Defendants’ Brief in Support of Supplemental Motion For Summary Judgment – Page i 

040752 000148 DALLAS 2642509.1 

IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF TEXAS 

DALLAS DIVISION 

CHRISTOPHER TYLER LOFTON, 

Individually and on behalf of the ESTATE 

of CHRISTOPHER M. LOFTON, et al., 

Plaintiffs, 

v. 

MCNEIL CONSUMER & SPECIALTY 

PHARMACEUTICALS, a Division of 

MCNEIL-PPC, INC.; and JOHNSON & 

JOHNSON, 

Defendants. 

Civil Action No. 3:05-CV-1531-L 

ECF 

DEFENDANTS’ BRIEF IN SUPPORT OF 

SUPPLEMENTAL MOTION FOR SUMMARY JUDGMENT

Respectfully submitted, 

OF COUNSEL: 

Vernon I. Zvoleff 

California Bar No. 81380 

Thomas W. Pulliam, Jr. 

California Bar No. 46322 

Kenneth P. Conour 

California Bar No. 148064 

Benjamin J. Holl 

California Bar No. 200630 

DRINKER BIDDLE & REATH LLP 

50 Fremont Street, 20th Floor 

San Francisco, CA 94105-2235 

415-591-7500 (Phone) 

415-591-7510 (Facsimile) 

By: /s/ Jackie Robinson 

Jackie Robinson 

State Bar No. 17092250 

Jackie.Robinson@tklaw.com

Attorney-in-charge 

 Robert K. Mitchell 

 State Bar No. 24041500 

Robert.Mitchell@tklaw.com

 Nathan W. Shackelford 

 State Bar No. 24070598 

Nathan.Shackelford@tklaw.com

THOMPSON & KNIGHT LLP 

1722 Routh Street, Suite 1500 

Dallas, Texas 75201 

(214) 969-1700 (Phone) 

(214) 969-1751 (Facsimile) 

ATTORNEYS FOR DEFENDANTS 

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CERTIFICATE OF SERVICE

 I hereby certify that on July 30, 2010, I electronically filed the foregoing document with 

the clerk for the United States District Court for the Northern District of Texas, using the 

electronic case filing system of the Court. The electronic case filing system sent a “Notice of 

Electronic Filing” to all attorneys of record. 

I further certify that I have served the foregoing document via certified mail, return 

receipt requested, to the following individuals: Ted B. Lyon, Ted B. Lyon & Associates, Town 

East Tower, Suite 525, 18601 LBJ Freeway, Mesquite, Texas 75150-5632. 

 

 /s/ Robert K. Mitchell 

 Robert K. Mitchell 

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Defendants’ Brief in Support of Supplemental Motion For Summary Judgment – Page iii 

040752 000148 DALLAS 2642509.1

TABLE OF CONTENTS 

I. INTRODUCTION........................................................................................................................1 

II. SUMMARY OF ARGUMENTS ................................................................................................2 

A. Defective Design......................................................................................................2 

B. Breach of Implied Warranty ....................................................................................3 

III. SUMMARY JUDGMENT MATERIALS AND EVIDENCE..................................................3 

IV. FACTUAL BACKGROUND....................................................................................................4 

A. Case History.............................................................................................................4 

B. Motrin’s Design Is FDA-Approved for OTC Use ...................................................6 

C. The Record Regarding Plaintiffs’ Design Defect Claim .........................................7 

1. Dexibuprofen and Ibuprofen Are Different Drugs ......................................7 

2. The FDA Has Never Approved Dexibuprofen for Use in 

the United States ..........................................................................................8 

3. Dexibuprofen Is Neither Technologically nor Economically 

Feasible as an Alternative to Motrin............................................................8 

V. ARGUMENTS AND AUTHORITIES.......................................................................................9 

A. Plaintiffs’ Design Defect Claim Fails Because Dexibupofen Is Not 

a Safer Alternative Design to Motrin.......................................................................9 

1. Dexibuprofen Is Not an “Alternative” Design.............................................9 

2. There Is No Evidence that Dexibuprofen Was a 

Technologically and Economically Feasible Alternative to 

Ibuprofen....................................................................................................13 

B. Plaintiffs’ Claim for Breach of Implied Warranty Is Predicated on 

Their Defective Design Claim and Should Also Be Dismissed. ...........................14 

1. Without Evidence of a Safer Alternative Design, Plaintiffs’ 

Breach of Implied Warranty Claim Is Untenable. .....................................14 

2. Plaintiffs’ Failure to Provide Timely Notice of Breach Is 

Fatal to Their Implied Warranty Claim. ....................................................16 

VI. CONCLUSION........................................................................................................................16 

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TABLE OF AUTHORITIES 

Federal Cases

Ackermann v. Wyeth Pharms., 471 F. Supp. 2d 739 (E.D. Tex. 2006).............................................................................. 16 

Flock v. Scripto-Tokai Corp., Civil Action H-00-3794, 2001 U.S. Dist. LEXIS 23878 (S.D. Tex. Nov. 

