Prather v. Organon USA, Inc. et al

Filing 66

MEMORANDUM AND ORDER: IT IS HEREBY ORDERED that Organon's motion for summary judgment Doc. 30 is GRANTED, in part, and DENIED, in part. Organon's motion for summary judgment is GRANTED, as to Counts I (Strict Products LiabilityDefective Manufacturing) and as to the portions of Count VIII (Negligence) of Prather's Amended Complaint that address defective manufacturing, and GRANTED as to Count XI (Successor Liability Against Defendant Merck) of Prathers Amended Complaint, as it applies to those derivative claims. IT IS FURTHER ORDERED that Organon's motion for summary judgment is DENIED as to Counts II, III, IV, V, VII, VIII, IX, X, and XI. 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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MARIANNE PRATHER,

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Plaintiff
v.
ORGANON USA, INC. et al.
Defendants.

Case No. 4:08-MD-1964 RWS

Case No. 4:08-cv-00558-RWS

MEMORANDUM AND ORDER
Plaintiff Marianne Prather claims that she suffered a pulmonary embolism
caused by the NuvaRing combined hormonal contraceptive. Defendants
(―Organon‖) bring this motion for summary judgment against Prather‘s claims of
negligence and strict liability. Prather fails to establish a genuine issue of material
fact as to the defective manufacture of NuvaRing as well as the successor liability
of Merck as to that claim. Prather establishes genuine issues of material fact as to
her claims of inadequate warning, fraud, misrepresentation, design defect, breach
of express warranty, breach of implied warranty, and violation of the Missouri

Merchandising Practices Act. Organon‘s motion for summary judgment will be
granted, in part, and denied, in part.
I.

BACKGROUND FACTS
NuvaRing is a combination hormonal contraceptive, or ―CHC,‖ that contains

two hormones: estrogen and progestin. The progestin inhibits ovulation, while the
estrogen component primarily mitigates breakthrough bleeding. The most
common estrogen in CHCs is ethinyl estradiol (―EE‖), which has been used with
various progestins over the years to form combination oral contraceptives. CHCs
are typically grouped by ―generation.‖ 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. 1 First-generation CHCs use
high levels of EE and are associated with high incidence rates of VTE. Secondgeneration 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
1

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

dose. Third-generation CHCs use lower amounts of estrogen than prior
generations; however, some studies have found an increased risk of VTE with
some third-generation oral CHCs as compared to second-generation oral CHC,
despite the decrease in estrogen dose.
In contrast with oral contraceptives, which are daily pills, NuvaRing is a
flexible vaginal ring that is inserted every 28 days. On day 21 of the cycle, the ring
is removed, and a new ring is inserted on the 28th day to continue treatment.
The Food and Drug Administration approved NuvaRing and its labeling.
NuvaRing‘s label contains two parts, a main package insert and a portion
designated specifically for patients. The main package insert contains numerous
sections that provide information on NuvaRing, including its chemical
composition, pharmacological data, indications for use, contraindications (patient
conditions that preclude NuvaRing use), warnings, reported adverse reactions,
overdosage, dosage and administration, and storage.2 The patient information
section contains some of the same information in layperson terms and includes
additional information on how to use and dispose of NuvaRing. (Id.).
The main package insert states that NuvaRing should not be used in women
who currently have certain conditions, including ―[t]hrombophlebitis or

2

(Doc. 32, Geist Decl. Exh. 1, FDA Approved Label for NuvaRing).
3

thromboembolic disorders.‖ (Id.). The label has an entire section devoted to
warnings:
WARNINGS
NuvaRing and other contraceptives that contain both an estrogen and
a progestin are called combination hormonal contraceptives. There is
no epidemiologic data available to determine whether safety and
efficacy with the vaginal route of administration of combination
hormonal contraceptives would be different than the oral route.
The use of oral contraceptives is associated with increased risks of
several serious conditions [,] including venous and arterial thrombotic
and thromboembolic events (such as . . . thromboembolism . . .) . . . ,
although the risk of serious morbidity or mortality is very small in
healthy women without underlying risk factors. The risk of morbidity
and mortality increases significantly in the presence of other
underlying risk factors such as certain inherited thrombophilias . . . .
The information contained in this package insert is principally based
on studies carried out in women who used oral contraceptives with
formulations of higher doses of estrogens and progestogens than those
in common use today. The effect of long-term use of oral
contraceptives with lower doses of both estrogens and progestogens
remains to be determined.
....
1.
THROMBOEMBOLIC
VASCULAR PROBLEMS
a.

