Drug coated stent recall will not occur, but serious safety concerns still exist

Austin Kirk

By Austin Kirk
Posted December 11, 2006


[alert type=”general” accent_color=”” background_color=”” border_size=”1px” icon=”fa-asterisk” box_shadow=”yes” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ class=”” id=””]UPDATE: Saiontz & Kirk, P.A. is no longer accepting new Plavix cases.
This archived post is for informational purposes.[/alert]

Following the meeting of an FDA panel of experts last week, it does not appear that there will be a drug coated stent recall or removal from the market.  However, medical experts have still indicated that there are serious safety concerns associated with drug eluting stents.  Most patients currently receiving the stents face an increased risk of blood clots, which could lead to heart attacks or death.

>>INFORMATION: Heart stent problems

The FDA panel was convened to review the safety of drug eluting heart stents after recent studies demonstrated an increased risk of blood clots, heart attacks and death associated with the devices.  The panel found that when the stents are used as approved, the benefits outweigh the risk.  However, it has been estimated that only 20-40% of all drug eluting stents are implanted in patients meeting the profile for which they have been determined to be safe.

Currently, the majority of cases where medicated stents are used to open clogged arteries are considered “off-label”.  At the FDA meetings, several presenters who analyzed the latest heart stents data, concluded that there is an increased risk of blood clots associated with these off-label uses.  Further drug coated stent studies are necessary to fully evaluate the extent of the the blood clot risk.   

Rather than concluding that a drug coated stent recall is necessary to protect the public, the panel has recommended that manufacturer do more to warn the public of these off-label dangers.

Off-label stent uses could include situations where the patient is sicker or has conditions such as diabetes, multiple blockages, or blocked narrow arteries.  Some experts indicated that those individuals may do better with heart bypass surgery instead of having a drug eluding stent implanted.

The FDA panel also recommended that individuals take an anti-clotting medication for at least a year after the stent is implanted.  Currently the manufacturer of the Cypher stent only recommends three months of blood thinner and the manufacturer of the Taxus stent only recommends six months.  Many doctors believe that anti-clotting medications, such as Plavix, need to be taken for even longer than one year.  However, there are serious concerns regarding Plavix side effects which could be increased with extended use of the blood thinner. 

Drug coated stent lawsuits are currently being investigated and reviewed for individuals who have suffered blood clots, reclogging of the artery, heart attacks or death.  The manufacturers have failed to adequately warn about the drug coated stent dangers

If you, a friend or family member believe you may have a case, request a free consultation and claim evaluation.

32 Comments • Add Your Comments

  • Doreen McNiven says:

    I have just had a drug eluting stent implanted Nov. 27. I am also type 2 diabetes. Am I in any kind of danger? Why would they put it in if there is such danger? This site has just added to my stress!

    Posted on December 15, 2006 at 12:36 am

  • Faith Chapman says:

    I had one implanted in april of 2004. I wish that they would have done a bypass instead. I had a near fatal heart attack in oct. 2004. after the stent was implanted i started feeling worse. I started having what they called were “spasms in my arteries”. I had had a heart attack in march of 2001 and had to have a clot buster to save me. cath results showed several small narrowed arteries. they couldn’t do anything about them but put me on meds.
    when they put the stent in he told me later that the artery was small and he almost couldn’t find a stent small enough to use. said he almost had to go the second step, meaning a bypass. now i wish so much that i’d had a bypass.
    the stent , in oct. 2004 had clogged. and now, the area is inoperable. so, i was more or less given a death sentence when the stent was placed in my artery. i just learned this this week when i went to get copies of my medical records. i’ve had a very emotional week.

    Posted on December 15, 2006 at 4:23 pm

  • JA Schwager says:

    I had a DES inplanted January 2006, so I’m a year into it. GI bleeding is showing up, so am planning on backing down from Plavix and perhaps upping the aspirin. But here is something for you to look at. These are alternatives that the drug cartels will never tell you about, for obvious reasons.

