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Generic Ranitidine Manufacturers Claim Plaintiffs Have Not Been Injured

The U.S. Food and Drug Administration (FDA) recalled all Zantac (ranitidine) antacid products from the market on April1, 2020, based on evidence that the products tested positive for unsafe levels of N-nitroso dimethylamine (NDMA), a cancer-causing substance. Since that time, many plaintiffs, who took the medication and were diagnosed with cancer, have filed against the makers of Zantac and generic ranitidine products. Some plaintiffs who were not diagnosed with cancer have also filed Zantac lawsuits because they fear they might get cancer in the future. In one such consolidated consumer class action complaint against generic manufacturers, the defendants have filed a motion to dismiss, alleging that the plaintiffs “fail to allege a true injury-in-fact,” if they have not been diagnosed with cancer.  To have a viable claim, the defendants argue that a plaintiff “must allege an injury that is distinct and palpable, as opposed to merely abstract, and the alleged harm must be actual or imminent, not conjectural or hypothetical.” The plaintiffs countered in their opposition response arguing the law holds that any products “that are so unsafe that they are illegal to buy or sell are also economically worthless and give rise to constitutional injury in fact when plaintiffs purchase them.” All federally filed Zantac and generic ranitidine lawsuits have been consolidated into the Southern District of Florida by the U.S. Judicial Panel on Multidistrict Litigation (JPML). Reference:  Luhanna, Roopal. “Generic Ranitidine Manufacturers Try to Get Class-Action Case Dismissed.” The Legal Examiner, 1 Dec. 2020. https://newyork.legalexaminer.com/health/generic-ranitidine-manufacturers-try-to-get-class-action-case-dismissed/

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Do I Qualify for the Zantac Lawsuit?

If you previously took Zantac and developed subsequent health problems, you may be entitled to pursue legal action. Not everyone who has side effects will be eligible to bring a successful lawsuit, which is why it’s crucial to understand who actually qualifies for the Zantac lawsuit. The FDA issued a warning that Zantac and its generic form ranitidine could cause cancer in some users. If you can show a cancer diagnosis linked to ranitidine usage, you may qualify to bring a Zantac lawsuit. To learn more about pursuing a claim for damages, speak to a Zantac lawsuit attorney at Gerling Law today. What Is Wrong with Zantac? Zantac is both a prescription and over-the-counter medication designed to decrease the amount of acid your stomach produces. It could help with heartburn, acid reflux, and other throat, gastrointestinal, and stomach issues. However, in April 2020, the FDA announced that companies should remove Zantac and its generic version ranitidine from their shelves as they discovered unacceptable amounts of NDMA. The FDA’s permissible daily intake is listed at 96 nanograms. However, routine testing by the online pharmacy Valisure discovered levels exceeding three million nanograms per tablet. NDMA In Zantac NDMA is the chemical N-nitrosodimethylamine, which is an environmental contaminant. Low levels of NDMA are found in some foods and water. At minimal levels, there is no expectation that your risk for cancer will increase. However, higher levels of exposure could increase your risk of cancer. Numerous studies have shown a link between NMDA and cancer in both animals and humans. It’s been known to cause cancer in animals and is probably carcinogenic to humans. It’s also the same carcinogen that led to a recall of the blood pressure drug Valsartan in 2018. Some studies on NDMA date back 40 years, and evidence suggests that manufacturers concealed the fact that there’s a potential link to cancer. By hiding this fact, companies like Sanofi and Boehringer Ingelheim profited significantly. Zantac was one of the first drugs to generate one billion dollars in sales. There are multiple theories on what causes NDMA to become carcinogenic in products like Zantac. There is a possibility that ranitidine’s inherent instability results in a chemical reaction that creates high levels of NDMA in your digestive tract. When nitrates are present, the chances increase. The FDA says NDMA is found in Zantac. Storing it at a temperature higher than room temperature could result in even higher NDMA levels. What Type of Cancer Does Zantac Cause? Research into the link between NDMA and cancer is ongoing. Some types of cancer that could result from NDMA exposure in ranitidine include: Stomach cancer, Esophageal cancer, Colorectal cancer, Bladder cancer, Intestinal cancer, Throat/nasal cancer, Pancreatic cancer, Liver cancer, Breast cancer, Lung cancer (non-smokers), and Prostate cancer. There could be other types of cancers related to Zantac use as well. These could include: Kidney cancer, Brain cancer, Thyroid cancer, Leukemia, Islet cell tumors, Multiple myeloma, and Non-Hodgkin’s lymphoma. If you have any of these types of cancer, it’s crucial to speak with a knowledgeable Zantac lawsuit attorney who can assist you. Who Is Suing Zantac? The initial lawsuit for Zantac was filed against Sanofi and Boehringer Ingelheim in California. The plaintiffs allege that these drug makers knew or should have known that Zantac was contaminated with a chemical with links to cancer. The plaintiffs suing Zantac are those people who developed cancer after taking ranitidine. There are already hundreds of plaintiffs, and the list is expected to grow by thousands more. There are several class-action suits, including plaintiffs who have used ranitidine but have not gotten sick. The plaintiffs in these suits are looking for reimbursement for the cost of the medication, and some are seeking equitable relief, such as medical monitoring. More manufacturers produced ranitidine tablets than just Sanofi or Boehringer. Other ranitidine products recalled in the FDA April 2020 release include: AHP (American Health Packaging)—ranitidine liquid unit dose cups and ranitidine tablets USP 150mg; Amneal (Amneal Pharmaceuticals, LLC)—ranitidine tablets 150mg and 300mg and Ranitidine syrup (Ranitidine Oral Solution, USP), 15 mg/mL; ANI (Appco Pharma LLC)—ranitidine tablets 150mg and 300mg; Apotex Corp. (Apotex Corp sold at Rite Aid, Walmart, and Walgreens)—ranitidine tablets 75mg and 150mg; Aurobindo & DG Health (Aurobindo Pharma, USA, Inc.)—ranitidine tablets and capsules 150mg; Glenmark (Glenmark Pharmaceuticals, Inc)—ranitidine tablets 150mg and 300mg.; Golden State Medical Supply, Incorporated (GSMS, Inc and Novitium Pharma LLC.)—ranitidine HCI 150mg and 300mg capsules; Lannett Company, Inc.—ranitidine syrup (ranitidine oral solution, USP) 15mg/mL; Northwind (Denton Pharma, Inc. dba Northwind Pharmaceuticals)—ranitidine tablets 150mg and 300mg; Perrigo Company PLC—ranitidine; Precision Dose (Amneal Pharmaceuticals)—ranitidine oral solution, USP 150mg/10mL; Dr. Reddy’s (Dr. Reddy’s Laboratories Ltd. sold at Kroger, Walgreens, Sam’s Club, CVS, and more)—ranitidine tablets and capsules; and Sandoz Inc.—ranitidine hydrochloride capsules 150mg and 300mg. If you still have any of these medications in your possession, keep the empty prescription bottles or other evidence that can help your lawsuit. However, you should properly destroy unused medicines following the FDA disposal guidelines. Who Actually Qualifies for the Zantac Lawsuit? To sue for Zantac-related cancer, you must meet the eligibility requirements. To start, you need to prove that you were taking Zantac. If you received a prescription for it, establishing usage is easier. If you took the over-the-counter version, it could be more challenging. You will need to gather any evidence that shows you took Zantac. Helpful evidence can include: Prescription records from your doctor; Pharmacy prescription records; Prescription bottles or packaging; and Purchase receipts. If you don’t have any of the items mentioned above, there may still be a way you can show proof. Very few people keep their bottles or receipts for medications, but you could also try to find records through the following:  Health saving accounts (HSA), Rx prescription drug cards, Health reimbursement accounts (HRA), Health flexible spending accounts (FSA), or Declarations or affidavits that you took over-the-counter Zantac. Next, you must have received a cancer diagnosis that aligns with one or more of the cancer types associated with exposure to NDMA....

