K.E., et al v. Smithkline Beecham Corp, et al
Filing
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ORDER granting 88 Motion for Summary Judgment; granting 89 Motion to Preclude. Signed by Judge Victor A. Bolden on 2/1/2017.(Ghosh, S.)
UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT
K.E., a Minor by his Parent and Natural
Guardian NICHOLE EL-MASSRI and
NICHOLE EL-MASSRI, Individually,
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Plaintiffs,
v.
GLAXOSMITHKLINE LLC, formerly
SMITHKLINE BEECHAM
CORPORATION
d/b/a GLAXOSMITHKLINE,
Defendant.
Case No. 3:14-cv-1294(VAB)
RULING ON DEFENDANT’S MOTIONS TO EXCLUDE EXPERT
TESTIMONY AND FOR SUMMARY JUDGMENT
K.E., a minor, has a heart defect, more specifically, a bicuspid aortic valve with aortic valve
insufficiency (“BAV”). K.E., along with his parent and natural guardian Nichole El-Massri
(“Plaintiffs”), have sued SmithKline Beecham Corporation d/b/a GlaxoSmithKline and
GlaxoSmithKline LLC (“GSK” or “Defendant”), the manufacturer of Paxil, an anti-depressant that
Ms. El-Massri allegedly ingested while pregnant and which Plaintiffs claim caused K.E.’s birth
defect.
In support of their claim, Plaintiffs rely on the proffered expert testimony of Dr. William
Ravekes, who opines that Paxil causes BAVs generally and caused K.E.’s BAV specifically. GSK
has moved to exclude Dr. Ravekes’s testimony [ECF No. 89] and, for this reason and others, has also
moved for summary judgment [ECF No. 88].
For the reasons that follow, both motions are GRANTED.
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I. Relevant Factual Background1
In 2001, during the early weeks of Ms. El-Massri’s pregnancy, K.E.’s heart began to grow.
As K.E.’s developing heart separated into four chambers, the truncus arteriosus, which would
eventually become K.E.’s pulmonary artery and aorta, began to emerge from the right ventricle.
Ravekes Report, Def.’s Mot. to Preclude, Ex. 28, ECF No. 90-16, 3 (“Ravekes Report”). Around the
eighth week of K.E.’s development, valves developed within his maturing arteries, regulated in part
by neural crest cells. Id. K.E.’s aortic valve, which connects his left ventricle with his aorta,
developed abnormally, growing only two cusps, or leaflets, rather than the three that most aortic
valves contain. Id.
On January 19, 2002, Ms. El-Massri gave birth to K.E. by Cesarean section. Def.’s L. R. 56
Stmt., ¶ 49; Scialli Report, Def.’s Mot. to Preclude, Ex. 7, ECF No. 90-4, 9. While K.E. initially
seemed healthy, his family later learned about his defective aortic valve. In 2009, a doctor diagnosed
Ms. El-Massri’s husband, Ameen El-Massri, with idiopathic hypertrophic subaortic stenosis
(“IHSS”), a heart disease characterized by abnormalities to the left ventricle. Def.’s L. R. 56 Stmt., ¶
51. The doctor also referred K.E. to a cardiologist to determine whether he risked developing the
disease, which is a genetic condition. Id. at ¶ 52 (citing Ravekes Report, 7).
Dr. Richard Berning evaluated K.E. and discovered that K.E. suffered from mild aortic valve
insufficiency. Id. at ¶53; Letter from Dr. Berning, Def.’s L.R. 56 Stmt., Ex. 17, ECF No. 93-18, 6.
At a subsequent evaluation in September 2010, Dr. Alicia Wang observed that K.E. had a BAV due
to fusion between his right and left coronary artery cusps. Id. at ¶ 54; Letter from Dr. Wang, Def.’s
L.R. 56 Stmt., Ex. 17, 2-3. Since then, K.E.’s echocardiograms have confirmed that he has a BAV,
but that he does not yet require surgery or another medical intervention. Ravekes Report, 6.
1
The relevant facts are taken from the Defendant’s Local Rule 56(a)1 Statement and Exhibits attached to the Local
Rule 56(a)1 Statement (ECF No. 88-14, and Nos. 88-15 – 88-47) and Plaintiffs’ Local Rule 56(a)2 Statement, ECF
No. 106-5, and Affidavit and attached Exhibits (ECF Nos. 106-6 - 106-14). See D. Conn. L. Civ. R. 56(a).
2
In addition to the costs of regularly monitoring K.E.’s heart, the BAV could cause greater
harm as he grows. Currently, K.E.’s defective valve causes some “leakage”—or “backflow” of
blood to his heart—which indicates that he may require further treatment or surgery at some point.
Dr. Wang also noted that the BAV could put K.E.’s health at risk if he continued playing competitive
sports as he got older. Letter from Dr. Wang, 3. K.E.’s BAV also takes an emotional toll on him and
his family, all of whom must accept the possibility of further harm and the uncertainty of his
prognosis.
Between one and two percent of the American population—and a greater proportion of
American males—has a BAV. Ravekes Report, 8; Scialli Report, 10. Like many birth defects, the
exact cause of the BAVs in these patients is unknown. Some researchers suggest that the defect has a
genetic cause, while others point to environmental agents that cause birth defects. These agents, also
called “teratogens,” include chemicals or hormones that may cause birth defects after a certain
amount of exposure. The cause of birth defects also could be multi-factored, with some individuals
having a genetic susceptibility to teratogens which would cause them to develop a BAV in situations
when others would not. Id.
Paroxetine hydrochloride, commonly known as Paxil, is a prescription medication designed
primarily to treat depression. Def.’s L.R. 56 Stmt., ¶¶ 59-60. Paxil, along with other antidepressants
such as Zoloft and Celexa, belongs to a class of drugs called selective serotonin reuptake inhibitors
(“SSRIs”), which alter the body’s sensitivity to the neurotransmitter serotonin. Id. Since 1992, the
FDA has approved of the use of Paxil to treat adult depression as well as other conditions. Id. By
2001, the FDA had approved of the use of the drug for obsessive compulsive disorder, panic
disorder, social anxiety disorder, and generalized anxiety disorder. Id. at ¶ 70. Some researchers
have suggested that paroxetine, the chemical present in Paxil, might be a teratogen that causes birth
defects in the developing fetuses of women who take the drug while pregnant. See, e.g. Ravekes
Report, 4. These researchers rely on epidemiological data that suggests that the incidence of certain
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birth defects is higher among women who took Paxil when pregnant, as well as animal studies in
which chemical changes in the amount of serotonin in the prenatal environment have caused similar
defects in developing embryos. Plaintiffs cite this research and allege that Defendant caused K.E.’s
birth defect because it manufactured Paxil, which Ms. El-Massri allegedly consumed while she was
pregnant. Def.’s L.R. 56 Stmt., ¶ 6, ¶ 59.
As Plaintiffs acknowledge, in order for Paxil to have caused K.E.’s birth defect, the BAV,
Ms. El-Massri would have to have consumed it during the first trimester of her pregnancy, when
K.E.’s heart was developing. See Pl.’s Opp. To Mot. to Preclude, ECF No. 105, 1 (“Dr. William
Ravekes, a well-respected physician … used a differential diagnosis to determine that the firsttrimester exposure of K.E. to Paxil, to a reasonable degree of scientific and medical certainty, is a
cause of his … congenital heart defect.”); Ravekes Report, 1 (“The purpose of this review is to
provide my opinion regarding the role of Paxil (paroxetine), a SSRI taken by [Ms. El-Massri] during
the first trimester of his gestation and its potential teratogenic effect on the development of Khalid’s
heart.”); Ravekes Dep., Pl.’s Opp. To Mot. to Preclude, Ex. C, ECF No. 105-3, 361: 18-22 (“Q: After
you ruled out all those factors, what was the one cause you were able to come up with? A: [The]
Paxil exposure during the first trimester”).
1. Ms. El-Massri’s Alleged Consumption of Paxil
Ms. El-Massri saw two doctors while she was pregnant: Dr. David DeLucia, who first treated
Ms. El-Massri on November 3, 2000, and Dr. Eleanor Berry, an obstetrician, who first treated Ms.
El-Massri on May 30, 2001. Id. at ¶ 7, ¶ 38. Ms. El-Massri likely conceived K.E. between April 25,
2001 and May 6, 2001, and gave birth to him on January 19, 2002. Def.’s L. R. 56 Stmt., ¶ 6.
During her pregnancy, Ms. El-Massri saw Dr. DeLucia only twice, on April 24 and April 30, 2001.
Id. at ¶ 8. After that, she did not see him again until 2003. Id.
Ms. El-Massri claims that Dr. DeLucia prescribed Paxil to her from the year 2000 until the
year 2002 and also gave her samples of the drug during that time. Def.’s L.R. 56 Stmt., ¶ 9, see also
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N. El-Massri Dep., Def.’s L.R. 56 Stmt., Ex. 5, ECF No. 93-6, 152: 2-5; 169-70: 22-1. She does not
claim to have received Paxil from any other source while she was pregnant. Id. at 189: 11-20. She
alleges that a different physician, Dr. Landry, prescribed the drug to her when she was discharged
from the hospital after giving birth to K.E. Id. at 189: 21-25.
Ms. El-Massri testified that she does not remember how much Paxil that she took during her
pregnancy or how often she took it. N. El-Massri Dep., Def.’s L.R. 56 Stmt., Ex. 5, 169: 16-21. She
also does not recall how many prescriptions Dr. DeLucia allegedly wrote for her or how many
samples he allegedly gave her. Id. at 182-83: 19-18; 169: 22 - 170: 5 (Q: “How many [samples were
you given by Dr. DeLucia]? A: “I don’t remember the exact number.” Q: “Can you ballpark it?” A:
“No.”).
2. Doctors’ Testimony and Medical Records of Alleged Paxil Consumption
There are no contemporaneous medical records indicating that Ms. El-Massri took Paxil
while pregnant and, if she did, how much she consumed. Pharmacy records are similarly sparse.
Ms. El-Massri’s then-boyfriend and now husband, Ameen El-Massri, testified that, during her
pregnancy, he filled two to three prescriptions for Paxil at the local CVS and Walgreen’s pharmacies
where she regularly filled prescriptions. Def.’s L.R. 56 Stmt., ¶ 10; A. El-Massri Dep., Def.’s L.R.
56 Stmt., Ex. 15, ECF No. 93-16, at 315:18-318:8 (agreeing that he filled a Paxil prescription
“maybe two times at Walgreens, one time at CVS … I can’t remember the exact times.”). Both
pharmacies kept records for Ms. El-Massri dating back to 2000. Id. at 11-15. The only Paxil
prescription in CVS’s records for Ms. El-Massri is from 2002, after K.E. was born. Def.’s L. R. 56
Stmt. ¶ 14. Walgreen’s records contain no reference to a Paxil prescription in Ms. El-Massri’s name.
Id. at ¶ 15. Mr. El-Massri also suggested that he may have filled a prescription at Arrow pharmacy,
but neither party provided records from that pharmacy. A. El-Massri Dep., Def.’s L.R. 56 Stmt., Ex.
15, 316:9.
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In medical records from 2001 and early 2002, Ms. El-Massri represented that she took some
medications, but not that she took Paxil. In a Patient Questionnaire from Dr. Berry’s practice dated
January 30, 2001, Ms. El-Massri wrote “Keflex” in response to a question asking her to list
prescription medications she took. Women’s Healthcare Records, Def.’s L.R. 56 Stmt., Ex. 12,
January 30, 2001 Note at 564265.014.MED00053. Similarly, a July 27, 2001 record from Waterbury
Hospital noted only “macrodantin and prenatal vit[amin]s” as Ms. El-Massri’s current medications.
See Medical Records, Def.’s L.R. 56 Stmt., Ex. 8, at 564265.034.DIS00374-77. A form completed
on January 19, 2002, when Ms. El-Massri was admitted for delivery of K.E, listed her current
medications as “Zithromax and PNV (prenatal vitamins).” See id, at 564265.034.DIS00160.
Ms. El-Massri’s doctors also fail to provide much evidence regarding her alleged
consumption of Paxil.
a. Dr. DeLucia
Dr. DeLucia testified that he did not prescribe Paxil or provide samples to Ms. El-Massri.
