Seufert v. Merck Sharp & Dohme Corp.
Seufert v. Merck Sharp & Dohme Corp.
Opinion of the Court
ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT
I. INTRODUCTION
On February 27, 2014, the FDA published the following in the New England Journal of Medicine'.
With approximately 25.8 million diabetic patients in the United States and 33 million in the European Union alone, the growing prevalence of diabetes worldwide poses a major public health challenge. Both the FDA and the European Medicines Agency are committed to en*1165 suring the safety of the drugs marketed for the treatment of diabetes, and post-marketing reports of pancreatitis and pancreatic cancer in patients taking certain antidiabetic medications have been of concern to both agencies.... Within the past year, the FDA and the EMA independently undertook comprehensive evaluations of a safety signal arising from postmarketing reports of pancreat-itis and pancreatic cancer in patients using incretin-based drugs. These investigations, now complete, included examination of data from a 2013 research report revealing a possible pancreatic safety signal .... Thus, the FDA and the EMA have explored multiple streams of data pertaining to a pancreatic safety signal associated with in-cretin-based drugs. Both agencies agree that a causal association between incre-tin-based drugs and pancreatitis and pancreatic cancer as expressed recently in the scientific literature and the media are inconsistent with the current data .... The FDA and the EMA believe that the current knowledge is adequately reflected in the product information and labeling.1
The publication, titled “Pancreatic Safety of Incretin-Based Drugs—FDA and EMA
II. BACKGROUND
Before the Court is defendants AstraZ-eneca Pharmaceuticals LP and Bristol-Myers Squibb Company’s (“Defendants”) motion for summary judgment. (Doc. No. 119.) Plaintiffs
Plaintiffs allege Defendants failed to warn that Onglyza and Kombiglyze cause or create an increased risk of pancreatic
Although the parties contest the significance of the following events, the following facts are undisputed. Ongylza obtained FDA approval on July 31, 2009, and Kom-biglyze obtained FDA approval on November 5, 2010. (Doc. Nos. 119-5 at 26-33; 119-5 at 34-39.) Both drugs contain the active ingredient saxagliptin, which regulates insulin production. (Doc. Nos. 119t1 at 12; 119-3 at 3.) The FDA has reviewed DDP-4 inhibitors such as Onglyza and Kombiglyze under the broader class of incretin mimet-ics or incretin-based therapies. (Doc. No. 119-3 at 2-3); (see also Doc. No. 119-5 at 61) (“Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), lira-glutide (Victoza), sitagliptin (Januvia, Jan-umet, Janumet XR, Juvisync, saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni) and linagliptin (Tradjenta, Jentadueto).”).
As evident from the record, the FDA first considered the pancreatic safety of incretin mimetics in-2009 when it reviewed adverse event reports
In April 2012, the FDA received a citizen petition
In June of the same year, the FDA participated in the National Institute of Diabetes ■ and Digestive and Kidney Diseases and National Cancer Institute’s Workshop on Pancreatitis-Diabetes-Pan-creatie Cancer. (Id. at 65-66; 69-70.) An FDA supervisory toxicologist at the workshop commented that incretin-based drugs were not associated with “overt pancreatic toxicity or pancreatic neoplasms ... that would indicate a risk to human safety.” (Id. at 65.) The FDA also acknowledged that postmarketing pancreatic toxicology studies provided by various incretin mimetic manufacturers did not “definitively demonstrate[ ] a treatment-related adverse effect on exocrine histology .or proliferation.” (Id.)
In February 2014, the FDA published its assessment of pancreatic safety in the New England Journal of Medicine (“Assessment”). (Doc. No. 119-3 at 2-5.) Four FDA officials and members of the European Medicines Agency authored the Assessment, which followed an independent and comprehensive review of pancreatic cancer risk. (Id. at 2.) In the Assessment, the FDA concluded that claims asserting a causal association between incretin mimet-ics and pancreatic cancer was “inconsistent with the current data” and that current knowledge was “adequately reflected in product information or labeling.” (Id. at 4.)
In March 2014, the FDA formally responded to the 2012 Victoza citizen petition, and declined to withdraw Victoza from the market. (Doc. No. 119-4 at 2-38.) With respect to pancreatic cancer risk, the FDA concluded that “any suspicion of a causal association between exposure to Victoza and pancreatic cancer is indeterminate at this time.” (Id. at 27.) The FDA made no pancreatic cancer labeling recommendations in rejecting the citizen petition. (Id.) (noting there was “no new evidence regarding the risk of pancreatic carcinoma in association with the use of Victoza that would support any changes to the current approved labeling”).
In September 2014, the FDA again reviewed pancreatic safety concerns related to an incretin mimetic marketed as Saxen-da. As part of a briefing document regarding Saxenda, the FDA acknowledged that pancreatic cancer had been “hypothesized but not proven” as a risk associated with incretin mimeties, and that studies had
. Most recently, the FDA has approved other incretin-based therapies without any reference to pancreatic cancer in product labeling. (See, e.g., Doc. Nos. 119-4 at 40-43; 119-4 at 55-67; 119-4 at 69-82.) The labeling of incretin mimetics, including Onglyza and Kombiglyze, does not reference pancreatic cancer. Defendants, as well as other incretin mimetic manufacturers, have not attempted to reference pancreatic cancer in product labeling, and the FDA has never precluded a manufacturer from referencing pancreatic cancer in in-cretin mimetic labeling.
