Including comments by Brent Wisner, Baum Hedlund.
MASS TORT NEWS
January 18, 2021
By Mark A. York, Editor
(MassTortNews.org) United States consumers are learning more and more that healthcare manufacturing oversight has failed to monitor what is in drugs offered to the general public. Zantac is now being confirmed to be contaminated with carcinogenic ingredients. While foreign production and manufacturing of ingredients might play a role in the contamination, corporations have at their fingertips the ability to cross-check manufacturing and quality control policies worldwide. How can pharmaceutical companies justify the sudden discovery of carcinogenic ingredients like NDMA in prescription and OTC drugs only when the FDA alerts the public?
As millions of US consumers rely more and more on foreign quality control in our pharmaceutical manufacturing that has been outsourced simply because of the catastrophic cost reductions overseas, when will the courts actually start penalizing Big Pharma, both financially and injunctively? It appears as if the regulatory oversight offered by foreign governments like China and India who are manufacturing critically needed pharmaceuticals is shallow at best and at times missing in action. With the recent administration slashing regulations here in the US, there’s little hope of enforcement overseas, where US interests are now seen as secondary and at best having a paper tiger enforcement role as well as being politically off-base.
There have been recent rulings in the Zantac MDL where certain claims may have adversely affected parts of the primary claims, or possibly not.
Brent Wisner of Baum Hedlund offered this on the recent rulings:
“The MDL Court’s ruling is a mixed bag,” stated Baum Hedlund trial attorney Brent Wisner, who obtained a $2B verdict as co-lead counsel in the Monsanto Roundup litigation. “Judge Rosenberg has clearly signaled that she wants this MDL focused on the Brand Defendants and users of brand name Zantac. But she left a lot of doors open. In fact, every defendant is still in the case and the Court gave excellent guidance about how the Plaintiffs can plead claims against each defendant, including claims against a generic manufacturer. Overall, despite the Defendants’ attempt to kill the case, these lawsuits are very much alive and we hope to press forward to trial, whether in the MDL or in state court, as soon as possible. Too many people have been devastated by this product, and the sooner we can get this misconduct before a jury, the sooner we can start finding justice for our clients.” Wisner is representing thousands of Zantac (ranitidine) cancer victims across the country.
Here is a link to a May 2020 complaint that alleges Zantac caused bladder cancer:
DOJ Starts False Claims Investigation
Following the U.S. Food & Drug Administration’s recall of Zantac products, the Department of Justice is now investigating at least two of the drug’s primary manufacturers for possible violations of the False Claims Act.
After issuing several warnings, the FDA in April officially requested that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine products from the market after results from multiple studies found unacceptable levels of NDMA, a potential carcinogen, in the commonly used heartburn drug.
The two drugmakers under investigation, Sanofi and GlaxoSmithKline, both pulled their products in October 2019, after the FDA issued a warning about drug’s safety. However, according to FiercePharma, the DOJ is now looking into whether the manufacturers knowingly failed to disclose information relating to the impurity.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
What happened to pro-active corporate governance in the healthcare industry—something that is obviously a thing of the past. Inspections of foreign facilities and manufacturing protocols are the responsibility of the US corporation that contracts with the Chinese or Indian facility to manufacture the finished product or produces the raw ingredients? When children’s clothing or other products made outside the USA are discovered to be flammable or dangerous in some other way, there’s an immediate product recall and rush to revise and improve foreign production, why and how isn’t this the same for pharmaceuticals manufactured in foreign countries.
When corporate executives proclaim that plaintiff’s lawyers and litigation are unfair, this failure of QC/QA policies by corporate boardrooms is the simplest way to disprove ose statements. Having the ability to show in a court of law the lack of oversight and corporate good conduct procedures in the current drug manufacturing process is by far the most viable way to keep these quality control failures in check. If that includes forcing corporate America to pay large jury verdicts or engage in high-dollar settlements, then that’s the price of corporate shortcuts in the manufacturing and supply chain process, that is so prevalent in the current American healthcare pharmaceutical drug pipeline.
There were recent rulings by Zantac MDL Judge Rosenberg, that have rippled through certain aspects of plaintiff strategies but overall the impact appears to be taken in stride by the plaintiff leadership who are leading the MDL.