DISORDERS

AND

OTHER

Thromboembolism

An increased risk of thromboembolic and thrombotic disease
associated with the use of oral contraceptives is well established.
Case control studies have found the relative risk of users compared to
4

non-users to be three for the first episode of superficial venous
thrombosis, four to 11 for deep vein thrombosis or pulmonary
embolism, and 1.5 to six for women with predisposing conditions for
venous thromboembolic disease. Cohort studies have shown the
relative risk to be somewhat lower, about three for new cases and
about 4.5 for new cases requiring hospitalization. The risk of
thromboembolic disease associated with oral contraceptives is not
related to length of use and disappears after pill use is stopped.
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 in-creased
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.
(Doc. 32-1, FDA Approved Label).
Under the heading, ―Adverse Reactions,‖ the label states:
Listed below are adverse reactions that have been associated with the
use of combination hormonal contraceptives. These are also likely to
apply to combination vaginal hormonal contraceptives, such as
NuvaRing.
An increased risk of the following serious adverse reactions has been
associated with the use of combination hormonal contraceptives (see
CONTRA-INDICATIONS and WARNINGS):
Thrombophlebitis and venous thrombosis with or without
embolism
Arterial thromboembolism
Pulmonary embolism
(Doc. 32-1, FDA Approved Label).
5

The label‘s ―Patient Information‖ section presents additional information:
What is NuvaRing?
....
Contraceptives that contain both an estrogen and progestins are called
combination hormonal contraceptives. Most studies on combination
contraceptives have used oral (taken by mouth) contraceptives.
NuvaRing may have the same risks that have been found for
combination oral contraceptives. This leaflet will tell you about risks
of taking combination oral contraceptives that may also apply to
NuvaRing users. . . .
....
What are the possible risks and side effects of NuvaRing?
Blood Clots
The hormones in NuvaRing may cause changes in your blood clotting
system which may allow your blood to clot more easily. If blood clots
form in your legs, they can travel to the lungs and cause a sudden
blockage of a vessel carrying blood to the lungs. Rarely, clots occur
in the blood vessels of the eye and may cause blindness, double
vision, or other vision problems. 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 blood control pills.3
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
3

(Id.) (emphasis added).
6

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 thirdgeneration oral contraceptives. Prather cites evidence that progestins
―counterbalance‖ the blood-clotting tendencies of estrogen, and that the progestin
in NuvaRing does not counterbalance as well as some earlier generations.4 Prather
contends that NuvaRing‘s use results in occasional bursts of estrogen that are
unopposed by progestin, and this increases the blood-clotting 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
4

Discovery motions brought as part of this multi-district litigation have addressed the
admissibility of much of Prather‘s evidence. See Order dated March 4, 2013 (denying
Organon‘s motion to exclude testimony on hormone counterbalancing); Order dated March 5,
2013 (denying Organon‘s motion to exclude testimony on estrogen bursts and hormone
variability).
7

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 presents several arguments which it believes establish a right to
summary judgment. First, Organon argues that Prather‘s failure-to-warn, breachof-warranty, and fraud claims fail, because NuvaRing‘s warnings are adequate as a
matter of law. Second, Organon alleges that Prather‘s express warranty,
misrepresentation, and Missouri Merchandising Practices Act claims fail, because
Prather has not shown that Organon made any warranty or representation. Third,
Organon alleges it is entitled to summary judgment as to Prather‘s implied
warranty claims. Fourth, Organon argues alleges that Prather has provided no
evidence in support of her defective manufacturing claims. Fifth, Organon argues
that Prather fails to support her defective design claims and that it is entitled to
protection from strict liability arising from defective design pursuant to Comment
k of the Restatement (Second) of Torts, Section 402A. Sixth, Organon argues that
all of Prather‘s claims fail, because Prather lacks evidence of causation. Finally,
Organon argues that it is entitled to summary judgment as to Defendant Merck‘s
successor liability deriving from Prather‘s claims. Missouri‘s substantive law
governs.5

5

Because this is a diversity case, see 28 U.S.C. § 1332(a), Missouri law applies. See Prudential
Ins. Co. of America v. Kamrath, 475 F.3d 920, 924 (8th Cir. 2007) (district court sitting in
diversity applies the law of the state in which it sits).
8

II.