III. LEGAL STANDARD
Federal Rule of Civil Procedure 56 governs motions for summary judgment. Summary judgment permits a court to enter judgment on factually unsupported claims, see Celotex Corp. v. Catrett, 477 U.S. 317, 327, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986), and may also be used in the area of affirmative defenses. Dam v. Gen’l Elec. Co., 265 F.2d 612, 614 (9th Cir. 1958). Granting summary judgment is proper if there is “no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A fact is material when, under the governing substantive law, it could affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute about a material fact is genuine “if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id.
Under the Supremacy Clause, “Congress has the power to preempt state law.” Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000); see also Oneok, Inc. v. Learjet, Inc., — U.S. -, 135 S.Ct. 1591, 1594-95, 191 L.Ed.2d 511 (2015), A preemption analysis begins -with two governing principles. First, congressional intent is the “ultimate touchstone.” Levine, 555 U.S. at 565, 129 S.Ct. 1187. Second, in a field the States have traditionally occupied, there is a presumption against preemption based on the notion that “Congress does not cavalierly pre-empt state-law causes of action.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).
Preemption occurs in three forms: (1) express preemption; (2) field preemption; and (3) conflict preemption. Ting v. AT & T, 319 F.3d 1126, 1135 (9th Cir. 2003). “Express preemption exists where Congress enacts an explicit statutory command that state law be displaced.” Id. Field and conflict preemption are forms of implied preemption. Field preemption occurs when federal regulation is sufficiently comprehensive that it leaves no room for supplementary state regulation. Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). Conflict preemption .occurs when: (1) “compliance with both federal and state regulations is a
Federal statute does not expressly preempt Plaintiffs’ failure-to-warn claims, and prescription drug regulation is a field the States have traditionally occupied. See Reigel v. Medtronic, Inc., 552 U.S. 312, 327, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (noting Congress could have expressly preempted claims regarding pharmaceutical drugs, but chose not to); Lefaivre v. KV Pharm., Co., 636 F.3d 935, 941 (8th Cir. 2011) (citing Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 166-67, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989) (“[T]he FDA [has] long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”)).
Defendants do not assert Plaintiffs’ claims create an obstacle to the full purposes and objectives of Congress, and thus obstacle preemption' is not at issue. As such, the Court’s inquiry will focus on whether concurrent compliance with federal regulations and state tort law is impossible.
IV. DISCUSSION
To resolve the instant motion, the Court must apply the standard set forth in Wyeth v. Levine, which requires a conflict preemption proponent to establish by “clear evidence” that the FDA would have rejected a labeling change specific to a plaintiffs claims. Levine, 555 U.S. at 571, 129 S.Ct. 1187 (“But absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”). Despite providing the relevant standard, neither Levine, nor controlling Ninth Circuit authority define what constitutes clear evidence and markedly few cases have found the clear evidence standard satisfied.
As an initial matter, the plain language of Levine does not support Plaintiffs’ contention that manufacturer submission and express rejection of a proposed warning is required to satisfy the clear evidence standard. The relevant inquiry in each conflict preemption case since Levine is stated as whether the FDA would have rejected a proposed labeling change, not whether the FDA did in fact issue an explicit rejection. See, e.g., Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 1237 (9th Cir. 2011) cert. granted, judgment vacated sub nom. L. Perrigo Co. v. Gaeta, — U.S. -, 132 S.Ct. 497, 181 L.Ed.2d 343 (2011); Koho v. Forest Labs., Inc., 17 F.Supp.3d 1109, 1116 (W.D.Wash. 2014); Dorsett v. Sandoz, Inc., 699 F.Supp.2d 1142, 1157 (C.D.Cal. 2010). As one court recently stated, conflict preemption requires a court to “weigh the evidence submitted by both sides in an at
Additionally, while few cases have found failure-to-warn claims conflict preempted under Levine, that does not mandate the same outcome in this case. Dobbs v. Wyeth Pharm., 797 F.Supp.2d 1264, 1270 (W.D.Okla. 2011) (“Although those decisions have universally found the manufacturer’s evidence inadequate to support conflict preemption, that result is not necessarily dictated here[.]”). Because the clear evidence standard remains undefined, application of Levine involves a fact specific inquiry dependent on the particular warning at issue in each case. Id.; see also In re Depakote, 87 F.Supp.3d 916, 922 (S.D.Ill. 2015) (“In Wyeth, the Supreme Court does not define clear evidence, so application of the clear evidence standard is necessarily fact specific.”) (internal quotation marks omitted). Moreover, a review of case law addressing conflict preemption supports the conclusion that a clear evidence analysis involves more than an inquiry into whether a manufacturer submitted a proposed labeling change to the FDA. Courts in this Circuit and others have considered several factors in assessing conflict preemption, including the regulatory history of the drug or drug class at issue, temporal gaps between FDA action and accrual of a plaintiffs claims, citizen petition submissions and rejections, available scientific data, and whether- the FDA has reviewed the particular harm at issue and the consistency of any resulting conclusions. See Levine, 565 U.S. at 572, 129 S.Ct. 1187; Gaeta, 630 F.3d at 1237; Koho, 17 F.Supp.3d at 1116-19; Dobbs, 797 F.Supp.2d at 1272-75; Mason v. Smith-Kline Beecham Corp., 596 F.3d 387, 395-96 (7th Cir. 2010). Thus, manufacturer submission of a proposed labeling change is relevant, but not dispositive, in determining whether a defendant can establish conflict preemption.
