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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

A Reglan Lawsuit Where Identifying the Product is an Issue

Posted in Reglan / Metoclopramide

One of the things a plaintiff in a Reglan lawsuit will almost always have to prove is which manufacturer’s version of Reglan or Metoclopramide the plaintiff took.  While all versions of Metoclopramide have the same side effects, that usually isn’t enough to hold manufacturer A liable for injuries caused by manufacturer B’s product.

Good Metoclopramide lawyers know how to find out which brand of the drug that the plaintiff took.  However, sometimes things don’t work out as planned:

10. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research maintains a National Drug Code Directory (NDC Directory) that serves as a universal product identifier for prescription drugs. Each prescription drug product listed under Section 510 of the Federal Food, Drug and Cosmetic Act is assigned a unique number, called its National Drug Code (NDC) number. 21 CFR 207.35, (App. at 134-136).

11. The NDC number “00031-6701-63” was assigned to brand name Reglan(R) 10mg tablets manufactured by Wyeth. (Affidavit of Dwayne Clark Custodian of Pharmacy Records for SUPERVALUE INC., at 3, App. at 139).

12. The NDC number associated with prescription No. 6414839 is not assigned to Schwarz. ( Id. at 4) Instead, Schwarz' NDC number for Reglan 10mg tablets, after December 27, 2001 when Schwarz acquired the rights to Reglan(R), was “00091-6701-63.” ( Id.).

13. The inclusion of the “SCHWZ” notation on prescription No. 6414839 was an error in the Albertson's Sav-On Pharmacy ASDRx records; this error occurred during the company's conversion from the Zadall database to the ADSRx database, when data regarding manufacturer numbers was supplied by First Data Bank. ( Id. at 2-3, 4-5, App. at 138-141). When First Data Bank mistakenly associated the NDC number “00031-6701-63” (which is assigned to Wyeth) with Schwarz, the abbreviated name “SCHWZ” was automatically, and erroneously, substituted for Wyeth in the manufacturer field for the ADSRx database. ( Id. at 4-5, App. at 140-141).

If you need help determining which brand of Reglan or Metoclopramide you took, don’t hesitate to contact me.  I’d love to help you identify the product manufacturer and point you to a good lawyer.

TABLE OF CONTENTS

I. Summary … 1

II. Summary Judgment Standard … 2

III. The Lawsuit … 3

A. Undisputed Facts … 3

B. Plaintiffs Claims … 7

IV. Schwarz Is Entitled to Summary Judgment on All Plaintiffs Claims … 8

A. Schwarz Is Not Liable For Alleged Injuries Caused By Another Manufacturer's Product … 8

B. There Is No Legal Basis Under Texas Law For The Claim That A Generic Manufacturer's Reliance On Schwarz Renders Schwarz Liable For The Generic Manufacturer's Product … 10

C. Texas Law Is Consistent With Decisions From Across the Country That Have Uniformly Rejected the Theory That Brand Name Manufacturers Are Liable For Injuries Caused By Generic Products … 12

D. Plaintiff Cannot Maintain A Claim Under The Minnesota Consumer Protection Act Because He Never Purchased A Product Manufactured By Schwarz … 24

E. Plaintiff Cannot Maintain A Claim Against Schwarz For Injuries Allegedly Caused By Generic Metoclopramide, No Matter How He Frames His Theory … 25

V. Conclusion and Request for Relief … 27

Certificate of Service … 29

INDEX OF AUTHORITIES

Case

Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) … 3

Armstrong Rubber Co. v. Urquidez, 570 S.W.2d 374 (Tex. 1978) … 9

Barnhill v. Teva Pharm. USA, Inc., 2007 U.S. Dist. LEXIS 44718 (S.D.Ala. April 24, 2007) … 13

Beutella v. A.H. Robins Co., Inc., 05-C V-2372, 2001 WL 35669202 (Utah Dist. Ct. Dec. 10, 2001) … 13, 16

Block v. Wyeth, No. 3:02-CV- 1077, 2003 WL 203067 (N.D. Tex. Jan. 28, 2003) … 2, 1 1, 12, 23, 26, 27

Burnett v. Wyeth P harm., Inc., Civ. No. 06-4923, 2008 WL 732425 (D. Minn. Mar. 17, 2008) … 9, 24

Celotex Corp. v. Catrett, 477 U.S. 317 (1986) … 3

Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006) … 13, 14, 27

Conte v. Wyeth, Inc., CGC-04-437382 (Cal. Super. Ct. Jan. 29, 2007) … 13, 20

Cooperman v. R. G. Barry Corp., 775 F. Supp. 1211 (D. Minn. 1991) … 24

Firestone Steel Prod. Co. v. Barajas, 927 S.W.2d 608 (Tex. 1996) … 2, 10, 11, 12, 26

Flynn v. Am. Home Prods. Corp., 627 N.W.2d 342 (Minn. Ct. App. 2001) … 13

Foster v. Am. Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994) … 12, 14, 15, 16, 17, 18, 20, 26

Fricke v. Owens-Corning Fiberglass Corp., 618 So.2d 473 (La. App. 1993) … 19

Gaulding v. Celotex Corp., 772 S.W.2d 66 (Tex. 1989) … 9, 25

Goldych v. Eli Lilly & Co., No. 5:04-C V- 1477, 2006 WL 203 843 6 (N.D.N.Y. July 19, 2006) … 13

Green v. Wyeth Pharm., Inc., et al., CV-06-3917 ER (Ala. Cir. Ct. May 15, 2007) … 13, 21

In re Baycol Prods. Litig., 218 F.R.D. 197 (D. Minn. 2003) … 9

Kelly v. Wyeth, 03-C V-33 14, 2005 WL 4056740 (Super. Ct. Mass. May 6, 2005) … 13, 18

LeBlanc v. Wyeth, Inc., No. Civ. A 04-0611, 2006 WL 2883030 (W.D. La. Oct. 5, 2006) … 13, 19

Morris v. Wyeth, No. 1:07-CV- 176-R, 2008 WL 2677048 (W.D. Ky. June 30, 2008) … 12, 22, 23

Motor Exp., Inc. v. Rodriguez, 925 S.W.2d 63 8 (Tex. 1996) … 12

Nebraska v. Wyoming, 507 U.S. 584 (1993) … 3

Nesladek v. Ford Motor Co., 46 F.3d 734 (8th Cir. 1995) … 9

Nodak Mut. Ins. Co. v. Am. Family Mut. Ins. Co., 604 N.W.2d 91 (Minn. 2000) … 9

Pustejovsky v. Wyeth, No. 4:07-CV-103-Y, 2008 WL 1314902 (N.D. Tex. Apr. 30, 2008) … 2, 12, 23, 26

