Valsartan Lawsuit | Class Action or Individual Lawsuit?
Valsartan is a medication that is intended to treat high blood pressure. However, the manufacturers of the drug have recalled lot after lot of the drug due to an impurity that can cause cancer in human beings. The lawsuits assert that numerous Valsartan batches were contaminated with NDMA, a widely known likely carcinogen. Interestingly, NDMA is the same carcinogen that is now the basis of the Zantac lawsuits. Victims of the amlodipine besylate 5mg recall, as a stand alone drug, probably have no legal recourse. However, if you were prescribed Valsartan, Amlodipine-Valsartan combination drug or amlodipine-valsartan-hydrochlorothiazide film-coated tablets and such medication caused any form of cancer, you should contact a valsartan recall lawyer. A Valsartan recall attorney can help you to get top compensation and hold the manufacturer accountable. Eventually, most of the lots of this drug, manufactured in China, were recalled from the marketplace due to both the cancer risk and other harmful side effects. As a result, the manufacturers of the drug are now facing numerous Valsartan lawsuit product liability claims.
Many Valsartan victims are seeking information about: “amlodipine recall.” Unfortunately, victims who only were prescribed Amlodipine as a stand alone drug will not be part of the Valsartan lawsuit even if the Amlodipine was recalled. It is crucially important that a victim does not miss a statute of limitations otherwise known as an Amlodipine Besylate deadline. Missing a Valsartan lawsuit deadline means that a seriously injured victim will never receive an Amlodipine payout. At the end of the day, according to the presiding justice handling the Valsartan cases, “This Multidistrict Litigation (“MDL”) arises out of plaintiffs’ alleged ingestion of “valsartan-containing drugs” containing impurities.” Opinion
Do I qualify for a Valsartan lawsuit?
- The victim had a lawful prescription for Valsartan, Amlodipine Valsartan or Valsartan- Hydrochlorothiazide (HCTZ) after July 1st, 2013
- The Victim had one of the following Valsartan complications or Valsartan side effects while using Valsartan: Lung Cancer, Pancreatic Cancer, Colon cancer, Colorectal Cancer, Kidney Cancer, Gastric Cancer, Liver Cancer or another type of Cancer.
- The Valsartan victim was cancer free prior to ingesting Valsartan and had no prior cancer diagnosis. *
The above described criteria are what Valsartan lawsuit law firm’s generally believe constitutes a good Valsartan lawsuit. However, victims who do not meet this criteria should still contact a Valsartan lawsuit attorney.
The Basics of Valsartan
- Treatment for high blood pressure and heart failure.
- Drug Class: angiotensin receptor blockers (ARBs)
- Brand name: Diovan
- GENERIC NAME: Valsartan
- You can file a valsartan lawsuit if Valsartan caused Cancer.
The Basics of Amlodipine-Valsartan medication
- Brand name: Exforge
- GENERIC NAME: Amlodipine-Valsartan
- Used for: High blood pressure (hypertension)
- Drugs are combined
- Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/ Valsartan Combination Tablets and Amlodipine /Valsartan/Hydrochlorothiazide Combination Tablets
- You can file a lawsuit If you took Amlodipine/ Valsartan Combination Tablets and it caused cancer.
The basics of amlodipine -valsartan- hydrochlorothiazide film-coated tablets
- Brand name: EXFORGE HCT®
- GENERIC NAME(S): Amlodipine-Valsartan-Hcthiazid
- Calcium Channel Blocker
- Used to treat high blood pressure
- Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/ Valsartan Combination Tablets and Amlodipine /Valsartan/Hydrochlorothiazide Combination Tablets
- You can file a lawsuit if you took Amlodipine-Valsartan-Hcthiazid tablets and it caused cancer.
The Basics of Amlodipine besylate (stand alone)
What is Amlodipine?
- Amlodipine can be taken as a stand alone drug or combined with other medications. It is prescribed for the treatment of high blood pressure.
- Drug Class: calcium channel blockers
- Brand Names of Amlodopine: Amvaz®(generic amlodopine) Katerzia®(amlodipine Oral Suspension 1mg/mL ) Norvasc® (brand name for amlodipine)
- Amlodipine was newsworthy when an insignificant study related to breast cancer determined that there was a link between breast cancer and people who were prescribed amlodipine for greater than ten years. Numerous more significant and better studies have determined that amlodipine does not make it more likely a person will be diagnosed with cancer.
