1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 THOMAS BAILEY, CASE NO. 18-cv-06926-YGR
8 Plaintiff, ORDER DENYING MOTION TO CERTIFY THE 9 vs. QUESTION OF FEDERAL PREEMPTION TO THE COURT OF APPEALS UNDER 28 U.S.C. 10 RITE AID CORPORATION, § 1292(B) 11 Defendant. Re: Dkt. No. 61
12 13 Plaintiff Thomas Bailey brings this putative class action against defendant Rite Aid 14 Corporation (“Rite Aid”) asserting eight causes of action arising out of defendant’s sale and 15 marketing of its over-the-counter rapid release acetaminophen gelcaps. (See Dkt. No. 15 16 (“FAC”).) On September 9, 2019, the Court granted in part and denied in part defendant’s motion 17 to dismiss the FAC. (Dkt. No. 60 (“MTD Order”).) Therein, the Court rejected defendant’s 18 preemption argument and denied its motion on that basis. (Id. at 5-9.) Now before the Court is 19 defendant’s motion for an order to certify the question of federal preemption to the Court of 20 Appeals under 28 U.S.C. § 1292(b) (“Section 1292(b)”).1 (Dkt. No. 61 (“Motion”).) Having 21 carefully considered the papers submitted, and for the reasons set forth more fully below, the 22 Court hereby DENIES defendant’s motion. 23 \\ 24
25 1 The Court has reviewed the papers submitted by the parties in connection with 26 defendant’s motion to certify a question. The Court has determined that the motion is appropriate for decision without oral argument, as permitted by Civil Local Rule 7-1(b) and Federal Rule of 27 Civil Procedure 78. See also Lake at Las Vegas Investors Group, Inc. v. Pacific Malibu Dev. 1 I. BACKGROUND 2 The factual allegations underlying this action are well-known to the parties and the Court 3 will not repeat them here. (See MTD Order at 2-3.) 4 Relevant here, defendant’s argument regarding federal preemption in its motion to dismiss 5 relied on its assertion that plaintiff’s claims were preempted by (1) a tentative final monograph 6 issued by the FDA in 1988 (the “1988 TFM”); and (2) two FDA guidance documents, namely one 7 regarding Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage 8 Form Drug Products Containing High Solubility Drug Substances, Guidance for Industry, U.S. 9 Dept. of Health and Human Services Food and Drug Administration (Aug. 2018) (the “Dissolution 10 Testing Guidance”) and another regarding the Waiver of In Vivo Bioavilability and 11 Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a 12 Biopharmaceutics Classification System, Guidance for Industry (December 2017) (the “In Vivo 13 Immediate-Release Guidance”) (collectively, “FDA Guidance”). (Dkt. No. 25 at 11-14.) 14 In its MTD Order, the Court determined that although the 1988 TFM constituted federal 15 regulation, the 1988 TFM, as well as the relevant incorporated documents, was silent as to the 16 dissolution standards for the type of acetaminophen at issue in plaintiff’s complaint, namely rapid 17 release acetaminophen. (MTD Order at 7-8.) With respect to the FDA Guidance, the Court 18 determined that it did not constitute a requirement under the National Uniformity for 19 Nonprescription Drugs provision of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 20 379r. (Id. at 8-9.) 21 II. LEGAL STANDARD 22 Section 1292(b) provides: When a district judge, in making in a civil action an order not otherwise 23 appealable under this section, shall be of the opinion that such order involves a 24 controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance 25 the ultimate termination of the litigation, he [or she] shall so state in writing in such order. 26 28 U.S.C. § 1292(b). Stated differently, “[a] district court may certify appeal of an interlocutory 27 order if: (1) the order involves a controlling question of law, (2) appealing the order may 1 materially advance the ultimate termination of the litigation, and (3) there is substantial ground for 2 difference of opinion as to the question of law.” In re Cement Antitrust Litig., 673 F.2d 1020, 3 1026 (9th Cir. 1982). Here, only the third requirement – substantial ground for difference of 4 opinion – is at issue. (See Dkt. No. 65 (“Opp.”) at 3-9.) 