Roberts v. Bioplastics, No. 93-2967, 2000 WL 34487072 (E.D. La. Feb. 11, 2000) … 19

Sanchez v. Liggett & Myers, Inc., 187 F.3d 486 (5th Cir. 1999) … 10, 25

Sharp v. Leichus, 04-CA-643, 2006 WL 515532 (Fla. Cir. Ct. Feb. 17, 2006) aff'd per curiam, 952 So.2d 555 (Fla. 1st DCA 2007) … 13, 19, 20

Sharp v. Wyeth, 952 So.2d 555 (Fla. 1st DCA 2007) … 20

Sheeks v. Am. Home Prods. Corp., No. 02CV337, 2004 WL 4056060 (Colo. Dist. Ct. Oct. 15, 2004) … 13, 18

Sloan v. Wyeth, No. MRS-L- 1183-04 (N.J. Super Ct. Oct. 13, 2004) … 13, 17

Smith v. Wyeth, No. 5:07-C V-18-R, 2008 WL 2677051 (W.D. Ky. June 30, 2008) … 13, 22, 23

Swicegood v. PLIVA, Inc., 543 F. Supp. 1351 (N.D. Ga. 2008) … 13, 21, 22

Tarver v. Wyeth, No. Civ. A. 3 -04-203 6, 2005 WL 40523 82 (W.D. La. June 7, 2005) … 13, 18

Tarver v. Wyeth, Inc., No. Civ A. 3-04-2035, 2006 WL 1517546 (W.D. La. Jan. 26, 2006) … 19

Van Dusen v. Barrack, 3 76 U.S. 612 (1964) … 9

Wilson v. Wyeth, No. 3:07-CV-378-CV, 2008 WL 2677049 (W.D. Ky. June 30, 2008) … 13, 22, 23

Rules & Statutes

Fed. R. Civ. P. 56(c) … 3

Tex. Civ. Prac. & Rem. Code Sec. 82.00 1 (2) … 9

I. Summary

This is a products liability case. Plaintiff Paul Burnett alleges that he suffered injuries arising from his ingestion of the prescription drug Reglan(R) or its generic version, metoclopramide, from February 1, 2000 until August 24, 2003.[FN1] Plaintiff sued Schwarz Pharma, Inc. (“Schwarz”), and other manufacturers of brand name Reglan(R) and generic metoclopramide, alleging various products liability theories. (Plaintiffs First Amended Complaint for Damages [Pl.'s Compl.] at ¶¶ 58-122, App. at 19-38.)

    FN1. Paul Burnett's spouse also brings a claim for loss of consortium, but for ease of reference, Burnett will be referred to in the singular as “Plaintiff.” The First Amended Complaint alleges that Plaintiff took metoclopramide until January 2005, but at his deposition, Plaintiff established that he last took the drug on August 24, 2003, see Deposition of Paul Burnett, March 17, 2008 at 277:21-278:7, Appendix in Support of Motion for Summary Judgment (App.) at 49-50, a fact that was confirmed by his medical records. Medical Record of David Bragg, M.D., App. at 57-58.

The evidence adduced in discovery establishes that Schwarz did not manufacture or supply any of the drugs that Plaintiff ingested. Thus, as a matter of well-settled Texas law, previously applied in virtually identical circumstances by two courts in the Northern District of Texas, Schwarz cannot be held liable for Plaintiffs alleged injuries. Nonetheless, Plaintiff seeks recovery against Schwarz, claiming that Schwarz, as the manufacturer of brand name Reglan(R) during a portion of the period in question, is responsible for the warnings and information distributed by manufacturers of generic metoclopramide. Arguing that generic drug manufacturers foreseeably copied brand name Reglan(R)'s warnings for use with the generic product, Plaintiff asserts that a brand name manufacturer may be held liable for any deficiencies in those warnings that accompanied the generic product, and for any injuries resulting from a plaintiff's use of the generic drug.

In Firestone Steel Prod. Co. v. Barajas, 927 S.W.2d 608 (Tex. 1996), the Texas Supreme Court rejected the exact theory of liability Plaintiff advances against Schwarz in this case — that a product manufacturer has a duty to warn about another manufacturer's product. Applying that law, the Northern District of Texas ruled in 2003 that a previous manufacturer of brand name Reglan(R) (Wyeth) was not liable to a plaintiff who took only the generic version of the drug. Block v. Wyeth, No. 3:02-CV-1077-N, 2003 WL 203067 (N.D. Tex. Jan. 28, 2003). Earlier this year, a second court in the Northern District of Texas granted summary judgment in favor of Schwarz and Wyeth holding that neither company, as brand name Reglan(R) manufacturers, had a duty to warn a plaintiff who took only generic versions of the drug. Pustejovsky v. Wyeth, No. 4:07-CV-103-Y, 2008 WL 1314902 (N.D. Tex. Apr. 30, 2008). Every other court in the nation to address the issue has likewise rejected attempts to extend liability to brand name drug manufacturers for injuries allegedly sustained through a plaintiff's use of a generic-equivalent drug. Because Texas law does not recognize Plaintiff's theory of liability against Schwarz, Schwarz is entitled to summary judgment on all claims asserted against it.

II.

Summary Judgment Standard

Summary judgment is proper when it appears from the record “that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” FED. R. CIV. P. 56(c). The movant must identify those portions of the pleadings or other evidence that demonstrate the absence of a genuine issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986).

Once a proper motion has been made, the nonmoving party must present affirmative evidence, setting forth specific facts, to show the existence of a genuine issue for trial. See Celotex Corp., 477 U.S. at 322-23; Anderson, 477 U.S. at 247-48. “Summary judgment is mandated if the nonmovant fails to make a showing sufficient to establish the existence of an element essential to her case on which he bears the burden of proof at trial.” Nebraska v. Wyoming, 507 U.S. 584, 590 (1993).

III.

The Lawsuit

A. Undisputed Facts

Discovery on product identification is complete, and the following facts are undisputed:

1. On or about December 27, 2001, Schwarz acquired certain rights associated with brand name Reglan(R) tablets from former brand name manufacturer Wyeth. (Declaration of Jeff Siefert (“Siefert Decl.”), App. at 60.)

2. Schwarz manufactured brand name Reglan(R) tablets from December 27, 2001 through and including August 2003, the end of Plaintiff Paul Burnett's ingestion period. ( Id.)

3. Schwarz has never manufactured nor owned any rights associated with generic metoclopramide tablets. ( Id.)

4. During the time that Plaintiff took Reglan(R) or its generic formulation, from February 1, 2000 until August 24, 2003, he always filled his prescriptions at the Sav-On Pharmacy at Albertsons in Garland, Texas. (Deposition of Paul Burnett, July 17, 2008 at 180:6-15; 331:19-332:6, App. at 50, 54).