SUMMARY JUDGMENT STANDARD
Pursuant to Federal Rule of Civil Procedure 56(c), a court may grant a

motion for summary judgment only if all of the information before the court shows
―there is no genuine issue of material fact and the moving party is entitled to
judgment as a matter of law.‖ See Celotex Corp. v. Catrett, 477 U.S. 317, 322
(1986). Rule 56(c)(1) ―provides that the mere existence of some alleged factual
dispute between the parties will not defeat an otherwise properly supported motion
for judgment; the requirement is that there be no genuine issue of material fact.‖
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48 (1986). Material facts are
those ―that might affect the outcome of the suit under the governing law,‖ and a
genuine material fact is one such that ―a reasonable jury could return a verdict for
the nonmoving party.‖ Id. Further, if the non-moving party has failed to ―make a
showing sufficient to establish the existence of an element essential to that party‘s
case, . . . there can be ‗no genuine issue as to any material fact,‘ since a complete
failure of proof concerning an essential element of the nonmoving party's case
necessarily renders all other facts immaterial.‖ Celotex, 477 U.S. at 322–23.
The initial burden of proof in a motion for summary judgment is placed on
the moving party to establish the non-existence of any genuine issue of fact that is
material to a judgment in its favor. City of Mt. Pleasant, Iowa v. Assoc‘d Elec.
Coop., Inc., 838 F.2d 268, 273 (8th Cir. 1988). Once this burden is discharged, if
9

the record reflects that no genuine dispute exists, the burden then shifts to the nonmoving party who must set forth affirmative evidence and specific facts showing
there is a genuine dispute on that issue. Anderson, 477 U.S. at 249. When the
burden shifts, the non-moving party may not rest on the allegations in its pleadings,
but by affidavit and other evidence must set forth specific facts showing that a
genuine issue of material fact exists. Fed. R. Civ. P. 56(e). The non-moving party
must show there is sufficient evidence favoring the non-moving party that would
enable a jury to return a verdict for it. Anderson, 477 U.S. at 249; Celotex, 477
U.S. at 324. ―If the non-moving party fails to produce such evidence, summary
judgment is proper.‖ Olson v. Pennzoil Co., 943 F.2d 881, 883 (8th Cir. 1991).
The evidence must be viewed in the light most favorable to the non-moving party
and give to that party the benefit of all favorable inferences. Adickes v. S. H.
Kress & Co., 398 U.S. 144, 157 (1970).
III.

ANALYSIS

A.

The Record Presents a Genuine Issue of Material Fact as to Whether
NuvaRing’s Warnings of VTE Risk Were Inadequate
Counts III and VIII of Prather‘s amended complaint assert negligence and

strict-liability claims against Organon for failure to warn of VTE risk.
To prevail on a negligent failure-to-warn claim, Prather must prove that
Organon manufactured or designed NuvaRing; that NuvaRing did not contain an
adequate warning of its alleged defect or hazard; that Organon failed to use
10

ordinary care to warn of the risk of harm from the alleged defect or hazard; and
that, as result of such failure, Prather sustained damage. Moore v. Ford Motor Co.,
332 S.W3d 749, 764 (Mo. banc 2011).
To recover under the theory of strict failure-to-warn liability, Prather must
prove that NuvaRing was unreasonably dangerous when put to a reasonably
anticipated use without knowledge of its characteristics; that Organon did not give
an adequate warning of the danger; that NuvaRing was used in a manner
reasonably anticipated; and that Prather was damaged as a direct result of
NuvaRing being sold without an adequate warning. Pollard v. Ashby, 793 S.W.2d
394, 397–98 (Mo. App. E.D. 1990) (en banc). Admissible expert testimony that
additional or other warnings might have altered the plaintiff's behavior is required
in failure-to-warn cases. See Bryant v. Laiko Int‘l Co., Inc., No. 05-00161, 2006
U.S. Dist. LEXIS 73682, 2006 WL 2788520 at *9–10 (E.D. Mo. Sept. 26, 2006);
Davidson v. Besser Co., 70 F. Supp. 2d 1020, 1023 (E.D. Mo. 1999).
―Missouri courts have held that in cases involving manufacturers of
prescription drugs, the manufacturer has ‗a duty to properly warn the doctor of the
dangers involved and it is incumbent upon the manufacturer to bring the warning
home to the doctor.‘‖ Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo.
App. 1999) (emphasis added) (quoting Krug v. Sterling Drug, Inc., 416 S.W.2d
143, 146 (Mo. 1967)).
11

Organon argues that the NuvaRing label provides adequate warnings as to
the risk of VTE and that no material fact exists as to that issue. Prather responds
that the warnings fail to adequately address the difference in risk between
NuvaRing and oral CHCs, including second-generation oral CHCs. I have already
allowed testimony from Prather‘s experts as to the inadequacy of the NuvaRing
label as it pertains to variability and bursts of estrogen and how those issues affect
the risk of VTE.6
NuvaRing‘s label provides:
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.
(Doc. 32-1, FDA Approved Label).
Prather argues that Organon knew that NuvaRing presented a risk of VTE
greater than second-generation oral contraceptives. In 1995, Prather notes, a study
funded by one of the Defendants reported an increased risk of VTE in third6

