Patients Sue Icelandic Drugmaker Over Recalled Heart Drug
Out goes the drug, in come the lawsuits.
On April 25, Icelandic generic drug maker Actavis recalled its heart drug Digitek, or digoxin, over concerns that some batches of the medicine may have contained tablets that were twice the normal thickness and strength.

Today, two weeks since the recall, a lawsuit seeking class action status was filed against privately-held Actavis, as well as Mylan and its UDL Laboratories unit, which distributed the meds. Plaintiffs are seeking damages over alleged injuries and to cover medical monitoring in case of future health trouble.
There’s been very little information about the scope of the problem with the drug. At the time of the recall, Actavis spokeswoman Hjördís Árnadóttir said the company didn’t know how many bad lots or batches were in distribution. The company learned of the problem when one double-strength tablet was found. “The only information we have from the drug companies is from the recall notice,” said Michael Weinkowitz, a plaintiffs’ attorney with Levin, Fishbein, Sedran & Berman, which filed the suit in U.S. District Court in New Jersey. “It fails to advise the public to the real extent” of the problem, the lawyer said.
In announcing the recall, Actavis said the double-strength tablets pose a risk of toxicity in patients with renal failure. The right amount of digoxin can strengthen a weak heart and calm fluttering heart beats. Too much digoxin can make you nauseous, depress your blood pressure, slow down your heart rate or kill you.
Actavis said it has received several reports of illnesses and injuries. The plaintiffs include a woman who alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage.
According to the lawsuit, the FDA issued a warning letter back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency. A Mylan spokesman said, “Since Actavis is the manufacturer and they initiated the recall, we believe they will be responsible for all costs associated with it, including the litigation.” The Health Blog contacted Actavis’s Árnadóttir today, and she declined to comment on the suit.
TORT ALERT, TORT ALERT, INCOMING!!!!!!!!!!!!!
While digoxin does have a very narrow therapeutic index and serious side effects, this seems damn fast for a class-action already…2 weeks! WEEKS!
This is not the first time this plant had problems. The FDA should suspend all production until the problems at the plant meet standards. What are they waiting for someone to die. More oversight
should be directed toward Generic Drugmakers.
Foreign companies that are as innovative as this one who focus on human health should be immune from suit. We cannot live and thrive as a nation with proper medication like this and just because one or two batches comes out bad is no reason to question the intentions of this fine corporation.
I’m sick of people looking for deep pockets and suing everyone. Perfection in any industry is almost impossible to attain as long as people are not perfect.
Foreign companies that are innovative as this one…? How many sugar pills can they sell to the baby boomers? Who is going to notice when they die? It is not about money it is about somebody’s father dying! Maybe you will be next.
For many years I have avoided physicians, mostly due to the mistaken belief in the cure-alls of BIG PHARMA. Just recently I (against my better judgment) agreed to try digoxin to forestall atrial fibrillation and ultimately a pacemaker. HUH! guess what there is a large recall on digoxin - the one I was prescribed. So far I’m not dead but who knows - tomorrow. So I return to my distrust of BIG PHARMA - I was just another timid sheep-baaaaaa when are we going to wake up and question the huge medical and pharmacy businesses, I have had enough, no more.
My husband was taking Digoxin before, during, and after his cancer treatments in 2006/2007. Last November after three months of strange symptoms and doctors not finding a cause, he was finally diagnosed (by doctor number 11) with digitalis toxicity. His weight was down to 125 lbs, was suffering dizziness, confusion, and mental awareness problems. After taking him off the digoxin, he regained mental capabilities, gained some weight back, but he never really recovered from this toxicity. He passed away March 31, 2008. Did this drug kill him? Probably not. Was it contributory in hastening his death? I believe it did.
comment on lonely in wisconsin
three main symptoms of dig-tox
confusion
visual distrubance (ie halo-effect
heart beat below 50/min
plus regular blood testing, i feel min. every 6 months.
more often when patient is under going any drastic medical changes. i get sad when i see cases such as this when no doctor and no pharmacist were able to catch thease problems sooner. one thing people can do is use smaller pharmacies and medical offices. large chains and big medical offices where you never see the same doctor or pharmacist twice add to many medical issues. i personally have caught dig-tox in 15-20 patients within weeks over my 15 years practice. i have caught many other simple errors and prolems just b/c i know a little about my patients and work in a smaller retail setting. just knowing the approximate weight of a patient,age, and occupation help me avoid problems every single week.
