Stent

J&J win in patent suit

Christe Bruderlin-Nelson — Wed, 01 Oct 2008 04:14:05 -0400

Johnson and Johnson received some happy news yesterday when a federal judge awarded its cardiac device unit $1.2 billion in a longstanding battle between the megacompany, Boston Scientific and Medtronic over a stent device.

The U.S. District Court in Delaware entered a final judgment benefiting Cordis Corporation, a Johnson & Johnson company, for patent infringements by Boston Scientific and Medtronic from cases from 2000 and 2005 involving the Palmaz balloon expandable stent. In all, the battle has been raging for just over a decade. Previous juries found that Boston Scientific's and Medtronic's stent products and ordered them to pay $703 million and $521 million, respectively.

The final amount includes accrued interest. The best part? The stent the companies were fighting over is no longer on the market.

- read the Wall Street Journal story
- find out more at MSN Money
- see MarketWatch's article

Boston Scientific's stent data flawed

Tracy Staton — Thu, 14 Aug 2008 10:54:19 -0400

Boston Scientific's new heart stent, awaiting approval for U.S. sales, is backed by flawed research despite the company's claims of success in a clinical trial, according to a Wall Street Journal review of the data. Report

FDA wants to lengthen stent testing

Thu, 27 Mar 2008 07:59:55 -0400

Looking for hard evidence that the FDA is tightening approval standards? Here it is. The agency today proposed tougher clinical trial guidelines for drug-coated stents. Rather than letting new versions of the artery-decloggers onto the market after nine months of study, the new rules would require data collected two years after the procedure. Then, after the stent is approved, companies would continue monitoring the product for complications, preferably for five years.

The new guidelines closely follow standards the agency used to assess new stents from Medtronic and Abbott Laboratories. The more stringent analysis of those products came after studies raised concerns about blood clotting in the stents long after they were implanted. For about a year, warring research muddied the safety waters around coated stents, but consensus has settled around a "perhaps" for clots years after the procedure and a "probably not" for increased deaths or blood clots overall. The FDA's new rules seek to minimize the "years later" risk, and according to analysts, aren't a big surprise. They "conform to the way the industry has already been thinking about product design," one told the Wall Street Journal. We'll see how the companies themselves respond.

- see the WSJ story
- check out the article in the Chicago Tribune

Related Articles:
Tough times for stent market. Report
Decline in drug-coated stent use at cardiac centers. Report
Insurers may cut stent payouts. Report
Little common ground in stent controversy. Report

Burning query: Will my Fidelis lead fail?

Fri, 14 Dec 2007 06:59:57 -0500

A shocking problem: Patients are trying to figure out whether to live with a recalled Medtronic defibrillator lead known as Fidelis, or to undergo lengthy, expensive surgery to have their devices replaced. Meanwhile, experts are debating just how many of these parts--thousands of which have already been implanted into patients--are likely to fail.

The part at issue, of course, is an electrical lead that connects a defibrillator to the patient's heart. When it "fractures," the lead can fail to shock a patient when necessary to correct a misfiring heart, or shock a patient unnecessarily and repeatedly. At a device conference, one expert estimated that half of all leads--not just Medtronic's version--removed from patients might have failed. One study, released in April, estimated that 40 percent fail within eight years. And even the FDA itself is saying that these parts might not be adequately tested before marketing.

Back at the hospital, the defibrillator-replacement procedure can cost $12,500 or more. Medtronic is paying $800 of that, plus contributing a replacement lead. Who pays the rest? Insurance companies say they'll consider it on a case-by-case basis.