See Order dated March 5, 2013, at *10–12 (denying Organon‘s motion to exclude all testimony
related to ―bursts‖ or ―high variability‖ in NuvaRing‘s estrogen delivery); Order dated March 4,
2013 (denying Organon‘s motion to exclude testimony by Dr. Shelly Ann Tischkau regarding
adequacy of NuvaRing‘s VTE warnings and pharmacokinetic data).
12

generation progestins when compared to second-generation progestins. (Doc. 494, Dr. Buncher Expert Report at *3 (citing Jick H. et al., ―Risk of Idiopathic
Cardiovascular Death and Nonfatal Venous Thromboembolism in Women Using
Oral Contraceptives with Differing Progestagen Components,‖ 346 The Lancet,
1589 (1995)).7 Prather cites to the occurrences of VTEs in NuvaRing clinical trial
subjects as evidence that the increased risk presented by third-generation
progestins in oral CHCs had manifested in NuvaRing prior to Prather‘s injury.
(Doc. 50-1, Parsian Report at ¶¶ 141 & 196). Prather alleges that these VTEs
reflect an incidence rate for NuvaRing at nearly double the calculated rate
(10.1/10,000 women-years versus 5.35/10,000 women-years). Prather further cites
to communications by Organon personnel resisting the inclusion of VTE
information in the label.8
Missouri law places the burden on the manufacturer to ―bring the warning
home‖ to a prescribing physician. Alpha Therapeutic, 3 S.W.3d at 419. The
7

See also id. at *2 (noting consensus opinion as to third- and second-generation progestin risk
differentials) (citing Vendenbroucke J.P. et al., ―Oral Contraceptives and the Risk of Venous
Thrombosis, 344 New England Journal of Medicine 1527 (2001)).
8
―My major comment on the U.S. [Package Insert] relates to including the one case of
thrombosis. We should really try to get it out of the text.‖ (Doc. 50-1, Parisian Report at ¶ 144).
―It is unclear to me why we are s opposed to including the animal data . . . could we use this as a
bargaining chip for other, more important issues such as the VTE warning, bleeding data, etc.?‖
(Id.). ―[T]he label change looks much better, however, I am still unhappy with the VTE section
of the label. Obviously, the case that we presented to them has made some impact, in that they
have added the statement about being unknown if NuvaRing has this increased risk. What are
the chances that this section can be removed all together?‖ (Id.). ―To my satisfaction a number
of critical issues have been implemented in the current proposal of the FDA (e.g. the deletion of
the single VTE case).‖ (Id.).
13

record contains admissible expert testimony regarding the inadequacy of warnings
Organon placed upon NuvaRing and tends to show that the NuvaRing label does
not disclose a known difference in risk between NuvaRing and second-generation
CHCs. Cf. Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1401 (8th Cir. 1969)
(affirming inadequacy of undisclosed difference in risk with comparator drug). I
find that Prather‘s evidence presents a genuine issue of material fact as to whether
Organon‘s warnings were inadequate.
Finally, Organon argues that, regardless of the warning‘s adequacy, Prather
cannot establish causation as a matter of law because her prescribing physician, Dr.
Schuetz, knew of the allegedly undisclosed risks.9 A corollary to the prescription
drug manufacturer‘s duty to warn a prescribing doctor is the ―learned intermediary
doctrine,‖ which recognizes the role of a physician as a ―learned intermediary‖
between a drug manufacturer and a patient. See Alpha Therapeutic, 3 S.W.3d at
420 (citation omitted). Under the learned intermediary doctrine, any warning
given to the physician is deemed given to the patient. Id. (citations omitted). A
manufacturer‘s failure to provide an adequate warning ―is not the proximate cause
of a patient‘s injury if the prescribing physician had independent knowledge of the
risk that the adequate warnings should have communicated.‖ Id. (citations
omitted).

9

Organon‘s remaining arguments as to causation are addressed below.
14

Dr. Schuetz acknowledged that she was aware that all ―combined hormonal
contraceptive products that contain estrogen, . . . as a class, carry an inherent risk
of blood clots.‖ (Doc. 50-5, Schuetz Dep. at 29). Dr. Schuetz admitted that she
learned of this risk during residency. (Id. at 30). Dr. Schuetz stated that she had
read the portion of the NuvaRing label that addressed the risk differential between
third-generation oral contraceptives and second-generation oral contraceptives.10
Dr. Schuetz testified that she understood the label to convey that ―we don‘t know
conclusively whether there‘s a difference in risk between NuvaRing and secondgeneration birth control pills.‖ (Id. at 146). Dr. Schuetz further testified that at the
time she prescribed NuvaRing to Prather, she understood that NuvaRing had the
same risk as birth control pills or other products on the market. (Id. at 127).11
Contrary to Organon‘s argument, this testimony does not tend to show that
Dr. Schuetz possessed independent knowledge that NuvaRing presented a greater
10

