Prather v. Organon USA, Inc. et al
Filing
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MEMORANDUM AND ORDER: IT IS HEREBY ORDERED that Organon's motion for summary judgment directed to plaintiff's punitive damages claim (Doc. 24 ) is DENIED. Signed by District Judge Rodney W. Sippel on 7/12/13. (ARL)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION
IN RE NUVARING® PRODUCTS
LIABILITY LITIGATION
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Case No. 4:08-MD-1964-RWS
MARIANNE PRATHER,
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Case No. 4:08-CV-00558-RWS
Plaintiff
v.
ORGANON USA, INC. et al.
Defendants.
MEMORANDUM AND ORDER
Defendants in this case, hereinafter ―Organon,‖ move for summary judgment directed to
Plaintiff Marianne Prather’s punitive damages claim. To decide Organon’s motion, I must first
determine which state’s law applies to this action. Applying the Second Restatement’s most
significant relationship test as required by Missouri’s choice-of-law rules, I conclude that
Missouri law applies to the punitive damages issue. To be entitled to summary judgment,
Organon must show there are no genuine issues of material fact as to Prather’s claim for punitive
damages. Organon has not carried its burden. As a result, Organon’s motion for summary
judgment will be denied.
1
I.
BACKGROUND1
Organon’s principle place of business is in New Jersey. NuvaRing, which is
manufactured, marketed, and sold by Organon, is a member of a class of prescription drugs
known as combined hormonal contraceptives (―CHCs‖). Unlike oral CHCs, which are taken
daily, NuvaRing takes the form of a flexible ring which releases hormones over the course of
treatment. The ring is vaginally inserted by women for birth control. Each month, the ring is
removed and a new ring is inserted.
CHCs contain an estrogen, typically ethinyl estradiol (―EE‖), and a progestin. The
―generation‖ of CHC depends upon the type of progestin. Each ―generation‖ of CHC typically
uses the following progestins: first-generation contains norethynodrel; second-generation
contains levonorgestrel; and third-generation CHCs contain desogestrel, gestodene, or
norgestimate. NuvaRing uses the active metabolite of desogestrel, etonogestrel, and is therefore
considered a third-generation progestin.
All CHCs can cause venous thromboembolism (―VTE‖), including deep vein thrombosis
(―DVT‖) and pulmonary embolism.2 First-generation CHCs use high levels of EE and are
associated with high incidence rates of VTE. Second-generation CHCs use a reduced amount of
EE and are associated with less risk of VTE. It is generally accepted that risk of thrombosis is
correlated with estrogen dose. Third-generation CHCs use lower amounts of estrogen than prior
generations; however, some studies have found an increased risk of VTE with some thirdgeneration oral CHCs as compared to second-generation oral CHCs.
1
I am finding these facts purposes of deciding this motion only, and neither party may rely on
this Order to establish any facts or defenses at trial.
2
Venous thromboembolism is a blood clot that forms within a vein. Deep vein thrombosis is a
blood clot that forms in a vein not externally visible, typically in the veins of the lower
extremities. A pulmonary embolism forms when part or all of a blood clot breaks free and
lodges in one of the lungs. These conditions have varying severity and can be life threatening.
2
Plaintiff, Marianne Prather (―Prather‖), is a resident of Missouri. Organon sold and
marketed NuvaRing in Missouri, which included the use of sales representatives. Dr. Evelyn
Schuetz prescribed NuvaRing to Prather in Missouri, and Prather began using NuvaRing in late
August 2003. At the end of September 2003, Prather began to experience leg discomfort and
shortness of breath. On October 4, 2003, Prather visited the emergency room in St. Charles,
Missouri, where an ultrasound revealed a deep vein thrombosis in her left leg, and a CT scan
revealed multiple pulmonary emboli.
Prather claims that NuvaRing presents an undisclosed risk of VTE, including both DVT
and pulmonary embolism, that is higher than second- and third-generation oral contraceptives.
Prather cites evidence that progestins ―counterbalance‖ the blood-clotting tendencies of estrogen.