5 III. ANALYSIS 6 “To determine if a substantial ground for difference of opinion exists under § 1292(b), 7 courts must examine to what extent the controlling law is unclear.” Couch v. Telescope Inc., 611 8 F.3d 629, 633 (9th Cir. 2010) (internal quotations omitted). “Courts traditionally will find that a 9 substantial ground for difference of opinion exists where ‘the circuits are in dispute on the 10 question and the court of appeals of the circuit has not spoken on the point, if complicated 11 questions arise under foreign law, or if novel and difficult questions of first impression are 12 presented.’” Id. (quoting 3 Federal Procedure, Lawyers Edition § 3:212 (2010)). “However, just 13 because a court is the first to rule on a particular question or just because counsel contends that 14 one precedent rather than another is controlling does not mean there is a substantial difference of 15 opinion as will support an interlocutory appeal.” Id. (internal quotations omitted). 16 Here, defendant asserts that the Court’s determination that plaintiff’s claims were not 17 expressly preempted by the FDCA was based on two “relevant components,” both of which, 18 defendant asserts provide substantial ground for difference of opinion. (Opp. at 3-4.) First, 19 defendant contends that the Court’s determination that the FDA Guidance did not constitute a 20 requirement under the FDCA is counter to the Ninth Circuit’s opinion in Degelmann v. Advanced 21 Medical Optics, Inc. (Opp. at 3 (citing 659 F.3d 835, 842 (9th Cir. 2011)).) Second, defendant 22 argues that the Court’s finding that the dissolution standards for immediate release acetaminophen 23 did not encompass testing and dissolution procedures for rapid release acetaminophen because the 24 two are not synonymous, but rather the latter is a subset of the former. (Id. at 4.) 25 1. Difference of Opinion Presented by Degelmann 26 In Degelmann, the Ninth Circuit addressed the suitability of an FDA guidance document 27 as a requirement under the FDCA. 659 F.3d at 842. Therein, the court found that by issuing “a 1 Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care 2 Products[(“Premarket Notification Document”),]” the FDA had promulgated specific 3 requirements. Id. Defendant does not provide any authority for its assertion that whether a 4 different FDA publication constitutes a requirement under the FDCA is dispositive as to the 5 suitability of another FDA document as a requirement under the FDCA. 6 Moreover, unlike the FDA Guidance at issue here, the Premarket Notification Document in 7 Degelmann, “is intended to provide comprehensive directions to enable a manufacturer of a 8 contact lens care product to submit at 510(k) that FDA believes adequately demonstrates whether 9 the device is substantially equivalent to a legally marketed device.”2 Ctr. for Devices and 10 Radiological Health, U.S.
Free access — add to your briefcase to read the full text and ask questions with AI
1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 THOMAS BAILEY, CASE NO. 18-cv-06926-YGR
8 Plaintiff, ORDER DENYING MOTION TO CERTIFY THE 9 vs. QUESTION OF FEDERAL PREEMPTION TO THE COURT OF APPEALS UNDER 28 U.S.C. 10 RITE AID CORPORATION, § 1292(B) 11 Defendant. Re: Dkt. No. 61
12 13 Plaintiff Thomas Bailey brings this putative class action against defendant Rite Aid 14 Corporation (“Rite Aid”) asserting eight causes of action arising out of defendant’s sale and 15 marketing of its over-the-counter rapid release acetaminophen gelcaps. (See Dkt. No. 15 16 (“FAC”).) On September 9, 2019, the Court granted in part and denied in part defendant’s motion 17 to dismiss the FAC. (Dkt. No. 60 (“MTD Order”).) Therein, the Court rejected defendant’s 18 preemption argument and denied its motion on that basis. (Id. at 5-9.) Now before the Court is 19 defendant’s motion for an order to certify the question of federal preemption to the Court of 20 Appeals under 28 U.S.C. § 1292(b) (“Section 1292(b)”).1 (Dkt. No. 61 (“Motion”).) Having 21 carefully considered the papers submitted, and for the reasons set forth more fully below, the 22 Court hereby DENIES defendant’s motion. 23 \\ 24
