not a response to a manufacturer’s proposed label change. The
United States’ amicus brief in Mensing is instructive on this distinction:
Indeed, it would be both paradoxical and contrary to FDA’s statutory
responsibilities for FDA to insist upon a labeling revision under a certain
standard – ‘reasonable evidence of an association of a serious hazard with a
drug,’ – and then fail to respond positively to a warning proposed in
conformity with that standard.
U.S. Amicus Brief at *25 (citing 21 C.F.R. § 210.57(e) (2001)). As a result, the Court
finds the letter from the FDA falls short of the clear evidence standard, even if it had been
properly a part of the trial record. That the FDA did not require a label change, after it
received the statutory authority to do so, in the face of a Citizen’s Petition, not supported
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by the manufacturer does not constitute clear evidence that the FDA would have rejected
a label change proposed by Ortho-McNeil before Schedin was prescribed Levaquin.
As discussed more thoroughly later in this Order, Ortho-McNeil asserts that the
fact it would have had to apply for a waiver to include comparative toxicity information
in Levaquin’s label supports its argument that these motions should be evaluated under
the “independent action” standard of Mensing.5 However, given the heightened standard
for brand-name manufacturers to establish pre-emption, and the likelihood that “clear
evidence” requires a rejection of a label change actually proposed under the previous
statutory framework, the same would hold true for comparative toxicity label changes.
Had Ortho-McNeil applied for a waiver from the “well-controlled studies” requirement
that the FDA rejected, it would possess clear evidence in its favor. It does not.
The Mensing Court rationalized the differing standards for generic and brandname manufacturers in part on the fact that most problems associated with a drug will
become evident during the patent period for a drug. “[G]enuinely new information about
drugs in long use (as generic drugs typically are) appears infrequently . . . because patent
protections ordinarily prevent generic drugs from arriving on the market for a number of
years after the brand-name drug appears.” Mensing, 131 S. Ct. at 2581 n.9 (citations and
internal quotation marks omitted). Accordingly, a heightened duty for a brand-name
5
The FDA requires either an “adequate and well-controlled stud[y]” or a waiver from
this requirement when a manufacturer intends to make statements in the “[i]ndications and
usage” section of the label comparing the safety or effectiveness of the drug with other agents for
the same indication. 21 C.F.R. § 201.57(c)(2)(iii). Greater discussion of this regulation as it
applies to the instant litigation can be found in Schedin v. Ortho-McNeil-Janssen Pharm., Inc.,
No. 08-5743, 2011 WL 834020, at *5-7 (D. Minn. Mar. 4, 2011).
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manufacturer makes practical sense. The brand-name manufacturer must be vigilant for
problems and provide adequate labeling during the patent life of its drugs. For all these
reasons, the Court finds that the motions at issue here are most properly evaluated under
the heightened duty the Wyeth and Mensing Courts have articulated for brand-name
manufacturers. Mensing does not, as Ortho-McNeil argues, dictate judgment as a matter
of law on the grounds of federal pre-emption. The Court now turns to the instant
motions.
II.
MOTION FOR A NEW TRIAL
Under Rule 59(a) of the Federal Rules of Civil Procedure, the Court may grant a
motion for a new trial “on all or some of the issues . . . .” Fed. R. Civ. P. 59(a)(1). “A
new trial is appropriate when the first trial, through a verdict against the weight of the
evidence . . . or legal errors at trial, resulted in a miscarriage of justice.” Gray v. Bicknell,
86 F.3d 1472, 1480 (8th Cir. 1996). “The authority to grant a new trial is within the
discretion of the district court.” Id. Ortho-McNeil argues it is entitled to a new trial since
the clear weight of the evidence did not support the verdict, the Court made erroneous
evidentiary rulings, and Schedin made improper arguments in closing during the punitive
damages phase, requiring a new trial on Ortho-McNeil’s liability.
A.
Clear Weight of the Evidence
With regard to the weight of the evidence, a new trial is warranted if “the verdict
was against the great, clear, or overwhelming weight of the evidence.” Frumkin v. Mayo
Clinic, 965 F.2d 620, 625 (8th Cir. 1992). Further, only if the jury’s verdict is so against
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the great weight of the evidence that it constitutes a miscarriage of justice should a
motion for a new trial should be granted. Ogden v. Wax Works, Inc., 214 F.3d 999,
1010 (8th Cir. 2000). In other words, there is a miscarriage of justice when there is
insufficient evidence to support a verdict. Douglas Cnty. Bank & Trust Co. v. United
Fin. Inc., 207 F.3d 473, 478 (8th Cir. 2000). “On a motion for new trial, the district court
is entitled to interpret the evidence and judge the credibility of witnesses, but it may not
usurp the role of the jury by granting a new trial simply because it believes other
inferences and conclusions are more reasonable.” Manus v. Am. Airlines, Inc., 314 F.3d
968, 973-74 (8th Cir. 2003) (internal quotation marks omitted); see also Harris v. Sec’y,
U.S. Dept. of the Army, 119 F.3d 1313, 1318 (8th Cir. 1997) (“In determining whether a
verdict is against the weight of the evidence, the trial court . . . can weigh the evidence,
disbelieve witnesses, and grant a new trial even where there is substantial evidence to
sustain the verdict. The district court, however, may not reweigh the evidence and set
aside the jury verdict merely because the jury could have drawn different inferences or
conclusions or because judges feel that other results are more reasonable.” (internal
quotation marks and citations omitted)).