June 2006, hospitalized for digitek poisoning .Only My pacermaker saved me per the doctors in the ER. Had to have dyalsis tratments. Had only 5 pecent of renal funtion experienced COnfusion, unable to hold items sever dierra, voimting, lost of time, unable to function on my own.
I have been on Digtek since sept. 2007. i have had swollen feet, very low pressure, confusion, memory loss, stomach trouble, fluttering of my heart, i feel something should be done, I am now on lonoxin & starting to feel better.
Tort reform let your mother and the grandmother of your children die because of an innovative company like this one (who continues to dish out bad meds as I have recently found out)then tell me how you would feel. The meds that were suppose to save her killed her. have you ever heard of the fish out of water syptom. . .you know when a person gasps for air but can’t get any? That is exactly how I watched my mother die so screw you and your concerns for “deep pockets”. This company can keep all that “hard-earned money” because it won’t bring my mom back. I just hope that the FDA and all others responsible for these mistakes realize the horrific hurt and pain they have caused to me and my family.
Just read about this today. My father was on this drug when he passed away suddenly. We did not do an autopsy at the time and are wondering if we can even prove this company is at fault.
Nobody is asking for perfection—just some simple RESPONSIBILITY!!! You cannot give people heart medication which is twice as strong as it’s supposed to be…I’ve been watching my father slowly die for 2 years, turning from a strong and healthy man to a withered, weak man who can barely button his shirt—because of heart medications!!! Do not talk about deep pockets and innovative companies…unless you’re talking about the company’s deep pockets, because they’re the ones making all the money selling drugs to people who are DIEING from them. Disgusting!
There are people selling drugs out on the streets and going to prison,but because these people have degrees to kill. they get away with it. my mother also died april3 with these same symptoms,and was a diaylis patient,there is nothing any one can do to bring her back,but i will sign up for this lawsuit.maybe it will open some eyes!
You should contact the lawyer in the article - you may be entitled to compensation. Let the lawyer worry about proof
My Mom, like most women in their eighties had been taking multiple medications for years. She was elderly but still alert and active.
In Sep. of 2006 she chose a more affordable insurance provider who could cover all of her perscriptions except Lanoxin With her Doctor’s ok Lanoxin was changed to Digitek.
Oct. of 2006 she began complaining of abdominal pain,weakness,nausea,confusion,diarrhea,dizzyness etc.
After her 3rd visit within 6 weeks to her frustrated doctor and multiple invasive medical tests, they could find no cause.
We were told she was just aging,lonely and depressed.
Her heart deteriorated and her symptoms increased (as did our search for a cause).
Wednesday May 21st 2008 she received a letter from the pharmacy telling her that Digitek had been recalled. It thanked her for her “attention to this matter”.
Mom is dead. She died November 21st, 2007 from CHF. Do I want to file a lawsuit? Hell No! Right now,I just want to know what the chances are that she HAD been receiving the APPROPRIATE LEVEL of Digitek.
Mom died recently.
Just now reading this info.
Found a bottle with the NDC#
and its “one of the recalled”
Damn.
I am a victim of the recalled Digitek. I received a call from my pharmacist the first week of May regarding the recalled Digitek. I’ve had all the same symptoms as the other have had including the people who have already died. I returned the bad Digitek pills to the pharmacy and was given Lanoxin. I just learned this evening the bad Digitek goes clear back to 2006 and here it is June 2008. I had the Digitek since the year 2000. I pray to get better since I’m on the Lanoxin. I want the FDA and also the pharmaceutical companies to take responsibility for their lack of checking on the medications. They are supposed to ensure the safety of all medications. Personally I now find it very difficult to trust any medication. My life has changed so much from being quite active to now not being able to do very much and that makes me very very unhappy because it’s all due to the neglect of the FDA and the neglect of the pharmaceutical companies who will have to take responsibility for all that has happened.
A victim in the State of Washington
My mother was on digoxin until last Friday when her doctor finally decided her levels were not where they should be (he only ordered her dosage be cut in half but I removed it altogether!). I had heard that there was a problem with this medication last week and contacted her pharmasist - I was told hers was not one with a problem. I beg to differ. She was a whopping 76 pounds before she was put on this medication, after 2 weeks of nausea, constant vomiting, diarrhea, confusion, weakness, even total vision blackouts, she was unable to even hold down a small drink of water, she is now 63 pounds and it breaks my heart. Fortunately, Monday was the first day she has been able to hold anything down and is feeling hungry again. I have home health care making multiple visits a week to her home and it was even suggested that I was the cause of her condition. That I was witholding nurishment from her or providing her with an unappropriate diet. PLEASE….if you have any loved one on this medication, DO NOT continue to trust using it. I tried to have faith in her doctors and even her pharmasist but it was not until I decided to remove the medication all together that she is finally starting to improve. I am currently waiting on a call from her doctor to tell him what I have done and to request he change her Rx for Lanoxin only - no more generic.