Can I file a lawsuit as a result of amlodipine (Amvaz / Norvasc / Katerzia) causing cancer?
No. There is no Amlodipine lawsuit as a stand alone drug. There is not definitive scientific proof that Amlodipine not combined with other drugs causes cancer. However, a victim taking Amlodipine combined with valsartan or combined with hydrochlorothiazide could mean the victim is eligible file a Valsartan lawsuit.
Valsartan lawsuits Updates –
Update- November 18, 2023- There are 1221 Valsartan lawsuits before Robert B. Kugler (Sr. District Judge) in MDL -2875 IN RE: Valsartan, Losartan, and Irbesartan Products Liability Litigation.
September 2023- In August of 2023, there were just 5 Valsartan lawsuits filed into the Valsartan MDL in New Jersey. There should be the first Valsartan bellwether trial in early 2024. The lawsuit is proceeding at a snail’s pace.
2-15-2022- There are 1054 Valsartan lawsuits in New jersey Federal Court before justice Robert B. Kugler (Sr. District Judge) in the IN RE: Valsartan, Losartan, and Irbesartan Products Liability Litigation (MDL -2875).
2/1/2021- “A New Jersey federal judge on Friday tossed out consumers’ fraud claims against distributors of generic valsartan blood pressure drugs but waved through allegations against manufacturers themselves. U.S. District Judge Robert Kugler allowed a variety of fraud allegations to proceed against a suite of valsartan drugmakers that consumers say knowingly sold their products tainted with the probable carcinogen N‐nitrosodimethylamine (NDMA). The companies include China’s Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Hetero Drugs, Mylan and Aurobindo Pharma, as well as Teva, Arrow Pharm Malta, Actavis Pharma and more, according to the judge’s opinion.” Fierce Pharma
9/18/2020- The Plaintiff victims filed a memorandum of law opposing the motion to dismissed which was filed by the Defendants. The Plaintiffs argued that the Federal Court should deny the motion to dismiss. The Plaintiff’s tried to convince the Court “that the potential for nitrosamine creation during the chemical synthesis of the active pharmaceutical ingredient in a drug “is well-established and long-known.” They added that the scientific literature reported that the chemical reactions to form the desired chemical compounds could lead to the unwanted creation of nitrosamines as well. The plaintiffs also argued that each manufacturer defendant had “inadequate processes that resulted in adulterated, misbranded, or unapproved VCDs [valsartan containing drugs].” Contrary to the defendants’ assertions in their motion to dismiss, the plaintiffs’ master complaints laid out “in 300+ pages of painstaking detail, allegations as to what each Defendant did, and when, how, and why they did it.” Legal
9/1/2020- The FDA determined guidelines for drug manufacturers concerning nitrosamine contamination in medication. the FDA demanded that their edicts be implemented as soon as possible. The guidance focused on detection and prevention of nitrosamine contamination in medication which is known to to cause cancer. These guidelines were issued after several recalls of popular drugs related to unacceptable high amounts of N-nitrosodimethylamine (NDMA) in drugs such as metformin, ranitidine (zantac), valsartan and other lesser known meds. Nitrosamines like NDMA can be located in the environment and may increase the likelihood of cancer if exposure occurs over a long period. “The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged,” FDA “Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.” Id. “Manufacturers should prioritize evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and number of patients treated.” Id.
July, 2020– “But in July 2020, various defendants filed a motion to dismiss all actions, arguing that the plaintiffs were filing complaints and raising allegations that were “unsustainable as a matter of law. According to the defendants, the plaintiffs’ claims were unsustainable for several reasons, including that they lacked “factual support” and were “inadequately pleaded.” The defendants added that absent from the complaints was the critical element that the defendants knew or had reason to know that the drugs contained a nitrosamine impurity. Since the defendants didn’t know, they argued, they couldn’t have warned about it.” New York Examiner
October 3, 2019 –the Court entered Case Management Order No. 16 [Doc. No. 249] which approved “Fact Sheets” to be answered by all personal injury plaintiffs. Plaintiffs who do not answer the Fact Sheets are subject to a “Show Cause Process” that may ultimately result in the dismissal of their cases.” opinion
8/28/2019 – The Federal Drug Administration put out a statement explaining the FDA’s s efforts to rectify safety concerns regarding valsartan and similar types of medications, which are part of a grouping of pharmaceuticals named angiotensin II receptor blockers (ARBs). The FDA states, “As we continue our analysis of this situation to better understand the root causes…we’re learning more about how nitrosamine impurities may have formed and been present in ARBs.” The FDA explained its actions, which have includes:
- “sending warning letters to manufacturers committing good manufacturing practice violations
- issuing recall announcements
- conducting laboratory testing
- sharing information with other regulatory agencies” Id.
