Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 1 of 14 PageID #: versus CIVIL ACTION NO. 1:03-CV-1367 MEMORANDUM AND ORDER

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1 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 1 of 14 PageID #: UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS JUDY ROMERO, Plaintiff, versus CIVIL ACTION NO. 1:03-CV-1367 WYETH PHARMACEUTICALS, INC., WYETH, INC., and WYETH LLC, Defendants. MEMORANDUM AND ORDER Pending before the court is Defendant Wyeth LLC s ( Wyeth ) Motion for Summary Judgment Regarding Plaintiff s Remaining Claims (#171). Wyeth argues that it is entitled to judgment as a matter of law on Plaintiff Judy Romero s ( Romero ) design defect claim, as well as all of her other causes of action, which Wyeth claims are premised on a failure to warn theory. Romero opposes Wyeth s motion, asserting that her design defect and failure to warn claims remain viable. Having considered the pending motion, the submissions of the parties, the pleadings, and the applicable law, the court is of the opinion that Wyeth s motion should be granted in part and denied in part. I. Background The parties are well acquainted with the facts of this case, and there is no need to repeat them here. Suffice it to say, shortly before trial, Wyeth indicated that it intended to file additional briefing arguing that certain of Romero s claims premised on a theory of failure to warn should be dismissed in light of the Texas Supreme Court s opinion in Centocor, Inc. v. Hamilton, S.W.3d, 2012 WL (Tex. June 8, 2012) ( Centocor II ), which was released after

2 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 2 of 14 PageID #: the motions deadline in this case. The court ordered Wyeth to file the instant motion addressing those claims as well as the effect of comment k to the Restatement (Second) of Torts on Romero s design defect claim in light of of the Texas Civil Practice & Remedies Code. Wyeth argues that nearly all of Romero s causes of action are based on an alleged failure to warn and, thus, are barred by Texas Civil Practice & Remedies Code , as well as Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), and Centocor II. Additionally, Wyeth avers that summary judgment is appropriate on Romero s design defect claim because comment k to the Restatement (Second) of Torts Section 402A bars such causes of action in matters involving prescription drugs. Romero responds that: (1) does not apply to her claims; (2) even if did apply, she has rebutted the presumption of non-liability for failure to warn with evidence that Wyeth promoted its drugs for off-label uses; (3) in the event the presumption does apply, her claims nonetheless are viable; and (4) her design defect claim is not barred. II. Analysis A. Failure to Warn Section Texas law contains a statutory presumption that a drug manufacturer is not liable for failure to warn if the warnings or information that accompanied the product in its distribution were those approved by the Federal Drug Administration ( FDA ).... TEX. CIV. PRAC. & REM. CODE (a)(1); Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767, 774 (S.D. Tex. 2008), aff d, 321 F. App x 350 (5th Cir. 2009). This presumption may be rebutted by evidence that: (1) the 1 The court granted in part and denied in part Wyeth s first motion for summary judgment in its May 30, 2012, memorandum and order. 2

3 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 3 of 14 PageID #: defendant... withheld from or misrepresented to the [FDA] required information that was material and relevant to the performance of the product and was causally related to the claimant s injury (the fraud on the FDA exception) or (2) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the FDA, and the claimant used the product as recommended, promoted, or advertised, resulting in his injury (the 2 overpromotion exception). TEX. CIV. PRAC. & REM. CODE (b)(1), (3). It is undisputed that the FDA approved the warnings associated with the hormone replacement therapy ( HRT ) drugs at issue in this lawsuit. In its prior motion for summary judgment, Wyeth argued that bars Romero s failure to warn claim because the FDA has made no finding of fraud as required by Lofton. See Lofton, 672 F.3d at 380. The court agreed, granting judgment as a matter of law in Wyeth s favor on this issue. As a matter of clarification, the court s previous summary judgment order adjudicated Romero s strict products liability failure to warn claim only, rather than her other causes of action that are premised on a failure to warn theory, as Wyeth failed to indicate the specific claims on which it was seeking summary judgment. Wyeth now asserts that the court s prior ruling should extend to Romero s remaining misrepresentation, fraud, and deceit; negligence; negligent misrepresentation; gross negligence; and Texas Deceptive Trade Practices Act ( DTPA ) causes of action. In response, Romero contends that is inapplicable because the effective date of the statute was September 1, 2003, three days after her suit was originally filed. This argument is unavailing. Section was enacted as part of Article 5 of House Bill 4 in Act of June 2, 2003, 78th Leg. R.S., ch 204, 5.02, 2003 Tex. Gen. Laws 847, 860 (2003). The bill 2 Several other exceptions also exist, although they are not relevant to the case at bar. 3

