The Bitter Pill

The Official Blog of UNITE –

More Scrutiny of Stenting for Profit Industry

Evelyn Pringle August 2007

The stenting for profit industry hit a major snag on March 1, 2007, when the US House Oversight and Government Reform Committee, ordered Johnson & Johnson and Boston Scientific to turn over documents related to their sales and marketing activities for drug-eluting stents.

Drug-eluting stents (DES) are mesh tubes used in patients with heart disease to keep arteries open after a procedures called angioplasty to remove blockage. The new drug-eluding stents were developed to address the problem of restenosis, which prevents renarrowing of the artery. The relative benefits of DES when compared to bare metal stents was supposed to be a reduction of death, heart attack and vessel revascularization.

“Since the new DES arrived on the market, stenting has evolved into a multi-billion dollar industry for the stent makers and doctors and hospitals alike. According to the May 17, 2007 Wall Street Journal, “Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees.”

Both J&J and Boston have received letters from Committee Chairman, Henry Waxman (D-CA), requesting documents to include correspondence with the FDA. The Committee also wants to know whether the companies used marketing funds to conduct clinical trials and how much researchers were paid and seeks information related to any adverse events revealed in the pre-approval clinical trials, as well as in post-approval use of the products.

In May 2007, after J&J announced that it would withdraw the Conor Medsystem’s heart stent from the Indian market after the device failed to complete clinical trials in the US, the Drug Controller General of India raided the company’s distributor’s office in New Delhi and seized all existing stock of the heart stent, India’s drug controller general M Venkateswarlu told the Economic Times on May 10, 2007.

The exact number of Conor stents currently on the market was still being assessed but the Times reports that thousands of patients in India could be at risk because an estimated 8,000 Indian patients have be implanted with the device.

Also the recent “Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE),”study published online on March 26, 2007, by the New England Journal of Medicine showed patients who received stents fared no better than patients who did not.

For the study, led by Dr William Boden of Buffalo General Hospital in New York, half of the roughly 2,300 patients underwent stenting procedures, took heart drugs, and were counseled to make lifestyle changes, such as losing weight, exercising, and giving up smoking and the other half received only lifestyle counseling and drugs to lower cholesterol, relax blood vessels, slow heart rate, and prevent blood clots. After an average of four and a half years, the study found a similar rate of death, heart attack, and stroke in both groups.

In an editorial accompanying the NEJM study, Dr Judith Hochman and Dr Gabriel Steg wrote: “The COURAGE trial should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings.”

Experts note that there are massive profits at stake. In 2006 alone, combined J&J and Boston earned $3 billion from the devices. On December 4, 2006, Bloomberg News reported that in 2005, the new stents accounted for 52% of total sales for J&J and 43% for Boston.

In July 2007, the stent makers announced their second-quarter earnings and J&J revealed that sales of the Cypher in the US have dropped 41% from this time last year, while Boston released sales figures for its Taxus showing a drop of 42%.

In December 2006, an FDA Advisory Panel determined that off-label use, or using a stent for a purpose outside the device’s approved label, is associated with an increased risk of stent thrombosis, death or heart attack compared to approved uses.

Some examples of off-label stenting include use in previously stented patients, patients with diabetes, patients who have stents placed immediately after a heart attack or patients who have stents placed in two arteries which branch off from each other.

Experts say that in the majority of cases the devices are being implanted in patients who could potentially be harmed. According to the FDA, over 60% of DES are being implanted in patients with more complex heart problems than the conditions for which the devices were approved.

With a priced tag of $10,000 to $38,000, as many as 85% of the stenting procedures are non-emergency and are being performed on people with only partially blocked arteries for the relief of recurrent chest pain, according to March 23, 2007 Associated Press.

The first DES was approved in April 2003, and by December 2006, at a hearing on the “Prospective on Drug eluting Stents: Balancing Risks and Benefits,” the Advisory Panel reported that 3 out of 5 implants were for unapproved uses.

Dr Ron Waksman presented the results for Contemporary Registries of Washington Hospital Center and reported that the rates of stent thrombosis were almost doubled in cases of off-label use compared to on-label use at 30 days and at 12 months.

He also said that in general, when they looked at on-label and off-label use, “the drug eluting stents are more thrombogenic than bare-metal stents.”

For both on-label and off-label use, Dr Waksman said, “over time, late stent thrombosis is seen more in the DES versus the bare-metal stents.”

Dr Peter Smith of Duke University told the panel that stenting is being performed on patients with high severity coronary problems such as 3 vessel disease who should be undergoing coronary bypass grafting surgery.

He presented data that showed in these types of cases, 1 out of every 20 patients who died after treatment with stenting would have survived if coronary bypass grafting would have occurred and that DES use in patients with 3 vessel disease results in about 3,600 premature deaths annually in the US.

In the end, the panel did recommend that a warning be added to the DES labels stating that off-label use may increase the risk of thrombosis, myocardial infarction, and death, and several members recommended that a black box warning be added. However, Dr Brian Zuckerman, director of the FDA’s division of cardiovascular devices, quickly quashed that idea, saying there would be no black box warning, according to MedPage Today on December 8, 2006.

But as usual, investigations have shown that the FDA was aware of the DES problems for years. Within 6 months of the approval of the first DES, the FDA had already identified 50 cases of allergic reactions and agency records show that a few months after the Cypher arrived on the market, the FDA received a cluster of sub-acute thrombosis reports and the FDA and J&J issued a letter notifying doctors of the initial reports in July 2003.

The Tarus was launched in March 2004, and on July 16, 2004, Boston announced a major recall of 85,000 of the devices after a death and serious injuries were linked to the DES, just two weeks after 200 were recalled following reports of malfunctions during implant procedures. At the time of the announcement, the company also said that it was recalling 11,000 bare metal stent systems, which the FDA found to be linked to two deaths and 25 serious injuries.

Two years later on October 23, 2006, Bloomberg reported that 2.9% of DES patients could develop clots within three years and said, “More than 4 million people have received such stents since 2001, which means clotting related to drug-coated devices may have caused as many as 20,000 heart attacks and 10,000 deaths worldwide.”

The American College of Cardiology posted an editorial online by Dr Sanjay Kaul, director of the cardiology fellowship training program at Cedars-Sinai Medical Center and a colleague on October 11, 2006, that warned that blood clots in drug-coated stents may be causing an extra 2,160 deaths in the US alone each year.

