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West v. Janssen Pharmaceuticals, Inc.

United States District Court, M.D. Alabama, Northern Division

April 4, 2018

PATRICIA WEST, as legal guardian of LAQUINTON K. WEST, Plaintiff,



         In this pharmaceutical products liability case, Plaintiff Patricia West, as legal guardian of LaQuinton K. West, [1] sues Defendant Janssen Pharmaceuticals, Inc., [2] alleging her son's ingestion of Risperdal and generic risperidone caused her son to develop gynecomastia, an abnormal development of breasts in males. Pending before the court are the Motion for Summary Judgment by Janssen (Doc. 184), Plaintiff's Motion to Exclude Certain Testimony by Janet Arrowsmith, M.D., (Doc. 175), Plaintiff's Motion to Exclude Certain Testimony by Elias G. Chalhub, M.D. (Doc. 177), Defendant's Motion to Preclude Expert Testimony by Michael D. Freeman, MedDr, MPH, FAAFS (Doc. 186), Defendant's Motion to Preclude Expert Testimony of Elizabeth Z. Naftalis, M.D. (Doc. 188), and Defendant's Motion to Preclude Expert Testimony of Laura M. Plunkett, PhD, DABT (Doc. 190). The parties filed sealed and unsealed joint exhibits in support, see Doc. 206, and have had the opportunity to fully brief the motions. See Docs. 176, 178, 185, 187, 189, 191, 192-205.[3] The court requested additional briefing on the Eleventh Circuit's recent opinion in Small v. Amgen, Inc., et al., No. 17-11440, 2018 WL 501354 (11th Cir. Jan. 22, 2018). (Docs. 207-09). For the reasons that follow, it is recommended that the Motion for Summary Judgment by Janssen (Doc. 184) be granted and the Daubert motions (Docs. 175, 177, 186, 188, 190) be denied as moot.


         Janssen Pharmaceuticals, Inc.[4] (“Janssen”) removed the case to this court pursuant to 28 U.S.C. § 1332 on the basis of diversity of citizenship and an amount in controversy in excess of seventy-five thousand dollars.[5] (Doc. 1). Plaintiff dismissed the individual Defendants, some of whom were non-diverse. (Doc. 13). The only remaining Defendant is Janssen Pharmaceuticals, Inc. The parties do not contest personal jurisdiction or venue, and the court finds sufficient information of record to support both. See 28 U.S.C. § 1391. On January 5, 2017, the above-styled matter was referred to the undersigned for recommendation on all pretrial matters. (Doc. 62); see also 28 U.S.C. § 636(b); Rule 72, Fed. R. Civ. P.; United States v. Raddatz, 447 U.S. 667 (1980); Jeffrey S. v. State Bd. of Educ. of State of Ga., 896 F.2d 507 (11th Cir. 1990).


         “The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). In ruling on a motion for summary judgment, the Court construes the facts and all reasonable inferences therefrom in the light most favorable to the nonmoving party. Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000). However, when faced with a “properly supported motion for summary judgment, [the nonmoving party] must come forward with specific factual evidence, presenting more than mere allegations.” Gargiulo v. G.M. Sales, Inc., 131 F.3d 995, 999 (11th Cir. 1997).

         Summary judgment is mandated “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). “Summary judgment may be granted if the non-moving party's evidence is merely colorable or is not significantly probative.” Sawyer v. Southwest Airlines Co., 243 F.Supp.2d 1257, 1262 (D. Kan. 2003) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250-51 (1986)).

         “[A]t the summary judgment stage the judge's function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Anderson, 477 U.S. at 249. “Essentially, the inquiry is ‘whether the evidence presents a sufficient disagreement to require submission to the jury or whether it is so one-sided that one party must prevail as a matter of law.'” Sawyer, 243 F.Supp.2d at 1263 (quoting Anderson, 477 U.S. at 251- 52).


