IN RE: Zantac (Ranitidine) Products Liability Litigation

Judicial Panel on Multidistrict Litigation, jpml-0:2019-md-02924

INTERESTED PARTY RESPONSE IN SUPPORT -- (re: pldg. (1 in MDL No. 2924)) Filed by Plaintiff PHILLIP MCDONALD.DELETED DUPLICATE ATTACHMENT NAMES

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Case MDL No. 2924 Document 9 Filed 11/08/19 Page 1 of 7 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION In Re: ZANTAC/RANITIDINE MDL No: 2924 NDMA Litigation INTERESTED PARTY RESPONSE OF PLAINTIFF PHILLIP MCDONALD TO MOTION FOR TRANSFER OF ACTIONS PURSUANT TO 28 U.S.C. § 1407 FOR COORDINATED OR CONSOLIDATED PRETRIAL PROCEEDINGS Oral Argument Requested Pursuant to Rule 6.2(e) of the Rules of Procedure for the Judicial Panel on Multidistrict Litigation ("Panel"), Plaintiff Phillip McDonald (Case No. 3:19-cv-04429 (N.D. FL)) ("Movant") respectfully files this Response to the Motion filed by Plaintiff Christina Garza (Case No. 5:19- cv-05772 (N.D. CA)) for Transfer of Actions to the District of New Jersey Pursuant to 28 U.S.C. § 1407 for Coordinated or Consolidated Pretrial Proceedings. See ECF 1. Movant agrees with Plaintiff Garza's request for coordinated or consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407. Movant requests that the proceedings be transferred to the Southern District of Florida before Judge Federico A. Moreno. In the alternative, Movant requests transfer to the District of New Jersey, but respectfully suggests that if the actions are centralized in the District of New Jersey that they be centralized before Judge Robert B. Kugler or the Camden Vicinage because: (1) this litigation involves the same NDMA carcinogen as the Valsartan MDL that is pending before Judge Kugler (located in the Camden Vicinage) and there will be significant overlapping scientific issues between the Valsartan MDL and the Zantac MDL, (these overlapping issues will include the chemical properties of NDMA carcinogen and the types of cancers caused by the NDMA carcinogen); and (2) numerous law firms (both plaintiffs and defendants) involved in the Valsartan MDL are also involved in the Zantac litigation, including lawyers who have already filed Zantac lawsuits. 1 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 2 of 7 I. BACKGROUND In the interest of brevity, Movant adopts the background set forth by Plaintiff Garza in her Motion. Movant underscores the argument that due to the instability of the ranitidine molecule itself and this molecule's propensity to break down into NDMA inside of the body, all Zantac and ranitidine has had the potential to cause cancer inside of consumers since Zantac was first introduced to the US market in 1983. The primary purpose of NDMA is to induce laboratory animals with tumors in order to study the effects of these tumors and the potential treatment options for these tumors. Between animal studies, human dietary studies, and occupational exposure studies, nearly two hundred scientific literature articles have been published that demonstrate NDMA's propensity to induce tumors at numerous organ sites, including the stomach, intestine, liver, pancreas, esophagus, kidney, and bladder. Valisure, an online pharmacy that also runs an analytical laboratory that is accredited by the International Organization for Standardization, demonstrated that with a high nitrite diet, the stomach was capable of breaking down hundreds of thousands of nanograms of NDMA from the ranitidine molecule. Glaxo's marketing campaign of Zantac included a consumer's ability to eat high nitrite diets (i.e. pizza) at the same time as ingesting Zantac. Valisure also demonstrated that the DDAH enzyme in the human tissues are capable of breaking down millions of nanograms of NDMA from the ranitidine molecule. These levels of NDMA are tens of thousands and hundreds of thousands of times higher than the daily threshold level of 96 nanograms of NDMA that has been adopted by the FDA. A Stanford University study conducted in 2016 showed that ranitidine users had 400 times the acceptable amount of NDMA in their urine. Understanding that NDMA has a high absorption rate inside the body, this also demonstrates that large amounts of NDMA are breaking down inside the body from the ranitidine molecule. Multiple other studies have also corroborated Valisure's and Stanford's findings that the ranitidine molecule breaks down into high amounts of NDMA inside the body. 2 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 3 of 7 The FDA's findings to date have not contradicted Valisure's findings, Stanford's findings, or the results of multiple other studies that have corroborated Valisure's and Stanford's findings that the ranitidine molecule breaks down into high amounts of NDMA inside the body. Rather, the FDA has simply tested the Zantac pill itself (before digestion in the body) and found that for numerous manufacturers, even the pill itself has NDMA levels that exceed