The next month, on November 29, 2006 analysis by researchers at the Cleveland Clinic found the risk of blood clots was increased as much as 5-fold in patients who receive drug-coated stents compared to patients implanted with the old bare-metal stents.

“There are hundreds of thousands of Americans who are currently getting stents placed who do not need it as initial therapy,” according to Dr Raymond Gibbons, professor of medicine at the Mayo Medical School and president of the American Heart Association, in a United Press International article.

In the March 28, 2007, Wall Street Journal Health Blog, Dr Andy Demajio wrote, “It has been distressing to see how interventional cardiologists have been happily stenting their patients to fatten their wallets.”

“This immoral practice should come to a stop,” he wrote. In May 2007, the Medicare Strike Force reported that one cardiologist had implanted 25 unnecessary stents in 2006 alone, with most procedures paid for by Medicare.

Legal experts are predicting that future lawsuits filed against Boston and J&J may well include the names of cardiologists and hospitals that helped turn the stenting for profit business into a billion dollar industry. Being there is no way to reverse the stenting procedure, patients face a life-time of worry because a blot clot in a stent can cause a stroke or heart attack without warning at any time.

Lawsuits against the stent makers continue to mount. On December 6, 2007, 46-year-old Sean O’Shea, a man who had five stents implanted, announced a lawsuit against J&J, alleging the company failed to warn him about potential blood clotting complications associated with the stents.

“Had I known there would have been this many complications,” he said in a news conference, “I would have chosen other options.”

On July 30, 2007, the Zimmerman Reed law firm announced the filing of a lawsuit against J&J by a Minnesota man who suffered a heart attack as a result of a blood clot at the site of his Cypher implant. According to the press release, it is estimated that over 50,000 patients have been implanted with the Cypher stent.

Filed under: 2007, Boston Scientific, FDA, Fraud, Johnson and Johnson, medical devices, stents

Boston Scientific Hit With Three new Guidant Lawsuits Per Day

Evelyn Pringle May 16, 2007

On March 2, 2007, the Boston Globe reported that since June 2005, Guidant, which was acquired by Boston Scientific early last year, has issued safety warnings or recalls for more than 88,000 defibrillators and 200,000 pacemakers.

At the time of purchase, the deal seemed solid for Boston because the Indianapolis-based Guidant was the second-largest manufacturer of implantable defibrillators. However, according to Boston’s first quarter March 2007 SEC filing, the company is now facing over 75 class action lawsuits and 1,100 individual lawsuits involving Guidant defibrillators and pacemakers, up from 842 lawsuits listed in the company’s November 2006 filing.

The Globe also reported that new lawsuits against the company are being filed at a rate of 3 per day. But medical experts say this is just the tip of the iceberg because many surviving family members will probably never know that a patient’s death was caused by Guidant’s defective products because heart devices are rarely evaluated to determine whether the unit was functioning correctly at the time of death.

According to analyst estimates cited by the Globe, Guidant related liabilities could reach $2 billion and since Boston acquired the firm in April 2006, Boston stock value has dropped about 29%.

As of December 31, 2006, according to SEC filings, Boston has set aside $485 million for legal matters, which represents a $100 million increase from the $384 million reported in September 2006 SEC filings.

Critic say the worst part of the Guidant debacle is that evidence is emerging that shows patients were implanted with defibrillators for profit and not need and the cost of a defibrillator can be as high as $35,000.

The January 2007, Journal of the American College of Cardiology, reported a study that found that as many as one third of defibrillators implanted in 768 patients between March 2001 and June 2004 for irregular heartbeats were unnecessary and therefore, up to a third of the patients received minimal benefits from the device.

In addition, documents have surfaced in litigation that show Guidant knew for years that the devices it was selling were flawed. A report by an independent panel appointed to review Guidant recalls was released in March 2006, and said the firm allowed about 4,000 potentially defective defibrillators to be implanted after the company learned of the malfunction in 2002.

Guidant executives tried to defend their actions by claiming the devices met all engineering projections and that notifying doctors about the flaw might have resulted in more harm than good by causing unnecessary surgery to replace the devices.

But the panel soundly rejected those arguments and concluded that defects need to be disclosed promptly, even when they occur in small numbers. “The Independent Panel believes,” it wrote, “that under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains with general guidelines.”

By the time of that report, at least 7 patients had died because their defibrillators had failed to work due to an electrical defect.

Lawsuits filed by two Corpus Christi, Texas residents who had defibrillators implanted in 2001, alleged that Guidant officials “actively concealed the … defect, suppressed reports, failed to follow through on FDA notification requirements, and failed to disclose a known defect to patients. Instead of revealing the defect, defendants continued to represent their product as safe for intended use, and continued to sell the flawed [devices] despite knowing of the dangers.”

The plaintiffs further allege they have suffered extreme mental anguish from knowing that the defective devices could malfunction at any time.

Legal experts say if plaintiffs can prove that Guidant knew about the problem with the defibrillators and continued to sell the devices, the plaintiffs would be entitled to punitive damages because Guidant has a documented history of knowingly selling defective products and the firm had promised not to do so in the future the last time the company was busted.

In 2003, a former Guidant subsidiary was fined $92 million by the US Department of Justice for concealing serious adverse events, including 12 deaths, related to its abdominal aortic grafts. At that time, as part of its settlement agreement with the DOJ, Guidant pledged to “verify and make sure their reporting procedures were in order, and that they were reporting adverse events for their devices.”

On February 23, 2006, the Associated Press reported that the FDA, US Department of Justice, the Securities and Exchange Commission and several state agencies were investigating Guidant over its recalls. In addition the AP advised that, “Guidant’s St. Paul facility has been the focus of the federal investigations and inquiries into the company’s manufacturing process.”

The DOJ jumped into the current controversy on January 28, 2006, and sent out a press release, when the US Attorney in Minneapolis issued a subpoena seeking the records that were disclosed in the Texas lawsuit that showed the company knew that the defibrillators could fail. Some of the specific documents requested evidence that Guidant executives had discussed whether they should warn doctors that some of the devices could short-circuit and decided against it.

