United States District Court, D. Connecticut
K.E., a Minor by his Parent and Natural Guardian NICHOLE EL-MASSRI and NICHOLE EL-MASSRI, Individually, Plaintiffs,
GLAXOSMITHKLINE LLC, formerly SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, Defendant.
RULING ON DEFENDANT'S MOTIONS TO EXCLUDE EXPERT
TESTIMONY AND FOR SUMMARY JUDGMENT
A. BOLDEN, UNITED STATES DISTRICT JUDGE
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
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].
reasons that follow, both motions are GRANTED.
Relevant Factual Background
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.
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).
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.
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.
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.
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 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,
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 first-trimester
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”).
Ms. El-Massri's Alleged Consumption of Paxil
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.
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 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:
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:
Doctors' Testimony and Medical Records of Alleged Paxil
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.
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.
El-Massri's doctors also fail to provide much evidence
regarding her alleged consumption of Paxil.
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. El-Massri 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.
El-Massri 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 ¶¶
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. El-Massri'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. El-Massri 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.
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.
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?”).
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.
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
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.
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.
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.
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. 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.
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?
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 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.
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:
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
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.
The Present Motions
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.
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
GSK's Motion to Exclude the Testimony of 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 medical
history. Id. He concluded that Paxil was a
“significant contributing factor” to K.E.'s
heart defect. Id. at 12.
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