In re Zantac (Ranitidine) Prods. Liab. Litig.

546 F.Supp.3d 1192

IN RE: ZANTAC (RANITIDINE) PRODUCTS LIABILITY LITIGATION

MDL NO. 2924

20-MD-2924

United States District Court, S.D. Florida.

Signed June 30, 2021

ORDER GRANTING IN PART AND DENYING IN PART BRAND-NAME MANUFACTURER DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ INNOVATOR-LIABILITY CLAIMS

ROBIN L. ROSENBERG, UNITED STATES DISTRICT JUDGE

This matter is before the Court upon Brand-Name Manufacturer Defendants’¹ ("Defendants") Rule 12 Motion to Dismiss Plaintiffs’ Innovator-Liability Claims ("Motion to Dismiss"). DE 3109. The Court held a hearing on the Motion to Dismiss on June 3, 2021 (the "Hearing"). The Court has carefully considered the Motion to Dismiss, Plaintiffs’ Opposition thereto [DE 3328], Defendants’ Reply [DE 3428], the arguments that the parties made during the Hearing, and the record and is otherwise fully advised in the premises. For the reasons set forth below, the Defendants’ Motion to Dismiss is GRANTED IN PART AND DENIED IN PART and Plaintiffs’ innovator-liability claims are DISMISSED WITHOUT PREJUDICE . The Court's dismissal is with leave to amend.

I. Factual Background²

This case concerns the pharmaceutical product Zantac and its generic forms, which are widely sold as heartburn and gastric treatments. The molecule in question—ranitidine—is the active ingredient in both Zantac and its generic forms.

Zantac has been sold since the early 1980s, first by prescription and later as an over-the-counter ("OTC") medication. In 1983, the U.S. Food and Drug Administration ("FDA") approved the sale of prescription Zantac. AMPIC ¶ 240. GSK first developed and patented Zantac. Id. ¶ 239. Zantac was a blockbuster—the first prescription drug in history to reach $1 billion in sales. Id. ¶ 240.

GSK entered into a joint venture with Warner-Lambert in 1993 to develop an OTC form of Zantac. Id. ¶ 233. Beginning in 1995, the FDA approved the sale of various forms of OTC Zantac. Id. ¶¶ 233, 237. The joint venture between GSK and Warner-Lambert ended in 1998, with Warner-Lambert retaining control over the sale of OTC Zantac in the United States and GSK retaining control over the sale of prescription Zantac in the United States. Id. ¶ 243. Pfizer acquired Warner-Lambert in 2000 and took control of the sale of OTC Zantac in the United States. Id. ¶ 245. The right to sell OTC Zantac in the United States later passed to BI and then to Sanofi. Id. ¶¶ 249–50, 253–55. When the patents on prescription and OTC Zantac expired, numerous generic drug manufacturers began to produce generic ranitidine products in prescription and OTC forms. Id. ¶¶ 260–62.

Scientific studies have demonstrated that ranitidine can transform into a cancer-causing molecule called N-nitrosodimethylamine ("NDMA"), which is part of a carcinogenic group of compounds called N-nitrosamines. Id. ¶¶ 348, 359, 365, 367. Studies have shown that these compounds increase the risk of cancer in humans and animals. Id. ¶¶ 398–404. The FDA, the Environmental Protection Agency, and the International Agency for Research on Cancer consider NDMA to be a probable human carcinogen. Id. ¶¶ 275, 279. The FDA has set the acceptable daily intake level for NDMA at 96 nanograms. Id. ¶¶ 302.

Valisure LLC and ValisureRX LLC, a pharmacy and testing laboratory, filed a Citizen Petition on September 9, 2019, calling for the recall of all ranitidine products due to high levels of NDMA in the products. Id. ¶ 322. The FDA issued a statement on September 13 warning that some ranitidine products may contain NDMA. Id. ¶ 323. On November 1, the FDA announced that testing had revealed the presence of NDMA in ranitidine products. Id. ¶ 333. The FDA recommended that drug manufacturers recall ranitidine products with NDMA levels above the acceptable daily intake level. Id. Five months later, on April 1, 2020, the FDA requested the voluntary withdrawal of all ranitidine products from the market. Id. ¶ 338.

II. Procedural Background

After the discovery that ranitidine products may contain NDMA, plaintiffs across the country began initiating lawsuits related to their purchase and/or use of the products. On February 6, 2020, the United States Judicial Panel on Multidistrict Litigation created this multi-district litigation ("MDL") pursuant to 28 U.S.C. § 1407 for all pretrial purposes and ordered federal lawsuits for personal injury and economic damages from the purchase and/or use of ranitidine products to be transferred to the undersigned. DE 1. Since that time, approximately 1,400 plaintiffs have filed lawsuits in, or had their lawsuits transferred to, the United States District Court for the Southern District of Florida. In addition, this Court has created a Census Registry where tens of thousands of claimants who have not filed lawsuits have registered their claims. See DE 547.