More specifically, the DOJ noted, the documents include notes from Fred McCoy, president of Guidant’s cardiac rhythm management division, that show a decision was made to sell inventory described by the executives as having sporadic ”life-threatening” defects. The DOJ merged its investigation with an investigation already underway by the FDA’s Office of Criminal Investigation.

Experts say product liability lawsuits such as those Guidant is facing have considerable financial implications for a company and failure to notify the public about device flaws can have a more devastating impact on a firm’s financial future than the notification itself.

“Company management should fear the prospect of being accused of deliberately refraining from physician disclosure in order to maintain a high market share that would enhance management’s financial interests,” says Genese Kay Dopson, special counsel at Sedgwick, Detert, Moran & Arnold LLP, in the May/June 2006, Medical Device Link.

“For example, in Guidant’s case,” she explains, “the aftermath of physician notification resulted in the decrease in the value of Guidant’s stock.”

“As a result,” she noted, “a company that was in negotiations to acquire Guidant prior to the physician disclosure negotiated a lower bid as a result of the decrease in stock value.”

“Shareholders have also initiated suits against Guidant for fraud,” she said.

“I think the company is potentially more damned,” she states, “if it does not make the physician disclosure.”

According to Ms Dopson, in product liability cases companies must be able to put forth a defense that demonstrates a commitment to patient safety. “Failure to adhere to the primacy of patient safety,” she says, “coupled with decisions leading to concealment of known defects from the medical community, will fuel lawsuits that lead to jury verdicts that include punitive damages.”

In December 2005, the FDA issued a warning letter to Guidant after inspectors found numerous problems with quality control and record-keeping procedures at the St Paul plant where the defibrillators were manufactured which meant that until the issues were resolved, the FDA would not approve any new Guidant products.

On April 17, 2007, the Boston Globe reported that the FDA had finally lifted the warning letter that had been hanging over Guidant, freeing up the company to introduce products that had been blocked by the quality-control problems.

On April 10, 2007, the FDA said a December 2006 inspection of Guidant indicated that the issues appeared to have been adequately addressed.

However, the good news was likely overshadowed by the FDA’s April 12, 2007, announcement of a recall of approximately 73,000 more defibrillators because of faulty capacitors. “The capacitors,” the FDA said, “may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months.”

The FDA instructed patients implanted with one of the recalled devices to contact their healthcare provider regarding the steps to take.

Aside from inheriting Guidant’s woes, Boston has major issues pending with the FDA of its own making. On January 26, 2006, Boston received a corporate warning letter from the FDA, notifying the company of serious regulatory problems at 3 facilities and advising Boston that the corrective action plan relating to 3 site-specific warning letters issued to the firm in 2005 was inadequate, according to Boston’s SEC filings.

The FDA warning letter sent on May 18, 2005, about quality-control standards said Boston failed to establish manufacturing controls for the quality of devices and did not properly track quality concerns.

On January 26, 2006, the Associated Press reported that FDA officials said that this was only the third time in the agency’s history that it had issued such a broad companywide warning involving a device maker’s systems to identify potentially defective and unsafe products

According to the AP, the problems identified during inspections involved the company’s headquarters and facilities in Maple Grove, Minn, and Spencer, IN, and also cited continuing problems at sites in Watertown, Mass; Glens Falls, NY, and Quincy, Mass.

On April 17, 2007, the Boston Globe, reported that the companywide warning letter that Boston received in January 2006 is still in effect and applies to Boston’s “drug-coated stent business and the rest of the pre-Guidant areas of the company.”

Company executives told the Globe that they did not expect the issues to be resolved until the second half of 2007. “Until then,” the Globe reports, “the company will be prevented from receiving agency approval of any new models of drug-coated stents.”

Filed under: 2007, Boston Scientific, DOJ, Guidant, medical devices, stents

Drug Eluting Stent Patients Beware

Evelyn Pringle January 24, 2007

Drug eluting stents were promoted as working so much better than the old bare metal stents that 6 million people worldwide have received them in the few years since the arrived on the market.

“It was a modern record for any medical device,” the Boston Globe reported on December 4, 2006. Some 2 to 3 million people in the US now carry one of these devices in an artery, according to FDA estimates, with new implants topping 900,000 per year.

Only two brands of DES are sold in the US, the Taxus, by Boston Scientific, and the Cypher, by Johnson & Johnson’s Cordis Division.

The trials submitted by the DES makers to obtain FDA approval for use in limited procedures with non-complex patients with single-vessel heart disease, involved a low risk population. However, off-label DES use for procedures not approved by the FDA has become rampant and according to the agency:

“It is estimated that a majority of DES are implanted in lesions outside of their current indications for use, such as in-stent restenosis lesions, bifurcation lesions, coronary artery bypass grafts, acute myocardial infarction, chronic total occlusions, overlapping and multiple stents per vessel and in patients with multivessel disease and chronic renal insufficiency.”

Surgeons have been implanting the new devices in every kind of heart patient. And for good reason. The stenting business represents maga bucks to device makers, hospitals and surgeons alike. In the US, the implant procedure itself costs $38,203, according to a report by the Associated Press on December 26, 2006.

But as has been the case with so many pharmaceutical products in recent years, after being massively promoted, and implanted in millions of patients for indications not approved, DES are proving to be no better than the bare metal stents, and in fact research has shown them to worse because they come with more adverse reactions.

In early December 2006, the FDA’s Circulatory System Devices Advisory Committee held a public meeting to review data on thrombosis both when DES were used according to their label and when they are implanted off-label for unapproved uses, and to address the appropriate duration for the use of the blood-thinning drug, Plavix, with DES patients.

In the briefing provided to the Committee before the hearing, the FDA informed the panel that recent presentations at scientific meetings had indicated a small but significant increase in the rates of death or myocardial infarction, and non-cardiac mortality, in DES patients when compared to patients who received bare metal stents.

The briefing included a specific discussion of presentations made at the Transcatheter Cardiovascular Therapeutics meeting, in October 2006, where doctors, Martin Leon and Gregg Stone, presented a meta-analyses of patient data from the Cypher and Taxus clinical trails.

Based on these analyses, Dr Stuart Pocock reported that after one year, five Cypher patients, compared to no bare metal patients, had experienced late thrombosis, and with the Taxus, thrombosis occurred in nine patients after one year compared with two bare metal stent patients.