    Go and research Ananese (it’s Bromelain, Cystein HCL, and Escharace) in a sublingual and is represented as working to dissolves clots. Also look at Nattokinase which does the same but is taken in gel caps. Both of these are over the counter. Look on the internet and also check ConsumerLab.com for honest testing (*NOT* to be confused with the different but similarly named consumer reports). ConsumerLab.com names brands which fail their tests, and why they fail. I haven’t seen them test Nattokinase or Ananese yet, but they have done a wide range of other products including CoEnzyme Q-10. Anybody, in my opinion, who is taking statins and not paying attention to Co-Q10 is well, just not paying attention. The drug companies will not help you here. The FDA urged them to include Co-Q10 in their statin preparations, but, nope, no profit for them, so we won’t find Co-Q10 there. You must take it as a supplement if you want it.

    These things, again in my opinion — and I’m not an MD — could extend your life and give you a higher quality of living while we are pursuing legal remedies.

    Posted on December 17, 2006 at 1:36 am

  • Austin Kirk says:

    Please note that no users should discontinue Plavix or any other blood thinner without first talking with their doctor and obtaining appropriate medical direction. Changing your anti-clotting medication without speaking with your doctor, especially after receiving a medicated stent, could lead to serious consequences.

    Our office is investigating potential lawsuits against the makers of drug eluting stents and Plavix. If you have received a medicated stent or are taking Plavix, you should review medical concerns with your doctor. If you believe that you have suffered an injury and wish to look into a legal claim, you can call our office toll free at (800) 522-0102 or request a claim evaluation.

    Posted on December 17, 2006 at 8:30 pm

  • Mike Hendricks says:

    I had medicated stents put in on 06/07/2005.Dotors told me to take the drug plavix for six mounths.After taking the drug.On feb 04 2006 i had MI. The doctors at the hospital that i was taking to had to put another stint in at the same place that were one of the others .He told me that i had 100%blockage which was a blood clot on the stent. They know tell me that i will be on the drug plavix for the rest of my life.I also lost 20% of my heart from the blood clot.I fill tierd all the time @stay stress out all the time woundering if it will happing again

    Posted on December 17, 2006 at 8:55 pm

  • Peggy says:

    I am just beginning to research the 7 medicated stints that were put in just a few days ago. I was told that bypass surgery was not a very sure thing. They didn’t have a very good place to go from and to. I had no chest pain – or any symptoms before the procedure (just had a stress test to get a baseline on my heart) so this was a total surprise. I have had Type II Diabetes for about 13 years – the damage was all diabetes related and family history. My cholesterol is 157 and blood pressure has always been very good.

    I’m freaking out at what I’m reading – and NOW I have pain all the time. I stay stressed out wondering what is going on. My follow up stress test was very good…but still the pain and I get NO explanation.

    Can someone tell me if it’s happened to them?

    Posted on December 22, 2006 at 12:53 am

  • bill morris says:

    Mike I understatn exactly what you mean. I had a stent placement may on 2006, november 2006 I had 2 heart attacks within 15 minutes of each other caused by a blood clot at the stent site. Before I left the hospital they put 2 more stents in, one on each side of the stent that I already had, at that time I did not know about the problem with these stents. I feel tired all the time just like you. I have also been told that I will have to be on plavix the rest of my life. My stents are in the lad artery which is also called “the widow maker”, so yes I am always thinking about it. I often wonder why since it was known about the stents why they did not just go ahead and do a bypass,or even if they can still do it now with 3 stents in the same artery? Mike, if you would like to e-mail me I will e-mail you back. My e-mail address is billybob5898@yahoo.com

    Posted on December 26, 2006 at 9:40 am

  • Robert says:

    I’m not sure I understand your timing. You said you got the medicated stent in May of 2005 and was told to take Plavix for 6 months. That would mean that you stopped taking Plavix in Nov of 2005. Then in Feb of 2006 you had a clot in the stent. So, you had just stopped taking the blood thiner Plavix approximately 3 months before getting the clot?