5. Plaintiff's first prescription for Reglan(R) or generic metoclopramide was filled on February 1, 2000; his last prescription for Reglan(R) or generic metoclopramide was filled on August 7, 2003. ( Id. at 288:12-16; Records attached to Plaintiffs' Notice of Product Identification Obtained from Albertson's Pharmacy Archives, at Bates Nos. PROD ID 10, PROD ID 30 (“Pharmacy Records”), App. at 70, 90;[FN2] Summary Chart of Reglan(R) Prescriptions, App. at 129-133).[FN3]

    FN2. These records were produced by Plaintiff and attached to Plaintiffs' Notice of Product Identification Obtained from Albertson's Pharmacy Archives, Docket No. 22, in Civil Action No. 06-4923 DWF/SRN, while this case was pending in the United States District Court for the District of Minnesota.

    FN3. This summary chart was prepared by defense counsel to assist the Court's review of the Pharmacy records, and is accompanied by a key provided to the Court explaining the relevant entries in the Pharmacy Records.

6. The pharmacy records of Sav-On Pharmacy at Albertsons for Plaintiff are comprised of records from the “Zadall” computer database for the period January 1, 1999 – December 31, 2000 and from the “ASDRx” computer database for the period January 1, 2000 – December 31, 2006. (Pharmacy Records at Bates No. PROD ID 4-67, App. at 64-127).

7. The pharmacy records of Sav-On Pharmacy at Albertsons from the ASDRx computer database contain one entry for prescription No. 6414839 that suggests that a prescription written by Dr. David Bragg on February 1, 2000, was filled with “Reglan 10mg tablet” on June 6, 2000; in the column that lists the manufacturer of the product that the pharmacy dispensed, it includes the name “SCHWZ.” (Pharmacy Records at Bates No. PROD ID 14, App. at 74).

8. Schwarz did not acquire rights to Reglan(R) until December 27, 2001 (Siefert Decl., App. at 60); therefore, Reglan(R) dispensed on June 6, 2000 could not have been manufactured or distributed by Schwarz.

9. The ASDRx pharmacy records of Sav-On Pharmacy at Albertsons for prescription No. 6414839 also contains a drug manufacturer identifier number of “000031-6701-63”, referred to as its “NDC” number. (Pharmacy Records at Bates No. PROD ID 14, App. at 74).

10. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research maintains a National Drug Code Directory (NDC Directory) that serves as a universal product identifier for prescription drugs. Each prescription drug product listed under Section 510 of the Federal Food, Drug and Cosmetic Act is assigned a unique number, called its National Drug Code (NDC) number. 21 CFR 207.35, (App. at 134-136).

11. The NDC number “00031-6701-63” was assigned to brand name Reglan(R) 10mg tablets manufactured by Wyeth. (Affidavit of Dwayne Clark Custodian of Pharmacy Records for SUPERVALUE INC., at 3, App. at 139).

12. The NDC number associated with prescription No. 6414839 is not assigned to Schwarz. ( Id. at 4) Instead, Schwarz' NDC number for Reglan 10mg tablets, after December 27, 2001 when Schwarz acquired the rights to Reglan(R), was “00091-6701-63.” ( Id.).

13. The inclusion of the “SCHWZ” notation on prescription No. 6414839 was an error in the Albertson's Sav-On Pharmacy ASDRx records; this error occurred during the company's conversion from the Zadall database to the ADSRx database, when data regarding manufacturer numbers was supplied by First Data Bank. ( Id. at 2-3, 4-5, App. at 138-141). When First Data Bank mistakenly associated the NDC number “00031-6701-63” (which is assigned to Wyeth) with Schwarz, the abbreviated name “SCHWZ” was automatically, and erroneously, substituted for Wyeth in the manufacturer field for the ADSRx database. ( Id. at 4-5, App. at 140-141).

14. Based upon the NDC numbers that were assigned to the brand name Reglan(R) manufactured by Wyeth and Schwarz, this was a misidentification of Schwarz by First Data Bank. ( Id., App. at 140-141).

15. Indeed, the record for prescription No. 6414839 in the Albertson's Sav-On Pharmacy Zadall database — the entry created at the time the prescription was filled — indicates that the Reglan(R) dispensed to Plaintiff on June 6, 2000 was identified by the NDC number “00031-6701-63”, which is the NDC assigned to brand name Reglan(R) 10mg tablets manufactured by Wyeth. ( Id. at 4, App. at 140). Further, the Zadall records identify “RO” as the manufacturer of the Reglan(R) dispensed to Plaintiff on June 6, 2000; “RO” is a shorthand notation for A.H. Robins, who manufactured name brand Reglan(R) tablets prior to Wyeth and under whose name Wyeth marketed the drug. ( Id. at 3, App. at 139).

16. No other entry in the pharmacy records from the ADSRx database (or the Zadall database) reflects that Paul Burnett purchased brand name Reglan(R) manufactured by Schwarz. ( Id. at 5, App. at 141).

17. According to these pharmacy records, Plaintiff purchased brand name metoclopramide manufactured by Wyeth (NDC No. 00031-6701-63), and generic metoclopramide manufactured by ESI Lederle, Inc. (NDC No. 59911-5815-02), Teva Pharmaceuticals, USA, Inc. (NDC Nos. 00093-2203-10; 00093-2203-05), and Pliva, Inc. (NDC No. 50111-0430-02) ( Id. at 5).

18. None of the Reglan(R) or generic metoclopramide Plaintiff purportedly used was manufactured or marketed by Schwarz.[FN4]

    FN4. In their Notice, Plaintiffs also indicated that Mr. Burnett may have ingested drugs manufactured by the Defendants during a hospital stay. However, hospital records produced by Plaintiffs do not indicate any provision to Mr. Burnett of a Schwarz product.

B. Plaintiff's Claims

Plaintiff alleges that Schwarz and other defendants manufactured and distributed the prescription drug Reglan(R) and its generic equivalent, metoclopramide. Plaintiff alleges that he took brand name Reglan(R) and/or generic metoclopramide tablets manufactured or marketed by these defendants. (Pl.'s Compl. at ¶¶ 47-50, App. at 16-17). He asserts claims against each of the defendants for strict liability, negligence, fraudulent concealment, breach of warranties, and unfair trade practices in connection with the manufacture or distribution of the drugs that purportedly injured him. ( Id. at ¶¶ 58-92, 120-152, 158-163, App. at 19-29, 37-42, 44-45).