Last year, the Swiss government commissioned a study to determine whether the DES were worth their price of between $2,200 and $2,700, when compared to the $600 to $800 for bare metal stents, and also to test how long Plavix should be prescribed to patients after the implantation of a DES to prevent blood clots from developing.

The study appeared in the December 19, 2006, Journal of the American College of Cardiology, and reported that patients with DES had double the risk of cardiac problems after stopping Plavix compared to patients with bare metal stents.

The Swiss researchers, led by Dr Matthias Pfisterer, found that when patients stop taking Plavix, they had a small but serious risk of blood clots leading to death or heart attack.

The lead author noted that the majority of DES implants in the study were off-label. “About two-thirds of our patients were really treated with off-label use of drug-eluting stents,” Dr Pfisterer told WebMD on December 5, 2006.

“The FDA label says these are only for stable patients with limited disease,” he notes. “But, in fact,” he told WebMD, “most doctors who use drug-eluting stents use them in unstable patients and in more complex disease.”

In an editorial accompanying the Pfisterer study, Dr Robert Califf and Dr Robert Harrington, warned that research on DES has not kept up with clinical realities. “As is frequently seen with new cardiac devices,” they wrote, “rapid increase in clinical adoption quickly outstripped what is known about the device from limited clinical trials.”

Medical professionals say an important point to keep in mind when considering the risks associated with the DES is that these devices have only been on the market in the US for less than four years and that many more unknown risks could surface in years to come.

More problems may have already surfaced according to Dr Joseph Muhlestein, a professor at the University of Utah. He told ABC New’s Healthday reporter on December 4, 2006, that his research group has followed patients receiving DES implants very carefully and has found “something we don’t understand.”

As expected, he said, the DES did reduce artery closure at the site where they were implanted, but the incidence of artery problems at other sites occurred “significantly more often than when we used bare-metal stents,” he told Healthday.

So, the overall incidence of artery problems ended up being the same, regardless of which type of stent was implanted, Dr Muhlestein said.

It is possible that the problem occurred because DES were used on more high-risk patients, he noted. But it’s also possible, he said, that the DES interfered with the endothelium, the delicate tissue that lines the arteries.

These doubts have caused some doctors to cut back on DES use. “We used to use them in 90 percent of cases,” Dr Muhlestein told Healthday. “Now, it’s about 40 percent.”

Finally, experts are warning that if unexpected health problems do develop in patients already implanted with the DES, removal of the stent is not possible because once it is placed in the body, the tissue in the artery grows over the stent.

Filed under: 2007, Boston Scientific, FDA, FDA hearing, Johnson and Johnson, Plavix, prices, stents, stroke

Guidant Settles Three Lawsuits – 549 To Go

Evelyn Pringle October 2, 2006

Attorneys for the plaintiffs in lawsuits against Guidant and its new owner, Boston Scientific, view the settlement of a Texas case days before a jury trial as a sign that the company is dodging the courtroom.

Guidant settled the case for an undisclosed amount with two plaintiffs avoiding a public trial set to begin on September 18, 2006.

Boston Scientific acquired Guidant’s heart device business in April 2006, following a year of major recalls of products that have resulted in hundreds of lawsuits against Guidant.

The settled case was to be the first state court jury trial and was scheduled to be heard in Neuces County District Court in Corpus Christi, Texas before Judge Jack Hunter.

Guidant Defibrillator lawsuitThe two plaintiffs, Bernice Hinojosa and Louis Motal, were implanted with Guidant’s Ventak Prizm 2 defibrillators in 2001, and alleged that Guidant continued to sell the defective devices for 3 years and “actively concealed the … defect, suppressed reports, failed to follow through on FDA notification requirements, and failed to disclose a known defect to patients.”

There was one earlier settlement of a case in November 2005, with the family of Joshua Oukrop, a college student who died while using a defective defibrillator, and who’s death helped force Guidant to acknowledge and recall the defects products.

When the student died suddenly, his doctors tried to get Guidant to warn doctors about the defective devices and when it refused, they went to the New York Times which in turn conducted its own an investigation. The first Guidant recall, was issued only days before the results of the Time’s investigation were set to become public.

With the settlements of these cases, it means the company has 3 down and roughly 549 lawsuits to go. According to Boston’s second quarter SEC filing, there are about 72 pending class-action lawsuits and about 477 individual lawsuits filed against Guidant in state and federal courts. The company’s first quarter filing three months earlier listed 300 individual cases.

As of June 30, Boston said in the filing, it has accrued $381 million “for legal matters that are probable and estimable.” At the end of 2005, Boston listed $35 million as set aside.

Overall, Boston’s stock has sunk to a 4-year low due to the downturn in its heart device markets, “as the firm confronts $9 billion in debt and legal liability from Guidant product recalls,” according to the September 27, 2006, Boston Globe.

Legal analysts say the Texas case was likely settled because the state trial would have publicized damaging information months before the other trials are scheduled to begin in March 2007.

According to Lawyers Weekly USA, the lead counsel for the Texas plaintiffs, Robert Hilliard, said documents obtained during discovery show that Guidant knew about the defects with certain devices as far back as April 2002, but failed to alert patients and doctors for 3 more years.

However, its unlikely that settling the case will stop the public disclosure of those documents because on January 28, 2006, the New York Times reported that Federal prosecutors had “opened a new front in their investigation into the Guidant Corporation by issuing a subpoena seeking records disclosed in a Texas lawsuit that indicate the company knew that some heart devices could catastrophically fail.”

The subpoena served on the plaintiff’s attorney, specifically sought internal company documents disclosed in the Texas case. “Among other things,” the Times wrote, “the records indicate that company executives debated whether to warn doctors that some heart defibrillators could short-circuit.”

“The records suggest,” it said, “that Guidant might have sold potentially flawed devices.”

The document request also indicates that federal prosecutors have merged their inquiry with an earlier investigation by the FDA’s Office of Criminal Investigations, the Times reported.

According to the Associated Press on January 28, 2006, the 10 pages of documents include notes from then Guidant president of the cardiac rhythm management division, Fred McCoy, that show that a decision was made to go ahead and sell the inventory that Mr McCoy described as having sporadic ”life-threatening” defects.

Legal experts consulted by the Times, said the broad range of the statutes cited indicate a serious investigation and could mean Guidant may face civil or criminal charges. “They are investigating in the broadest possible way,” said Joan Krause, a director of the Health Law and Policy Institute at the University of Houston.