Def.’s L. R. 56 Stmt., ¶¶ 27-28. Dr. DeLucia also testified that he did not treat or diagnose Ms. ElMassri for depression and that, if he prescribed Paxil to Ms. El-Masri, he would have noted it in his
records. Id. at ¶¶ 20-25. Dr. DeLucia’s records note that Ms. El-Massri reported taking several
medications, but not Paxil, at a November 3, 2000 visit. Id. at ¶ 17. On April 24, 2001, Ms. ElMassri visited Dr. DeLucia and reported that she thought she was pregnant, which he also noted in
his records. Id. at ¶31, see also De Lucia Records, Def.’s L.R. 56 Stmt., Ex. 2, ECF No. 93-3,
MED00055 (“DeLucia Records”). These records also contain a note that says “no meds for now. (at
all).” Def.’s L.R. 56 Stmt., ¶ 32, see also De Lucia Records, MED00055 (emphasis in original). Dr.
DeLucia saw Ms. El-Massri again on April 30, 2001 and after that visit did not treat her again until
2003. Id. at ¶ 8. Plaintiffs admit that DeLucia does not recall prescribing Paxil to Ms. El-Massri and
agree that his notes do not suggest that he did. Pl.’s Stmt. of Disputed Facts, ECF No. 106-6, at ¶¶
27-28.
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b. Dr. Berry
Dr. Eleanor Berry, an obstetrician, treated Ms. El-Massri during her pregnancy. Def.’s L. R.
56 Stmt., ¶ 38. Ms. El-Massri’s first prenatal visit with Dr. Berry was on May 30, 2001. Id. Dr.
Berry testified that she did not recall prescribing Paxil to Ms. El-Massri before or during Ms. ElMassri’s pregnancy with K.E. Id. at ¶ 39, see also Berry Dep., Def.’s L. R. 56 Stmt., Ex. 10, ECF
No. 93-11, 194: 21-23 (“Def.’s Berry Dep.”). None of Dr. Berry’s prenatal records regarding Ms. ElMassri contain any reference to Paxil. Id. at ¶ 41, see also Def.’s Berry Dep., 190: 17-21 (agreeing to
the statement “you don’t have any records from during the pregnancy indicating Paxil as a current
medication, correct?”). Dr. Berry does not remember personally giving Ms. El-Massri any samples
of Paxil, but testified that she “[did not] remember all the samples that came through [her] office”
and that “it could be a possibility” that Ms. El-Massri obtained samples from Dr. Berry’s office
during her pregnancy. Pl.’s Stmt. Disp. Facts, ¶ 2; see also id. at Ex. A, ECF No. 106-1, Berry Dep.,
251:7-12.
Dr. Berry stated that Ms. El-Massri reported that she was taking Paxil to Dr. Berry at an
appointment while she was pregnant. Specifically, she attested:
It is my understanding that [Ms. El-Massri] was taking Paxil when she became pregnant and
continued to take Paxil throughout her first trimester and throughout the remainder of her
pregnancy. …Based upon my recollection and review of medical notes, Nichole was taking
Paxil pursuant to a prescription written by her primary care physician, Dr. David
Delucia.
Berry Aff., Def.’s L.R. 56 Stmt., Ex. 10, ECF No. 93-12, ¶¶ 4-5. Dr. Berry said that this statement
was based on her “recollection that [Ms. El-Massri] took Paxil throughout the pregnancy” and on
“conversations” that she remembered. Def.’s Berry Dep., 248: 18-21. Dr. Berry admitted having no
direct knowledge that Ms. El-Massri received any samples of Paxil from Dr. Berry’s office or from
any other source. See Def.’s L.R. 56 Stmt., ¶ 40; Def’s Berry Dep. 251: 3-6 (agreeing to the
statement “you don’t have any personal knowledge about Ms. El-Massri getting samples, correct?”).
c. Other Records
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The record contains evidence suggesting that Ms. El Massri took Paxil just after K.E.’s birth.
Records from the Waterbury Hospital Health Center dated January 22, 2002 indicate that a healthcare
provider initially recommended that Ms. El-Massri take Celexa on January 21, and then switched his
or her recommendation to Paxil the next day. Women’s Healthcare Records, Def.’s L. R. 56 Stmt.,
Ex. 12, 564265.034.DIS00182-83; id. at 564265.034.DIS00159. The records also indicate that Ms.
El-Massri “seemed to feel comfortable with the switch.” Id. One of these records, made after K.E.’s
birth, suggests that Ms. El-Massri may have taken Paxil before giving birth. At a consultation on
January 23, 2002, just after K.E. was born, Nurse Laurie Duncan reported that Ms. El Massri had
“been trialed on medications Zoloft and Paxil in the past by her primary care physician Dr.
DeLucia.” Medical Records, Def.’s L.R. 56 Stmt., Ex. 2, ECF No. 93-3, 564265.034.DIS00186.
Whenever she started, Ms. El-Massri stopped using Paxil shortly after giving birth. See
Women’s Healthcare Records, 64265.014.MED00050. At a consultation on January 3, 2003, Dr.
Reinhardt noted that “Dr. Berry had placed [Ms. El-Massri] on Paxil for two weeks which the patient
stopped due to side effects.” Id. at Ex. 8, ECF No. 93-9, Prenatal Flow Record at
64265.014.MED000256. A 2002 medical form indicates that Ms. El-Massri stated to a medical
professional that “her combination of meds made her spacey,” presumably prompting her to
discontinue the use of Paxil. Id. The only record of a Paxil prescription at Ms. El-Massri’s local
CVS was from January 23, 2002, after K.E.’s birth. Id. at ¶ 14.
3. Paxil’s Label
In May 1996, after prompting by the FDA, GSK changed the label on Paxil to include the
following passage:
There are no adequate and well-controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
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Def.’s L. R. 56 Stmt., ¶ 68 (citing May 1996 Paxil Prescribing Information, Ex. 26, ECF No. 88-40).
At that time, the company also changed the label to state that “[p]atients should be advised to notify
their physician if they become pregnant or intend to become pregnant.” Id. at ¶ 69. The label also
indicated that Paxil was a Category C drug, referencing an FDA designation that meant that:
(1) animal reproduction studies have shown an adverse effect on the fetus, there are
no adequate and well-controlled studies in humans, and the benefits from the use of
the drug by pregnant women may be acceptable despite its potential risks, or (2) there
are no animal reproduction studies and no adequate and well-controlled studies in
humans.
Id. at ¶ 61. In addition to “Category C,” the FDA used two other categories to indicate to healthcare
professionals that a drug was not advisable for pregnant women, “Category D” and “Category X.”
Id. The FDA used Category D to indicate there was “adverse reaction data from investigational or
marketing experience or studies [of the drug] in humans,” and Category X to indicate “studies [of the
drug] in animals or humans have demonstrated fetal abnormalities or there is positive evidence of
fetal risk.” Id. In 2005, GSK announced that it would revise its label to make Paxil a Category D
drug. Provider Letter, Pl.’s Stmt. Disp. Facts, Ex. 6, ECF No. 107-2, 1.
Dr. DeLucia testified that he would not have prescribed an SSRI, including Paxil, to a patient
he suspected to be pregnant. Def.’s L. R. 56 Stmt. ¶ 30 (quoting DeLucia Dep. Def.’s L. R. 56 Stmt.
Ex. 7, ECF No. 93-8, 203: 3-6) (“I believe Paxil was a Category C drug [in 2001], but I would not
have deemed it safe for use by women who were pregnant.”) Dr. Berry stated at deposition that “in
light of the new information [concerning Paxil] and the different pregnancy category rating,” she
would have “talked to [Ms. El-Massri] about switching to a different drug, a “Category B or
Category C rather than Category D drug.” Id. at Def.’s Berry Dep. at 220:8-16. Dr. Berry further
stated that she “usually” would tell a patient being prescribed a Category D drug that “you should
talk to your doctor and see if they can give you something different.” Id. at 221: 1-12.
In 2005, GSK circulated a letter to healthcare professionals suggesting that studies had
reported “positive evidence of human fetal risk” and that Paxil can “cause” fetal harm. Pl.’s Stmt.
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Disp. Facts, 5; see also Provider Letter, Pl.’s Stmt. of Disp. Facts, Ex. 6, ECF No. 107-2. The letter
stated that “updated analyses” from an epidemiological study and “new data from another study
utilizing a large medical birth registry” had “now become available.” Id. The letter referred to
“recent findings” and a “new study,” as well as two abstracts presented at 2005 conferences. Id. at 2,
7. The letter stated that GSK “considered [it] appropriate at the current time to revise the pregnancy
precaution [of Paxil] to Pregnancy Category D.” Id. at 2.
4. Procedural History
Ms. El-Massri learned that K.E. had a BAV during a visit to the cardiologist in September
2010. Letter from Dr. Berning, Def.’s L.R. Stmt, Ex. 17. On June 28, 2011, she visited K.E.’s
pediatrician, who noted in her records that Ms. El-Massri “took Paxil during pregnancy.” Bristol
Pediatric Center Records, Def.’s L.R. 56 Stmt., Ex. 13, ECF No. 93-14, 1. Ms. El-Massri testified
that, at this point, she was “having concerns” about whether or not Paxil had caused her son’s health
issues. N. El. Massri, Dep., 325: 9-13.
Q: Well, by this point in time, were you considering filing a lawsuit and thinking
about the issue of whether or not Paxil caused your son's heart issues?
A: Yes. I have concern over it.
Q: And by this point in time, those thoughts had already started to formulate, right?
A: Yes.
Id. at 325: 9-16. Ms. El-Massri suggested at deposition that the basis for her belief that her use of
Paxil caused K.E.’s birth defect was a television commercial. Id. at 330: 18-25 (“Q: What’s the basis
for that belief [that Paxil use during pregnancy caused K.E. to have a heart defect]? A: His symptoms
are similar to what I have seen on the commercial. The exact same diagnosis.”). The record does not
establish when in 2011 she viewed these advertisements. Def’s L. R. 56 Stmt., ¶¶ 46-48. However,
it is clear that Ms. El-Massri and her husband had seen the advertisement at least once before calling
a law firm. Id. at ¶ 48; A. El-Massri Dep., 408: 2-7 (Q: “Well, did you see the commercial on more
than one occasion? A: Yes. Q: Had she seen the commercial previously? A: Yes. Q: And what -- had
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she already called when you saw the commercial? A. No.”). Ms. El-Massri called a law firm about
this dispute on July 27, 2011. Def.’s L.R. 56 Stmt., ¶ 46; Pl.’s Opp. Mem., 5-6.
Ms. El-Massri signed a contract with the law firm on Sept. 30, 2011, after submitting
“paperwork” by mail. See Paxil Birth Defects Claims – Contract of Employment, Pl.’s L.R. 56
Stmt., Ex. 5, ECF No. 106-10, 1. The contract confirms that the firm opened a file for Ms. El Massri
on July 27, 2011. Id. Ms. El-Massri testified that she did not hear from the law firm for several
years after signing the contract. N. El. Massri, Dep., 348: 14-23.
Ms. El-Massri filed her original complaint on July 25, 2014 in the Court of Common Pleas of
Philadelphia County. See Compl., ECF No. 1; Pls.’s Opp. Mem. 6. Plaintiffs’ cause of action was
then removed to federal court in the Eastern District of Pennsylvania on August 19, 2014. Id.
Plaintiffs and GSK subsequently filed a Joint Motion to Transfer Venue to this Court on September
4, 2014. See Joint Motion to Transfer, ECF No. 6. The action was transferred to this Court for
further proceedings on September 8, 2014. See Notice of Transfer, ECF No. 10.
In their short form complaint, which GSK references in its motion for summary judgment,
Plaintiffs bring sixteen claims. Short Form Complaint/Notice to Defend, Ex. B, ECF No. 1-3. These
claims are: (1) breach of express warranty (Count I); (2) breach of implied warranty (Count II); (3)
fraud (Count III); (4) intentional infliction of emotional distress (Count IV); (5) loss of consortium
(Count V); (6) negligence (Count VI); (7) negligence per se (Count VII); (8) negligent
pharmacovigilance (Count VIII); (9) failure to warn (Count IX); (10) negligent misrepresentation
(Count X); (11) strict products liability (Count XII); (12) loss of income (Count XVI); (13) violation
of Connecticut’s consumer act (Count XIV); (14) medical expenses (Count XVII); (15) design defect
(Count XVIII), and (16) punitive damages (Count XI). Plaintiffs’ long form complaint references
many of the same claims, but uses different numbers. See Case Management Track Form, ECF No.