Plaintiff also brings claims against Schwarz and Wyeth, the brand name manufacturers, for negligent misrepresentation and fraudulent concealment, and against Wyeth for negligence, claiming that they, as marketers of brand name Reglan(R), are liable for the generic manufacturers' alleged failure to provide adequate warnings about the risks associated with the use of generic metoclopramide product. ( Id. at ¶¶ 93-102, 103-119, 153-157; App. at 29-36, 42-43). Plaintiff argues that the brand name marketers knew or should have known that the generic manufacturers would rely upon and use the brand name marketers' warnings in selling generic versions of the drug. He further claims that the brand name marketers knew both that prescribing physicians would rely upon the brand name marketers' warnings and information to prescribe the product, and that pharmacies would dispense the generic formulation. ( Id. at ¶ 109; App. at 33). Thus, Plaintiff asserts, Schwarz is liable for the actions and products of the generic manufacturers, and, as a consequence, is liable to him for his use of generic metoclopramide.

IV.

Schwarz Is Entitled to Summary Judgment on All Plaintiff's Claims

A. Schwarz Is Not Liable For Alleged Injuries Caused By Another Manufacturer's Product.

The undisputed evidence in this case establishes that Schwarz did not manufacture or market the drugs that Plaintiff ingested. Therefore, Schwarz cannot be liable under Texas law for Plaintiff's alleged injuries.[FN5]

    FN5. Texas law, the location of Plaintiff's residence and the place where he took the drugs and allegedly was injured, applies to this case transferred from Minnesota. Van Dusen v. Barrack, 376 U.S. 612 (1964) requires the court to apply the state law that the transferee court in Minnesota would have applied had there been no venue transfer. Thus, this court must apply Minnesota's choice-of-law rules. Minnesota applies “the significant contacts test” to determine which jurisdiction's substantive law applies, Nodak Mut. Ins. Co. v. Am. Family Mut. Ins. Co., 604 N.W.2d 91, 94 (Minn. 2000), and federal courts applying this test have held that in a personal injury, products liability case, the law of the venue where the plaintiffs reside and where the events giving rise to the lawsuit occurred should apply. Nesladek v. Ford Motor Co., 46 F.3d 734, 738-41 (8th Cir. 1995) (holding Nebraska substantive law applicable under Minnesota's choice-of-law rules in product liability wrongful death lawsuit where injuries and almost all other events giving rise to the lawsuit occurred in Nebraska); In re Baycol Prods. Litig., 218 F.R.D. 197, 207 (D. Minn. 2003) (holding that the law of the state of the plaintiffs' residence and location of their injuries was applicable under Minnesota's choice-of-law rules in prescription drug product liability litigation). As the Minnesota district court stated in its transfer order, “… this case bears little or no connection to Minnesota …. There is no question that this action lacks any meaningful connection to Minnesota.” Burnett v. Wyeth Pharm., Inc., Civ. No. 06-4923, 2008 WL 732425, at *1 (D. Minn. Mar. 17, 2008).

Each of Plaintiff's theories of liability against Schwarz is barred. Under Texas law, his claims constitute a “products liability action” under statute. Section 82.001(2) of the Texas Civil Practice and Remedies Code provides that:

“Products liability action” means any action against a manufacturer or seller for recovery of damages arising out of personal injury … allegedly caused by a defective product 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 Ann. § 82.001(2) (Vernon 2005).

Texas law precludes the imposition of products liability on a defendant who did not manufacture or distribute the product that allegedly caused the plaintiffs injuries. “A fundamental principle of traditional products liability law is that the plaintiff must prove that the defendants supplied the product which caused the injury.” Gaulding v. Celotex Corp., 772 S.W.2d 66, 68 (Tex. 1989). Put differently, products liability “rests on the defendant ‘placing into the stream of commerce a product which is demonstrated at trial to have been dangerous.’ ” Armstrong Rubber Co. v. Urquidez, 570 S.W.2d 374, 376 (Tex. 1978). The Fifth Circuit similarly has recognized that under Texas products liability law, no liability attaches to a defendant who did not manufacture the product at issue. Sanchez v. Liggett & Myers, Inc., 187 F.3d 486, 491 (5th Cir. 1999).
B. There Is No Legal Basis Under Texas Law For The Claim That A Generic Manufacturer's Reliance On Schwarz Renders Schwarz Liable For The Generic Manufacturer's Product.

Even though well-settled Texas law bars his claims against Schwarz, Plaintiff seeks to impose liability on Schwarz for an injury allegedly caused by his use of generic metoclopramide, which Schwarz did not manufacture or market, because the generic manufacturer used the brand name drug's warnings in marketing the generic version of the drug. This theory of derivative liability finds no support in Texas law, and therefore, Schwarz cannot be held liable for any alleged injuries caused by a product it did not supply. Another manufacturer's decision to use the language contained in Schwarz's warnings does not create liability on the part of Schwarz for injuries caused by that other manufacturer's product.

The Texas Supreme Court has rejected the type of derivative claims that Plaintiff asserts against Schwarz. In Firestone Steel Prod. Co. v. Barajas, 927 S.W.2d 608 (Tex. 1996), the plaintiffs' son was fatally injured by a defective automobile wheel manufactured by defendant Kelsey-Hayes. The plaintiffs claimed that defendant Firestone was liable for their son's injuries, because Firestone formulated the design that it licensed to Kelsey-Hayes, who then relied on that design in manufacturing the allegedly defective wheel. The Texas Supreme Court rejected this theory of derivative liability, holding that “Firestone proved that it did not supply the product that caused [the decedent's] death.” Firestone Steel Prod. Co., 927 S.W.2d at 616. The court then held that “[a] manufacturer does not have a duty to warn or instruct about another manufacturer's product, though those products might be used in connection with the manufacturer's own products.” Id. (emphasis added).

In 2003, in a case also involving name brand Reglan(R) and generic metoclopramide, a court in the Northern District of Texas reiterated that no such duty exists under Texas law. In Block v. Wyeth, No. 3:02-CV-1077, 2003 WL 203067 (N.D. Tex. Jan. 28, 2003), App. at 203-204, the plaintiff ingested only generic metoclopramide that was not manufactured by the defendant Wyeth, but he nevertheless sued Wyeth, as Reglan(R)'s developer, for injuries he allegedly sustained from use of the generic product. The plaintiff asserted claims for strict liability, as well as negligence, negligent misrepresentation, fraud, conspiracy, and malice, alleging that his injury was a foreseeable consequence of Wyeth's allegedly inadequate warnings about Reglan(R), a product that he did not use. The Court found Barajas controlling, and held that Wyeth had no legal duty to consumers of a generic equivalent “arising out of the content of product labeling and descriptions formulated for the name brand drug.” Block, 2003 WL 203067, at *1-*3, App. at 203-204. The Court further ruled that all of plaintiff's theories of liability failed given this lack of duty, and granted Wyeth's motion to dismiss for failure to state a claim. In so doing, the Court expressly declined the plaintiff's invitation “to extend Texas law into new and uncharted territory.” Id. at *2-*3, App. at 203-204.