Ortho-McNeil argues that the jury’s verdict on Schedin’s failure to warn claim is
against the clear weight of the evidence because Schedin failed to prove that the
Levaquin label was inadequate to communicate the risks of tendon disorders. OrthoMcNeil also argues that the verdict contravened the weight of the evidence because
information regarding the comparative toxicity of other fluoroquinolones, information
Schedin alleged rendered the label inadequate, did not exist with scientific certainty.
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Finally, Ortho-McNeil argues the punitive damages award is not supported by the clear
weight of the evidence since it took several affirmative steps to enhance the Levaquin
warning based on events in Europe, thereby negating a finding of deliberate disregard.
1.
Inadequacy of the label
Ortho-McNeil argues that Schedin failed to prove the label was inadequate and
points to the fact that the Levaquin label has contained warnings related to tendon
ruptures since 1997 when it was first marketed in the United States. Ortho-McNeil
updated the label in 2001 to indicate that the tendon rupture risk was greater for those
taking concomitant corticosteroids and the elderly. Schedin’s prescribing physician,
Dr. Beecher, testified that he read the Levaquin label when he first began prescribing it,
and that he was aware of information including the general tendon warning in the earliest
Levaquin label. (Trial Tr. at 1090:9-17, Nov. 19, 2010.) He also testified, however, that
he did not read the revised label prior to his prescription to Schedin and thus was unaware
of the increased warning for the elderly and those taking concomitant corticosteroids.
(Id. at 1106:23-1107:11.)
Moreover, Beecher testified that he no longer prescribes
Levaquin unless a patient demands it. (Id. at 1098:08-10 (Q: Okay. In your deposition,
did you say you don’t give [Levaquin] anymore unless somebody pretty much demands
it? A: It’s true.”).) Furthermore, Schedin presented evidence that sales representatives
did not communicate the label change to Beecher, despite Ortho-McNeil’s argument that
Beecher simply did recall such communications. (See, e.g., id. at 1016-19 (related to the
sales calls of Monica Sadar).)
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Ortho-McNeil relies on case law supporting the proposition that warnings are
adequate as a matter of law when a plaintiff has not identified a piece of information that
would have convinced the prescribing physician to alter his treatment regimen. See, e.g.,
Greiner v. Sofamor, S.N.C., No. 4-95-645, 1999 WL 716891, at *5 (D. Minn. Mar. 8,
1999). However, the jury could infer from the fact that Beecher no longer prescribes
Levaquin that some piece of information would have altered his prescribing decision
since, in fact, he has changed his prescribing patterns as a result of his increased
awareness of the risks of the drug. Therefore, Sofamor is unavailing.
Ortho-McNeil next argues that since Beecher admitted he had not read the
Levaquin label in effect at the time of the Schedin’s prescription in 2005, no additional
information in that label could have altered his prescribing decision, breaking the causal
chain. See Johnson v. Zimmer, Inc., No. 02-1328, 2004 WL 742038, at *9 (D. Minn.
Mar. 31, 2004) (“[W]here an adequate warning could not have prevented a plaintiff's
injuries, causation does not exist as a matter of law.”). In Zimmer, the prescribing doctor
testified that “he had never, in any context, seen the warnings provided . . . .” Id. at *10.
In contrast here, Beecher had read the original warning and worked with a team of
doctors with whom he often discussed patients and outcomes. (Trial Tr. at 1093-94,
Nov. 19, 2010.) To hold, as a matter of law, that causation does not exist in a situation
where the prescribing doctor read and was aware of an initial warning and worked with
other doctors who could have read the more updated label, is an unwarranted extension of
Zimmer.
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It also fails to account for the U.S. Supreme Court holding that “the manufacturer
bears responsibility for the content of its label at all times. It is charged both with
crafting an adequate label and with ensuring that its warnings remain adequate as long as
the drug is on the market.” Wyeth, 129 S. Ct. at 1197-98. While it is true that, in this
case, a differently worded warning in the package label alone may not have altered
Beecher’s choice of drug, the gravamen of Schedin’s case was that Ortho-McNeil did not
take various reasonable measures, including but not limited to a stronger label, to ensure
the communication of any enhanced warning. The Mensing Court noted, for example,
that “Dear Doctor letters qualify as ‘labeling.’” 131 S. Ct. at 2576. Hence, the wording
in the package label by itself cannot disrupt the jury’s verdict with regard to the adequacy
of the warning.