I HAVE TAKEN LANOXIN (CHANGED TO DIGITEK LATER) FOR 16 YEARS!!! LAST MAY I WENT TO MY PRIMARY DR BECAUSE I WAS NOT FEELING WELL, SHE DID A BLOOD TEST FOR DIG LEVEL AND CALLED MY HOME 6 HRS LATER TO TELL ME TO IMMEDIATELY DISCONTINUE MY MEDICATION, THAT I WAS TOXIC. THAT WAS ON FRIDAY, AND I CALLED MY CARDIOLOGIST ON MONDAY AND TOLD HIM OF THE INCIDENT AND HE TOLD ME TO GO IMMEDIATELY TO THE HOSPITAL (STAT) FOR BLOOD TEST AGAIN, THAT IT WOULD TAKE SEVERAL HOURS AT HIS OFFICE AND HE NEEDED TO KNOW MY DIG STATUS IMMEDIATELY IT WAS DOWN SOMEWHAT AND I DISCONTINUED AND LATER DECREASED THE DOSE. THE 16 YEARS I TOOK THE MED, I WAS NEVER IN THERAPUDIC RANGE, BUT WAS TAKING THE MAX FOR MY WEIGHT - THEN “BINGO” TOXIC. SINCE THEN I HAVE EXPERIENCED THREE ER TRIPS FOR ATRIAL FIB TO INCLUDE NAUSEA, SPENT 4 DAYS IN THE HOSPITAL FOR ATRIAL FIB (WHICH REOCCURRED WHILE IN THE HOSPITAL) BRADYCARDIA, LOW BLOOD PRESSURE AND SLOW PULSE. MY DR TOOK ME OFF DIGITEK AFTER MY JAN. 2008 HOPSITAL STAY SO THAT HE COULD PUT ME ON ANDIODERONE TO CONTROL AF. HAS DIGITEK TOXICITY DONE SOMETHING TO SEVERELY INCREASE MY AF EVENTS????? I WILL BE TALKING TO AN ATTORNEY. I HAVE ONLY ONE LIFE AND PEOPLES NEGLECT TO RECOGNIZE THAT NEED TO BE CITED. MDT
my husband started taking digitek in 2002. His prescription was under the “Bertek” label. He had his knee replaced in Aug. 07 and had to go back Sept.26,07 to have his knee manipulated (frozen)while in operating room his heart rate went to 12. His cardio.Dr.recommended him to wear a holter monitor home on Sept28,2007 the monitor showed his heart rate fast then dropping to 49 then pausing twice for 3 seconds. Needless to say he underwent pacemaker surgery on Oct.18,2007. Seems pretty fishey that he has not had any problems with his heart until now. Received a recall letter in May 2008 stating that you could get a refund if your digitek was filled between Nov.06 to April 08. My husbands heart problem “just happened” right in the middle of the recall dates. What’s the price you put on your heart? We are seeking an attorney!
My mother bought a pacemaker and suffered a stroke as a result of her slow heart rate due to digitek and now is facing losing her independent living status and the sale of her home to support her care for the rest of her life. This has all occurred with in the past 3 weeks and 2 days after she was told to stop her digitek.,
Call the lawyer who filed the suit - you have rights
I have never had a heart problem until April of 2007 when I had sudden drop in blood presure I was put on digetek then. I kept gettting weaker and dizzyier the rest of the year - rapid heart beat up to 185 during the day and 50 at night. according to heart monitor. I had a pacemake put in November 2007 and taken off digitek. I have had no problem since. May have been pacemeaker or may have been Digitek. I need a lawyer.
This is all a crime.
To those that think its all a about the money, you are wrong, have you ever lost a mother or a father, or a loved one. If not then you can go to hell…. my mother died May the 5th from this digitek, and if I could I would put them people in jail.
So don’t tell me its all about the money
My step Father was on Digitek and he is gone now. He had all of the symptoms that every one mentioned. He died December 13, 2005.
ths comment it to deep pockets have you lost anyone to yhis overdose of digtek i did i lost my mother 3 weeks ago i resent you saying we are only out for the money no amount of money will bring her back a sinceless death maybe you should take it .
