Medical Device Link The Online Information Source for the Medical Device Industry.

Times haven’t been easy for Baxter International. Yesterday the company agreed to pay a $15,000 fine for improperly testing irradiation equipment at its facility in Puerto Rico. The Associated Press is reporting that a March 2007 inspection revealed Baxter didn’t conduct regular safety tests of irradiators that are used to kill germs on medical products. They also failed to keep accurate and complete records of the safety inspections and maintenance tests, according to inspectors, who attributed the problems to “deliberate acts” committed by Baxter employees.

The same facility was fined $44,000 in 2004 for violations that included not following safety protocols intended to protect employees from radiation exposure.

Baxter has been under the spotlight recently for its blood thinner heparin that has resulted in several deaths. The company recalled nearly all of its heparin products this week. Baxter doesn’t manufacture drugs at the facility where the irradiation device issues occurred.

An official for the Department of Health and Human Services told Congress yesterday that existing laws are not strong enough to prevent device companies from making inappropriate payments to doctors. Gregory Demske, assistant inspector general for HHS, told the Senate Special Subcommittee on Aging that “the anti-kickback statute itself is insufficient to address the influence of money in this industry because of the high burden of proof,” Reuters reports. The statute requires the government to prove willful conduct, which makes it difficult to win cases, he explained.

A bipartisan proposed bill would require device and drug firms to report all payments to doctors via an annual report that would be made public online.

Not every payment is inherently sketchy, as device companies must rely on physician feedback during the device-development process. But it will help boost public confidence in the device industry if the payments are made part of the public record, and the public can distinguish the payments for legitimate purposes from the ones that are no more than pointless perks or sham consulting arrangements.

The Senate Special Committee on Aging is holding a hearing today on medical device companies’ payments to doctors, in light of disclosure that five orthopedics companies made $221 million in such payments in 2007. (These are the same firms that settled antikickback charges last year; the disclosure is part of the settlement.)

The committee is asking questions about retaining physicians as consultants. Its chairman, Herb Kohl (D-WI), is proposing a bill that would mandate disclosure of consulting payments by device and drug companies with $100 million or more in annual revenues. AdvaMed has come out in favor of the bill, provided that it is amended to “protect legitimate payments to surgeons.” Medtronic, too, issued a statement in favor, but is calling for the bill to apply to firms of all sizes.

Former U.S. Attorney General John Ashcroft is under fire from Congress over his consulting firm’s arrangement to monitor Zimmer Holdings as part of the orthopedics firm’s settlement with the government over kickback charges. The Washington Post reports that Ashcroft has agreed to testify before a House subcommittee on the monitoring arrangement, which could net his firm between $28 million and $52 million over 18 months.

Congressional Democrats and some scholars are concerned whether such high fees are justified, and whether corporate monitorships are in danger of becoming tools for political patronage. Zimmer agreed to the monitoring in exchange for the government holding off on an indictment. It and four other orthopedics firms were accused of paying kickbacks to doctors as an incentive to use their products. Zimmer paid the largest fine of the five and is by far the largest company of the four that agreed to accept federal monitoring. It makes sense that Zimmer would have to pay the largest monitoring fee, but is $28 million or more really justified?

The political intrigue is what gets the headlines, but the real issue is that there are no guidelines about how monitors are selected or about how they should be compensated. The Justice Department needs to establish some as soon as possible.

ConforMIS announced that it has launched a unicompartmental knee resurfacing implant and related disposable instrumentation. It represents another step toward “personalized medicine.”

The iUni is one of the firm’s four patient-specific implants designed for those with osteoarthritis of the knee. It is geared for patients who have damage in the medial or lateral compartments of the knee, but not in other parts. Each implant is designed from a patient’s CT scan and is made specifically for that patient. The company says that because each implant is custom-designed, it allows for true resurfacing of the femur and complete coverage of each weight-bearing surface.

A patient suing the current marketer of the ProDisc after it came apart in his back is now also suing two companies involved in its development, alleging they misled FDA and patients about its safety and effectiveness, reports the New York Times. This comes after revelations that a number of doctors involved in ProDisc’s clinical trials stood to benefit financially if it succeeded, and may not have disclosed their ties properly. (FDA and the New Jersey attorney general’s office are investigating.)

After his device failed, Calvin Timberlake sued Synthes, which currently owns the rights to ProDisc. Yesterday, he added Spine Solutions, the original developer of the product, and Viscogliosi Brothers, an investment firm that owned a major stake in Spine Solutions, to the suit. Synthes acquired Spine Solutions in 2003 for $350 million. The ProDisc received FDA approval in 2006.

But here’s the bombshell: The suit alleges that Viscogliosi Brothers had incentive to mislead FDA and get ProDisc approved so they could sell Spine Solutions and use the proceeds to “repay embezzled funds” and “prevent financial ruin and likely criminal indictment.”

Viscogliosi Brothers vigorously denied the allegations, saying all investigations against it were disbanded without charges. Synthes declined to comment.