19, 2001) ........................................................................................................................... 15 

Flock v. Scripto-Tokai Corp., 183 F. Supp. 2d 917 (S.D. Tex. 2001) .............................................................................. 15 

Foster v. Ford Motor Co., 621 F.2d 715 (5th Cir. 1980) ............................................................................................ 15 

Holland v. Hoffman-La Roche, Inc., No. 3-06-CV1298-BD, 2007 U.S. Dist. LEXIS 84507 (N.D. Tex. Nov. 15, 

2007) ................................................................................................................................. 16 

Martin v. Home Depot U.S.A. Inc., 369 F. Supp. 2d 887 (W.D. Tex. 2005)............................................................................. 16 

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)...................................................................................................... 3, 12 

Palmco Corp. v. Am. Airlines, 983 F.2d 681 (5th Cir. 1993) ............................................................................................ 16 

Patterson v. Rohm Gesellschaft, 608 F. Supp. 1206 (N.D. Tex. 1985) ................................................................................ 15 

Rider v. Sandoz Pharms. Corp., 295 F.3d 1194, 1201 (11th Cir. 2006) ............................................................................. 11 

Smith v. Louisville Ladder Co., 237 F.3d 515 (5th Cir. 2001) ...................................................................................... 10, 15 

Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999) ............................................................................................ 10 

Wyeth v. Levine, 552 U.S. 1161 (2008).......................................................................................................... 5

Wyeth v. Levine, 555 U.S. __, 129 S. Ct. 1187 (2009)................................................................................... 5 

State Cases

Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420 (Tex. 2007)............................................................................................. 10 

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Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760 (Tex.App.—Houston [14th Dist.] 2009, no pet.)............. 2, 10, 11, 12, 13 

Carroll Instr. Co. v. B.W.B. Controls, 677 S.W.2d 654 (Tex. App.—Houston [1st Dist.] 1984, no writ).................................... 16 

Caterpillar, Inc. v. Shears, 911 S.W.2d 379 (Tex. 1995)............................................................................. 9, 10, 13, 15 

Hyundai Motor Co. v. Rodriguez, 995 S.W.2d 661 (Tex. 1999)............................................................................................. 15 

Nissan Motor Co. v. Armstrong, 145 S.W.3d 131 (Tex. 2004)............................................................................................. 14 

Otis Spunkmeyer, Inc. v. Blakely, 30 S.W.3d 678 (Tex.App.—Dallas 2000, no pet.)............................................................ 15 

U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194 (Tex. App. – Houston [1st Dist.] 2003, pet. denied).............................. 16 

Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328 (Tex. 1998)......................................................................................... 9, 13 

Federal Statutes, Rules, & Regulations

21 U.S.C § 355(j)...................................................................................................................... 3, 12 

21 U.S.C. § 355(a) ........................................................................................................................ 14 

21 U.S.C. § 355(b) ........................................................................................................................ 14 

State Statutes, Rules, & Regulations

Tex. Bus. & Com. Code Ann. § 2.607(c)(1)................................................................................. 16 

Other Authorities

Restatement (Second) of Torts § 402A cmt. k................................................................................ 5 

Restatement (Third) of Torts: Product Liability § 2 cmt. f........................................................... 13 

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040752 000148 DALLAS 2642509.1

IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF TEXAS 

DALLAS DIVISION 

CHRISTOPHER TYLER LOFTON, 

Individually and on behalf of the ESTATE 

of CHRISTOPHER M. LOFTON, et al., 

Plaintiffs, 

v. 

MCNEIL CONSUMER & SPECIALTY 

PHARMACEUTICALS, a Division of 

MCNEIL-PPC, INC.; and JOHNSON & 

JOHNSON, 

Defendants. 

Civil Action No. 3:05-CV-1531-L 

ECF 

DEFENDANTS’ BRIEF IN SUPPORT OF 

SUPPLEMENTAL MOTION FOR SUMMARY JUDGMENT

I. 

INTRODUCTION

As the Court is aware, this is a products liability case. Plaintiffs contend that Christopher 

Lofton’s use of over-the-counter Motrin caused an extremely rare skin disorder, known as 

Stevens-Johnson syndrome (“SJS”) or Toxic Epidermal Necrolysis (“TEN”), which resulted in 

his death. 

On January 27, 2010, the Court entered an Order granting Defendants’ Motion for 

Summary Judgment in part (the “Order”).1

 The only remaining issues are the wrongful death 

and survival claims of Mr. Lofton’s children for defective design and breach of implied 

 1

 Jan. 27, 2010 Mem. Op. and Order at 30 (App. 32) (dismissing Plaintiffs’ claims for 

marketing defect, breach of express warranty, negligence, and violations of the Texas Deceptive 

Trade Practices Act, and Sandy Lofton’s wrongful death and survival claims).

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warranty.2

 These claims are premised on Plaintiffs’ expert Randall Tackett’s theory that 

dexibuprofen was an available, safer alternative design to Motrin at the time of Christopher 

Lofton’s use in May 2000.3 

As shown below, Tackett’s opinion ignores the fact that dexibuprofen has never been 

approved for sale in the United States, and most importantly for purposes of this motion, it was 

not approved for, and not available for sale, in May 2000. Accordingly, it is not an available 

“alternative design” upon which Plaintiffs may base their claims. Moreover, under Texas law, 

even if dexibuprofen were available it would not be an alternative design, as it is a different drug. 