4 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 4 of 14 PageID #: specifically recognizes that while its effective date is September 1, 2003, the provisions contained in Article 5, including , apply to an action filed on or after July 1, Id (c), 2003 Tex. Gen. Laws at ; Satterfield v. Crown Cork & Seal Co., 268 S.W.3d 190, 210 n.20 (Tex. App. Austin 2008, no pet.). Accordingly, is applicable in this instance, and this court has already found that Romero is unable to avail herself of either of the aforementioned exceptions. 3 Regarding Wyeth s contention that extends to Romero s other warning-based claims, the court agrees. The statute expressly applies to products liability actions alleging failure to warn, whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories. TEX. CIV. PRAC. & REM. CODE (2), (a). In short, [i]f [a] claim is based upon [a product s] labeling, its omissions, or inaccuracies, it falls under this purview of the... Texas Civil Practices and Remedies Code provision[]. Del Valle v. Qualitest Pharms. Inc., No. B , 2012 WL , at *2 (S.D. Tex. June 22, 2012) (recognizing that Texas law groups all inadequate warning causes of action together regardless of how they are pleaded ); see also Murthy v. Abbott Labs., 847 F. Supp. 2d 958, 967 (S.D. Tex. 2012) (applying Texas s statutory presumption of non-liability for failure to warn to plaintiff s breach of warranty, strict liability, and negligence claims); cf. Centocor II, 2012 WL , at *22-23 (stating that where 3 Romero argues in her response that she has proffered evidence regarding s overpromotion exception. This contention was addressed and rejected in the court s May 30, 2012, memorandum and order and will not be revisited here. Moreover, Romero is reminded that the June 1, 2012, order she repeatedly cites in her briefing regarding her physicians reliance on Wyeth s marketing materials was superseded by the court s July 26, 2012, order, which prohibited Romero from reasserting the arguments raised in her motion for reconsideration. 4

5 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 5 of 14 PageID #: the crux of a plaintiff s suit is based on a failure to warn, the learned intermediary doctrine applies equally to all claims premised on that theory). 4 Romero seeks to distinguish failure to warn claims based upon a drug manufacturer s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. Specifically, citing dicta from the Texas Court of Appeals opinion in Centocor, Inc. v. Hamilton ( Centocor I ), Romero asserts that the scope of may be limited to a medication s package insert. 310 S.W.3d 476, 505 n.17 (Tex. App. Corpus Christi 2010) (stating that it is not clear that this statute was intended to cover something other than a package insert, which accompanies a prescription drug in its distribution ). Romero s reliance on this statement is questionable, however, given that Centocor I was reversed in part by the Texas Supreme Court in Centocor II. See generally Centocor II, 2012 WL Indeed, the statute itself states that it applies to allegations that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product. TEX. CIV. PRAC. & REM. CODE (a) (emphasis added). Finally, at least one other Texas federal district court has rejected the same argument put forth by Romero, characterizing the Centocor I court s reasoning as unsupported conjecture. See Murthy, 847 F. Supp. 2d at 976. Because Romero cites no other authority for the proposition that s provisions should be so strictly applied, the court declines to make such a determination here. Accordingly, whether Romero s failure to warn claims are based on statements made in Wyeth s labeling or promotional materials, they fall within the purview of Romero asserts that Centocor II is distinguishable because, in that case, the plaintiff s fraud claim was based on side effects wholly omitted from a drug s label, while this action deals with affirmative misrepresentations. The court finds this distinction immaterial. 5

