Silva v. Smithkline

Opinion

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1 IN THE COURT OF APPEALS OF THE STATE OF NEW MEXICO

2 ANTHONY AND CHENG SILVA, 3 Individually and as Personal Representatives 4 of THE ESTATE OF SUSAN SILVA, 5 DECEASED; and ANTHONY SILVA JR., 6 and JINLEN SILVA, AS SURVIVING SIBLINGS 7 OF SUSAN SILVA,

8 Plaintiffs-Appellants, 9 v. NO. 31,276

10 SMITHKLINE BEECHAM 11 CORPORATION, d/b/a 12 GLAXOSMITHKLINE,

13 Defendant-Appellee, 14 and

15 LOVELACE HEALTH SYSTEM, 16 INC.; and DR. ISABEL LOPEZ-COLBERG,

17 Defendants.

18 APPEAL FROM THE DISTRICT COURT OF VALENCIA COUNTY 19 William A. Sanchez, District Judge

20 Bowles & Crow 21 Jason Bowles 22 B.J. Crow 23 Monnica L. Garcia

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1 Albuquerque, NM

2 for Appellants 3 Modrall, Sperling, Roehl, Harris, & Sisk, P.A. 4 Alex C. Walker 5 Albuquerque, NM 6 King & Spalding, LLP 7 Stephen B. Devereaux 8 Robert B. Friedman 9 Heather M. Howard 10 Atlanta, GA

11 Domenici Law Firm, P.A. 12 Peter V. Domenici, Jr. 13 Charles N. Lakins 14 L. Hollingsworth 15 Albuquerque, NM

16 for Appellees

17 MEMORANDUM OPINION 18 GARCIA, Judge. 19 After a user of a generic prescription medication known as paroxetine 20 committed suicide, her relatives brought a wrongful death products liability action 21 against the manufacturer of the name-brand form of paroxetine that is registered with 22 the Food and Drug Administration (FDA) as Paxil. The district court granted 23 summary judgment in favor of the manufacturer of Paxil, and the patient’s relatives 24 filed this appeal. We affirm. 25 BACKGROUND

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1 Paxil and its generic equivalent (Generic Paroxetine) are selective serotonin 2 reuptake inhibitors designed to treat depression and anxiety. Smithkline Beecham 3 Corporation, d/b/a, Glaxosmithkline (GSK) manufactures Paxil and Paxil CR. Teva 4 Pharmaceuticals, USA (Teva) manufactures Generic Paroxetine. 5 On May 13, 2004, Dr. Isabel Lopez-Colberg prescribed Paxil or Generic 6 Paroxetine to Susan Silva (Patient). On April 13, 2006, Patient committed suicide. 7 Throughout the course of her treatment, Patient’s prescription was filled with both 8 Paxil and Generic Paroxetine. At the time of her death, however, Patient’s 9 prescription had been filled solely with Teva’s Generic Paroxetine for more than a 10 year. 11 Following Patient’s death, Patient’s relatives (Plaintiffs) filed a product liability 12 suit for wrongful death alleging, among other things, that GSK provided inadequate 13 warnings about the risks of Paxil and Generic Paroxetine. GSK moved for summary 14 judgment on Plaintiffs’ claims, arguing that Patient was not exposed to Paxil at the 15 time of her death. The district court granted GSK’s motion for summary judgment, 16 determined that GSK could not be held liable for injuries related to Patient’s 17 consumption of Generic Paroxetine, and dismissed all claims against GSK. Plaintiffs 18 timely appealed the district court’s grant of summary judgment in favor of GSK. 19 STANDARD OF REVIEW 20 We review de novo a district court’s grant of summary judgment, construing

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1 the evidence most favorably to the non-moving party. City of Albuquerque v. BPLW 2 Architects & Eng’rs, Inc., 2009-NMCA-081, ¶ 7, 146 N.M. 717, 213 P.3d 1146; 3 Headley v. Morgan Mgmt. Corp., 2005-NMCA-045, ¶ 5, 137 N.M. 339, 110 P.3d 4 1076. “Summary judgment is appropriate where there are no genuine issues of 5 material fact and the movant is entitled to judgment as a matter of law.” Self v. United 6 Parcel Serv., Inc., 1998-NMSC-046, ¶ 6, 126 N.M. 396, 970 P.2d 582. “If the facts 7 are undisputed and only a legal interpretation of the facts remains, summary judgment 8 is the appropriate remedy.” Bd. of Cnty. Comm’rs v. Risk Mgmt. Div., 120 N.M. 178, 9 179, 899 P.2d 1132, 1133 (1995). “Summary judgment should not be granted when 10 material issues of fact remain or when the facts are insufficiently developed for 11 determination of the central issues involved.” Vieira v. Estate of Cantu, 12 1997-NMCA-042, ¶ 17, 123 N.M. 342, 940 P.2d 190. We conclude that there are no 13 material facts in dispute and we can decide this case as a matter of law. 14 “A defendant seeking summary judgment . . . bears the initial burden of 15 negating at least one of the essential elements upon which the plaintiff's claims are 16 grounded.” S. Farm Bureau Cas. Co. v. Hiner, 2005-NMCA-104, ¶ 9, 138 N.M. 154, 17 117 P.3d 960 (internal quotation marks and citation omitted). “Once such a showing 18 is made, the burden shifts to the plaintiff to come forward with admissible evidence 19 to establish each required element of the claim.” Id. 20 DISCUSSION