Plaintiffs filed their first Master Complaints on June 22, 2020. DE 887, 888, 889. In those Master Complaints, Plaintiffs contended that the ranitidine molecule is unstable, breaks down into NDMA, and has caused thousands of consumers of ranitidine products to develop various forms of cancer. DE 887 ¶¶ 1, 6, 19. They alleged that "a single pill of ranitidine can contain quantities of NDMA that are hundreds of times higher" than the FDA's allowable limit. Id. ¶ 4. The Plaintiffs pursued federal claims and state claims under the laws of all 50 U.S. states, Puerto Rico, and the District of Columbia. See generally DE 889.

The Court has entered numerous Pretrial Orders to assist in the management of this MDL. In Pretrial Order # 36, the Court set a schedule for the filing and briefing of the first round of motions to dismiss under Rule 12 directed to the Master Complaints. DE 1346. The various defendants filed motions to dismiss.

Relevant to this Order, Defendants moved to dismiss all claims premised upon the innovator-liability theory³ asserted against them by generic ranitidine product consumer Plaintiffs in California and Massachusetts courts for lack of specific personal jurisdiction. DE 1584 at 14.⁴ Additionally, Defendants moved to dismiss claims premised on the same theory brought in states in which Defendants were subject to general personal jurisdiction because the Due Process Clause constrains those states from applying the law of California or Massachusetts to Plaintiffs’ claims. Id. at 17. The Court first concluded that Plaintiffs failed to allege a prima facie case of specific personal jurisdiction as to any Defendant in California or Massachusetts. The Court's analysis of the parties’ respective arguments was limited because Plaintiffs failed to allege specific, non-conclusory facts demonstrating that any of Defendants’ activities took place in any state or territory, including in California or Massachusetts, the only two states that recognize Plaintiffs’ theory of liability. In light of the absence of specific factual allegations, Plaintiffs failed to meet their burden to establish specific jurisdiction because they failed to allege that Plaintiffs’ claims arose from or related to Defendants’ activities in California and Massachusetts.⁵ Plaintiffs also failed to meet their burden because they failed to allege that Defendants should have foreseen being haled into Massachusetts or California court due to their activities within those forums. The Court also held that Plaintiffs failed to establish that California and Massachusetts have legislative jurisdiction within those states that have general personal jurisdiction over Defendants. DE 2516 at 20-23. Therefore, the Court granted Defendants’ Motion to Dismiss, dismissing without prejudice for lack of personal jurisdiction all claims brought by generic ranitidine product consumer Plaintiffs against Defendants, with the exception of Defendant Patheon Manufacturing Services, LLC ("Patheon"), in California and Massachusetts. Id. at 23-24. The Court granted Plaintiffs leave to amend the MPIC to plead a prima facie case of personal jurisdiction in California and Massachusetts. Id.

Following an amendment to Pretrial Order # 36, Plaintiffs filed the AMPIC on February 8, 2021. DE 2759. After the Court granted a two-week extension of time [DE 2720], Plaintiffs filed the MMC [DE 2832-1] and the ELC [DE 2835] on February 22, 2021. In Pretrial Order # 61, the Court set a schedule for the filing and briefing of the second round of motions to dismiss under Rule 12 directed to the Master Complaints. DE 2968. The Defendants filed the Motion to Dismiss addressed herein pursuant to that schedule.

III. The Amended Master Personal Injury Complaint

Plaintiffs assert Counts XII and XIII against Defendants under the innovator-liability theory. AMPIC ¶¶ 2668-2721. Count XII is a claim for negligent misrepresentation brought by generic ranitidine product consumers residing in California ("California Plaintiffs"). Id. ¶¶ 2668-92. California Plaintiffs allege that Defendants owe a duty of care to all generic consumers of ranitidine products and that Defendants made false representations regarding the safety of ranitidine products, thereby breaching their duty. Id. Count XIII is a claim for reckless misrepresentation brought by generic ranitidine product consumers residing in Massachusetts ("Massachusetts Plaintiffs"). Id. ¶¶ 2693-2721. Massachusetts Plaintiffs allege that Defendants owe a duty of care to all generic consumers of ranitidine products, that Defendants made false representations regarding the safety of ranitidine products, and that Defendants’ conduct demonstrated a "conscious disregard, or indifference to, a significant possibility of causing serious injury" to any consumer of ranitidine products. Id. ¶¶ 2718-20. Additionally, Counts XV-XVII are derivative claims and include: loss of consortium, survival actions, and wrongful death. Id. ¶¶ 2939-3267.

It is undisputed that Counts XII and XIII are based on a theory of liability that is currently recognized under only California and Massachusetts law. See DE 1585 at 6; DE 1973 at 15. This theory of liability has been...