6 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 6 of 14 PageID #: Romero s amended complaint confirms that many of her claims are premised on a failure-towarn theory. For example, her misrepresentation, fraud, and deceit cause of action alleges that Wyeth through promotional materials, publications and literature regarding HRT drugs, product inserts, and labeling, advertisements, letters to healthcare professionals... made misrepresentations to plaintiff and her prescribing physicians of material facts regarding the risks and benefits of HRT drugs. Similarly, her negligence claim asserts that Wyeth: (1) owed a duty to fully and truthfully inform users of the increased risks and adverse effects associated with the use of HRT drugs, (2) breached its dut[y] by failing to exercise ordinary care in its... warnings; and (3) [f]ailed to accompany [its] HRT drugs with proper warnings regarding all possible adverse side effects and health risks.... Her allegations regarding violations of the DTPA likewise state that Wyeth failed to disclose information concerning goods or services which was known at the time of the transaction. Moreover, Romero claims that Wyeth violated 17.50(a)(2) of the Texas Uniform Commercial Code by failing to contain, package, and label its products accurately, and her gross negligence cause of action is premised on Wyeth s purported misrepresentations. Finally, Romero s negligent misrepresentation claim states that Wyeth owed a duty to prescribing physicians and ultimate end users... to accurately and truthfully represent the risks and benefits of HRT drugs, which it breached by misrepresenting the risks and benefits of the drug... to the prescribing physicians and ultimate users, including the plaintiff. It is clear that the foundation of all of the aforementioned claims is Romero s contention that Wyeth failed to warn adequately of the risks associated with the use of HRT. Accordingly, because these causes of action are based on a failure to warn, summary judgment is appropriate. See Del Valle,

7 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 7 of 14 PageID #: WL , at *2; Murthy, 847 F. Supp. 2d at 967; cf. Centocor, Inc., 2012 WL , at * B. Failure to Test Romero asserts that she has alleged a failure to test claim that survives irrespective of the fate of her failure to warn causes of action. Her amended complaint contains several negligence allegations regarding failure to test. For example, Romero states that Wyeth: owed a duty to plaintiff and her prescribing physician to exercise reasonable care to properly... test... HRT drugs.... [Wyeth] breached its dut[y] by failing to exercise ordinary care in its... testing... of HRT drugs... in that [Wyeth] knew or should have known that HRT drugs created a foreseeable high risk of unreasonable, dangerous side effects and health events.... [Wyeth] was negligent in the... testing... of HRT drugs in that it: Failed to use due care in the... testing... of HRT drugs so as to prevent and/or avoid severe risks to individuals when HRT drugs were used;... [and] Failed to conduct adequate pre-clinical and clinical testing and post-marketing surveillance to determine the safety of HRT drugs. Wyeth maintains that these allegations are subsumed within Romero s failure to warn claims and, thus, precluded under Under Texas law, one has a duty to exercise reasonable care to avoid foreseeable injury to others. See McCullough v. Godwin, 214 S.W.3d 793, 805 (Tex. App. Tyler 2007, no pet.); Lukasik v. San Antonio Blue Haven Pools, Inc., 21 S.W.3d 394, 403 (Tex. App. San Antonio 2000, no pet.). Moreover, [a] manufacturer has a duty to test... [its] product. The extent of research... must be commensurate with the dangers involved. Borel v. Fibreboard Paper Prods. Corp., 493 F.2d 1076, 1090 (5th Cir. 1973), cert. denied, 419 U.S. 869 (1974). Here, although a large percentage of Romero s claims are premised on a failure to warn, the above 5 In light of this determination, the court need not address Wyeth s arguments regarding the learned intermediary doctrine. 7