    Posted on January 1, 2007 at 3:03 pm

  • Ray Stuckey says:

    I had 4 stents put in in February 1 2004. After about 3 months I started having pains a went back to my cardiologist. I passed a stress test but still the pain was getting worst so I went back about 2 weeks later and told the doctor. They scheduled another angioplasty and discovered that the same area where the stents were implanted had clogged again. They put 4 more stents inside of those. In or around about march or April of 2006 my doctor took me off of the plavix that I had been taking since the first procedure. in July I had to be Hospitalized for what was called an arythmic heart beat. Then in October I had started to have the pains again .I went back to the cardiologist took antother stress test, passed it but still was not satistfied so another angioplasty was scheduled and guess what? You’ve guessed it. blockage in the same area and in many small arteries past the blockage are now also cogged and I’ve been told that I have to live with it and now all these articles come out. Man I’m so stressed till I don’t know what to do. I was told that maybe I had some kind of genetic heart problem and that I would have to take plavix for the rest of my life. This is so scary.

    Posted on January 1, 2007 at 11:20 pm

  • Austin Kirk says:

    Robert, That timing described by Mike is not at all an uncommon finding as we are investingating these medicated stent lawsuits. One of the recommendations following the recent FDA hearings is that users need to be followed on a blood thinner (such as Plavix) longer than the 3 to 6 months initially recommended by the manufacturers of the medicated stents. Some doctors have indicated that the medicated stents may require follow up on a blood thinner for four years or longer due to the risk of “late stent thrombosis”, or blood clots which can form at the site of these medicated stents years later. The drug coating on the stents allows them to act as a “clot magnet” for much longer than the manufacturers warned about.

    Of course, given the concerns regarding plavix side effects, many experts have expressed concerns over the safety of plavix being taken for over a year. Plavix side effects increase the risk of gastrointestinal bleeding, ulcers, ttp blood disorder, heart attacks or strokes.

    Posted on January 2, 2007 at 9:35 pm

  • Janice says:

    Has any progress been made on these lawsuits?

    Posted on January 8, 2007 at 2:46 pm

  • Annette Carpenter says:

    I had open heart in 2003 and then I had to go back in and have 3 stents put in in Febuary 2006. They have me on Plavix now and they said I could never stop taking it,all of this is very upsetting to me I’m stressed out all the time thinking about it I can’t sleep at night I have chest pain all the time I have a serious neck problem and no one will hepl me cause I am on the Plavix, all of this is starting to interfer with my job now and I believe that someone should compensate us for all the pain and suffering we all are going through. Not only are we suffering but my Husband is suffering with me. This just isn’t right, does anyone know if there is anyone out there that is sueing for all of our sufferings.

    Posted on January 17, 2007 at 11:42 am

  • Austin Kirk says:

    Annette, at this time lawsuits are being investigated for users who have suffered only certain injuries as a side effect of Plavix or drug eluting stents. For Plavix, we are investigating claims for anyone who has suffered internal bleeding, ulcers, heart attacks, strokes or TTP blood disorder. For stents, we are only investigating claims where there has been a reclogging of the artery after the stent was implanted or a heart attack.

    These cases are currently in the very early stages of investigation. At this time, we are not pursuing claims for individuals who have received a drug eluting stent forcing them to remain on Plavix or another blood thinner to reduce the risk of blood clots or thrombosis, unless they have suffered one of the above injuries.

    Certainly there may be some future drug eluting stent class action suits. Plavix is a very expensive medication and cardiologists have pointed out that the risk of serious injury or death is significantly increased if the medication is stopped after a stent is implanted.

    Our lawyers have received calls from several individuals who are concerned since they have a drug eluting stent. We will be updating this portion of our website with any news or information about additional class action claims for users who have not suffered any of the injuries outlined above. Click here to subscribe and receive notice of updates by email. You can also click here to subscribe to receive our quarterly newsletter.

    Austin P. Kirk, Esq.
    Saiontz, Kirk & Miles, P.A.

    Posted on January 21, 2007 at 10:55 pm

  • Edward says:

    I as well suffered multiple collapsed arteries in my heart ( AKA an MI ) on 4/5/05. at which time I was rushed into the Cath Lab and an Angioplasty was performed. Including placement of a Boston Scientific medicated Taxus Stent was placed into one of my arteries.
    I spent 3 days in the hospital for recovery and when released I was put on a coronary cocktail of medications that I was informed that I would have to take for the rest of my life.
    The medications are as follows….

