Medtronic

Lawsuit: Medtronic perks wooed docs

Tracy Staton — Thu, 25 Sep 2008 11:12:05 -0400

What do a Memphis gentlemen's club, trips to Alaska and ill-gotten patent royalties have in common? They're all perks that Medtronic gave to doctors, according to a lawsuit brought by a former Medtronic lawyer. The incentives were handed out by the company's $3 billion spinal devices unit, which has already been under investigation for its physician relationships.

As you know, Sen. Charles Grassley has been probing off-label use of Medtronic's spine products, examining whether those unapproved uses were driven by incentives given to doctors. The FDA has warned that off-label use of a Medtronic bone graft has led to potentially life-threatening side effects in dozens of patients.

The allegations were made in a lawsuit, filed in 2002 but only recently--and partially--unsealed. A heavily redacted copy of the complaint is the only version publicly available. But the Wall Street Journal got an unredacted copy, which alleged that kickbacks were "pervasive" in the spinal unit.

Medtronic says that it's changed many business practices since that lawsuit was filed. The company says it's "committed to reform and transparency in the industry."

- read the Wall Street Journal story

Johnson & Johnson wins reinstatement

Christe Bruderlin-Nelson — Wed, 17 Sep 2008 05:38:20 -0400

In a patent infringement lawsuit over a decade old that has involved multiple trials, Johnson & Johnson's Cordis unit won reinstatement of more than $595 million in damages. The United States District Court in Delaware handed down the decision.

The company went up against Medtronic and Boston Scientific over coronary artery stents. In 2000, the courts told Medtronic to pay $271 million and Boston Scientific to pay $324 million plus interest at the prime rate based on damages after taxes.

Boston Scientific had motioned for a new trial, but the courts denied it and instead ruled favorably on J&J's motion to move toward final judgment, which it will enter on September 30, 2008.

That's not likely to be the end of the story, however, as Boston Scientific says it will appeal the decision.

- view the Boston Scientific release
- check out the Johnson & Johnson release
- read the WSJ Market Watch article

SPOTLIGHT: Medtronic to shed 1,100 jobs

Wed, 07 May 2008 06:59:52 -0400

Stalling sales of implantable defibrillators have prompted device maker Medtronic to cut 1,100 jobs; that's on top of 900 positions cut last year. The company employs nearly 40,000 total. Report | Report

AAMC: Ban pharma gifts at med schools

Mon, 28 Apr 2008 06:59:57 -0400

Will all medical schools bar the door to pharma giveaways? The Association of American Medical Colleges hopes so. After two years of study, the influential group drafted a policy that would ban drug and device companies from handing over free food, gifts, travel, and ghostwriting services to docs, staff, and students in all 129 U.S. med schools. "Most medical schools do not have strong conflict-of-interest policies, and this report will change that," one anti-conflicts of interest activist told the New York Times.

Schools can ignore the association's advice, but most don't. And though the rules would apply only to med schools, they could in turn influence providers of all stripes.

Drug companies spend more to soft-soap doctors than they do on research or consumer ads--and med schools are big targets, because they harbor not only influential profs but green students. "Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception... that practitioners are being 'bought' or 'bribed' by industry," the association's report said.

Interestingly, the task force that drafted this report wasn't expected to be so strident: Members included CEOs of Pfizer, Eli Lilly, Amgen, and Medtronic, and it was chaired by former Merck chief Dr. Roy Vagelos.

- get the AAMC report
- read the NYT story

Arms twisted, pharma promises disclosure

Fri, 11 Apr 2008 06:59:55 -0400

Pharma knows that self-regulation is the best kind. That's why 12 drug and device makers have promised Sen. Chuck Grassley that they are working on plans to disclose CME grants. You know, the money companies spend to sponsor educational conferences for doctors--conferences where sponsors sometimes influence not only who speaks, but what those speakers say. Some companies are even pledging to disclose their support of patient groups such as the American Heart Association or the American Diabetes Association.

Eli Lilly already discloses its CME funding. In response to Grassley's prodding, Medtronic and AstraZeneca said they'd post payments for professional meetings and patient-advocacy groups on their company websites, beginning May 1 and August 1, respectively. Merck said it's "developing an action plan." Amgen and Abbott Labs have formed working groups to study the subject.

Only Schering-Plough balked. "We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us," the company wrote Grassley. We'll see if that refusal stands.