The duty to warn rests on the manufacturer such that the manufacturer must do
just that – warn. The jury found that fine print changes to the label of a drug that had
been on the market for years with no other communication to prescribers failed to fulfill
that duty. The Court finds that the jury had sufficient evidence from which to conclude
Ortho-McNeil breached its duty to warn and that this breach caused Schedin’s injuries.
Therefore, under the standard for granting a new trial, the verdict was not against the
great weight of the evidence such that it constitutes a miscarriage of justice. See Ogden,
214 F.3d at 1010.
2.
Comparative toxicity
Ortho-McNeil argues that the clear weight of the evidence does not support a
finding that it owed a duty to provide comparative toxicity information for Levaquin and
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other fluoroquinolones.6 Recapping extensively the testimony of its own experts, OrthoMcNeil concludes that the volume of expert testimony demonstrates there was not
reasonable evidence that Levaquin was more tendon toxic than other fluoroquinolones. It
challenges the nature of the scientific evidence that Schedin’s experts utilized, arguing
adverse event reports (“AER”) and case studies are not reliable for establishing an
association or causality, as explained by Ortho-McNeil’s expert Peter Layde. (Trial Tr. at
2215:12-2216::14, Nov. 30, 2010.) However, Schedin’s expert, Gregory Bisson, relied
on AERs and cases studies in part to offer his opinion that a greater tendon toxicity
exists. (Trial Tr. at 257:6-283:4, Nov. 16, 2010.) Ortho-McNeil never raised a motion to
exclude Bisson’s testimony prior to trial and, while it objected to the admission of AERs
as hearsay, Bisson’s use of AERs in forming his opinions comports with the rules of
evidence. See Fed. R. Evid. 703 (“If of a type reasonably relied upon by experts in the
particular field in forming opinions or inferences upon the subject, the facts or data need
not be admissible in evidence in order for the opinion or inference to be admitted.”).
Essentially, Ortho-McNeil argues the Court should afford more weight to the
opinions of its witnesses that Levaquin is not more tendon toxic than other
fluoroquinolones and that even if it is, such a determination was not evident at the time of
Schedin’s prescription. However, given the admissibility of the evidence proffered by
Schedin’s experts, to order a new trial on this basis would usurp the role of the jury in the
6
Ortho-McNeil’s pre-emption arguments regarding comparative toxicity are discussed
below in relation to its motion for judgment as a matter of law.
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a manner not within the discretion of the Court on a motion for a new trial. See Manus,
314 F.3d at 973-74.
3.
Punitive damages
Ortho-McNeil argues the punitive damages award was against the clear weight of
the evidence in large part because the standard for awarding punitive damages is a higher
standard than for underlying liability. See Minn. Stat. § 549.20, subd. 1(a) (“Punitive
damages shall be allowed in civil actions only upon clear and convincing evidence that
the acts of the defendant show deliberate disregard for the rights or safety of others.”).
However, on a motion for a new trial, the Court applies the same standard of review
regardless of the underlying burden on the plaintiff, and must view the evidence in a light
most favorable to the jury verdict. Inacom Corp. v. Sears, Roebuck and Co., 254 F.3d
683, 689 (8th Cir. 2001) (“The strictures of the review process dictate that we view the
evidence [on punitive damages] in a light most favorable to the jury’s verdict. Reversible
error occurs only when there is a complete absence of probative facts to support the
conclusion reached.” (alteration and internal citations omitted)).
Here, Schedin presented evidence that Ortho-McNeil knew of the potential for
higher tendon toxicity of Levaquin (see Pl.’s Ex. 88 (letter to the FDA discussing
knowledge of Ortho-McNeil in October of 2001)), assisted in the design of a study
allegedly to hide that potential and cloud the field of academic literature on the topic (see
Pl.’s Ex. 14 (meeting minutes discussing changes to the Ingenix study so as to protect the
U.S. market)), and then failed to adequately warn prescribers as discussed above. From
this, the jury had sufficient evidence to determine that Ortho-McNeil had deliberately
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disregarded the rights and safety of others to warrant an award of punitive damages. The
Court declines to draw different inferences from the evidence as urged by Ortho-McNeil.
See Harris, 119 F.3d at 1318.
B.
Erroneous Evidentiary Rulings
The Court may also grant a new trial where improper evidentiary rulings “had a
substantial influence on the jury’s verdict[,]” Littleton v. McNeely, 562 F.3d 880, 888 (8th
Cir. 2009) (internal quotation marks omitted), and the admission of evidence was “so
prejudicial that a new trial would likely produce a different result.” Harrison v. Purdy
Bros. Trucking Co., Inc., 312 F.3d 346, 351 (8th Cir. 2002) (internal quotation marks
omitted). Erroneous evidentiary rulings do not warrant a new trial unless they affected
the substantial rights of the parties. Fed. R. Civ. P. 61;7 Anderson v. Genuine Parts Co.,
Inc., 128 F.3d 1267, 1270 (8th Cir. 1997); Norton v. Caremark, Inc., 20 F.3d 330, 338 (8th
Cir. 1994). Ortho-McNeil objects specifically to three evidentiary rulings of the Court
that it claims created undue prejudice: the admission of evidence pertaining to post-2005
Levaquin label changes, the admission of evidence pertaining to foreign regulatory
actions, and the admission of evidence related to AERs.