“They are looking at potential fraud involving government plans,” she noted, “like Medicare, private health plans and employee benefit plans.”

In addition to all its troubles with the FDA and Federal prosecutors, Guidant is also being investigated by attorneys general on behalf of 34 states, according to the January 30, 2006 issue of Lawyers Weekly USA.

Most of the Federal civil lawsuits have been transferred under multi-district litigation rules to a US District Court in Minnesota, where Guidant has several manufacturing facilities, with the first federal trial scheduled to begin on March 15, 2007.

Ted Meadows, a plaintiffs’ attorney with Beasley Allen law firm in Montgomery, Alabama, who specializes in medical device litigation, says a key to the plaintiffs’ claims will be to show that Guidant “knew or should have known there was a potential for this problem.”

Any evidence that suggests the company knew about the problem and responded improperly, he says, would entitle plaintiffs to seek punitive damages.

In 2003, a former Guidant subsidiary was fined $92 million by the Department of Justice for not disclosing serious health problems, including 12 deaths, related to its abdominal aortic grafts. According to Mr Meadows, as part of its agreement, Guidant pledged to “verify and make sure their reporting procedures were in order, and that they were reporting adverse events for their devices.”

If it can be shown that the company failed to promptly disclose problems with its heart devices, he said, “This could become an important part of evidence in this case.”

“Part of the allegation we’re making is that they did not tell the healthcare community in a timely manner,” he said.

The stakes got higher for Boston last month when according to Bloomberg News the plaintiffs in the MSL in Minnesota, filed a motion with the court to officially add Boston as a defendant in all the individual lawsuits in light of its purchase of Guidant. The motion also mentions the more recent problems with defective products since Boston took control of the company, including a June 2006 recall of thousands of devices because of a capacitor problem.

Its unlikely that Boston ever imagined the nightmare ahead when it set out to purchase Guidant. By all accounts when the bidding began, Guidant’s heart device division seemed like a gold mine.

According to the February 28, 2006 New York Times, it accounted for about half of the company’s $3.8 billion in sales in 2004. Defibrillators, which cost up to $35,000 each, the Times said, have a profit margin of about 75 percent.

However, that was then and this is now because the number of defibrillators implanted in the US in the last 12 months dropped 8%, according to the Prudential Equity Group, after a decade when implants rose from 21,000 in 1995 to 250,000 in 2005. Analysts blame the downfall on the highly publicized recalls over the past year.

The market for pacemakers seemed equally lucrative until last year. According to the American Heart Association, pacemaker procedures went from under 50,000 in 1979 to more than 200,000 in 2003. In 2004 alone there were about 150,000 devices implanted worldwide, and the market had continued to grow at a steady pace.

However, according to the Associated Press on September 29, 2006, after all the bad publicity about recalls, consumer confidence has now gotten so bad that the FDA “is considering not using the word “recall” to warn patients and doctors about defective pacemakers and defibrillators at the request of a physicians’ group struggling to deal with a loss of public confidence in the safety of implantable heart devices.”

“It’s a terrible term,” Dwight Reynolds, president of the Heart Rhythm Society, an association of doctors who implant the devices told the AP. “The anxiety created among patients and physicians by this term is the No. 1 cause for replacement of devices.”

According to Mr Reynolds, patients who learn they have a faulty device assume they need to have it removed immediately, even though the surgery to replace the device often involves more risk than leaving it in.

The Heart Rhythm Society is asking the FDA to use “safety advisory” or “safety alert” when referring to device problems.

Boston sparked a bidding war in December 2005 that derailed a deal for J&J to purchase Guidant for a little over $24 billion. In January 2006, Boston offered a $27.2 billion bid and won the prize.

However, according to Dow Jones newswire on September 27, 2006, J&J has now filed a multi-billion dollar lawsuit against Boston and Abbott Laboratories, claiming the companies induced Guidant to breach its merger agreement with J&J.

In a complaint filed in a New York US district court, J&J accuses Boston of leaking “confidential” information to Abbott “for the purpose of arranging a prepackaged divestiture of significant Guidant business to Abbott.”

The lawsuit also alleges that that as a result of the disclosure, Abbott agreed to acquire Guidant’s coronary stent business and provide financing for the deal.

J&J is seeking $5.5 billion in general and special damages for the alleged breach of contract. J&J has already received a $705 million termination fee stipulated under its failed agreement with Guidant, but the company maintains it is still entitled to damages due to the breach. The lawsuit also asks for reimbursement of court costs, attorney fees and interest.

Under the merger deal, according to Dow Jones, Abbott agreed to buy Guidant’s stent and vascular business for $4.1 billion, in order to make the deal more acceptable to anti-trust regulators, and agreed to loan Boston $900 million and buy $1.4 billion in company stock.

In the meantime, both J&J and Boston’s drug-coated stent sales are suffering due to recent research that showed the devices increase the risk of blood clots, when compared to the older bare metal stents that are not drug-coated.

And Boston had better set aside a few hundred million more for its legal defense fund because more heart device lawsuits are filed every month. For instance, in mid-September, an Illinois woman filed a 40-count personal injury lawsuit against both Guidant and Boston with claims that a defective pacemaker required her to be hospitalized, according to the September 19, 2006 Madison St Clair Record.

According to the lawsuit, because Boston acquired Guidant and its subsidiaries in January 2006, it assumed Guidant’s liabilities in this litigation.

The plaintiff claims the pacemaker was not of “merchantable” quality and not safe or fit for its intended use because it was unreasonably dangerous.

She also alleges that, “Defendants actively concealed the defect and its wrongful conduct in order to prevent, and succeeded in preventing, adverse publicity and Plaintiff from discovering the defect.”

In the lawsuit, the plaintiff is seeking damages for pain, suffering, mental anguish, emotional distress, loss of capacity to enjoy life, lost past and future income and incurred expenses.

According to the May-June 2006, Medical Device Link, in addition to the legal and regulatory weight of the lawsuits against Guidant, the cases also involve ethical considerations related to patient and physician notification. And when presented before juries of laypersons, MX says, such considerations could have genuine sway over the people determining Guidant’s fate.

“Once in a courtroom, in the context of a plaintiff who has been injured by the drug or device in question, the jury examines the manufacturer’s actions with hindsight,” experts at Vetter & White told MX. “It is then often more difficult to argue that additional steps should not have been taken.”

