Smith v. Teva Pharm. USA, Inc.

• Decision Date: 04 February 2020
• Docket Number: Case No. 17-61058-CIV-GAYLES/SELTZER
• Citation: 437 F.Supp.3d 1159
• Parties: Michelle SMITH, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
• Court: U.S. District Court — Southern District of Florida

437 F.Supp.3d 1159

Michelle SMITH, Plaintiff,

v.TEVA PHARMACEUTICALS USA, INC., Defendant.

Case No. 17-61058-CIV-GAYLES/SELTZER

United States District Court, S.D. Florida.

Signed February 4, 2020

Jeffrey Louis Haberman, Schlesinger Law Offices, Fort Lauderdale, FL, for Plaintiff.

Hannah W. Scheper, Michael J. Suffern, Pro Hac Vice, Jeffrey F. Peck, Pro Hac Vice, Jennifer Snyder Heis, Pro Hac Vice, Ulmer & Berne LLP, Cincinnati, OH, Daniel Jay Gerber, Rumberger Kirk & Caldwell, Orlando, FL, for Defendant.

ORDER

DARRIN P. GAYLES, UNITED STATES DISTRICT JUDGE

THIS CAUSE comes before the Court on Defendant Teva Pharmaceuticals USA, Inc.'s Motion for Summary Judgment (the "Motion") [ECF No. 68]. The Court has reviewed the Motion and the record and is otherwise fully advised. For the reasons that follow, the Motion is granted.

I. BACKGROUND

A. Plaintiff's Injuries

This case arises from injuries that Plaintiff sustained while taking various oral contraceptives. Relevant here, Plaintiff was prescribed a brand-name oral contraceptive, Seasonale

, in October 2006. [ECF No. 74, ¶ 5]. From 2006–2008, Plaintiff took a generic equivalent of Seasonale, Quasense. [ECF No. 114 at 3]. In 2008, Plaintiff also began taking Jolessa, another generic equivalent of Seasonale. [ECF No. 114 at 2]. The next year, Plaintiff started taking another brand-name oral contraceptive, Seasonique. [ECF No. 67, ¶ 5]. In 2011, Plaintiff switched to Seasonique's generic equivalent, Camrese, which she took until April 2013. [Id. ¶¶ 6–7].¹

In June 2013, Plaintiff went to the hospital complaining of abdominal pain, nausea, and vomiting. [Id. ¶ 9]. Tests revealed that Plaintiff had developed hepatic adenomas

(tumors) on her liver and the surrounding tissue. [Id. ¶¶ 10–17, 27]. Plaintiff's adenomas later ruptured and hemorrhaged, requiring surgical intervention. [ECF Nos. 67, ¶¶ 19, 26; 74, ¶ 18].

B. Development of Seasonique

and Camrese

The Food and Drug Administration (the "FDA") regulates the manufacture, sale, and labeling of prescription drugs sold in the United States through a structured statutory scheme. Before a person can introduce a new drug into the market, they must file, and the FDA must approve, a New Drug Application ("NDA") for the drug. 21 U.S.C. § 355(a). In 2006, Duramed Pharmaceuticals Inc. ("Duramed") submitted, and the FDA approved, an NDA for Seasonique

. [ECF No. 114 at 1]. In 2009, Duramed changed its name to Teva Women's Health, Inc. ("TWH"), and, in 2012, TWH transferred Seasonique's NDA to Teva Branded Pharmaceutical Products R & D, Inc. ("Teva R & D"). [Id. at 1–2]. Teva R & D continues to hold Seasonique's NDA today. [Id. at 2]. Camrese is sold under Seasonique's

NDA. [Id. ].

TWH is a subsidiary of Barr Pharmaceuticals, LLC, which is a subsidiary of Defendant. [Id. at 3]. Similarly, Teva R & D is a subsidiary of IVAX LLC, which is a subsidiary of Defendant. [Id. ]. Defendant has never held Seasonique's

NDA. [ECF Nos. 114 at 3; 115 at 1]. At all times relevant here, Defendant was two steps removed on the corporate ladder from Seasonique's NDA holders. Defendant has, however, sold and distributed Seasonique since October 2009. [ECF No. 114 at 3]. In 2011, Defendant also began distributing Camrese. [ECF No. 67, ¶ 41].

C. Procedural Background

Plaintiff filed her Amended Complaint on December 13, 2018, against Defendant,² alleging four state-law claims: (1) products liability for defective design, (2) products liability for failure to warn, (3) negligence, and (4) negligent failure to warn. [ECF No. 46]. Plaintiff's claims are all premised on the allegation that the labels for the oral contraceptives she took relevant to this matter fail to adequately warn that their prolonged use increases the risk of contracting hepatic adenomas

.

On August 14, 2019, Defendant moved for summary judgment on all claims, arguing: (1) the products' labels are adequate, (2) Plaintiff failed to adequately rebut Florida's Government Rules Defense under Florida Statute § 768.125, (3) the learned-intermediary doctrine bars Plaintiff's claims, (4) Plaintiff failed to prove causation, (5) Plaintiff's claims are preempted under federal law, and (6) Plaintiff is not entitled to punitive damages. [ECF No. 68]. As the Court finds that Plaintiff's claims are preempted, it will limit its analysis to that ground.