7
Rule 61 of the Federal Rules of Civil Procedure provides:
Unless justice requires otherwise, no error in admitting or excluding evidence – or
any other error by the court or a party – is ground for granting a new trial, for
setting aside a verdict, or for vacating, modifying, or otherwise disturbing a
judgment or order. At every stage of the proceeding, the court must disregard all
errors and defects that do not affect any party’s substantial rights.
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1.
Post-2005 Labeling
At trial, Ortho-McNeil objected to the admission of evidence of post-2005 labeling
of Levaquin, asserting that such evidence should have been excluded as a subsequent
remedial measure, see Fed. R. Evid. 407, and that the jury would be unduly prejudiced by
such evidence to conclude that pre-2005 labeling was de facto inadequate.8 The Court
found the evidence admissible since “[a]n exception to Rule 407 is recognized for
evidence of remedial action mandated by superior governmental authority . . . .” In re
Levaquin Prods. Liab. Litig., Nos. 08-1943, 08-5743, 2010 WL 4882595, at *1
(D. Minn. Nov. 24, 2010). To address any potential prejudice, the Court gave the jury a
limiting instruction.9 The Court finds the admission of the evidence was not erroneous
under Rule 407 and any potential harm or prejudice was sufficiently mitigated by the
Court’s limiting instruction to the jury on the issue. See Gen. Indus. Corp. v. Hartz
Mountain Corp., 810 F.2d 795, 808 (8th Cir. 1987) (“Admission of evidentiary matters is
8
Schedin took Levaquin in 2005.
9
The post-2005 labeling limiting instruction read as follows:
You have heard evidence that the Food and Drug Administration (“FDA”)
approved Levaquin as safe and effective for its intended uses, that the FDA
approved Levaquin’s label or “package insert” in place at the time of plaintiff’s
prescription, and that the FDA required changes to the label in 2008 after the time
of plaintiff’s prescription. You may consider that evidence, along with all of the
other evidence presented, in evaluating whether plaintiff has proven his claims by
a preponderance of the evidence. Neither the FDA’s approval of the drug and its
label, nor its requirement of label changes, is necessarily conclusive or controlling
on any issue you have been asked to decide. You may give it as much or as little
weight as you think it deserves, in light of all the evidence, under the law as set
forth in these instructions.
(Jury Instructions at 15, Docket No. 176.)
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within the discretion of the trial court and will not be disturbed on appeal unless abuse of
that discretion is shown. . . . Moreover, the limiting instruction given by the district court
sufficiently informed the jury of the restrictions on its use of the [evidence].”). Finding
no error in the admission of the evidence, the Court concludes that no substantial rights
were affected to warrant a new trial.
2.
Foreign Regulatory Action
At trial, Ortho-McNeil objected to the admission of foreign regulatory action
related to Levaquin, arguing that such evidence was hearsay, irrelevant, and highly
prejudicial. The Court admitted this evidence as it was being offered for the purposes of
notice and motive. In re Levaquin Prods. Liab. Litig., Nos. 08-1943, 08-5743, 2010 WL
4676973, at *5 (D. Minn. Nov. 9, 2010). The Court noted that Schedin’s evidence was
not final foreign regulatory action, which courts have deemed potentially prejudicial
given differing regulatory schemes. Id. (citing In re Seroquel Prods. Liab. Litig., 601
F. Supp. 2d 1313, 1315 (M.D. Fla. 2009); In Re Baycol Prods. Litig., 532 F. Supp. 2d
1029, 1054 (D. Minn. 2007)). Paradoxically, Ortho-McNeil submitted evidence of final
foreign regulatory action at trial. (Def.’s Ex. 123.) Further, Ortho-McNeil argued such
evidence was probative of the underlying adequacy of its U.S. label. (Trial Tr. at
3029:14-24 (“[I]n October 2003, the final report . . . by the MHRA assessor . . . found
that tendon warnings in Europe which mirrored, pretty much mirrored the tendon
warnings that were put out by Ortho-McNeil in the United States were adequate.”).)
Since a core argument of Schedin’s case was that Ortho-McNeil knew of the
higher tendon toxicity of Levaquin because of its experiences in Europe and that it took
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inappropriate actions to protect its share of the U.S. market as a result, the Court finds
that admission of the documents between foreign regulators and Ortho-McNeil were
relevant to notice and motive. Ortho-McNeil argues it is entitled to a new trial because
the admission of this evidence “encouraged jurors to defer to the judgments of foreign
regulators.” (Mem. in Supp. at 28, Docket No. 226.) However, foreign regulators did not
require any label changes; to the extent that this evidence may have encouraged jurors to
defer, it arguably would have done so in favor of Ortho-McNeil. Additionally, the Court
mitigated any potential prejudice with a limiting instruction to the jury on the proper use
of such evidence.10 See Gen. Indus. Corp., 810 F.2d at 808. As a result, the Court denies
a new trial on the basis of its evidentiary ruling relating to foreign regulatory action.