         Patricia K. West (“Plaintiff”) is the mother and legal guardian for her son, LaQuinton K. West (“West”). (Doc. 1-13, ¶ 4). Plaintiff filed this lawsuit against Janssen related to the design, manufacture, sale, marketing, advertising, promotion, and distribution of Risperdal and generic risperidone.[6] Id., ¶ 1. She alleges that West ingested Risperdal[7] and suffered injuries as a result, including a condition called gynecomastia, [8] abnormal development of breasts in males. Id., ¶ 2- 3. Plaintiff asserts claims against Janssen for failure to warn under the Alabama Extended Manufacturer's Liability Doctrine (“AEMLD”) (Count I), negligence (Count II), wanton misconduct (Count III), failure to warn (Count IV), breach of implied warranty of merchantability (Count V), fraud (Count VIII), and negligent misrepresentation (Count IX).[9] (Doc. 1-13). The facts, viewed in a light most favorable to Plaintiff as the non-moving party, are as follows:

         A. West's Risperdal and Risperidone Use

         West was born January 19, 1983. (Doc. 206-82 at 35:2). He was 32 years old when this lawsuit was filed in 2015. He was diagnosed with autism at an early age. (Doc. 206-82 at 34:18- 24).[10] Plaintiff testified her son was first prescribed Risperdal by Dr. Love at the Vaughn Clinic.[11](Doc. 206-82 at 47:14-48:14). West first saw Dr. Jan Mathisen in 1995 when he was 12 years old; Dr. Mathisen did not prescribe Risperdal at that time. (Doc. 206-83 at 81:7-16). He first prescribed Risperdal for West in October 2000, which was approximately three months prior to West turning 18 years old. Id. at 81:7-16; 90:15-92:23. In the October 11, 2000 visit, Plaintiff indicated to Dr. Mathisen that her son's behavior was getting worse and he was not sleeping well. Id. at 90:15-91:5. Dr. Mathisen prescribed Risperdal for West's autism and obsessive compulsiveness. Id. at 90:15-92:23. West was 17 years old.[12] Id. Dr. Mathisen testified that West was physically fully developed, at Tanner Stage V, at that time. (Doc. 206-103 at 367:3- 369:9). In West's follow-up visit with Dr. Mathisen on April 26, 2001, it was noted that West had no side effects from the Risperdal and “Mom is very pleased with his progress”; the plan was to continue him on Risperdal and to follow up in six months. (Docs. 206-112 at 2, 206-83 at 94:7- 95:2). Dr. Mathisen saw West in October 2001, and he was doing quite well with no reported new problems; Risperdal was continued. Id. at 96:12-21. When West was next seen in April 2002, his mother reported concerns with her son's increasing libido. Id. at 98:2-10. Because he knew that Risperdal can reduce libido at certain doses, Dr. Mathisen increased West's Risperdal prescription to three milligrams per day. Id. at 98:11-100:9. The doctor had a conversation with Plaintiff about alternatively using first-generation antipsychotics, Haldol or Prolixin, but the Plaintiff did not want to pursue those medications because of their side effects. Id. at 100:10-20. There are no records of visits with Dr. Mathisen between the April 10, 2002 visit and January 19, 2006. Id. at 101. There are pharmacy records of Risperdal prescription refills, however, during this period between visits.[13] See (Docs. 206-83 at 106-20, 206-84 at 4). The last time Dr. Mathisen saw West was January 19, 2006. (Doc. 206-83 at 101:19-103:9). At the January 2006 visit, West was 23 years old, and it was reported he wasn't taking his medications and he had an increased libido. Id. at 101-02. Dr. Mathisen offered the option of taking intermittent doses of Risperdal in a melt version. Id. at 102:15-23. Although January 2006 was the last office visit, the last risperidone prescription where Mathisen was the prescribing doctor was filled by West in April 2007. Id. at 120:6-11.