II. LEGAL STANDARD

Summary judgment, pursuant to Federal Rule of Civil Procedure 56(a), "is appropriate only if the movant shows that there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law." Tolan v. Cotton , 572 U.S. 650, 134 S. Ct. 1861, 1866, 188 L.Ed.2d 895 (2014) (per curiam) (quoting Fed. R. Civ. P. 56(a) ) (internal quotation marks omitted). "By its very terms, this standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 247–48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (emphasis in original). An issue is "genuine" when a reasonable trier of fact, viewing all of the record evidence, could rationally find in favor of the nonmoving party in light of his burden of proof. Harrison v. Culliver , 746 F.3d 1288, 1298 (11th Cir. 2014). And a fact is "material" if, "under the applicable substantive law, it might affect the outcome of the case." Hickson Corp. v. N. Crossarm Co. , 357 F.3d 1256, 1259-60 (11th Cir. 2004). "Where the material facts are undisputed and all that remains are questions of law, summary judgment may be granted." Eternal Word Television Network, Inc. v. Sec'y of U.S. Dep't of Health & Human Servs. , 818 F.3d 1122, 1138 (11th Cir. 2016). The Court must construe the evidence in the light most favorable to the nonmoving party and draw all reasonable inferences in that party's favor. SEC v. Monterosso , 756 F.3d 1326, 1333 (11th Cir. 2014). However, to prevail on a motion for summary judgment, "the nonmoving party must offer more than a mere scintilla of evidence for its position; indeed, the nonmoving party must make a showing sufficient to permit the jury to reasonably find on its behalf." Urquilla-Diaz v. Kaplan Univ. , 780 F.3d 1039, 1050 (11th Cir. 2015).

III. DISCUSSION

The Supremacy Clause of the U.S. Constitution provides that the Constitution and the laws of the United States "shall be the supreme Law of the Land." U.S. Const. art. VI, cl. 2. Under this principle, "any state law that interferes with, or is contrary to, federal law is preempted." Estrada v. Becker , 917 F.3d 1298, 1302 (11th Cir. 2019) (citation and internal quotations omitted). Congress may preempt state law through: (1) express preemption, (2) field preemption, and (3) conflict preemption. Id. at 1303. Impossibility preemption, a type of conflict preemption that is relevant here, occurs "when it is impossible for a private party to comply with both state and federal requirements." Merck Sharp & Dohme Corp. v. Albrecht , ––– U.S. ––––, 139 S. Ct. 1668, 1672, 203 L.Ed.2d 822 (2019) (citation and internal quotations omitted). In that case, a court must find that the record demonstrates an "inevitable collision" between the state and federal schemes; "dissimilarity of the standards" is not enough. Fla. Lime & Avocado Growers, Inc. v. Paul , 373 U.S. 132, 143, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963).

Defendant argues that Plaintiff's claims are impossibility preempted because it would have been impossible for Defendant to comply with both its state duties to change the products' labels and its federal duties not to make such changes. As the Court finds that federal law prohibited Defendant from altering the labels, preemption applies and summary judgment is required.

A. Relevant Statutory Scheme and FDA Regulations

Brand manufacturers wishing to market a novel drug in the United States must submit an NDA to the FDA that includes proposed labeling for the drug. 21 U.S.C. § 355(b)(1). If a manufacturer later seeks to amend the approved labels, it may file with the FDA a supplemental NDA that outlines the proposed changes. 21 C.F.R. § 314.70. Though "any person" may file an initial NDA, 21 U.S.C. § 355(b)(1), only those entities deemed "applicants" may submit changes to approved NDAs, 21 C.F.R. § 314.70(a)(1)(i). The FDA regulations explain: "the applicant must notify [the] FDA about each change in each condition established in an approved NDA beyond the variations already provided for in the NDA." Id. An "applicant" is defined as "any person who submits an NDA ... or an amendment or supplement to an NDA ... to obtain FDA approval of a new drug and any person who owns an approved NDA ...." 21 C.F.R. § 314.3(b).

When an applicant seeks to make "major changes" to approved drugs, which would have "a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product[,]" the FDA must approve the applicant's supplemental NDA before the altered product can be distributed. 21 C.F.R § 314.70(b)(1). But when a manufacturer only seeks to "add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," it may use the FDA's "changes being effected" ("CBE") regulation to make the change immediately upon filing its supplemental NDA with the FDA rather than waiting for approval. Wyeth v. Levine (Wyeth ), 555 U.S. 555, 568, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (citing 21 C.F.R. § 314.70(c)(6) ("the holder of an approved NDA may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change")) (internal quotations omitted).

In addition to applicants, the statute also authorizes the United States Secretary of Health and Human Services (the "Secretary") to initiate label changes to...