Other courts have similarly concluded the clear evidence standard may be satisfied outside of express FDA rejection of a manufacturer proposed labeling change; See Cerveny v. Aventis, Inc., Case No. 2:14cv545, 155 F.Supp.3d 1203, 1213-16, 2016 WL 1065826 at *8-9 (D.Utah, Mar. 16, 2016) (“Courts have universally rejected the notion that Levine requires a showing that the manufacturer attempted to apply the warning suggested by the plaintiff but that the labeling was ultimately rejected by the FDA.”); Reckis v. Johnson and Johnson, 471 Mass. 272, 290 n. 29, 28 N.E.3d 445 (2015) (“The court in Wyeth specifically suggested that ‘clear evidence’ could be established by the FDA’s rejection of a drug maker’s attempt to give the warning underlying a claim of failure to warn.... That is not to say that the Wyeth standard of clear evidence can be satisfied only by the FDA’s rejection of a manufacturer’s request for an additional warning.”).
Plaintiffs also raise a similar argument premised on the distinction between FDA consideration of a risk and FDA consideration of a proposed warning. (See Doc. No. 125 at 10-12.) Plaintiffs assert that the FDA’s consideration of a risk, when not accompanied by specific warning language addressing that risk, is insufficient to establish conflict preemption. (Id.) As support for this position, Plaintiffs contend Levine and Gaeta both involved FDA consideration of the risk implicated by the plaintiffs claims, but found against preemption because the FDA had not considered and rejected the warnings proposed by the plaintiffs. (Id.) Plaintiffs also rely on cases addressing preemption and failure-to-warn claims with antidepressants and suicidality as illustrating the need for the FDA to consider specific warning language in connection with a conflict preemption analysis. (Id. at 16-17; Doc. No. 130 at 16-19.)
The cases relied on by Plaintiffs are distinguishable on several grounds. Significantly, in mány conflict preemption cases the risk considered by the FDA did not correspond to the safety issue the plaintiff alleged should have been included in product labeling. For example, in Levine, the plaintiff argued the defendant should have warned of the risks associated with the “IV-push” method of administering Phen-ergan. 555 U.S. at 560, 129 S.Ct. 1187. The record in Levine, however, established that the FDA had given no more than passing attention to the risks associated with that specific method of administration. Id. at 572, 129 S.Ct. 1187 (noting there was “no evidence in th[e] record that either the FDA or" the manufacturer gave more than passing attention to the issue of IY-push versus IV-drip administration”) (internal quotation. marks omitted). Thus, Levine involved not only a specific warning about the method of administration, but also a lack of FDA consideration, and action regarding the risk implicated by the plaintiffs claim. Id. at 572-73, 129 S.Ct. 1187.
Similarly, in Gaeta, the FDA had reviewed the general safety of ibuprofen on several occasions, including evidence that ibuprofen was safe and effective. Gaeta, 630 F.3d at 1236-37. There was limited evidence however, that the FDA had- considered the risk of hepatotoxicity associated with concurrent use of ibuprofen and other drugs known to cause liver toxicity. Id. The Ninth Circuit accordingly concluded there was insufficient evidence that the FDA had considered the specific warning sought by the Gaetas. Id. (“Nowhere does Perrigo point to any evidence that the FDA was presented with and actually considered the risk of hepatotoxicity, due to concomitant use of ibuprofen and other drugs known to be hepatotoxic, which is the specific warning requested by the Gae-tas in this case.”). Finding the evidence no more compelling than that in Levine, the court concluded the plaintiffs’ claims were not preempted. Id,
Additionally, the warning Plaintiffs seek is distinguishable from those at issue in the fine of cases assessing suicide risk and antidepressants. Several cases have considered failure-to-warn claims stemming from the use of antidepressants, specifically those known as SSRI’s,
Moreover, many of the warnings at issue in the antidepressant cases were directed at particular patient groups, such as pediatric or young adult patients. Cf. Mason, 596 F.3d at 389 (considering a warning of increased suicide risk, especially among young adults), with Dobbs, 797 F.Supp.2d at 1265 (addressing suicide warnings directed at adult patients). Because the SSRI cases implicated specific warning language directed at different patient groups, the FDA, and by extension, the courts’ analyses of FDA action, parsed specific warning language to compare what the FDA had already considered and what was presently included in product labeling.
