Gerber v. Hoffmann-La Roche Inc.

• Decision Date: 20 May 2005
• Docket Number: No. Civ.A. H-03-1886.,Civ.A. H-03-1886.
• Citation: 392 F.Supp.2d 907
• Parties: Matthew GERBER, Plaintiff, v. HOFFMANN-LA ROCHE INC., Defendant.
• Court: U.S. District Court — Southern District of Texas

Page 907

392 F.Supp.2d 907

Matthew GERBER, Plaintiff, v. HOFFMANN-LA ROCHE INC., Defendant.

No. Civ.A. H-03-1886.

United States District Court, S.D. Texas, Houston Division.

May 20, 2005.

Memorandum Denying Reconsideration July 1, 2005.

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John D. Sloan, Jr., Sloan Monsour PC, Longview, TX, Michael J. Ryan, Krupnick Campbell et al., Fort Lauderdale, FL, Milton Raymond Hatcher, II, Sloan Monsour et al., Longview, TX, Paul Landria Smith, Paul L. Smith & Associates, Austin, TX, for Plaintiff.

Kenneth J. Ferguson, Clark Thomas et al., Austin, TX, for Defendant.

MEMORANDUM AND ORDER

ATLAS, District Judge.

Pending before the Court in this products liability case is Defendant Hoffmann-La Roche's Motion for Summary Judgment [Doc. # 23] ("Defendant's Motion"). Plaintiff Matthew Gerber has filed a Response to Defendant's Motion for Summary Judgment [Doc. # 30] ("Plaintiff s Response"). Defendant has filed a Reply in Support of its Motion for Summary Judgment and an Objection to Plaintiff's Evidence [Doc. # 31].¹ Having considered the parties' submissions, all matters of record, and applicable legal authorities, the Court concludes that Defendant's Motion for Summary Judgment should be granted.

I. FACTUAL AND PROCEDURAL BACKGROUND

Shirley Gerber visited dermatologist Michael Coverman, M.D., in November of 1983 seeking acne treatment. He diagnosed her with "inflammatory cystic acne with much early scarring and post-inflammatory hyperpigmentation." Because she had already unsuccessfully tried other acne medications and was "very discouraged," Dr. Coverman prescribed Accutane (isotretinoin or 13-cis retinoic acid).² Accutane is regarded as a uniquely effective drug for the treatment of severe recalcitrant cystic acne.³ Since 1982, Hoffmann-La Roche ("Roche") has marketed Accutane to dermatologists for treatment of this condition. The drug is a potent teratogen⁴ a capable of causing malformation in embryos. Dr. Coverman "stress[ed] [to Shirley Gerber] she must not get pregnant while on this drug." Shirley Gerber explained that she utilized an intrauterine contraceptive device ("IUD").⁵

Shirley Gerber's IUD failed, and she conceived a child while taking Accutane. Plaintiff Matthew Gerber was born in November of 1984 with numerous and severe birth defects, including scoliosis, an absence of the right kidney, an imperforate anus, clubbed feet, Spengel's deformity of the right shoulder, absent ribs on his right side, and a short, webbed neck.⁶ These birth defects are permanent in nature. As a result of these defects, Mr. Gerber has had to undergo numerous examinations, treatments, and surgical procedures to treat his deformities, and has suffered great pain and mental anguish.⁷

Mr. Gerber brings this product liability suit against Hoffmann-La Roche for damages allegedly caused by Roche's design, manufacturing, and marketing of Accutane. He alleges that Roche failed in the version of the Accutane package insert that Shirley Gerber's physician saw⁸ to adequately warn dermatologists of the dangers involved with use of Accutane in women of childbearing potential. Plaintiff specifically focuses on the absence of sufficient detail about precautions for safe use of the drug in this subset of patients. In particular, Mr. Gerber alleges that Roche failed to inform doctors in 1983 that: any method of birth control can fail; IUD's fail one to two percent of the time and are expelled from a woman's uterus in five to seven percent of patients (often without the patient's knowledge); females should demonstrate multiple negative pregnancy tests before receiving Accutane; females should be on two forms of birth control concurrent with Accutane treatment; and females should receive reproductive counseling prior to treatment.⁹ Roche asserts that under the "learned intermediary" doctrine, its warning was adequate as a matter of law because it warned of the specific side effect complained of; that any inadequacy in warning was not a producing cause of Mr. Gerber's injury; and that, in any event, Plaintiff cannot recover damages for "wrongful life." On Plaintiff's other claims, Roche argues that there is no evidence that Accutane is defective in design, and there is no evidence that the Accutane at issue was defectively manufactured.