1-4.
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5. The Present Motions
In support of their claims, Plaintiffs intend to call Dr. William Ravekes, a medical doctor and
an expert in pediatric cardiology. Dr. Ravekes seeks to testify that Ms. El-Massri’s consumption of
Paxil caused K.E.’s BAV.
On June 16, 2015, GSK moved to exclude Dr. Ravekes’ opinion testimony. On the same
date, GSK moved for summary judgment. GSK argues that it is entitled to summary judgment
because (1) all claims are time-barred and (2) even if not time-barred, all claims fail because
Plaintiffs cannot establish that Ms. El-Massri’s alleged use of Paxil was the proximate cause of
K.E.’s BAV. GSK also makes specific arguments about the insufficiency of Plaintiffs’ claims for
breach of express and implied warranty, fraud and negligent misrepresentation, intentional infliction
of emotional distress, loss of consortium, negligence per se, negligent pharmacovigilance, strict
liability and design defect, violation of the Connecticut Unfair Trade Practices Act, and punitive
damages. Because Dr. Ravekes’ testimony is crucial to Plaintiffs’ case, the Court addresses the
motion to exclude his testimony first and then will address the motion for summary judgment on
these and any other grounds.
II. GSK’s Motion to Exclude the Testimony of Dr. Ravekes
Dr. William Ravekes, a medical doctor licensed in the State of Maryland, is an Assistant
Professor of Pediatric Cardiology at Johns Hopkins University School of Medicine. See Ravekes
CV, Pl.’s Mem. in Opp., Ex. A, ECF No. 105-1 (“Ravekes CV”). He is also an attending physician
of Pediatric Cardiology at Johns Hopkins Hospital and sees patients in several other hospitals in the
Baltimore area. Ravekes Report, 1. He has practiced medicine for sixteen years and also participates
in research, academic leadership, and the education of future pediatric cardiologists. Id. at 2. In his
report, he reviewed various publications on the causes of and risk factors for congenital heart disease,
opines on the biological effects of serotonin on fetal development and reviews Ms. El-Massri’s
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medical history. Id. He concluded that Paxil was a “significant contributing factor” to K.E.’s heart
defect. Id. at 12.
Defendants move to exclude his testimony generally, because he is unqualified, and also
move to exclude his testimony on general and specific causation. Def.’s Mot. to Preclude, ECF 89-1.
While the Court finds that Dr. Ravekes is qualified to offer opinions in this case, it concludes that his
opinions on the issue of general causation are, in part, inadmissible and that his opinions on the issue
of specific causation are wholly inadmissible. As a result, Defendant’s motion to exclude Dr.
Ravekes’ expert testimony is granted.
A. Standard of Review
Expert opinions must be both reliable and relevant to the issues in a given case before they
can be presented to the trier of fact. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S.
579 (1993) (“under the Rules the trial judge must ensure that any and all scientific testimony or
evidence admitted is not only relevant, but reliable”); Fed. R. Evid. 702, Advisory Committee Notes,
2000 Amendments (noting that trial judges have “the responsibility of acting as gatekeepers to
exclude unreliable expert testimony”). Evidence is relevant if the testimony “has any tendency to
make the existence of any fact that is of consequence to the determination of the action more
probable or less probable than it would be without the evidence.” Amorgianos v. Amtrak, 303 F.3d
256, 264 (2d Cir. 2002).
If expert testimony is relevant, the trial court must then determine “whether the proffered
testimony has a sufficiently ‘reliable foundation’ to permit it to be considered” by the trier of fact.
Amorgianos, 303 F.3d at 265 (quoting Daubert, 509 U.S. at 597). An expert’s testimony is reliable if
(1) it is based upon sufficient facts or data, (2) it is the product of reliable principles and methods,
and (3) if the witness has applied the principles and methods reliably to the facts of the case. Fed. R.
Evid. 702.
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Generally, when an expert reliably utilizes scientific methods to reach a conclusion, any
asserted lack of textual support for these methods goes “to the weight, not the admissibility” of his or
her testimony. Amorgianos, 303 F.3d at 267. A “contrary requirement,” the Second Circuit has
noted, would “be at odds with the liberal admissibility standards of the federal rules and the express
teachings of Daubert.” Id. At the same time, “nothing in Daubert or the Federal Rules of Evidence
requires a district court to admit opinion evidence that is connected to existing data only by the ipse
dixit of the expert.” Id. (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A district
court’s assessment of expert testimony thus requires a case-specific and “rigorous” consideration of
the “facts on which the expert relies,” the expert’s “method,” and how he or she “applies the facts
and methods to the case at hand.” Id. at 267.
B. Discussion
1. Qualifications of Dr. Ravekes
GSK argues that Dr. Ravekes is not qualified to testify to the relationship between birth
defects and exposure to the chemicals in Paxil because he draws on literature from the fields of
teratology and epidemiology, which are far from his clinical expertise. Def.’s Mot. to Preclude, 1215. The Court disagrees.
Expert opinion testimony is permitted only if the witness “is qualified as an expert by
knowledge, skill, experience, training, or education,” and the expert’s “scientific, technical, or other
specialized knowledge will assist the trier of fact to understand the evidence or to determine the fact
in issue.” Fed. R. Evid. 702. District courts have broad discretion to determine whether an expert is
qualified and may determine that an expert is qualified to testify outside of his or her formal training
or specialty. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1042-43 (2d Cir. 1995) (rejecting
argument that because the causation expert, a medical doctor, had “no experience performing or
interpreting air quality studies” he was not qualified to testify).
14
There is no bright-line rule about whether experts in clinical medicine can also assist the jury
in determining general causation. Courts have allowed medical doctors to testify about
epidemiological studies. See, e.g., United States v. Thorn, 317 F.3d 107, 114-15 (2d Cir. 2003)
(approving of district court’s decision to allow medical doctor specializing in asbestos-related disease
to testify about various epidemiological studies of asbestos exposure); Danley v. Bayer (In re Mirena
IUD Prods. Liab. Litig.), 169 F. Supp. 3d 396 (S.D.N.Y. 2016) (admitting medical doctor’s
testimony concerning epidemiological studies); Lyman v. Pfizer, Inc., No. 2:09-cv-262, 2012 U.S.
Dist. LEXIS 101150, at *11 (D. Vt. July 20, 2012) (allowing medical doctor’s testimony that
“metoclopramide use produces tardive dyskinesia at a higher rate than that of certain other drugs, and
an explanation of why that may be so,” because the expert had “explained his methodology, and his
methods and opinions have been published in peer-reviewed journals”). In Danley, for example, the
court denied the plaintiff’s motion to exclude expert opinions regarding epidemiological studies
because the experts were clinicians, familiar with the allegedly tortious product, and had “experience
evaluating (and in some cases conducting) epidemiological studies as part of their clinical work.”
Danley, 169 F. Supp. 3d at 426.
Courts have excluded the testimony of clinicians about general causation, but only when the
clinicians had either negligible experience with pharmacology or little familiarity with observational
studies in general. In Smith v. Pfizer, Inc., which GSK cites, the court decided that the plaintiff’s
expert, a psychiatrist, was not qualified to opine about general causation. Smith, No. 98-4156-CM,
2001 U.S. Dist. LEXIS 12983, at *24 (D. Kan. Aug. 14, 2001). The psychiatrist, an expert in
suicidiality, did not have expertise in either epidemiology or pharmacology, which, the court
reasoned, would be necessary to show general causation. Id. In Bextra, which defendant also cites,
the court excluded general causation testimony from a medical doctor who had “never participated in
an observational study of any kind,” and thus was unqualified “to opine that one or two observational
studies are correct while all the other studies … are wrong.” In re Bextra & Celebrex Mktg. Sales
15
Practices & Prod. Liab. Litig., 524 F. Supp. 2d 1166, 1176 (N.D. Cal. 2007). The fact that the expert
in question had only reviewed the relevant data for the purposes of litigation also weighed in the
Bextra court’s decision to exclude his testimony. Id.
Dr. Ravekes, however, has extensive experience and understanding of the biological
mechanisms by which chemicals might affect neonatal development. He also has experience
designing observational studies due to his work with the National Registry of Genetically Triggered
Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC). See Ravekes Rept., 3. As
co-primary investigator and steering committee member of GenTAC, Dr. Ravekes analyzed relevant
data and summarized the results of GenTAC’s studies. Ravekes CV, 3-4. Additionally, he has
published observational studies in many journals. See id. (listing articles under “peer-reviewed
original science research,” including No. 28 “Longitudinal systolic ventricular interaction in pediatric
and young adult patients with TOF: a cardiac magnetic resonance and M-mode echocardiographic
study,” No. 48 “Echocardiographic Reference Values for Right Atrial Size in Children with and
without Atrial Septal Defects or Pulmonary Hypertension,” and No. 5 “Magnetic resonance imaging
of a distorted left subclavian artery course: an important clue to an unusual type of double aortic
arch”). Moreover, Dr. Ravekes has examined defective aortic valves in numerous patients,
accumulating knowledge that would help him understand the relevant epidemiological literature.
The relationship between Dr. Ravekes’ clinical expertise and the epidemiology in question makes
him sufficiently qualified to testify about epidemiological studies under Daubert.
Similarly, Dr. Ravekes is qualified to testify about hypothetical ways that Paxil might affect
embryonic serotonin levels and cause heart defects. He has conducted “clinical research in the area
of pediatric cardiology” and has “published over 70 articles, editorials, annotations and book
chapters” in peer-reviewed journals including Pediatric Cardiology, the American Heart Journal, the
International Journal of Cardiology, and the Journal of the American Society of Echocardiography.
Ravekes Rept., 1-2; Ravekes CV, 2-5. He is accustomed to reading and reviewing scientific studies
16
and evaluating arguments about the heart’s biological functions. GSK argues that Ravekes “has
never conducted original research or published an article on Paxil, SSRIs, serotonin, or serotonin’s
role in heart development,” Def.’s Mot. to Preclude, ECF 89-1, 14, but an expert need not testify on
his original research, provided that he or she has expertise in the research topic more generally.
Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94 (2d Cir. 2000) (“[A]n expert may rely on data
that she did not personally collect.”).
As a result, the Court finds that Dr. Ravekes has the expertise necessary to testify about the
relationship between birth defects and Paxil.
2. Dr. Ravekes’ Opinions on General Causation
Of course, the fact that Dr. Ravekes is qualified to offer opinions does not mean that the
opinions he offers are admissible. Fed. R. Evid. 702 (“[A] witness qualified as an expert … may
testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient
facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness
has applied the principles and methods reliably to the facts of the case.”) GSK also moves to exclude
Dr. Ravekes’ opinions on general causation because his report ignores recent analyses of the
relationship between Paxil and birth defects, does not eliminate other causes—including chance, bias
and confounding—in assessing the association and does not follow a “set, written-down
methodology” to establish general causation. Def.’s Mot to Preclude, 15. The Court agrees with
respect to Dr. Ravekes’ review of epidemiological evidence, but disagrees with respect to his opinion
on biological plausibility.
a. Dr. Ravekes’ Review of the Epidemiological Evidence
GSK argues that Dr. Ravekes’ report is unreliable because it does not account for seven
meta-analyses on the relationship between Paxil and birth defects, which are provided by Defendants
as exhibits 31-37. Def.’s Mot. to Preclude, 18-24; id. at 20, n. 128. The Court agrees. Even if this
17
omission was not ill-intentioned, it renders Dr. Ravekes’ review of the evidence incomplete. This
portion of Dr. Ravekes’ general causation opinion is therefore unreliable.
When experts rely on epidemiological evidence to support causation, they must provide the
jury with a full picture of the state of the field. Guardians Asso. of N.Y.C. Police Dept., Inc. v. Civil
Serv. Com., 633 F.2d 232, 240 (2d Cir. 1980) (“If the sample is adequate, the data gathering
techniques reliable, and the conclusions drawn demonstrated to be statistically significant, such
estimates and projections may properly be admitted into evidence.”); see also Norris v. Baxter
Healthcare Corp., 397 F.3d 878 (10th Cir. 2005). In Norris, the Tenth Circuit approved of the
exclusion of expert testimony that “completely ignored the many epidemiological studies that do not
find a link between silicone gel breast implants and any systemic disease” and rather “stated that
epidemiological studies relied on by the industry ‘are not definitive.’” Id. at 885. In In re Zoloft, the
court excluded the testimony of two experts on causation who had “given scant attention to the
epidemiology research in their reports [and] failed to reconcile inconsistent epidemiological evidence
with their opinions on human causation.” In re Zoloft (Sertraline Hydrocloride) Prods. Liab. Litig.