In a stunning official account, that seems to have the same opinion as the victims’ arguments in the Valsartan lawsuits, the FDA stated, ““we have known that certain drug manufacturing processes pose a risk for forming genotoxic impurities, and this is an issue the FDA and other regulators have been working on for a number of years—well before the nitrosamine impurities were discovered in ARBs last summer.”
Update- April 15, 2022- There are 1087 Valsartan cases pending before the honorable Robert B. Kugler (Sr. District Judge) in MDL -2875 which is known as “IN RE: Valsartan, Losartan, and Irbesartan Products Liability Litigation.”
October 29th, 2021- “ACCORDINGLY, IT IS HEREBY ORDERED the Rule to Show Cause issued as part of Special Master Order No. 46 (ECF No. 1615) is DISCHARGED, and IT IS
RESPECTFULLY RECOMMENDED that the medical monitoring claims against Torrent Pharmaceuticals, Ltd., Torrent Pharma, Inc. Albertson’s, LLC, Humana Pharmacy, Inc., the
Kroger Co., OptumRx, and Arrow Pharma Malta be dismissed with prejudice. IT IS FURTHER RECOMMENDED that the economic loss claims against Humana Pharmacy, Inc. and Arrow Pharma Malta be dismissed with prejudice.” SPECIAL MASTER ORDER NO. 51 WITH RECOMMENDATIONS
4/16/19- The UNITED STATES JUDICIAL PANEL on MUITIDISTRICT LITIGATION issued a transfer order “IN RE: VALSARTAN PRODUCTS LIABILITY LITIGATION MDL No. 2875”
3/27/19 – “The initial Case Management Conference for the Valsartan MDL was held in the District of New Jersey before the Honorable Robert B. Kugler” (National law review)
2/14/19- “On February 14, 2019, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federally filed valsartan lawsuits to be consolidated into the District of New Jersey for pre-trial proceedings.” New York Legal Examiner “the Judicial Panel on Multidistrict Litigation (“JPML”) centralized in this court the valsartan cases filed in federal courts around the country. Since that time the Court and parties have worked diligently to organize and manage the litigation.” opinion
10/24/18– Robert Kruk, the plaintiff in Kruk v. Zhejiang Huahai Pharmaceutical Co. et al., No. l8-cv-005944 (N.D. tll.), filed a motion for transfer “pursuant to 28 U.S.C. $ 1407 and entry of an order transferring the actions listed below and in the accompanying Schedule of Actions (collectively, the “Scheduled Actions”) to the United States District Court for the District of New Jersey for consolidated or coordinated pretrial proceedings.”
7/13/18- “The FDA alerted health care professionals and the public about the voluntary recall of several drugs that contained valsartan (used to treat high blood pressure and heart failure). The recall was due to the discovery of an impurity, N-nitrosodimethylamine (NDMA), which had been found in the recalled drugs. The allegation is that some of the patients who took these recalled drugs will develop certain types of cancer.” Id.
The Valsartan consolidated Litigation (MDL): the 411
- MDL Number: MDL No. 2875
- Case name: IN RE: VALSARTAN NNITROSODIMETHYLAMINE (NDMA) CONTAMINATION PRODUCTS LIABILITY LITIGATION
- Presiding Judges: Hon. Robert B Kugler (Court Room: 4D), U.S.D.J & Hon. Joel Schneider, U.S.M.J
- View the orders related to the case here
- Federal Court: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY CAMDEN VICINAGE
- Location of Court: Mitchell H. Cohen Building & U.S. Courthouse 4th & Cooper Streets Camden, NJ 08101 856-757-5021
- Civil No: Civil No. 19-2875 (RBK/JS)
- Chief Justice of Court: Freda Wolfson
- Judicial Assistant of Judge Kugler – Marcy Golub, 856-757-5019- Courtroom Deputy – Larry MacStravic, 856-757-5433 -Court Reporter – Carl Nami, 856-757-5019
Is there a Valsartan class action lawsuit?