Under the facts of this case, Plaintiffs (a) cannot produce the required evidence of an 

available safer alternative design to support their defective design and breach of implied 

warranty claims, and (b) failed to provide Defendants with the required notice of their implied 

warranty claim before filing suit. Therefore, Defendants respectfully ask this Court to dismiss 

Plaintiffs’ remaining design defect and implied warranty claims as a matter of Texas law. 

II. 

SUMMARY OF ARGUMENTS

A. Defective Design

Under Texas law, a plaintiff cannot prove a design defect by claiming the defendant 

should have sold a different product.4 Plaintiffs’ proposed alternative design—dexibuprofen—is 

 2 Id. 

3

 In the Order, the Court ruled that: (a) Texas law recognizes Plaintiffs’ design defect 

claim; and (b) Tackett’s opinion that “pure S+ ibuprofen [found in dexibuprofen] is less likely to 

cause SJS or TEN than the specific mixture of R- and S+ ibuprofen in Motrin” is admissible to 

support Plaintiffs’ design defect allegations. Id. at 10, 26 (App. 12, 28). 

4 See, e.g., Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760, 770-71 (Tex.App.—

Houston [14th Dist.] 2009, no pet.). 

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not an “alternative” design at all, but a materially different drug with different pharmacological 

properties and metabolic profiles. The manufacture and marketing of dexibuprofen is neither 

reasonable nor feasible. Indeed, it is illegal because there has never been FDA approval; it is not 

possible to market dexibuprofen—and it was not in May 2000. FDA committees and the FDA 

itself were not convinced that dexibuprofen was safe enough to be marketed, and the FDA 

therefore did not approve a New Drug Application (“NDA”) to market dexibuprofen.5 

B. Breach of Implied Warranty

Under Texas law, Plaintiffs’ claim for breach of implied warranty is predicated on their 

allegation that Motrin was defectively designed, and should be dismissed because the design 

defect claim fails. This claim should also be dismissed because Plaintiffs failed to provide 

Defendants with the notice required to prosecute an implied warranty claim for their alleged 

injuries. 

III. 

SUMMARY JUDGMENT MATERIALS AND EVIDENCE

Defendants rely on the following materials and evidence to support this Motion, all of 

which are included in the accompanying Appendix pursuant to Local Rule 56.6. 

Exhibit A Declaration of Thomas W. Pulliam, Jr. in Support of Defendants’ Supplemental 

Motion for Summary Judgment 

Exhibit B January 27, 2010 Memorandum Opinion and Order 

 5

 Declaration of Steven M. Weisman, Ph.D. in Support of Supplemental Motion for 

Summary Judgment (“Weisman Decl.”) at ¶ 10 (App. 148). The FDA’s request for additional 

safety testing is evidence that dexibuprofen is a different product than FDA-approved ibuprofen 

because generic forms of the same drug do not require additional safety testing. See Merck 

KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 196 n.1 (2005) (“The sponsor of a generic 

drug does not have to make an independent showing that the drug is safe and effective, either in 

preclinical or clinical studies. It need only show that the drug includes the same active 

ingredients as, and is bioequivalent to, the drug that it is mimicking.” (citing 21 U.S.C §§ 

355(j)(2)(A), (8)(B)).

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Exhibit C Excerpts from Defendants’ Motion for Summary Judgment, filed May 2, 2008 

Exhibit D Plaintiffs’ Second Amended Complaint 

Exhibit E Excerpts from the Declaration of Randall Tackett, Ph.D. in Support of Plaintiffs’ 

Opposition to Defendants’ Motion for Summary Judgment 

Exhibit F Excerpts from the deposition of Randall Tackett, Ph.D. taken April 4, 2008 

Exhibit G June 22, 2006 FDA Response to Citizen’s Petition 

Exhibit H Defendants’ Answer to Plaintiffs’ Second Amended Complaint 

Exhibit I Declaration of Steven M. Weisman in Support Defendants’ Supplemental Motion 

for Summary Judgment 

Exhibit J Curriculum Vitae of Steven M. Weisman 

Exhibit K Excerpts from the October 9, 1996 Joint FDA Committee Hearing Transcript 

Exhibit L Declaration of Anthony Temple in Support of Defendants’ Supplemental Motion 

for Summary Judgment 

Exhibit M September 19, 1974 Approval of New Drug Application for Motrin Prescription 

Tablets 

Exhibit N April 15, 1983 New Drug Application for over-the-counter Motrin Ibuprofen 

Tablets 

Exhibit O May 18, 1984 Approval of New Drug Application for over-the-counter Motrin 

Ibuprofen tablets 

IV. 

FACTUAL BACKGROUND

A. Case History6

Plaintiffs’ Second Amended Complaint, filed on February 15, 2006, alleges that 

Christopher Lofton’s use of Motrin in May 2000 led to the development of SJS/TEN and caused 

his death on June 3, 2000. Plaintiffs asserted claims for: (a) defective design, (b) marketing 

 6

 For the sake of brevity, Defendants incorporate by reference the fact section of 

Defendants’ Motion for Summary Judgment filed May 2, 2008, pp. 5-17 (App. 35-47). 