    Aspirin 325MG – 1 Per day
    Metoprolol 50MG – 1 tab twice per day
    Lisinopril 20MG – 1 Per day
    Lipitor 80MG – 1 Per day
    Clopidogrel 75MG – 1 Per day ( This is generic for Plavix )

    Two months after the stent was put in, I found myself back in the emergency room due to having a blood clot in the medicated stent. Again another Angioplasty was performed to remove the clotting.
    Needless to say, the pain I suffered due to the clotting was IMMENSE and I would have sworn that I was dying. Which I most likely would have if the clot was not removed.
    I have survived almost two years now after that clotting without another clot…YET ( Thank God, I do NOT look forward to suffering through what I went through again ).
    However, I live every day with constant pain in the center of my chest since the stent was put in. As well as shortness of breath, and SEVERE and constant tiredness.
    I am a 37 year old male, that up until the MI and stent placement, led a very normal life and was a very active person. However, since then not only have I gain ALOT of weight. But I hardly ever leave my house unless its to go to my doctors appointments, Not only is this due to my severe lack of energy and shortness of breath when doing anything…but I have delt with a failed spine fusion surgery for the past 6 years and am disabled due to it.
    Again,I live day to day not only suffering with the chest pain, but am very stressed out and I am not embarassed to say…VERY SCARED to potentially relive another clogging of the stent. It was a very horrific and painfull event as you can imagine.
    I guess I am writing this reply to let it be known that there are indeed people out here that are suffering and have suffered as a result of the medicated stents. And I cannot imagine that they are still allowed to be used considering their obvious flaws.

    I am also writing this reply to possibly get feedback to this question…

    As I stated…one of the medications I am currently taking is Clopidogrel 75MG – which is generic for Plavix.
    Being that there are many issues arising with the use of Plavix, I would like to know if that includes Plavix in GENERIC form ?…or just Plavix name brand?
    Reason I ask is because I JUST became aware of these issues with the medicated stents and Plavix, and I have an upcoming doctors appointment. And would like to be better informed when speeking with my doctor about the Plavix.

    I will be checking this site often in the hopes of obtaining further information.

    I sincerely wish everyone that is having the same problems the very best, God bless you all. And hopefully these companies that continue to push their flawed product will wake up and realize that not only is their product causing people to suffer in pain. But causing emotional pain to the families of those who have lost their lives due to the use of their products.
    This is peoples LIVES were talking about, not just a recall on a car muffler or something !!
    Again wish you all the very best….and look forward to some feedback in regard to my generic Plavix concerns.

    Albany, New York

    Posted on February 15, 2007 at 4:34 am

  • Austin Kirk says:

    Edward, Thank you for sharing your experiences. We have spoken with several individuals who have had to undergo an additional procedure to reopen the artery after blood clots formed at the site of the drug eluting stent. The drug coating was intended to reduce the risk of another blockage caused by scar tissue, but the blood clot side effects have not only lead to an increased risk of heart attacks and death, but also to the possibility of another blockage as a result of the clots. Based on what you have described, you may be entitled to compensation through a stent lawsuit. If you have not already spoken with one of our attorneys, click here to request a claim evaluation or call our office toll free at (800) 522-0102.

    In response to your question about Plavix vs generic clopidogrel, they do carry the same side effects and risks, as they are essentially the same medication. However, at this time, we are only investigating potential lawsuits regarding use of the name brand Plavix, not the generic clopidogrel which has recently been made available.

    Austin Kirk, Esq.
    Saiontz, Kirk & Miles, P.A.

    Posted on February 19, 2007 at 4:03 pm

  • steve says:

    I had a stent put in Feb of 2005, i started having problems again 6 months later,
    in August of 2006 I had to have a second stent put in just above where the first one was put.I have been on plavix since feb. 2005 and have not ha any more problems. Dr. did say i may have to stay on plavix for rest of my life. I am now 61 Steve

    Posted on February 20, 2007 at 9:49 pm

  • Margaret says:

    Can you please tell me the month and year that these drug coated stents began being used. My husband had one stents in 1994 and one year later had to have two stents to reopen the same location. In 1999, he underwent 6 bypasses and by 2005 had a pacemaker/defibulator inplanted. Thanks for the help.