Out for money? I’m out for answers! If money comes along with it, so be it. The hell this toxicity has put so many of us through goes far beyond the “out for money” mindset. People do make mistakes but after doing so much research on this subject, the fact that this drug company knew about the “double dose” pills long before they notified the public, in my opinion makes them fair game for whatever comes their way in the line of lawsuits.
I took the product and ended up in the ER and the Hospital for 4 days…
My colon, prostate and bladder all shut down…My wife had to call the abalance to get me to the ER.
I survived most died.
My mom was on Digitek and experienced rapid pulse, stomach problems, dizziness, muscle weakness, all the same symptoms everyone else states. In May 2007, I called her cardiologist and demanded they do something (had no idea it was Digitek) because she couldn’t walk across the room! The nurse said take her off Digitek immed. that it could be “digoxin toxicity” in Sept 2007 she had to have a pacemaker put in. That was after a “normal” EKG the year before. I know that my mom would be dead if I hadn’t called and demanded something be done. She still has muscle weakness and problems which I believe are related to the damage done by the Digitek. Condolences to those whose loved ones didn’t make it. I know how I would feel now if that had happened.
My sister had been taking dioxin/Digitek for over a year, she loved to paint pictures using scriptures from the bible. She stopped painting due to blurred vision, an in April 08 she complained of chest pains and pain in her abdomen, an ambulance rushed her to the hospital she stayed for a couple of days and then died on her Birthday. She always complained of nausea and pain along with blurred vision where she was prescirbed glasses and more digitek.
She had renal failure and now she is dead I know this medicine killed her and these companies should be facing criminal charges for their greed and disregard for humanity. Anyone I’m sure feels the same way. If being compensated is possible so be it but if not at least these companies are exposed. I hope the FDA and Judges across the US does something about this. “HELP, THESE GREEDY COMPANIES ARE KILLING US, WHAT’S NEXT?
IS THIS ANOTHER ATTACK ON AMERICANS LIE HEPARIN? HOW MANY OF US MUST DIE BEFORE GOD DECIDES ITS OUR TIME TO GO, THESE MEDS ARE SUPPOSED TO TREAT US NOT KILL US.
A GRIEVING SISTER”.
What a beautiful flower coming from China, just like everything else coming from over there (Toxic). While the Chinese are buying up pieces of America, Trillions of Dollars in loans and real estate, celebrating the Olympics in Bejing our families are dying. Activis, Bertek, Mylan, UDL you all should be ashamed of yourselves to unleash harmful drugs on people knowing the consequences. I hope you pay for what you have done to our loved ones. Your pockets are the ones that are deep and we have lost people that we have grown with and will never see again. All we have a photos and memories. Now you all want to point the finger, you may as well have sent your representatives to each state with machine guns and started shooting people with congestive heart failure it is the same thing you murderers.
My mom was on Digitek for 3 mos. and had all the symptons listed plus she was just so sick and the drs. could not figure out what was going on and why she was going downhill so fast. She had contant bladder infections, violent vomiting, dizziness, couldn’t eat, could barely make it from room to room, lost of weight, etc. She died Jan 18, 2008 a very painful and violent death. Drs. are so confused they put down on the death certificate death by an illness she did not even have. No one seems to know what is going on these days. Lawsuit in the works.
To those of you that think the Digitek lawsuit is about money you are VERY WRONG!!I almst lost my dad to this poisoning and i believe my aunt his sister DIED from this.I want to ask you a question?Let say you get into a car accident and your car gets totaled and you suffered bodily injury would you sue for your loss??I would bet my years salary you would so before you go around judging and mocking people that lost a loved one whether do to death or no longer able to function as they use to, before a COMPANY took that away from them maybe you should evaluate how you would handle this situation!If we the consumers don’t hold these companies accountable who will??
I have a Downs Syndrome sister that was put on this drug. She began to have all types of symptoms. We took her to the family Dr. and with one look he said she toxic due to the Digetek. I ask you, how would you like to be having these symptoms and unable to tell anyone? I wonder just how my sister must have suffered and done so in silence. She is unable to communicate to us, and we must use our common sense and our Dr. for her safety. Just imagine not being able to communicate that your heart is acting up and that you feel sick to your stomach, etc. She could have died. As a matter of fact, my mother was starting to plan her funeral she was so ill. We thought she was going to die, but didn’t know why.
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