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defect, (c) breach of express warranty, (d) breach of implied warranty, (e) negligence, and (f) 

Texas Deceptive Trade Practices Act violations. Plaintiffs based their claims on allegations that 

Defendants defectively marketed Motrin by not adequately warning of the risk of SJS/TEN from 

use of the product,7 made false and misleading statements to promote Motrin,8 and defectively 

designed the product.9

Defendants filed a motion for summary judgment on May 2, 2008; Plaintiffs responded 

on May 29, 2008. While the motion was pending, on July 30, 2008, the Court administratively 

closed this case pending United States Supreme Court decision of relevant preemption issues in 

Wyeth v. Levine.

10 The Levine opinion was issued in March 2009.11 This case was re-opened on 

July 30, 2009. 

The Court’s January 27, 2010 Order granted Defendants’ summary judgment motion in 

part, dismissing Plaintiffs’ claims for marketing defect, breach of express warranty, negligence, 

and violations of the Texas Deceptive Trade Practices Act, as well as Sandy Lofton’s wrongful 

death and survival claims.12 But drawing a distinction between prescription drugs and OTC 

drugs, the Court declined to apply the “unavoidably unsafe product” exception from comment k 

of the Restatement (Second) of Torts § 402A to OTC drugs.13 The Court also upheld the 

magistrate judge’s ruling that Tackett’s unpublished safer alternative design theory is admissible, 

 7

 Pls’ Second Am. Compl. at ¶¶ 4.3, 4.4, 4.6, 4.8, 4.9 (App. 52-55). 

8 Id. at ¶ 4.12 (App. 55-56). 

9 Id. at ¶ 4 (App. 52). 

10 552 U.S. 1161 (2008). 

11 Wyeth v. Levine, 555 U.S. __, 129 S. Ct. 1187 (2009). 

12 Jan. 27, 2010 Mem. Op. and Order at 30 (App. 32). 

13 Id. at 25-26 (App. 27-28). 

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and ruled that Plaintiffs’ implied warranty claim remains for trial.14 Thus, the only issues 

remaining before this Court are the wrongful death and survival claims of Mr. Lofton’s children 

for defective design and breach of implied warranty.15 Plaintiffs’ sole evidence of a safer 

alternative design is the testimony of expert witness Randall Tackett. Tackett is a 

pharmacologist and toxicologist, not a medical doctor.16 

B. Motrin’s Design Is FDA-Approved for OTC Use

The FDA approved Motrin for OTC use in 1984.17 Motrin’s active ingredient is 

ibuprofen, a propionic acid non-steroidal anti-inflammatory drug (“NSAID”).18 The ibuprofen 

contained in Motrin is the only form of ibuprofen approved for use, and the only form of 

ibuprofen sold, in the United States.19 Motrin is a widely used drug, available in both 

prescription and OTC forms.20 Since its introduction to the market in 1967, billions of doses of 

ibuprofen have been sold worldwide.21 In fact, since at least 1992, U.S. consumers alone have 

purchased more than 6 billion ibuprofen doses annually—which does not even include the 

millions of doses provided by doctors and hospitals to patients each year.22

 14 Id. at 10, 30 (App. 12, 32). 

15 Id. at 30 (App. 32). 

16 Declaration of Randall Tackett In Support of Plaintiffs’ Opposition to Motion for 

Summary Judgment (“Tackett Decl.”) at ¶ 2 (App. 63-64). 

17 See Declaration of Anthony R. Temple, M.D. in Support of Motion for Supplemental 

Summary Judgment (“Temple Decl.”) at ¶ 5 (App. 180); May 18, 1984 FDA approval letter 

(App. 190). 

18 Temple Decl. at ¶ 3 (App. 180). 

19 Id. at ¶ 7 (App. 181). 

20 Id. at ¶¶ 3-6 (App. 180-181). 

21 Id. at ¶ 6 (App. 181). 

22 Id.

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C. The Record Regarding Plaintiffs’ Design Defect Claim

Plaintiffs allege that Motrin was defectively designed because “the drug contained the 

racemic mixture of S+ and R- ibuprofen, rendering it more toxic that [sic] the alternative design 

well known to defendants, called dexibuprofen.”23 Plaintiffs further claim dexibuprofen would 

have prevented or reduced the risk of decedent’s injury and death, and was economically and 

technologically feasible.24 

Plaintiffs’ claim for design defect is based solely on Tackett’s theory. As a matter of law, 

his opinion is insufficient to support this claim. 

