Digitek Problems Linked to 667 Deaths

Following Actavis Totowa’s Digitek recall in April 2008, the FDA received a spike in adverse event reports involving the generic digoxin heart drug and it has been identified as the “primary suspect” in at least 667 deaths reported to the agency from April 1 through June 30, 2008.

Digitek (digoxin), which was manufactured by Actavis Totowa, is used to treat heart failure and irregular heart rhythms. A recall for all lots of the drug was issued on April 25, 2008, after it was discovered that some tablets may be twice as thick as they are supposed to be, containing up to double the appropriate amount of the active pharmaceutical ingredient.

Oversized Digitek tablets could increase the risk of a digoxin overdose, know as digitalis toxicity, which can cause serious and potentially fatal injuries, including arrhythmias, heart failure and death

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The Center for Public Justice, which is a nonprofit organization that produces original investigative journalism on issues of public concern, released a report on December 22, 2008, which questions whether the FDA and drug maker missed critical signals of Digitek problems and whether additional steps should have been taken to protect the public.

An analysis of FDA records indicates that there was a spike in reports Digitek problems during the months around the recall.

The Center’s report criticizes the FDA for taking too long to act on manufacturing problems at the New Jersey plant where Digitek was made, as FDA inspections up to two years prior to the recall uncovered signs of poor manufacturing practices and quality control problems. In addition, a number of public health experts indicate that the spike in reports of Digitek problems should have caused the FDA to more aggressively warn doctors, pharmacists and consumers about the risk of potentially defective tablets.

Despite the spike in Digitek problem reports, Actavis has maintained that none of their double strength pills ever reached the public, and that the recall was only issued as a precaution.

The company faces potentially hundreds of Digitek lawsuits filed on behalf of users who allege that serious and fatal digoxin overdose injuries were caused by oversized tablets they received. As of early November, at least 66 lawsuits over Digitek problems filed in federal courts have been centralized in an MDL in the U.S. District Court for the Southern District of West Virginia, and additional lawsuits have been in various state courts throughout the United States.

10 Comments

  • PatriciaMarch 29, 2021 at 6:47 pm

    My father was taken ill the week-end of Feb 28, 2009 with dizziness, an inability to focus, a lack of appetite, and falling. He was 83 years old, lived independently and went out all the time. Prior to getting sick, he had a history of heart disease and two weeks prior to his illness, he was put on Digoxin fir heart rhythm regulation. He fell on Feb 28th and was admitted into the hospital as a res[Show More]My father was taken ill the week-end of Feb 28, 2009 with dizziness, an inability to focus, a lack of appetite, and falling. He was 83 years old, lived independently and went out all the time. Prior to getting sick, he had a history of heart disease and two weeks prior to his illness, he was put on Digoxin fir heart rhythm regulation. He fell on Feb 28th and was admitted into the hospital as a result of the fall and symptoms of confusion. Within 3 days his kidney started to shut down and his skin filled with fluid. He couldn’t be touched the fluid was so extension. He had swelling and sores in his throat and could not talk. He would lie in the bed with tears coming down and no way to communicate. We were told he had an acute illness and they did not know what was causing it. The hospital gave up hope as his organs shut down and said there was nothing they could do fir him. He was moved to hospice on his birthday, March 26, 2009 and died on March 28, 2009. One week later Humana Health care (his prescription provider) contacted us to take his Digoxin back to the pharmacy. It was identified in a lot that was an overdose amount. Too late. I contacted 2 law practices that declined the case because his death certificate said he had pulmonary artery disease. Too many cover ups and no accountability.

  • CaryNovember 20, 2010 at 10:04 pm

    My mother was happy, helping making food for a friends sick husband the day before mother's day 2008. On mothers day we missed her call, but the message she left was happy and upbeat telling me thank you for the gift. The next day she was rushed to the hospital and 6 hours later desd. Autopssy said renal failure due to too much digitek in her system.We filed law suit when we found out about doubl[Show More]My mother was happy, helping making food for a friends sick husband the day before mother's day 2008. On mothers day we missed her call, but the message she left was happy and upbeat telling me thank you for the gift. The next day she was rushed to the hospital and 6 hours later desd. Autopssy said renal failure due to too much digitek in her system.We filed law suit when we found out about double amount of pills were recalled. Now they are trying to get me to sign an opted out settlement that says dollar amount for each point will be decided later but go ahead and opt out. Are they out of there minds, they killed my mother. Her life is worth more then a point system. Now they are saying her age makes a differenc, well I wasn't aware that pill companies are God and know when a person is going to die just because they hit a certain age. They murdered my mom and they will be accountable for it by a law suit and with money. No amount of money can bring my mother back, but we cannot let them get away with murdering people and just getting a slap on the hand. I am just a simple man, but murder by hand or with medication is still murder.

  • TimOctober 15, 2009 at 4:16 am

    Who was responsible for determining who, if anyone, received the incorrectly manufactured products which was presumably determined by matching lot numbers to prescription numbers. Was it the manufacturer? Was it the pharmacist? Was it the FDA? Was it another entity? Did any and/or all work together in determining who, if any, received the incorrectly manufactured products? Is it fair to assum[Show More]Who was responsible for determining who, if anyone, received the incorrectly manufactured products which was presumably determined by matching lot numbers to prescription numbers. Was it the manufacturer? Was it the pharmacist? Was it the FDA? Was it another entity? Did any and/or all work together in determining who, if any, received the incorrectly manufactured products? Is it fair to assume that some or all of those involved have individuals working for the organization and/or own the organization who might have legal liability as a result of this apparent error? If so, is it fair to assume that some might have a very strong interest in avoiding liability and, if so, is it also fair to assume that some or all of those individuals might not be completely forthcoming in terms of their involvement or that some or all of those individuals might have strong motivations to cover up or misrepresent their involvement. If I had a family member pass away as a result of a heart problem around this time period and they were using this drug, I think I would pursue legal action even if information was made available that contradicted a finding of error. My assumption would be that almost everyone involved has a strong motivation to lie and believing the fox when he says he didn't eat the chicken would be irresponsibly naive.