26 F. Supp. 3d 466 (E.D. Pa. 2014); see also In re Rezulin Prod. Liab. Litig., 369 F. Supp. 2d 398,
425 (S.D.N.Y. 2005) (“[I]f the relevant scientific literature contains evidence tending to refute the
expert’s theory and the expert does not acknowledge or account for that evidence, the expert’s
opinion is unreliable”).
In these cases, the experts had ignored epidemiological research that was contrary to their
eventual conclusion, “cherry-picking” among studies to give the illusion of clarity in favor of their
position. See, e.g. In Re Rezulin, 369 F. Supp. 2d at 425 (“Courts have excluded expert testimony
where the expert selectively chose his support from the scientific landscape”) (internal citations
omitted). In this case, Dr. Ravekes’ error may be more benign. Some of the research he excluded
from his report actually supports his position. The recently published meta-analysis by Anick
Bérard, et. al., for example, actually observes a “trend towards increased risk” of heart defects after
18
exposure to Paxil’s component chemicals. Abstract, Bérard et. al, (2015), Def.’s Mot. to Preclude,
Ex. 32. Myles, et. al. also report that Paroxetine “was associated with increased risk of cardiac
malformations.” Abstract, Myles, et. al. (2013), Def.’s Mot. to Preclude, Ex. 33. Nevertheless,
while Dr. Ravekes’ report does not “selectively” cite supporting science, it does present an
incomplete and therefore unreliable view of the secondary literature.
For this reason, the portion of Dr. Ravekes’ expert testimony that summarizes the
epidemiological data about general causation is excluded.
b. Dr. Ravekes’ Opinion on Biological Plausibility
GSK further argues that the second half of Dr. Ravekes’ report, which relies on “biological
plausibility,” is unreliable and inadmissible because it makes conclusions about Paxil’s effect on
humans from data concerning animals or isolated tissues. Def.’s Mot. to Preclude, 31. The Court
disagrees.
Dr. Ravekes refers to “numerous animal studies” to show that changes to a mother’s
serotonin level can “interfere with neural crest cells” in her developing fetus. Ravekes Report, 4.
GSK contends that Dr. Ravekes does not explain whether Paxil alters serotonin levels in utero and
“cites no data” to support this conclusion. Def.’s Mot. to Preclude, 32. Furthermore, GSK argues
that Dr. Ravekes improperly draws conclusions from a controversial study by Sloot, et. al., which
used Whole Embryo Cultures (“WECs”) from rats to predict the teratogenic effect of SSRIs on
humans (the “Sloot Paper”). Id. at 33.
GSK also points to a general flaw in the literature on toxic chemicals, in which scholars often
draw conclusions about the human experience from in vitro research—research “concerning the
effects of a chemical on human or animal cells, bacteria, yeast, isolated tissues, or embryos”—
because it would be unethical to test the chemical on humans extensively. See Bernard D. Goldstein
& Mary Sue Henifin, Reference Guide on Toxicology, in FED. JUD. CTR., REFERENCE MANUAL ON
19
SCIENTIFIC EVIDENCE, 663 (3rd Ed. 2011) (hereinafter “Reference Manual”). Toxicology studies that
use live animals are often similarly implicated.
While animal studies are necessarily inconclusive as evidence of causation in humans, they
may be admissible when the “gap between what these sources reasonably imply and more definitive
scientific proof of causality is not too great,” and when “the inferences are of a kind that physicians
and scientists reasonably make from good but inconclusive science.” In re Ephedra Prods. Liab.
Litig., 393 F. Supp. 2d 181, 197 (S.D.N.Y. 2005); see generally In re “Agent Orange” Prod. Liab.
Litig., 611 F. Supp. 1223, 1241 (E.D.N.Y. 1985) (“[L]aboratory animal studies are generally viewed
with more suspicion than epidemiological studies, because they require making the assumption that
chemicals behave similarly in different species”). When animal studies are admissible, the expert’s
“extrapolation from studies to support [his or her] conclusions, as well as [his or her] use of in vitro
versus in vivo studies [goes] to the weight and not the admissibility of expert testimony.” Danley,
169 F. Supp. 3d at 432 n.23 (S.D.N.Y. 2016) (citing In re Ephedra, 393 F. Supp. 2d at 189).
GSK cites to several cases where courts excluded expert testimony that inferred from animal
and in vitro studies a corresponding effect of SSRIs on developing embryos. For example, a court in
a similar case found that plaintiff’s causation expert failed to consider the “dose response
relationship” and relied instead on studies in which animals were exposed to concentrations of Zoloft
that were “well above the maximum recommended human dose.” In re Zoloft, 26 F. Supp. 3d at 478.
That court also found that the expert’s report was unreliable because it did not consider studies of
Zoloft in living mammals, or otherwise considered studies that did not provide evidence that
serotonin pathways were similar across species. Id. at 480. This was especially troubling, the court
reasoned, because the “optimal range of serotonin in pregnant women” was unknown. Id.
In another case, the court excluded expert testimony on “alteration of serotonin signaling
[that] can impact embryonic development resulting in ... congenital malformations,” stating that these
decisions were “nothing but speculation without support since [the expert had] no information as to
20
the baseline level of serotonin causing signaling” or how SSRIs changed serotonin levels. Porter v.
SmithKline Beecham Corp., et al., No. 03275, 2015 WL 5970639 at *6 (Pa. Com. Pl. Oct. 5, 2015).
The expert in question also had not reviewed animal studies from after 1998 and had not
“acknowledged … a significant body of human exposure studies.” Id. at *4.
Dr. Ravekes, like the experts in the Zoloft cases defendant cites, does not specify exactly how
Paxil or another SSRI would impact the prenatal environment in a human. He also does not attest to
the optimal range of serotonin in pregnant women, so his assessment of the effect of changing
serotonin levels on the prenatal environment, which is based partially on animal studies, suffer from
that drawback. Potential plaintiffs, however, would be overly burdened by a standard that would
disallow any expert testimony on serotonin’s effect on animals because the optimal range of
serotonin in pregnant women is unknown. See Heller v. Shaw Indus., Inc., 167 F.3d 146, 155 (3d
Cir. 1999) (“Given the liberal thrust of the Federal Rules of Evidence, the flexible nature of the
Daubert inquiry, and the proper roles of the judge and the jury in evaluating the ultimate credibility
of an expert’s opinion, we do not believe that a medical expert must always cite published studies on
general causation in order to reliably conclude that a particular object caused a particular illness. …
To so hold would doom from the outset all cases in which the state of research on the specific
ailment or on the alleged causal agent was in its early stages.”).
In this case, the Court recognizes the significant limitations of the studies on which Dr.
Ravekes relies, but believes these would be best addressed with precautionary instructions to the jury
and rigorous cross examination. See 1-4 Drug Product Liability § 4.04; see also Daubert, 509 U.S. at
596 (“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the
burden of proof are the traditional and appropriate means of attacking shaky but admissible
evidence.”); McCullock, 61 F.3d at 1044 (disputes about an expert’s use of differential diagnosis “go
to the weight, not the admissibility, of [the expert’s] testimony”).
21
In any event, GSK’s own proposed expert, Dr. Anthony Scialli, plans to testify in detail about
the Sloot Paper. Dr. Scialli opines that studies involving WECs, like Sloot’s, are inappropriate for
assessing what is a teratogen in human risk assessment. See Scialli Report, 16-17. He addressed the
errors in the Sloot Paper in a subsequent publication as well as in his report. Id. As a result of the
article, the authors of the Sloot Paper clarified that their definition of teratogenicity was “made for
the purposes of Whole Embryo Culture tests” and might not speak to the effect of paroxetine on
human embryos. Id.; see also Frischhertz v. SmithKline Beecham Corp., No. 10-2125, 2012 U.S.
Dist. LEXIS 181507, at *8 (E.D. La. Dec. 21, 2012) (commenting on Dr. Scialli’s testimony as to the
Sloot study in that case). If the jury heard Dr. Ravekes’ testimony, it would be able to draw on Dr.
Scialli’s opinions to form its own assessment of Dr. Ravekes’ reliability, to the extent that his
testimony is admissible and necessary.2
As a result, Dr. Ravekes’ testimony on the biological plausibility of Paxil’s causation of
BAVs generally is admissible, even though it relies on animal studies.
3. Dr. Ravekes’ Opinion about Specific Causation
Dr. Ravkes’ testimony that Paxil can cause BAV generally is of no value if he cannot also
testify that Paxil caused K.E.’s BAV. Amorgianos, 303 F.3d at 268 (“[T]o establish causation, [the
plaintiff] must offer admissible expert testimony regarding both general causation, i.e., that xylene
exposure can cause the type of ailments from which Amorgianos claims to suffer; and specific
causation, i.e., that xylene exposure actually caused his alleged neurological problems.”); Blanchard
v. Eli Lilly & Co., 207 F. Supp. 2d 308, 314 (D. Vt. 2002) (“Plaintiffs … must prove both general
and specific causation in order to prevail on their claim.”) (citations omitted).
2
Pending before the Court is a separate motion regarding the admissibility of Dr. Scialli’s expert testimony. Pl.’s
Mot. to Exclude Testimony of Anthony Scialli, ECF No. 92. Because this Court ultimately determines that Dr.
Ravekes’ expert testimony is inadmissible and therefore, excludes it and grants summary judgment for GSK, the
Court does not reach the question of whether Dr. Scialli’s expert testimony is admissible. In a subsequent ruling, the
Court will declare Plaintiffs’ motion to be moot.
22
GSK argues that Dr. Ravekes’ testimony regarding specific causation is inadmissible because
Dr. Ravekes improperly assumed that Ms. El-Massri took Paxil during her first trimester. Def.’s
Mot. to Preclude, 31, 36 (Dr. Ravekes “simply assumed, at counsel’s direction, that Ms. El-Massri
took Paxil” during this time). The Court agrees that Dr. Ravekes’ specific causation testimony is
inadmissible.
A causation expert must rely on some evidence that the patient was exposed to the substance
in question. “Although exact data on exposure need not be required, an expert should … be able to
provide reasonable explanations for his or her conclusions about the amount of exposure that sufficed
to cause plaintiffs’ injuries.” Reference Manual, 25. In most prescription drug cases, this is not a
problem, because prescriptions or medical records can be used to surmise the exact amount of the
allegedly toxic substance that the plaintiff consumed. Id. In this case, though, the record contains
very little evidence that Ms. El-Massri consumed Paxil while she was pregnant and no evidence from
which Dr. Ravekes can reasonably infer how much Paxil Ms. El-Massri possibly could have
consumed. Since expert opinion testimony must be based “upon sufficient facts or data,” Fed. R.
Evid. 702, the lack of evidence of Ms. El-Massri’s Paxil consumption renders Dr. Ravekes’ expert
testimony on specific causation inadmissible.
a. Dr. Ravekes’ Research and Method
Generally, when the “reliability of certain facts accepted by an expert is questionable,” the
Court can rely on “the exercise and process of cross-examination to allow a [party] to bring any such
factual disputes to the attention of the jury.” Howard v. Walker, 406 F.3d 114, 127-28 (2d Cir.
2005). In some cases, courts have allowed experts to testify that a toxic substance caused a
plaintiff’s injury without concrete knowledge of whether the plaintiff was exposed to the substance,
reasoning that the issue of exposure is best left for the jury to determine. See, e.g. Green v.
McAllister Bros., No. 02 Civ. 7588 (FM), 2005 U.S. Dist. LEXIS 19789 (S.D.N.Y. Sep. 6, 2005), *34. In Green, the court admitted the testimony of a plaintiff’s expert even after the expert conceded
23
that his opinion that the plaintiff’s injury was caused by exposure to WTC dust while working on the
defendant’s boat was “based on the assumption that Green had not previously been exposed to WTC
Dust at [another point],” because “if a jury accept[ed] Green's testimony that he had no prior
exposure to WTC Dust, [the] expert opinion would permit the jury to find that Green’s asthma was
caused by his work for McAllister.” Id.