Earlier this year, another court in the Northern District of Texas granted summary judgment for Schwarz and Wyeth in a case where the evidence established that the plaintiff took only generic metoclopramide that had not been manufactured by the Reglan(R) brand name marketers. Pustejovsky v. Wyeth, No.4:07-CV-103-Y, 2008 WL 1314902 at *2 (N.D. Tex. April 3, 2003), App. at 206-207. Citing Barajas, Block, and other cases, the Pustejovsky court ruled that “the manufacturer of a name-brand drug does not owe a legal duty to a consumer of a generic drug,” and therefore the generic consumer could not maintain a products liability claim against them. Id. at *2.

The present case is identical in all material respects to Block and Pustejovsky: the evidence establishes that Schwarz did not manufacture or distribute the products that Plaintiff used, and, therefore, Schwarz cannot be liable to Plaintiff for the alleged injuries caused by his use of another manufacturer's product. This Court should reject Plaintiff's request to dramatically and without precedent extend Texas tort liability to reach a manufacturer who did not supply the product that allegedly caused his injuries.[FN6]

    FN6. Because Plaintiff Paul Burnett's claims against Schwarz fail as a matter of law, the claim asserted by his wife, should also be dismissed. See Motor Exp., Inc. v. Rodriguez, 925 S.W.2d 638, 640 (Tex. 1996).

C. Texas Law Is Consistent With Decisions From Across the Country That Have Uniformly Rejected The Theory That Brand Name Manufacturers Are Liable For Injuries Caused By Generic Products.

Texas law as articulated by the Texas Supreme Court (and as applied in Block and Pustejovsky) is consistent with the rulings of courts throughout the country that have rejected the contention that a brand name prescription drug manufacturer can be liable for injuries caused by the plaintiff's ingestion of the generic form of the drug. Every other court that has confronted the issue has held that a brand name manufacturer cannot be held liable for a plaintiff's injuries caused by the ingestion of a generic manufacturer's product. See Foster v. Am. Home Prods. Corp., 29 F.3d 165, 171 (4th Cir. 1994); Morris v. Wyeth, No. 1:07-CV-176-R, 2008 WL 2677048 (W.D. Ky. June 30, 2008), App. at 208-211; Wilson v. Wyeth, No. 3:07-CV-378-CV, 2008 WL 2677049 (W.D. Ky. June 30, 2008), App. at 212-215; Smith v. Wyeth, No. 5:07-CV-18-R, 2008 WL 2677051 (W.D. Ky. June 30, 2008), App. at 216-219; Swicegood v. Pliva, Inc., 543 F. Supp. 1351 (N.D. Ga. 2008); Barnhill v. Teva Pharm. USA, Inc., 2007 U.S. Dist. LEXIS 44718 (S.D. Ala. April 24, 2007), App. at 220-233; LeBlanc v. Wyeth, Inc., No. Civ. A 04-0611, 2006 WL 2883030, at *6 (W.D. La. Oct. 5, 2006), App. at 238; Goldych v. Eli Lilly & Co., No. 5:04-CV-1477, 2006 WL 2038436, at *3-*6 (N.D.N.Y. July 19, 2006), App. at 241-245; Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 540-41 (E.D. Pa. 2006); Tarver v. Wyeth, No. Civ. A. 3-04-2036, 2005 WL 4052382, at *2 (W.D. La. June 7, 2005), App. at 249; Flynn v. Am. Home Prods. Corp., 627 N.W. 2d 342, 350 (Minn. Ct. App. 2001), App. at 251-259; Sharp v. Leichus, 04-CA-643, 2006 WL 515532, at *4 (Fla. Cir. Ct. Feb. 17, 2006), App. at 262-263, aff'd per curiam, 952 So.2d 555 (Fla. 1st DCA 2007); Green v. Wyeth Pharm., Inc., et al., CV-06-3917 ER, Order at 1 (Ala. Cir. Ct. May 15, 2007), App. at 268; Conte v. Wyeth, Inc., CGC-04-437382 (Cal. Super. Ct. Jan. 29, 2007), App. at 269-275; Kelly v. Wyeth, 03-CV-3314, 2005 WL 4056740, at *2 (Super. Ct. Mass. May 6, 2005), App. at 277-278; Sheeks v. Am. Home Prods. Corp., No. 02CV337, 2004 WL 4056060, at *2 (Colo. Dist. Ct. Oct. 15, 2004), App. at 281-282; Sloan v. Wyeth, No. MRS-L-1183-04, slip op. at 5 (N.J. Super Ct. Oct. 13, 2004), App. at 287; Beutella v. A.H. Robins Co., Inc., 05-CV-2372, 2001 WL 35669202, at *2 (Utah Dist. Ct. Dec. 10, 2001), App. at 294. Thus, courts have rejected such claims under the laws of 15 different states (Alabama, California, Colorado, Florida, Georgia, Louisiana, Maryland, Massachusetts, Kentucky, Minnesota, New Jersey, New York, Pennsylvania, Texas and Utah). There is not a single decision to the contrary.

Further, as explained below, twelve courts in eleven different states specifically have held that Schwarz and/or Wyeth, as the manufacturers of name brand Reglan(R), may not be held liable for any alleged injuries caused by the ingestion of generic metoclopramide.
1. Foster – The Leading And Universally Accepted Authority.

The leading case on whether a name brand manufacturer can be held liable for injuries allegedly resulting from the use of a generic equivalent drug is Foster, which has been adopted by every court that has addressed the issue. Colacicco, 432 F. Supp. 2d at 540 (“a review of caselaw [sic] reveals that every state and federal district which has confronted the issue of innovator drug-manufacturer liability has either adopted the Foster reasoning or cited Foster with approval”).

In Foster, the parents of a child who died after ingesting generic promethazine brought suit against Wyeth, the manufacturer of Phenergan(R), the name brand version of the drug. Id. at 167. Even though the parents conceded that only the generic product had been ingested, they argued (as Plaintiffs do in this case) that Wyeth, as the name brand manufacturer, could be held liable because it knew that generic manufacturers were using and relying upon Wyeth's exact same product warning information. Id. at 168. Thus, to the extent that there was any defect in that warning, the plaintiffs argued that Wyeth was liable for the decedent's injuries:

The [plaintiffs] argue that because generic drugs are required by federal law to be equivalent to their name brand counterparts, any representations Wyeth makes when advertising Phenergan also apply to generic promethazine, and name brand manufacturers, such as Wyeth, know that generic manufacturers rely on their studies and duplicate their labeling, and that if the name brand manufacturer does not issue a warning, it will simply not be made. Wyeth is also aware that when Phenergan is prescribed, the patient may actually receive generic promethazine.

