DARRIN P. GAYLES, UNITED STATES DISTRICT JUDGE

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].

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, 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 drug products currently in distribution. 21 U.S.C. § 355(o)(4). "If the Secretary becomes aware of new information ... that the Secretary determines should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person[.]" 21 U.S.C. § 355(o)(4)(A). The term "responsible person" means one who is the holder of, or has submitted, an NDA. 21 U.S.C. § 355(o)(2)(A).

B. Plaintiff's Claims Regarding Camrese

Though brand manufacturers may submit label changes to the FDA, generic manufacturers are treated differently. "[U]nlike a brand name, a generic manufacturer may not unilaterally change a drug's label, design or formulation." Allbright v. Teva Pharm. USA, Inc. , 290 F. Supp. 3d 1321, 1328 (S.D. Fla. 2017). This is because generic manufacturers have a "duty of sameness," which means that "the warning labels of a brand-name drug and its generic copy must always be the same[.]" PLIVA, Inc. v. Mensing , 564 U.S. 604, 613, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). This disparate treatment allows generic manufacturers "to forego the FDA's onerous approval process," which in turn allows "generic drugs [to] enter the market faster and for lower cost." Allbright , 290 F. Supp. 3d at 1327.

In PLIVA , the Supreme Court held that the duty of sameness renders state-law claims against generic manufacturers that are premised on inadequate warnings preempted by federal law because "it [is] impossible for [generic manufacturers] to comply with both their state-law duty to change the label and their federal law duty to keep the label the same." 564 U.S. at 618, 131 S.Ct. 2567. There, the respondents argued that under the FDA's CBE regulation, the generic-manufacturer petitioners could have unilaterally strengthened the drugs' labels. Id. at 614, 131 S.Ct. 2567. Deferring to the FDA's interpretation of its own regulations, the Court rejected this argument because such unilateral action would "violate the statutes and regulations requiring a generic drug's label to match its brand-name counterpart's." Id. This is because, as the FDA explained, generic manufacturers could only use the CBE process to change their generic drug labels to "match an updated brand-name label or to follow the FDA's instructions." Id. The CBE process was therefore unavailable to generic manufacturers to initiate the type of label changes that the state law required. Id. at 615, 131 S.Ct. 2567. The Court recognized that while federal drug regulations had dealt the respondents an "unfortunate hand[,]" their state claims were nonetheless preempted because federal law barred the generic manufacturers from independently changing the drugs' labels. Id. at 624–25, 131 S.Ct. 2567.

So too here. Because federal law demands that Camrese's labels be the same as Seasonique's labels, Defendant's duty of sameness demands that it only make changes to Camrese's labels upon FDA-approved changes to Seasonique's labels. There is no dispute that at all times relevant here, Camrese's labels matched Seasonique's labels. Therefore, the impossibility of Defendant's dual compliance with its state duties to unilaterally change Camrese's labels and its federal duties not to make such changes renders Plaintiff's claims as to Camrese preempted.

C. Plaintiff's Claims Regarding Seasonique

Plaintiff argues that the PLIVA decision is inapposite to preemption questions concerning branded drugs. Not so. The rationale undergirding PLIVA —that federal law preempts state claims against parties that are unable to unilaterally effectuate label changes—applies with equal force here. Whether Plaintiff's state-law claims as to Seasonique are preempted is wholly dependent on whether Defendant had the authority to "unilaterally" initiate changes to Seasonique's labels. See Wyeth , 555 U.S. at 573, 129 S.Ct. 1187 (finding no preemption where defendant could have unilaterally changed labels). The Court finds that preemption applies because Defendant could not have unilaterally changed Seasonique's labels.

As the record makes clear that Defendant never submitted Seasonique's NDA, never submitted an amendment or supplement to Seasonique's NDA, and never held Seasonique's NDA, the Court does not construe Defendant to be an applicant for purposes of submitting label changes for Seasonique to the FDA. Recall that FDA regulations state that "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[,]" 21 C.F.R § 314.70(a)(1)(i), and that an "applicant" is "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). Beyond the applicant, federal law only authorizes the Secretary to initiate label changes. 21 U.S.C. § 355(o)(4). In that case, the Secretary must communicate the proposed changes to the "responsible person" who, again, is someone who holds, or has submitted, an NDA. 21 U.S.C. § 355(o)(2)(A).

