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K.E. v. GlaxoSmithKline LLC

United States District Court, D. Connecticut

February 1, 2017

K.E., a Minor by his Parent and Natural Guardian NICHOLE EL-MASSRI and NICHOLE EL-MASSRI, Individually, Plaintiffs,



         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.

         I. Relevant Factual Background[1]

         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.

         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 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 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”).

         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 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.

         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. 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 ¶¶ 27-28.

         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. 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.

         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

         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.

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. 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 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.

         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 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 ...

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