the 96 nanogram threshold. In addition, the FDA has demonstrated that with a normal diet (as opposed to a high nitrite diet), the stomach does not break down high amounts of NDMA from the ranitidine molecule. Likewise, Valisure had also previously reported that the stomach does not break down high amounts of NDMA from the ranitidine molecule with a normal diet, but rather, breaks down high amounts of NDMA from ranitidine use with a high nitrite diet and/or from the DDAH enzyme in the human organ tissues. The FDA has also recognized that it has not conducted any human studies (like the Stanford Study and multiple other studies that corroborated Valisure's findings) that demonstrate whether or not NDMA breaks down inside the body from ranitidine use. Movant's counsel represents nearly a thousand clients who allege that they were diagnosed with cancer after taking Zantac and from movant's counsel's discussions with other counsel who represent similarly situated clients, movant's counsel believes thousands of personal injury Zantac lawsuits will be filed over the next couple of years. II. ARGUMENT IN SUPPORT OF CENTRALIZATION Movant agrees with the arguments set forth in Plaintiff Garza's motion and will not belabor the key points favoring centralization, which Movant briefly summarizes below. Movant requests centralization in the Southern District of Florida before the Judge Federico A. Moreno, but in the alternative, Movant requests the District of New Jersey and proffers additional reasons why this matter is uniquely suited for assignment to Judge Robert B. Kugler or the Camden Vicinage. 3 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 4 of 7 Movant agrees with Plaintiff Garza that the pending Zantac cases involve common questions of fact. Movant also agrees that the most prominent common question centers on instability of the ranitidine molecule that breaks down into extremely large amounts of NDMA in the body, that the pending class action cases involve many common or overlapping questions of law with each other, and that the personal injury cases currently filed involve questions of law and fact that are common with both each other and with the filed class action cases. Currently, a total of 15 Zantac lawsuits have been filed (6 class actions and 9 personal injury actions)1. The personal injury Zantac cases currently on file represent the tip of the iceberg of the Zantac cases to be filed in the next couple of years. Movant's counsel expects thousands of lawsuits will be filed by plaintiffs who will allege that the ingestion of Zantac caused their cancers. Movant's counsel currently represents nearly a thousand personal injury clients who have been diagnosed with cancer after ingesting Zantac. Movant's counsel has also communicated with multiple prominent personal injury law firms who have also stated that they currently represent hundreds of similar plaintiffs. This litigation will not be limited to a loose collection of largely overlapping class cases; it will likely become a large collection of consumer class, medical monitoring, third party payer, and personal injury cases. Movant also agrees with Plaintiff Garza that coordinated or consolidated pretrial proceedings will conserve the parties' and judicial time and resources for all of the reasons set forth in Plaintiff Garza's motion. III. ARGUMENT IN SUPPORT OF SOUTHERN DISTRICT OF FLORIDA, OR IN THE ALTERNATIVE, DISTRICT OF NEW JERSEY Movant requests the Southern District of Florida as transferee court. As of October 15, 2019, the Southern District of Florida only has five pending MDLs. Four of these MDLs have 1. See attached Schedule of Actions 4 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 5 of 7 fewer than 20 active cases, and the other MDL has fewer than 200 active cases. The Southern District of Florida is an efficient court. According to the September 2018 Federal Court Management Statistics, the Southern District of Florida ranks 1st among districts in the entire country in median time from filing to disposition for civil cases (3.9 months compared to a nationwide median of 9.2 months).2 In terms of percentages of civil cases over three years old, the Southern District of Florida is 6th among districts in the entire country with only 2.0% of its civil cases pending three years or more (compared to a nationwide average of 19.8%). The Southern District of Florida is convenient for parties and witnesses with the Miami International Airport being American Airlines' third largest hub and being served by numerous other major airlines with direct flights and connections throughout the United States. American Airlines is the largest airline in the world (according to fleet size, revenue, passengers carried and revenue passenger miles). Currently, more Zantac federal lawsuits are pending in Florida than any other state, and Southern District of Florida has three of those pending Zantac lawsuits. The