VISION PHARMA, LLC v. SUNRISE PHARMACEUTICAL, INC.

CourtDistrict Court, D. New Jersey
DecidedSeptember 29, 2022
Docket2:13-cv-04692
StatusUnknown

This text of VISION PHARMA, LLC v. SUNRISE PHARMACEUTICAL, INC. (VISION PHARMA, LLC v. SUNRISE PHARMACEUTICAL, INC.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
VISION PHARMA, LLC v. SUNRISE PHARMACEUTICAL, INC., (D.N.J. 2022).

Opinion

NOT FOR PUBLICATION UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY VISION PHARMA, LLC, Civil Action No. 13-04692 Plaintiff, OPINION v. SUNRISE PHARMACEUTICAL, INC., Defendant. CECCHI, District Judge. This matter comes before the Court on the motion for summary judgment of Sunrise Pharmaceutical, Inc. (“Sunrise” or “Defendant”), seeking judgment in favor of Defendant on all counts of the Complaint (ECF No. 1) (“Compl.”) filed by Vision Pharma, LLC (“Vision” or “Plaintiff”). ECF No. 139. The Court has considered the submissions made in support of and in opposition to the instant motion, see ECF Nos. 140 (“Def. Br.”), 157 (“Pl. Br.”), 170 (“Def.

Reply”), the declarations and exhibits supporting those submissions, see ECF Nos. 142, 152, 159, 166, and heard oral argument, see ECF No. 187 (“Oral Arg. Tr.”). For the reasons set forth below, Defendant’s Motion is GRANTED in part and DENIED in part. I. BACKGROUND1 This dispute arises from a contractual relationship between two pharmaceutical companies that called for the manufacture and sale of unapproved new prescription drug products that

1 Plaintiff’s Response to Defendant’s Local Rule 56.1 statement (“Pl. SMF Resp.”), and Plaintiff’s own Counter Local Rule 56.1 statement (“Pl. SMF”), are contained in the same document (ECF No. 158). As such, the Court will use the abbreviations stated above to differentiate them. contained hyoscyamine and colchicine (the “Drug Products”).2 The relationship at issue here began in 2006 and, though its exact nature is disputed, was based generally on various written instruments including certain term sheets (styled by the parties as the “Supply Agreements”), purchase orders, packing slips, as well as the parties’ course of dealing and industry custom. Id. ¶¶ 6, 10-12, 15, 17, 25. It is undisputed that at the time the parties began to engage with one another, both parties were aware that the Drug Products had not yet been approved by the FDA. Id. ¶¶ 6-9; Oral Arg. Tr. at 48:2-5. One of the Supply Agreements for another substance, Methylene Blue, which the parties ultimately never developed or manufactured,

included a notice provision (“Notice Term”), providing that Defendant was obligated to notify Plaintiff within five days if the FDA sent Defendant any Form 483s (forms used by the FDA to document concerns after an inspection, hereinafter “483s”), warning letters, or any of Defendant’s responses thereto. ECF No. 158 ¶ 29 (“Pl. SMF Resp.”). Whether the Notice Term was incorporated into each Supply Agreement or the overall contractual relationship for the other Drug Products is disputed. Pl. SMF Resp. ¶ 29; Def. SMF ¶ 29. Plaintiff also maintains that the two parties entered into a separate “verbal agreement” regarding the Notice Term, which Defendant strongly contests. Id. ¶¶ 31-46; Pl. SMF Resp. ¶¶ 31-46. On January 14, 2010, Defendant received a warning letter from the FDA. Def. SMF ¶ 70;

ECF No. 142-43, Ex. RR (the “Sunrise Warning Letter”). In the letter, the FDA stated the following: that the FDA’s inspection of Defendant’s facility “identified significant violations of the Current Good Manufacturing Practice regulations” (“CGMPs”) in manufacturing the Drug