         Dr. Daniel Mejer first saw West on July 6, 2006. (Doc. 206-86 at 31:20-25). West was present with his parents who expressed concerns of insomnia and exhibitionist behavior. Id. at 33. Current medication included Risperdal, but the notes reflect he was non-adherent to his medication. Id. at 33-34. Dr. Mejer did not recall West's autism diagnosis. Id. at 36. Dr. Mejer next saw West November 16, 2006, and he was doing well behaviorally and denied adverse events. Id. at 39:23-40:23. In his next visit of February 1, 2007, West was doing well with no reports of sexually inappropriate behavior. Id. at 42:19-20. On May 3, 2007, West was reportedly tired in the mornings and not taking his medication at school. In response, Dr. Mejer changed the time for his medication administration. Id. at 43-44. In his next visit of July 5, 2007, his weight was at 176 and he still had some exhibitionist behavior, albeit less frequent. Id. at 45. In December 2007, his weight was 174 and in March 2008 his weight was 165. Id. at 45-46. Dr. Mejer ordered labs to check for a metabolic issue which is a known side effect of second-generation antipsychotics. Id. at 50. In the May 2008 visit, his weight was stable at 165, there was no concern with his medication, but his symptoms worsened with non-adherence. Id. at 51:19-52:9. Up to this point in Dr. Mejer's treatment of West, he observed that West did better when compliant with his medication, and that West did not experience side effects from Risperdal. Id. at 58:11-23, 60:8- 16. Dr. Mejer prescribed Risperdal and generic risperidone for West starting in July 2006 and continuing into October 2015. (Docs. 206-86 at 97:10-16; 206-85 at 6-13). Dr. David Schaffer took over West's care for a period starting in September 2008. Id. at 54.

         Dr. Shaffer saw West from approximately September 2008 to June 2011. (Doc. 206-87 at 31:21-32:1). West was physiologically an adult the entire time he was treated by Dr. Schaffer. Id. at 82:9-83:17. Notes from the September 4, 2008 visit, show West's weight was 168 pounds, he was having problems with inappropriate sexual behavior, and part of his problem was due to noncompliance with his medication. Id. at 76:12-16. Dr. Schaffer continued West on the Risperdal that he was previously prescribed. Id. at 76:17-78:2. He was next seen by Dr. Schaffer on December 4, 2008, his behavior had improved, with room for further improvement, and there were no side effects of the medication. Id. at 92:9-15. He was continued on Risperdal. Dr. Schaffer saw West again on March 5 and then June 4, 2009. Id. at 95-96. Overall, he was doing well, and he was continued on the Risperdal M. Id. West was next seen January 7, 2010. Id. at 101. His behavior was stable, and his prescription for Risperdal M was renewed. Id. In his July 1, 2010 visit, West reported he was fine. Id. at 102. Dr. Schaffer noted a diagnosis of ADHD and prescribed Adderal, in addition to the Risperdal. Id. at 102-03. In his January 6, 2011 visit, West's parents requested his Risperdal dosage be increased to help with his walking outside at nighttime. Id. at 109. From September 2008 until January 2011, West's weight went from 168 to 164 pounds. Id. at 110:6-111:7. During his time treating West, Dr. Schaffer did not note any side effects of the Risperdal, nor did the parents report any. Id. at 110-112. It was Dr. Schaffer's opinion that the benefits of Risperdal outweighed any side effects or negative effects. Id. at 113:20-22.

         Pharmacy records show West was prescribed generic risperidone not manufactured by Janssen from October 2012 through October 2015. (Docs. 206-85 at 6-8; 93-2 at 2-11). Dr. Bernard Hale saw West January 15, 2016 for a physical and prescription refill. (Doc. 206-88 at 24:9-13). West weighed 185 pounds on that date. Id. at 70. There is no mention of gynecomastia in Dr. Hale's notes. Id. at 76. Pharmacy records show West was prescribed risperidone by Dr. Hale and nurse practitioner Jodie Shedd in early 2016 after this lawsuit was filed. (Doc. 206-85 at 13-14). Additionally, Plaintiff testified in July 2016 that West was still taking generic risperidone at that time. (Doc. 206-82 at 78:21-79:1).

