Adulterated Valsartan Litigation Update
BY STEPHEN CHANCE AND ROBIN LOURIET he APIs from ZHP and Hetero are incorporated into finished pills, which are sold in the United States to unsuspecting consumers. Many American pharmaceutical companies have made, distributed, marketed and/or sold these Valsartan products. Millions of contaminated pills are believed to have been consumed in the United States, and it is believed that the contaminated pills have been sold in America since at least 2014. Early testing of Valsartan revealed high levels of the toxic substances, and the API manufacturers were aware of the test results. However, the findings were downplayed by the manufacturers as testing inaccuracies. Eventually, after additional testing was conducted, the European Medicines Agency (EMA) issued recalls for Valsartan and the FDA followed suit. The FDA initially issued a report that 1 in 8,000 people taking Valsartan may develop cancer, but scientific evidence reveals the number of cancer cases is likely significantly higher.here has been a great deal of press in the past year surrounding the FDA’s July 13, 2018 voluntary recall of the drug, Valsartan. Valsartan is the generic form of Diovan, which is an angiotensin II receptor blocker (ARB) used to treat high blood pressure and heart conditions. Divan was first introduced in 1996. After the patent for Diovan expired in 2012, several generic manufactures began making and distributing Valsartan. The active pharmaceutical ingredient (API) for Valsartan is manufactured in countries other than the United States, due to the ability to make the API at a lower cost. Several of the foreign API manufacturers changed the manufacturing process in 2012. It is believed that the change in the manufacturing process resulted in unintended byproducts, which contaminated the drug with impurities, including N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and/or N-Methylnitrosobutyric acid (NMBA). These toxic substances are classified as probable human carcinogens, which means they are more likely than not to cause cancer in humans. Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs Limited (Hetero) in India are two of the API manufacturers that used the altered manufacturing process. It is estimated that ZHP has 45% of the US market share of the Valsartan API production.
This article is meant to give a general overview of the recall and the current state of this relatively new litigation.
WHAT IS THE CURRENT STATE OF PENDING LITIGATION?
Multidistrict Litigation (MDL) has been approved and currently pends in the US District Court for the District of New Jersey Camden Vicinage, MDL No. 2875 In re: Valsartan Products Liability Litigation. The MDL includes class actions for plaintiffs seeking purely economic damages based on the purchase of a tainted product. It also includes plaintiffs who have sustained personal injury as a result of ingesting these products. Plaintiffs alleging personal injury, from all jurisdictions, are permitted to file suit directly in the New Jersey MDL. MDL Centrality is warehousing the documents for individual cases. Access to MDL Centrality is through the website located at http://www.browngreer.com/mdl-centrality.html.
There are a small number of cases filed in New Jersey state court against some of the New Jersey manufacturers. As the number of cases filed in New Jersey state court increases, it is anticipated that multicounty litigation (MCL) will be approved.
ARE THESE CASES PREEMPTED?
Some of the defendants have filed motions to dismiss/summary judgment based on a federal preemption argument. Federal preemption is generally applicable where a state law sets out different requirements from federal law in an arena that is controlled by the federal government. The manufacture and sale of drugs fall within the purview of the FDA. Federal law requires generic drug manufacturers to use labeling and warnings that are identical to those approved by the FDA for the brand-name drug. In theory, the generic manufacturers cannot be held responsible for failing to give additional or different warnings to their consumers. The Valsartan manufacturers have asserted that they were prohibited by federal law from warning the consumer about the contamination in the drug. Additionally, the manufacturers have asserted they were powerless to alter their (negligent) manufacturing process without FDA approval. These arguments are not only against public policy, they are not supported by the current state of the law.
The federal drug labeling preemption argument is premised on the requirement that the brand-name drug has been thoroughly tested and vetted by the FDA prior to its approval. In turn, the generic drug is required, by Federal law, to be a bioidentical drug in all respects to the brand-name drug, thus, there is no need for different warnings. The generic manufacturer has an ongoing “duty of sameness” – the generic must remain “identical [to its branded equivalent] in active ingredients, safety and efficacy,” just as each generic drug must “ensur[e] that its warning label is the same as the brand name’s.” PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2574-75 n.1 (2011). Diovan, the brand-name drug, does not contain the toxic contaminates found in the generic Valsartan, thus, the drugs are not bioidentical, and the manufacturers have not maintained the “duty of sameness.”
Moreover, federal law expressly prohibits the manufacture and sale of misbranded or adulterated drugs. The contaminated Valsartan is both misbranded and adulterated since it is not the bioidentical of Diovan and it contains toxic substances. Here, the negligent manufacture of Valsartan resulted in the adulteration, and the manufacturers had a duty to stop manufacturing and selling this drug as soon as they were made aware of this adulteration. Both Georgia state law and federal law prohibit the negligent manufacture and sale of adulterated drugs, thus, the state and federal claims are parallel. There is no conflict between the laws and no preemption.