Prather contends that NuvaRing’s use results in occasional bursts of estrogen that are unopposed
by progestin, and this increases the prothrombotic propensities of NuvaRing. Prather further
alleges that the progestin component of NuvaRing reaches optimum levels more slowly than the
estrogen component and that this also increases the risk of blood clots. Prather alleges that
Organon knew of these issues and that these properties of NuvaRing are not reflected in the
drug’s label and packaging inserts. Prather further alleges that Organon failed to timely disclose
the occurrences of VTEs in NuvaRing clinical patients and that Organon’s sales representatives
misrepresent NuvaRing’s hormonal ―burst‖ propensity by telling doctors that the ring ―releases a
steady dose‖ of estrogen and progestin per day. (See Doc. 46-3, NuvaRing Sales Support, at 16).
Organon seeks summary judgment on Prather’s claim for punitive damages, and Organon
asserts that New Jersey law should govern the punitive damages issue. Prather contends that
Missouri law controls. Organon responds that even under Missouri law, it is entitled to summary
judgment.
3
II.
DISCUSSION
A.
Standard of Review
Summary judgment is proper if the evidence, viewed in the light most favorable to the
nonmoving party, indicates there is no genuine issue of material fact and the moving party is
entitled to judgment as a matter of law. Castillo v. Ridge, 445 F.3d 1057, 1060 (8th Cir. 2006)
(citing Gipson v. INS, 284 F.3d 913, 916 (8th Cir. 2002)). The summary judgment rule is
intended ―to isolate and dispose of factually unsupported claims‖ and should be applied to
accomplish this purpose. Celotex Corp. v. Catrett, 477 U.S. 317, 323–324 (1986). When a party
moving for summary judgment points out an absence of evidence on a dispositive issue for
which the nonmoving party bears the burden of proof at trial, the non-moving party must ―go
beyond the pleadings and by [his] own affidavits, or by the depositions, answers to
interrogatories, and admissions on file, designate specific facts showing that there is a genuine
issue for trial.‖ Id. at 324–25 (internal quotations and citation omitted). Thereafter, summary
judgment is mandated against the non-moving party who fails to make a showing sufficient to
establish a genuine issue of fact for trial. Id. at 322, 324–25. The party opposing a motion for
summary judgment must rely on more than conclusory statements or allegations unsupported by
facts. Davis v. U.S. Bancorp, 383 F.3d 761, 765 (8th Cir. 2004) (citation omitted). In ruling on
a motion for summary judgment, a court must consider all inferences drawn from the underlying
facts in a light most favorable to the party opposing the motion and resolve all reasonable doubts
against the moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). Summary
judgment is not proper if the evidence is such that a reasonable jury could return a verdict for the
nonmoving party. Id. at 248.
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B.
Choice of Law for Punitive Damages
As a threshold matter, the parties in this case dispute whether the law of Missouri or New
Jersey should be applied to Prather’s claim for punitive damages. Neither party contests that the
respective laws conflict.3 A district court sitting in diversity must apply the choice-of-law rules
of the state in which the action was originally filed. Klaxon Co. v. Stentor Elec. Mfg. Co., 313
U.S. 487, 496 (1941); Wolfley v. Solectron USA, Inc., 541 F.3d 819, 823 (8th Cir. 2008). When
determining choice-of-law issues, Missouri courts apply the ―most significant relationship‖ test
established by the Restatement (Second) of Conflicts of Law. Kennedy v. Dixon, 439 S.W.2d
173, 184 (Mo. banc 1969). This test is applied individually to each particular issue under the
principle of ―dépeçage.‖ See Glasscock v. Miller, 720 S.W.2d 771, 775 (Mo. Ct. App. 1986).
To determine whether a state has a more significant interest than the state of injury,
Missouri courts apply Restatement (Second) Section 145, which provides two sets of criteria for
determining the state with the most significant relationship. Natalini v. Little, 185 S.W.3d 239,
248–50 (Mo. Ct. App. 2006); Goede v. Aerojet General Corp., 143 S.W.3d 14, 25 nn.7 & 8, 26
(Mo. Ct. App. 2004) (abrogated on other ground by Sanders v. Ahmed, 364 S.W.3d 195, 207
(Mo. banc 2012). First, courts must consider whether a state has a more significant interest
under the principles stated in Restatement (Second) Section 6, which include:
(a) the needs of the interstate and international systems;
3
In Missouri, awards of punitive damages are limited to the greater of $500,000 or five times the
net amount of the judgment awarded plaintiff against the defendant. R.S. Mo. § 510.265.1
(2005). In contrast, New Jersey law provides:
Punitive damages shall not be awarded if a drug or device . . . which
caused the claimant’s harm was subject to premarket approval . . . by the federal
Food and Drug Administration . . . and was approved . . . . However, where the
product manufacturer knowingly withheld or misrepresented information required
to be submitted under the agency’s regulations, which information was material
and relevant to the harm in question, punitive damages may be awarded.