If you have taken Valsartan and have either been diagnosed with cancer or experienced other severe side effects, you should promptly contact a Valsartan lawsuit attorney to discuss a possible Valsartan recall lawsuit. Many victims are wondering, “Is there a Valsartan class action lawsuit?”, “how can I get compensation from a Valsartan class action lawsuit?”,”What is the diovan recall?” and “Norvasc side effects lawsuit.” To learn more about Valsartan recall in the USA, please read this article carefully. An Amlodipine besylate recall is a serious matter that must be properly investigated by victims.
View a valsartan recall list here!
What is Valsartan?
- Valsartan (Diovan) is the name of a class of drugs that contain the specific ingredient.
- It is classified as the following type of drug: ARB (angiotensin receptor blocker)
- It is sold under a variety of different trade names. As such, there are several different manufacturers of the drug.
- It was approved by the FDA for use and came onto the marketplace in 1996.
- The drug works by acting as a blocker of angiotensin II.
- The medication acts at the receptor and activates aldosterone.
- The effect of Valsartan is that blood vessels do not narrow.
- It can also be used to treat to reduce heart failure and to help people whose hearts have been damaged in a previous cardiac episode.
- A carcinogen is a type of substance which can lead to cancer.
- Valsartan medication contains two types of carcinogens: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
- NDMA may result in growth of tumors in various animals. Historically, utilized in manufacturing rocket fuel. It is well known and infamous as a carcinogen to humans by the United Sates and certain regulatory agencies internationally.
- “Impurities in NDEA (N-Nitrosodiethylamine) and NDMA (N-Nitrosodimethylamine) have been classified as “probable human carcinogens,” meaning they cause cancer. While both substances are found in water and food, the FDA declares “their presence in drug products is not acceptable.” Miami herald
What is Amlodipine and Valsartan?
“Amlodipine is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Valsartan is an angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. The combination of amlodipine and valsartan is used to treat high blood pressure (hypertension). This medication is usually given after others have been tried without successful treatment of hypertension. Amlodipine and valsartan may also be used for purposes not listed in this medication guide.” Cardio Smart
Amlodipine besylate recall
Below you will find an Amlodipine besylate recall update: “A Food and Drug Administration recall of a heart medication due to a cancer-causing chemical now includes two blood pressure medications. Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/ valsartan combination tablets and amlodipine /valsartan/ hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA. The FDA announced the recall on its website Tuesday.
The move is due to the detection of a probable human carcinogen known as NDEA, which has been found in valsartan API, the FDA said.” ABC News
What is Norvasc?
“Norvasc (amlodipine) is a calcium channel blocker that dilates (widens) blood vessels and improves blood flow. Norvasc is used to treat chest pain (angina) and other conditions caused by coronary artery disease. Norvasc is also used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack. Amlodipine is for use in adults and children who are at least 6 years old.” Drugs
Valsartan recall lawsuit
The original manufacturer of Valsartan was Novartis Pharmaceutical. After the patent expired in 2012, numerous drugmakers launched their own generic versions of the drug. There are nearly 50 versions on the market worldwide. In 2010, sales of the drug in the U.S. were approximately $2 billion. The side effects of Valsartan are generally not considered to be severe. However, after many years of the drug being available in the market, the medication has been subject to many recalls. Specifically, the drug has been found to contain an impurity that is a possible carcinogen. Please keep visiting this site for more info about the diovan recall.
Valsartan is a widely used prescription medication often prescribed by physicians. Valsartan is prescribed to medical patients for high blood pressure. This legal post explains: valsartan recall in usa. It is also widely prescribed to treat patients for congestive heart failure (CHF). After a heart attack, this medication can be used to prolong a heart attack victim’s life. Valsatan (diovanis) often utilized for victims of heart failure. “Valsartan is an angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Valsartan is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. Valsartan is also used in adults to treat heart failure, and to lower the risk of death after a heart attack” https://www.emedicinehealth.com/drug-valsartan/article_em.ht
Is there a valsartan class action lawsuit?