II. LEGAL STANDARDS FOR SUMMARY JUDGMENT

Rule 56 of the Federal Rules of Civil Procedure mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a sufficient showing of the existence of an element essential to the party's case, and on which that party will bear the burden at trial. Baton Rouge Oil and Chem. Workers Union v. ExxonMobil Corp., 289 F.3d 373, 375 (5th Cir.2002) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)).

In deciding a motion for summary judgment, the Court must determine whether "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." FED. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Calbillo v. Cavender Oldsmobile, Inc., 288 F.3d 721, 725 (5th Cir.2002). An issue is material if its resolution could affect the outcome of the action. Terrebonne Parish Sch. Bd. v. Columbia Gulf Transmission Co., 290 F.3d 303, 310 (5th Cir.2002) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). In deciding whether a fact issue has been created, the facts and the inferences to be drawn from them must be reviewed in the light most favorable to the nonmoving party. Hotard v. State Farm Fire & Cas. Co., 286 F.3d 814, 817 (5th Cir.2002). However, factual controversies are resolved in favor of the nonmovant "only when there is an actual controversy — that is, when both parties have submitted evidence of contradictory facts." Olabisiomotosho v. City of Houston, 185 F.3d 521, 525 (5th Cir.1999).

The party moving for summary judgment has the initial burden of demonstrating the absence of a material fact issue with respect to those issues on which the movant bears the burden of proof at trial. Smith v. Brenoettsy, 158 F.3d 908, 911 (5th Cir.1998). The movant meets this initial burden by showing that the "evidence in the record would not permit the nonmovant to carry its burden of proof at trial." Id. If the movant meets this burden, the nonmovant must go beyond the pleadings and designate specific facts showing that there is a genuine issue for trial. Littlefield v. Forney Indep. Sch. Dist., 268 F.3d 275, 282 (5th Cir.2001) (quoting Tubacex, Inc. v. M/V Risan, 45 F.3d 951, 954 (5th Cir.1995)). A dispute over a material fact is genuine if the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Id. (quoting Smith v. Brenoettsy, 158 F.3d 908, 911 (5th Cir. 1998)); see also Quorum Health Resources, L.L.C. v. Maverick County Hosp. District, 308 F.3d 451, 458 (5th Cir.2002).

The nonmovant's burden is not met by mere reliance on the allegations or denials in the nonmovant's pleadings. See Morris v. Covan World Wide Moving, Inc., 144 F.3d 377, 380 (5th Cir.1998); Diamond Offshore Co. v. A & B Builders, Inc., 302 F.3d 531, 545 n. 13 (5th Cir.2002) (noting that "unsworn pleadings do not constitute proper summary judgment evidence," quoting Johnston v. City of Houston, 14 F.3d 1056, 1060 (5th Cir.1994)). Likewise, "unsubstantiated or conclusory assertions that a fact issue exists" do not meet this burden. Id. Instead, the nonmoving party must present specific facts which show "the existence of a `genuine' issue concerning every essential component of its case." Id. In the absence of any proof, the court will not assume that the nonmovant could or would prove the necessary facts. McCallum Highlands, Ltd. v. Washington Capital Dus, Inc., 66 F.3d 89, 92 (5th Cir.1995), revised on other grounds upon denial of reh'g, 70 F.3d 26 (5th Cir.1995); Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (5th Cir.1994) (citing Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 888, 110 S.Ct. 3177, 111 L.Ed.2d 695 (1990)).

III. ANALYSIS

A. Strict Products Liability

In Texas, strict product liability claims are generally analyzed under § 402A of the Restatement (Second) of Torts, which states in pertinent part:

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm caused to the ultimate user, consumer, or to his progeny, if

(a) the seller is engaged in the business of selling such a product;

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

RESTATEMENT (SECOND) OF TORTS § 402A; Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 334-35 (Tex.1998); Brumley v. Pfizer, Inc., 149 F.Supp.2d 305, 309 (S.D.Tex.2001) (Jack, J.). In order to recover under the theory of strict liability a Plaintiff must establish (1) the defective and unreasonably dangerous condition of the defendant's product; and (2) a causal connection between such condition and the plaintiff's injuries or damages. Lucas v. Texas Indus., Inc., 696 S.W.2d 372, 377 (Tex.1984); Brumley, 149 F.Supp.2d at 309. More specifically, in order to prove a claim of strict liability, the plaintiff must demonstrate that a defect in the defendant's product was the "producing cause" of his or her injuries. See, e.g., Dico Tire, Inc. v. Cisneros, 953 S.W.2d 776, 783 (Tex. App. — Corpus Christi 1997, writ denied).¹⁰ A producing cause is "an efficient, exciting, contributing cause which, in a natural sequence, produced the injuries complained of." Id. A product may be defective if it is (1)...