N.J. Stat. Ann. § 2A:58C–5c (1995).
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(b) the relevant policies of the forum;
(c) the relevant policies of other interested states and the relative interests of those
states in the determination of the particular issue;
(d) the protection of justified expectations;
(e) the basic policies underlying the particular field of law;
(f) certainty, predictability and uniformity of result; and
(g) the ease in the determination and application of the law to be applied.
Restatement (Second) § 6 (1971).
Second, Section 145 requires that courts must consider the following contacts when
applying the Section 6 principles: (1) the place of the injury; (2) the place of misconduct; (3) the
domicile, residence, nationality, place of incorporation, and place of business of the parties; and
(4) the place where the relationship between the parties is centered. Id. § 145(2). The number of
contacts favoring a particular state plays little importance; rather, Missouri courts ―evaluate the
contacts based on their relative importance to the particular issue.‖ Goede, 143 S.W.3d at 26
(citing Dillard v. Shaughnessy, Fickel & Scott Architects, Inc., 943 S.W.2d 711, 715 (Mo. Ct.
App. 1997)). Thus, under Missouri’s choice-of-law rules, the law of the state with the most
significant relationship to the punitive damages issue will govern Prather’s claim for punitive
damages.
Section 146 of the Restatement applies to actions for personal injury and calls for states
to apply the substantive law of the ―state where the injury occurred‖ unless, ―with respect to the
particular issue[,] some other state has a more significant relationship‖ to the parties and
occurrences under the principles listed in Section 6. Restatement (Second) § 146. With respect
to the issue of damages, Restatement Section 171 provides that the state selected by Section 145
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determines the measure of damages. Restatement (Second) § 171; see also id. at cmt. d (―The
law selected by application of the rule of § 145 determines the right to exemplary damages.‖).
Section 145 requires an analysis into the purpose of the issue. Where, as with punitive damages,
the primary purpose of the rule involved is to deter or punish misconduct, the place where the
conduct occurred has particular significance. See Restatement (Second) § 145 cmt. e; see also
Bradshaw v. Deming, 837 S.W.2d 592, 594 (Mo. Ct. App. 1992) (―Punitive damages . . . have as
their purpose, not the compensation of the plaintiff, but the punishment of the defendant and the
deterrence of the offending conduct in the future.‖).
1)
Relevant Contacts under Restatement § 145(2)
a)
Place of Injury
Both parties agree that Missouri is the state of the alleged injury. Organon argues,
however, that because the place of injury is merely ―fortuitous,‖ it should be afforded little
weight. It has been held that ―[w]here a party is domiciled in the place of injury, purchases the
allegedly defective product there, and uses it only there, the place of injury is not fortuitous.‖
Yocham v. Novartis Pharmaceuticals Corp., 736 F. Supp. 2d 875, 882 (D.N.J. 2010). The
Restatement provides an example of a fortuitous injury: a plaintiff purchases an airline ticket in
one state to fly to another state, and the airplane crashes in a third state. See Restatement
(Second) § 146 cmt. d. In such a case, the place of injury ―bears little relation to the occurrence
and the parties‖ and the defendant would have no reason to foresee that the injury would occur in
the particular state. See Restatement (Second) § 145 cmt. e. This is not a case where a plaintiff
purchased a product and then travelled into a new, unforeseen jurisdiction when calamity struck.