The warning at issue in this case is far less specific and is not directed at any particular group of patients taking incretin mimetics. Additionally, product labeling does not currently reference pancreatic cancer, making the initial determination of whether to include pancreatic cancer in product labeling paramount to consideration of specific warning language. As such, it would likely be premature for the FDA to consider specific warning language when neither a manufacturer nor the FDA has determined that pancreatic cancer.risk should be included in product labeling.
Plaintiffs also rely on Reckis v. Johnson & Johnson for the argument that preemp
The court in Reckis concluded that claims asserting the defendant should have warned of SJS or TEN by name were preempted. Id. at 290-91, 28 N.E.3d 445. The court’s preemption finding was limited, however, noting that it was “anybody’s guess” whether the FDA would approve a label referencing a “life threatening” disease or other language that did not raise consumer unfamiliarity concerns. Id. at 289, 28 N.E.3d 445 (“Whether the FDA also would consider including a mention of life-threatening diseases, by itself, to be inappropriate and off limits on the [over the counter] label is anybody’s guess; certainly the reason specified by the FDA for rejecting use of the disease names—consumer unfamiliarity—does not apply to use of such a phrase,”).
. Although Plaintiffs argue that it is similarly unknown what the FDA would do with a pancreatic cancer label change, Reckis is perhaps the most distinguishable from the facts of this matter. First, as prescription drugs not available for over-the-counter purchase, incretin mimetics do not pose the same consumer familiarity issues present in Reckis. This negates, at least in part, the need for the FDA to consider specific warning language to ensure consumer familiarity. Similarly, neither party in this case has asserted that pancreatic cancer is a term patients are unfamiliar with, so as to suggest the FDA would permit a reference to pancreatic cancer risk through different or more specific language. Lastly, in Reckis, the FDA agreed that product labeling should reflect the risk of SJS and TEN. Here, the FDA has repeatedly rejected the proposition that incretin mimetic labeling should reflect a risk of pancreatic cancer. Based on these differences, the fact that the FDA has not considered pancreatic cancer risk in the context of a proposed warning does not prevent the Court from finding Plaintiffs’ claims conflict preempted.
Having concluded the facts of this case do not preclude preemption as a matter of law, the Court now turns to the evidence offered in support of preemption.
A. Clear Evidence Exists that the FDA Would Reject a Pancreatic Cancer Reference in Product Labeling
Following a thorough review of the record, clear evidence exists that the FDA would have rejected a pancreatic cancer labeling change. The FDA has consistently considered pancreatic cancer risk and con-
. The FDA’s failure to act regarding pancreatic cancer risk also weighs in favor of finding Plaintiffs’ claims preempted. If the FDA believed scientific data supported a labeling reference to pancreatic cancer, it could have mandated a label change independent to, or .concurrently with, any one of its reviews of pancreatic safety. While the FDA’s failure to mandate a label change does not establish clear evidence under Levine, the FDA’s failure to act when presented with data specific to pancreatic cancer risk supports a finding of preemption. Cf. Gaeta, 630 F.3d at 1237 (“Nor does Perrigo suggest that it supplied the FDA with any ‘evaluation or analysis concerning the specific dangers’ posed by such concomitant use, and that the FDA refused to act.”) (internal citations. omitted).
As the Supreme Court noted in Levine, a manufacturer has a duty to make labeling changes when a risk becomes apparent. Levine, 555 U.S. at 571, 129 S.Ct. 1187 (“Thus, when the risk of gangrene from IV-push injection of Phenergan became apparent, Wyeth had a duty to provide a warning that adequately described that risk, and' the CBE regulation permitted it to provide such a warning before receiving the FDA’s approval”). Here, Defendants did not have a duty to submit a pancreatic cancer warning to the FDA because the risk of pancreatic cancer was never readily apparent from available data.
Finally, the evidence establishes that if Defendants had submitted a pancreatic cancer labeling change, the FDA would have rejected it. The regulatory standards governing prescription drug labeling are the same whether the FDA is considering data as part of an independent review, in connection with a citizen petition, or in response to a manufacturer submitted CBE. Though Plaintiffs argue the FDA gives deference to submissions made by a manufacturer, the authority relied upon by Plaintiffs does not establish the degree or manner of deference the FDA would afford a manufacturer submission. See, e.g., Reckis, 471 Mass. at 289; Baumgardner v. Wyeth Pharmaceuticals, 2010 WL 3431671, at *1 (E.D.Pa. Aug. 31, 2010), Schedin v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.Supp.2d 1125, 1133
Thus, although the CBE provision is an integral means for a manufacturer to maintain adequate product labeling, a manufacturer must utilize that provision only when a submission is supported by sufficient scientific data. It is a well-settled maxim of jurisprudence that the law does not require idle acts. When considered in the context of federal regulations governing prescription drug labeling, Defendants did not have to submit a pancreatic cancer labeling change to establish conflict preemption. The unprecedented facts of this matter readily establish by clear evidence that the FDA would have rejected a labeling change referencing pancreatic cancer.
