Hernandez v. Aurobindo Pharma USA, Inc.
| Decision Date | 24 January 2022 |
| Docket Number | Case No. 8:20-cv-2409-CEH-JSS |
| Citation | 582 F.Supp.3d 1192 |
| Parties | Makayla HERNANDEZ, Plaintiff, v. AUROBINDO PHARMA USA, INC., and CVS Pharmacy, Inc., Defendants. |
| Court | U.S. District Court — Middle District of Florida |
Karl Frederick Pansler, The Ison Law Firm, Chase Robert Pansler, Christopher Ison, The Pansler Law Firm, PA, Lakeland, FL, for Plaintiff.
Kristen Lee Richer, Pro Hac Vice, Barnes & Thornburg LLP, Los Angeles, CA, Robert Christopher Folland, Barnes & Thornburg, LLP, Palm Beach Gardens, FL, for Defendant CVS Pharmacy Inc.
Jessica M. Heinz, Pro Hac Vice, Ernest Frank Koschineg, Ethan R. Feldman, Pro Hac Vice, Cipriani & Werner, P.C., Blue Bell, PA, Kyle A. Diamantas, Michael Patrick Kaney, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Orlando, FL, for Defendant Aurobindo Pharma USA, INC.
This cause comes before the Court upon Defendant Aurobindo Pharma USA, Inc.’s Motion for Judgment on the Pleadings Pursuant to Federal Rule of Civil Procedure 12(c) (Doc. 35) and Defendant CVS Pharmacy, Inc.’s Motion for Judgment on the Pleadings Pursuant to Fed. R. Civ. P. 12(c) (Doc. 37). Plaintiff Makayla Hernandez, as the personal representative of the estate of Rose Marie Hernandez, responds in opposition (Doc. 43). Aurobindo and CVS reply (Docs. 48, 49). Aurobindo's request for judicial notice (Doc. 73) and CVS's request for judicial notice (Doc. 74) also pend.
After Rose Marie Hernandez ingested her prescribed dosage of Losartan
HCTZ 50-12.5 mg oral tablets for the first time, she went into respiratory shock. The next day, she died. Her estate's personal representative brings state-law claims against the alleged manufacturer of the drug and the dispensing pharmacy. Those entities now move for judgment on the pleadings, arguing chiefly that federal law preempts the claims. The Court agrees. For the reasons set forth below, the Court will grant Aurobindo Pharma USA's Motion for Judgment on the Pleadings and grant CVS Pharmacy's Motion for Judgment on the Pleadings.
In April of 2019, Rose Marie Hernandez received a prescription for Losartan
HCTZ 50-12.5 mg oral tablets. Doc. 1-1 ¶17. An angiotensin receptor blocker, this medication is designed to treat high blood pressure by relaxing blood vessels. Id. at ¶13. She filled her prescription at a CVS Pharmacy location in Bartow, Florida, where she received a container with thirty Losartan HCTZ 50-12.5 mg oral tablets. Id. at ¶18. On April 20, 2019, she ingested her prescribed dosage of these tablets, for the first time, in accordance with her prescription. Id. at ¶19. Shortly after ingesting her prescribed dosage, she went into respiratory shock. Id. at ¶20. At Bartow Regional Medical Center, her health quickly deteriorated. Id. She died on April 21, 2019. Id.
Aurobindo Pharma USA, Inc. designed, manufactured, marketed, developed, tested, labeled, promoted, distributed, warranted, and sold their product, Losartan
HCTZ 50-12.5 mg oral tablets. Id. at ¶7. The Losartan tablets contained boxed warnings, which served to educate and advise the potential user, or the user's prescribing physician, of the potential side effects and adverse reactions related to the medication. Id. at ¶14. However, the boxed warnings for these Losartan tablets did not contain adequate and sufficient warnings about the associated risk and possibility of death while using the medication. Id. at ¶15. Aurobindo marketed, advertised, and distributed Losartan HCTZ 50-12.5 mg oral tablets that were defectively designed, more dangerous than the ordinary customer would expect, and unreasonably unsafe for their intended use when they left Aurobindo's possession. Id. at ¶16. The Decedent exercised reasonable prudence and caution when she ingested the Losartan and used the medication in a manner in which Aurobindo knew, or should have known, that the product would be used. Id. at ¶21. She did not alter, or cause to be altered, any part of the Losartan HCTZ 50-12.5 mg oral tablets. Id. at ¶22.
Makayla Hernandez, the Decedent's daughter, now brings this action as the personal representative of the Decedent's estate. Id. at ¶¶2–4. She lodges the following claims against Aurobindo: (1) "Strict Product Liability – Failure to Warn"; (2) "Negligent Failure to Warn"; (3) "Negligence"; (4) "Wrongful Death"; and (5) "Products Liability – Breach of Implied Warranty of Merchantability." Doc. 1-1 ¶¶23–76. She also sues CVS for: (1) "Strict Product Liability – Failure to Warn"; (2) "Negligent Failure to Warn"; and (3) Wrongful Death. Id. at ¶¶77–106.