The portion of the NuvaRing label to which Dr. Schuetz refers states:
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.
(Doc. 32-1, FDA Approved Label).
11
See also (id. at 130 ) (―[Q] Just assuming . . . there‘s an increased risk with NuvaRing of
causing thrombotic events in comparison with second-generation birth control products . . .
would you agree that the label does not clearly tell you that NuvaRing is any more likely to cause
thrombotic events than other birth control products available on the market?‖ . . . A: Correct.‖).
15

VTE risk than second-generation oral contraceptives. Rather, when viewed in the
light most favorable to Prather, Dr. Schuetz‘s testimony supports Prather‘s claim
that the VTE warning was inadequate. I will, therefore, DENY Organon‘s motion
for summary judgment as to Counts III and VIII of Prather‘s complaint.
B.

Prather’s Claims for Breach of Express Warranty, Intentional
and/or Negligent Misrepresentation, and Violation of the Missouri
Merchandising Practices Act (Counts IV, IX, and X) Do Not Fail
Due to any Lack of Proof that Organon Made a Warranty or
Misstatement to Prather or Dr. Schuetz

A plaintiff seeking to recover for breach of an express warranty must
establish that the defendant represented to the plaintiff that the goods were of
certain kind or quality. Carpenter v. Chrysler Corp., 853 S.W.2d 346, 357 (Mo. Ct.
App. 1993) (citing Rev. Stat. Mo. 400.2-313). To state a claim for negligent
misrepresentation, a plaintiff must show, among other elements: the speaker
supplied information in the course of his or her business and because of a failure
by the speaker to exercise reasonable care, the information was false. Renaissance
Leasing, LLC v. Vermeer Mfg. Co., 322 S.W.3d 112, 134 (Mo. banc 2010).
Similarly, a Missouri fraud claim requires a representation. Joel Bianco Kawasaki
Plus v. Meramec Valley Bank, 81 S.W.3d 528, 536 (Mo. banc 2002). To establish
a claim under the Missouri Merchandising Practices Act (―MMPA‖), a plaintiff
must ―allege facts establishing that defendants used or employed a deception,
fraud, false pretense, false promise, [or] misrepresentation . . . .‖ Chochorowski v.
16

Home Depot U.S.A., Inc., 295 S.W.3d 194, 197–98 (Mo. Ct. App. 2009) (citing
Rev. Stat. Mo. § 407.020.1).
Organon contends that it is entitled to summary judgment because Prather
fails to allege that a particular representation was made to her by a defendant.
However, Prather alleges that Organon sales personnel represented to Dr. Schuetz
that NuvaRing is a new product and carries the same risks as birth control pills
with respect to blood clots. (Doc. 50-5, Schuetz Dep. at 141–42).12 Dr. Schuetz
further testified that she would have informed Prather of the increased risk for
pulmonary embolism if it had been disclosed. (Doc. 50-5, Schuetz Dep. at 132–
33). Likewise, Prather testified that if she had known of the increased VTE risk
presented by NuvaRing, she would not have used the product. (Doc. 50-6, Prather
Dep. at 21–22).
Prather has set forth an allegedly false statement made by Organon upon
which she relied. Prather establishes a genuine issue of material fact as to Counts

12

Under the ―learned intermediary doctrine,‖ warnings given to a physician are deemed given to
the patient. See Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 420 (Mo. App. 1999). Prather
does not cite any Missouri cases applying the doctrine to breach of warranty, fraud, or
misrepresentation claim, though she cites holdings from numerous other jurisdictions. See, e.g.,
Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1161 (D. Or. 1989); Boles v. Merck & Co. (In re
Fosamax Prods. Liab. Litig.), 647 F. Supp. 2d 265, 283 (S.D.N.Y. 2009) (―A fraud on the
physician is a fraud upon the patient.‖). Physicians are the gatekeepers to prescription medicine
in America, and common sense dictates that any representations made to a doctor would
foreseeably influence their prescribing practices. Cf. Plubell v. Merck & Co., Inc., 289 S.W.3d
707, 714 (Mo. Ct. App. 2009) (noting that under the MMPA, a plaintiff need not prove she or her
physician relied upon the misrepresentation). In any case, Organon does not challenge the
application of the doctrine as to Prather‘s claims in Counts IV, IX, and X.
17

IV, IX, and X, and I will DENY Organon‘s motion for summary judgment as to
those counts.
C.