Organon marketed and sold NuvaRing in Missouri, where Prather purchased and used it. Prather
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suffered her DVT and pulmonary emboli in Missouri. The place of injury is not fortuitous as
that term is used in the choice-of-law analysis.
b)
Place of Misconduct
The state in which the misconduct occurs is the contact that bears the most significance to
the issue of punitive damages. See Restatement (Second) § 145 cmt. c. Organon argues that the
majority of the relevant conduct occurred in New Jersey because that state was Organon’s point
of contact with the FDA. Prather responds that the relevant conduct occurred in Missouri, as
Organon employed sales representatives in Missouri who, when promoting NuvaRing, allegedly
failed to warn Prather’s physician of NuvaRing’s dangers. Prather has the better argument.
―[T]he conduct causing injury in a prescription drug products liability case, including failure to
warn and warranty cases, occurs primarily where the injured party was prescribed and ingested
the drug.‖ Yocham, 736 F. Supp. 2d at 882 (citing Montgomery v. Wyeth, 540 F. Supp. 2d 933,
944 (E.D. Tenn. 2008); Bearden v. Wyeth, 482 F. Supp. 2d 614, 620 (E.D. Pa. 2006); Cornett v.
Johnson & Johnson, 998 A.2d 543, 551–52 (N.J. Super. App. Div. 2010)). I find that the
majority of the misconduct occurred in Missouri.4
c)
Domicile of the Parties
Prather is a Missouri resident. Organon’s principle place of business in the United States
is New Jersey. Because Prather is from Missouri and Organon is from New Jersey, this factor
has a neutral effect on the choice-of-law analysis.
d)
Place Where the Relationship Between the Parties Is Centered
4
The parties allude to the possibility that some decisions by Organon may have been made in
either the Netherlands or Germany. If so, this would merely dilute Organon’s argument that
New Jersey bears the most significant relationship. The parties fail to adequately support this
premise in the record.
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Missouri is the place at which the parties’ relationship centers, as their relationship arises
solely through this litigation. See Cornett, 998 A.2d at 552 (placing locus of relationship in state
where patient and doctors received warnings or suffered from their absence). This contact,
however, has little significance to the choice of law analysis here. See Chicago, 644 F.2d at 612
n.20 (noting contact’s significance primarily derives from interest in regulating conduct).
2)
Section 6 Principles
The second step of the Restatement analysis is to apply the principles enumerated in
Section 6 of the Restatement and thereby determine whether Missouri, as the state of injury,
plaintiff’s domicile, locus of the parties’ relationship, and the site of much of the alleged
misconduct, retains a greater significance than New Jersey, the state of Organon’s principle
business and the state in which some misconduct allegedly occurred.
Organon argues that the ―justified expectations‖ of the parties weighs in favor of New
Jersey law. However, ―the protection of the justified expectations of the parties, which is of
extreme importance in such fields as contracts, property, wills and trusts, is of lesser importance
in the field of torts[;] . . . persons who cause injury . . . unintentionally . . . usually act without
giving thought to the law that may be applied . . . .‖ Restatement (Second) cmt. b. Similarly,
―the values of certainty, predictability and uniformity of result are of lesser importance in torts‖
than in areas like contracts or estates where the parties are likely to plan their transactions in
accordance with applicable law. See id. Moreover, Missouri’s status as the locus of the parties’
relationship militates against Organon’s claim that it justifiably expected New Jersey law would
govern Missouri NuvaRing claims. Organon sold and marketed NuvaRing in Missouri. In doing
so, Organon should have expected to be subjected to Missouri law regulating such conduct.
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Organon argues that applying New Jersey law would simplify the determination and
application of a punitive damages analysis. It bases this argument upon a ruling by that state’s
courts that essentially bars all punitive damages in pharmaceutical cases where the FDA
approves the label. See, e.g., McDarby v. Merck & Co., Inc, 949 A.2d 223, 276 (N.J. Super.
App. Div. 2008) (finding exception preempted by Federal Food Drug and Cosmetic Act).
However, federal courts are not bound by state court rulings on preemption. See Casey v. FDIC,
583 F.3d 586, 592 (8th Cir. 2009). Moreover, federal courts have reached differing conclusions
on the preemption issue. See Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 727, 767–
68 (D. Md. 2012) (discussing divergence). Contrary to Organon’s argument, I find that applying
New Jersey law to punitive damages would entail more difficulty in applying the law.