There is no valsartan class action lawsuit. Instead of a Valsartan class action lawsuit, there is a valsartan Multi-District litigation. On February, 14th, 2019 the UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION created a MDL and transferred all Valsartan lawsuits in the Federal Courts to the District of New Jersey. “IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside the District of New Jersey are transferred to the District of New Jersey and, with the consent of that court, assigned to the Honorable Robert B. Kugler for coordinated or consolidated pretrial proceedings. IT IS FURTHER ORDERED that, in light of this opinion, MDL No. 2875 is renamed In re: Valsartan Products Liability Litigation.” UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION IN RE: VALSARTAN N-NITROSODIMETHYLAMINE (NDMA) CONTAMINATION PRODUCTS LIABILITY LITIGATION MDL No. 2875
Recalls of Valsartan
The initial recalls were made in July 2018. At first, the recall was limited to Europe, and it was thought the issue that necessitated the recall did not affect the medications sold in the U.S. However, subsequent recalls were undertaken in the U.S. as various lots of the medicine were found to contain impurities. This Valsartan recall progressively spread to cover additional lots and has unfolded over many months. The FDA has published a list of the medications that have been affected by the Valsartan recall. Since there are many different drugs that contain the ingredient Sartan, dozens of products have been recalled. Mnay victims are wondering if they can get a settlement as a result of a valsartan recall lawsuit.
“AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product Aurobindo Pharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18” FDA
Norvasc side effects lawsuit
Specifically, the drug has been found to contain an impurity called N- Nitrosodimethylamine. This ingredient has also been used to make jet fuel and other lubricants. It has also been used in intentional poisonings. While it would not intentionally be included in the pharmacology for a medication, it is a byproduct of chemical reactions. Not only can this damage internal organs, but the Department of Health and Human Services believes that it is a possible carcinogen. The manufacturers have had difficulty tracing the source of the impurity given that this drug is manufactured with supplies produced worldwide. Novartis claims that the recalls have been made as a precaution and there have been no reports of adverse events associated with its brand of Valsartan.
As with any defective pharmaceutical, there is the possibility of lawsuits against the manufacturers for any damages suffered by those who have used the product. Since the alleged defect involves a carcinogen, it may be years before the full effect of this imperfection is known. Given the large size of the market for Valsartan, if the carcinogen does cause damage, it will likely be widespread with the companies facing a large legal amlodipine besylate 5mg recall liability as a result of the valsartan recall lawsuit. Many victims are searching online for a medication lawsuit list.
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/ Valsartan Combination Tablets and Amlodipine /Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
- “eva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.” FDA
- “Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure. To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan.’
- “Patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.”https://www.fda.gov/Safety/Recalls/ucm626802.htm
Class Actions Against the Manufacturers
Shortly after the initial recalls, the first Valsartan lawsuits were filed against manufacturers of the drug. There was a class action lawsuit filed against Prinston Pharmaceutical Inc., Huahai US Inc. and Teva Pharmaceuticals USA, Inc. in federal court in New Jersey. The lawsuit claims that the defendants should have known that the products being produced at a plant in China contained contaminants. Specifically, the complaint alleges that the impurity started being introduced in 2012, after the defendants changed their manufacturing process. According to the plaintiffs, not only did the defendants know about the impurity, but they also took steps to conceal it when health inspectors visited the manufacturing plant. When the FDA inspected the plant in 2017, it found that the manufacturer did not consistently document any impurities that were found in the medicine during the manufacturing process. In addition, the FDA had found that the manufacturing facility was not adequately maintained in order to ensure the quality of the product.
Exposed to a carcinogen
The plaintiffs are those who have been prescribed and have taken the medication. The damage that they have suffered is that they have been exposed to a carcinogen. They will likely have to be monitored for the rest of their lifetimes to ascertain whether or not they have developed tumors as a result of this medication. Additionally, there was a Valsartan lawsuit filed in federal court in Missouri against some of the same defendants with similar allegations. If you were a victim of the amlodipine besylate 5mg recall, you need to seek compensation and justice.