Prather Established Her Claim for Implied Warranty (Count V)

Missouri has adopted the Uniform Commercial Code (―UCC‖). See Rev.
Stat. Mo. § 400.1-101; see also Bracey v. Monsanto Co., Inc., 823 S.W.2d 946,
947 (Mo. banc 1992). In order to recover under the UCC‘s breach of an implied
warranty of merchantability theory, ―a plaintiff must prove (1) that a merchant sold
goods, (2) which were not ‗merchantable‘ at the time of the sale, (3) injury and
damages to the plaintiff or his property (4) which were caused proximately or in
fact by the defective nature of the goods, and (5) notice to the seller of the injury.‖
Ragland Mills, Inc. v. General Motors, Corp., 763 S.W.2d 357, 360 (Mo. Ct. App.
1989) (citing Rev. Stat. Mo. § 400.2-314). In order to be merchantable, goods
must, among other requirements, be ―fit for the ordinary purposes for which such
goods are used.‖ Rev. Stat. Mo. § 400.2-314.
Organon argues that it is entitled to summary judgment for two reasons: (1)
there can be no breach of an implied warranty where a product warns of the precise
risk giving rise to plaintiff‘s claim; and (2) Prather fails to prove that NuvaRing
was not fit for its ordinary and intended purposes.
Organon cites Haddix v. Playtex Family Prods. Corp. for the proposition that
the warranty of merchantability is not breached when a user is harmed by a
18

specific risk against which the product warns. 964 F. Supp. 1242, 1246–47.
However, Haddix requires that the warning not only be specific, but adequate. See
id. at 1247. As discussed above, Prather has shown that a genuine issue of material
fact exists as to the adequacy of NuvaRing‘s warnings.
Under Section 2-314 of the UCC, a manufacturer may breach its implied
warranty of merchantability, based on lack of fitness for ordinary purposes, by
failing to provide adequate instructions or warnings. See Madsen v. Am. Home
Prods. Corp., 477 F. Supp. 2d 1025, 1037–38 (E.D. Mo. 2007) (applying Iowa
codification of UCC § 2-314); Grinage v. Mylan Pharms., Inc., 840 F. Supp. 862,
871 (D. Md. 2011) (applying Maryland adoption of UCC § 2-314).13 Prather has
shown that a question of fact exists as to the adequacy of Organon‘s warnings. I
cannot, as a matter of law, hold that Organon is entitled to summary judgment as to

13

Compare Barkley Clark & Christopher Smith, The Law of Product Warranties, ¶ 5.01 [2][a], at
5–9 (1984) (―For a product to flunk the merchantability test, it must contain an inherent
defect. . . . The cases indicate that the courts find goods to be unfit for their ordinary purposes
when they can identify one of three general types of defects: manufacturing defects, design
defects, and failure to give the buyer proper instructions with respect to the goods. This tripartite
test for defect is essentially the same as that required when the theory is strict tort liability under
Section 402A of the Restatement (Second) of Torts, except that goods may violate Section 2-314
without being ‗unreasonably dangerous‘ . . . .‖) with Hill v. Searle Labs, Inc., 884 F.2d 1064,
1066 (8th Cir. 1989) (―[A] product is ‗defective‘ when it is properly made according to an
unreasonably dangerous design, or when it is not accompanied by adequate instructions and
warning of the dangers attending its use.‖) (citing Prosser, Law of Torts, 659 (4th ed. 1971)).
19

Prather‘s claim for breach of implied warranty.14 Organon‘s motion for summary
judgment as to breach of implied warranty will be DENIED.
D.

Prather Has Not Shown a Genuine Issue of Material Fact as to
Defective Manufacturing (Counts I and VIII)

―[A] manufacturing defect occurs when something goes wrong in the
manufacturing process and the product is not in its intended condition. The
product is evaluated against the producers‘ own standards, and compared to like
products.‖ Richcreek v. Gen. Motors Corp., 908 S.W.2d 772, 776 (Mo. Ct. App.
1995) (internal quotation marks omitted).
Prather has provided no evidence that anything has ―gone wrong‖ in the
manufacturing process, which caused the NuvaRing she used to deviate from
Organon‘s specifications. Because Prather fails to show that a genuine issue of
material fact exists as to defective manufacturing, I will GRANT Organon‘s
motion for summary judgment as to those issues.
E.