8 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 8 of 14 PageID #: allegations assert an independent negligence cause of action based upon Wyeth s failure to test, a claim that does not pertain to any purportedly inadequate warnings issued by Wyeth. See Murthy, 847 F. Supp. 2d at 977 (dismissing plaintiff s strict liability and negligence claims premised on failure to warn in light of but acknowledging that plaintiff had a remaining allegation that defendant failed to adequately and properly test [its] drug both before and after placing the drug on the market ); Blackmon v. Am. Home Prods. Corp., 346 F. Supp. 2d 907, (S.D. Tex. 2004) (recognizing a claim for failure to test, but ultimately granting summary judgment in favor of defendant in the absence of evidence that drug manufacturer breached its duty); Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997) (allowing plaintiff s negligent failure to 6 test claim to withstand summary judgment); Sico N. Am., Inc. v. Willis, No CV, 2009 WL , at *8 n.7 (Tex. App. Houston [14th Dist.] 2009, no pet.) (distinguishing between a failure to warn and a negligent failure to test claim). Accordingly, Romero s negligent failure to test claim survives Wyeth s motion. Romero is cautioned, however, that she must confine her evidence at trial to the issue of inadequate testing. Evidence pertaining to warnings or lack of warnings issued by Wyeth will not be permitted. 6 Wyeth cites Grinnell for the proposition that failure to test claims are routinely subsumed within failure to warn allegations. To the contrary, while the Grinnell court granted summary judgment on one of plaintiffs failure to test theories of liability, which it found inextricably intertwined with their failure to warn claim, it allowed another failure to test theory unrelated to inadequate warnings to proceed to trial. See 951 S.W.2d at 437. Similarly, the court notes that Dow Agrosciences LLC v. Bates, also cited by Wyeth for the principle that a failure to test claim is not distinct from a negligent failure to warn claim, is inapposite. 332 F.3d 323 (5th Cir. 2003), vacated and remanded by 544 U.S. 431 (2005). In that case, the Fifth Circuit, citing Grinnell, stated that a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn. Id. at 333. As discussed above, that was not the holding of Grinnell and, importantly, in vacating the Fifth Circuit s judgment in Dow, the United States Supreme Court addressed failure to warn and failure to test as distinct theories of recovery, finding one preempted but not the other. See generally Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005). 8

9 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 9 of 14 PageID #: C. Design Defect Finally, Wyeth maintains that comment k to the Restatement (Second) of Torts bars Romero s claim for defective design. Specifically, Wyeth asserts that the court s finding regarding the applicability of in this case is at odds with its prior determination that comment k does not foreclose Romero s design defect claim. The duty to design a safe product is an obligation imposed by law. Grinnell, 951 S.W.2d at 432 (quoting McKisson v. Sales Affiliates, Inc., 416 S.W.2d 787, 789 (Tex. 1967)); accord Robins v. Kroger Co., 982 S.W.2d 156, 161 (Tex. App. Houston [1st Dist.] 1998, pet. denied). A design defect renders a product unreasonably dangerous as designed, taking into consideration the utility of the product and the risk involved in its use. Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760, 769 (Tex. App. Houston [14th Dist.] 2009, no pet.) (citing Gen. Motors Corp. v. Sanchez, 997 S.W.2d 584, 588 (Tex. 1999)). To recover on a design defect claim in Texas, a plaintiff must show: (1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was the producing cause of the injury for which the plaintiff seeks recovery. Timpte Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009) (citing TEX. CIV. PRAC. & REM. CODE ); Hernandez v. Tokai Corp., 2 S.W.3d 251, (Tex. 1999). 7 Nonetheless, comment k states: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.... Such a product, properly prepared, 7 Wyeth summarily takes issue with Romero s evidence regarding a safer alternative design to Premphase and Prempro. The court has already determined that Romero has proffered evidence of lowdose HRT as an alternative design and will not revisit that ruling. 9

