>>FDA LINK: Boston Scientific Stent Recall

The Boston Scientific stent recall was originally issued on June 6, 2008, but the notice was just posted on the FDA website today. The carotid stents were manufactured by Boston Scientific between June 12, 2007 and May 2, 2008, and distributed between June 19, 2007 and May 5, 2008 throughout the United States.

The stents are used to treat carotid artery disease, where the artery on either side of the neck that supplies blood to the brain is blocked. If the tip of the carotid stent delivery system detaches during the procedure, it could cause:

• Stroke
• Vessel Wall Injury
• Increased Procedure Time
• Emergency Surgery to Remove the Detached Stent Tip

According to information posted on the FDA website, the carotid stent recall does not affect stents that have already been implanted. Those who already have the stent implanted, and have not experienced problems can contact Boston Scientific at (763) 494-1700 with any questions or concerns.

BOSTON SCIENTIFIC CAROTID STENT LAWSUITS

The stent lawyers at Saiontz & Kirk, P.A. have been investigating lawsuits against Boston Scientific on behalf of clients who received the Taxus drug eluting heart stent. Potential claims are also being evaluated and reviewed for individuals who received the Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, and suffered injuries as a result of the detachment of the tip of the carotid stent delivery system during the procedure.

If you, a friend or family member have suffered a stroke, vessel wall injury or additional surgical procedure to recover a detached stent tip, request a free consultation and claim evaluation.

The Wall Street Journal reports that a letter was sent by the FDA on August 30, warning Boston Scientific that they committed “serious violations” of federal regulations designed to ensure the safety of consumers,  The violations stem from a small study involving an abdominal aorta stent which the company later abandoned after it was discovered that a large number of the stents were fracturing, and at least five of those involved in the study died.

According to the FDA, two deaths which occurred on December 14, 2005 and December 8, 2006 were not reported to federal regulators in an adverse event listing provided to the agency on June 8, 2007.  The warning followed an inspection conducted between May 9 and May 16, 2007.  The inspection was performed to ensure that data and information provided by the company were valid and accurate, as well as to ensure that human subjects were protected from undue hazard.

The FDA called Boston Scientific’s attempts at corrective actions “inadequate” since their decision to provide a “refresher training course”  on adverse event reporting requirements for their project team did not address the underlying issue of ensuring timely follow up and evaluating adverse events.

>>LINK: Boston Scientific Warning Letter from FDA

The company has been in hot water with the FDA on at least two prior occasions in recent years.  In January 2007, a warning was issued due the company’s failure to properly report problems in their medical devices.  In addition, an earlier warning issued due to complaints of sloppy manufacturing was just lifted in April 2007 after the company addressed the problems.

BOSTON SCIENTIFIC STENT LAWSUITS

The heart stent lawyers at Saiontz & Kirk, P.A. are reviewing potential Boston Scientific lawsuits for individuals who had a Taxus Express Drug Eluting Stent implanted into a previously blocked artery, and subsequently suffered a heart attack, death or reclogging of the artery.  Recent studies have demonstrated that medicated stent problems increase the risk of potentially fatal blood clots which can develop years after the stent is implanted.

If you, a friend or family member experienced heart stent problems, request a free claim evaluation.

>>INFORMATION: Drug Coated Stent Problems

Researchers analyzed two years of data from 2,300 patients in 14 countries who received a bare metal stent or a drug coated stent.  During the first six months after the stent was implanted, data indicated that there was no difference between the result of the two groups.  However, between six months and two years, those with a drug coated stent were found to be 4.7 times more likely to die.

The data analyzed was obtained from a registry, which often provides important information about real world applications of medical treatments.  About 75% of the people included in the study had an older and less expensive bare metal stent implanted into a blocked artery, with 25% receiving one of the newer drug coated heart stents.  Despite the smaller number of people receiving a drug coated stent, researchers found that 49 of the people in that group died, compared to only 27 of those who received a bare metal stent.

Stents are small mesh tubes which are inserted into blocked arteries to prop them open and maintain blood flow to the heart.  A heart attack is a serious medical emergency which is the leading cause of death among both men and women throughout the world.  They occur when the blood supply to the heart is interrupted and in emergency rooms stents are often used to open blocked arteries following a heart attack.