Plaintiffs raise two additional arguments in opposition to preemption. First, Plaintiffs cite the: FDA’s acknowledgement that it has not reached a “final conclusion” regarding pancreatic cancer risk as weighing against preemption. (Id. at 22-24.) According to Plaintiffs, because the FDA has not reached a final conclusion, the Court cannot conclude that the FDA would reject a pancreatic cancer warning if sought by Defendants. However, the Supreme Court has acknowledged that risk information accumulates over time. Levine, 555 U.S. at 569, 129 S.Ct. 1187. Likewise, clinical studies of incretin mimetics remain ongoing nearly a decade after initial FDA approval. (See, e.g., Doc. Nos. 119-3 at 8-17; 119-4 at 106-14). Thus, the contention that the FDA or a ■ manufacturer would reach a final conclusion regarding the safety of a prescription drug is inconsistent with the CBE provision and a manufacturer’s duty to maintain the adequacy of product labeling. Plaintiffs’ position also illustrates the incongruity of tort law and science. The law requires a level of decisiveness that is neither required, nor expected, of science. The scientific discoveries of tomorrow may redefíné our understanding of the safety and efficacy of prescription drugs. Yet, the Court must adjudicate the issues raised by the present motion without waiting until, if ever, the FDA renders a final decision regarding the pancreatic safety of incretin mimetics. Given the evolving nature of scientific data and medical research, arguments challenging the finality of the FDA’s conclusions are not persuasive.
Next, Plaintiffs argue Defendants cannot reconcile the reference to pancreatitis in product labeling with the FDA’s conclusion regarding pancreatitis in the Assessment. (Doc. No. 125 at 24-25.) The Assessment addressed concerns regarding pancreatitis and pancreatic cancer and concluded with respect to both that evidence of a causal association as reflected in the media and scientific literature did not reflect scientific data. (Doc. No. 119-3 at 4.) Plaintiffs rely on this language to argue the reference to pancreatitis in product labeling suggests the FDA would approve a reference to pancreatic cancer.
It is evident from the record that although the FDA has referenced pancreatic cancer and pancreatitis together, it has repeatedly differentiated between the two. Indeed, it is easy to reconcile the reference to pancreatitis in product labeling as the record shows a qualitative difference in available data. For example, the Assess
As noted by defense. counsel at the hearing on this motion, pancreatic cancer and pancreatitis are distinct medical entities, a fact undisputed by Plaintiffs. As different medical conditions, pancreatitis and pancreatic cancer also carry significantly different health implications, which could reasonably account for the reference to pancreatitis, but not pancreatic cancer, in product labeling. The fact the FDA has maintained a reference to pancreatitis in product labeling does not support the conclusion the FDA would permit a reference to pancreatic cancer. For these reasons, the reference to pancreatitis in product labeling does not undermine the Court’s conclusion that the FDA would have rejected a pancreatic cancer labeling change.
As detailed above, the record establishes the FDA has reviewed, independently investigated, and commented publicly on the specific issue implicated by Plaintiffs’ claims. Accordingly, Defendants have established by clear evidence that the FDA would have rejected a pancreatic cancer labeling change. See Robinson, 615 F.3d at 873 (“The FDA decided not to require such a warning ... and a court cannot order a drug company to place on a label a warning if there is ‘clear evidence’ that the FDA would not approve it.”).
B. Plaintiffs’ Request for Additional Discovery
Plaintiffs request the Court permit additional discovery in lieu of entering summary judgment. (Doc. No. 125 at 25.) Plaintiffs seek discovery beyond the February 27, 2014 cutoff date, arguing the date was arbitrary and prejudiced Plaintiffs in their ability to obtain information about the FDA’s actions and potential new safety information in Defendants’ possession. (Id. at 25-26.)' Defendants challenge Plaintiffs’ request as untimely, inconsistent with previous acknowledgements that discovery is complete, and irrelevant to preemption. (Doc. No. 126 at 10-11.) Defendants note that only one plaintiff in these consolidated proceedings consumed Ongly-za after the discovery cutoff date, and evidence after Plaintiffs’ claims accrued is not relevant to a preemption analysis. (Id. at 11.)
Plaintiffs challenge to the discovery cutoff date is untimely. The Court addressed this issue after considering briefing and oral argument on the subject in December 2014. (See Doc. Nos. 73, 75, 77.) At that time, Defendants argued the Court should limit discovery based on the date of the FDA’s assessment of pancreatic safety. In opposition, Plaintiffs argued the February 27, 2014, discovery cutoff date would be a de facto protective order precluding Plaintiffs from discovery into key evidence. (Doc. Nos. 75 at 5; 125 at 25.)
On December 17, 2014, the Court held a telephonic conference on the issue where, following argument by all parties, the Court concluded the date of the Assessment was the appropriate cutoff date for discovery. (See Doc. No. 78.) The Court noted the need for a fixed point from which to analyze the data before the FDA and from which to resolve Defendants’ affirmative defense of conflict preemption. (Mat 16-17.)
In the context of the present request, Plaintiffs do nothing more than reiterate the points raised in December 2014. The same reasons that the Court cited previously for establishing February 27, 2014, as the discovery cutoff date apply with equal force in the context of the present motion. Additionally, the relevant inquiry for conflict preemption is whether the FDA would have approved a change to product labeling at the time a plaintiffs claims accrued. Whether the FDA would reject a labeling change now is less indicative of whether the FDA would have accepted a change at the time a plaintiff was prescribed and consumed Onglyza or Kom-biglyze. Notably, all but one Plaintiff consumed Onglyza and or Kombiglyze months or years prior to the February 27, 2014 cutoff date.