In some cases, though, the duration and amount of exposure is so crucial to an expert’s causal
argument that the expert must rely on at least circumstantial evidence of exposure. This is especially
true where, as here, a substance is allegedly toxic or teratogenic only at certain levels, but can be
consumed safely at others. In Wills, the court evaluated the report of an expert doctor whose
causation testimony was based on the theory that even a small amount of exposure to benzene, the
toxic substance that was allegedly present on defendant’s ship, would cause cancer. Wills v.
Amerada Hess Corp., No. 98 -7126, 2002 U.S. Dist. LEXIS 1546, at *29-52 (S.D.N.Y. Jan. 31,
2002). The expert doctor’s animal studies suggested that benzene was carcinogenic at certain doses,
which rendered his specific causation opinion unreliable unless it was based on non-conclusory
allegations about the amount of benzene to which plaintiff was exposed. Id. at *36. “Theoretically,”
the court noted, “any exposure at all to mutagens may increase the risk of cancer, although the risk
may be very slight and not achieve medical probability.” Id. at *44-45 (citing Bernard D. Goldstein
& Mary Sue Henifin, Reference Guide on Toxicology, in FED. JUD. CTR., REFERENCE MANUAL ON
SCIENTIFIC EVIDENCE, 426 (2d ed. 2000)).
In Amorgianos, the Second Circuit affirmed the district court’s exclusion of the testimony of
plaintiff Amorgianos’ treating physician, Dr. Moline. Amorgianos, 303 F.3d at 270. Dr. Moline
relied on a number of published articles to conclude that exposure to xylene at defendant’s workplace
caused Amorgianos’ injury. The court concluded that the studies on which Dr. Moline relied did not
speak to specific causation because they differed from Mr. Amorgianos’ situation in key areas,
including exposure. None of the studies provided “evidence of the neurological effects of short-term
24
xylene exposure,” which would be key to establishing causation in Amorgianos’ case. As a result,
the district court concluded that there was “too great an analytical gap between the conclusions
reached by the authors of Dr. Moline’s cited articles and the conclusions that she draws from their
work.” Id. (citing Amorgianos v. Amtrak, 137 F. Supp. 2d 147, 185 (E.D.N.Y. 2001)); see also
Reference Manual, 613, n. 196 (“a risk estimate from a study that involved a greater exposure is not
applicable to an individual exposed to a lower dose”) (citing In re Bextra, 524 F. Supp. 2d at 1175-76
(relative risk found in studies of those who took twice the dose of others could not support expert’s
opinion about causation for latter group); Wright v. Willamette Indus., 91 F.3d 1105, 1106 (8th Cir.
1996) (“[A] plaintiff in a toxic tort case must prove the levels of exposure that are hazardous to
human beings generally as well as the plaintiff’s actual level of exposure to the defendant's toxic
substance before he or she may recover.”)).
The epidemiological studies on which Dr. Ravekes relies base their conclusions on some
proof of exposure. As a result, there is an “analytical gap” between these studies and his conclusions
about specific causation. Many of the researchers Dr. Ravekes cited were unable to identify the
exact dose or duration of Paxil exposure in the women they studied. See Kallen (2007), Def.’s Mot.
to Preclude, Ex. 11, ECF No. 89-12, 306 (“The … problem is that little is known about actual dosage
and timing of drug use” among the subjects studied). Generally, though, these studies draw
conclusions from women who reported regular use of Paxil for at least the first trimester of their
pregnancy. Furthermore, while many of the cited scientists determined exposure using self-reports,
most of these reports were obtained at interviews taken during or immediately after pregnancy,
making them more reliable gauges of actual exposure.3
A report by Alwan (2007), for example, limited its conclusions to mothers who had taken the
drug during the period lasting from one month before pregnancy until three months after conception.
3
Louick (2007) used self-reports given within six months of delivery. See Louick (2007), Def.’s Mot. to Preclude,
Ex. 6, 2676. Kallen (2007) used data from routine midwife interviews at the first antenatal care center visit. See
Kallen (2007), Def.’s Mot. to Preclude, Ex. 11, ECF No. 89-12, 302.
25
See McDonagh, et. al. (2014), 4 Def.’s Mot. to Preclude, Ex. 36, ECF No. 89-37, E-32; see also
Louick (2007), Def.’s Mot. to Preclude, Ex. 6, ECF No. 89-7, 2681 (presuming that the drugs studied
were “used on a regular basis for nontrivial indications”). In Bérard (2007), one of the few studies in
which exposure was measured precisely, the average dose among the 542 subjects who had taken
Paxil was 22.4 m.g. for an average duration of 64 days. McDonagh, et. al. (2014), E-33. For Dr.
Ravekes to draw parallels between these epidemiological studies and this case, he would need to rely
on some evidence that Ms. El-Massri took a “non-trivial” amount of Paxil during most or all of the
first trimester of her pregnancy.5
This evidence, however, is lacking in the record. Dr. Ravekes admitted that his opinion on
causation was “based on the assumption that [Ms. El-Massri] took” Paxil during the critical period of
fetal heart development. Ravekes Dep., Def.’s Mot. to Preclude, Ex. 8, ECF No. 90-5, 282: 10-25.
He also acknowledges that dosage and duration of exposure are important components of his method
of analyzing causation. “In forming my opinions,” Ravekes explains, “I engaged in an appropriate
causation assessment, considering many factors, including temporal relationships, dose, duration of
exposure, biological plausibility/mechanism [and] the medical records of both [Plaintiffs].” Ravekes
Rept., 3. Thus, in Ravekes’ opinion, the consideration of exposure to a teratogen is an important
factor when assessing whether the teratogen caused a particular birth defect.
This Court must consider “the indicia of reliability identified in Rule 702” and assess whether
Dr. Ravekes drew on “sufficient facts or data” in making his testimony, used “reliable principles and
methods” in his conclusions and “applied the principles and methods reliably to the facts of the
4
The Court relies on McDonagh, et. al., Def.’s Mot. to Preclude, Ex. 36, for its overview of many of the studies the
parties reference, both because the review provides a helpful assessment of the studies and because the record does
not contain all of the scientific articles that Dr. Ravekes cited.
5
While some epidemiologists draw conclusions about causation without precise data on dose or duration of
exposure in populations studied, most acknowledge the importance of this problem and try to correct it. See Louick
(2007), 2681 (acknowledging difficulty of “recall bias” in study that relied on maternal self-reports of drug
exposure, but considering such bias unlikely because anti-depressants are generally taken for long periods). Other
studies use prescription data to speak more precisely to the importance of extent and duration of exposure in the
relationship between Paxil and birth defects.
26
case.” Fed. R. Evid. 702; see also Amorgianos, 303 F.3d at 267 (requiring a “rigorous examination”
of these factors). In Amorgianos, the Second Circut upheld a lower court’s determination that an
expert was unreliable because he “failed to apply his own methodology reliably.” Id. Here, Dr.
Ravekes did not “apply his own methodology reliably,” because there is nothing in the record from
which he could consider thoroughly, much less reasonably, the dose of Paxil Ms. El-Massri
consumed during her pregnancy and the duration of her exposure to the drug. These fundamental
flaws in his expert testimony render any opinion he may wish to provide on specific causation
inadmissible.
b. Dr. Ravekes’ Use of Differential Diagnosis
Plaintiffs suggest that the fundamental flaws identified in Dr. Ravekes’ expert testimony—the
lack of evidence of the dosage and duration of Ms. El-Massri’s Paxil use—are overcome by his
reliance on differential diagnosis to show causation in the absence of such evidence. The Court
disagrees.
Differential diagnosis is a “patient-specific process of elimination that medical practitioners
use to identify the most likely cause of a set of signs and symptoms from a list of possible causes.”
Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir. 2005) (internal quotation marks and
citations omitted). As the Second Circuit recognized in Ruggiero, “[t]here may be instances where,
because of the rigor of differential diagnosis preformed, the expert’s training and experience, the type
of illness or injury at issue, or some other case-specific circumstance, a differential diagnosis is
sufficient to support an expert’s opinion in support of both general and specific causation.”
Ruggiero, 424 F.3d at 254; Plourde v. Gladstone, 190 F. Supp. 2d 708, 722 n.7 (D. Vt. 2002)
(“courts have looked favorably on causation testimony that is primarily based on differential
diagnosis”); see also Perkins, 299 F. Supp. 2d at 57 (“Differential diagnosis is a reliable basis to
prove general causation in this circuit”). Dr. Ravekes’ differential diagnosis here, however, is not
one of those instances.
27
An expert’s use of differential diagnosis to determine specific causation does not absolve the
expert of having to satisfy Rule 702 of the Federal Rules of Evidence. Indeed, the Second Circuit’s
decision in Ruggiero expressly relies on its previous decision in Amorgianos, citing this earlier
decision to support the proposition that: “When an expert opinion is based on data, a methodology or
studies that are simply inadequate to support the conclusion reached, Daubert and Rule 702 mandate
the exclusion of that unreliable opinion testimony.” Ruggiero, 424 F.3d at 253 (quoting Amorgianos,
303 F.3d at 266). In other words, Dr. Ravekes’ testimony on specific causation cannot be admitted if
there is insufficient evidence in the record for Dr. Ravekes to conclude that Ms. El-Massri took Paxil
and, if so, how much and for how long, or, to put it in Rule 702’s terms, inadequate data “to support
the conclusion” that Paxil caused K.E.’s BAV. That certainly is the case here.
Dr. Ravekes employed differential diagnosis to rule in all potential causes of K.E.’s BAV and
then “rule[] out all other potential causes” besides Paxil. Ravekes Dep., Def.’s Mot. to Preclude, Ex.
8, ECF No. 90-5, 361:23-25 (“Q: After ruling out everything else, is it fair to say the only thing you
were left with was the Paxil usage? A: Correct.”). He acknowledges, however, that he “cannot rule
out a genetic/familial risk factor or predisposition to congenital heart disease.” Ravekes Rept., 12.
This concession alone undermines the notion that Dr. Ravekes was able to rule out every potential
cause but Paxil and exposes the inadequacy of this methodology in this case.
Dr. Ravekes’ analysis also failed to “rule out” factors including Ms. El-Massri’s experience
of several infections while pregnant. Def.’s Mot. to Preclude, 11, 39. Since both parties agree that
birth defects can be caused by a variety of factors and that the majority of defects have an unknown
cause, see Ravekes Report, 8 (“[a]pproximately 40% of birth defects have a known cause”), these
omissions further reveal the inadequacy of the differential diagnosis performed here
Just as importantly, Dr. Ravekes’ differential diagnosis fails to overcome the lack of evidence
of exposure to Paxil. Sufficient proof of exposure can be and, in this particular case, is critical to a
differential diagnosis. In Mancuso, the court reviewed the “generally accepted methodology for
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determining whether a person’s illness was caused by a specific toxin.” Mancuso v. Consol. Edison
Co., 967 F. Supp. 1437, 1445-46 (S.D.N.Y. 1997); accord Mancuso v. Consol. Edison Co., 56 F.
Supp. 2d 391, 399 (S.D.N.Y. 1999), aff’d in relevant part 216 F.3d 1072 (2d Cir. 2000). According
to Mancuso, the proper methodology in such situations is:
First, the level of exposure of plaintiff to the toxin in question must be determined;
second, from a review of the scientific literature, it must be established that the toxin
is capable of producing plaintiff's illness—called ‘general causation’—and the
dose/response relationship between the toxin and the illness—that is, the level of
exposure which will produce such an illness—must be ascertained; and third,
‘specific causation’ must be established by demonstrating the probability that the
toxin caused this particular plaintiff's illness, which involves weighing the possibility
of other causes of the illness—a so-called ‘differential diagnosis.’
Id. (citing Bernard D. Goldstein & Mary Sue Henifin, Reference Guide on Toxicology, in FED. JUD.
CTR., REFERENCE MANUAL ON SCIENTIFIC EVIDENCE, 663 (1st Ed. 1994)). The court in Mancuso
excluded the testimony of the plaintiff’s expert because he made “no serious effort to perform the
first step of the methodology by evaluating the dosage of the toxin plaintiffs have received.” Id. at
1499. Without establishing exposure, the court held, the expert’s differential diagnosis was merely
“circular reasoning.” Id. at 1450. As a result, it was “improper for an expert to presume that the
plaintiff ‘must have somehow been exposed to a high enough dose to exceed the threshold [necessary
to cause the illness], thereby justifying his initial diagnosis.’” Id. (citing O’Conner v.
