Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
| Decision Date | 30 September 2008 |
| Docket Number | Civil Action No. 06-3024. |
| Parties | Marion L. KNIPE, Individually and as Administratrix and Administratrix Ad Prosequendum of the Estate of Harold Stanley Jake Garrison, Deceased, and Harold L. Garrison, Jr., Individually, Plaintiffs, v. SMITHKLINE BEECHAM d/b/a GlaxoSmithKline, Defendant. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
Bijan Esfandiari, Frances M. Phares, George W. Murgatroyd, III, Kate E. Gillespie, Baum Hedlund Aristei & Goldman PC, Los Angeles, CA, Cara Luther, Baum Hedlund Aristei Goldman & Menzies PC, Washington, DC, for Plaintiffs.
Andrew Thomas Bayman, Franklin P. Brannen, Jr., Heather M. Howard, Robert B. Friedman, S. Samuel Griffin, Todd P. Davis, King and Spalding LLP, Atlanta, GA, Cindy K. Bennes, Peter D. Braun, Robert E. Glanville, Thomas S. Wiswall, Phillips Lytle LLP, Buffalo, NY, Mark S. Brown, King & Spalding, Washington, DC, Joseph E. O'Neil, Hing, Wilson, Adler & Cheng, P.C., Melissa R. Margulies, Lavin O'Neil Ricci Cedrone & Disipio, Philadelphia, PA, for Defendant.
Currently pending before the Court are (1) Defendant GlaxoSmithKline's Motion for Summary Judgment on Plaintiffs' Causes of Action, (2) the Response of Plaintiffs Harold L. Garrison, Jr., individually, and Marion Knipe, individually and as administratrix and administratrix ad prosequendum of the Estate of Harold Stanley Jake Garrison, and (3) Defendant's Reply Brief. In addition, the Court jointly considers Plaintiffs' Motion to Strike Evidence Submitted by GSK in Support of its Motion for Summary Judgment (Causes of Action) and Defendant's Response thereto.
This motion is the second of its kind in this case. The litigation commenced on July 10, 2006, when Plaintiffs sued Defendant for the wrongful death of sixteen-year old Harold Stanley Jake Garrison ("Jake" or "Jake Garrison"), who committed suicide after taking Paxil, an antidepressant medication manufactured and sold by GlaxoSmithKline ("GSK"). Plaintiffs' claims allege that GSK breached its state law duty to warn of the increased risk of suicide in pediatric users of the drug. Defendant originally moved for summary judgment on the grounds that Plaintiffs' state tort claims were preempted by federal law, i.e. the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., and its implementing regulations. On August 28, 2008, the Court denied that motion in its entirety. Defendant again seeks summary judgment, this time alleging that each of Plaintiffs' causes of action fails as a matter of law. For the following reasons, the Court grants the motion in part and denies it in part.
In February 2001, deceased Plaintiff Jake Garrison was referred to dermatologist Booth Durham, M.D. for treatment of his acne. ( Originally, Dr. Durham treated Jake with Accutane. (Id. at 15:2-16.) In light of the drug's labeling, the doctor informed Jake and his mother that the drug could cause suicidal behavior, and required them to sign a consent form. The Accutane course of treatment was completed in August or September 2001. (Durham Dep. 21:13-22:2.)
On January 10, 2002, Jake, who was fifteen years old at the time, returned to Dr. Durham. (Id. at 22:3-23:12.) Jake had been complaining of nausea and redness on his face, and had been refusing to go to school. (Knipe Dep. 110:8-21; 132:4-133:6.) At the time, however, Dr. Durham observed no signs of suicidal ideation. (Durham Dep. 52:23-53:7.) As a result of Jake's self-consciousness, Dr. Durham diagnosed Jake with body dysmorphic disorder,2 for which he prescribed a fifteen-day supply of Paxil. (Id. at 23:12-25:21.) The dosage was to increase to twenty milligrams after two weeks. (Id. at 25:16-25:21.) This was not the first time Dr. Durham had prescribed Paxil for a patient. (Id. at 27:1-27:9.) Upon prescribing Paxil to Jake, Dr. Durham claims to have told Marion Knipe, Jake's mother, that body dysmorphic disorder could worsen depression, cause further withdrawal, inhibit sleeping, increase hostile behavior, and lead to suicidal ideation. (Id. at 25:6-26:25.) Ms. Knipe testified that she could not recall Dr. Durham saying anything about suicide or suicidal ideation, particularly with respect to Jake's use of Paxil. (Knipe Dep. 125:5-19, 134:18-135:11.)