Similarly, the plaintiff that, consumed Onglyza after the February 27, 2014, discovery cutoff date did so from August 12, 2014, through September 2014. (See Case No. 15cv219Q, Doc. No. 1 ¶ 96.) Given the proximity to the date of the Assessment, and the evidence in the record that extends beyond the cutoff date,. clear evidence remains that the FDA would have rejected a pancreatic cancer labeling change had one been submitted in August or September of 2014. In September 2014, the FDA was actively reviewing the safety and efficacy of Saxenda, which included data specific to pancreatic cancer. At that time, the FDA relied on its- review underlying the Assessment to reiterate that pancreatic cancer had not been proven as a risk associated with incretin mimetics and that data did not support pancreatic cancer as an incretin mimetic-mediated event. (See Doc. No. 119-4 at 103.) Thus, the relevance of new safety information.arising between February 2014 and September 2014 is also limited because available evidence provides insight to the FDA’s position regarding pancreatic cancer risk. For these reasons, the Court declines to reconsider the propriety of the February 27, 2014, discovery cutoff date.
In further support of additional discovery, Plaintiffs argue Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), does not preclude obtaining evidence in support of preemption and liability arguments.
Both cases cited by Plaintiffs aré' distinguishable, as they do not address Buck-man's, relevance to a clear evidence analysis under Levine. In re Yasmin involved a challenge to an expert’s testimony about when a manufacturer provided information to the FDA. 2011 WL 6302287 at *2. Finding the expert’s testimony admissible under Daubert, the court concluded Buck-man did not apply. Id. at *11. The court did not discuss the clear evidence analysis set forth in Levine, or explain how evidence regarding compliance or noncompliance with FDA regulations would alter an inquiry into whether a plaintiffs failure-to-warn claims are conflict preempted. See id. at *1 (noting the plaintiffs’ claimed the manufacturer misrepresented information pertaining the safety and efficacy of Yaz and Yazmin).
Similarly, in In re: Gen. Motors LLC Ignition Switch Litigation, the court considered a motion in limine to exclude evidence that the defendant had intentionally misled or concealed information from a federal agency. Case No. 14md2543, 2015 WL 8130449, at *1 (S.D.N.Y. December 3, 2015). Finding the evidence admissible despite Buckman, the court noted the evidence was not being used to create liability for misstatements to a federal agency, but instead making evidentiary use of alleged misstatements to establish traditional state tort claims. Id. at *2; see also In re Celexa & Lexapro Marketing, 779 F.3d at 41 (noting that a state law duty to initiate a labeling change is not a second guess of FDA judgment).
■ In this case, however, Plaintiffs assert that misrepresented or withheld data is relevant to overcome preemption and undermine the FDA’s publicly expressed conclusions regarding pancreatic cancer. This Court has recognized that Ninth Circuit authority similarly holds that Buckman does not preempt state law claims that parallel a duty to disclose information to a federal agency. See Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013) (“The central question in this appeal is whether the MDA preempts a state-law claim in which the state-law duty of care ‘parallels’ a federal-law duty imposed by the MDA. We conclude that such a state-law claim is not preempted[.]”). As raised in the instant context, as a defense to Defendants’ proffered clear evidence, Plaintiffs are not using alleged misrepresentations to establish parallel state law duties to disclose information to the FDA. Accordingly, Buckman does not permit discovery on the grounds that information withheld from the FDA can rebut a finding of clear evidence. To hold otherwise would allow a plaintiff to cite any data, presumably unconsidered by the FDA, to overcome a conflict preemption defense. Although the burden imposed on a conflict preemption proponent is high, the Court is unconvinced it requires a defendant to establish the FDA has considered all available data before rendering its conclusion regarding product labeling. For these reasons, authorizing additional discovery premised on allegations that Defendants withheld or misrepresented data to the FDA is not appropriate. Plaintiffs’ request for additional discovery is denied.
y. CONCLUSION
The unprecedented facts of this matter demonstrate by clear evidence that the FDA would have rejected a pancreatic cancer labeling change if submitted by Defendants. The FDA’s repeated review of pancreatic safety, coupled with its consistent conclusion that product labeling adequately reflected the state of scientific data presents facts distinguishable from
IT IS SO ORDERED.
. Doc. No. 119-3 at 2-5.
. "EMA” refers to the European Medicines Agency.
. On October 3, 2014, the Court consolidated all claims against Defendants under the lead case Seufert, Case No. 13cv2169. (See Doc. No. 61.) Although Teresa Seufert is the lead plaintiff, the instant motion affects the rights of several other plaintiffs whose cases the Court consolidated under Seufert,
.All cases consolidated under Seufert involve the prescription drug Onglyza. Defendants’ motion for summary judgment also pertains to Case No. 15cvl98, Elosegui v. Bristol-Myers Squibb Company, one of two cases filed in this District involving Kombigylze. The other case involving Kombiglyze, Copeland v. Bristol-Meyers Squibb Co., (Case No. 15cvl884) involved concurrent use Onglyza and Kombi-glyze.