         Plaintiff testified the first time she observed her son's symptom of swelling of the chest was in July 2013. (Doc. 206-82 at 184:16-20). Dr. Chigozie Obiaka diagnosed West with gynecomastia on September 19, 2013, at the age of thirty.[14] (Docs. 206-93 at 3-4; 206-59). Plaintiff filed a declaration stating she would not have allowed West to take Risperdal if Dr. Mathisen had advised her that Risperdal could cause gynecomastia. (Doc. 206-59). It is undisputed that Risperdal improved West's behavior and provided a benefit. (Doc. 206-82 at 135-36, 151- 52, 155-56, 192).

         B. 1993 and 2006 Risperdal Labels

         The 1993 Risperdal label contained the following information in the “precautions” section:

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. … Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients.

(Doc. 209-90 at 3). The 1993 label additionally noted that gynecomastia had been reported in pre-marketing clinical trials:

Other Events Observed During the Pre-marketing Evaluation of RISPERDAL
Endocrine Disorders: Rare:[15] gynecomastia, male breast pain, antidiuretic hormone disorder.

(Doc. 206-90 at 6). The above language from the 1993 Risperdal label continued to be contained in the Risperdal labels until October 2006. See Docs. 206-45-206-58, 206-90. During these years, as it relates to pediatric use, the Risperdal label stated that “Safety and effectiveness in children have not been established.” See id.

         In 1996, Janssen added a section to the label concerning adverse events since market introduction which were temporally (but not necessarily causally) related to Risperdal. Up until October 2006, the section never included a reference to gynecomastia being an adverse event. See Docs. 206-45-206-5.

         The October 2006 Risperdal label added and deleted certain language as it relates to hyperprolactinemia. Specifically, the reference to the “clinical significance of elevated serum prolactin levels is unknown for most patients” was deleted in the October 2006 version. Compare Doc. 206-45 at 4 with Doc. 206-90 at 3. The revised language contained in the “precautions” section stated:

Hyperprolactinemia As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. … Galactorrhea, amenorrhea, gynecomastia and impotence have been reported in patients receiving prolactin-elevating compounds.

(Doc. 206-90 at 4). The October 2006 Risperdal label included the following language regarding pediatric use and the risk of gynecomastia for children/adolescents:

The efficacy and safety of RISPERDAL in the treatment of irritability associated with autistic disorder were established in two 8-week, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years. …
Hyperprolactinemia, Growth, and Sexual Maturation Risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults.
In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients.

(Doc. 206-90 at 5).

         C. Janssen Studies and Knowledge of Risks Prior to 2006 Label Change

         In December 1994, Janssen conducted a Risperdal taskforce examining the strengths and weaknesses of Risperdal versus competitors' drugs. (Doc. 206-121). High prolactin increase was listed as a Risperdal weakness, id. at 8, compared to Sertindole which had a strength of no prolactin increase, id. at 6, Seroquel had low prolactin increase, id. at 5, and Olanzapine had limited prolactin increase, id. at 4. In July 1997, Janssen conducted a “Risperdal National Advisory Board” meeting in which Janssen recognized Ziprasidone's “prolactin increase is less than observed with Risperdal, ” and “prolactin increase does produce related-side effects regardless of what Integrated Safety Base data shows.” (Doc. 206-122 at 3). In August 1997, Janssen prepared a 1998 Business Plan recognizing that Olanzapine, Quetiapine, and Sertindole had “low prolactin, ” and that “prolactin elevation” was a weakness for Risperdal. (Doc. 206-123 at 3-4). In December 1998, Janssen presented a comparison of risperidone and olanzapine to the American College of Neuropsychopharmacology in which it was acknowledged that gynecomastia is an adverse event “definitely causally related to serum prolactin.” (Doc. 206-125 at 2-3). Janssen conducted a study between 1996 and 2000 comparing risperidone and haloperidol in adult patients. (Doc. 206-126). The results of the study issued in a July 2003 report demonstrated prolactin-related adverse events were seen in a higher number of risperidone subjects than haloperidol subjects. Id. at 3.