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1 Plaintiffs claim that even though Patient was taking Generic Paroxetine—a drug 2 not manufactured by GSK—for the fifteen months prior to her death, GSK could 3 nevertheless be deemed liable for her death because Patient became addicted to GSK’s 4 Paxil CR when she took it from September 2004 to December 2004. As a result, 5 Plaintiffs claim that there are issues of fact as to whether Patient’s exposure to Paxil 6 CR contributed to her death. 7 Plaintiffs failed to meet their burden to defeat summary judgment on the basis 8 of this argument. GSK presented evidence in support of summary judgment, 9 including the testimony of Plaintiffs’ own expert that all molecules of GSK- 10 manufactured Paxil had been eliminated from Patient’s blood at the time she 11 committed suicide and that “the Paxil brand name” did not play any role in Patient’s 12 death. Plaintiffs failed to present any evidence to refute GSK’s initial burden by 13 connecting a claimed addiction in late 2004 to Patient’s suicide in April 2006. 14 Therefore, the district court properly granted summary judgment on this basis. 15 Plaintiffs also contend that the district court erroneously granted summary 16 judgment on their claim that GSK provided inadequate warnings about the risks of 17 Paxil and Generic Paroxetine. Plaintiffs ask this Court to hold that the duty owed by 18 a name-brand prescription drug manufacturer when providing product warnings 19 extends not only to consumers of its own product, but also to those patients whose 20 doctors foreseeably rely on the name-brand manufacturer’s product information when

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1 prescribing a medication, even if the prescription is filled with the generic version of 2 the prescribed drug. The crux of Plaintiffs’ claims against GSK is that Patient’s use 3 of Generic Paroxetine was a cause of her death and could have been avoided had GSK 4 disseminated adequate warnings about the true suicidal risk associated with the use 5 of Paxil and its generic equivalent. GSK responds that the absence of an adequate 6 warning that Paxil can cause suicide is immaterial because, even if such a warning had 7 been provided by GSK, the undisputed evidence establishes that such a warning 8 would not have changed Dr. Lopez-Colberg’s decision to prescribe Paxil or its generic 9 equivalent to Patient. As such, GSK contends that the district court correctly granted 10 summary judgment because Plaintiffs cannot establish the causation element of their 11 warning claims under either a strict liability theory or a negligence theory. See, e.g., 12 Hines v. St. Joseph’s Hosp., 86 N.M. 763, 765, 527 P.2d 1075, 1077 (Ct. App. 1974) 13 (“Ordinarily the manufacturer’s duty to warn of the dangers of prescription drugs is 14 to the attending physician, not the patient. The physician, in turn, has a duty to 15 disclose dangers to the patient.” (citations omitted)). 16 A plaintiff asserting causes of action based on a failure to warn must prove that, 17 (1) no warning was provided or the warning was inadequate; and (2) the inadequacy 18 or absence of the warning caused the plaintiff’s injury. See Richards v. Upjohn Co., 19 95 N.M. 675, 678, 625 P.2d 1192, 1195 (Ct. App. 1980) (“[Causation] is a factual 20 issue, unless all facts regarding causation are undisputed or, as a matter of law, there

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1 is an independent intervening cause.”). To satisfy the burden of proving causation in 2 the present case, Plaintiffs must show that adequate warnings would have altered Dr. 3 Lopez-Colberg’s decision to treat Patient with Paxil or its generic equivalent. See id. 4 (precluding summary judgment in favor of a defendant drug company in a suit arising 5 out of personal injuries suffered by the plaintiff which allegedly resulted from medical 6 treatment by a medication the defendant manufactured, “unless, as a matter of law, 7 (1) [the defendant]’s warnings are adequate, or (2) [the prescribing doctor]’s failure 8 to consult the appropriate literature before prescribing the [medication] constitutes an 9 independent intervening cause”). As such, if it is factually established that Dr. Lopez- 10 Colberg would have prescribed Paxil or Generic Paroxetine to Patient even if GSK 11 had provided a more adequate warning about the risk of suicide, then Plaintiffs cannot 12 prove the causation element of its claims of inadequate warning and GSK is entitled 13 to summary judgment. 14 Given the undisputed facts of this case—regardless of whether the warnings by 15 GSK were adequate or inadequate—Plaintiffs failed to present evidence to rebut 16 GSK’s prima facie showing that the warnings about Paxil’s risks did not contribute 17 in any way to Patient’s death. While Plaintiffs argue that it is common for prescribing 18 doctors to rely upon a name-brand manufacturer’s information when prescribing 19 generic equivalents, they have provided no evidence to rebut the prima facie showing 20 that Dr. Lopez-Colberg did not rely on any representations or warnings provided by

