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In the wake of an alarming rise of diabetic rates globally, the use of medications to manage the condition has become increasingly prevalent. Metformin, a widely prescribed drug for Type 2 diabetes, has been the cornerstone in the battle against this chronic illness. However, the recent developments have shed light on the darker side, as an increasing number of Metformin lawsuits emerge, raising concerns about the drug’s safety.
To know the latest Metformin lawsuit 2024 updates, follow our blog.
Before delving on to the details of Metformin lawsuits, let’s know the statistics on diabetic patients around the world.
Statistics on Diabetes
As per the International Diabetes Federation, more than 10.5% of the global adult population, approximately 537 million individuals aged 20 to 79, grapple with diabetes at the present. Shockingly, over 90% of these cases are classified as Type 2 diabetes, contributing to a staggering 4 million deaths annually. The forecast is equally grim, with an estimated 783 million people projected to be living with diabetes by the year 2045. Another statistics by the National Diabetes Report says that around 11.6% of the U.S. population fight with diabetes at the present. These statistics underscore the urgent need for effective and safe treatments for this widespread health condition.
What is metformin?
Metformin is a diabetic drug approved by the FDA in 1994 to treat Type 2 diabetes. It reduces the blood sugar level by preventing liver from releasing more glucose. It also helps in boosting insulin and controls the blood sugar level.
Metformin, a biguanide extracted from French lilac or Goat’s Rue, has been used therapeutically since 1922, initially recognized for its ability to reduce glucose levels without affecting heart rate or blood pressure.
Metformin comes in two forms- immediate release and extended-release versions. According to the National Center for Biotechnology Information (NCBI), it is also used to treat the following conditions as an off-label usage:
- Gestational diabetes management
- Weight gain issues from antipsychotic drugs
- Polycystic ovary syndrome (PCOS) prevention
- Oligomenorrhea from PCOS
- Type 2 diabetes prevention
It is also found that Metformin can be used to increase the efficacy of cancer treatments as it has the ability to activate specific molecular pathways that inhibit cell growth and proliferation. Key among these is the activation of AMPK (adenosine monophosphate-activated kinase) through the LKB1 pathway, which in turn inhibits mTOR (mammalian target of rapamycin), a protein involved in cell growth and protein synthesis.
Metformin’s ability to halt the cell cycle and trigger apoptosis, reduce blood insulin levels (thereby reducing cancer cell growth stimulation), and inhibit angiogenesis, among other effects, positions it as a potential complementary agent in cancer treatment.
Metformin is advised to be taken with a meal to avoid gastrointestinal issues. People with severe kidney disease and diabetic ketoacidosis are advised against taking Metformin.
Side Effects of Metformin
Metformin has received a black box warning for causing lactic acidosis, a dangerous lactic acid build up in blood. Lactic acidosis is a serious condition, which necessitates immediate medical attention as it may lead to death.
Most common side effects of Metformin are related to gastrointestinal side effects such as nausea, vomiting and diarrhea. Other side effects include:
- Asthenia
- Hypoglycemia (low blood sugar)
- Indigestion
- Headache
Reason for Metformin Recall
In the recent past, several pharma companies had initiated voluntary recall of Metformin products. What’s behind the recall? Let’s glance through the details.
In 2019, the FDA announced that some of the Metformin drugs sold outside the U.S. contained low levels of NDMA, a carcinogenic substance.
The recall recommendation by the FDA was made after the private lab, Valisure “detected high levels of NNitrodimethylamine (‘NDMA’) in specific batches of prescription drug products containing metformin.”
In the mid of 2020, the FDA came out with a shocking revelation that many of the U.S. Metformin brands with extended-release versions contained unacceptable levels of NDMA. The agency recommended ER Metformin products with NDMA level more than the acceptable intake limit (96 nanaograms/day) to be recalled.
Followed by this in 2020 and 2021, many extended-release Metformin brands were recalled. The FDA analysis had not found the NDMA presence in immediate release versions. The FDA advises patients on recalled Metformin to continue their medication until a safer alternative is provided by healthcare professionals, emphasizing Metformin’s significant role in diabetes management despite the recalls.
To know the recalled lots visit the FDA website.