Commonwealth Edison Co., 807 F. Supp. 1376, 1396 (C.D. Ill. 1992)); see also Zwillinger v.
Garfield Slope Hous. Corp., No. 94-4009, 1998 U.S. Dist. LEXIS 21107, at *59 (E.D.N.Y. Aug. 17,
1998) (excluding testimony of a doctor who had “no information about plaintiff’s level of exposure”
to the allegedly tortious product and had not reviewed plaintiff’s complete medical records, which
included evidence that she complained of similar injuries before being exposed to the product).
Without sufficient evidence of Ms. El-Massri’s exposure to paroxetine during the crucial first
trimester of pregnancy, Dr. Ravekes’ differential diagnosis is unreliable. “Courts are reluctant to
admit causation testimony based on a differential diagnosis where the proffered expert possesses only
29
weak circumstantial evidence that some exposure occurred and makes no effort to scientifically
evaluate or roughly estimate the degree of exposure or dosage.” Plourde, 190 F. Supp. 2d at 722. A
differential diagnosis therefore must offer a “reliable basis” for concluding that the allegedly tortious
product is “capable of causing” the injury in question, or—in other words—a “reliable ground upon
which [the product] may be ‘ruled in’” as a plausible cause. Ruggiero, 424 F.3d at n.5. In this case,
for Dr. Ravekes’ differential diagnosis to be relevant and reliable, it must be grounded in sufficient
evidence of K.E.’s prenatal exposure to Paxil. That evidence is absent from this record.
Of course, courts should be flexible about the type of evidence on which experts rely to
establish exposure or dosage levels, especially given the “liberal thrust” of the Federal Rules.
McCullock, 61 F.3d at 1042. In McCullock, the Court allowed an expert’s causation testimony that
relied on evidence that plaintiff was “in the breathing zone of the hot-melt glue fumes” during
plaintiff’s four years of employment and “that she and other employees could smell the unventilated
glue fumes, especially when the pot overheated.” Id. at 1045. Thus, expert testimony on toxic injuries
may be admissible where dosage or exposure levels have been roughly established through reliable
circumstantial evidence. See also Plourde, 190 F. Supp. 2d at 723 (excluding expert testimony on
causation because “in contrast to the medical doctor in McCullock, there is no evidence [that expert
doctor] based his opinion on an objective showing that Mr. Plourde was in an “exposure zone” for
any period of time”). In the Second Circuit, a district court “has broad discretion in determining
whether in a given case a differential diagnosis is enough by itself to prove causation.” Ruggiero v.
Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir. 2005). In this case, however, Dr. Ravekes’
differential diagnosis does not reliably assist with determining specific causation.
Birth defects such as BAVs are caused by a wide variety of factors, many of which are
unknown. Because only forty percent of birth defects have known causes, it would be hard for Dr.
Ravekes to “rule out” every potential alternative cause of K.E.’s BAV, even with a well-constructed
differential diagnosis. See Reference Manual, 618 (“for diseases for which the causes are largely
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unknown, such as most birth defects, a differential etiology is of little benefit”). Given this
difficulty, Dr. Ravekes’ differential diagnosis is unreliable. Sufficient evidence of Ms. El-Massri’s
exposure to Paroxetine is essential, particularly when Dr. Ravekes failed to assess several factors,
such as K.E.’s genetic history, that could have caused his BAV.
C. Conclusion
Without sufficient and reliable evidence that Ms. El-Massri took Paxil during her first
trimester, or, if she did, how much she took, Dr. Ravekes cannot offer reliable specific causation
testimony. There is simply “too great an analytical gap” between the studies Dr. Ravekes himself
relied on and Dr. Ravekes’ own conclusions. Amorgianos, 303 F.3d at 270. For the same reason—
because there was insufficient evidence of Ms. El-Massri’s exposure to Paxil, in terms of dosage and
duration—Dr. Ravekes does not follow an accepted methodology for assessing specific causation.
While differential diagnosis may be an acceptable methodology for specific causation in some cases,
it is unreliable in this one.
GSK’s motion to exclude the expert testimony of Dr. Ravekes [ECF No. 89] therefore is
GRANTED because of the inadmissibility of Dr. Ravekes’ testimony on specific causation. Dr.
Ravekes’ testimony concerning general causation would be admissible to the extent that he describes
the biological mechanisms by which Paxil could have caused K.E.’s heart defect. However, because
of the critical role that dosage and exposure play in determining causation, Dr. Ravekes’ opinion on
specific causation is inadmissible. As a result, his expert testimony must be excluded in its entirety.
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III. GSK’s Motion for Summary Judgment
GSK also moves for summary judgment. GSK first argues that without admissible expert
testimony about causation, Plaintiffs cannot create a genuine issue of material fact that would sustain
any of their claims. In the alternative, it argues that summary judgment is appropriate because
Plaintiffs filed this lawsuit after the expiration of the applicable statute of limitations. The Court
agrees that summary judgment is warranted for both reasons. Finally, the Court notes the absence of
a genuine issue of material fact regarding Count I, Count II, Count III, Count IV, Count V, Count
VII, Count VIII, and Count XIV of the short-form complaint. Accordingly, GSK’s motion is
GRANTED.
A. Standard of Review
In a motion for summary judgment, the burden is on the moving party to establish that no
genuine issues of material fact remain in dispute and that it is entitled to judgment as a matter of law.
Rule 56(a), Fed. R. Civ. P. A fact is “material” if it “might affect the outcome of the suit under the
governing law” and is “genuine” if “a reasonable jury could return a verdict for the nonmoving
party” based on it. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
When a motion for summary judgment is supported by documentary evidence and sworn
affidavits and demonstrates “the absence of a genuine issue of material fact,” the party opposing the
motion “must come forward with specific evidence demonstrating the existence of a genuine dispute
of material fact.” Robinson v. Concentra Health Servs., Inc., 781 F.3d 42, 44 (2d Cir. 2015)
(citations omitted). In doing so, the non-moving party may not merely rely on “conclusory
allegations or unsubstantiated speculation.” Id.
In reviewing the record, the court must “construe the evidence in the light most favorable to
the non-moving party and to draw all reasonable inferences in its favor.” Gary Friedrich Enters.,
L.L.C. v. Marvel Characters, Inc., 716 F.3d 302, 312 (2d Cir. 2013) (citations omitted). If there is
32
any evidence in the record from which a reasonable factual inference could be drawn in favor of the
opposing party on the issue on which summary judgment is sought, summary judgment is
inappropriate. See Sec. Ins. Co. of Hartford v. Old Dominion Freight Line Inc., 391 F.3d 77, 83 (2d
Cir. 2004); Anderson, 477 U.S. at 250 (summary judgment is proper only when “there can be but one
reasonable conclusion as to the verdict”).
B. Discussion
1. Causation
Defendant argues that the absence of viable expert testimony on the issue of causation is fatal
to Plaintiffs’ claims, because Plaintiffs must establish that Ms. El-Massri’s use of Paxil was the
proximate cause of K.E.’s BAV. The Court agrees.
Courts in Connecticut have recognized that “expert [causation] testimony is unnecessary in
cases where jurors are as capable of comprehending the primary facts and of drawing correct
conclusions from them as are witnesses possessed of special or peculiar training.” Wills, 379 F.3d at
46 (internal quotation marks omitted). But when a plaintiff’s theory of causation “would not be
obvious to the lay juror, expert evidence is often required to establish the causal connection between
the accident and some item of physical or mental injury.” Id. (internal citations omitted). Compare
DeBartolo v. Daimler Chrysler Corp., No. 10-030482725S, 2005 Conn. Super. LEXIS 3579, at *12
(Super. Ct. Dec. 22, 2005) (“[C]ourts have permitted product defects involving automobiles to be
presented to a jury in the absence of expert testimony where the fact of a defect is within the common
knowledge of ordinary consumers.”) with Zelle v. Bayer Healthcare, LLC, No. 08-094019435, 2012
Conn. Super. LEXIS 481, at *23 (Super. Ct. Feb. 16, 2012) (“A finding of a defect in the drug is not
within the common knowledge of an ordinary person.”); see also Wills v. Amerada Hess Corp., 379
F.3d 32, 46 (2d Cir. 2004) (“In a case such as this, where an injury has multiple potential etiologies,
expert testimony is necessary to establish causation.”).
33
In this case, admissible expert testimony on specific causation is necessary for all of
Plaintiffs’ claims to survive summary judgment. A reasonable jury would otherwise have no way to
conclude that Defendant’s drug—rather than K.E.’s genetic susceptibility to the disease, Ms. ElMassri’s medical history, or any other factor—caused K.E.’s birth defect. See Sanders v. Fireline,
Inc., 295 F. App’x 373, 374 (2d Cir. 2008) (“Given that Sanders’ personal injury claim turned on the
precise physical conditions in which ceramic cups fracture, the jury was not ‘as capable [as an expert
witness] of comprehending the primary facts and of drawing correct conclusions from them.’”)
(citing Salem v. United States Lines Co., 370 U.S. 31, 35 (1962)); see also DeVito v. Smithkline
Beecham Corp., No. 02-CV-0745 (NPM/DRH), 2004 U.S. Dist. LEXIS 27374, at *38 (N.D.N.Y.
Nov. 29, 2004) (“Because plaintiff's only causation evidence has been excluded, it necessarily
follows that [the defendant] is entitled to summary judgment in its favor.”); Zwillinger, 1998 U.S.
Dist. LEXIS 21107 (granting summary judgment in defendants’ favor after excluding doctor’s
testimony, which was plaintiffs only causation evidence).
While Plaintiffs are correct that tort law does not demand the unyielding certainty of
scientific research, proof as to cause is clearly required. In the absence of expert opinion on specific
causation, no reasonable fact finder could come to the conclusion that Paxil caused K.E.’s injury.
Summary judgment is appropriate on all of Plaintiffs’ claims.
2. Statute of Limitations
Even if the Court admitted Plaintiffs’ expert testimony, summary judgment would still be
proper because plaintiffs’ claims are time-barred. Defendant argues that Plaintiff’s cause of action
accrued when Ms. El-Massri learned of K.E.’s diagnosis, or at the very least, when she told the
pediatrician that she had taken Paxil while pregnant and testified that her “concerns” about Paxil had
started to formulate. Def.’s Mem. for Summ. J., ECF No. 88-1, 23. Plaintiffs respond that Ms. ElMassri did not have “constructive knowledge” of the link between Defendant and her son’s birth
34
defects until she contacted a law firm on July 27, 2011. Pl.’s Opp. Mem., 5. The Court agrees with
the Defendant.
Under Connecticut law, a product liability claim must be brought within “three years from
the date when the injury ... is first sustained or discovered or in the exercise of reasonable care should
have been discovered.” Conn. Gen. Stat. § 52-577a. The cause of action accrues “when a plaintiff
suffers actionable harm” or when the plaintiff “discovers or should discover, through the exercise of
reasonable care, that he or she has been injured and that the defendant’s conduct caused such injury.”
Gnazzo v. G.D. Searle & Co., 973 F.2d 136, 138-39 (2d Cir. 1992). In other words, the limitation
period accrues when “a plaintiff has knowledge of the essential elements of a cause of action,”
including the duty she was owed, the breach of that duty, and “a causal connection between that
breach and the resulting harm to the plaintiff.” Lagassey v. State, 268 Conn. 723, 748 (2004).
While the question of when a plaintiff discovered or should have discovered the actual harm
is normally reserved for the jury, the issue can be resolved as a matter of law when there is evidence
of a plaintiff’s concrete awareness of a causal connection between the defendant and the injury
suffered. Lagassey, 268 Conn. 723 at 739 (“[A]lthough our cases make clear that the point at which
a plaintiff discovered or in the exercise of reasonable care should have discovered an injury is
generally a question of fact, that issue has been resolved as a matter of law on some occasions.”).