2 The specific drugs produced by Defendant and purchased by Plaintiff are: (1) Colchicine .6mg Tablets; (2) Hyoscyamine Sulfate Tablets .125mg; (3) Hyoscyamine Sulfate Orally Disintegrating Tablets .125mg; and (4) Hyoscyamine Sulfate Sublingual Tablets .125mg. Def. SMF ¶ 7. As explained further below, the parties also reached terms for the manufacture and sale of a fifth drug, Methylene Blue. Products; that these violations caused the Drug Products to be deemed “adulterated” pursuant to 21 U.S.C. § 351(a)(2)(B); and that the Drug Products were “unapproved new drugs,” and as such, they were in violation of the Federal Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. Def. SMF ¶ 72; Sunrise Warning Ltr. at 1. Defendant subsequently notified Plaintiff of the Sunrise Warning Letter on February 2, 2010. Id. ¶ 71. On April 29, 2010, Plaintiff also received its own warning letter from the FDA. Id. ¶ 75; ECF No. 142-45, Ex. TT (“Vision Warning Letter”). The Vision Warning Letter expressly referenced the Sunrise Warning Letter; it went on to state that because the Drug Products were new and lacked approval, they could not be introduced into interstate

commerce. Vision Warning Ltr. at 1. It also stated that the Drug Products were adulterated— another reason why they were prohibited from being sold. Id. The parties dispute whether the FDA’s use of “adulterated” in the warning letter referred only to manufacturing processes or also suggested that the Drug Products themselves were not of proper quality. See Pl. Br. at 23-25, Def. Br. at 27-29. Although the details are contested, after receiving the Vision Warning Letter, it appears Plaintiff attempted to negotiate with the FDA to find a way to sell its inventory. Def. SMF ¶¶ 79-80. The FDA ultimately rejected this attempt on June 2, 2010. See ECF No. 142-47, Ex. VV. On June 23, 2010, Plaintiff emailed Defendant a letter demanding a refund for its inventory of adulterated Drug Products, which Defendant purportedly refused. Pl. SMF ¶ 126.

It was later revealed that in addition to the Sunrise Warning Letter, Defendant also received multiple 483s at the conclusion of four separate inspections of Defendant’s facility by the FDA occurring in September 2006, January-February 2007, July-August 2007, and June-July 2009 (Defendant received a 483 after each inspection). Pl. SMF ¶ 96. Each 483 identifies multiple CGMP violations observed by the FDA during its inspections. Id. ¶ 97. There is no evidence that Defendant notified Plaintiff of the 483s. Id. ¶¶ 104-05. However, Defendant contends that the 483s were referenced in the Sunrise Warning Letter, so Plaintiff was constructively aware of them as of February 2, 2010—the date Defendant notified Plaintiff of its warning letter. ECF No. 175 ¶¶ 104- 05 (“Def. Reply SMF”). Defendant maintains that after it notified Plaintiff of the Sunrise Warning Letter, Plaintiff still tried to order more Drug Products knowing that the products were adulterated and unapproved. Def. SMF ¶ 89. Plaintiff acknowledges that it did do so, but only if Defendant “correctly manufactured [the Drug Products] according to CGMPs.” Pl. SMF Resp. ¶ 89. Nevertheless, Defendant refused to manufacture and sell additional Drug Products to Plaintiff, thereby ending their contractual relationship. Def. SMF ¶ 90. II. PROCEDURAL HISTORY

This action was filed on August 5, 2013. See Compl. Plaintiff asserts the following causes of action: violation of the New Jersey Consumer Fraud Act (“NJCFA”) (Count I), breach of contract (Count II), breach of the implied warranty of merchantability (Count III), breach of the implied warranty of fitness for a particular purpose (Count IV), breach of the implied covenant of good faith and fair dealing (Count V), unjust enrichment (Count VI), negligence (Count VII), deceptive trade practices (Count VIII), and fraud and deceit (Count IX). See Compl. ¶¶ 51-120. Although the relationship between the parties ended in 2010 at the latest, with no additional purchase orders after that point, Plaintiff seeks relief primarily in the form of lost profits it claims it could have captured from 2010 to 2017 had the parties continued working together to sell these

Drug Products “but-for” Defendant’s alleged wrongful acts. ECF No. 142-32, Ex. GG, Pl. Damages Exp. Rep. at 14-15; Def. SMF ¶¶ 23-24. On February 26, 2016, Defendant moved to dismiss Plaintiff’s claims. See ECF No. 72. By Opinion and Order dated June 20, 2018, the Court granted Defendant’s motion to dismiss as to the NJCFA claim (Count I) only.

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VISION PHARMA, LLC v. SUNRISE PHARMACEUTICAL, INC., Counsel Stack Legal Research, https://law.counselstack.com/opinion/vision-pharma-llc-v-sunrise-pharmaceutical-inc-njd-2022.