The evidence on this point does not look good for Guidant. On June 22, 2006, the Indy Star reported that a Guidant defibrillator failed 10 times more often than the company projected at the time of the recall, citing a FDA document.

The document, unsealed in the Texas lawsuit, was written by FDA staffers one day before Guidant began recalling the devices.

At the time, Guidant said no more than 292 of the Contak Renewal units were likely to break down, but the FDA document shows the agency projected thousands of malfunctions within five years.

Filed under: 2006, Boston Scientific, Guidant, Johnson and Johnson, medical devices, stents

Boston Scientific and Guidant Off to Texas Slaughterhouse

Evelyn Pringle September 6, 2006

The first, but by no means the last, Guidant trial is scheduled to begin on September 18, 2006, in Neuces County District Court in Corpus Christi, Texas before Judge Jack Hunter.

The two plaintiffs, Louis Motal, 63, and Bernice Hinojosa, 65, are surviving patients implanted with Guidant’s Ventak Prizm 2 defibrillators in 2001. The lawsuit claims that Guidant “actively concealed the … defect, suppressed reports, failed to follow through on FDA notification requirements, and failed to disclose a known defect to patients.”

“Instead of revealing the defect,” the plaintiffs allege, “defendants continued to represent their product as safe for intended use, and continued to sell the flawed [devices] despite knowing of the dangers.”

Both plaintiffs claim they suffered extreme mental anguish from knowing that the defective devices could malfunction at any time.

According to the company’s latest tally, there are about 72 class-action lawsuits and about 477 individual lawsuits filed against Guidant in various state and federal courts, Boston Scientific reported in its second quarterly report filed with the SEC. The latter number is up from about 300 cases noted in the firm’s first quarterly report filed three months earlier.

As of April 2006, Boston became the proud owner of Guidant after winning a bidding battle with Johnson and Johnson, in what will certainly not go down in history as the deal of the century.

In addition to all the lawsuit already filed, according to Boston latest SEC filing, there are more than 3,300 claims of individuals that may or may not be filed, up from 3,000 claims in the earlier report.

The lawsuits all relate to defective defibrillators and pacemakers. Defibrillators are $30,000 devices that are wired directly to the heart and send electric shocks when abnormal heart rhythms are detected and pacemakers speed up hearts that beat too slowly, and cost between $4,000 and $20,000 for each unit, according to Bloomberg News on June 26, 2006.

According to Boston report, “the majority of claimants allege no physical injury, but are suing for medical monitoring and anxiety.”

The numbers have really grown compared to Guidant’s regulatory filing with the SEC on February 22, 2006, that predicted as many as 2,500 patients may seek damages. Those claims are distinct, Guidant noted in the filing, from the claims already filed by patients in 211 individual and class action lawsuits in the US and Canada.

And the potentially bleak future of Boston does not hinge entirely on what happens in civil lawsuits. Back on February 23, 2006, the Associated Press reported that the FDA, US Department of Justice, the Securities and Exchange Commission and several state agencies are investigating Guidant over its recalls.

The company is in fact being investigated by three attorneys general on behalf of 34 states, according to the article, Litigation Mounts Over Guidant Heart Devices, in Lawyers Weekly USA, on January 30, 2006.

“In addition,” the article states, “New York State and the city of Bethlehem, Pa. are suing Guidant for reimbursement of medical costs involved in replacing the devices.”

All lawsuits pending in federal courts have been consolidated under multi-district litigation rules and moved to a US District Court in Minnesota, where Guidant has several manufacturing facilities, with the first federal trial scheduled to begin on March 15, 2007.

On June 13, 2006, the Minnesota Supreme court appointed one judge to preside over all state court cases involving lawsuits linked to last year’s Guidant product communications, Boston Scientific notes in its report.

According to Lawyers Weekly USA, the lead counsel for the Texas plaintiffs, Robert Hilliard, of Hilliard & Munoz, said documents obtained during discovery show that Guidant knew about problems with its devices as far back as April 2002, but failed to alert doctors and patients for 3 years.

“They knew they were going to kill people based on this defect,” he said.

Ted Meadows, a plaintiffs’ attorney with the Beasley Allen lawfirm in Montgomery, Alabama, who specializes in medical device litigation, told Lawyers Weekly, “There were literally tens of thousands of people who’ve had these devices implanted in them.”

“Now they’re faced with the concern,” he said, “the device might not work properly when they need it most.”

And critics say there is certainly plenty of cause for concern. On June 7, 2006, the New York Times reported that least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of the electrical defect, five involving Contak Renewals.

“But many experts believe that the number is probably higher,” the Times wrote, “because an implanted heart device is rarely examined after a patient’s death to determine if it was working properly.”

According to Mr Meadows, a key to plaintiffs’ claims will be showing that Guidant “knew or should have known there was a potential for this problem.” In addition, he said, any evidence that indicates Guidant knew about the problem and responded improperly would entitle plaintiffs to seek an award for punitive damages.

Legal experts say this evidence exists and point to a report released in March 2006, by an independent panel appointed to review the recalls that shows Guidant allowed about 4,000 potentially defective defibrillators to be implanted in patients after the company found a flaw in 2002 that caused malfunction.

“The Independent Panel believes,” the report says, “that under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains with general guidelines.”

The panel also said that Guidant and other devices makers need to increase the level of data collected on device failures because studies have shown that only a relatively small number of failures are reported to the manufacturers and the FDA because doctors and hospitals do not always report problems and devices are not ordinarily inspected after a patient die.

According to Boston Scientific, the devices that may be flawed include certain Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators.

These products were manufactured by the company’s Cardiac Rhythm Management Group, formerly Boston Scientific/Guidant’s CRM business, and some were implanted in patients as late as between December 2005 and June 2006.

On June 7, 2006, the New York Times reported that in one analysis, Guidant engineers projected that 1 out of every 100 Contak Renewals could short-circuit, a failure rate considered high by experts.

Guidant also suspected by late 2004 that the Renewal models would become increasingly prone to failure as the devices aged, the Times said documents indicate.

The Contak Renewal combines a pacemaker and a defibrillator, often referred to as a cardiac resynchronization therapy device, or CRT-D and costs about $35,000, the Times notes.