Jake refilled a thirty-day prescription for Paxil twenty milligrams, on January 27, 2002. (Defendant's Statement of Undisputed Facts on Causes of Action Motion ("DSUF Causes of Action") ¶ 31, Ex. L.) During Jake's February 7, 2002, follow up visit, Dr. Durham remarked that Jake was tolerating Paxil well, was not having any side effects, and "[felt] good about himself." (Durham Dep. 41:18-25; DSUF Causes of Action ¶ 24, Ex. M.). He was to continue Paxil twenty milligrams daily. (DSUF Causes of Action, ¶ 36, Ex. M.) Jake refilled another thirty-day supply for Paxil twenty milligrams on April 8, 2002. (Id. ¶ 38, Exs. J, L.) For reasons unknown to Plaintiff Knipe, Jake stopped taking Paxil sometime in April or May. (Id. ¶ 38, Ex. O, Daneen Spitaletto Dep. ("Spitaletto Dep.") 90:2-7, Jan 10, 2008; Knipe Dep. 146:2-7:18.) Jake next returned to Dr. Durham on August 21, 2002, at which time the doctor noted that Jake's acne was starting to flair and that Jake had "not needed" Paxil for a few months. (Durham Dep. 32:19-25.) Dr. Durham remarked that Jake seemed fine that day and had no notation about the redness that seemed to be the original basis of the body dysmorphic disorder. (Id. at 35:16-36:3.)
On September 11, 2002, the first day of Jake's junior year of high school, Jake vomited at school. (DSUF Causes of Action ¶ 45, Ex. Q; Knipe Dep. at 159:11-160:4.) According to investigative reports, Jake had told his mother that kids were teasing him due to his face turning red.3 (DSUF Causes of Action ¶ 46, Exs. Q and R, Lona Ecker Dep. ("Ecker Dep.") 33:4-21, Apr. 1, 2008.) Jake refilled another Paxil twenty milligram prescription that day, without contacting Dr. Durham, and took the medicine for three days. (DSUF Causes of Action ¶ 47-48, Ex. J; Durham Dep. 34:18-21.) On September 14, 2002, Jake committed suicide by gunshot. (DSUF Causes of Action ¶ 49.)
At the time of the prescriptions and refills described above, the label for Paxil contained the following statement in the "PRECAUTIONS" section:
Suicide: The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Precautions for Paxil should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. (Pls' Ex. 35 at 1610.) The 2002 label also included, in a section entitled "Other Events Observed During the Premarketing Evaluation of Paxil" (under the subheading "Nervous System"), the adverse reaction of "emotional lability," which was identified as a "frequent event." (Id. at 1614.) Under the section entitled "Pediatric Use," the label stated, "Safety and effectiveness in the pediatric population have not been established." (Id. at 1611.)
Dr. Durham knew that Paxil had not been approved by the Food and Drug Administration ("FDA") for use by pediatric patients at the time he prescribed it to Jake, but nonetheless gave it to him (Durham Dep. 37:24-38:14.) As a result of the FDA's addition of the black box warning on pediatric use, however, Dr. Durham no longer prescribes Paxil for pediatric patients since, according to his understanding, "it may give them enough energy to actually commit suicide." (Id. at 57:16-57:23.)
Dr. Durham testified that he had seen an advertisement for Paxil or Paxil CR in journals, but not on television. (Id. at 75:9-13.) He had never, however, seen any brochures or patient information that was left in his department or office from GSK pertaining to Paxil, nor had he ever met with a representative from GSK regarding Paxil. (Id. at 75:18-76:16.) Nonetheless, Dr. Durham explained that he reads the Physician's Desk Reference ("PDR") several times a week to obtain information about medications. (Id. at 72:10-73:12.) In addition, his other sources of information for his prescribing practices include journals, conferences, tapes, and lectures. (Id. at 73:13-18.) He is also aware of Medical Letters, wherein manufacturers announce their changes in medications. (Id. at 73:19-25.) Although Marion Knipe never saw advertisements for Paxil (Knipe Dep. 30:13-15), Jake's father, Harold Garrison had seen "quite a lot" of television commercials for Paxil prior to Jake taking Paxil. (Garrison Dep. 15:17-17:5.)
Paxil is generally classified as a selective serotonin reuptake inhibitor ("SSRI"), currently approved on a prescription basis only for the treatment of depression, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder and premenstrual dysphoric disorder in adult patients. (Defendant's Statement of Undisputed Facts for Federal Preemption Motion ("DSUF Preemption"), Ex. A, Arning Decl. ("Arning Decl.") ¶ 5.) On November 20, 1989, SmithKline Beecham Pharmaceuticals ("SB")5 filed a new drug application ("NDA") for paroxetine ("Paxil") seeking FDA approval for the treatment of depression in adults. (Arning Decl. ¶ 19.) In support of this application, SB submitted data to the FDA,...
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