Conclusion excerpt from a Zantac MDL Order December 31, 2020: Judge Rosenberg
For the foregoing reasons, it is ORDERED AND ADJUDGED that Defendants’ Motion to Dismiss and/or Strike Master Personal Injury Complaint on Grounds of Impermissible Shotgun Pleading and Incorporated Memorandum of Law is GRANTED; Defendants’ Amended Motion to Dismiss and/or Strike Consolidated Consumer and Third Party Payor Class Action Complaints on Grounds of Impermissible Shotgun Pleading and Lack of Article III Standing and Incorporated
Memorandum of Law is GRANTED IN PART AND DENIED IN PART; and The Generic Manufacturers’ and Repackagers’ Rule 12 Motion to Dismiss Consolidated Consumer and Third-Party Payor Class Action Complaints on the Ground of Failure to Allege an Injury and Incorporated Memorandum of Law is DENIED.
- The Master Personal Injury Complaint, Consolidated Consumer Class Action Complaint, and Consolidated Third Party Payor Class Complaint are DISMISSED WITHOUT PREJUDICE AND WITH LEAVE TO AMEND consistent with this Order.
- All claims and allegations of physical injury and medical monitoring in the CCCAC, including Counts 45, 67, 139, 167, 238, 280 and 302, are STRICKEN WITHOUT PREJUDICE. The Injury Plaintiffs may seek leave of Court for an alternative pleading to allege their class physical injury and/or medical monitoring claims.
- Under Pretrial Order # 36, the repled Master Complaints are due 30 days after the Court issues its Order on Article III standing. DE 1346 at 4. The Court AMENDS that requirement in Pretrial Order # 36. The repled Master Complaints are due 30 days after the Court issues its forthcoming Order on Branded Defendants’ Rule 12 Partial Motion to Dismiss Plaintiffs’ Three Complaints as Preempted by Federal Law. DE 1580. All other requirements in Pretrial Order # 36 remain in place.
DONE and ORDERED in Chambers, West Palm Beach, Florida, this 31st day of December, 2020.
Judge Robin Rosenberg
General Summary of Dec 31, 2020 orders here
First: “Order Granting Brand-Name Manufacturer Defendants’ Motion To Dismiss Plaintiffs’ Innovator-Liability Claims,” In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Dec. 31, 2020), available here. It is what it says. (1) Following Erie conservatism in predicting state law. (2) Predicting that 35 states would reject innovator liability. (3) Holding that the two states (CA and MA) that recognize innovator liability cannot assert personal jurisdiction over all but one defendant, as they are neither incorporated nor have a principal place of business in those two states.
Second: “Order Granting Generic Manufacturers’ & Repackagers’ Rule 12 Motion To Dismiss On The Ground Of Preemption,” In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Dec. 31, 2020), available here. Dismissing generic manufacturers and repackagers on impossibility preemption. (1) Misbranding claims do not defeat generic preemption. (2) Misbranding allegations do not make the vast body of preemption law meaningless. (3) Plaintiffs failed to plead claims based on expiration dates and testing, transportation, and failure-to-report. (4) Plaintiffs failed to plead manufacturing defects with allegation of identical defects in every unit of the product. (5) Magnuson-Moss claims dismissed to the extent they rely on FDA-approved language.
Third: “Order Granting Defendants’ Motion To Dismiss and/or Strike Master Personal Injury Complaint on Grounds of Impermissible Shotgun Pleading; Granting in Part & Denying in Part Defendants’ Amended Motion To Dismiss and/or Strike Consolidated Consumer & Third Party Class Action Complaints on Grounds Of Impermissible Shotgun Pleading & Lack Of Article III Standing; & Denying Generic Manufacturers’ & Repackagers’ Rule 12 Motion To Dismiss Consolidated Consumer & Third-Party Payor Class Action Complaints on the Ground of Failure To Allege an Injury,” In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Dec. 31, 2020), available here. (1) Personal injury complaint dismissed as improper “shotgun” pleading. (2) Juridical link doctrine does not apply. (3) No standing to assert claims on behalf of putative class members in other states. (4) Some medical monitoring properly pleaded, but most are not. (5) Economic loss rule not decided. (6) Injunctive claims allowed for the time being.