As more revelations come out about additional plants, one can anticipate that the number of Valsartan lawsuits against the manufacturers of these medications will continue to grow. Right now, these suits have not been filed as a Valsartan class action. There is no Valsartan class action even though there are common grounds of complaint among the plaintiffs and they have suffered similar harms.However, there is a Valsartan MDL lawsuit pending in New Jersey Federal Court. The Varsartan MDL is better then any hypothetical Valsartan class action lawsuit because in an MDL, a victim has the right to their own individual trial and the victim can reject a settlement and proceed to an individual trial.
Amlodipine besylate recall
If you have been prescribed any drug that has Valsartan as an ingredient, you should promptly contact a Valsartan lawsuit lawyer or a diovan recall law firm to find out more about how you can file a legal claim against the manufacturer of the medication. At present, these amlodipine besylate recall legal actions are still in their early phases. There is not yet any visibility about when they would go to trial if they reach that stage. This means that any possible financial recovery is likely years away. However, no financial compensation is available to you unless you file a claim.
“InvaGen Pharmaceuticals Inc. is recalling 2880 bottles of amlodipine besylate USP 10-mg tablets (NDC 69097-128-15) over concerns about subpotency, according to the October 17, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recall is for 1000-count bottles from lot GG80218 (Exp. 12/19). Cipla Ltd. manufactured the medication for Cipla USA. The affected bottles were distributed within the United States.”
“InvaGen Pharmaceuticals voluntarily initiated the recall October 3, 2018. The FDA designated the recall Class III October 11, 2018. The designation suggests use of the affected product is unlikely to cause adverse health consequences. Amlodipine besylate is a prescription calcium channel blocker used to treat patients with high blood pressure and angina.” Managed Health Care
Findings of Judicial Panel setting up MDL for the Diovan recall lawsuit:
This is not a Valsartan class action lawsuit. “On the basis of the papers filed and the hearing held, we find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions involve common factual questions arising out of allegations that plaintiffs purchased or used generic formulations of valsartan medications containing the nitrosamine impurities NDMA and/or NDEA; that these 5 impurities present a risk of cancer and liver damage; and that defendants knew, or should have known, of the impurities as early as 2012. All actions stem from the same FDA investigation and voluntary recall announced in July 2018, and the voluntary recalls are ongoing. Although the investigation, and the earliest-filed actions, focused on ZHP as the source of the alleged impurities, the FDA investigation and the actions before the Panel now encompass alleged industry-wide issues concerning the production of the valsartan active pharmaceutical ingredient (API) which will be common to all actions. The common questions of fact include: (1) whether the generic valsartan sold by defendants contained NDMA or NDEA; (2) the cause of the alleged impurities, including alleged defects in the manufacturing and sampling process; (3) when defendants knew or should have known of the impurities; (4) how long the NDMA- and NDEA- containing valsartan medications were in circulation; and (5) whether the amounts of NDMA and NDEA in the medications presented a risk of cancer or other injuries. All of the valsartan actions will raise these issues, regardless of whether the alleged supplier of the valsartan API was ZHP, Mylan, Hetero Labs 7 Limited, or some other entity. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings, including with respect to class certification and Daubert motions; and conserve the resources of the parties, their counsel, and the judiciary.” TRANSFER ORDER
Amlodipine side effects
“Although all pending actions on the motion before us are putative consumer class actions seeking economic damages, we received extensive briefing and oral argument on whether the MDL should include personal injury actions. Based on this record, we believe that the centralized proceedings should include the related personal injury actions alleging that plaintiffs developed cancer as a result of using valsartan containing NDMA or NDEA impurities. The core factual issues in the personal injury actions will be the same as in the consumer class actions – in particular, the cause of the alleged impurities; the nature and extent of the health risks posed by the NDMA and NDEA levels at issue; defendants’ knowledge of the alleged impurities; and the impact of any findings made by the FDA. Additionally, there is significant overlap in defendants in the consumer class actions and personal injury actions. Thus, discovery undoubtedly will overlap among these actions. The Panel often has recognized the efficiencies of centralizing economic loss class actions with personal injury actions, explaining that “liability discovery in all the cases will certainly overlap,” and that, in our experience, the individual discovery required in personal injury actions is “regularly and successfully coordinated” within MDLs involving both kinds of actions. For these 9 reasons, we intend to include personal injury potential tag-along actions in this MDL through the conditional transfer order process. See Panel Rule 7.1(b).” TRANSFER ORDER
Amlodipine besylate recall sources:
- source: Consumer- Advisory- Group