3.
AERs
At trial, Ortho-McNeil objected to the discussion of AERs regarding Levaquin,
arguing that such evidence was not reliable to show causation. The Court had denied its
previously filed motion in limine regarding AERs, finding that the evidence was
10
The foreign regulatory action limiting instruction read as follows:
You have heard evidence on various regulatory issues that occurred outside of the
United States. The legal standards used by foreign regulatory agencies may be
different from those used in the United States. Therefore, you should not use
regulatory actions by foreign regulatory agencies to determine whether or not
defendant abided by or violated any legal duty in the United States. However, the
evidence surrounding these foreign regulatory events may be considered by you
as a basis for understanding defendant’s actions in the United States, defendant’s
notice about issues that were relevant in the United States, and defendant’s
motives in responding to those issues which may have impact within the United
States.
(Jury Instructions at 16, Docket No. 176.)
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admissible to show notice and could also support a finding of causation. In re Levaquin
Prods. Liab. Litig., 2010 WL 4676973, at *4. The Court noted that AER databases are
commonly used by experts in the field to determine causation in conjunction with other
evidence. Id. Ortho-McNeil moves for a new trial primarily based on the conclusions
drawn by Bisson that the AERs and other evidence demonstrated a higher tendon toxicity
for Levaquin. However, the bases of Bisson’s opinions were permissible under Rule 703,
as explained above, and he was subject to vigorous cross examination by Ortho-McNeil.
Ortho-McNeil also presented its own experts who challenged Bisson’s conclusions. (See
generally Trial Tr. at 2202-2322, Nov. 30, 2010, Docket No. 206 (testimony of defense
expert Dr. Peter Layde); Trial Tr. 2807-2897, Dec. 2, 2010, Docket No. 208 (testimony
of defense expert Dr. George Holmes).) Finally, the Court issued a limiting instruction
to the jury to mitigate any potential prejudice from the jury viewing AERs as causation
evidence standing alone.11 The Court finds the admission of this evidence was not error,
11
The AERs limiting instruction read as follows:
You have heard testimony and have seen exhibits relating to case reports,
case series, spontaneous reports, and adverse events reporting injuries in persons
who have taken Levaquin. This type of information alone should not be
considered by you as evidence of a causal relationship between use of the drug
and the injury, but may be considered along with other evidence to determine
whether the drug is a substantial contributing factor to the injury. These reports
may be considered as one type of evidence of a signal that there may be an
association between a drug and the adverse event.
Likewise, this type of information or data alone should not be considered
by you as evidence of the incidence of the injury associated with the drug, or
evidence of making comparisons between drugs.
Simply because one drug may have more reports of a particular injury, is
not evidence that it presents more of a risk of that injury than other drugs.
(Footnote continued.)
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and any prejudice was mitigated by both cross examination and the limiting instruction.
See Gen. Indus. Corp., 810 F.2d at 808.
C.
Improper Closing Arguments
“[W]hen a new trial motion is based on improper closing arguments, a new trial
should be granted only if the statements are ‘plainly unwarranted and clearly injurious’
and ‘cause prejudice to the opposing party and unfairly influence a jury’s verdict.’”
Harrison, 312 F.3d at 351 (alternations omitted) (citing Alholm v. Am. Steamship Co.,
144 F.3d 1172, 1181 (8th Cir. 1998). Ortho-McNeil asserts that the punitive damages
award reflects passion and prejudice on the part of the jury since the award is out of line
with the jury’s finding of no liability on the Consumer Fraud Act claim. Ortho-McNeil
claims the award is a direct result of improper arguments on the part of Schedin’s counsel
during the punitive damages phase of the trial. Since the majority of the evidence
considered by the jury was presented during the liability phase of the trial,12 OrthoMcNeil asserts the Court should order a new trial on the underlying claims to redress the
prejudice in the punitive damages closing arguments. Ortho-McNeil stresses Schedin’s
closing arguments were improper on three bases: Schedin encouraged the jury to award
_____________________________
(Footnote continued.)
Epidemiologists consider such evidence together with more formal studies and
other factors in deciding whether there is causation.
(Jury Instructions at 14, Docket No. 176.)
12
During the punitive damages phase, little new evidence was introduced with the
exception of sales revenue figures for Levaquin from 1997-2009, offered by Schedin, and each
party gave closing arguments on punitive damages.
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damages for conduct unrelated to his injuries, urged the jury to speculate about OrthoMcNeil’s profits, and misrepresented the evidence.
1.
Conduct unrelated to injuries
In the context of punitive damages, “[a] defendant’s dissimilar acts, independent
from the acts upon which liability was premised, may not serve as the basis for punitive
damages. A defendant should be punished for the conduct that harmed the plaintiff, not
for being an unsavory individual or business.”
State Farm Mut. Auto. Ins. Co. v.