Id. at 169 (emphasis added).

The Fourth Circuit rejected the Fosters' argument and ruled that one manufacturer cannot be held liable for injuries resulting from another manufacturer's product:

The [plaintiffs] are attempting to hold Wyeth liable for injuries caused by another manufacturer's product, and we are persuaded that Maryland courts would reject this effort to circumvent the necessity that a defendant be shown to have manufactured the product that caused an injury prior to being held liable for such injury.

Id. at 168 (emphasis added).

Explaining its decision, the Fourth Circuit noted that generic manufacturers are independently responsible for issuing adequate warnings about their products:

We do not accept the assertion that a generic manufacturer is not responsible for negligent misrepresentations on its product labels if it did not initially formulate the warnings and representations itself. When a generic manufacturer adopts a name brand manufacturer's warnings and representations without independent investigation, it does so at the risk that such warnings and representations may be flawed.

* * *

Manufacturers of generic drugs, like all other manufacturers, are responsible for the representations they make regarding their products.

Id. at 169, 170 (emphasis added).

The court then specifically held that name brand manufacturers cannot be held liable for injuries allegedly caused by a generic manufacturer's product:

We also reject the contention that a name brand manufacturer's statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer's drug.

* * *

There is no legal precedent for using a name brand manufacturer's statements about its own product as a basis for liability for injuries caused by other manufacturers' products, over whose production the name brand manufacturer has no control.

* * *

The [plaintiffs'] negligent misrepresentation action against Wyeth also fails because Wyeth is under no duty of care to the [plaintiffs].

* * *

We think to impose a duty in the circumstances of this case would be to stretch the concept of foreseeability too far.

* * *

Id. at 170, 171 (emphasis added).

The Foster decision is consistent with Texas law. It has been universally accepted and applied, including in fifteen cases involving generic metoclopramide. In those fifteen cases, as in the case at hand, plaintiffs asked the courts to hold Schwarz and/or Wyeth liable for “fraud” or “misrepresentation” for injuries resulting from the ingestion of generic metoclopramide. As explained below, each court refused.
2. Beutella (Utah) – Rejected These Same Claims.

In Beutella, the court held that A.H. Robins (a Wyeth predecessor company) owed no duty to a patient who consumed only generic metoclopramide. 2001 WL 35669902, at *3, App. at 294-295. The plaintiff in Beutella admitted “that all of the metoclopramide she ingested were generic equivalents of the drug and that she had not take[n] any Reglan manufactured by [defendants].” Id. at *2. As a result, the court adopted the reasoning and holding of Foster — that a name brand manufacturer may not be held liable for injuries caused solely by the ingestion of generic metoclopramide: “This Court is persuaded that the conclusions of the Foster case are sound and reasonable, and are sufficiently similar to this case to impel the same conclusion here.” Id. at *3.
3. Sloan (New Jersey) – Rejected These Same Claims.

In Sloan, a New Jersey court rejected plaintiff's attempt to avoid the application of New Jersey product liability doctrine to injury claims arising from metoclopramide use “by asserting that there is a distinction to be drawn by the Court, that defendant Wyeth was a ‘disseminator’ of negligently false and misleading information, rather than a ‘manufacturer’ of a defective product.” Docket No. MRS-L-1183-04, slip. op. at 5, App. at 287. Notwithstanding this argument, the court held that “nothing before it allows for any viable argument that either New Jersey or the Federal authorities intended to expand prescription drug manufacturer liability to injuries sustained by consumers of products manufactured by generic drug companies, which use formulations developed by the brand name company.” Id. at 9. The Sloan court also rejected the argument that a duty arose “because the plaintiff's physicians, who prescribed the drug, relied on information derived from Wyeth which that defendant promulgated in connection with its brand name products Reglan.” Id. at 2. The court reasoned that imposing a duty would place an undue burden on name brand manufacturers because they “would be less likely to develop new products if liability were imposed upon these companies for injuries wrought by products of generic manufacturers.” Id. at 9.
4. Sheeks (Colorado) – Rejected These Same Claims.

A court in Colorado rejected the same claims in Sheeks, holding that “[r]egardless of how termed, the action brought by the [plaintiffs] is a product liability action.” 2004 WL 4056060, at * 1, App. at 281. In Sheeks, it was undisputed that Wyeth did not make or sell the generic metoclopramide allegedly ingested. Id. As a result, the application of Colorado law imposing liability only on the manufacturer of the product used by plaintiff barred the plaintiffs' claims. Id. The court further held that “Wyeth owed no duty to Plaintiffs to warn of a drug that it did not manufacture or supply.” Id. at *2.
5. Kelly (Massachusetts) – Rejected These Same Claims.

In Kelly, the court rejected plaintiffs' argument that Wyeth, as the brand name manufacturer, had “a duty towards patients for whom, not only Regian [sic] is prescribed, but also towards those who actually ingest a pharmecologically [sic] identical generic equivalent.” 2005 WL 4056740, at *3, App. at 278. Relying heavily on Foster, the court observed:

The statutory scheme governing premarketing approval for drugs simply does not evidence Congressional intent to insulate generic drug manufacturers from liability for misrepresentations made regarding their products, or to otherwise alter state product liability law. Manufacturers of generic drugs, like all other manufacturers, are responsible for the representations they make regarding their products.

Id. at *5 (quoting Foster, 29 F.3d at 168).
6. Tarver (Louisiana) – Rejected These Same Claims.

In Tarver, yet another court rejected an attempt to impose liability on a name brand manufacturer, in this instance Schwarz, when the plaintiff ingested only generic metoclopramide. Plaintiffs argued that the claim was for negligent misrepresentation rather than a products-based claim subject to the requirements of products liability law. See Tarver, 2005 WL 4052382, at *3, App. at 249-250. The court disagreed, holding: “The claim in this case is that plaintiff was injured by a product which should not have injured her. It is, therefore, a products liability case, regardless of who are the defendants.” Id. The court further pointed out: “The law is clear that Louisiana imposes on a manufacturer no duty to warn of the dangers of another company's product.” Id. at *2 (citing Fricke v. Owens-Corning Fiberglass Corp., 618 So. 2d 473 (La. App. 1993); Roberts v. Bioplastics, No. 93-2967, 2000 WL 34487072 (E.D. La. Feb. 11, 2000)).[FN7]

    FN7. The Court's holding in Tarver has since been relied upon by the court in LeBlanc which dismissed claims against the manufacturer of name brand Cordarone(R) when only a generic version of that drug had been ingested. 2006 WL 2883030, at *6, App. at 238.