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1 GSK when she prescribed Paxil or its generic equivalent to Patient. Indeed, all the 2 prima facie evidence was to the contrary. See, e.g., id. at 679-81, 625 P.2d at 1197-99 3 (concluding summary judgment was improper where a fact issue remained unresolved 4 regarding whether the treating physician’s negligent use of a drug remained 5 reasonably foreseeable even if the potentially inadequate warning had been read prior 6 to the improper use of the drug.). During her deposition, Dr. Lopez-Colberg could not 7 recall receiving any literature from GSK regarding Paxil or ever having read the Paxil 8 prescribing information. Instead, Dr. Lopez-Colberg indicated that she most likely 9 selected Paxil or its generic equivalent for Patient simply because it was on Patient’s 10 formulary. 11 Moreover, the evidence established Dr. Lopez-Colberg was actually aware of 12 the risks that Plaintiffs claimed GSK should have made as part of its warning to 13 physicians. Dr. Lopez-Colberg testified in her deposition that she was aware that both 14 Paxil and Generic Paroxetine were accompanied by a “black box” warning for the risk 15 of suicidal thinking and behavior in some patients at the time she prescribed Paxil or 16 its generic equivalent to Patient. Dr. Lopez-Colberg was also aware of the existence 17 of a longstanding concern that antidepressants may play a role in the worsening of 18 depression and the emergence of suicidality in certain patients. However, in Patient’s 19 case, Dr. Lopez-Colberg believed that the medical benefits of the drug outweighed the 20 risks. In addition, although the FDA required label changes to the warnings for Paxil

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1 and its generic equivalent after Dr. Lopez-Colberg’s prescription decision, she 2 explained in her deposition that “[n]othing in the FDA required label changes would 3 affect [her] decision to prescribe Paxil today” to patients who present in the same way 4 that Patient did when Dr. Lopez-Colberg was treating her. Whatever may be said 5 about Dr. Lopez-Colberg’s treatment policies and medical decisions, her unequivocal 6 position to use Paxil or its generic equivalent to treat Patient irrespective of the 7 adequacy of GSK’s warning label information regarding the risk of suicide precludes 8 Plaintiffs’ inadequate warning claims against GSK. 9 The record establishes that GSK’s warnings were not a causation factor in Dr. 10 Lopez-Colberg’s decision to treat Patient with Paxil or its generic equivalent. 11 Plaintiffs have failed to provide proof of causation under the theories of liability 12 against GSK that are set forth in their complaint. See Lent v. Emp’t Sec. Comm’n, 99 13 N.M. 407, 410-11, 658 P.2d 1134, 1137-38 (Ct. App. 1982) (recognizing that once 14 movants make a prima facie showing of entitlement to summary judgment, the party 15 opposing the motion has the burden of showing there was an issue defeating summary 16 judgment). Because Plaintiffs have failed to present evidence that Dr. Lopez-Colberg 17 would have changed her treatment decision when she prescribed Paxil or its generic 18 equivalent to Patient had a more adequate suicide warning been provided, we 19 conclude that the district court did not err when it granted summary judgment in favor 20 of GSK. See Glaser v. LeBus, 2012-NMSC-012, ¶ 12, 276 P.3d 959; Maralex Res.,

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1 Inc. v. Gilbreath, 2003-NMSC-023, ¶ 13, 134 N.M. 308, 76 P.3d 626 (“[A]n appellate 2 court will affirm the district court if it is right for any reason and if affirmance is not 3 unfair to the appellant.” (internal quotation marks and citation omitted)). It is, 4 therefore, unnecessary in this case to address Plaintiffs’ arguments regarding the 5 adequacy of GSK’s product warnings. 6 Finally, Plaintiffs asserted in their reply brief that the summary judgment 7 decision by the district court did not consider their other liability claims, specifically 8 the remaining claims of negligence and fraud. Although Plaintiffs’ brief in chief 9 generally identifies numerous causes of action set forth in the original complaint, no 10 argument or other authority was provided to raise any issue regarding the scope of the 11 summary judgment ruling by the district court. A party is not allowed to raise new 12 issues for the first time in its reply brief. Alb. Bernalillo Co. Water Utility Authority 13 v. NMPRC, 2010-NMSC-013, ¶ 59, 148 N.M. 21, 229 P.3d 494 (“It is well established 14 that [our Supreme Court] will not address issues ‘raised for the first time in the reply 15 brief.’” (citation omitted)). Under Rule 12-213(C) NMRA, the reply brief “shall reply 16 only to arguments or authorities presented in the answer brief.” Because the scope of 17 the district court’s summary judgment ruling was neither raised as an issue in the brief 18 in chief nor presented for review in the answer brief, it will not be addressed any 19 further by this Court. See In re Estate of Duran, 2007-NMCA-068, ¶ 23, 141 N.M. 20 793, 161 P.3d 290 (noting that this Court will not consider new issues raised for the

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1 first time in a reply brief). 2 CONCLUSION 3 For the foregoing reasons, we affirm the judgment of the district court. 4 IT IS SO ORDERED.

5 ______________________________ 6 TIMOTHY L. GARCIA, Judge

7 WE CONCUR:

8 _________________________ 9 CYNTHIA A. FRY, Judge

10 _________________________ 11 LINDA M. VANZI, Judge