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Sanofi Faces Financial Conduct Authority Claims

November 12, 2020 — U.S. District Judge Anita B. Brody “trimmed” claims accusing Sanofi’s predecessor, Aventis Pharmaceuticals, of false advertising and giving kickbacks to physicians who promoted Taxotere.  Claims stated that between 1996 and 2004, the drug manufacturer paid doctors to attend advisory boards focused on advertising Taxotere.  The doctors then prescribed Taxotere or off-brand versions of Taxotere to their patients after receiving kickbacks. Judge Brody ruled that the evidence likely indicates that Sanofi was aware its advisory boards did not align with its internal compliance policies.   The manufacturer was able to get rid of a false advertising claim.  It also avoided allegations of running a scheme in which sales representatives shadowed doctors and distributing kickbacks through meals and gift baskets. Reference: “Sanofi Must Face Cancer Drug FCA Claims At Trial.” Law360, www.law360.com/trials/articles/1328289/sanofi-must-face-cancer-drug-fca-claims-at-trial

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Taxotere Trial Schedule Update November 6, 2020

November 6, 2020 — “The Court amended certain pretrial deadlines for the third, fourth, and fifth bellwether trials.” Reference: “United States District Court.” MDL – 2740 Taxotere (Docetaxel) Products Liability Litigation | Eastern District of Louisiana | United States District Court, 28 Dec. 2020, www.laed.uscourts.gov/case-information/mdl-mass-class-action/taxotere.

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Timeline For Zantac Class Action Discovery

October 5, 2020 — On October 5, 2020, Judge Rosenberg ordered a timeline for class action discovery in Pretrial Order #49.  The timeline runs from October 23, 2020 to December 20, 2021, which is the deadline for fact discovery and class motions. Reference:  “United States District Court.” 20-MD-2924-Rosenberg – In Re: Zantac (Ranitidine) Products Liability Litigation | Southern District of Florida | United States District Court, 31 Dec. 2020, www.flsd.uscourts.gov/zantac.