- see the Los Angeles Times story
- check out the item in the WSJ Health Blog

ALSO: According to California's Public Interest Research Group, disclosure of doctor payments isn't working to enforce limits on those gifts. A new report on these payment limits concluded that drugmakers don't always count meals as "gifts," that some companies reserve the right to exceed the limits if they choose to, and others say they're following limits, but don't say what their limits are. Some don't even post their policies. Study

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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

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SPOTLIGHT: FDA deems Medtronic warning a 'recall'

Thu, 20 Mar 2008 07:59:52 -0400

Oh, by the way, that was a recall. The FDA tells Medtronic that its January warning to doctors--of the increased inflammation risk when its drug infusion systems SynchroMed and IsoMed were used with certain meds--would be classified as a Class I recall. The categorization doesn't change the warning or its recommendations. Report

Grassley takes aim at Prodisc

Thu, 28 Feb 2008 06:59:54 -0500

Yet another medical device maker has been called on the Congressional carpet. Sen. Charles Grassley is asking Synthes, which makes an artificial spinal disk known as Prodisc, whether doctors whose research led to its FDA approval also had a financial interest in its success.

Last month, The New York Times reported on financial relationships between Prodisc's developer, Spine Solutions, and the doctors who helped test it. A New York investment firm financed R&D on the device via investment funds in which many of the clinical investigators owned an interest. Spine Solutions later was sold to Switzerland-based Synthes.

Grassley asked Synthes for information on the company's financial disclosures to the FDA and for details about the clinical researchers' interests in Prodisc. The senator also wrote to the FDA, asking whether the agency knew about the financial relationships between those doctors and the device's developer. "If FDA found out the investment interests did not raise serious questions about the study's integrity," Grassley wrote, "why not?"

- read the article from the New York Times

Related Articles:
Congress probes med device payments. Report
Feds probe Medtronic payments to docs. Report
Medtronic's doc payments draw new fire. Report
Medtronic will settle accusations on kickbacks. Report

Congress probes med device payments

Wed, 27 Feb 2008 06:59:54 -0500

Should device makers retain surgeons as consultants? That's what the Senate Special Committee on Aging plans to discuss today at a hearing over some $221 million in payments five companies made to docs in 2007.

The companies--Zimmer Holdings, Biomet, Stryker, Smith & Nephew, and Johnson & Johnson's DePuy Orthopaedics--agreed to disclose those payments in September to settle government allegations that they violated anti-kickback laws. Four of the companies agreed to pay $310 million to settle kickback claims.

Sen. Herb Kohl, chair of the Senate committee, has proposed legislation that would mandate disclosure of the consulting payments.

- read the story in the Wall Street Journal

Related Articles:
Feds probe Medtronic payments to docs. Report
Medtronic's doc payments draw new fire. Report
Medtronic will settle accusations on kickbacks. Report

Supreme Court shields device makers

Thu, 21 Feb 2008 06:59:58 -0500

Medical device makers got some supreme protection yesterday. The highest court raised a partial shield against lawsuits, saying that devices that passed the FDA's most stringent premarketing review are exempt from consumer lawsuits. Essentially, the justices ruled that federal law--i.e., FDA regulation--preempts liability under state law for these devices.

Can drugmakers anticipate their own celebration when the Supreme Court decides a couple of other preemption cases that involve meds instead of a device? Don't buy the champagne yet, some legal experts say. In ruling for Medtronic yesterday, the Court relied on a federal law specific to medical devices, not drugs. The Medical Device Amendments of 1976 set up detailed requirements for FDA testing of devices, wrote Justice Antonin Scalia in the majority opinion, and prohibited states from imposing different requirements.

The ruling will affect numerous outstanding lawsuits, but some pending cases will still be allowed to go forward; the ruling doesn't keep consumers from suing if a device was made improperly, contrary to FDA specifications.

The Court will hear one drug-related case Monday and will consider another in October. Ironically, the justices are considering these rules just as big questions have been raised about the FDA's ability to effectively regulate drugs and devices. Several recent reports have castigated the agency for scientific shortcomings, outdated technology, and mismanagement. Experts say the agency is way underfunded and understaffed. If the courts want FDA as our final authority, then shouldn't it be good at its job?

- read the story in the Washington Post
- see this New York Times article
- check out the NYT's take on preemption under an inadequate FDA
- find this Q&A with a consumer in a preemption case at Pharmalot

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