Campbell, 538 U.S. 408, 422-23 (2003). Ortho-McNeil asserts that Schedin urged the
jury to consider actions after Schedin’s prescription, sales aids that were never seen by
Beecher directly, and Ortho-McNeil’s studies on Levaquin and children as a means to
extend its patent. Further, it argues that Schedin improperly used an Abraham Lincoln
quote from the Gettysburg Address.
First, Schedin did discuss the 2008 enhanced “black box” warning in closing.
However, he did so only in the context of characterizing Ortho-McNeil’s attitude towards
increasing the warnings associated with Levaquin as consistent with its behavior prior to
Schedin’s injury. (Trial Tr. at 3202:21-23, Dec. 8, 2011, Docket No. 212 (“[T]hey
studied it and figured out that a black box and a Dear Doctor letter would cost them 15
percent of their sales volume.”).) This discussion of the black box is directly related to
Schedin’s theory of underlying liability. See Campbell, 538 U.S. at 422-23.
Second, Beecher testified that he never saw sales aids. However, Schedin’s failure
to warn claim rested in part on the casual nexus of Ortho-McNeil’s failure to warn the
medical community at large, on which Beecher relied for information. As a result, the
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discussion of sales aids and the absence of reference to tendon injuries and the coadministration of corticosteroids is not independent from the acts upon which liability
was premised. See id.
Third, Schedin referenced Ortho-McNeil’s scientific studies on Levaquin and
children so as to discredit Ortho-McNeil’s expert Noel who testified as to Ortho-McNeil
“doing good things about kids.” (Id. at 3195:25-3196:6.) The impugning of a witness,
through reference to evidence, is proper fodder for closing argument. See, e.g., United
States v. Franklin, 568 F.2d 1156, 1158-59 (8th Cir. 1978).
Fourth, Schedin’s use of a quote from the Gettysburg Address, while possibly an
ill-fitted analogy, does not rise to the level of prejudicial argument that would incite the
passion of the jury.
Minnesota courts have found reference to irrelevant personal
characteristics of the plaintiff an inappropriate appeal to the jury’s prejudice and
sympathy. See, e.g., Jenson v. Peterson, 264 N.W.2d 139, 145 (Minn. 1978) (finding
improper discussion of the plaintiff’s physical disabilities that were unrelated to the
contract dispute at issue). However, analogies to general societal experiences do not
usually constitute prejudicial error. See, e.g., Hall v. Luebbers, 341 F.3d 706, 719 (8th
Cir. 2003) (finding no prejudice where the prosecutor, in closing, referenced war and
courage and “commented about the fear of society as a whole and how this case would
affect anyone presented with the same situation”). The Court finds the Civil War distant
enough in history so as to not incite the personal passions of the jurors in this case. Cf.
United States v. Steele, 390 Fed. App’x 6, 15 (2d Cir. 2010) (noting no prejudice in
discussion of Al Qaeda in a racketeering case despite characterizing the comments as a
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“blatant and improper ploy to evoke images of terrorists so soon after the attacks of
September 11, 2001” (referencing United States v. Burden, 600 F.3d 204 (2d Cir. 2010)).
In sum, the Court finds Schedin’s closing arguments did not arouse such passion and
prejudice in the jury, nor were they so removed from issues regarding the liability
incurring actions of Ortho-McNeil, so as to warrant setting aside the punitive damages
award and ordering a new trial. See Harrison, 312 F.3d at 351.
2.
Speculation about profits
Ortho-McNeil argues Schedin’s reference to profits from the sale of Levaquin
required the jury to speculate improperly. Minnesota’s punitive damages statute allows a
jury to consider a list of factors that is not exclusive. Minn. Stat. § 549.20, subd. 3 (“Any
award of punitive damages shall be measured by those factors which justly bear upon the
purpose of punitive damages, including . . . the financial condition of the defendant . . .
.” (emphasis added)). Ortho-McNeil asserts that the statute allows the jury to consider
the net worth of a defendant but not the profit from a single product. The Court finds no
support for such a proposition from the inclusive nature of the statutory language.
Minnesota courts have allowed lost profits to be considered in punitive damages awards.
See, e.g., Hydra-Mac, Inc. v. Onan Corp., 430 N.W.2d 846, 855 (Minn. Ct. App. 1988),
rev’d on other grounds, 450 N.W.2d 913 (Minn. 1990). Accordingly, the Court finds
earned profits suitable for consideration and supported by adequate evidence. (Trial Tr.
3158:8-13, Dec. 8, 2011, Docket No. 212.) Furthermore, the Court gave the jury a
limiting instruction to not speculate when determining punitive damages. (Supp. Jury
Instructions, Docket No. 180.) As a result, the Court does not find the mention of profits
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in Schedin’s closing arguments incited such passion and prejudice so as to justify
overturning the award and granting a new trial. See Harrison, 312 F.3d at 351.
3.