  • LizSeptember 16, 2009 at 11:03 pm

    My grandfather passed away in January 2009. We received a letter from a pharmacy company in April 2009 that the Digoxin he was taking was being recalled, for the same reason as the Digitek product, varying pill sizes. My grandfather was very healthy and active. He was always on top of his regular physician visits, taking his meds, exercising. When he passed, even his doctor was shocked. We ha[Show More]My grandfather passed away in January 2009. We received a letter from a pharmacy company in April 2009 that the Digoxin he was taking was being recalled, for the same reason as the Digitek product, varying pill sizes. My grandfather was very healthy and active. He was always on top of his regular physician visits, taking his meds, exercising. When he passed, even his doctor was shocked. We had no reason to believe that it could have been his medication. His death is recorded as heart failure. Because the paramedics declared it as natural causes, there was no autopsy or toxicology report done. Now, there is no way to prove that this could have been the cause of his death. After receiving the letter, I began my research. How could a company manufacturing a classified dangerous drug not implement additional quality control procedures knowing that their competitors had 667 deaths linked to the defective pills. It is criminal. No amount of money is going to bring him back, Mr. Latrosky from Caraco Pharmaceuticals stated that there have been no deaths linked to the drug. I think he is wrong. I think my grandfather would still be alive today if it wasn't for their gross negligence. I don't think that my grandfather is the only one that this may have happened to either.

  • NikiMay 29, 2009 at 3:32 am

    My Father was prescribed Dogoxin for his heart condition and didn't live past his 47th birthday. This is horrible that doctors can prescribe any medication that they may think will work and is safe for everyone to take. My whole family is suffering from their mistake! There is nothing in this world that can bring my father back!

  • kimApril 17, 2009 at 7:09 pm

    My father was a strong man that drove himself to the hospital for his heart surgery. He recovered did his rehabilitation but could never quite snap out of it. He received the digitek in april approximately 8 months after his heart surgery. He was a nonsmoker, not over weight and very mobile person. He drowned in his own congestive heart failure. He's heart could beat hard enough to keep him mo[Show More]My father was a strong man that drove himself to the hospital for his heart surgery. He recovered did his rehabilitation but could never quite snap out of it. He received the digitek in april approximately 8 months after his heart surgery. He was a nonsmoker, not over weight and very mobile person. He drowned in his own congestive heart failure. He's heart could beat hard enough to keep him moving and from getting tired. The heart monitor was very erratic and slow. I was with him when he took his final breath at hospice. He was only 66. He was such a good person. He trusted everyone. even when it came to taking his medicine he thought it was the right thing to do. After he passed away we received the letter that he did get medicine from the lots that were double strength. It hurts so much.

  • Digoxin Recall Causes Other Generic Drug Makers to Step Up Supply - AboutLawsuits.comApril 3, 2009 at 8:34 pm

    [...] 667 deaths have been reportedly linked to a Digitek overdose, highlighting the dangers associated with production problems involving [...]

  • Generic Digoxin Recall Issued Due to Oversized Tablets - AboutLawsuits.comApril 1, 2009 at 5:47 pm

    [...] According to a report issued by the Center for Public Integrity in December 2008, at least 667 digoxin deaths were reported to the FDA between April 2007 and June 2007 involving potentially double strength [...]

  • Watson Propafenone HCL Recall Due to Oversized Tablets - AboutLawsuits.comMarch 25, 2009 at 4:33 pm

    [...] may have been commercially released that contained up to twice the appropriate amount of the drug. Oversized Digitek tablets have been linked to 667 deaths between April 2008 and June 2008, and a growing number of Digitek [...]

  • JenniferDecember 31, 2008 at 3:47 am

    My father passed away this past April after taking Digitek. I have an attorney and I assume it will be going to court soon. But none of that matters. No amount of money will bring my Dad back or take away any of the pain that he suffered before he passed or any of the pain that I suffer now. I recently read that 667 people may have died because of this drug. That is 667 too many. 667 Grandparents[Show More]My father passed away this past April after taking Digitek. I have an attorney and I assume it will be going to court soon. But none of that matters. No amount of money will bring my Dad back or take away any of the pain that he suffered before he passed or any of the pain that I suffer now. I recently read that 667 people may have died because of this drug. That is 667 too many. 667 Grandparents, Moms, Dads, Husbands, Wives, Sons, Daughters, Brothers, Sisters, Aunts, Uncles, Cousins and Friends. Not to mention the countless others that are living with other complications because of this medication. When are these drug companies going to stand up and take responsibility. I can't remember the last time that I went to any Doctor without a drug rep waiting in the waiting room or catering lunch for the Doctor and his staff. One of my Doctors was even sent on vacation by one of these drug companies. Should that even be legal?

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted today)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted yesterday)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.

Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children
Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children (Posted 4 days ago)

Plaintiffs have submitted a baby food lawsuit Master Complaint that is expected to streamline the filing of lawsuits alleging that toxic heavy metals in Beech-Nut, Gerber, Hain and Nurture products caused ADHD, autism and other developmental disorders.