1. Dexibuprofen and Ibuprofen Are Different Drugs 

Dexibuprofen is not an alternative design to ibuprofen. It is a different drug that is not 

FDA-approved for OTC or prescription use.25 Like many drugs, ibuprofen is a racemic mixture 

of two enantiomers, R- and S+ ibuprofen.26 As Tackett explained: “[t]he two enantiomers of 

ibuprofen are . . . different in terms of their pharmacological properties and may be regarded as 

two different drugs. They also differ in terms of their metabolic profiles. Both enantiomers are 

 23 Pls’ Second Am. Compl. at ¶ 4 (App. 52). 

24 Id. at ¶ 4.2 (App. 52). Plaintiffs’ claim for design defect includes allegations 

Defendants failed to: (a) adequately test Motrin for OTC use before seeking FDA approval; (b) 

conduct a large enough clinical trial to test for SJS/TEN; (c) adequately and completely report 

clinical trial data regarding the drug’s risks; and (d) suppressed and diluted evidence of skin 

reaction, including SJS, and did not report them to the FDA or healthcare community. Id. at ¶ 

4.1 (App. 52). As discussed, infra p. 9, these allegations are irrelevant to the showing required to 

prevail on a design defect claim. 

25 See Weisman Decl. at ¶ 4 (App. 147). 

26 Tackett Decl. at ¶ 149 (App. 69-70). Tackett elaborated: “[T]wo stereochemical 

structures depicted (the R and S symbols) are related as non-superimposable mirror images, and 

are identical in all respects except that one form is dextrorotary while one is levorotary. 

However, both forms have equal magnitude of rotation. This phenomenon is enantiomerism and 

each of the stereoisomers is called an enantiomer.” Id. (App. 69). 

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pharmacologically active.”

27 Dexibuprofen, on the other hand, only contains one enantiomer—

the S compound.28

Tackett agrees that ibuprofen and dexibuprofen work differently: “Dexibuprofen will 

bind differently than a racemic mixture of Ibuprofen.”29 And he agrees the two drugs have 

different chemical compositions: “[dexibuprofen is] a more pure compound than the 

Ibuprofen.”30

2. The FDA Has Never Approved Dexibuprofen for Use 

The FDA has never approved dexibuprofen for marketing.31 FDA committees and the 

FDA considered an application but were not convinced that dexibuprofen was sufficiently safe to 

be marketed, and accordingly, the FDA did not approve an NDA to market dexibuprofen.32 

3. Dexibuprofen Is Neither Technologically nor Economically Feasible as an 

Alternative to Motrin 

The record does not support Tackett’s conclusion that “a safer alternative design was 

 27 Id. at ¶ 149 (App. 69-70) (emphasis added).

28 See id. at ¶ 153 (“[dexibuprofen is] an enantiomerically pure preparation of the Senantiomer”) (App. 71); Deposition of Randall (“Tackett Dep.”) at 233:6-8 (dexibuprofen is a 

“racemically pure compound”) (App. 100).

29 Tackett Dep. at 230:13-14 (App. 100). 

30 Id. at 230:19-20 (App. 100); see also id. at 222:9-223:7 (App. 98) (“[T]here are unique 

structural differences between each . . . NSAID[] that give them specific properties which . . . 

would explain why you would have differing effects between different NSAIDs.”); id. at 231:18-

22 (App. 100) (“[T]here’s a number of papers that are out that talk about the altered metabolism 

of the racemic mixture, which you don’t get with the Dexibuprofen.”); Tackett Decl. at ¶ 155 

(App. 71-72). 

31 Weisman Decl. at ¶¶ 4, 10, 11 (App. 147-148); see also Joint FDA Committee Hearing 

Transcript at 292:4-293:24 (App. 175-176) (declining to approve an application to market OTC 

dexibuprofen). 

32 Weisman Decl. at ¶ 10 (App. 148); Joint FDA Committee Hearing Transcript at 

292:10-15, 293:8-15, and 294:11-25 (App. 175-177) (citing safety concerns and the lack of 

history of dexibuprofen on an OTC market anywhere in the world or a long history of it as a 

prescription drug—including no history in the United States). 

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scientifically and technologically feasible, and affordable to these defendants to use in order to 

provide a safer alternative design to Motrin, racemic ibuprofen, by designing and marketing 

dexibuprofen.”33 The fact that dexibuprofen is registered and marketed as a prescription drug in 

foreign countries34 does not change the fact that it has never been approved by the FDA for sale 

in the United States, as an alternative to ibuprofen or otherwise. Thus, dexibuprofen has never 

been available for marketing or sale in the United States.35 Most importantly, it was not 

available for marketing in the United States in May 2000, which is the relevant date for 

determining the existence of an available, safer alternative design. 

V. 

ARGUMENTS AND AUTHORITIES

A. Plaintiffs’ Design Defect Claim Fails Because Dexibuprofen Is Not a Safer 

Alternative Design to Motrin.

To defeat a motion for summary judgment on a design defect claim, a plaintiff must, 

among other things, offer legally sufficient evidence to create a question of fact that: (1) there 

was a safer, alternative design; and (2) the safer, alternative design was available, i.e.,

technologically and economically feasible at the time it left the manufacturer’s control—here, 

prior to May 2000.36 Plaintiffs lack the necessary evidence to meet these threshold requirements. 

1. Dexibuprofen Is Not an “Alternative” Design 

Plaintiffs cannot prevail on their defective design theory by arguing that Defendants 

 33 Tackett Decl. at ¶ 159 (App. 73-74). 

34 See id. at ¶ 157 (App. 72-73) (citing European countries that have approved 

dexibuprofen for prescription use). 