Drug coated stents contain a medication which is designed to reduce the risk of scar tissue which can form inside the artery leading to a reclogging.  However, a much more serious problem which could be caused by the drug coating was identified about a year ago.  Drug coated stent problems increase the risk of potentially fatal blood clots which can form years after the stent is implanted, known as “late stent thrombosis”.  About half of those who are impacted by this problem are killed by the dangerous clots.

Prior studies which demonstrated that the use of drug coated stents increase the risk of heart attacks and death have focused primarily on non-emergency use of the devices.  Top experts have recommended that doctors should be very selective about the use of drug coated stents in an emergency setting following a heart attack.  It is expected that this data will further hurt the market for drug coated heart stents, which have already seen a drop in sales of about $1 billion over the past 12 months.

DRUG COATED STENT LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are investigating lawsuits for individuals who have experienced drug coated stent problems resulting in a heart attack or reclogging of the artery.  The manufacturers of the Taxus Express stent and Cordis Cypher stent have minimized the risk associated with their products to protect the revenues the devices generate.  As a result of the stent makers’ failure to act responsibly and provide accurate and complete warnings, thousands of individuals have suffered a heart attack or died after having a drug coated stent implanted into their artery.

If you, a friend or family member believe you may have a drug coated stent lawsuit, request a free consultation and claim evaluation.

>>REQUEST A DRUG COATED STENT CLAIM EVALUATION<<

>>INFORMATION: Drug eluting stent problems

Drug eluting stents were approved in the United States in 2003 and 2004.  They quickly grew to replace bare metal stents as the top treatment choice for blocked arteries, accounting for over 90% of all stents implanted.  By the end of 2006, over 6 million people worldwide had a drug coated stent placed inside of a previously clogged artery to prop it open, and approximately 130,000 stents were being implanted each month.

In October 2006, cardiologists began to question the safety of these newer stents, following studies which confirmed that they increase the risk of potentially fatal blood clots, which could lead to a heart attack or reclogging of the artery.  In the months that followed, many doctors turned back to bare metal stents and use of drug eluting stents fell.

Earlier this year, in March 2007, a study published in the New England Journal of Medicine further hurt stent sales, when researchers indicated that those with mild chest pains could safely delay implanting a stent to try treatment with drugs.  Other studies indicated that heart bypass surgery may produce better long-term results and be a better option for heart patients.

According to data released last month by Goodroe Healthcare Solutions, LLC, fewer heart stents were implanted in June 2007, than in any other month in 2006.  The Norcross, Georgia company surveyed 75 hospitals which implant heart stents, finding that all stent usage has fallen another 16% since January 2007.

Only two drug eluting stents are approved for sale in the United States, the Johnson & Johnson Cypher stent and the Boston Scientific Taxus Express stent.  The second quarter earning reports for both companies demonstrate a sharp decline in the use of the drug coated devices.

Boston Scientific reported a 42% drop in sales of the Taxus heart stent from the same period a year ago, and Johnson & Johnson reported a 41% drop in U.S. sales of it Cypher heart stent.  This data confirms the impact that several medical studies released late in 2006 had on stent sales.

DRUG ELUTING STENT LAWSUITS

Many heart patients who suffered a heart attack or reclogging of their artery as a result of drug eluting stent problems are pursing compensation from the manufacturers.  Millions received a medicated stent without being warned of the potential long-term risk of deadly blood clots.  The lawyers at Saiontz & Kirk, P.A. are continuing to review drug eluting stent lawsuits nationwide.

If you, a friend or family member suffered a heart attack or reclogging of the artery after receiving a drug eluting heart stent, request a free claim evaluation.

>>INFORMATION: Drug Eluting Stent Problems

Stents are tiny mesh scaffolds which are used to prop open clogged arteries.  They originally were introduced as bare metal devices which were permanently implanted into the artery.  The bare metal stents were shown to increase the risk of restenosis, or re-narrowing of the artery as a result of scar tissue caused by the stent.  To reduce the risk of this problem, drug eluting stents were introduced in 2003 and 2004, which placed a medicated coating on the metal to reduce scarring.  However, as a side effect of the medicated stents, heart patients have faced an increase in the risk of blood clots, which could lead to a heart attack or re-clogging of the artery.