The Manhattan district attorney’s office did investigate Viscogliosi Brothers in 2002, but declined to pursue charges, finding that investors were not swindled.

Potentially more significant is the suit’s claim that Viscogliosi Brothers set out to find surgeons for the clinical trial who would invest in its funds. That brings into play conflict-of-interest issues. The firms have said in the past that the surgeons’ financial status had no bearing on the findings.

Could this suit be tossed because of the “federal preemption” principle upheld in the Supreme Court this week? Not if the product is, or has the potential to be proved as, adulterated or misbranded. And Timberlake’s lawyer says the conflict-of-interest issues raise questions about the validity of the data FDA used in its review. If the data turn out to be faulty, the product is misbranded.

UPDATE: Sen. Charles Grassley (R-IA) has asked FDA and Synthes to provide information about what Synthes disclosed during ProDisc’s application process, the New York Times reports.

Some Congressional Democrats want to change the law that allowed Medtronic to prevail in a Supreme Court decision released yesterday.

Sen. Edward Kennedy, D-MA, told the New York Times that “Congress obviously needs to correct the Court’s decision.” He said that when Congress passed the Medical Device Amendments of 1976, it did not intend to give “blanket immunity to manufacturers from liability for injuries caused by faulty devices.”

Never mind that device companies do NOT have “blanket immunity” under the law. It still allows patients to sue in state courts when a PMA device fails to meet FDA standards — i.e., is adulterated or misbranded.

Over in the House, Rep. Henry Waxman, D-CA, was equally incensed. “The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” he said, presumably in a prepared statement, as the quote showed up in both the Times and the Washington Post. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

As for legislation being passed as quickly as possible, the Democrats’ best strategy may be to wait until next year. This sounds like an issue that will split along party lines, which means they won’t have a veto-proof majority. And President Bush would likely veto such a bill, as his Justice Department sided with Medtronic. If the Democrats win the White House, though, the bill would stand much less of a chance of being vetoed next year.

Unless, of course, the real motive is to engage in election-year populism and placate one of the party’s biggest contributors, the trial lawyers.

UPDATE: Waxman and Frank Pallone (D-NJ) said they will introduce a bill overturning federal preemption in April.

Medtronic has won a case that went to the U.S. Supreme Court over whether patients could sue manufacturers of PMA-approved devices in state courts. The high court ruled 8-1 that because FDA has already made a determination about the safety and effectiveness of the product, state lawsuits are barred when they would impose different requirements. The ruling, which pertained to a patient named Charles Riegel who was injured by a Medtronic catheter, was released this morning, reports the Associated Press. The lone dissenter, Justice Ruth Bader Ginsburg, said that Congress never envisioned “a radical curtailment of state common-law lawsuits” when it granted FDA ultimate authority to determine the safety and effectiveness of PMA products. 510(k) products are subject to suits in state courts because they have not been evaluated as rigorously.

This is a victory not only for Medtronic, but for FDA and the device industry as a whole. A loss would have meant that state courts could have made their own determinations as to what constituted safety and effectiveness. This would have undermined FDA’s authority, exposed device companies to increased liability, and potentially thrown the whole medical device regulatory system into chaos. Remember, patients can still sue if the product violated FDA regulations. This is not the stripping-of-legal-rights scenario that some will make it out to be.

 

On Friday FDA issued a draft guidance that would allow device companies to distribute articles from medical and scientific journals that discuss unapproved uses of medical devices. The “Good Reprint Practices” document has suggestions companies should follow when giving out journal reprints and other reference materials. Guidelines include that the article be peer-reviewed and published by an organization that has an editorial board, and that there’s full disclosure of conflicts of interest. The guidance also recommends against distributing materials that have been funded by one or more of the manufacturers of the products in the article. FDA is currently seeking public comments on the draft guidance.

The diagnostics proportion of personalized medicine is dramatically underappreciated, underattended, and underfunded, according to Edward Ludwig, president and CEO of Becton Dickinson (Franklin Lakes, NJ). Ludwig is also AdvaMed’s chairman, and he spoke on behalf of the association at a press conference on Wednesday. Although the term personalized medicine might sound “highfalutin” to some people, it’s an important process of evaluating, diagnosing, and treating a patient, said Ludwig. The concept provides an accurate and effective way of identifying a medical condition that is present or a person is trying to prevent, and provides the best way of dealing with it. Ludwig is hopeful that personalized medicine with not only pick up momentum here in the U.S., but on a global scale too. He anticipates that methods such as HPV screening, which is becoming more accurate with advances in technology to reduce cervical cancer incidences dramatically, will become a screening method used in other parts of world soon. Diagnostics that conduct rapid screening will also help treat patients who have contracted harmful infections in a matter of hours instead of days. While the idea of personalized medicine is quite promising for patients, let’s hope that reimbursement will allow this innovative technology to actually be used on a widespread scale.