Aurobindo and CVS answer and assert affirmative defenses (Docs. 17, 32). With the pleadings closed, Aurobindo and CVS move for judgment on the pleadings. (Docs. 35, 37), to which Hernandez responds (Doc. 43). Aurobindo and CVS also reply (Docs. 48, 49). The Court held oral argument. See Doc. 72 at 1. Afterwards, Aurobindo and CVS filed requests for the Court to take judicial notice (Docs. 73, 74).
When resolving a motion for judgment on the pleadings under Rule 12(c), Fed. R. Civ. P., the Court must consider all of the pleadings: the complaint, the answer, and any documents attached as exhibits. Eisenberg v. City of Miami Beach , 54 F. Supp. 3d 1312, 1319 (S.D. Fla. 2014). "Judgment on the pleadings is proper when no issues of material fact exist, and the moving party is entitled to judgment as a matter of law based on the substance of the pleadings and any judicially noticed facts." Cunningham v. Dist. Attorney's Office for Escambia Cnty. , 592 F.3d 1237, 1255 (11th Cir. 2010) (internal quotation marks omitted). "In determining whether a party is entitled to judgment on the pleadings, [a court must] accept as true all material facts alleged in the non-moving party's pleading and ... view those facts in the light most favorable to the non-moving party." Perez , 774 F.3d at 1335 ; Cunningham , 592 F.3d at 1255. "If a comparison of the averments in the competing pleadings reveals a material dispute of fact, judgment on the pleadings must be denied." Perez , 774 F.3d at 1335. "A motion for judgment on the pleadings is governed by the same standard as a motion to dismiss under Rule 12(b)(6)." Carbone v. Cable News Network, Inc. , 910 F.3d 1345, 1350 (11th Cir. 2018).
"The FDA regulates prescription and [over-the-counter drugs] under the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. § 301 et seq. " In re Zantac (Ranitidine) Prods. Liab. Litig. , 510 F. Supp. 3d 1234, 1241 (S.D. Fla. 2020), appeal filed , No. 21-10335. Under the FDCA, "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of any application filed pursuant to [ 21 U.S.C. § 355(b) or (j) ] is effective with respect to such drug." 21 U.S.C. § 355(a).2 In relevant part, § 355(b) provides that any person who files an application with respect to any drug subject to § 355(a) must submit items from an exhaustive list as part of the application. Id. § 355(b)(1)(A). And § 355(j) addresses abbreviated new drug applications. Id. § 355(j). Thus, "[a]pplications for FDA approval can be filed in one of two ways: as a new drug application (‘NDA’) under § 355(b), or as an abbreviated new drug application (‘ANDA’) under § 355(j)." Valley Drug Co. v. Geneva Pharms., Inc. , 344 F.3d 1294, 1296 (11th Cir. 2003).
Under § 355(b), an NDA must include numerous items, such as "full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use," "a full list of articles used as components of such drug," and "a full statement of the composition of such drug." 21 U.S.C. § 355(b)(1)(A)(i)–(iii). Although "any person" may file an initial NDA under § 355(b), "only those entities deemed ‘applicants’ may submit changes to approved NDAs," Smith v. Teva Pharms. USA, Inc. , 437 F. Supp. 3d 1159, 1163 (S.D. Fla. 2020), as the regulations state that "the applicant must notify FDA about each change in each condition established in an approved NDA beyond the variations already provided for in the NDA," 21 C.F.R. § 314.70(a)(1)(i). "A drug approved under the NDA process, commonly referred to as a ‘brand-name drug,’ is ‘listed’ by the FDA as having been ‘approved for safety and effectiveness.’ " In re Zantac , 510 F. Supp. 3d at 1241 (quoting 21 U.S.C. § 355(j)(7) ). "Following the approval of its NDA, a brand-name drug has a certain period of exclusivity in the marketplace." Id. (citing 21 U.S.C. § 355(j)(5)(F) ).
Turning to ANDAs, under the Drug Price Competition and Patent Term Restoration Act, known as Hatch-Waxman Amendments, " ‘generic drugs’ can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA." PLIVA, Inc. v. Mensing , 564 U.S. 604, 612, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (citing 21 U.S.C. § 355(j)(2)(A) ). As a result, manufacturers may "develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." Id. Section 355(j), which addresses ANDAs, states that "[a]ny person" may file "an abbreviated application for the approval of a new drug." 21 U.S.C. § 355(j)(1). Among other requirements, the FDCA generally requires an ANDA to show that the generic drug is the "bioequivalent" of the listed drug and to show that it contains the same active ingredients, employs the same route of administration, contains the same dosage form, and employs the same strength as the listed drug. Id. § 355(j)(2)(A)(ii)–(iv).
As for labeling, an NDA must include the applicant's proposed labeling for the drug, id. § 355(b)(1)(A)(vi) (); 21 C.F.R. § 314.50(c)(2) (...
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