- read the report from the New York Times
- get more on the debate from the Wall Street Journal

Related Articles:
Did patient lawsuit spur Medtronic recall? Report
Medtronic withdraws defibrillator part. Report
FDA panel: Approve Medtronic stent. Report
Study questions Medtronic stent. Report

Abbott Labs to cut 1,200 jobs

Wed, 05 Dec 2007 06:59:54 -0500

A new entrant into the layoff club is Abbott Laboratories, which says it's cutting 1,200 jobs in Ireland and California. Some 500 workers will be laid off from a stent-making factory in Galway, Ireland. Another 700 jobs will be cut from a facility in Temecula, California. Abbott employs about 65,000 people worldwide, so these layoffs represent less than 2 percent of its workforce. The company plans to take a charge against fourth-quarter earnings for the cuts.

The layoff announcement met with consternation in Ireland, where Abbott now employs about 3,400. Closing the Galway plant will have "major consequences" for the economy there, officials said, calling the layoffs there a "cruel blow." Some politicians called for the Irish government to invest in the Galway region to counteract the effects of the cuts; others want the government to reverse business-tax increases so that Ireland can attract more foreign investment.

- take a look at the report from the Chicago Tribune
- read this account of the local layoffs in The Irish Times

Related Articles:
Panel gives cautious OK to Abbott stent. Report
GE negotiating for Abbott diagnostics unit. Report
J&J sues Abbott to block new stent. Report
Top 5 layoffs of 2007. Report

Boston Sci settles more Guidant cases

Tue, 20 Nov 2007 06:59:54 -0500

How's about $45 million more? Boston Scientific says it's bolstering its fund for Guidant defibrillator patients to $240 million from the $195 million it agreed to pay in July. The new total covers more patients, too. It will settle 8,500 claims stemming from Guidant defibrillators that were recalled or subject to safety warnings before Boston Scientific bought the company in April 2006. The previous deal had involved some 4,000 claims.

The company believes this will lay to rest "substantially all" of the U.S. cases. And given that it had set aside some $732 million to cover expenses, it may have money to spare. But it has to pay its attorneys first.

- check out the release from Boston Scientific
- read the BusinessWeek report

Related Articles:
Boston Scientific hands out pink slips. Report
Boston Scientific preps for big layoffs. Report
Boston Scientific deals with debt. Report
Tough times for stent market. Report

Docs reconsider drug-coated stents

Mon, 12 Nov 2007 06:59:54 -0500

Well, maybe drug-coated stents aren't so bad after all. Some doctors are now saying that the medical community overreacted to data on the clotting risks of the eluting stents. New data, plus a closer analysis of the old, is leading cardiologists to consider returning to the drug-coated stents for some patients.

But even if the clotting risks aren't as bad as originally thought, some doctors and researchers still say that only the sickest patients should get stents at all. Diet and drugs--including statins and beta blockers--should come first for most, they say. For high-risk patients, on the other hand, stents work. And drug-coated stents don't appear to be less safe than the bare ones. They are, however, less costly--which may continue to drive sales away.

- read the New York Times report

Related Articles:
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Decline in drug-coated stent use at cardiac centers. Report

Boston Scientific hands out pink slips

Thu, 08 Nov 2007 06:59:56 -0500

Look for Boston Scientific workers at the nearest job fair. The device maker's previously announced job cuts--some 2,300, according to company forecasts--have begun. The Massachusetts-based company started letting staff go in Minnesota on Tuesday, with terminated workers getting 60 days' notice, plus severance and outplacement services. An estimated 500 to 600 will be laid off in Arden Hills, Minnesota; the company has another big operation in Maple Grove.

- read the Bizjournal report
- get more details from TwinCities.com

Related Articles:
Boston Scientific preps for big layoffs. Report
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Tough times for stent market. Report
Boston Scientific implant gets EU nod. Report
Top five layoffs of 2007. Report

Study: Coated stents aren't cost-effective

Fri, 02 Nov 2007 07:59:54 -0400

If drug-eluting stents were on the shelves at Costco, most value-conscious customers wouldn't buy. A new Swiss study has found that the coated stents aren't cost-effective for most patients--and wouldn't be even if prices were cut substantially. In fact, it would be "almost impossible" for the more expensive stents to become cost-effective in low-risk patients. That doesn't hold out much hope to manufacturers Johnson & Johnson and Boston Scientific.