On June 6, 2006, Texas Judge Jack Hunter, unsealed documents containing information about recalled defibrillators, saying he did not trust Guidant’s claims that they contain trade secrets. The files show that Guidant had drafted, but never sent, a “Dear Doctor” letter detailing significant potential problems with the Contak Renewal and Contak Renewal 2 model defibrillators, according to Bloomberg News on June 7, 2006.

Guidant fought hard to keep the documents confidential and for good reason obviously. The never-sent “Dear Doctor” letter disclosed the short-circuiting problem and stated that the company had “removed all non-implanted Renewal and Renewal 2CRT-Ds from hospital shelves and Guidant inventory.”

However, records reveal that by this time Guidant had already sold most of its inventory.

Earlier in 2004, the documents show that company officials drafted a memorandum for their sales representatives explaining why it was asking them to return all the unsold Contak Renewals, but the memorandum was never sent either.

Some documents provide strong evidence that Guidant weighed the risks to patients and the loss of profits and chose to place profits over the lives of patients. For instance, one company document shows that Guidant estimated it would lose about $9 million by purging its inventory of defective Contak Renewal units and parts.

Attorney Hilliard says other documents reveal that Guidant performed a risk analysis that showed there was a possibility the devices could short-circuit, and if they did, “the likelihood of death or serious injury was very likely.”

He also told Lawyers Weekly that Guidant also violated federal regulations by redesigning the devices to eliminate the flaw in 2002, without informing the FDA, and that Guidant continued selling the older devices without notifying patients of the risks.

In what experts are calling the strongest evidence to present to a jury, testimony in a 168-page deposition taken in January 2006 in the Texas case, that was made public in February 2006, has Guidant executive, Fred McCoy, acknowledging that the company made changes to one of its defibrillators in 2002, and incorrectly told the FDA that it had no effect on the product’s performance.

Mr McCoy testified that Guidant made two modifications to the Ventak Prizm 2 in 2002, to keep it from short-circuiting and that neither was approved by the FDA.

And as it turns out, only one of the changes was disclosed in the company’s annual report that year also, and Guidant said that change had no affect on the device’s performance.

In addition, in a report filed two years later, the company said that it had received FDA approval to make the changes when it had not.

Mr Hilliard told the Associated Press on February 22, 2006, that Mr McCoy’s testimony proves that Guidant sold an unapproved defibrillator in violation of federal law.

In the deposition, Mr McCoy claims that he did not learn about problems with the devices until May 2005.

More damning evidence was revealed on June 23, 2006, when the Pioneer Press reported that, “Guidant’s implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit.”

“A judge in a product-liability lawsuit involving Guidant’s defibrillators,” the newspaper said, “recently unsealed the FDA document dated June 16, 2005.”

Back when Guidant began its recall in the summer of 2005, the firm said no more than 292 of the units were likely to break down. “But the FDA said “most” of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years of use,” the Press wrote, “and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency.”

At that rate, it said, at least 3,200 Renewal units would be likely to fail.

Legal experts predict that the higher projection will hurt Boston Scientific in lawsuits. “This is as damaging a document as we’re going to come across,” said Attorney Hunter Shkolnik, one of many lawyers representing patients suing Guidant, in an interview with Pioneer Press.

“It flies in the face of all the excuses Guidant has been giving for not telling patients to take these devices out immediately,” he added.

It’s difficult to imagine how things can get much worse for shareholders. In the second quarter of 2006, the company lost 27% of its value. On June 29, 2006, the Globe & Mail reported that:

“Boston Scientific, which laid out $27.5-billion in cash and shares for Guidant, has bought itself what, so far, looks like a massive and costly series of headaches, in the form of product recalls and lawsuits. These have helped drive its stock price to a four-year low of less than $17 on the New York Stock Exchange, down more than $9 from early January.”

However, critics say Boston Scientific also has its laundry list of problems. According to the Globe, before it acquired Guidant, both Boston and its target, received corporate warning letters from the FDA saying that, until they have demonstrably improved their quality control, the agency will not approve new products for sale in the US.

Filed under: 2006, Boston Scientific, Guidant, medical devices, prices, settlement

Boston Scientific inherits Guidant Heart Device Lawsuits

Evelyn Pringle August 1, 2006

According to the FDA, the reason there are not more deaths reported in patients implanted with Guidant’s defective defibrillators is because most patients die outside the clinic or hospital and the devices are not sent back to the manufacturer to be checked.

On June 23, 2006, Bloomberg News reported that Guidant’s Contak Renewal devices might fail about 10 times more often than the company projected last year, citing an FDA analysis released in a Texas lawsuit.

The judge in the case unsealed the document that was dated June 16, 2005, which means it was written by FDA officials one day before Guidant began recalling the devices.

At the time of the recall, Guidant claimed that no more than 292 of the units were likely to break down, but the FDA estimate projects thousands of malfunctions within 5 years. In fact, the FDA said “most” of the 16,000 defibrillators may have damaged insulation within five years of use, and 40% of those would fail to produce an adequate electrical shock in a medical emergency, meaning over 3,000 units would likely fail.

“We have no surveillance process for discovering fatal defibrillator malfunctions,” the agency said. “We do not know the death rate associated with this defect.”

“It is probably greater than reported,” the FDA memo noted, “and may be much greater than reported.”

Attorneys representing the plaintiffs against Guident, recognize the significance of the unsealed FDA analysis. “This is as damaging a document as we’re going to come across,” said Attorney, Hunter Shkolnik.

“It flies in the face of all the excuses Guidant has been giving,” he said, “for not telling patients to take these devices out immediately.”

The Texas lawsuit is but one of about 340 product liability cases in the courts so far, and Boston Scientific, the new owner of Guidant, believes more than 3,000 patients may eventually file claims, according to its SEC filing in May.

Boston’s projection may have been made with inside knowledge of the next hurdle right around the bend. In one of its first honorary duties as the new owner, on May 15, 2006, Boston disclosed in a warning letter to doctors, that another batch of 996 defibrillators might stop working due to an electronic defect that causes the batteries to fail, and warned that the battery failures could prevent the devices from functioning properly and restarting a patient’s heart.

The estimated 900 faulty defibrillators that were implanted in patients were not recalled, according to the May 16, 2006, Boston Globe.