Misrepresenting evidence
Ortho-McNeil argues that Schedin misrepresented evidence in a manner that was
“plainly unwarranted and clearly injurious.” See Griffin v. Hilke, 804 F.2d 1052, 1057
(8th Cir. 1986). First, it argues Schedin misrepresented certain evidence – articles related
to the decline in sales from sending out Dear Doctor letters – arguing the articles
discussed dispensing rates and not overall sales. Review of the evidence shows that the
overall result of the study referenced in the article showed just such a decline: Schedin
did not overinflate the findings of the study. (Pl. Ex. 623 (“Results: A highly publicized
letter sent in June 1998 was associated with a notable decline (58%) in the concomitant
dispensing rate . . . .”).) To the extent that dispensing rates differ from sales, the Court
finds that reference to dispensing rates in closing argument is not so clearly injurious as
to set aside the punitive damages award.
Second, Ortho-McNeil argues that Schedin’s discussion of an email newsletter
erroneously implied the number of individuals involved in decisions related to labeling of
Levaquin. However, review of the exhibit indicates Schedin did not misrepresent the
number of people who received the email. (Pl. Ex. 1169.) Further, Schedin’s argument
about the exhibit related to what was missing from the email – mention of the
strengthened warning label for tendon injury – which was probative of his failure to
communicate claim. Therefore, the Court does not find Schedin misrepresented evidence
such that a new trial is warranted.
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In sum, the Court finds that Schedin’s closing arguments in the punitive damages
phase were not so prejudicial as to warrant a new trial on the punitive damages award.
As a result, the Court denies the request for a new trial on the underlying liability.
V.
JUDGMENT AS A MATTER OF LAW
Under Rule 50 of the Federal Rules of Civil Procedure, judgment as a matter of
law is appropriate if no reasonable juror could return a verdict for the nonmoving party.
Weber v. Strippit, Inc., 186 F.3d 907, 912 (8th Cir. 1999). In analyzing a Rule 50 motion,
the Court must consider the evidence in the light most favorable to the nonmovant,
resolve all factual conflicts in the nonmovant’s favor, and give the nonmovant the benefit
of all reasonable inferences. Ogden, 214 F.3d at 1002. “[J]udgment as a matter of law is
proper when the record contains no proof beyond speculation to support the verdict.”
Heating & Air Specialists, Inc. v. Jones, 180 F.3d 923, 932–33 (8th Cir. 1999) (internal
quotation marks omitted). “Motions for judgment as a matter of law must meet standards
that are more stringent than the standards applied to motions for a new trial.”
Spectralytics, Inc. v. Cordis Corp., 650 F. Supp. 2d 900, 904 (D. Minn. 2009), aff’d in
part, vacated in part on other grounds by Nos. 20090156, 2010-1004, 2011 WL 2307402
(8th Cir. June 13, 2011).
The motions brought by Ortho-McNeil for a new trial and for judgment as a matter
of law are based on substantially the same arguments. Ortho-McNeil contends Schedin
did not show the Levaquin label was inadequate to warn Beecher of the risks of tendon
rupture, failed to show Ortho-McNeil had a duty to provide comparative information
about other fluoroquinolones, and failed to show with clear and convincing evidence that
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Ortho-McNeil acted with deliberate disregard. Since the Court has determined those
arguments fail under the less stringent standard of that for a new trial, this Order
evaluates only those arguments unique to the judgment as a matter of law motion under
the more stringent standard.
In its motions in limine and earlier motions for judgment as a matter of law,
Ortho-McNeil argued more extensively that the doctrine of pre-emption applied to many
of the arguments made by Schedin on his failure to warn claim because of FDA
regulations. Ortho-McNeil re-raises two pre-emption arguments in its third motion for
judgment as a matter of law. First, it argues that FDA regulations pre-empt the provision
of label warnings that include comparative toxicity. Second, it argues that Buckman preemption, involving fraud on the FDA, applies to bar Schedin’s punitive damages claim.
As described earlier, the Court finds the pre-emption analysis of Wyeth, as clarified in
Mensing, is the prevailing legal standard applicable to the instant motions.
A.
Comparative Data
In the Court’s earlier Order on one of Ortho-McNeil’s previous motions for
judgment as a matter of law, the Court held that Ortho-McNeil was not impliedly preempted from providing comparative data about other fluoroquinolones in the Levaquin
label based on differing language between the “[w]arnings and precautions” section of
FDA labeling regulations and the “[i]ndications and usage” section. Schedin, 2011WL
834020, at *5-6. The latter section requires either an adequate and well controlled study
to make a change to a label in that section or a waiver from this requirement. 21 C.F.R.
§ 201.57(c)(2)(iii). The former section allows a label change in the “[w]arnings and
- 28 -
precautions” section regarding a “clinically significant hazard as soon as there is
reasonable evidence of a causal relationship with a drug; a causal relationship need not
have been definitively established.” Id. § 201.57(c)(6)(i).
Ortho-McNeil argues that the portion of the regulation in effect at the time of
Schedin’s injury would not have allowed comparative representations. The relevant
regulation defines an adverse reaction as “an undesirable effect, reasonably associated
with the use of the drug, that may occur as part of the pharmacological action of the drug
or may be unpredictable in its occurrence.” Id. § 210.57(g) (2005). The regulation goes
on to state that “[a]ny claim comparing the drug to which the labeling applies with other
drugs in terms of frequency, severity, or character of adverse reactions shall be based on
adequate and well-controlled studies . . . unless this requirement is waived . . . .” Id.