An analysis of the states’ interests does not yield a result favoring New Jersey law. New
Jersey adopted its products liability law in order to ―limit[] the liability of manufacturers of
FDA-approved products by reducing the burden placed on them by product liability litigation.‖
Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767, 774 (N.J. 2007). In doing so, the New Jersey
legislature ―balanced the need to protect individuals against the need to protect an industry with a
significant relationship to [its] economy and public health.‖ Id. Missouri allows punitive
damages in order to punish and deter similar conduct. See Vaughan v. Taft Broadcasting Co.,
708 S.W.2d 656, 660 (Mo. banc 1986). Moreover, Missouri presumably considered the effect
that its laws would have upon its own economy when it placed limits upon the amount of
punitive damages. This case presents a true conflict of laws, because both New Jersey and
Missouri have interests that would be furthered by applying their respective statutes to Prather’s
claim.
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While New Jersey has an interest in protecting its corporations from the burdens of
frivolous lawsuits, that interest is diminished where the defendant corporation’s conduct occurs
outside the state. Cf. Rowe, 917 A.2d at 629 (―To allow a life-long Michigan resident who
received an FDA-approved drug in Michigan and alleges injuries sustained in Michigan to bypass his own state’s law . . . overvalu[es] [New Jersey’s] true interest in this litigation.‖).
Organon allegedly engaged in misconduct in Missouri and in doing so injured a Missouri citizen
in Missouri. Having considered the principles set forth in Section 6, I find that Missouri has the
most significant relationship to the parties and occurrences. Missouri law will govern punitive
damages.
C.
Motion for Summary Judgment
Organon contends it is entitled to summary judgment as a matter of Missouri law on the
issue of punitive damages. In a negligence action, punitive damages may be awarded if the
defendant knew or had reason to know a high degree of probability existed that the action would
result in injury. Stojkovic v. Weller, 802 S.W.2d 152, 155 (Mo. banc 1991), overruled on other
grounds by Rodriguez v. Suzuki Motor Corp., 936 S.W.2d 104 (Mo. banc 1996); Hoover’s
Dairy, Inc. v. Mid–America Dairymen Inc., 700 S.W.2d 426, 436 (Mo. banc 1985). Similarly, in
a strict liability case, punitive damages may be awarded if a plaintiff presents evidence that the
defendant placed in commerce an unreasonably dangerous product with actual knowledge of the
product’s defect. Letz v. Turbomeca Engine Corp., 975 S.W.2d 155, 164–65 (Mo. Ct. App.
1997) (citing Sparks v. Consolidated Aluminum Co., 679 S.W.2d 348, 354 (Mo. Ct. App. 1984)).
Under both negligence and strict liability theories, a plaintiff must also show that the defendant
exhibited a complete indifference to or conscious disregard for the safety of others in order to
recover punitive damages. Id.
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Organon presents one argument in support of its motion for summary judgment under
Missouri law.5 Organon asserts that its warnings preclude a finding of conscious disregard
towards the risk of VTE and pulmonary embolism that NuvaRing presents.
A ―specific and explicit‖ warning of the defective condition can negate the inference of a
defendant’s indifference to consumer safety. Drabik v. Stanley-Bostich Inc., 997 F.2d 496, 510
(8th Cir. 1993); see also Jone v. Coleman Corp., 183 S.W.3d 600, 610 (Mo. Ct. App. 2005)
(finding warning that ―burning products consume oxygen‖ and ―ample ventilation must be
provided‖ negated conscious disregard of safety towards carbon monoxide danger).
Organon argues that its warnings explicitly state that there is a risk of pulmonary
embolism and VTE associated with all hormonal contraceptives, including NuvaRing. However,
the issue here is not whether the label warns of the risk of VTE and pulmonary embolism
presented by NuvaRing. Rather, the issue is whether the label warns of the difference in risk of
those conditions between NuvaRing and second- and third-generation oral contraceptives.
The NuvaRing label prominently addresses the risk differential of VTE:
Several epidemiology studies indicate that third generation oral
contraceptives, including those containing desogestrel (etonogestrel, the progestin
in NuvaRing, is the biologically active metabolite of desogestrel), are associated
with a higher risk of venous thromboembolism than certain second generation
oral contraceptives. In general, these studies indicate an approximate two-fold
increased risk, which corresponds to an additional one or two cases of venous
thromboembolism per 10,000 women-years of use. However, data from
additional studies have not shown this two-fold increase in risk. It is unknown if
NuvaRing has a different risk of venous thromboembolism than second generation
oral contraceptives.