The same day, Boston also issued a separate warning to doctors about problems with another group of defibrillators but said it did not know how many patients were affected. Some of those devices were implanted underneath the chest muscles, the company said, instead of under the skin and over the muscles and that positioning caused the defibrillators’ titanium cases to wear, leading to malfunctions.

However, Boston must not have been too worried about these added problems because on May 14, 2006, the Financial Times reported that five “Boston Scientific executives have received special bonuses, some potentially worth more than last year’s salary.”

The five included Lawrence Best, the company’s chief financial officer; Paul Sandman, the general counsel; Jim Gilbert, a strategy co-ordinator; Lucia Quinn, the human resources chief; and Paul Donovan, a public relations executive, and were awarded bonuses worth at least $1.98m in cash, plus options and deferred stock grants, the Times said.

They were given the choice of accepting a large cash payment plus options, or options only and deferred stock. The largest cash payment offered, the Times said, was $625,000 to Mr Best, a amount equal to his salary for 2005.

But next month, it was back to the grind on June 26, when Boston announced yet another recall of 27,200 pacemakers and defibrillators involving six brands of devices. According to an FDA press release, this batch of devices were implanted between December 2005 and June 2006. Boston also asked that about 23,000 more devices, in stock at hospitals or with sales representatives, be returned.

Boston says, of the 27,200 patients implanted with the devices worldwide, 13,800 are in the US and five failures have been reported. One malfunction occurred at the time of implantation and four others failed in patients already implanted. In those cases, the patients needed to have the device replaced. Two of the patients lost consciousness, but there were no reported deaths, according to a July 11, 2006, Up Date statement issued by the FDA. This particular recall includes:

Some Insignia and Nexus pacemakerspacemakers
Contak Renewal TR and TR 2 cardiac resynchronization pacemakers
Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter defibrillators)

Guidant recommends replacing the implanted devices like its a minor inconvenience. In a July 18, 2005, Dear Doctor Letter, Guident said it will provide “a replacement device at no charge for pacemaker-dependent patients and other patients deemed by their physicians to be best served by replacement, provided the replacement occurs prior to the normal appearance of elective replacement indicators. “

Experts say, its not quite that simple. On March 30, 2006, a New York Times headline read: “Replacing Heart Device Found Risky; It may be safer to leave possibly defective defibrillators in patients, studies show.”

As it turns out, surgery to replace a defibrillator carries a high risk of complications, including death, according to a study published in the March 30, 2006, Journal of the American Medical Association .

The research in JAMA found that one out of every 50 patients needed to have the replacement defibrillator removed because of severe postoperative infections.

One of the study’s lead authors, Dr Andrew Krahn, of Canada’s University of Western Ontario, said the overall complication rate was three to five times higher than expected.

Experts say, patients need to consider all the risks when deciding whether to replace or retain a defibrillator recalled by its maker.

Additionally, the Dear Doctor letter said, “Guidant will reimburse patients up to $2,500 for medical expenses remaining after Medicare and/or health insurance coverage, including device replacement or additional follow-up procedures.” According to SEC filings, Guidant had a $113 million charge in last year’s second quarter for the cost of replacing the recalled defibrillators.

However, Boston had better start putting money aside to pay for the damages because lawsuits are already being filed to force the company to pay up. According to the January 30, 2006, Lawyers Weekly article, “New York State and the city of Bethlehem, Pa. are suing Guidant for reimbursement of medical costs involved in replacing the devices.”

“The bulk of the liability damages sought are for either the cost of explant and replacement surgery or the cost of medical monitoring, which includes periodic evaluation by a physician to test the reliability of devices that remain implanted,” says Attorney Victoria Davis, a partner in the product liability group of Alston + Bird LLP in Atlanta, in the May/June issue of Medical Device Link.

“So obviously the financial implications are huge,” she told Medical Device, “whether you are talking about the cost of defending the growing number of lawsuits or the cost of any payments made to plaintiffs and their lawyers, which could be in the millions if the plaintiffs prevail.”

Even before it acquired Guidant, Boston had its own quality control problems. According to the March/April 2006, issue of Medical Device Link, “just hours after Boston Scientific Corp. (Natick, MA) bested rival suitor Johnson & Johnson Inc. (J&J; New Brunswick, NJ) and nailed down its $27.2 billion bid, the company learned that, in addition to cleaning up the problems at Guidant, it now has to get its own house in order.”

In a warning letter from FDA, Boston was notified of “serious regulatory problems” with medical devices produced at its facilities in Natick, MA; Maple Grove, MN; and Spencer, IN. The letter also referred to three earlier warnings regarding the company’s production plants in Watertown, MA; Glens Falls, NY; and Quincy, MA.

According to the FDA, Boston’s inability to address these issues in a timely manner indicated a “systemic problem with the entire corporate quality management system.”

FDA official, Daniel Schultz, MD, said the warning was only the third time in the FDA’s history that the agency had issued such a broad-based warning to a medtech company. The letter called on Boston “to resolve these serious violations promptly, and to do it not as it relates to specific products, but rather on a corporate wide basis.”

Of particular concern to Boston, MX said, is the stipulation that FDA will not approve any new products until the company’s quality system is in order.”

Which analysts say, likely means that Boston will not be unable to get approval for a new drug-coated coronary stent, until the first quarter of 2007, rather than the final period of 2006, as Boston had hoped.

Boston and Johnson & Johnson are now the only two companies on the US market with drug-coated stents, according to the July 18, 2006, Chicago Tribune.

Last year, Boston paid $750 million, the Tribune says, to settle claims that it broke a contract to jointly manufacture stents by setting up a secret factory in Ireland.

The worldwide market for drug-eluting coronary stents reached an estimated $4.2 billion in 2004, and is expected to nearly double by 2010. In the US, about 1.5 million patients were implanted with stents in 2005, according to The Medtech Marketplace in 2006, Medical Device Link, January/February 2006

The domestic market MX says, is dominated by the Taxus stent from Boston and the Cypher stent from Cordis Corp, a Johnson & Johnson company. Cypher received FDA approval in 2003, and Taxus gained approval in 2004.

However, there was more bad news for Boston in June 2006, when the Wall Street Journal reported that some US hospitals were reducing their use of Boston’s top product, drug-coated heart stents, after a Swiss study found that uncoated stents had a lower rate of complication.

Filed under: 2006, Boston Scientific, Guidant, Johnson and Johnson, medical devices, stents


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