Reports regarding the dangers of drug eluting stents began to surface in September 2006.  At that time, drug eluting stents accounted for nearly 90% of all stents used and generated annual sales of annual sales of about $5 billion.  Recently sales have fallen sharply as doctors and patients have considered *alternatives to stents, such as heart bypass surgery and medications.  Thousands of injured heart stent patients are pursuing lawsuits against the manufacturers for failing to warn about the risk of blood clots.

>>INFORMATION: Heart stent lawsuits

In the June 2 edition of The Lancet, a report indicates that new heart stents, known as a biodegradable or absorbable stents, could provide a future alternative to drug eluting stents.  They are designed to last long enough to open the blocked artery, and then slowly dissolve without leaving any permanent device behind. 

Researchers hope that biodegradable stents will eventually gain FDA approval and replace drug eluting stents as the first choice for treatment of blocked arteries in the United States.  However, there has only been limited testing in humans. 

The article published in The Lancet, focused on tests conducted by doctors in Germany and New Zealand involving absorbable heart stents made with magnesium.  The stents are designed to last approximately four months.  According to a one year study, which evaluated their use in 63 humans, not one of the participants had a blood clots form within the stent and there were no heart attacks or deaths.  However, about 45% of those in the study had to have their artery reopened within a year of the stent placement, with 24% requiring a reopening within four months.

DRUG ELUTING STENT LAWYERS

The lawyers at Saiontz & Kirk, P.A. are currently investigating heart stent lawsuits for individuals who suffered a heart attack or reclogging of the artery after receiving a drug-eluting stent.  If you, a friend or family member have been injured by a stents, request a free claim evaluation.  No fees are taken until recovery is obtained.

>>REQUEST A FREE CONSULTATION<<

>>INFORMATION: Heart stint lawsuits

Heart stents are used to open clogged arteries and restore blood flow.  In 2003 and 2004, drug eluting heart stents were approved, containing a medication which coats the tiny scaffolds to prevent the artery from becoming reblocked as a result of scar tissue, known as restenosis.  By 2006, DES stents accounted for 90% of all stent sales, generating $6 billion worldwide.

Late last year information was released about heart stent problems, which could result in an increased risk of potentially fatal blood clots that may form months or even years after the stent was implanted.  The manufacturers failed to properly warn of this heart stent risk, and researchers have been working to obtain a better understanding of the extent of the danger.

The Journal of the American Medical Association (JAMA) published two studies and an editorial this week, discussing the widespread use of medicated heart stents in patients with conditions which have not been tested or determined to be safe for stent use.  This “off-label” stent use involves people who are in the midst of a heart attack, have multiple blockages or other more complex and serious medical issues.

One of the stent studies involved 5,541 patients, and researchers found that the risk of death, heart attack or blood clots was doubled when used in patients with unapproved conditions or blockages.  The other stent study involved 3,323 patients and found that over 50% had at least one of the characteristics which should have ruled the patient out for stent use if following FDA guidelines.  Researchers found that those who did not meet the approved profile had higher rates of death, heart attacks and vessel revascularization (the need to retreat an artery which has been stented).  The heart stent problems occurred in nearly 11% of the off-label group, compared with 5% for the on-label group.

HEART STENT LAWSUITS

The drug eluting heart stent lawyers at Saiontz & Kirk, P.A. represent individuals who have died, suffered a heart attack or reclogging of the artery after receiving one of these devices.  If you, a friend or family member believe you may have a case, request a free claim evaluation to determine if compensation may be available.

>>CLICK HERE TO REQUEST A CLAIM EVALUATION<<

>>INFORMATION: Heart Stent Lawsuits

The manufacturers of drug coated stents, Johnson & Johnson and Boston Scientific, previously indicated that it would only be necessary for individuals to remain on Plavix for three to six months following stent placement.  However, they failed to properly research their product or warn about the heart stent problems which could lead to blood clots at the site of the stent months or even years later.  As a result, many doctors are now recommending that patients remain on Plavix for a long time to reduce the risk of injury in the future.