25 1 The Court has reviewed the papers submitted by the parties in connection with 26 defendant’s motion to certify a question. The Court has determined that the motion is appropriate for decision without oral argument, as permitted by Civil Local Rule 7-1(b) and Federal Rule of 27 Civil Procedure 78. See also Lake at Las Vegas Investors Group, Inc. v. Pacific Malibu Dev. 1 I. BACKGROUND 2 The factual allegations underlying this action are well-known to the parties and the Court 3 will not repeat them here. (See MTD Order at 2-3.) 4 Relevant here, defendant’s argument regarding federal preemption in its motion to dismiss 5 relied on its assertion that plaintiff’s claims were preempted by (1) a tentative final monograph 6 issued by the FDA in 1988 (the “1988 TFM”); and (2) two FDA guidance documents, namely one 7 regarding Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage 8 Form Drug Products Containing High Solubility Drug Substances, Guidance for Industry, U.S. 9 Dept. of Health and Human Services Food and Drug Administration (Aug. 2018) (the “Dissolution 10 Testing Guidance”) and another regarding the Waiver of In Vivo Bioavilability and 11 Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a 12 Biopharmaceutics Classification System, Guidance for Industry (December 2017) (the “In Vivo 13 Immediate-Release Guidance”) (collectively, “FDA Guidance”). (Dkt. No. 25 at 11-14.) 14 In its MTD Order, the Court determined that although the 1988 TFM constituted federal 15 regulation, the 1988 TFM, as well as the relevant incorporated documents, was silent as to the 16 dissolution standards for the type of acetaminophen at issue in plaintiff’s complaint, namely rapid 17 release acetaminophen. (MTD Order at 7-8.) With respect to the FDA Guidance, the Court 18 determined that it did not constitute a requirement under the National Uniformity for 19 Nonprescription Drugs provision of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 20 379r. (Id. at 8-9.) 21 II. LEGAL STANDARD 22 Section 1292(b) provides: When a district judge, in making in a civil action an order not otherwise 23 appealable under this section, shall be of the opinion that such order involves a 24 controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance 25 the ultimate termination of the litigation, he [or she] shall so state in writing in such order. 26 28 U.S.C. § 1292(b). Stated differently, “[a] district court may certify appeal of an interlocutory 27 order if: (1) the order involves a controlling question of law, (2) appealing the order may 1 materially advance the ultimate termination of the litigation, and (3) there is substantial ground for 2 difference of opinion as to the question of law.” In re Cement Antitrust Litig., 673 F.2d 1020, 3 1026 (9th Cir. 1982). Here, only the third requirement – substantial ground for difference of 4 opinion – is at issue. (See Dkt. No. 65 (“Opp.”) at 3-9.) 5 III. ANALYSIS 6 “To determine if a substantial ground for difference of opinion exists under § 1292(b), 7 courts must examine to what extent the controlling law is unclear.” Couch v. Telescope Inc., 611 8 F.3d 629, 633 (9th Cir. 2010) (internal quotations omitted). “Courts traditionally will find that a 9 substantial ground for difference of opinion exists where ‘the circuits are in dispute on the 10 question and the court of appeals of the circuit has not spoken on the point, if complicated 11 questions arise under foreign law, or if novel and difficult questions of first impression are 12 presented.’” Id. (quoting 3 Federal Procedure, Lawyers Edition § 3:212 (2010)). “However, just 13 because a court is the first to rule on a particular question or just because counsel contends that 14 one precedent rather than another is controlling does not mean there is a substantial difference of 15 opinion as will support an interlocutory appeal.” Id. (internal quotations omitted). 16 Here, defendant asserts that the Court’s determination that plaintiff’s claims were not 17 expressly preempted by the FDCA was based on two “relevant components,” both of which, 18 defendant asserts provide substantial ground for difference of opinion. (Opp. at 3-4.) First, 19 defendant contends that the Court’s determination that the FDA Guidance did not constitute a 20 requirement under the FDCA is counter to the Ninth Circuit’s opinion in Degelmann v. Advanced 21 Medical Optics, Inc. (Opp. at 3 (citing 659 F.3d 835, 842 (9th Cir. 2011)).) Second, defendant 22 argues that the Court’s finding that the dissolution standards for immediate release acetaminophen 23 did not encompass testing and dissolution procedures for rapid release acetaminophen because the 24 two are not synonymous, but rather the latter is a subset of the former. (Id. at 4.) 