10 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 10 of 14 PageID #: and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. [This] is true of many... drugs, vaccines, and the like, many of which for this reason cannot legally be sold except to physicians, or under the prescription of a physician.... The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. RESTATEMENT (SECOND) OF TORTS 402A cmt. k (1965). Courts have interpreted this provision as foreclosing design defect claims pertaining to prescription drugs where the products were accompanied by proper directions and warnings. See Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591, 595 (W.D. Tex. 2002) ( The Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not... accompanied by proper warnings. ); Holland v. Hoffman-La Roche, Inc., No. 3:06-CV-1298-BD, 2007 WL , at *3 (N.D. Tex. Nov. 15, 2007) (same); cf. Reyes v. Wyeth Labs., 498 F.2d 1264, 1274 (5th Cir. 1974) ( [A]n unavoidably unsafe product is neither defective nor unreasonably dangerous if... accompanied by proper directions and warning ); Blackmon, 328 F. Supp. 2d at 664 (noting that comment k rejects design defect claims if a product includes a sufficient warning). Wyeth avers that Romero s failure to rebut the statutory presumption discussed supra renders its warnings adequate as a matter of law and, thus, she cannot overcome comment k s applicability. As an initial matter, the court rejects Wyeth s attempt to characterize its holding regarding the statutory presumption as a finding that Wyeth s warnings were adequate as a matter of law. To the contrary, this court found that Romero was unable to overcome the presumption of non-liability set forth in not that Wyeth s warnings were sufficient as a matter of law. [T]he sole effect of a presumption is to fix the burden of producing evidence.... [I]t is nothing 10

11 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 11 of 14 PageID #: more than a rule for the guidance of the trial judge in locating the burden of production at a particular time. Tex. A&M Univ. v. Chambers, 31 S.W.3d 780, 784 (Tex. App. Austin 2000, pet. denied). A plaintiff s inability to rebut Texas s presumption of non-liability for failure to warn, therefore, is markedly different from an express finding that a manufacturer s warning is adequate as a matter of law for all purposes. Indeed, the court s research failed to unearth any case recognizing that the effect of is to render an FDA approved warning adequate as a matter of law. For this reason, it is not incongruent for Romero to defeat comment k as discussed in the court s prior memorandum and order. Nothing in bars Romero from presenting warning evidence at the summary judgment stage in the specific context of a comment k analysis. 8 Alternatively, although the court was unable to locate a Texas case characterizing comment k as an affirmative defense, most jurisdictions treat it as such. See Scelta v. Boehringer Ingelheim Pharms., Inc., 404 F. App x 92, 95 (8th Cir. 2010) ( Comment k provides for an affirmative defense to the design defect cause of action described in section 402A of the Restatement (Second) of Torts. ); Moss v. Wyeth, Inc. F. Supp. 2d, 2012 WL , at *4 (D. Conn. May 24, 2012) (in the context of HRT litigation, recognizing the majority view that comment k is an affirmative defense). Indeed, Wyeth pleaded it as an affirmative defense in this case. As such, it is Wyeth s burden to show that the drug s risk is unavoidable by demonstrating that, given the current state of knowledge, no feasible alternative design exists that would accomplish the same 8 Despite Wyeth s contentions to the contrary, Romero s lack of the specific evidence necessary to overcome s presumption that is, a finding by the FDA that Wyeth committed fraud does not equate to a lack of proof regarding comment k (if indeed she bears the burden of proof on that issue). In any event, at this juncture, the court considers the issue of comment k closed. Tellingly, the Texas pattern jury instructions do not reference comment k in any manner, and juries are charged only as to the elements of a design defect claim as set forth above. 11

12 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 12 of 14 PageID #: purpose with a lesser risk. Next, the manufacturer must demonstrate that the drug s overall benefits outweigh the risks it presents to individual safety. Hanrahan v. Wyeth, Inc., No. 4:04CV01255, 2012 WL , at *13 (E.D. Mo. June 25, 2012) (quotations and citations omitted) (HRT litigation). Here, beyond its flawed assertion that Romero s inability to rebut the presumption of rendered its warning adequate as a matter of law, Wyeth presents no evidence that its HRT products are unavoidably unsafe products subject to comment k s protection. See DaimlerChrysler Motors Co., LLC v. Manuel, 362 S.W.3d 160, 187 n.27 (Tex. App. Fort Worth 2012, no pet.) (recognizing that burden of proof is on party asserting affirmative defense); Hanrahan, 2012 WL , at *13 (holding Wyeth could not avail itself of comment k protection where it failed to meet its burden of production). Additionally, by its express terms applies solely to actions alleging failure to warn. See TEX. CIV. PRAC. & REM. CODE (a) (limiting its application to a products liability action alleging that an injury was caused by a failure to provide adequate warnings... ) (emphasis added). As the Texas Supreme Court has recognized, it s a fair assumption that the Legislature tries to say what it means and, therefore the words it chooses should be the surest guide to legislative intent. Fitzgerald v. Advanced Spine Fixation Sys., Inc., 996 S.W.2d 864, 866 (Tex. 1999); accord City of Seabrook v. Port of Houston Auth., 199 S.W.3d 403, (Tex. App. Houston [1st Dist.] 2006, pet. dism d). Thus, when a court strays from the plain language of a statute, [it] risk[s] encroaching on the Legislature s function to decide what the law should be. Fitzgerald, 996 S.W.2d at 866. Persuasively, in regard to , the Legislature clearly chose to limit its reach to claims premised on a failure to warn. As noted previously, the crux of a design defect claim is that the defendant s defective design of a product rendered it unreasonably 12