The Connecticut Products Liability Act’s (“CPLA”) statute of limitations does not impose a
“duty to investigate” on potential plaintiffs, and the court should limit its inquiry to the “facts known
to the plaintiff at that time.” Taylor v. Winsted Mem’l Hosp., 262 Conn. 797, 809 (2003). In some
cases, expert advice from doctors, lawyers, or reporters will be necessary for a reasonable plaintiff to
be aware of her legal injury. In Lagassey, the Connecticut Supreme Court agreed that plaintiffs’
cause of action accrued only when she received an expert’s opinion explaining that the defendant
physician “may have been negligent.” Lagassey, 268 Conn. 723 at 751 (holding in the context of a
motion to dismiss that “we cannot conclude, as a matter of law, that the plaintiff in the exercise of
35
reasonable care should have discovered actionable harm sometime prior to obtaining [the expert’s]
opinion”); see also Taylor, 262 Conn. at 810 (denying summary judgment when “the plaintiff
testified, and the jury reasonably could have believed, that he was not aware of any causal connection
between the medical treatment he received by the hospital on March 10, 1993, and the injuries he
suffered from his subsequent stroke, until he read articles about the treatment of strokes in a
magazine.”).
However, when the record indicates that a plaintiff was aware of links between the defendant
and the injury she suffered, her cause of action has certainly accrued. Gnazzo, 973 F.2d at 138-39.
In Gnazzo, the Second Circuit approved of the district court’s conclusion that plaintiff should have
known of her cause of action when she learned that an IUD manufactured by the defendant had
caused her sterility-related injury. At that point, she had been having trouble becoming pregnant and
had testified that she “started hearing [and] reading about how damaging IUDs could be [and had]
figured that was [the] problem.” Id. Because of this testimony, the Court ruled that no genuine issue
of material fact existed regarding whether or not Gnazzo knew or should have known about the cause
of her injury at that point. Id.; see Barnes v. Schlein, 192 Conn. 732, 736-37 (1984) (plaintiff’s cause
of action accrued at the point when, according to her deposition, she “knew that something was
wrong with her leg” after a second medical consultation and also had “discuss[ed her legal injury] to
the point where it could be a suit”); see also Lagassey, 268 Conn. at n.14 (confirming that the trial
court in Barnes was correct in concluding that the case was time-barred because “the plaintiff
indicated in her deposition that she knew something was wrong with her leg in April, 1973, and had
decided to bring an action against her physician at that time.”).
The record here establishes that Ms. El-Massri was aware of her legal injury by the end of
June 2011. The record indicates that she was “having concerns” about whether Paxil had caused her
son’s birth defect as early as June 28, 2011, when she visited K.E.’s pediatrician, and was
“considering filing a lawsuit” at that time. N. El. Massri, Dep., 325: 9-13. Like the plaintiff in
36
Gnazzo, who had “figured that [the defendant’s product] was the problem,” Gnazzo, 973 F.2d at 13839, or the plaintiff in Barnes, who knew that “there could be a suit,” Barnes, 192 Conn. at 736-37,
Ms. El-Massri thought K.E.’s injury was related to her use of Paxil.
Furthermore, the record indicates that before she contacted a law firm on July 27, 2011, Ms.
El-Massri saw at least one advertisement connecting BAV to Paxil. Like the newspaper articles in
Taylor or the expert consultant in Lagassey, the advertisement represents an outside assessment of
Plaintiffs’ legal injury. Ms. El-Massri’s testimony about seeing the advertisement indicates that she
knew or should have known of her cause of action before July 27, 2011. Plaintiffs filed their lawsuit
on July 25, 2014, so this suit would be timely if their cause of action accrued any time after July 25,
2011. The exact date on which Ms. El-Massri first viewed the commercials is unclear. However,
even if Ms. El-Massri viewed the commercials only between July 25 and July 27, 2011, her claim
would still be time-barred. As discussed above, she was “having concerns” about Paxil as early as
June 28, 2011.
While there were many possible conclusions that a layperson could come to in Ms. ElMassri’s position, Ms. El-Massri’s own testimony indicates that she had started to conclude that
Paxil had caused her son’s birth defect before July 25, 2011. Indeed, she stated that she had concerns
about the effect of the drug in June of that year. Thus, we can say that Ms. El-Massri “knew or
should have known” of her claims before July 25, 2011. Gnazzo, 973 F.2d at138-39. The Court
already has determined that summary judgment is appropriate on Plaintiffs’ claims because she lacks
admissible evidence of causation, as discussed above. The Court notes that their claims are also
time-barred.
3. Other Claims
Even if Plaintiffs had admissible expert testimony for causation purposes, and even if their
claims were not otherwise time-barred, summary judgment nevertheless is warranted on Plaintiffs’
37
claims for breach of express warranty, breach of implied warranty, intentional infliction of emotional
distress, loss of consortium, CUTPA, and punitive damages.
a. Breach of Express Warranty Claim
Defendant argues that Plaintiffs’ breach of express warranty claim fails because GSK did not
make any express warranties regarding the safety of Paxil use during pregnancy. The Court agrees.
Under Connecticut law, “any affirmation of fact or promise made by the seller to the buyer
which relates to the goods and becomes part of the basis of the bargain creates an express warranty
that the goods shall conform to the affirmation or promise.” Conn. Gen. Stat. § 42a-2-313.
Generally, the fact-finder determines whether a particular statement from a manufacturer as an
“affirmation or promise” on which a breach of warranty claim can be based. See Vezina v. Nautilus
Pools, Inc., 27 Conn. App. 810, 816 (Conn. App. Ct. 1992) (“[T]he question of whether an express
warranty exists is one of fact.”).
In product liability cases concerning drugs, however, “a drug manufacturer’s representation
in advertising or a warning label that a product is safe or effective, or an advertisement or warning
label that does not adequately highlight a particular known or knowable risk does not create an
express warranty in the absence of a guarantee that the particular product is free from all harmful side
effects.” Fraser, 857 F. Supp. 2d at 257-58 (citing Basko v. Sterling Drug, Inc., 416 F.2d 417, 428
(2d Cir. 1969)) (although the issue of strict liability for defendant’s failure to warn plaintiff of the
risk of a drug was a jury question, plaintiff was not entitled to a jury instruction on express warranty
because defendant “did not represent either (1) that its drugs were free from all harmful side effects
or (2) that its drugs were absolutely harmless”) (applying Connecticut law).
In Fraser, this Court (Arterton, J.) granted summary judgment on plaintiff’s breach of
express warranty claim against defendant drug company Wyeth. Plaintiff claimed that the label for
Prempro stated that “most scientific studies showed [that Prempro produced] no increased risk of
breast cancer.” Id. at 257. Specifically, however, the label said that: “The effect of [the drug] on the
38
risk of breast cancer is unknown, although a moderately increased risk in those taking [the drug] has
been reported. Other studies have not shown this relationship.” Id. at 254 (quoting Prempro’s FDAApproved Label). Given this language, there was no basis for an express warranty because the
company had not promised no risk of breast cancer from taking the drug. Id. at 257-58. To the
contrary, Wyeth had disclosed some of the attendant risks of its consumption. Id.
In 2001, when Ms. El-Massri allegedly took Paxil, the product included a label stating that
“[p]atients should be advised to notify their physician if they become pregnant or intend to become
pregnant,” Def.’s L. R. 56 Stmt. ¶ 67 (citing May 1996 Paxil Prescribing Information, Ex. 26). It
further noted that Paxil was a “Category C” drug because “there are no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.” Id. at ¶ 69 (citing May 1996 Paxil Prescribing Information, Ex. 26). In
other words, rather than promise that the consumption of Paxil posed no risk to pregnant women,
GSK instead expressly stated that no such promise could be made.
Given this language, no reasonable jury could conclude that this statement was a “guarantee
that the particular product is free from all harmful side effects” or constituted an express warranty.
Fraser, 857 F. Supp. 2d at 257-58. Summary judgment therefore is appropriate on Plaintiffs’ express
warranty claim.
b. Breach of Implied Warranty Claim
GSK argues that summary judgment should be granted on Plaintiffs’ implied warranty of
merchantability claim because GSK did not imply that Paxil was fit for use by pregnant women. The
Court agrees.
Under Connecticut law, a product must be “fit for the ordinary purposes for which such
goods are used.” Conn. Gen. State. § 42a-2-314. See also Standard Structural Steel v. Bethlehem
Steel Corp., 597 F. Supp. 164, 187 (D. Conn. 1984). When determining the ordinary purpose of a
39
product, the Court’s inquiry focuses on the consumer’s expectations of the product when used in the
customary, usual and reasonably foreseeable manner. See Rosenthal v. Ford Motor Co., 462 F. Supp.
2d 296, 310 (D. Conn. 2006).
GSK argues that the “ordinary purpose” of Paxil was to treat depression and anxiety and that
it effectively served that purpose in Ms. El-Massri’s case. Def’s Mem., 26. While the Court does not
hold that an anti-depressant or other drug’s ordinary purpose is limited to its stated and FDAapproved use, here, GSK, through its labelling, expressly stated that Paxil’s ordinary purpose did not
include treating pregnant women. Because the drug’s label stated that “[p]atients should be advised
to notify their physician if they become pregnant or intend to become pregnant,” the ordinary
purpose of the drug would not include use by women during a pregnancy, as defined by a reasonable
consumer’s expectation.
Indeed, in similar cases, courts have understood the “ordinary purpose” of Paxil-like drugs to
be the treatment of depression and anxiety disorders. See, e.g. Ackermann v. Wyeth Pharms., 471 F.
Supp. 2d 739, 745 (E.D. Tex. 2006) (“There is no evidence that Effexor is not fit for the ordinary
purpose for which it is used, treating depression and general anxiety order. The gravamen of
Plaintiff’s complaint is that a drug which is normally fit for most patients reacts in a certain way with
a small group of patients. … The fact that drugs such as Effexor may cause different reactions in a
small group of patients is not tantamount to a holding that the drug is somehow inadequate.”)
Summary judgment therefore is appropriate on Plaintiffs’ breach of implied warranty claim.
c. Intentional Infliction of Emotional Distress Claim
Plaintiffs argue that GSK is liable for the emotional distress it caused to K.E. and his mother
by manufacturing and marketing Paxil, since it knew or should have known that this would cause
distress. GSK argues that Plaintiffs cannot satisfy the “very high threshold to establish their claim of
intentional infliction of emotional distress.” Def.’s Mem., 29. The Court agrees.
40
To sustain a claim for intentional infliction of emotional distress, a plaintiff must show “(1)
that defendant intended to inflict emotional distress or that defendant knew or should have known
that emotional distress was the likely result of its conduct; (2) that the conduct was extreme and
outrageous; (3) that the conduct was the cause of the plaintiff’s distress, and (4) that the emotional
distress sustained by the plaintiff was severe.” Stancuna v. Schaffer, 998 A.2d 1221, 1227 (Conn.
2010). “In assessing a claim for intentional infliction of emotional distress, the court performs a
gatekeeping function. In this capacity, the role of the court is to determine whether the allegations of
a complaint … set forth behaviors that a reasonable fact finder could find to be extreme or
outrageous.” Id. (internal quotation marks omitted).
In support of its motion for summary judgment on this claim, GSK argues that it “acted
diligently in reviewing adverse event reports, monitoring spontaneous data, evaluating the relevant
medical literature for Paxil and other SSRIs, and conducting reviews and assessments of adverse
event reports.” Def.’s Mem., 29. GSK also “conducted safety reviews for Paxil and submitted all
required information to FDA in regulatory submissions.” Id. Plaintiffs do not respond to GSK’s
motion for summary judgment on this claim. However, they generally assert that GSK “failed to
adequately disclose the risk of congenital heart defects associated with Paxil use to the medical
community,” which resulted in “willful, wanton and outrageous” behavior. Pl.’s Opp. Mem., 19-20
(citing Pl.’s Stmt. Of Disp. Facts, ¶¶ 5-8).
The disputed facts that Plaintiffs cite for this proposition—“Dear Healthcare Provider” letters
from 2005 and testimony from Mr. Stephen Hobbiger, GSK’s Global Labeling Committee Chairman,
regarding GSK’s position on Paxil in 1996—do not support this proposition. Pl.’s Stmt. Of Disp.
Facts at ¶ 7. Mr. Hobbiger’s testimony only represents that GSK’s position in 1996 was that Paxil
“should not be used during pregnancy … unless the potential benefit outweighs the possible risk.”
Pl.’s Stmt. of Disp. Facts, Hobbiger Dep., Ex. 8. The provider letters refer to “new studies” and cite
studies published in 2005, after K.E. was born. See Provider Letters, Pl.’s Stmt. of Disp. Facts, Ex.