The FDA's regulations nowhere contemplate a distributor of a brand drug, albeit a distributor closely affiliated with the NDA holder, initiating changes to an approved NDA. If Congress sought to allow corporate affiliates to submit changes on behalf of NDA holders, it would have done so explicitly. See e.g. , 21 U.S.C. § 207.17 (clearly stating circumstances under which "parent, subsidiary, or affiliate company" may submit drug registration information on behalf of affiliated establishments). "Where Congress knows how to say something but chooses not to, its silence is controlling." In re Haas , 48 F.3d 1153, 1156 (11th Cir. 1995), abrogated by In re Griffith , 206 F.3d 1389 (11th Cir. 2000) (citation omitted).

Citing no authority, Plaintiff argues that PLIVA preemption should not extend to Defendant because Defendant is a distributor of Seasonique and the parent of the parent of Seasonique's prior and current NDA holders. The Court finds no reason to depart from the wealth of authority clearly stating that a company that does not hold an NDA, regardless of its connection to the NDA holder, is powerless to submit label changes to the FDA. See e.g., In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig. , 756 F.3d 917, 940 (6th Cir. 2014) (affirming dismissal of state claims against brand manufacturer as preempted because it had "no more power to change the [brand] label than did [the generic manufacturer]" since defendant had divested its NDA prior to plaintiff ingesting drug); Brazil v. Janssen Research & Dev. LLC , 196 F. Supp. 3d 1351, 1364–65 (N.D. Ga. 2016) (holding state claims against one company preempted where NDA was held by a related company); In re Fosamax (Alendronate Sodium) Prod. Liab. Litig. (No. II) , No. MDL 2243 JAP-LHG, 2012 WL 181411, at *3 (D.N.J. Jan. 17, 2012) (holding defendant had no power to alter the drug's labeling because "[t]hat power lies with the applicant who filed the [NDA]"). To be sure, "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times." Wyeth , 555 U.S. at 570–71, 129 S.Ct. 1187 (emphasis added).

Plaintiff persists, arguing that under Wyeth , a non-manufacturer like Defendant can use the FDA's CBE process to change drug labels without FDA approval. But the issue in Wyeth was whether the brand-manufacturer defendant could use the CBE process to immediately add or strengthen FDA-approved labels while awaiting FDA approval of a supplemental NDA. See id. at 580, 129 S.Ct. 1187. Plaintiff admits as much. See [ECF Nos. 75 at 19–20; 125 at 2]. Ignoring the fact that the record makes clear that Defendant is not a manufacturer of Seasonique, Plaintiff argues that Defendant still could have submitted a CBE for Seasonique because Defendant and Seasonique's current NDA holder, Teva R & D, are "plainly intertwined" and because Defendant sells, promotes, and is responsible for Seasonique's "pharmacovigilance". [ECF No. 75 at 23]. This is not the inquiry. Indeed, the CBE regulation that Plaintiff claims would have allowed Defendant to have submitted changes to the FDA states that the "holder of an approved NDA[,]" not the parent of the parent of an NDA holder, may submit a supplemental application for label changes. 21 C.F.R § 314.70(c)(6) (emphasis added). Fatal to Plaintiff's claims is that Defendant is not Seasonique's NDA holder. As there was no federally lawful way for Defendant to have altered Seasonique's FDA-approved labels, Plaintiff's claims are preempted.

IV. CONCLUSION

Based on the foregoing, it is ORDERED AND ADJUDGED that Defendant's Motion for Summary Judgment [ECF No. 68] is GRANTED , all other pending motions are DENIED AS MOOT , and the case is CLOSED .

DONE AND ORDERED in Chambers at Miami, Florida, this 4th day of February, 2020.