Having rejected the plaintiff's attempt to impose liability on Schwarz, the Tarver court subsequently granted Wyeth's motion for judgment on the pleadings on the same basis. Tarver v. Wyeth, Inc., No. Civ A. 3-04-2035, 2006 WL 1517546, at *2-*3 (W.D. La. Jan. 26, 2006), App. at 297-298.
7. Sharp (Florida) – Rejected These Same Claims.

A Florida court entered summary judgment in favor of Wyeth and Schwarz on the plaintiffs' claims for fraud/intentional misrepresentation, negligent misrepresentation, and fraud by concealment involving Reglan(R) and generic metoclopramide, noting: “It is abundantly clear that the Plaintiffs' case is, in fact, a products liability case.” Sharp, 2006 WL 515532, at *6, App. at 264-265. Further, in response to the plaintiffs' argument that Wyeth and Schwarz owed a duty of care to patients who might consume the generic equivalents of branded Reglan(R), the court noted that “a legal duty is not established by evidence of foreseeability alone.” Id. at *7 (citations omitted). Rather, the court stated, “there must also be evidence or allegations showing that … defendant's conduct created or controlled the risk.” Id. (citations omitted).

The plaintiffs did not allege, nor could they, that Wyeth or Schwarz were in a position to create or control the generic manufacturer's making or distribution of generic metoclopramide. Id. Moreover, the Sharp court rejected the idea that, based on a market share liability theory, a plaintiff may impose liability on two manufacturers that can show they did not manufacture a drug ingested by plaintiff. Id. at *3.

On January 22, 2007, the First District Court of Appeals affirmed the Sharp court's grant of final summary judgment in favor of Wyeth and Schwarz per curiam. See Sharp v. Wyeth, 952 So.2d 555 (Fla. 1st DCA 2007) ( per curiam). Seeing no need to issue a written opinion in support of its ruling, the First District Court of Appeals simply cited to Foster, signifying the Court's wholesale adoption of the reasoning and analysis of the Foster case. See id. at 555.
8. Conte (California) – Rejected These Same Claims.

The Superior Court of the State of California for the County of San Francisco granted summary judgment in favor of Wyeth on plaintiff's claims that Wyeth “disseminated fraudulent and misleading information” about Reglan. Conte, CGC-04-437382 at 2, App. at 270. Plaintiff allegedly suffered neurological damage after ingesting generic metoclopramide. The court emphasized that Wyeth “had no connection with plaintiff's injuries save the fact it developed the product and prepared the description and other pharmaceutical literature on the drug Reglan when the Food and Drug Administration approved it.” Id. at 4. The court ruled that Wyeth had no duty to plaintiff because she never ingested Wyeth's product. Further, the judge noted that to impose liability on Wyeth would violate public policy by making Wyeth the insurer for its competitors' products. In addition, it would “tend to discourage development of new drugs because of the unlimited exposure to the non-benefiting developer of the original product.” Id. at 7. Thus, public policy requires a generic manufacturer to be responsible for its own products.
9. Green (Alabama) – Rejected These Same Claims.

Plaintiffs' lawyers attempted to assert claims for fraud, negligent misrepresentation and strict liability against Wyeth and Schwarz in Alabama even though “Wyeth and Schwarz did not manufacture the [Reglan(R)] syrup formulation ingested by plaintiff, Tyler Green.” Green v. Wyeth Pharmaceuticals, Inc., CV-06-3917 ER, Order at 1, App. at 268. Remarking that the courts “that have considered the issues presented in this case have found that only the manufacturer of the generic drug which was sold [is] liable,” the Alabama court granted summary judgment in favor of Wyeth and Schwarz and rejected those plaintiffs' claims. Id.
10. Swicegood (Georgia) – Rejected These Same Claims.

Approximately four months ago, a federal court applying Georgia law dismissed strict liability, negligence, misrepresentation, concealment and breach of implied warranty claims against Wyeth and Schwarz in the Reglan(R)/generic metoclopramide context. “This Court joins with other courts nationwide in rejecting the claim that the manufacturer of the branded product is liable for misrepresentation in the labeling of the generic product.” Swicegood, 543 F. Supp. 2d at 1358. (citing Foster with approval). In Swicegood, it was undisputed that the plaintiff did not ingest a metoclopramide product manufactured or distributed by Wyeth or Schwarz. Notwithstanding this fact, the plaintiff once again sought to rely on the theory that had repeatedly failed before — that Wyeth and Schwarz, as the brand name manufacturers, could be held liable for statements contained in the label of the generic metoclopramide that the plaintiff actually ingested. Id. at 1354. Plaintiff fared no better in Swicegood: as Judge Thrash systematically rebutted and dismissed each of plaintiff's claims under Georgia law. Id. at 1356 (concluding that the FDA regulations for prescription drug labeling do “not require a name brand manufacturer to ensure that the generic brand's label is accurate.”).
11. Smith, Wilson and Morris (Kentucky) – Rejected These Same Claims.

Most recently, a Kentucky federal court dismissed various product liability claims asserted against Wyeth and Schwarz, as the name brand manufacturers of Reglan(R), by three plaintiffs who had consumed only generic metoclopramide. See Smith, 2008 WL 2677051, at *4; Wilson, 2008 WL 2677049, at *4; Morris, 2008 WL 2677048, at *4. In each case, Judge Thomas B. Russell concluded that: “As a product liability action under Kentucky law, Plaintiff must show that Reglan was the legal cause of her [Tardive Dyskinesia]. Because Plaintiff does not allege that [Plaintiff] ever took Reglan, [Plaintiff] has not alleged a claim under Kentucky products liability law.” Smith, 2008 WL 2677051, at *3; Wilson, 2008 WL 2677049, at *2; see also Morris, 2008 WL 2677048, at *3.