    Posted on March 23, 2007 at 11:56 am

  • Austin Kirk says:

    Margaret, There are two types of drug coated stents which have been approved for use in the United States. They were approved in 2003 and 2004. In most cases, after the stents are placed, your husband would have been given a card with the type of stent used. If you need further information, please contact our office toll free at (800) 522-0102.

    Posted on March 25, 2007 at 8:09 pm

  • DON says:


    Posted on March 27, 2007 at 3:55 pm

  • Janice says:

    Do you think there will be a settlement anytime soon?

    Posted on April 11, 2007 at 1:18 pm

  • Austin Kirk says:

    Janice, legal claims involving dangerous medical products and medications often take several years. There is no indication that there will be a quick settlement for the heart stent lawsuits. However, if you believe you may have a legal claim, you should request a claim evaluation sooner rather than later, as every claim has a statute of limitations which will require that your claim be filed by a certain date. We would be happy to speak with you and review any further questions you may have about the legal process to pursue compensation for heart stent injuries.

    Posted on April 12, 2007 at 7:46 pm

  • Janice says:

    i had a medicated stint put in in 2003 I also take plavix. Ididnt know that there were so many problems with this.i do know that i have not felt good since i had my heart attack.I have also had all kinds of bowel and gas problems.I think this is caused from the plavix.I dont know.how do i find out what kind of stint it was.

    Posted on April 25, 2007 at 12:38 am

  • Pat says:

    As well my husband had five Johnson and Johnson DES’s placed in the right side of his heart (the widow maker). We were never told anything about these side effects. In 1991 he had a double bypass, both (window makers) right and left side of the heart. They say they last about 10 years, however he started feeling very tried and had troble breathing about 4 years ago, got tried very easy) So now we are into the 16th years and he had another heart attack. Cath was done and found 100% closer on the right side (which was one of the graphs in 1991)
    They placed 5 stents inside that graph which was already 16 years old and put him on Plavix for the rest of his life. QUESTION: does anyone no if this could be more of a problem due to the age of the graph they placed these 5 stents into?

    We are so worried now that we have found all this information, things no one told us about. So far he is doing ok, but we had a relative that the same thing happened and he died instantly with a blood clot that had formed in the J & J stent, he had not had any open heart and it was only one stent with our relative, so I case you all can see our worries about this. I hope everyone well and I’m so glad to be able to share this worry I have with you all.

    Posted on May 7, 2007 at 4:13 pm

  • bill morris says:

    I understatnd your worry, their is only a small percentage of people who are having problems with these stents,or so they say, but your relatives family needs to contact a lawyer. I have and they have been very helpful so far. Your husband needs to keep taking plavix and the doctor should have put him on asprin. I know tha their are risks taking the plavix with its side effects but he and I are in a catch 22 situation. I will not go into detail about my problems if interested I am number 7 on this blog listing. Just tell your huxband to pay attention to all the signs and to see his doctor regularly. He also chould talk to the doctor about nitroquick tablets that go under the tung. You and he both need to talk to a lawyer about you case because you could have one, I do. Your doctor is not to blame because the facts did not start comming out until december of 2006. I wish both of you well and I say that because the spouse goes through alot of worry just like the patient.

    Posted on May 9, 2007 at 6:50 am


    mY HUSBAND JUST HAD ASTENT PLACED IN THE LCA ON JULY 9 2007. i FOUND ALL THIS INFO JUST AFTER HE HAD UNDERGONE THE PROCEDURE.To make matters worse we believe that his MI was due to his lengthy intake of the diabetes drug Avandia.Iasked the MD why they would be using the eluding stent,and then treat the patient with plavix and asa afterwards, in light of all the documented problems.The MD stated that it is still the best treatment available, and that only a small % of people are experiencing problems. I replied that the so called “small % of people”, issue goes right out the window when it is your loved one who is affected.We were not told about the problems with the eluding stents, the associated risks of plavix, or the required duration of post procedure treatment with Plavix.I think at the very least , if a patient MUST remain on the expensive Plavix for a lifetime, or even a year or more the drug company should be forced to supply the drug to all those who were not informed of this requirement pre-procedure. They should also bear the cost of any medical follow up, which should include diagnostic studies to detect problem very early on.My husband is a type 2 diabetic, who has elevated cholesterol, triglycerides, and hypertension. He has thr added burden of liver disease which further predisposes him to bleeding, etc. He, it seems is just the type of patient that the above should have been contraindicated.All I can do now is help him to reduce and or eliminate all of those risk factors that led to his problem, and pray to God for healing and a long life.I wish all of you fine people the very best, and I hope that only good follows you from now on. I will keep you all in my prayers.