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Taxotere Trial Schedule Update August 19, 2020

August 19, 2020 — “Per the parties’ agreement, the Court amended certain pretrial deadlines and trial dates.” Reference: “United States District Court.” MDL – 2740 Taxotere (Docetaxel) Products Liability Litigation | Eastern District of Louisiana | United States District Court, 28 Dec. 2020, www.laed.uscourts.gov/case-information/mdl-mass-class-action/taxotere

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Department of Justice Investigates Zantac Manufacturers

August 1, 2020 – The Department of Justice (DOJ) investigated Sanofi-Aventis US LLC and GlaxoSmithKline LLC regarding the allegations that the heartburn drug, Zantac, caused cancer. The DOJ and U.S. Attorney’s Office were specifically interested in whether these companies violated the False Claims Act by failing to reveal their knowledge about the presence of NDMA in their product. The probes began in July, 2020 and during that time the New Mexico Attorney General also filed a suit against several Zantac manufacturers for violating the False Advertising Act, the Unfair Practices Act, and other laws.  Although Zantac cases have already been consolidated in the MDL in Southern Florida, attorneys for 40 plaintiffs in California were separately attempting to consolidate their cases consolidated there, also. Cancers being attributed to Zantac include testicular, bladder, prostate, kidney, and thyroid. The claims also state that makers of the heartburn drug have known about its potential to cause injuries since the 1980s and that some of the manufacturers even used efforts to wrongfully end those clinical research studies. Zantac manufacturers continued to deny these claims asserted against them that their heartburn drug caused cancer and contended that there was no causal link between Zantac and cancer. Reference: Konnath, H. (2020, July 30). Sanofi and GSK Face DOJ Probes Over Zantac Cancer Risk. August 02, 2020, www.law360.com/articles/1297127/sanofi-and-gsk-face-doj-probes-over-zantac-cancer-risk

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Zantac Cancer Lawsuits Consolidated in Southern Florida District Court

July 5, 2020 – Two more Zantac cancer lawsuits were consolidated into the U.S. District Court of Florida, where the Zantac litigation is pending. The two plaintiffs, one from Pennsylvania and the other from Florida, were both women who claimed that regular use of Zantac lead them (or their decedent) to develop cancer. The Pennsylvania-based plaintiff filed a claim on behalf of a deceased family member’s estate. The decedent had been diagnosed with pancreatic cancer in 2018, succumbing to the illness on August 31, 2019. According to her complaint, the decedent used Zantac regularly and followed the directions regarding drug usage. The plaintiff’s complaint stated that the decedent would have not used Zantac if he had been aware of the cancer risks associated with Zantac. The Florida-based plaintiff’s complaint stated that she had begun taking over-the-counter Zantac regularly more than 20 years ago, using both 75 mg and 150 mg does, initially beginning to use the drug to reduce her stomach acid after undergoing an endoscopy. Similar to the Pennsylvania plaintiff’s claim, the Florida plaintiff stated that she used the drug as directed on the label. She began with 75 mg doses but transitioned to 150 mg doses after the higher dose became available in the US market. She also noted that she would have not used Zantac if she had been aware of the cancer risks associated with the drug. The Florida plaintiff was diagnosed with stage IIC colon cancer in April 2018. She subsequently underwent invasive surgery to have a large part of her colon removed. She has since received various cancer treatments, including chemotherapy treatment. Both pancreatic cancer and colon cancer have been linked to Zantac use. Both plaintiffs sought compensatory damages as well as punitive damages against the manufacturer. Reference: Luhana, Roopal. “Plaintiffs File New Zantac Lawsuits, Claim Drug Caused Colon, Pancreatic Cancer.” New York Injury Law News, The Legal Examiner, 5 July 2020, www.newyork.legalexaminer.com/health/plaintiffs-file-new-zantac-lawsuits-claim-drug-caused-colon-pancreatic-cancer/

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Incretin Mimetics Cases in 2020

June 15, 2020 — There are 986 cases pending as of June 15, 2020. Reference:  “Pending MDL Dockets by District.” Judicial Panel on Multidistrict Litigation, www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-15-2020.pdf.

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Schedule For Zantac Discovery and Case Management

June 18, 2020 — On June 18, 2020,  Judge Rosenberg ordered a schedule for discovery and case management in Pretrial Order #30.  The schedule runs from June 15, 2020, which was the beginning of fact discovery, to August 3, 2022. Reference:  “United States District Court.” 20-MD-2924-Rosenberg – In Re: Zantac (Ranitidine) Products Liability Litigation | Southern District of Florida | United States District Court, 31 Dec. 2020, www.flsd.uscourts.gov/zantac.

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