UPDATE 3-Boston Scientific shipping problems 'serious' -FDA
Tue Aug 23, 2005 05:39 PM ET
(Adds details and background throughout, updates shares to close)
By Susan Heavey
WASHINGTON, Aug 23 (Reuters) - Boston Scientific Corp.'s (BSX.N: Quote, Profile, Research) distribution process has "serious" problems that allowed flawed medical devices to be shipped, including its Taxus drug-coated stent, U.S. regulators said in a letter made public on Tuesday.
FDA inspectors said the company failed to properly monitor products so that only acceptable devices were distributed, according to the letter dated Aug. 10.
The warning, which also targeted the device maker's Vaxcel chest ports and Symmetry catheter, is the latest setback for the device maker after a string of manufacturing-related product recalls and other FDA warnings.
Boston Scientific spokesman Charles Rudnick said the distribution problems did not harm patients and the company had already taken some corrective actions.
The company's shares, which have underperformend the S&P 500 by 28 percent since January, closed down 4.53 percent, or $1.23, to $25.92 on the New York Stock Exchange. Earlier on Tuesday it had hit a new 52-week low of $25.75.
Yet industry analysts said Tuesday's letter was not major because it faulted oversight practices, not products. But it did renew worries about the beleaguered medical device sector, which has been hit hard during the last year with a series of manufacturing-related problems, they said.
"We do not dispute that some of these mistakes occurred," Rudnick said. "We're working on the process issues."
The latest FDA warning letter followed an inspection of Boston Scientific's Quincy, Massachusetts, shipping facility that ended in May.
Agency inspectors said the company did not have adequate management oversight to review quality and "failed to implement procedures to assure that only devices approved for release are distributed."
It also did not properly document corrective actions or review data that could help pinpoint problems.
"On a number of occasions, your firm shipped medical devices that were not considered acceptable for release," it said. The letter did not mention any impact on patients and an FDA spokeswoman was not available for comment.
Eight Taxus heart stents that failed a quality test were sent to hospitals, although Boston Scientific said it later recovered them. The FDA also said the company shipped five Vaxcel units on three different dates after they were recalled in August 2004.
Boston Scientific initially responded to the FDA's concerns with a June 20 letter offering its commitment to improving its quality controls, the latest warning said. But the agency said that was insufficient.
"Your response does not identify how and when you plan to implement significant, broad-based corrective actions, nor does it provide sufficient evidence to establish that you have made real changes to your current quality system," the FDA said.
Last year, Boston Scientific recalled 99,000 Taxus stents after reports of malfunctions. Rival Guidant Corp. (GDT.N: Quote, Profile, Research) , which agreed to be acquired by Johnson & Johnson (JNJ.N: Quote, Profile, Research) , has recalled some defibrillators and heart pacemakers.
Ryan Rauch, an analyst with Jefferies & Company Inc., said the FDA was not likely to take action against the Taxus devices because it would cut the U.S. supply in half. But he added that the warning highlighted sector woes.
A.G. Edwards analyst Jan Wald said Boston Scientific's inadequate response to the FDA was a concern.
"It sounds like there's more work to do for Boston Scientific."
The FDA said Boston Scientific has 15 working days after receiving the letter to give an updated response.
Agency officials issue dozens of warning letters each year. Most are resolved without pena
This company is totally falling apart at the seems the pump and dumpeders want out bad its back in the toilet. The insiders are voting themselves more bonuses while they lose market share, as they lose more and more money in lawsuits and litigation and the costs of recalls, not to mention failed investments, Its a shame to lose so much money.
How much will these lawsuits cost?
Problems With Boston Scientific Heart Stent Persisted After Even After Recall, Report Says
NATICK, Mass. (AP) -- Doctors continued reporting surgical problems with a heart stent made by Boston Scientific Corp. even after the company recalled nearly 100,000 of the devices and fixed a manufacturing flaw, according to a published report.
Tiny balloons used to insert the stents into coronary arteries failed to deflate or were so difficult to remove that numerous people died and dozens more were injured during surgeries after last year's recall, The Wall Street Journal reported Wednesday, citing U.S. Food and
Does anyone know if the negative data on late restinosis could have an impact on the 6 class action lawsuits?
BSX no longer sells the Glidewire,glidecath or
pinnacle sheaths? I know it is not as glamorous as
Coronary stents but how will this affect the bottom line?
Nice to see the executives giving themselves raises and bonuses again, while the company crumbles, even Terumo doesn't want anything to do with BSX any more. But I want to hear peoples opinions on the real issues facing the company such as the sweeping health and Medicare reform laws passing through congress that have potential negative effects, and the large amount of preffered shares that could be transferred increasing the dilution to shareholders.
I don't like some of the things I've found out about the company, I am selling also, I have been very disapointed by the stock all year, I will be happy to join the class action lawsuit too, looks like thats the only way to make any money with this dud of a stock, these insiders are just dumping stock and wasting shareholder equity, why do they get paid so much to do nothing? We have decreasing cash every quarter this year, and now losses? Why don't they do something about the debt? This is rediculous, oh well I'm done with it I'm getting out. Good luck all.
I just sold this pos after holding a while for a small loss, feels good to be out of such a loser. This company really knows how to shaft its shareholders, don't see any point in holding it, if they buy Guidant the share dilution will make your shares worth next to nothing, and the debt will probably kill the company and thats if they decide not to get rid of the stock and reissue new stock. If they don't buy Guidant they have shown their weak position, and will continue to lose market share, miss estimates, and report losses. I think the management are clueless here and are more worried about giving themselves bonuses, and stock options to sell. Why should they care they have a golden parachute. My advice anyone holding this bag get out theres much better companies out there that pay dividends.
You have posted the same material repeatedly so much so that it is not even worth my time to hit the delete key anymore. You are the first recipient of the ignore feature this time around.
"Truth hurts don't it?"
To hear you talking about truth is hilarious. You wouldn't know the truth if it hit you in the head (not a bad idea).....
Been looking through you recent posts, trying to find a trace of truth; there isn't any!
BSX should be at $20 by january.
I'm sure the huge debt, failed products, etc and the cost of recalls is going to hit the bottom line, so they want out by getting suckers to buy on hype while they dump, but I think the real reason they want out so bad is because they know that EECP is catching on and it will put an end to BSX.
BSX only real product is totally obsolete. Its history say night night.
Doctors have cut into Theodore Dippy's heart twice to clear clogged arteries, other times they attempted to sweep aside blockages with tiny balloons, and once left a metal stent inside an artery to keep it propped open, after going through numerous heart procedures he finally found relief with a little known treatment that involves sqeezing the legs in large cuffs to propel more blood to the heart. The nonsurgical approach, called Enhanced External Counterpulsation, has been found by studies to provide a significant reduction in chest pains and blockages. The low tech treatment is carried out during one hour sessions while the patient lies on a padded table, with 3 large cuffs on each leg.
Dippy's doctor, cardiologist Ken Kronhaus, has treated more than 600 patients with EECP.
Today, doctors throughout the U.S. offer the treatment at prestegious medical centers, including the Mayo Clinic, and the Cleavland Clinic, have centers for the procedure.
Researchers have been able to document the improved blood flow by doing heart scans on patients before and after treatment to look for changes. Medicare recently began paying for the procedure. Other insurers also cover the procedure. Doctors who offer the therapy see a trend toward its greater use.