WHICH PRODUCTS HAVE BEEN RECALLED?
Not all Valsartan products have been recalled, however, the list has been expanded and updated in the past several months, and it is likely to continue to grow. The recalled drugs now include some Losartan and Irbesartan products. The list of recalled Valsartan, Losartan and Irbesartan products may be found on the FDA website at https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and.
HOW DO I DETERMINE WHETHER MY CLIENT HAS TAKEN A RECALLED DRUG?
- The first step to make this determination is to obtain your client’s pharmacy records.
- The pharmacy records should contain a National Drug Code (NDC) listed beside each Valsartan entry. The NDC is a unique 10 or 11 digit, three-segment, number. This number is a universal product identifier for drugs in the United States.
- The NDC can be searched in databases such as http://www.ndclist.com/search; or http://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. The search should identify the manufacturer of the drug.
- The FDA databank or the manufacturer’s own list of recalled products can then be used to determine if the manufacturer has issued a recall on your client’s pill batch or lot.
- Be aware that many consumers have taken Valsartan or other “sartan” products manufactured by multiple manufacturers, thus, all pharmacy records and all NDC numbers should be evaluated.
- Some, but not all, consumers have received recall notices from their pharmacies, doctors, and/or the manufacturers. Even if your client has received a recall notice, you should confirm that the client did, in fact, ingest a recalled drug.
- If your client’s drug has not been recalled, bear in mind that the recall list is continuing to be expanded, and you should advise your client of this fact when informing him or her that his/her drug is not on the current recall list.
HOW DO I DETERMINE WHETHER MY CLIENT HAS A VIABLE CASE?
- Liver, colorectal, intestinal, stomach, kidney and bladder cancers are the cancers that have current medical literature to support causation.
- Significant liver injury cases should also be given consideration.
- It is important to establish that the recalled product was ingested for at least a year before the cancer diagnosis.
- Negative factors that should be considered before filing a case include a history of smoking, obesity, a strong family history of cancer; and use of Actos (if the client has bladder cancer). ●
- Instruct your client to turn over any unused pills and the original container as evidence in the case. Store the evidence properly. Testing of the pills may be required as the litigation progresses.
- If your client received a recall notification, retain this important document.
- Instruct your client to request a printout of his or her pharmacy records beginning in 2012. Most pharmacies will provide a printout quickly in response to the patient’s request.
- Georgia has the “discovery rule” in products liability cases. The statute of limitations runs 2 years from when the injured person knew or should have known that the injury resulted from the product. Optimally, filing suit should occur within 2 years of the cancer diagnosis or liver injury; however, in reliance on the discovery rule, it is possible to file suit within 2 years of the recall date of July 13, 2018. One could also argue that a later date of when the injured party learned of the recall triggers the statute of limitations. If your client is from a state other than Georgia, research whether that state has the discovery rule to determine the statute of limitations.
- If you plan to file suit in the New Jersey state court against New Jersey defendants be aware that the Third Circuit, of which New Jersey is a part, permits a practice called “snap removal.” 28 U.S.C. § 1441(b)(2) states that an action “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” Historically, this statute has prohibited removal of a case unless there is complete diversity between the parties. In recent years, however, defendants have sought removal even when there is a resident defendant. In removing these actions, the defendants rely on the “properly joined and served” language in the statute, arguing that a defendant should be able to remove a case before a named forum defendant has been served. Based on the plain meaning of “properly joined and served,” many courts have allowed for this practice, called “snap removal.” As a practical matter, snap removal prevention requires that the suit be filed and served on all defendants almost simultaneously. We have been successful in completing this daunting task and will be happy to give pointers on how we were able to accomplish this goal.
Adulterated sartans place millions of people around the world at unreasonable risk of developing cancer. The conduct creating this unreasonable risk – putting profits over people by altering an FDA approved manufacturing process to save money – resulted in the failure of generic sartan manufacturers to deliver bioequivalent drugs to the market. As with all mass torts, these cases face challenges, but the trial bar has the capability to meet these challenges and create a safer generic drug marketplace.
ABOUT THE AUTHORS
Stephen Chance is a partner with Watkins, Lourie, Roll & Chance in Atlanta where he primarily focuses on medical malpractice and nursing home litigation. Stephen currently serves as a member of the GTLA Executive Committee and can be reached at firstname.lastname@example.org.
Robin Lourie is the founding partner of Robin Lourie, P.C. in Atlanta. She has more than 30 years of experience in the legal field on both the defense and plaintiffs side, but the past 10 years have been solely dedicated to her work for injured parties. Robin currently serves on the GTLA Executive Committee and can be reached at email@example.com.