Recalled Metformin Brands
Apotex
Apotex, a Canada-based global health company produced the APO-METFORMIN ER (Metformin Hydrochloride Extended-Release tablets) to treat adult patients withtype-2 diabetes. On May 28, 2020, Apotex initiated a class I recall of all lots of its extended version Metformin HCL 500 mg tablets for having unacceptable levels of N-nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals
Amneal Pharmaceuticals LLC, a New Jersey based Pharma Company issued a nationwide voluntary recall of Metformin HCL ER tablets, USP, 500 mg and 750 mg, on May 29, 2020, due to the detection of NDMA. Though the FDA recommended for a recall of it 7 tested lots, Amneal extended the recall and included all its lots.
Marksans Pharma
In October 2020, Marksans Pharma extended its recall of Metformin Hydrochloride Extended-Release Tablets by adding 76 more lots in addition to the prior recall. The recall included both 500 and 750 mg packs of the Metformin HCL Extended-Release Tablets.
Prior recall initiated on June 2, 2020 included only Metformin Hydrochloride Extended-Release Tablets, USP 500mg. These tablets distributed by Time-Cap Labs, Inc. will have numbers “101” and “102” etched on them.
Lupin Pharmaceuticals
On June 11, 2020, Lupin Pharmaceuticals Inc. voluntarily recalled all lots of its Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg following the FDA recommendation. The FDA had found unacceptable levels of NDMA in some lots of Lupin’s extended-release Metformin versions.
Teva Pharmaceuticals
Teva Pharmaceuticals USA, Inc. initiated a voluntary recall of fourteen lots of Metformin Hydrochloride Extended-Release Tablets (ACTAVIS), USP 500 mg and 750 mg, 100 and 1000 count bottles on June 2, 2020.
On February 22, 2023, Teva made another recall of 12,044 ACTAVIS bottles distributed in California due to the presence of NDMA impurities. This recall was designated as Class II by the FDA.
Nostrum Labs
On January 25, 2021, Missouri-based Nostrum Laboratories, Inc. voluntarily recalled one lot of its Metformin HCl Extended Release Tablets, USP 750 mg due to NDMA contamination.
What is NDMA?
N-Nitrosodimethylamine is a known human carcinogen. NDMA was proved to cause cancer in animals and may possibly cause cancer in humans too. NDMA impurity was detected in medications like Valsartan and Zantac earlier. Prolonged exposure to NDMA can lead to cancer as diabetic patients consume Metformin throughout their life after being diagnosed with diabetes.
Prolonged exposure to NDMA can cause the following cancers.
- Bladder cancer
- Colon cancer
- Esophageal cancer
- Intestinal cancer
- Kidney cancer
- Liver cancer
- Ovarian cancer
- Pancreatic cancer
- Stomach cancer
- Testicular cancer
Metformin Lawsuits
Is there a lawsuit against Metformin? Following the recalls, there has been a surge in Metformin lawsuits, accusing manufacturers of not adequately warning about NDMA risks. Though there were no reports of adverse side effects or cancer from Metformin, the plaintiffs claim that the manufacturers concealed the presence of NDMA, a probable human carcinogen in Metformin products.
Kristen Wineinger
A New Jersey woman, Kristen Wineinger filed a Metformin class action lawsuit against Granules USA Inc. on March 8, 2020 for marketing NDMA contaminated Metformin tablets. Valisure, a private lab identified that Granules’ Metformin products contained twice the daily intake limit of NDMA.
This Metformin recall lawsuit was filed under the following allegations:
- Breach of The Implied Warranty Of Merchantability
- Unjust Enrichment
- Fraudulent Concealment
- Fraud
- Conversion
The plaintiff demanded class representation, jury trial, “an order declaring the Defendants’ conduct violates the statutes,” compensatory, statutory and punitive damages, monetary reliefs, injunctive relief, and attorney fee and court expenses as relief.
Stelios Mantalis
New-York-based Stelios Mantalis filed a class action lawsuit on April 15, 2020 against Ascend Laboratories, LLC for manufacturing and selling NDMA-contaminated Metformin tablets. He started using the tablets since 2011.
The plaintiff alleged “As a direct and proximate cause of Defendant’s fraudulent concealment, Plaintiff and the Class and Subclass suffered damages in the amount of monies paid for the defective metformin.”