Prather’s Claims for Negligent Design and Strict Liability
(Counts II and VIII) Do Not Fail Due to any Lack of Proof of a
Design Defect and Comment K to Section 402A of Restatement
(Second) of Torts Does Not Preclude Prather’s Strict Liability
Claims

Organon argues it is entitled to summary judgment as to Prather‘s designdefect claims. Organon asserts that Prather‘s strict liability design-defect claims
14

As discussed later, Prather has presented a colorable claim for defective design. The evidence
supporting that claim would equally support her argument that NuvaRing was not merchantable.
See Hill, 884 F.2d at 1066.
20

are barred pursuant to Missouri‘s adoption of comment k to the Restatement
(Second) of Torts, Section 402A (―comment k‖). Organon also alleges that Prather
has failed to establish that any defect in the Design of NuvaRing proximately
caused her pulmonary embolism.
Comment k to section 402A specifically addresses the application of strict
liability to unavoidably unsafe products such as prescription drugs. Comment k
states:
k. Unavoidably unsafe products. There are some products
which, in the present state of human knowledge, are quite incapable of
being made safe for their intended and ordinary use. These are
especially common in the field of drugs. An outstanding example is
the vaccine for the Pasteur treatment of rabies, which not
uncommonly leads to very serious and damaging consequences when
it is injected. Since the disease itself invariably leads to a dreadful
death, both the marketing and the use of the vaccine are fully justified,
notwithstanding the unavoidable high degree of risk which they
involve. Such a product, properly prepared, and accompanied by
proper directions and warning, is not defective, nor is it unreasonably
dangerous. The same is true of many other drugs, vaccines, and the
like, many of which for this very reason cannot legally be sold except
to physicians, or under the prescription of a physician. It is also true
in particular of many new or experimental drugs as to which, because
of lack of time and opportunity for sufficient medical experience,
there can be no assurance of safety, or perhaps even of purity of
ingredients, but such experience as there is justifies the marketing and
use of the drug notwithstanding a medically recognizable risk. The
seller of such products, again with the qualification that they are
properly prepared and marketed, and proper warning is given, where
the situation calls for it, is not to be held to strict liability for
unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and
desirable product, attended with a known but apparently reasonable
risk.
21

Missouri courts limit the application of comment k to drugs ―shown to be
incapable of being made safe given the present state of human knowledge but
which have such a high degree of social need that their use is warranted, so long as
there are sufficient warnings.‖ Pollard v. Ashby, 793 S.W.2d 394, 399–400 (Mo.
Ct. App. 1990) (en banc).
Comment k is an affirmative defense, and the manufacturer of a prescription
drug bears the burden of showing that the drug falls under the protection of
comment k. Id. at 400. Organon fails to show that NuvaRing is incapable of being
made safe and that there is such a need for the drug that its use is warranted.
Organon makes no showing in its initial brief; in reply to Prather, Organon merely
points to evidence that all CHCs present some risk of VTE and that some oral CHC
users have difficulty remembering when to take their pills.15 Organon fails to
identify and quantify NuvaRing‘s risks, and further fails to respond to Prather‘s
argument that NuvaRing might have been made safer by employing a secondgeneration progestin.16 I find that Organon has failed to establish the applicability
of comment k.

15

It should be noted that there are an abundance of other contraceptive methods available, not all
of which involve combinations of hormones.
16
Organon argues that prescription CHCs as a class fall under the protection of comment k, and
that I should not follow an Eighth Circuit decision that held that the comment requires an
individualized inquiry as to the drug‘s risks and benefits. See Hill v. Searle Labs., 884 F.2d
1064, 1068–70 (8th Cir. 1989) (evaluating a hormonal contraceptive and declining to apply
22

Organon also argues that Prather fails to show a design defect and, therefore,
it is entitled to summary judgment as a matter of law. However, Prather alleges
that NuvaRing is defective due to use of a third-generation progestin in lieu of a
second-generation progestin; due to the failure of NuvaRing‘s progestin
component to properly counterbalance its estrogen component; and due to the use
of a vaginal delivery system that results in unopposed ―bursts‖ of estrogen.17
Prather has also provided admissible expert evidence of causation stemming from
these defects.18 I find that Prather has established a genuine issue of material fact
as to whether a design defect in NuvaRing caused her pulmonary embolism. As a
result, I will DENY Organon‘s motion for summary judgment as to Prather‘s
design defect claims.
F.

Prather’s Claims Do Not Fail for Lack of Causation

Organon argues that Prather‘s claims fail to establish causation for several
reasons. First, Organon argues that Prather cannot show she would not have used
NuvaRing if it had been accompanied by an adequate warning. Second, Organon
also alleges that Prather‘s claims are all barred as a matter of law because there is
comment k). Organon argues that Hill is distinguishable ―because Missouri law does not limit
application of comment k to exceptional circumstances.‖ (Doc. 60, Def. Reply at *18 & n.13).
Organon ignores Missouri case law that is directly on point and which Organon itself cites in its
immediately preceding paragraph. See Pollard, 793 S.W.2d at 400 (―This court holds that
comment k is an affirmative defense and its applicability must be determined by the trial courts
on a case-by-case basis.‖) (citing Hill, 884 F.2d at 1069).
17
See supra, notes 4, 6 & 7 and accompanying text.
18
See Order dated April 10, 2013 (admitting expert causation testimony from Dr. John Richart);
see also (Doc. 50-3, Richart Dep. at 249); (Doc. 49-5, Richart Report at *2, 7–10).
23