35 See id.; Weisman Decl. at ¶¶ 10-11 (App. 148). 

36 See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 335 (Tex. 1998); 

Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 383-84 (Tex. 1995). 

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should have transformed ibuprofen into another product—dexibuprofen. Dexibuprofen is not an 

alternative design for ibuprofen. It is a different product. The Texas Supreme Court has held 

that a plaintiff cannot prove a design defect by claiming that a defendant should have sold what 

amounts to a different product.37 

In Caterpillar, the Texas Supreme Court rejected the plaintiff’s argument that the 

defendant should have manufactured a front-end loader with a removable rollover-protective 

structure (“ROPS”) so the ROPS was not removable. The court reasoned the plaintiff’s 

argument would have essentially transformed the machine into a different product. 

The Caterpillar Court explained: 

A motorcycle could be made safer by adding two additional wheels 

and a cab, but then it is no longer a motorcycle. A convertible can 

be made safer by fully enclosing the cab, but then it is just an 

ordinary car. The law of products liability demands that 

manufacturers and distributors take feasible steps to make their 

products reasonably safe. It is not rational, however, to impose 

liability in such a way as to eliminate whole categories of useful 

products from the market.38

Likewise, “[t]he Fifth Circuit has found that a plaintiff cannot prove that a safer 

alternative design exists by pointing to a substantially different product, even when the other 

product has the same general purpose as the allegedly defective product.”39 

 37 Caterpillar, 911 S.W.2d at 384-85 (plaintiff cannot prove design defect by claiming a 

defendant should have sold an entirely different product); Brockert, 287 S.W.3d at 770 

(plaintiffs’ design defect claim not viable under Texas law where a drug’s proposed safer 

alternative design was a different product) (citing Caterpillar). 

38 Caterpillar, 287 S.W.3d at 385; see also Am. Tobacco Co. v. Grinnell, 951 S.W.2d 

420, 433, n.10 (Tex. 2007) (dismissal of design defect claims was proper because there was no 

safer alternative design for cigarettes; “[c]ategorical liability is not only an unworkable solution, 

but also a position repeatedly rejected by courts.”) (citations omitted). 

39 Brockert, 287 S.W.3d at 770 (citing Theriot v. Danek Med., Inc., 168 F.3d 253, 255-56 

(5th Cir. 1999) (applying Louisiana law)). Notably, the proof required to support a safer 

alternative design theory under Louisiana law is “very similar” to Texas law. Smith v. Louisville 

Ladder Co., 237 F.3d 515, 519-20 (5th Cir. 2001).

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In Brockert v. Wyeth, the Fourteenth Court of Appeals applied this reasoning to a 

pharmaceutical case involving the allegedly defective design of Prempro, a hormonereplacement therapy drug. Like the Plaintiffs in this case, Brockert argued that a pure drug 

product (estrogen) was a safer design for Prempro, which contains a combination of estrogen and 

progestin.40 Brockert held that the plaintiff’s expert testimony arguing for the pure-estrogen 

formula was not evidence of a safer alternative design.41 Brockert recognized that under 

Caterpillar, this testimony (like Tackett’s) did not support a defective design theory, but 

impermissibly sought to require Wyeth to sell a different product.42 And this recognition that 

changing the formula transforms the drug is consistent with the fundamental principle of 

pharmacology and toxicology that even minor differences in the composition and structure of a 

chemical compound can substantially change its pharmacologic properties.43 

Thus, a safer alternative design must affect the product at issue—here, ibuprofen—but 

not change it into a different product.44 Tackett’s testimony shows dexibuprofen is not a safer 

design for ibuprofen—it is a different formula for a different drug. Nowhere does Tackett 

explain how ibuprofen could be modified or improved; instead he opines that the FDA-approved 

two-enantiomer ibuprofen compound should instead be a one-enantiomer dexibuprofen formula 

that the FDA did not approve. The fact that the FDA did not approve dexibuprofen for 

marketing (neither OTC nor by prescription), but has approved the marketing of ibuprofen (both 

 40 Brockert, 287 S.W.3d at 669. 

41 Id. at 770. 

42 Id. at 770-71. 

43 See, e.g., Rider v. Sandoz Pharms. Corp., 295 F.3d 1194, 1201 (11th Cir. 2006) (“Even 

minor differences in chemical structure can radically change a particular substance’s properties 

and propensities.”). 

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OTC and by prescription) makes plain that these are considered different drugs.45 

In sum, the record shows: 

• Ibuprofen is a racemic mixture that contains two enantiomers, Rand S+ ibuprofen.46

• “[T]he two enantiomers of ibuprofen are . . . different in terms of 

their pharmacological properties and may be regarded as two 

different drugs. They also differ in terms of their metabolic 

profiles. Both enantiomers are pharmacologically active.”47

• “Dexibuprofen will bind differently than a racemic mixture or 

ibuprofen,” and is “a more pure compound than the Ibuprofen.”48

• “[T]here are unique structural differences between each . . . 