Fourth: “Order Granting Retailer & Pharmacy Defendants’ Rule 12 Motion To Dismiss on the Ground of Preemption, Granting Distributor Defendants’ Rule 12 Motion To Dismiss on the Ground of Preemption, Denying as Moot Retailer & Pharmacy Defendants’ Rule 12 Motion To Dismiss on State Law Grounds, & Denying as Moot Distributor Defendants’ Rule 12 Motion To Dismiss on Various Group-Specific Grounds, In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Dec. 31, 2020), available here. (1) Absolute liability does not exist. (2) All claims against pharmacies and retailers preempted by impossibility because such entities cannot cure defects in FDA-approved drugs. (3) Misbranding claims preempted for these reasons and for the reasons stated in order #1. (4) Storage claims inadequately pleaded. (5) Drug Supply Chain Security Act preemption not decided. (6) Magnuson-Moss claim fails with preemption of all state-law warranty claims.
FDA INITIAL ZANTAC WARNING STATEMENT
For Immediate Release:
September 13, 2019
Director – FDA Center for Drug Evaluation and Research
Janet Woodcock M.D.
The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.
In Zantac, Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. OTC and prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available. /END
The FDA’s OXYMORONIC ADVICE
The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition.
FDA’s testing of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these medicines. This is the comment in one of the later FDA notices to the public on the NDMA warnings, that fail to note that all of the drugs above cited as alternatives are part of an ongoing federal litigation over kidney failure and other adverse reactions, see Proton Pump Inhibitor MDL 27XX, pending in the USDC of New Jersey.
Comments by lead defendant Glaxo, et al, GSK says it had considered the potential formation of nitrosamines in the body—during ranitidine’s development, during its regulatory review and in subsequent studies. Scientists had hypothesized that any drugs that raised the stomach’s pH could increase the growth of bacteria that produce nitrites, which could interact with chemicals called amines to produce nitrosamines. Although several studies did find that taking ranitidine could increase the concentration of nitrites in the stomach—and at least one found a statistically significant increase in nitrosamines—that does not mean they cause cancer, GSK says. The company adds that ranitidine was not carcinogenic in studies of rodents whose diet and bacterial metabolism were similar to those of humans and claims that “extensive pharmacovigilance monitoring, regular safety reviews and substantive epidemiological studies have not linked ranitidine to raised cancer risks.”
Further, the issue of nitrosamine formation in the body “is fundamentally different to the current regulatory interest in the presence of NDMA in drug substance and drug product,” says GSK, which has issued a recall of its generic version of Zantac. “The reason for the current precautionary recall of ranitidine is due to an emerging finding that some sources of drug substance and therefore drug product may contain very small amounts of nitrosamine. While the manufacturers, suppliers and regulatory authorities clarify the root cause of this issue, we have stopped supply and recalled product from the market as a precautionary measure.”
How those corporate bullet points compare to the science remains to be seen, but the fact that the FDA was part of the less than voluntary recall by GSK, Sanofi and the other Big Pharma cohorts, does not encourage the average consumer, whether and OTC or physician prescribed Zantac recipient to have confidence in the quality control guidance by the drug makers.
Other Zantac MDL orders regarding plaintiff census requirements:
Food and Drug Administration Ranitidine (Zantac) References:
FDA STATEMENT TIMELINE ON ZANTAC (RANITIDINE)
April 1, 2020 FDA Removal Request: https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
Update [10/23/19] The U.S. Food and Drug Administration is releasing a second liquid chromatography-mass spectrometry (LC- MS) method for manufacturers and regulators to detect and quantify NDMA in ranitidine. The agency is using this method to test potential NDMA-containing ranitidine samples. The second LC-MS method for NDMA in ranitidine uses a more widely available technology than the first posted method. The agency is sharing the second method to provide alternatives to firms wishing to test their drug products for NDMA.
FDA is also alerting health care professionals and patients to two voluntary recalls of ranitidine:
- Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
- Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.
Update [10/2/19] FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. In addition, the agency has asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA in their ranitidine products and to send samples of ranitidine products to FDA to be tested by
[9/26/19] The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
For additional information on Zantac from the Baum Hedlund Firm, contact https://www.baumhedlundlaw.com/prescription-drugs/zantac-cancer-lawsuit/
Notice: This is a media release of Mass Tort News and certain segments and excerpts were taken from publicly available third party media and governmental agency sources. Nothing in this document is to be considered legal advice or guidance. Please direct any inquiries to: [email protected]
Mass Tort News
ZANTAC MDL 2924 ORDERS (Check the court official docket for full directory of orders) MDL court link: https://www.flsd.uscourts.gov/zantac
Aug. 18: MDL Pretrial Order # 39 – Protocol for Voluntarily Dismissing Short-Form or Individual Long-Form Complaints in Their Entirety, for Dismissing Particular Claims, and/or for Dropping Particular Defendants
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