no evidence of a causal link between any alleged wrongdoing by Organon and
Prather‘s pulmonary embolism.
Organon argues that Prather cannot establish that a different warning would
have altered the decision of Dr. Schuetz to prescribe NuvaRing for her. However,
Missouri aids plaintiffs in proving that a warning would have altered the behavior
of their prescribing physicians by presuming that a warning will be heeded.
Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. banc 1992). This
―heeding presumption‖ may be rebutted by the defendants. Grady v. Am. Optical
Corp., 702 S.W.2d 911, 918 (Mo. Ct. App. 1985).
Organon argues that it has rebutted the heeding presumption because Dr.
Schuetz testified that up until her deposition, she still prescribed NuvaRing. (Doc.
50-5, Schuetz Dep. at 34). However, Organon‘s argument requires an
impermissible inference: that Dr. Schuetz was at that point in time aware of all of
NuvaRing‘s risks. See Schilf v. Eli Lilly & Co., 687 F.3d 947, 951 (8th Cir. 2012).
Even if Organon could show that Dr. Schuetz still prescribes NuvaRing with
full knowledge of its risks, the record shows that Prather would not have used
NuvaRing had the warning been adequate. Dr. Schuetz testified that Prather had
the right to know that a drug being considered has increased risk of blood clots.
(Doc. 50-5, Schuetz Dep. at 133). Dr. Schuetz stated that had she understood that
NuvaRing was more likely to cause a pulmonary embolism, she would have
24

disclosed that fact to Prather. (Id. at 132–133). Prather testified that had she
known of the increased risk for blood clots, she would not have taken NuvaRing.
(Doc. 50-6, Prather Dep. at 21). Regardless of Dr. Schuetz‘s prescribing practices,
there exists evidence that Prather would not have taken NuvaRing had the risks
been adequately disclosed. Viewing this information in the light most favorable to
the non-moving party, I find that Prather has raised a genuine issue of material fact
as to whether she would have taken NuvaRing had its warning been adequate.
Organon also alleges that Prather‘s claims are all barred as a matter of law
because there is no evidence that Prather have avoided her pulmonary embolism
had she not taken NuvaRing. I have already ruled that Prather‘s expert, Dr. John
Richart, may testify that but for Prather‘s use of NuvaRing, she would not have
suffered her pulmonary embolism.19 Organon‘s argument that Prather‘s claims fail
for lack of causation will be DENIED.
G.

Successor Liability (Count XI)

Organon finally argues that Prather‘s claim for successor liability against
Merck fails for want of an underlying claim. A successor liability claim is
predicated upon the existence of liability on the part of a predecessor entity. See
Santa Maria v. Owens-Illinois, Inc., 808 F.2d 848, 851 n.5 (1st Cir. 1986).
Because Prather has introduced genuine issues of material fact, as discussed above,
19

See Order dated April 10, 2013 (denying Organon‘s Daubert motion to exclude testimony of
Dr. Richart).
25

I will deny Organon‘s motion for summary judgment as to successor liability
deriving from those claims. However, I have found that Prather fails to introduce
evidence in support of her manufacturing defect claim. I will, therefore, GRANT
Organon‘s motion for summary judgment regarding successor liability as to
manufacturing defect.
IV.

CONCLUSION
In conclusion, I will grant Organon‘s motion for summary judgment as to

Prather‘s manufacturing defect claims and as to Merck‘s successor liability
deriving from those dismissed claims. Prather has introduced genuine issues of
material fact as to her remaining counts.
Accordingly,
IT IS HEREBY ORDERED that Organon‘s motion for summary judgment
[Doc. 30] is GRANTED, in part, and DENIED, in part. Organon‘s motion for
summary judgment is GRANTED, as to Counts I (Strict Products Liability—
Defective Manufacturing) and as to the portions of Count VIII (Negligence) of
Prather‘s Amended Complaint that address defective manufacturing, and
GRANTED as to Count XI (Successor Liability Against Defendant Merck) of
Prather‘s Amended Complaint, as it applies to those derivative claims.

26

IT IS FURTHER ORDERED that Organon‘s motion for summary
judgment is DENIED as to Counts II, III, IV, V, VII, VIII, IX, X, and XI

_______________________________
RODNEY W. SIPPEL
UNITED STATES DISTRICT JUDGE
Dated this 12th day of July, 2013.

27