         From November 1997 until May 1998, Janssen conducted a study comparing Risperdal and olanzapine in adults aged 18 to 64. (Doc. 206-129). The results of the study published in June 2000 revealed gynecomastia and lactation nonpuerperal were adverse events attributable to prolactin disorder and that prolactin-related adverse events occurred in four risperidone subjects and in two olanzapine subjects. Id. at 6. In September 1999, Janssen reported on a study comparing risperidone and olanzapine which demonstrated a hyperprolactinemia rate of 7.1% for risperidone users compared to 0.0% for olanzapine subjects. (Doc. 206-130 at 7).

         From May 1997 until October 1998, Janssen conducted a study of risperidone use in children aged 5 to 12 years. (Doc. 206-127). The November 2000 report on the study showed a 12.7% rate for hyperprolactinemia in the children treated with risperidone. Id. at 3. In a risperidone study conducted September 18, 1997 until July 1, 1999 in children aged 5 to 12 years, Janssen reported in November 2000 that the study revealed an 11.3% rate for hyperprolactinemia in the children and adolescents treated with risperidone.[16] (Doc. 206-128 at 2-5). In a September 2003 report, Janssen admitted that “[e]levated prolactin plasma levels can directly induce galactorrhea and gynecomastia, ” and in long-term phase III trials, 3.7 % of males reported gynecomastia. (Doc. 206-131 at 3).

         In a 2003 article titled Prolactin Levels During Long-Term Risperidone Treatment in Children and Adolescents, see Doc. 206-133, the authors noted “[n]o correlation was found between SHAP [side effects hypothetically attributable to prolactin] and prolactin levels, even when male gynecomastia during puberty was included.” Id. at 8. Plaintiff has proffered communications between the authors and Janssen representatives, prior trial testimony of the authors, and drafts of the manuscript to demonstrate Janssen was aware of a statistically significant relationship at usage for 8 to 12 weeks between SHAP and prolactin levels, which directly contradicts the article's statement of no correlation. (Doc. 199 at 21-22). A white paper from Janssen Medical Affairs, LLC, dated August 2004 and titled Prolactin: From Mechanisms to Sequelae, stated: “Current evidence suggests that risperidone leads increases in prolactin levels when other atypicals have comparative weak to neutral effects on prolactin.” (Doc. 206-83 at 183).

         D. Knowledge of Prescribing Physicians

         1. Dr. Mathisen

         Dr. Mathisen started prescribing antipsychotics early in his practice in approximately 1988. (Doc. 206-83 at 66:5-15). He prescribed first-generation antipsychotics such as Haldol and Mellaril. Id. In the 1996-1997 time frame, he began prescribing Risperdal, a second-generation antipsychotic, to his patients. Id. at 68. This was considered an off-label[17] use because an indication for Risperdal in autistic children and adolescents was not approved until 2006. Id. at 69:7-12. He was aware that hyperprolactinemia was a side effect of the first-generation antipsychotics and because Risperdal was a drug that similarly blocked the dopamine receptor, “it made sense that it would have a similar response, that it would cause some elevation of prolactin.” Id. at 72:17-73:7. His understanding, however, was that there were no specific long-term issues. Id. at 73:7-10. He was aware that prolactin elevation can cause side effects of galactorhhea, breast enlargement, and osteoporosis. Id.

         As of October 2006, Dr. Mathisen had treated over one thousand patients with Risperdal without any patient experiencing gynecomastia as a side effect. (Doc. 206-103 at 517:18-518:7). If he had seen something unusual, he would have spent more time looking at the package insert regarding it. Id. at 518:7-13. Dr. Mathisen was aware that gynecomastia was a potential side effect of prolactin-elevating compounds independent of what was contained in the label.

Q. And with respect to the information in the label, without a doubt it was there; and had you read it, you would have seen it, and you could have taken it into account in your prescribing decisions, correct? …
A. That's true.

Id. at 518:18-519:3

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