Further, Judge Russell rejected plaintiffs' argument that Schwarz's and Wyeth's respective warnings, labeling and marketing concerning Reglan(R) “should also be seen as the warning, labeling and marketing of products manufactured by companies that are Defendants' direct competitors in the prescription drug market.” Smith, 2008 WL 2677051, at *3; Wilson, 2008 WL 2677049, at *3; Morris, 2008 WL 2677048, at *3 . “Upon examination of applicable Kentucky law, the Court finds that in the generic drug context, Kentucky does not recognizes [sic] a cause of action against a manufacturer for its representations concerning its own product, based on an injury caused from the use of another manufacturer's product.” Smith, 2008 WL 2677051, at *4; Wilson, 2008 WL 2677049, at *4; Morris, 2008 WL 2677048, at *4.
12. Block (Texas) – Rejected These Same Claims

As set forth in Sec. IV. B., supra, this Court held that a plaintiff's allegation that Wyeth was liable for a generic manufacturer's sale of metoclopramide failed to state a claim and dismissed the suit against Wyeth.
13. Pustejovsky (Texas) – Rejected These Same Claims

As set forth in Sec. IV. B., supra, a court in the Northern District of Texas granted summary judgment for Schwarz and Wyeth, where the evidence demonstrated that the plaintiff did not ingest their drugs. The court specifically rejected the plaintiff's claims that they could be liable under Texas law as brand name manufacturers, absent the plaintiff's use of their products.
D. Plaintiff Cannot Maintain A Claim Under The Minnesota Consumer Protection Act Because He Never Purchased A Product Manufactured By Schwarz.

In addition, Count 5 of the Amended Complaint asserts a cause of action against Schwarz under the Minnesota Consumer Protection Act (a/k/a Minnesota Consumer Fraud Act). (Pl.'s Compl. at 142-52, Docket No. 18) Here, however, Plaintiff– who did not purchase any name brand Reglan(R) tablets manufactured by Schwarz — has no standing to assert a claim under the Minnesota Consumer Protection Act. See id. (dismissing claim under the Minnesota Consumer Protection Act because plaintiff did not allege it was a consumer of the services provided by defendant and therefore did not have standing to bring such a claim); Cooperman v. R.G. Barry Corp., 775 F. Supp. 1211, 1213-14 (D. Minn. 1991) (holding that a representative of a manufacturer had no standing to assert a claim under the consumer protection act because the alleged fraud did not occur in a sale of merchandise between a seller and a buyer. “Plaintiff itself has bought nothing, and has encountered no fraud in the context of a sale.”). Accordingly, Plaintiffs claim under the Minnesota Consumer Protection Act fails.

Further, Plaintiff is not a Minnesota resident nor has he averred any other nexus between himself (or his wife or doctor) and Minnesota. See Burnett v. Wyeth Pharm., Inc., No. 06-4923 (DWF/SRN), 2008 WL 732425, at *1 (D.Minn. Mar. 17, 2008) (“Plaintiffs are residents of Texas and do not reside in or have any apparent connection to Minnesota”). In other words, any alleged representations purportedly made by Schwarz in the State of Minnesota neither induced Mr. Burnett, a Texas citizen, who filled his prescriptions at a Texas pharmacy, to purchase metoclopramide or his doctor, a Texas practitioner, to prescribe metoclopramide. Indeed, as an out-of-state purchaser of another manufacturer's product, Plaintiff likewise has no grounds for asserting a claim on behalf of unidentified in-state consumers.[FN8]

    FN8. Similarly, if Plaintiff, as a Texas resident, had sought to assert a claim under Texas' corollary, the Texas Deceptive Trade Practice Act (“DTPA”), such a claim could not stand. As the Fifth Circuit observed in dismissing claims against cigarette manufacturers: “A DTPA claim requires an underlying consumer transaction; there must be a nexus between the consumer, the transaction, and the defendant's conduct. There is no consumer transaction involving the non-manufacturer defendants.” Sanchez, 187 F.3d at 491 (citations omitted). Here, because Plaintiff did not ingest a Schwarz product, there cannot be any nexus between Plaintiff and Schwarz.

E. Plaintiff Cannot Maintain a Claim Against Schwarz for Injuries Allegedly Caused by Generic Metoclopramide, No Matter How He Frames His Theory.

Despite the fact that all fifteen previous attempts to hold Schwarz or Wyeth liable for injuries allegedly caused by generic metoclopramide have failed, Plaintiff comes before this Court with the same arguments made and rejected in each of the previous cases. The result in this case should be the same — Plaintiff should not be allowed to impose liability on Schwarz when he did not ingest Schwarz's products, no matter how Plaintiff tries to frame his liability theory.

It is a fundamental principle of Texas law that for a defendant to be liable for the sale or distribution of a defective product in a products liability action, the plaintiff must show that the defendant supplied the product. Gaulding, 772 S.W.2d at 67. The evidence here establishes that Schwarz did not supply any of the drugs that Plaintiff alleges injured him. Thus, as a matter of law, he cannot recover from Schwarz on his theories that the drug manufacturer supplied a defective product.

Plaintiff's negligent misrepresentation claim against Schwarz is premised on the contention that it failed to provide adequate warnings about the risks of Reglan(R) or disseminated false information about the drug. But a claim of failure to warn or misrepresentation is predicated upon the existence and breach of a legal duty to the plaintiff. As the Texas Supreme Court held in Barajas, manufacturers such as Schwarz have no duty to warn about a product that they do not supply, and thus a plaintiff cannot maintain negligence or negligent misrepresentation claims against manufacturers who did not supply the product he used. And the courts in Block and Pustejovsky correctly rejected those plaintiffs' efforts to differentiate between their various products liability claims and their additional fraud and malice claims (all of which fall under the definition of “products liability” claims under Texas law). Here, all of Plaintiff's failure to warn theories against Schwarz require the existence of a duty, which Texas law does not impose under these circumstances. Accordingly, all of Plaintiffs claims against Schwarz should be dismissed.

To hold otherwise would improperly make name brand manufacturers responsible for every injury caused by equivalent products made by generic manufacturers in the United States. Indeed, because Schwarz, as a former brand name manufacturer of Reglan(R), competed with generic metoclopramide manufacturers, imposing liability on Schwarz in this case would be tantamount to holding Schwarz responsible for its competitors' products. Such an inequitable, unprecedented, and illogical result would have a devastating impact on the pharmaceutical industry. See, e.g., Foster, 29 F.3d 170, (observing that such liability would be “especially unfair” because “the generic manufacturer reaps the benefits of the name brand manufacturer's statements by copying its labels and riding on the coattails of its advertising.”). For these very reasons, courts uniformly have refused to extend tort law into Plaintiff's proposed “new and uncharted territory.” Block, 2003 WL 203067, at *3, App. at 204; see also Colacicco, 432 F.Supp. 2d at 543 (rejecting plaintiff's invitation “to drastically expand the boundaries of Pennsylvania tort law without precedent or policy to support his position.”)

Because Texas law imposes no duty on Schwarz to warn of another manufacturer's products, Schwarz is entitled to summary judgment on each of Plaintiff's claims.

V.

Conclusion and Request for Relief

Because Plaintiff has no legally cognizable theory of recovery against Schwarz, this Court should grant summary judgment on all his claims against this defendant.

Respectfully submitted,