The long term use of Plavix can result in unpleasant side effects for users, as well as an increased risk of other injuries such as excessive bleeding, ulcers, gastrointestinal bleeding and a rare blood disorder known as TTP (Thrombotic Thrombocytopenic Purpora)

>>INFORMATION: Plavix side effects

LAWSUITS FOR HEART STENTS AND PLAVIX

For several months, Saiontz & Kirk, P.A. has been representing individuals who suffered a heart attack or reclogging of the artery after receiving a drug coated stent.  Our lawyers are now also reviewing potential claims for individuals who have not experienced a blood clot, but now must remain on Plavix long term.  To determine if you may have a potential claim, request a stent lawsuit consultation.

>>INFORMATION: Drug eluding stent problems

Drug eluting stents were designed to improve upon bare-metal stents by containing a drug coating which releases medication to prevent scar tissue from forming and blocking the artery.  However, studies have confirmed that the newer heart stents could actually cause fatal blood clots and heart attacks, or result in a reclogging of the artery. 

There are two medicated stents currently available in the United States, the Johnson & Johnson Cordis Cypher Stent and the Boston Scientific Taxus Express Stent.  After they were introduced in 2003 and 2004, the new stents quickly replaced bare-metal stents.  By early 2006, estimates indicate that drug eluting stints were used in 90% of all proceedures.  However, since studies have been released regarding the dangers of medicated stents, doctors have considered alternative treatments and are slowly moving away from the potentially dangerous devices.  According to recent estimates, drug coated stents now only account of 70% of all stents placed, and each month the number continues to fall.

DRUG COATED STENT ALTERNATIVES

There are several new stent studies which are raising further questions about the continued use of medicated stents over other alternatives.  Alternatives to drug coated stents include using older bare-metal stents, bypass surgery or medication to treat the blockage.

Next week, a stent study known as COURAGE will be presented at a meeting of the American College of Cardiology in New Orleans.  It is expected that this study comparing the benefits and dangers of stents during angioplasty to medications designed to reduce the risk of heart attacks and death could further hurt sales of medicated stents.  The study shows that there was no difference in terms of preventing heart attacks and deaths for the group of patients reviewed.  Experts will be closely evaluating the results of this study which will be presented Tuesday, March 27.

Three other studies and editorials will be published later this month raising questions about the clinical and cost effectiveness of stents when compared with bypass surgery.  The research suggests that minimally invasive bypass surgery may produce better long term results and may be a better option for some heart patients.

Many physicians are also considering bare-metal stents, which are considerably less expensive and do not require patients to remain on anti-clotting therapy for as long of a time after the placement.  Bare metal stents cost approximately $800 each, compared with about $2,000 a piece for medicated stints.  Given the long-term risk of blood clots, patients receiving drug eluding stents also require a medication to reduce clotting, such as Plavix.  However, Plavix requires patients spend another $1,500 a year for the drug, and could cause serious harm if it is stopped or taken inconsistently.  There are also concerns regarding Plavix side effects which could lead to gastrointestinal bleeding, ulcers and a blood disorder known as TTP (thrombotic thrombocytopenic purpura).

DRUG ELUTING STENT LAWSUITS

Many individuals who received a medicated stent since 2003 are angry over the manufacturers’ failure to properly study their product and warn about the problems which could increase their risk of death years after the procedure.  As a result of the stent makers’ actions, they not only face declining sales, but will also have to answer to drug eluting stint lawsuits which are being filed on behalf of individuals who suffered a heart attack or reclogging of the artery.

>>INFORMATION: Drug eluting stent lawsuits

The recent decline in use of medicated stents in favor of other alternatives demonstrates how important it is that medical product manufacturers properly warn of problems and side effects.  Information regarding the dangers of drug eluting stents clearly impacts the “risk – benefit analysis” which doctors and patients consider before deciding on a course of treatment.

The drug eluding stent lawyers at Saiontz & Kirk, P.A. represent those who were injured by these dangerous devices.  To determine if you, a friend or family member may be entitled to compensation, request a free claim evaluation.

>>INFORMATION: Drug Eluting Stent Dangers

Stents are small wire devices which are designed to be inserted into blocked arteries to prop them open and keep blood flowing.  Since last fall, a lot of national attention has been focused on the widespread overuse of drug eluting stents.  Research indicates that the devices carry a statistically significant increased risk of blood clots, which could lead to a re-blockage of the artery, a heart attack or death.