first case docketed in Southern District of Florida was assigned to Judge Federico A. Moreno. In this litigation that is expected to have thousands of filed cases, Judge Federico – who has experience presiding over the Takata Airbags MDL that historically had over 300 actions and is now under 200 pending actions – would be an excellent fit for presiding over the Zantac MDL. However, in the alternative, Movant agrees with Garza's counsel that the District of New Jersey is a logical choice as transferee court. As of the time of this filing, three Zantac lawsuits are pending in the District of New Jersey. The District as a whole has substantial MDL experience, the District is efficient, the US Sanofi defendants are located in the District of New Jersey (along with several of the expected generic ranitidine defendants), and the District of New 2. See UNITED STATES DISTRICT COURTS – NATIONAL JUDICIAL CASELOAD PROFILE (September 30, 2018), available at https://www.uscourts.gov/sites/default/files/data_tables/fcms_na_distprofile0930.2018.pdf (last accessed Jan. 14, 2019) 5 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 6 of 7 Jersey is conveniently located for the other defendants in the case. Within the District of New Jersey, Judge Robert B. Kugler is a uniquely situated jurist to efficiently preside over this litigation. Judge Robert B. Kugler currently presides over the Valsartan MDL – another litigation dealing with the NDMA carcinogen. The Valsartan MDL and the Zantac MDL will have significant overlapping scientific issues, including the types of cancers caused by the NDMA carcinogen and the chemical properties of NDMA. With the Valsartan MDL, there have already been significant discussions regarding the NDMA carcinogen and the injuries caused by the NDMA carcinogen in front of Judge Robert B. Kugler and the Magistrate Judge Joel Schneider, and these discussions will be ongoing in that litigation. Therefore, Judge Kugler's extensive, recent experience with the NDMA carcinogen makes him uniquely suited to preside over this litigation, as his up-to-date knowledge of and familiarity with the science and chemical properties of the NDMA carcinogen will allow him to hit the ground running and enhance overall efficiencies for all parties in the Zantac litigation. Moreover, the Benicar litigation is nearly completely wrapped up. In just four years, Judge Kugler has guided that roughly 11,000-case litigation through a settlement process (nearly 9,000 of those cases were unfiled cases that participated in the settlement program and/or Court Ordered registration). The matter is in the final settlement stages with the vast majority of settlement payments to plaintiffs to be completed by the end of 2019. Other than the winding-down Benicar MDL and the Valsartan MDL, Judge Kugler does not have any other pending MDLs on his docket. While Movant does not deny that other District of New Jersey Judges have the experience to oversee centralized proceedings, Movant submits that Judge Kugler's recent and ongoing experience with the NDMA carcinogen in the Valsartan MDL, along with his success in overseeing the Benicar MDL, makes him an ideal choice for the Zantac MDL. 6 Case MDL No. 2924 Document 9 Filed 11/08/19 Page 7 of 7 In addition, numerous law firms (both plaintiffs and defendants) involved in the Valsartan MDL are also involved in the Zantac litigation, including lawyers who have already filed Zantac lawsuits. Efficiencies could be gained for all parties if Judge Kugler were handling both the Zantac MDL and the Valsartan MDL. As an alternative to Judge Kugler handling both MDLs, the Zantac MDL could be transferred to another Judge in the Camden Vicinage of the District of New Jersey. Having both MDLs in the Camden Vicinage would allow for better co-ordination of the potential overlapping NDMA scientific issues and the overlapping counsel between the Zantac MDL and the Valsartan MDL. As for convenience, the Camden courthouse is only approximately 12 miles from Philadelphia International Airport, one of the biggest airports in the country, which is less congested than neighboring airports in Newark and New York, and serves as a hub for American Airlines, the largest airline in the world (according to fleet size, revenue, passengers carried and revenue passenger miles). III. CONCLUSION For the foregoing reasons, Movant joins in Plaintiff Garza's request for centralization and asks for the Southern District of Florida before Judge Federico A. Moreno, or in the alternative, requests the District of New Jersey, but respectfully suggests the litigation should be assigned to Judge Robert E. Kugler or the Camden Vicinage. Dated: November 8, 2019 Respectfully submitted, /s/Daniel A Nigh Daniel A. Nigh Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. 316 S. Baylen Street, Suite 600 Pensacola, FL 32502 Phone: (850) 435-7013 Fax: (850) 436-6013 Email: dnigh@levinlaw.com Attorney for Plaintiff 7