    Posted on July 16, 2007 at 6:07 am

  • bill says:

    christina, i understand your concern. i had a drug coated stent , my first, in may of 06. i had two massive heart attacks in november of 06. i am one of those lucky percent that you dont hear of because they are dead, i clinicly died with each of my heart attacks. i am not saying you to worry you but with your husbands problems he needs to follow the doctors orders. tell your husband about me and if he wants to email me he can. tell him to try his best not to worry about things but to pay close attentions to his condition. if he has any unusual pain in the chest, arm, and or jaw to see a doctor. my heart attacks were on the same side of the heart as your husband but was my lad,the widow maker artery, as its called. thankfully i was already in the hospitol. i wish you and your husband the best.

    Posted on August 4, 2007 at 12:53 am

  • bill morris says:

    Hi Christina
    how is your husband doing now? I did not see a reply and I was wondering. If your would like to talk, I have a good ear. Hope you and he are both in good health. Just wanted you to know that there is a group on yahoo groups listed as heartattack. Me and several others are members and we help each other through hard times. If you join what ever you post goes to all the members by e-mail. Then people respond and every time some one joins or respons all members get an e-mail. This way you get a wide range of answers from some one who might help you and your husband. I know from what I am going through this group has helped me alot. Best wishes. Bill

    Posted on January 8, 2008 at 1:13 pm

  • joy says:

    I am worried, i returned home after having my second stent put in after a clot formed in my last metal stent, this time a medication releasing one. I have two more blockages 30% they used to be 10%. The last stent lasted a year before I ended up with the same symptoms. I am worried because I remember being told I have small vessels. My artery was blocked the first time 90% this time the doctor said 70%. I am feeling like a time bomb waiting to go off. What can I do. Should I have had a by-pass, my dad did and 8 of his brothers and sisters have had by-passes. am I a guinnea pig, I never know if what I am feeling in my heart is the one, the last thing I will feel, please someone what should I do what questions should I ask and what research should I do. Who will be truthful. I don’t want sugar coated answers. I dont even know what to eat any more. I am scared. Joy

    Posted on February 14, 2008 at 12:16 pm

  • bill says:

    Your worries are justified. All heart patients worry. You need to eat good carbs and low fat. I have 3 drug coated stents in me. The number of people they say that have problems with these stents are only 5 percent. I was one of the unlucky ones. If your given the choice of bypass or stents I would choose bypass. I only wish I had that option offered to me. I am not saying this to scare you. I have several friends who have coated stents and have no problems. I am a member of a yahoo group listed as heartattack. You may want to join this group. Go to yahoo and click on groups. Find heartattack click and join. Any and all postings go to all the members this way we all try to help eachother. We all see the question and all of the responses and by clicking on the reply can add to that response. Best wishes. Bill

    Posted on February 16, 2008 at 12:55 am

  • Edward says:

    Oh yea, I have also since my initial heart attack in 2004 when the stent was put in, AND I was put on plavix as one of my heart medications, been diagnosed with type 2 diabetes, and not only do I now take a pill 2 times a day for it, but I inject myself with insulin 4 times a day as a result of my diabetes.

    Could my becoming diabetic be as a result of the taxus stent and/or the plavix ???

    Posted on November 7, 2009 at 5:29 am

  • SCOTT A. says:


    Posted on April 18, 2010 at 3:55 pm

  • Denise says:

    My dad. Recently died of a heart attack 13 days after his doctor placed a medicated stent in his main ventricle. He said he had a pain in his back then he said he was cold then he fell over they tried everything but could not keep his heart beating! 12 days earlier he had a doplar EKG and dr said flow was great he has another twelve years.
    Little did we know he had 12 days . He was diabetic and just had hip replacement surgery three weeks prior to the stent placement, two reasons he should not have had a medicated stent…dad was 70 and we will never get over what they have done to him

    Posted on October 29, 2012 at 10:05 pm

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • 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.