13 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 13 of 14 PageID #: dangerous, resulting in injury to the plaintiff, where a safer design was available. See Goodner v. Hyundai Motor Co., Ltd., 650 F.3d 1034, 1040 (5th Cir. 2011); Timpte Indus., Inc., 286 S.W.3d at 311; Hernandez, 2 S.W.3d at The ultimate issue, therefore, is the existence of a defective product. To that end, Romero s amended complaint alleges Wyeth s HRT drugs were defective because: (1) the foreseeable risks exceeded the benefits associated with the design ; (2) when it left the hands of the manufacturer and/or suppliers, it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect, and more dangerous than other [HRT] drugs available on the market ; and (3) Wyeth conducted inadequate pre-market testing which, if conducted properly, would have revealed the serious problems with [HRT drugs] prior to the first sale. 9 Thus, Romero seeks to hold Wyeth liable for designing a defective product where a safer alternative was available, rather than for issuing inadequate warnings. This is a wholly distinct theory of recovery from failure to warn. See Eckhardt v. Qualitest Pharms., Inc., No. M , 2012 WL , at *7 (S.D. Tex. Apr. 30, 2012) (addressing design defect as a claim separate from those subject to ). Moreover, in addition to her strict products liability defective design cause of action, Romero asserts a claim for negligent defective design, which is not subject 10 to comment k. See Blackmon, 328 F. Supp. 2d at 666 (recognizing that comment k is restricted 9 To the extent Romero alleges that Wyeth s products were defectively designed due to inadequate warnings, however, her claim is subject to the failure to warn analysis set forth above. 10 Wyeth contends that Romero is precluded from pursuing a negligent design claim because it is encompassed in her strict liability theory. The authority cited by Wyeth on this issue, however, concerns submitting both causes of action to a jury, rather than a plaintiff s ability to plead the claims as alternate grounds for recovery. While Texas law recognizes both causes of action, it is also well settled that where the controlling issues regarding the existence of a defect for strict liability [and] negligence... are functionally identical, a trial court is not required to, and should not, confuse the jury by submitting differently worded questions that call for the same factual finding. TEXAS PATTERN JURY 13

14 Case 1:03-cv MAC Document 178 Filed 08/31/12 Page 14 of 14 PageID #: to strict liability claims). Therefore, even if the court found her strict liability design defect claim barred by comment k, Romero could still proceed on a cause of action for negligent defective design. Accordingly, summary judgment is not warranted on this claim. III. Conclusion Consistent with the foregoing analysis and the discussion contained in the court s May 30, 2012, memorandum and order, Wyeth is entitled to judgment as a matter of law on Romero s misrepresentation, fraud, and deceit; negligence; gross negligence; negligent misrepresentation; DTPA; and design defect claims to the extent they are based on a theory of failure to warn. Romero s negligent failure to test and the portion of her design defect claims not premised on inadequate warnings, however, survive. CHARGES MALPRACTICE, PREMISES & PRODUCTS 71.4 (2010 ed.) (quotation omitted), see also id (setting forth the elements of negligent design). Hence, the court agrees that both theories should not be submitted to the jury for consideration. Nevertheless, these authorities do not bar Romero from pursuing negligent design as an alternate theory of recovery at this juncture. 14