41
6-7, ECF Nos. 107-2, 107-3. The letters thus do not support the notion that GSK was aware of
Paxil's alleged danger when Ms. El-Massri took the drug. As a result, Plaintiffs have not put forward
evidence that GSK withheld information about Paxil from the medical community or recklessly
avoided studying Paxil’s impact. Based on the evidence in this record, no jury could find that GSK
was “extreme” or “outrageous.”
Summary judgment therefore is appropriate on Plaintiffs’ intentional infliction of emotional
distress claim.
d. Loss of Consortium Claim
GSK argues that it is entitled to summary judgment on Plaintiffs’ claim for loss of
consortium of a child because Connecticut law does not recognize the claim. The Court agrees.
The majority of jurisdictions, including Connecticut, have held that “a parent may not
recover from a third-party tortfeasor, as an element of damages for injury to his child, for loss of the
child’s society and companionship attributable to the injury.” Cimino v. Yale Univ., 638 F. Supp.
952, 956 (D. Conn. 1986); see also Hyun v. S. Kent Sch., 166 F.R.D. 272, 275 (D. Conn. 1996) (“The
courts of this district have repeatedly stated that there is no right to relief for loss of filial or parental
consortium.”). Since Connecticut law does not recognize Plaintiffs’ loss of consortium claim,
summary judgment is appropriate on this claim.
e. Negligence per se & Negligent Pharmacovigilance
GSK moves for summary judgment on Plaintiffs claim of negligence per se, based on GSK’s
violation of a “statutory duty established by federal regulations,” and negligent pharmacovigilance.
Def.’s Mem., 30-31. It argues that Plaintiffs have not specifically identified a statute on which to
base their negligence per se claim and have not identified Connecticut precedent to substantiate their
claim of negligent pharmacovigilance. Id. The Court disagrees.
In Connecticut, a requirement imposed by statute may establish a duty of care that could
provide the underpinning for a tort claim. See Commercial Union Ins. V. Frank Perrotti & Sons,
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Inc., 20 Conn. App. 253, 260 (1989) (a municipal ordinance requiring separation of combustible
materials from other trash could supply the standard of care in negligent disposal of flammable fuel
claim). Violations of statutory standards may form the basis of a claim of negligence per se if the
plaintiff is within the class of persons whom the statute was intended to protect and if the harm was
of the type the enactment was intended to prevent. Gore v. People’s Savings Bank, 235 Conn. 360,
375-76 (1995). Contrary to Defendant’s contention, the statutory basis for a negligence per se claim
need not provide for a private right of action. See Walker v. Barrett, 1999 Conn. Super. LEXIS 3030,
1999 WL 1063189 (Conn. Super. 1999).
The Court recognizes that federal statutes and regulations have imposed certain duties on
drug manufacturers. These statutes suggest or require companies to engage in “pharmacovigilance”
by monitoring consumers’ side effects and adverse reactions to a drug. The Court construes
Plaintiffs’ claims of negligence per se and negligent pharmacovigilance as components of their claim
that GSK was negligent in manufacturing and marketing Paxil (Count VII). Summary judgment
would thus be inappropriate on these claims, if Plaintiffs’ expert testimony were admissible and their
claims were not time-barred.
f. Claims under CUTPA
GSK argues that summary judgment is appropriate on Plaintiffs’ CUTPA claims because of
the CPLA provides the exclusive remedy for Plaintiffs’ claims. The Court agrees.
Connecticut law does not allow a plaintiff to pursue damages pursuant to the Connecticut
Unfair Trade and Practices Act (“CUTPA”) for a claim governed by the CPLA. This is correct given
the CPLA’s exclusivity provision. See Conn. Gen. Stat. § 52-572n (a) (“[a] product liability claim as
provided in sections 52-240a, 52-240b, 52-572m to 52-572q, inclusive, and 52-577a may be asserted
and shall be in lieu of all other claims against product sellers, including actions of negligence, strict
liability and warranty, for harm caused by a product”); see also Hurley v. Heart Physicians, P.C.,
278 Conn. 305, 324-25 (2006) (dismissing a plaintiff’s CUTPA count in because trial court
43
determined that the plaintiff was “pursuing a claim for personal injuries … caused by the defendant’s
pacemaker” and holding that generally – “a product liability claim under the [liability] act is one that
seeks to recover damages for personal injuries … caused by the defective product.”); Gerrity v. R.J.
Reynolds Tobacco Co., 263 Conn. 120, 128 (2003) (“the language of the exclusivity provision makes
clear that the product liability act was intended to serve as the exclusive remedy for a party who
seeks recompense for those injuries caused by a product defect”). GSK therefore is entitled to
summary judgment on Plaintiffs’ CUTPA claim.
g. Punitive Damages
GSK argues that it is entitled to summary judgment on plaintiffs’ request for punitive
damages because it did not act with an “evil motive” or with “reckless indifference to the interests of
others.” Def.’s Mem., 35-36. Citing Due Process Clause jurisprudence, it further asserts that
plaintiffs cannot use punitive damage awards to punish conduct directed at non-parties or conduct
that post-dated the alleged injury. Def.’s Resp. Mot, ECF No. 113 (citing Phillip Morris USA v.
Williams, 549 U.S. 346,353-55 (2007)). The Court agrees that no reasonable jury would find
punitive damages to be appropriate in this case.
Connecticut statutes provide for punitive damages in product liability actions when the “harm
suffered was the result of the product seller’s reckless disregard for the safety of product users,
consumers or others who were injured by the product.” Conn. Gen. Stat. § 52-240b (2016). To show
the “recklessness” required for punitive damages, a plaintiff must point to defendant’s “highly
unreasonable conduct,” or an “extreme departure from ordinary case … more than thoughtlessness,
or inadvertence, or simply inattention.” Dubay v. Irish, 207 Conn. 518, 533 (1988). Courts have
granted summary judgment on claims for punitive damages when plaintiffs presented no evidence
that a defendant manufacturer “ceased to be concerned for the safety and health of [consumers].”
Dunn v. Zimmer, Inc., No. 3:00CV1306 (DJS), 2005 U.S. Dist. LEXIS 5345, at *32-33 (D. Conn.
Mar. 31, 2005). Similarly, courts have dismissed claims for punitive damages when plaintiff
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“fail[ed] to state in [their] allegations that the defendants were aware of the alleged defects and
continued to manufacture, sell and distribute the item despite such knowledge.” Andrews v. H.J.
Heinz Co., D.N. CV960153316S, 1997 Conn. Super. LEXIS 461, at *4 (Super. Ct. Feb. 25, 1997).
In several cases, courts have allowed punitive damages claims regarding GSK’s production
of Paxil to survive summary judgment. In these cases, though, the plaintiffs had produced evidence
that GSK had deliberately avoided studying the impact of Paxil on patients or disregarded studies of
Paxil’s risk. See Hayes v. SmithKline Beecham Corp., No. 07-CV-0682-CVE-TLW, 2009 U.S. Dist.
LEXIS 116081, at *19 (N.D. Okla. Dec. 14, 2009) (denying summary judgment on the plaintiffs’
punitive damages claims because the plaintiffs had “provided evidence from which a jury could find
that in 1993 and 1994, GSK deliberately avoided doing reproductive toxicology studies for Japanese
regulators because the studies could provide potentially damaging results for labeling in the United
States [and] that GSK wanted to make sure that [a particular] study would not look specifically at
Paxil”); Knipe v. Smithkline Beecham, 583 F. Supp. 2d 602, 640-41 (E.D. Pa. 2008) (denying
summary judgment on the punitive damages claim because the plaintiff had presented evidence,
including internal GSK documents, “showing that GSK knew of the risk of pediatric suicidality as of
1998” but had not changed its label or warned doctors of the risk). Unlike the plaintiffs in these
cases, Plaintiffs provide no evidence that GSK knew of the risks associated with Paxil, withheld
information about the risks associated with Paxil consumption, or had tried to prevent future Paxil
research at the time Ms. El-Massri allegedly consumed the drug. On the record before the Court, no
reasonable jury could conclude that GSK willfully disregarded Ms. El-Massri’s safety when
promoting and manufacturing Paxil.
Plaintiffs claim that GSK “was or should have been in possession of evidence demonstrating
that Paxil caused congenital birth defects … and continued to market the products by providing false
and misleading information with regard to safety,” and that it did so “willfully, intentionally and with
reckless disregard for the rights of plaintiffs and the public.” Long Form Compl., ¶¶ 112-114. In
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their response to GSK’s motion for summary judgment, Plaintiffs cite disputed facts to assert that
GSK “failed to adequately disclose the risk of congenital heart defects associated with Paxil use to
the medical community,” resulting in serious injury to women taking Paxil during pregnancy. Opp.
Mem., 19 (citing Pl.’s Stmt. of Disputed Facts, ¶¶ 5-8). GSK argues that it did not know about the
“potential association between Paxil and birth defects” prior to 2005. Further, GSK argues that it
accurately reflected what it did know—that there was inconclusive evidence that Paxil consumption
caused “pup death” in animal studies—in the drug’s FDA Prescribing Information sheet. Def.’s Mot.
Summ. J., 45.
Even when responding to GSK’s motion for summary judgment, Plaintiffs offer no evidence
to suggest that GSK was aware of the alleged deficiencies in their product at the time period in which
it allegedly sold the product to Ms. El-Massri. While Plaintiffs contend that GSK “knew of the
heightened risks of birth defects associated with Paxil use during pregnancy as far back as 1996,”
they present no non-conclusory evidence to support this conclusion. Pl.’s Opp. Mem., 17 (citing
Pl.’s Stmt. Of Disp. Facts, ¶¶ 5-8). While K.E. was born in 2001, the “Dear Healthcare Provider”
letter and e-mail that Plaintiffs cite for this proposition are all dated 2005 and refer to “new studies”
or studies published in 2005. Provider Letters, Pl.’s Stmt. of Disp. Facts, Ex. 6-7, ECF Nos. 107-2,
107-3. Plaintiffs also cite testimony from Mr. Stephen Hobbiger, GSK’s Global Labeling Committee
Chairman. Id. at ¶ 7. This testimony only represents that GSK’s position in 1996 was that Paxil
“should not be used during pregnancy … unless the potential benefit outweighs the possible risk.”
Pl.’s Stmt. Of Disp. Facts, Hobbiger Dep., Ex. 8. Plaintiffs provide no other evidence to support
their claims for punitive damages.
Plaintiffs thus do not offer any evidence that GSK disregarded or misled the public as to the
risk that Paxil was unsafe for pregnant women, or that it even knew of the risk that Paxil caused birth
defects at the time Ms. El-Massri was pregnant. Ordinarily, the finder of fact should determine
whether a defendant was reckless, but in this case there is no evidence supporting Plaintiffs’ claim
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for punitive damages. See Walters v. Howmedica Osteonics Corp., 676 F. Supp. 2d 44, 56 (D. Conn.
2009) (granting summary judgment when there was “no indication in the record whatsoever that [the
defendant] acted with reckless disregard [and the defendant had] developed trays that complied with
regulatory and customer requirements”); see also Gottlieb v. Cty. of Orange, 84 F.3d 511, 518 (2d
Cir. 1996) (in motion for summary judgment, “the opposing party is required to come forward with
materials envisioned by the Rule, setting forth specific facts showing that there is a genuine issue of
material fact to be tried. … The motion will not be defeated merely on the basis of conjecture or
surmise”).
For this reason, summary judgment is appropriate on Plaintiffs’ claim for punitive damages.
IV. Conclusion
In summary, GSK’s Motion to exclude the expert testimony of Dr. Ravekes [ECF No. 89] is
GRANTED. Given the absence of admissible expert testimony, summary judgment is appropriate on
all of Plaintiffs’ claims. Furthermore, all of Plaintiffs’ claims are time-barred. Finally, summary
judgment would be appropriate on several of Plaintiffs’ claims even if Plaintiffs could offer
admissible causation testimony and had brought their case within the applicable statute of limitations.
For these reasons, GSK’s Motion for Summary Judgment [ECF No. 88] is granted.
SO ORDERED at Bridgeport, Connecticut this 1st day of February, 2017.
/s/ Victor Bolden
VICTOR A. BOLDEN
UNITED STATES DISTRICT JUDGE
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