.At oral argument, Plaintiffs appeared to challenge whether the FDA has treated all incretin mimetics the same regardless of the active ingredient or the mechanism of operation, i.e. whether the drug is a DPP-4 inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist. (See Doc. No. 130 at 4.) The record does not support a distinction on either grounds. The FDA has consistently referred to all incretin-based therapies collectively, and the parties have done the same. (See generally Doc. Nos, 119, 125, 126); (see also Doc, No. 119-3 at 3) (making no distinction between data specific to active ingredient or mechanism of action); (Doc. No. 119-5 at 65) (noting GLP-1 based therapeutics includes DPP4 inhibitors and GLP-1 analogues). Accordingly, the Court properly considers the FDA’s review of all incretin mimetics in evaluating whether the FDA would have rejected a labeling change to Onglyza or Kombiglyze.
. Federal regulations define an adverse event as "any untoward medical event associated with the use of a drug in humans, whether or not considered drug-related.” 21 C.F.R. § 312.32(a).
. A citizen petition is a procedural method by which an individual citizen, group, or entity may request that the FDA change or strengthen drug labeling. See 21 C.F.R. § 10.30.
. The Assessment was updated with non-substantive information on June 5, 2014. (Id. at 6.)
. Defendants argue Plaintiffs' opposition seeks reconsideration of In re Incretin-Based Therapies Products Liability Litigation, 142 F.Supp.3d 1108 (S.D.Cal. 2015), and the Court’s October 6, 2014 order denying MDL Plaintiffs' motion to compel discovery, (Case No. 13md2452, Doc. No. 705). The Court does not construe Plaintiffs' opposition as a motion for reconsideration, and therefore considers Defendants’ motion under Rule 56 and Supreme Court precedent governing conflict preemption in the prescription drug context.
. The Court recently surveyed conflict preemption case law as applied to pharmaceutical drug regulation in In re Incretin-Based Therapies Products Liability Litigation, 142 F.Supp.3d at 1115-19. In the interest of efficiency, the Court incorporates that discussion by reference as if set forth fully herein.
, Plaintiffs challenge the Court's reliance on Reckis in light of the Supreme Court’s recent denial of certiorari. See Johnson & Johnson v. Reckis, — U.S. -, 136 S.Ct. 896, 193 L.Ed.2d 809 (2016). According to Plaintiffs, the denial constitutes implied approval of a narrow interpretation of Levine requiring FDA rejection of a proposed warning. (See Doc. No. 125 at 17) (arguing "the Supreme Court was comfortable with Reckis, and 'most courts’ interpreting Levine narrowly, so that the 'clear evidence' standard could only be met where there had been an ‘explicit rejection’ ”). A denial or grant of certiorari has no precedential authority and does not reflect the Supreme Court's position regarding the merits of a case or a lower court’s ruling. See, e.g., Elgin, Joliet, & E. Ry. Co. v. Gibson, 355 U.S. 897, 78 S.Ct. 270, 2 L.Ed.2d 193 (1957) ("Al
. See § II, supra.
. "SRRI’s” are formally known as selective serotonin reuptake inhibitors.
. Plaintiffs also rely on Newman v. McNeil Consumer Healthcare, Case No.. 10cv01541, 2012 WL 39793, at *8 (N.D.Ill. Jan. 9, 2012), for the proposition that the FDA must consider and comment on specific proposed warning language. Newman, however, states that consideration of warning language "may be necessary in some instances,” but that "the FDA may reject a whole series of warnings without concerning itself with various formulations.” (Id. at *8, n. 6.) For the reasons set forth above, the FDA did not need to consider specific pancreatic cancer warning language.
. Plaintiffs argue “the only statement by the FDA through its official channel for drug safety communications” is the 2013 safety communication published on the FDA’s website. (See Doc. No. 125 at 22-23.) However, FDA officials authored the Assessment, which lacked a disclaimer required when publications are not considered official FDA work, and referenced the safety communication. (See Doc, No. 119-5 at 72-73) (discussing requirements for “FDA-assigned” and "non-.assigned” publications and speeches). That the FDA chose to publish its conclusion in the New England Journal of Medicine instead of through its own website does not weaken the extent of the FDA’s review underlying the Assessment, and the FDA’s conclusions as articulated therein.