§ 210.57(g)(4). As a result, Ortho-McNeil argues the impossibility of a well-controlled
comparative study rendered it unable to alter Levaquin’s label, pre-empting any duty to
provide comparative warnings.
However, in Wyeth and Mensing, the Supreme Court held that pre-emption only
applies to brand-name manufacturers like Ortho-McNeil if there exists “clear evidence
that the FDA would not have approved a change to [the drug’s] label . . . .” Wyeth, 29
S. Ct. at 1198; Mensing, 131 S. Ct. at 2581 n.8. As this Court has previously noted:
Here, both parties concede that a “well-controlled study” as defined by the
FDA cannot be conducted ethically since such a study requires a placebo
concurrent control group that could be fatal to elderly patients with
respiratory infections.
Regardless, Ortho–McNeil has presented no
evidence that it applied for a waiver from that requirement as the regulation
permits.
Schedin, 2011 WL 834020, at *6 (internal citations omitted).
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As discussed above in regard to the Mensing Court’s articulation of the “clear
evidence” standard, the Court finds that Ortho-McNeil has failed to show clear evidence
that the FDA would have rejected a proposed label change under these circumstances so
as to relieve it from state law liability. Ortho-McNeil has provided no evidence that it
applied for a waiver from the well-controlled studies requirement and, as such, the
requirements of the “demanding defense” of impossibility pre-emption have not been
met. See Wyeth, 129 S. Ct. at 1199; Mensing, 131 S. Ct. at 2581 n.8.
B.
Fraud on the FDA
Ortho-McNeil renews its argument that Schedin’s punitive damages claim is preempted by the fraud on the FDA doctrine as outlined in Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341 (2001). The Buckman Court held that “the federal statutory
scheme amply empowers the FDA to punish and deter fraud against the Administration,
and that this authority is used by the Administration to achieve a somewhat delicate
balance of statutory objectives.” Id. at 348. Since policing fraud against federal agencies
is not a traditional state function, such claims are pre-empted. Id. Ortho-McNeil argues
that since Schedin’s punitive damages claim rests on a finding that Ortho-McNeil
intentionally manipulated the Ingenix study to thwart regulatory action, the claim is one
of fraud on the FDA, and thus is pre-empted under Buckman.
However, the punitive damages claim, as noted in the Court’s previous Order,
does not hinge on a defrauding of the FDA. Schedin, 2011 WL 834020, at *8. As the
Eighth Circuit has recently affirmed, the predicate for Buckman pre-emption is that a
claim focuses on harm perpetrated against the FDA as opposed to consumers. Lefaivre v.
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KV Pharm. Co., 636 F.3d 935, 944 (8th Cir. 2011) (addressing adulterated drugs that did
not meet current good manufacturing processes). Here the punitive damages claim is
based on harm that was visited upon consumers – namely the failure to warn them of the
tendon toxicity of Levaquin – in part through alleged manipulation of the Ingenix study.
“[S]imply because [that] conduct violates the [Food, Drug and Cosmetics Act (“FDCA”)]
does not mean a state-law claim based on that same conduct depends on the FDCA’s
existence[,]” warranting pre-emption. Id. (internal quotation marks omitted).
Furthermore, Schedin’s punitive damages claim was based on more than just
Ortho-McNeil’s alleged manipulation of the Ingenix study. As such, even if pre-emption
applied to one theory of the claim, it would not foreclose punitive damages on other
alleged bases.
(See Punitive Damages Order, Docket No. 119 (“From Schedin’s
evidence, . . . a jury could reasonably infer that defendants: had knowledge of or
intentionally disregarded medical research regarding Levaquin’s tendency to cause
tendon injuries, particularly in seniors using corticosteroids; sought to prevent European
regulatory action regarding levofloxacin’s risks that would negatively impact the drug’s
reputation; manipulated the Ingenix Study to produce a commercially favorable result;
failed to adequately warn Schedin and his doctor of dangers, despite knowing the
particular risks of tendon injury Levaquin posed to seniors using corticosteroids, and the
higher risk posed by Levaquin as compared to other fluoroquinolones; affirmatively
misrepresented Levaquin’s safety profile through its marketing campaign and other
means.”).) As a result, the Court denies Ortho-McNeil’s motion for judgment as a matter
of law.
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ORDER
Based on the foregoing, and the records, files, and proceedings herein, IT IS
HEREBY ORDERED that:
1.
Defendant’s Motion for a New Trial [Docket No. 224] is DENIED.
2.
Defendant’s Motion for Judgment as a Matter of Law Renewed Motion
[Docket No. 219] is DENIED.
DATED: August 26, 2011
at Minneapolis, Minnesota.
____s/
____
JOHN R. TUNHEIM
United States District Judge
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