But here's one positive to comfort stent makers. They're a good value for a subset of high-risk patients, concluded the study, published in this week's The Lancet. In these patients, who had small-vessel or bypass-graft stenting, the drug-coated versions were cost-effective. In some cases, the coated stents saved money that would have been spent treating complications.

-read The Lancet's release about the study

Related Articles:
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Medical device makers to fund stent safety study. Report
Decline in drug-coated stent use at cardiac centers. Report

Why didn't Medtronic recall sooner?

Tue, 30 Oct 2007 07:59:56 -0400

Big cardiac clinics across the country stopped using Medtronic's Fidelis defibrillator lead in early February because they considered it unsafe. So why did the company wait till October to recall it? And why did it blame doctors' technique for some of the malfunctions?

Those are the questions the Wall Street Journal poses today in a piece that not only questions Medtronic's actions, but also the FDA's system for regulating medical devices, which aren't subject to the stringent testing prescription drugs undergo before hitting the market.

- read the article in the Wall Street Journal (sub. req.)

Related Articles:
Medtronic recall spawns inquiry. Report
Did patient lawsuit spur Medtronic recall? Report
Medtronic withdraws defibrillator part. Report
Medtronic's fortunes depend on new stent. Report

Medtronic recall spawns inquiry

Wed, 24 Oct 2007 06:59:56 -0400

Little did Medtronic know that it would touch off a Congressional investigation when it recalled a key defibrillator component last week. The Committee on Oversight and Government Reform now is reviewing the FDA's procedures for approving heart-device components.

Committee Chairman Henry Waxman, a longtime U.S. Representative from California, is asking the agency for information on testing procedures for defibrillator leads. Meanwhile, the FDA said it would conduct its own internal review on whether to require lab testing before these products hit the market.

- check out the article from the New York Times

Related Articles:
Did patient lawsuit spur Medtronic recall? Report
Medtronic withdraws defibrillator part. Report
FDA panel: Approve Medtronic stent. Report
Medtronic's fortunes depend on new stent. Report

SPOTLIGHT: Medtronic's fortunes depend on new stent

Fri, 19 Oct 2007 06:59:52 -0400

Could Medtronic's new Endeavor stent make up for its multimillion-dollar losses from the recall of the Fidelis defibrillator lead? Report

Boston Scientific preps for big layoffs

Tue, 16 Oct 2007 06:59:57 -0400

Welcome to the wake, Boston Scientific. The device maker is poised to join its healthcare colleagues in laying off thousands of workers. Analysts that follow the company predict it will cut up to 12 percent of its global workforce, or up to 3,400 people.

Boston Scientific already cut some 500 to 600 jobs this year. Company officials said this summer that they'd announce more layoffs by year's end; that word is expected soon, perhaps this week. The company has been faltering since it bought Guidant two years ago, loaded as it is with debt and beset by falling sales of its drug-coated stents.

- read the article from the Boston Globe

Related Articles:
Boston Scientific deals with debt. Report
Tough times for stent market. Report
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Read more on: Boston Scientific

SPOTLIGHT: Study questions Medtronic stent

Mon, 08 Oct 2007 06:59:52 -0400

Ahead of next week's FDA panel review of Medtronic's new Endeavor stent, the agency released documents questioning its effectiveness; the company's stock dipped 2 percent on the news. Report

SPOTLIGHT: Coated stents better for at-risk patients

Thu, 04 Oct 2007 06:59:52 -0400

Another day, another stent study. Research published in the New England Journal of Medicine shows that drug-coated stents actually worked better than bare-metal models in a specific subset of high-risk patients. The drug-eluting sort were less likely to spawn new procedures and didn't significantly boost heart attacks--but only in patients at risk of a condition called restenosis. Report

ALSO NOTED: JHP takes over King Pharma plant; AstraZeneca expands giveaway program