5
Organon also makes a one-sentence argument that punitive damages should be foreclosed,
because Prather’s causation expert, Dr. Richart, conceded that no data exist to show a difference
in risk between NuvaRing and second-generation pills. However, Dr. Richart cites in his
supplementary affidavit an epidemiological study that links NuvaRing specifically to an
increased risk of VTE. (Doc. 37-2 ¶ 10). This argument, therefore, fails.
12
(Doc. 32-1, NuvaRing Approved Label) (emphasis added). NuvaRing’s Patient Information
section similarly states: ―The risk of getting blood clots may be greater with the type of progestin
in NuvaRing than with some other progestins in certain low-dose birth control pills. It is
unknown if the risk of blood clots is different with NuvaRing use than with the use of certain
birth control pills.‖ (Id.). The NuvaRing label also states that ―[t]here is no epidemiologic data
available to determine whether safety and efficacy with the vaginal route of administration of
combination hormonal contraceptives would be different from the oral route.‖ (Id.).
The uncertainty inherent to NuvaRing’s warnings is made apparent by the effect they had
on Prather and her prescribing physician, Dr. Schuetz. Dr. Schuetz testified that, after reading
the NuvaRing label, she did not ―have an understanding that NuvaRing had hormonal ingredients
in it that had a higher risk of causing blood clots than other birth control products.‖ (Doc. 42-5,
Schuetz Dep., at 113; id. at 127 (―I did not perceive that as a different—difference in risk.‖)).
Similarly, Prather stated that, after reading the patient information section of the NuvaRing label,
she did not understand that NuvaRing was associated with an increased risk of blood clots,
including pulmonary embolism. (Doc. 42-6, Prather Dep. at 166).6
The cases cited by Organon are distinguishable from the one at bar. In those cases, the
warning specifically listed known risks for the product upon which they appeared. See Jone,
183 S.W.3d at 610–11 (warning on propane lantern fuel canister stated ―all burning products
consume oxygen‖); Scharff v. Wyeth, No. 2:10-CV-220-WKW, 2012 WL 3149248, at *9 & n.12
(M.D. Ala. Aug. 1, 2012) (warning on estrogen replacement drug stated that estrogen
replacement drugs can increase risk of breast cancer); Salvio v. Amgen, Inc., No. 2:11-CV00553, 2012 WL 627446, at *8 (W.D. Pa. Feb. 15, 2012) (―[S]erious infections and sepsis,
6
This statement occurred as part of the deposition’s errata and corrects Prather’s previous
contradictory statement. For the purposes of this motion, she is entitled to all favorable
inferences.
13
including fatalities, have been reported with the use of Enbrel.‖). Not only did the NuvaRing
warning address oral contraceptives—a different pharmaceutical product—but the warning
explicitly stated that it was unknown whether increased risks intrinsic to those products could be
attributed to NuvaRing. Rather than evidencing care towards consumers, when read in the light
most favorable to Prather, the NuvaRing label exhibits agnosticism.
After considering the testimony of Dr. Schuetz and Prather and the plain language of
NuvaRing’s label, I cannot find as a matter of law that the NuvaRing label specifically and
explicitly warns of the difference in risk of VTE and pulmonary embolism such that punitive
damages should be foreclosed. Organon fails to carry its burden to show it is entitled to
summary judgment as is required by Celotex. 477 U.S at 324–25. I will, therefore, deny
Organon’s motion for summary judgment regarding punitive damages.
III.
CONCLUSION
For the foregoing reasons, I find that Missouri law controls the issue of punitive damages.
I also find that the NuvaRing label does not foreclose punitive damages as a matter of law.
Accordingly,
IT IS HEREBY ORDERED that Organon’s motion for summary judgment directed to
plaintiff’s punitive damages claim (Doc. 24) is DENIED.
_______________________________
RODNEY W. SIPPEL
UNITED STATES DISTRICT JUDGE
Dated this 12th day of July, 2013.
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