NSAID[] that give them specific properties which may mean — 

which would explain why you would have differing effects 

between different NSAIDs.”49 

• The FDA views the two as different drugs; it has approved 

ibuprofen for OTC and prescription use,50 but has not approved 

dexibuprofen for use.51 

 In other words, dexibuprofen is not an alternative design for ibuprofen, but a different 

drug product. 

“[A]s the supreme court has explained, Texas law does not recognize this sort of 

 44 See Brockert, 287 S.W.3d at 770. 

45 See Merck KGaA, 545 U.S. at 196 n.1; see also 21 U.S.C. § 355 (j)(2)(A). 

46 Tackett Decl. at ¶ 149 (App. 69-70). 

47 Id. (emphasis added). 

48 Tackett Dep. at 230:13-14 (App. 100). 

49 Id. at 222:9-223:7 (App. 98). 

50 Temple Decl. at ¶¶ 3, 5, 7 (App. 180-181). 

51 Weisman Decl. at ¶ 4 (App. 147). 

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categorical attack on a product.”52 Moreover, “the range of consumer choice among products are 

factors that may be taken into account” in alternative design cases.53 Notable here, the FDA 

responded to a Citizen’s Petition asking it to modify the labeling of NSAID drugs (including 

OTC ibuprofen) by emphasizing the public health importance of maintaining “a range of options

in the NSAID class from which physicians and patients may choose.”54 The FDA declined to 

remove OTC ibuprofen products from the marketplace. Instead, it stated that the “overall benefit 

versus risk profile” for ibuprofen products remained “very favorable.”55 

Therefore, Plaintiffs’ defective design claim fails. 

2. There Is No Evidence that Dexibuprofen Was a Technologically and 

Economically Feasible Alternative to Ibuprofen. 

Whether a product has a design defect is evaluated “in light of the economic and 

scientific feasibility of safer alternatives.”56 The degree of feasibility is one factor courts weigh 

in balancing the utility of a product against its risks.57

As a matter of law, dexibuprofen cannot constitute a technologically and economically 

feasible alternative. When proving the existence of a reasonable alternative design, the drug 

must first be available. Dexibuprofen is not available. More importantly, it was not available in 

May 2000. 

Dexibuprofen is not simply a redesign of ibuprofen, but a different, foreign drug product 

 52 See Brockert, 287 S.W.3d at 771. 

53 Uniroyal Goodrich Tire Co., 977 S.W.2d at 335 (quoting the Restatement (Third) of 

Torts: Product Liability § 2 cmt. f). 

54 June 22, 2006 FDA Response to Citizens’ Petition at 2 (App. 105) (emphasis added). 

55 Id. at 9 (App. 112). 

56 Caterpillar, 911 S.W.2d at 384. 

57 Id.

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that is neither marketed nor approved for marketing (OTC or prescription) in this country. The 

FDA did not approve an application to market the design submitted in 1996. Plaintiffs’ designdefect argument completely ignores the requirement that all drugs sold in the United States must 

first have FDA approval.58 Because the FDA did not approve the request for approval of 

dexibuprofen,59 it was not an available design in May 2000.60 The ibuprofen contained in 

Motrin is the only form of ibuprofen approved for use, and the only form of ibuprofen that may 

be sold, in the United States.61 And that was true in May 2000. 

“Whether a product was defective must be judged against the technological context 

existing at the time of its manufacture.”62 Plaintiffs have made absolutely no showing as to the 

technological feasibility of manufacturing and marketing dexibuprofen in May 2000, or at any 

time. Nor could they, because the simple fact is that it could not be marketed in the United 

States in May 2000. As a matter of law, it cannot be considered an available, safer alternative 

design, and cannot support a design defect claim. 

B. Plaintiffs’ Claim for Breach of Implied Warranty Is Predicated on Their Defective 

Design Claim and Should Also Be Dismissed.

1. Without Evidence of a Safer Alternative Design, Plaintiffs’ Breach of Implied 

Warranty Claim Is Untenable. 

Plaintiffs allege that Defendants impliedly warranted that Motrin was of merchantable 

 58 See 21 U.S.C. § 355(a) (“No person shall introduce or deliver for introduction into 

interstate commerce any new drug, unless an approval of an application filed pursuant to 

subsection (b) or (j) of this section is effective with respect to such drug.”). 

59 See nn. 31-32, supra. 

60 See 21 U.S.C. § 355(a), (b).

61 Temple Decl. at ¶ 7 (App. 181). 

62 Nissan Motor Co. v. Armstrong, 145 S.W.3d 131, 139 (Tex. 2004). 

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quality, and was safe and fit for its intended use, but it was not.63 The Court has dismissed 

Plaintiffs’ claims based on marketing defect and the failure to warn.64 Thus, design defect is the 

only remaining basis for Plaintiffs to impose implied warranty liability.65 If the Court dismisses 

Plaintiffs’ design defect claims for the reasons set forth above, there will be no grounds upon 

which Plaintiffs’ breach of implied warranty claim can proceed.66 

Addressing this very issue under Texas law, the Fifth Circuit held that a claim for breach 

of implied warranty fails where the plaintiff offers insufficient evidence of a safer alternative 

design to support a design defect theory.67 This is because “the issues regarding the existence of 

design defect and breach of warranty [are] identical.”68

 63 Pls’ Second Am. Compl. at ¶ 4.7 (App. 54). 

64 Jan. 27, 2010 Mem. Op. and Order at 30 (App. 32). 

65 Caterpillar, 911 S.W.2d at 381-82 (Texas law recognizes product liability theories of 

manufacturing, design, or marketing defect). Plaintiffs do not allege a defect in the manufacture 

of Motrin. 