.. Plaintiffs argue the FDA’s belief regarding a causal association between incretin mimet-ics and pancreatic' cancer is irrelevant for preemption purposes and does not answer the question of whether the FDA would have rejected a Changes-Being-Effected ("CBE”) submitted by the manufacturer. (Doc. No. 125 at 22.) However, what the FDA believed and publicly expressed regarding pancreatic cancer risk is the best indicator of what the FDA would have done in response to a manufacturer submitted CBE, The CBE provision permits a manufacturer to make changes prior to obtaining FDA approval. See 21 C.F.R. § 314.70(c)(6)
. Notably, the Oxford English Dictionary defines “apparent” as "manifest to the understanding; evidence, plain, clear, obvious; palpable.” 'Apparent; OED Online, Oxford University Press, March 2016, http://www. oed.com/view/Entry/9518?rskey=NUKqsL& result= l&isAdvanced=false#eid The same source defines the term "indeterminate" as "not determined; undetermined." Indeterminate, OED Online, Oxford University Press, March 2016, http://www.oed.com/view/Entry/ 9435 7?redirectedFrom=indeterminate#eid
. In support of summary judgment, Defendants cite data from emerging clinical trials, including the SAVOR, EXAMINE TECOS, and ELIXA studies. While it is apparent from the Assessment that the FDA considered data from the SAVOR and EXAMINE studies, the same is not true for the TECOS or ELIXA data. As the Court cannot second-guess the FDA’s determinations, it also cannot bolster the FDA’s conclusions with data the FDA may not have considered. Nonetheless, emerging data is notable, if only for the fact that it suggests an inverse relationship between in-cretin mimetics and pancreatic cancer as that proffered by Plaintiffs. The EXAMINE clinical . trial, dealing with the active ingredient alo-gliptin, involved 5,380 patients and reported no incidences of pancreatic cancer. (Doc. Nos. 119-3 at 4; 119-4 at 106-114.) SAVOR involved 16,492 patients and resulted in seventeen cases of pancreatic cancer, twelve of which occurred in patients taking a placebo, and five in patients taking saxaglitpin. (Doc. No. 119-3 at 4.) TECOS was similarly sized, with 14,700 patients and twenty-three cases of pancreatic cancer. (Doc. No. 119-5 at 2-12.) Of the twenty-three cases, fourteen cases occurred in patients taking a placebo, and nine occurred in patients taking sitagliptin. (Id.) Finally, the ELIXA study involved lixise-natide and 6,000 patients. The study resulted in twelve cases of pancreatic cancer, only three of which occurred in patients taking lixisenatide. (Doc. No. 119-5'at 14-24.) While this data does not factor into the Court’s conclusion that Plaintiffs’ claims are conflict preempted, the Court notes it as recent data offered by Defendants in support of preemption.
. The dates of usage for Plaintiffs in this litigation are as follows: Plaintiff Seufert, (Case No. 13cv2169), consumed Onglyza from April 30, 2010 through June 13, 2012, and was diagnosed with pancreatic cancer on September 9, 2011. (Doc. No. 1 ¶¶ 82, 83.) • Plaintiff Lara, (Case No. 13cv2928), consumed Onglyza from December 18, 2009 through November 2011, and was diagnosed with pancreatic cancer on December 7, 2011. (Doc. No. 1. ¶¶ 107, 108.) Plaintiff McDaniel, (Case No. 13cv3191), consumed Onglyza from May 25, 2010 through June 2010, and was diagnosed with pancreatic cancer on January 28, 2011. (Doc. No. 1 ¶¶ 99, 100.) Plaintiff Gaines, (Case No. 14cv0056), consumed Ong-lyza from June 30, 2010 through November 2010, and was diagnosed with pancreatic cancer on January 24, 2011. (Doc. No. 1 ¶¶ 97, 98.) Plaintiff Marble, (Case No. 14cv0611), consumed Onglyza from- November 24, 2009 through March 2012, and was diagnosed with pancreatic cancer on February 28, 2012. (Doc. No. 1 ¶¶ 97, 98.) Plaintiff Stoval, (Case No. 14cvl612), consumed Onglyza from November 28, 2011 through May 2013, and was diagnosed with pancreatic cancer on July 8, 2013. (Doc. No. 1 ¶¶ 107, 108.) Plaintiff Heindl, (Case No. 14cvl973), consumed Ong-
, In MDL 2452, the Court declined to compel discovery from Defendants on the grounds that the information sought would establish that Defendants withheld or misrepresented pancreatic cancer data to the FDA. (See Case No, 13md2452, Doc. No, 705.) Relying on the reasoning set forth in Buckman v. Plaintiffs’ Legal Committee, the Court concluded that fraud-on-the-FDA claims were preempted when not asserted as an element of a parallel state tort law duty. Although the Court did not issue that order in this case, this case has mirrored the MDL proceedings, and thus Plaintiffs’ argument regarding the applicability of Buckman appropriately raised here.
Reference
- Full Case Name
- Teresa SEUFERT v. MERCK SHARP & DOHME CORP. Lara v. Merck Sharpe & Dohme Corp., (13cv2928) McDaniel v. Merck Sharpe & Dohme Corp., (13cv3191) Gaines v. Amylin Pharmaceuticals, LLC, (14cv0056) Marble v. Merck Sharpe & Dohme Corp., (14cv0611) Stovall v. Amylin Pharmaceuticals, LLC, (14cv1612) Heindl v. Merck & Co., Inc., (14cv1973) Blazer v. Amylin Pharmaceuticals, LLC, (15cv1149) Gisbon v. Bristol-Myers Squibb Co., (15cv1340) Deihl v. Merck Sharpe & Dohme Corp., (15cv1435) Copeland v. Bristol-Meyers Squibb Co., (15cv1884) Mathews v. Merck Sharp & Dohme Corp., (15cv2190)
- Cited By
- 5 cases
- Status
- Published