The heart stent problems could occur days, months or even years after the stents are placed.  Experts have estimated that approximately 2,000 deaths each year could have been caused by the use of drug eluting stents, and most cardiologists are now ensuring that the devices are only implanted into patients who meet the FDA approved profile.

Since drug coated stents were introduced in 2003, they have quickly grown to account for approximately 90% of all stents placed in the United States.  Some reports indicate that as few as 20% of all patients who received the devices met the approved profile.  As a result of the wide-spread overuse and concerns about stent risks, an FDA advisory panel recently stressed the importance that physicians only place the devices in patients who meet the published stent recommendations.

MARYLAND STENT MISTAKES

According to initial reports, a Maryland cardiologist, John R. McLean, M.D., performed at least 25 stent placements on patients who were well outside of the recommended guidelines.  While the American College of Cardiology recommends that patients have an artery that is at least 70% blocked, Dr. McLean inserted stents at the Maryland hospital in patients with blockages as low as 35 percent, which exposes them to unnecessary risk of stent problems.

At the time of the announcement, the hospital suggested that a “recently diagnosed” vision problem caused the doctor to misread 25 different patients’ diagnostic reports.  However, it appears more likely that a desire for profits was placed ahead of patient safety.

Hospitals, cardiologists and stent placement specialists have a financial incentive to recommend the use of medicated stents for treatment of partially blocked arteries instead of alternative therapies, such as medications.  Stents account for approximately $6 billion in sales each year, and hospitals charge around $10,000 to $15,000 per patient to implant them.

>>INFORMATION: Overuse of medicated stents

According to the Associated Press, Dr. McLean has not had any prior Maryland medical malpractice judgments filed against him in the last 10 years.  It remains to be seen what actions will be taken against the physician or Peninsula Regional Medical Center, but there could be administrative hearings, medical malpractice lawsuits or possibly even criminal fraud charges.

MEDICAL MALPRACTICE LAWYERS

The attorneys at Saiontz & Kirk, P.A. represents individuals who have suffered problems after receiving a drug eluting stent as well as those who were injured by medical mistakes.  While cases are investigated and pursued nationwide, our main offices are located in Maryland.  For more information about medical malpractice or drug eluting stent lawsuits, request a free consultation with one of our lawyers.

>>VIDEO: FDA Patient Safety Alert: Drug Eluding Stents

In December 2006, an FDA advisory panel was convened to discuss medicated stent concerns which have existed among cardiologists since recent studies indicated the small wire devices are associated with an increased risk of blood clots when compared with older bare metal stents.

>>INFORMATION: Drug eluting stent concerns

The FDA show indicates that the Cypher stent and Taxus stent were approved because they may reduce the rate of re-clogging of the arteries, known as vessel restenosis.  However, problems caused by the medicated coating actually increases the risk of potentially fatal blood clots, which many believe is a much greater concern than restenosis.

The increased risk of blood clots in drug eluding stints could continue for several years after the device is placed in the artery.  Therefore, the FDA panel emphasized the importance of patients remaining on antiplatelet medications for at least twelve months after the surgery, despite the fact that prior recommendations by the stent makers was for patients to remain on three to six months of anti-clotting therapy.

For many patients who have received the devices, their biggest concern about drug coated stents is why the manufacturers failed to warn of the dangers associated with their product.  Had the problems been disclosed, physicians may have recommended alternate treatment such as bypass surgery, medication or bare metal stents.

Now that safety concerns are known, experts are stressing that physicians should only implant the stints for clinically stable patients and in patients who are able to stay on antiplatelet therapy for a long time.  Before the safety concerns surrounding drug coated stents were disclosed, the vast majority of all stents implanted were “off-label”, for more complex conditions, which increases the risk of blood clots further.  In addition, many patients who received the stents were not properly educated about the importance of continuing long-term antiplatelet therapy, which could reduce the risk of potentially fatal injuries.

DRUG ELUTING STENT LEGAL RIGHTS

Individuals who received a medicated stent and suffered a blood clot, reclogging of the artery or heart attack, may be entitled to financial compensation as a result of the manufacturer’s failure to warn of the stent problems.  The drug eluting stent lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have been injured.  To protect your family’s rights, request a free stent lawsuit claim evaluation.