66 See Hyundai Motor Co. v. Rodriguez, 995 S.W.2d 661, 665 (Tex. 1999) (In personal 

injury cases, the defect required to support a strict liability claim and a breach of implied 

warranty claim are “functionally identical.”); see also Patterson v. Rohm Gesellschaft, 608 F. 

Supp. 1206, 1211 (N.D. Tex. 1985) (“There can be no valid products liability claim without a 

product which has a defect.”); Otis Spunkmeyer, Inc. v. Blakely, 30 S.W.3d 678, 690 

(Tex.App.—Dallas 2000, no pet.) (“depending on the facts of each case, whether a 

manufacturing defect exists for purposes of products liability often resolves whether a product 

was defective and, therefore, breached an implied warranty of merchantability.”); Flock v. 

Scripto-Tokai Corp., Civil Action H-00-3794, 2001 U.S. Dist. LEXIS 23878, at *62 (S.D. Tex. 

Nov. 19, 2001) (“To the extent that [Plaintiffs’ breach of warranty] claims are based on theories 

of marketing and/or manufacturing defects, however, they are foreclosed, as Plaintiffs have not 

demonstrated the existence of such alleged defects in the products.”); Foster v. Ford Motor Co., 621 F.2d 715, 719-20 (5th Cir. 1980) (under Texas law, elements for breach of implied warranty 

and strict liability are substantially similar; plaintiff not entitled to breach of warranty 

instruction). 

67 Smith, 237 F.3d at 521 (“In sum, because Smith failed to establish a safer alternative 

design for the ladder in use at the time of the accident, his claim predicated on breach of implied 

warranty must fail, along with his design defect claim.”). 

68 Id. at 521 (citing Hyundai Motor Co., 995 S.W.2d at 667). See also Flock v. ScriptoTokai Corp., 183 F. Supp. 2d 917, 920-21 (S.D. Tex. 2001) (“The warranty claims require the 

same evidence of causation as the product liability claims. They are thus untenable.”) (citations 

omitted). 

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2. Plaintiffs’ Failure to Provide Timely Notice of Breach Is Fatal to Their 

Implied Warranty Claim. 

In Texas, “a buyer, upon accepting tender, must notify the seller of any breach ‘within a 

reasonable time after he discovers any breach . . . or be barred from any remedy.’”69 As Texas 

courts have recognized, the “pre-suit notice requirement is condition precedent” to recover under 

a breach of implied warranty theory.70 Plaintiffs bear the burden to plead and prove timely 

notice.71

There is no evidence that Plaintiffs supplied Defendants with notice of any alleged breach 

of warranty before filing suit.72 Because “there is no room for ordinary minds to differ” 

regarding Plaintiffs’ failure to satisfy the statutory notice requirement, Plaintiffs’ claim for 

breach of implied warranty fails as a matter of law for this additional reason.73 

VI. 

CONCLUSION

For these reasons, Defendants respectfully request that this Court grant Defendants’ 

Supplemental Motion for Summary Judgment, and enter judgment in Defendants’ favor. 

 69 Palmco Corp. v. Am. Airlines, 983 F.2d 681, 684 (5th Cir. 1993) (quoting Tex. Bus. & 

Com. Code Ann. § 2.607(c)(1)); see also Holland v. Hoffman-La Roche, Inc., No. 3-06-CV1298-

BD, 2007 U.S. Dist. LEXIS 84507, at *8 (N.D. Tex. Nov. 15, 2007) (barring a breach of 

warranty claim in a personal injury pharmaceutical case because the plaintiff failed to give the 

drug manufacturer notice of the claim); Ackermann v. Wyeth Pharms., 471 F. Supp. 2d 739, 745 

(E.D. Tex. 2006) (same); U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 199 (Tex. 

App.—Houston [1st Dist.] 2003, pet. denied). 

70 See Holland, 2007 U.S. Dist. LEXIS 84507 at *8 (citing U.S. Tire-Tech, 110 S.W.3d at 

199); Martin v. Home Depot U.S.A. Inc., 369 F. Supp. 2d 887, 893 (W.D. Tex. 2005). 

71 See Holland, 2007 U.S. Dist. LEXIS 84507 at *8 (relying on U.S. Tire Tech to grant 

summary judgment as to plaintiff’s breach of warranty claim). 

72 See Pls’ Second Am. Compl. at ¶¶ 3-4.7 (App. 50-54); see also Defs’ Answer to Pls’ 

Second Am. Compl. at ¶ 15 (App. 139). 

73 Palmco Corp., 983 F.2d at 685 (quoting Carroll Instr. Co. v. B.W.B. Controls, 677 

S.W.2d 654, 657 (Tex. App.—Houston [1st Dist.] 1984, no writ)). 

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