Thu, 04 Oct 2007 06:59:50 -0400

> King Pharma sold off its Rochester, Michigan, manufacturing plant to JHP Pharmaceuticals for $93 million in cash; JHP will take on the plant employees and contract manufacturing there. Release

> AstraZeneca is adding 150 more facilities to its list of healthcare providers that get free AZ drugs for low-income patients. Report

> A new study shows that flu shots do benefit patients 65 and older, adding fuel to the argument over the efficacy of the vaccines in the elderly. Report

> The Irish pharmaceuticals distributor United Drug says its year-end profits will beat market expectations, with double-digit year-over-year sales growth. Report

> Three of Europe's biggest drugmakers have teamed up with the British government to launch Stem Cells for Safer Medicines (SC4SM), a non-profit that will develop stem cells for safety testing of new drugs. Report

And Finally... Oh, the tangled web of intellectual property claims woven by stent makers since the devices were born in 1994. With $6.5 billion in annual sales at stake, no wonder so many companies are fighting over who owns what. Article

SPOTLIGHT: J&J's risky infringement defense flops

Tue, 25 Sep 2007 06:59:52 -0400

Here's a new infringement-suit tactic: say your product isn't as safe as your opponent's, so it falls outside the patent's safety profile. That's what Johnson & Johnson said in its defense against Boston Scientific claims of stent-related poaching. It didn't work. The judge said that the infringement ruling stands. Report

J&J job cuts hit Belgian subsidiary

Wed, 19 Sep 2007 06:59:56 -0400

Johnson & Johnson's restructuring has come home to roost in Belgium. Drug maker Janssen-Cilag, a J&J subsidiary, will slice 521 full-time and 167 part-time workers from its payroll of 4,723 in-country.

Back in July, J&J announced it would cut its global work force by up to 4,820 jobs. Contributing factors: Falling stent sales, lagging Procrit prescriptions, and expiring patents. It's the company's biggest cutback ever, amounting to about 4 percent of its payroll. An update on the restructuring is due with third-quarter earnings reports October 16.

- check out the article in the International Herald Tribune

Related Articles:
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Data backs use of J&J's Cypher stent

Fri, 14 Sep 2007 06:59:57 -0400

On the scales of stent safety, the evidence is piling up in favor of the previously discredited drug-coated models--Johnson & Johnson's Cypher in particular. On top of positive research announced at last week's European cardiology congress comes a new meta-analytical study, published in today's Lancet, that concludes patients with drug-eluting stents don't have a greater risk of death than patients whose stents are bare.

Unfortunately for Boston Scientific, the study also suggested that patients implanted with the company's Taxus stent had a slightly increased risk of heart attack when compared with patients with Cypher stents. Taxus patients also were a bit more likely to develop blood clots and to require follow-up procedures, the study shows.

- here's J&J's release
- read the article from The New York Times

Related Articles:
Little common ground in stent controversy. Report
Congress spotlights J&J stent ops. Report
Decline in drug-coated stent use at cardiac centers. Report
Insurers may cut stent payouts. Report

ALSO NOTED: Abbott stent gets review; Studies ease finasteride fears; The Pill cuts cancer risk;

Wed, 12 Sep 2007 06:59:50 -0400

> And in other stent news, the FDA plans to schedule an advisory committee meeting to discuss Abbott Laboratories' Xience drug-coated version, already sold overseas. Report

> New studies may ease fears of finasteride, a generic drug that's effective in preventing prostate cancer--but until now was thought to promote fast-growing tumors in those patients who did develop cancer. Release

> The Pill may actually cut cancer risk--up to 12 percent, in fact--provided women don't take it for longer than eight years, according to a new study published in the British Medical Journal. Report

> Natco Pharma has launched a generic version of Lenalid, used to treat Myelo Dysplastic Syndrome. Report

> Venture capitalists are betting big on nanotechnology. Report

And Finally... Pharma companies may be experts at some technologies, but their online advertising is mired in the Internet dark ages. Report