25 1. Difference of Opinion Presented by Degelmann 26 In Degelmann, the Ninth Circuit addressed the suitability of an FDA guidance document 27 as a requirement under the FDCA. 659 F.3d at 842. Therein, the court found that by issuing “a 1 Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care 2 Products[(“Premarket Notification Document”),]” the FDA had promulgated specific 3 requirements. Id. Defendant does not provide any authority for its assertion that whether a 4 different FDA publication constitutes a requirement under the FDCA is dispositive as to the 5 suitability of another FDA document as a requirement under the FDCA. 6 Moreover, unlike the FDA Guidance at issue here, the Premarket Notification Document in 7 Degelmann, “is intended to provide comprehensive directions to enable a manufacturer of a 8 contact lens care product to submit at 510(k) that FDA believes adequately demonstrates whether 9 the device is substantially equivalent to a legally marketed device.”2 Ctr. for Devices and 10 Radiological Health, U.S. Dep’t of Health and Human Servs., Guidance Document, at 2 (1997). 11 The FDA Guidance at issue here does not reflect a similar purpose to establish guidelines for a 12 legally marketed product. Accordingly, defendant has failed to establish substantial ground for 13 difference of opinion as to whether the FDA Guidance at issue here constitutes a requirement 14 under the FDCA. Thus, the Court DENIES defendant’s motion on this basis. 15 2. Difference of Opinion Presented by the Meaning of “Immediate” Release 16 As a preliminary matter, defendant provides no authority for its contention that a contrary 17 order from another district court, outside of the relevant circuit, creates substantial ground for a 18 difference of opinion. C.f. Couch, 611 F.3d at 633 (“Courts traditionally will find that a 19 substantial ground for difference of opinion exists where ‘the circuits are in dispute on the 20 question and the court of appeals of the circuit has not spoken on the point[.]”). 21 Defendant’s contention that because the FDA has regulated the subject matter of the 22 dissolution of acetaminophen tablets, despite not using the phrase “rapid release,” plaintiff’s 23 claims are preempted fails. (Motion at 4; see also Dkt. No. 67 (“Reply”) at 5.) Plaintiff’s claims 24 are grounded in whether the acetaminophen dissolved fast enough to allow for marketing as “rapid 25 release.” As the Court explained in its MTD Order, FDA publications, including those provided 26
27 2 This is because lens care products for soft contact lenses are classified by the Medical 1 by defendant in support of its motion to dismiss, suggest that “immediate” and “rapid” are not 2 synonymous and that drugs with “rapid” dissolution are, at most, a subset of those categorized as 3 “immediate” release. (See, e.g., Dkt. No. 26, Ex. B at 3 (explaining that “some IR [immediate- 4 || release] solid oral dosage forms are categorized as having rapid or very rapid dissolution’”).) 5 Therefore, the fact that the FDA may have regulated the subject-matter of immediate release 6 acetaminophen does not establish that a substantial ground for a difference of opinion exists where 7 the plaintiff challenges the designation and marketing of defendant’s product at rapid release. 8 IV. CONCLUSION 9 For the foregoing reasons the Court DENIES defendant’s motion to certify the question of 10 || federal preemption to the Court of Appeals. Further, as this Order addresses the basis for the 11 request to continue the case management conference, that request is similarly DENIED. ag 12 This Order terminates Docket Numbers 61 and 69.
13 IT Is SO ORDERED.
15 || Dated: October 25, 2019 2 YVONNE GONZALEZ ROGERS = 6 UNITED STATES DISTRICT COURT JUDGE 17
18 19 20 21 22 23 24 25 26 27 28