He demanded jury trial and punitive damages for the defendant’s willful and malicious conduct. The manufacturer knew or should have known that Metformin tablets were contaminated with carcinogenic NDMA.
The allegations in this Metformin lawsuit were made based on the following counts:
- Breach of The Implied Warranty Of Merchantability
- Unjust Enrichment
- Fraudulent Concealment
- Fraud
- Conversion
- Violation Of New York General Business Law § 349
- Violation Of New York General Business Law § 350
Masao Hendrix
Masao Hendrix, a Californian man filed a class action lawsuit on July 16, 2020 against Amneal Pharmaceuticals and AvKare, Inc. demanding jury trial.
Valisure had found out
NDMA contamination levels of between 235 and 450 ng/tablet, with levels reaching up to 16.5x the FDA’s interim daily limit in Amneal’s Metformin ER products.
This class action lawsuit alleged the given causes of action:
- Breach of express warranties
- Breach of implied warranties of merchantability and fitness
- Magnuson-Moss Warranty Act, 15 U.S.C. § 2301, Et Seq
- Fraud- Affirmative misrepresentation, omission, and concealment
- Negligent misrepresentation and omission
- Violation of state consumer protection laws
- Unjust enrichment
- Negligence
- Negligence Per Se
The Metformin lawsuit demanded class action status, preliminary and/or final injunctive relief, exemplary or punitive damages, an award of attorneys’ fees, expert witness fees, and costs and statutory penalties.
Link between Metformin and Genital Birth Defects
According to a Stanford Medicine research in 2022, the use of Metformin by men 3 months before conception can lead to genital birth defects in their male babies. Another study found out earlier that diabetes medications like Metformin could affect male reproductive system.
Of the 1,116,779 babies included in the study, 3.3% had at least one major birth defect and 51.4% were boys. Among the 1,451 babies exposed to metformin, 49.4% were male and the rate of birth defects was 5.2%. In particular, genital birth defects were more common and occurred only in boys.
This study proves that the health of the newborns also depend on the medications consumed by both the parents. To be fathers should be cautious about the medications they take before planning for a family. The rise in genital defects in boy may later turn out in the form of Metformin birth defects lawsuits.
Metformin Lawsuit Kidney Damage
Kidney injury is a possible side effect from using Metformin. High levels of Metformin can lead to lactic acidosis, which could further worsen in the form of an acute kidney injury. As per the Journal of Medical Case Reports, the case of a Japanese man with “severe acute renal failure accompanied with significantly elevated Metformin plasma concentrations and signs of lactic acidosis.” People with acute kidney injury risks should be aware of the fact that even a recommended Metformin dosage could cause renal failures.
People who are affected by Metformin-induced renal failures can file Metformin kidney damage or Metformin Gangrene lawsuits.
How to file Metformin lawsuits?
Like every personal injury lawsuit, filing a Metformin side effects lawsuit also insist of gathering potential evidence to link your cancer diagnosis from Metformin intake. You can collate this evidence from your medical records, Metformin prescriptions, medicine purchase receipts, and other records related to the treatments.
If you want to join the failure to warn claims after the Metformin recalls, be patient and watchful of the course of the ongoing Metformin class action lawsuits. Try to push your claim forward at the announcement of settlement and within the statutes of limitation.
If you want to file a Metformin cancer lawsuit, seek the legal counsel of experienced Metformin lawsuit lawyers to the eligibility of your claim. If you have a family history of cancers, you may find it difficult to prove your claim.
The Metformin lawsuit payout will be based on the period of your Metformin use, severity of Metformin side effects you have undergone, treatments required for the side effects, medical expenses and so on.
To wrap up,
The global rise in diabetes rates has spurred an increased reliance on medications like Metformin, presenting a double-edged sword of potential relief and unforeseen consequences. As Metformin lawsuits become more prevalent, it is evident that the pursuit of diabetic care should not come at the cost of severe side effects and life-altering complications. It is crucial to prioritize patient safety and continue the search for effective and safe treatments for the millions battling diabetes worldwide.
If affected by Metformin, don’t hesitate to pursue Metformin lawsuits with an experienced Metformin attorney by your side.
