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New legislation attempts to reverse Riegel v. Medtronic decision.

Democrats in Congress have introduced legislation that would overturn last year’s controversial Riegel v. Medtronic U.S. Supreme Court decision, which protects medical device companies from being sued for failures of devices that have received U.S. Food and Drug Administration (FDA) premarket approval. Frank Pallone Jr. (D-N.J.) and Henry Waxman (D.- Calif.) introduced the Medical Device Patient Safety Act of 2009 in the U.S. House of Representatives, and Edward Kennedy introduced companion legislation in the Senate.

In the Riegel case, the Supreme Court ruled that a patient injured by a catheter from Medtronic could not sue under state laws. That decision was based on a federal law prohibiting states from imposing their own requirements on devices. As a result, state courts, citing the high court’s decision, have dismissed thousands of lawsuits against Medtronic and other device companies.

The new legislation was introduced a day after the Supreme Court decided that federal rules do not protect drug companies from state lawsuits. The court ruled against drug giant Wyeth (in Wyeth v. Levine), which maintained that it could not be sued in state courts for its Phenegran (an anti-nausea medication) because the FDA already approved the drug. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the drug, claiming Wyeth did not properly warn healthcare providers about the danger of the medication.

The central question in both cases is whether the FDA’s approval of a drug or device is enough to absolve the manufacturer from liability. Democratic lawmakers seem to be answering “no” to that question.

“The Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” Pallone said, speaking about the Wyeth decision. “We introduced legislation that gives patients that same right when injured by a medical device.”Pallone and other Democrats claim that philosophy overlooks decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. Waxman, chairman of the Energy and Commerce Committee, is expected to hold a number of hearings on the issue.

“The court’s decision [in Riegel v. Medtonic] has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval devices or inadequate safety warnings,” Pallone and Waxman wrote in a statement. “It also removed one of the industry’s most important incentives to maintain product safety after approval and disclose newly discovered risks to patients and physicians.”
The idea that corporations are shielded from state liability claims by federal rules was aggressively advocated under the Bush administration.

The Advanced Medical Technology Association (AdvaMed) was quick to respond.
“This bill does not in any way improve patient safety,” asserted Steve Ubl, president and CEO of AdvaMed. “It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher healthcare costs for all Americans.

Ubl said the bill would allow state courts to review medical devices and ultimately lead to a “patchwork of inconsistent and confusing guidance” on the use of medical devices or limit their availability.

“America needs a central expert authority to regulate medical devices based on a scientific risk-based approach to public health and safety for all Americans, not ad hoc regulation through state court verdicts” he added. “Congress provided FDA with this central authority more than 30 years ago, and we should not weaken the agency’s effectiveness or ability to meet its mandate to protect the public health and safety.”

Despite the industry’s concern, the bill has drawn support from a wide range of interest groups, including consumer advocates, trial lawyers and the AARP.

An editorial published in the New England Journal of Medicine (NEJM) recommended swift passage of the bill.

“Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard,” physicians who authored the NEJM editorial wrote. “We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation’s supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.”

Given the current makeup of the House and Senate, most believe that the legislation will pass quickly.

Massachusetts Finalizes Gift Ban for Device Firms

In mid-March, the Massachusetts Public Health Council gave its final approval to regulations banning medical device (and pharmaceutical) companies from providing gifts to physicians, including a limit on when firms can pay for doctors’ meals and a requirement that companies publicly disclose payments to doctors of more than $50 for certain types of consulting and speaking engagements.

Last summer, Massachusetts lawmakers passed (and Gov. Deval Patrick signed) a bill enacting the gift ban and other restrictions, but the drafting of regulations was left to the commonwealth’s Department of Public Health (DPH). Many industry stakeholders, including biotech companies, doctors, trade association and even the hotel and convention industry, lobbied for changes to the initial draft. The final regulations as recently approved, however, are close to what DPH officials proposed at the end of last year and passed along to the Public Health Council.

There are two substantive changes worth noting. Companies must disclose payments to doctors and hospitals for research designed to promote a particular product, but funding for research designed to answer a scientific question will not have to be disclosed. The DPH nixed a provision allowing companies to provide financial assistance for medical residents and other trainees to attend conferences and education courses.

There is a $2,000 disclosure fee payable to the state for all medical device firms, regardless of size (industry had argued that this would be burdensome for start-up device firms). Though the rules ban companies from providing free entertainment (such as sports tickets) and, under some circumstances, free meals, officials also made it clear that device companies can still sponsor continuing medical education events that include free meals for attendees, as long as the companies have no role in organizing the sessions or paying speakers. According to department officials, the rules are the most comprehensive in the country.

Massachusetts is now the only state to require disclosure by device manufacturers as well as drug companies. Minnesota, for example, requires drug company disclosures, but state lawmakers there are debating making the laws stricter and including device companies. Vermont also has reporting requirements.

The commonwealth maintains that the regulations are intended to control costs by reining in unnecessary prescribing of expensive drugs and to make doctors’ potential conflicts of interest transparent to the public. Any company doing business in Massachusetts must comply with the regulations, which take effect July 1. The first public reporting by companies will be due a year later. The information will be posted on the DPH Web site and will be searchable by company and by healthcare provider.

Many companies said the proposal was excessive and could discourage firms from doing business in Massachusetts.

“Massachusetts is now seen as the most unfriendly state in the nation toward industry,” Robert Coughlin, president of the Massachusetts Biotechnology Council, told the Boston Globe. “In these tough economic times, you don’t want to send a chilling message to an industry that’s a growth industry.”

Tom Sommer, president of the Massachusetts Medical Device Industry Council, has said the regulations put the device industry in Massachusetts at a competitive disadvantage and that a national standard would make the playing field level. At the federal level, the Physician Payments Sunshine Act of 2009 recently was reintroduced in Congress, which would require all medtech companies to report payments of more than $100. As currently drafted, however, the proposed federal law would not supersede state law. While it will preempt any similar state disclosure requirements, it also includes a provision saying that companies would have to comply with any additional state requirements, which could mean that companies’ hands are tied if a state has stricter rules beyond what the federal law requires.

Cardinal Health Chooses Name for Spinoff

Cardinal Health has selected a name for the medical technology company that will be formed through the proposed spinoff of its Clinical and Medical Products businesses, which the company announced last September.

The new company will be dubbed CareFusion. According to Cardinal officials, the name reflects “the diverse blend of medical technologies” the firm will offer, including infusion and medication safety technologies, respiratory equipment, automated medical supply dispensing and infection prevention devices.

“CareFusion is a name that clearly communicates our ability to bring together technologies that improve patient safety and streamline the care process,” said David Schlotterbeck, Cardinal Health’s vice chairman and future CEO of CareFusion. Schlotterbeck predicted the spinoff would be an “immediate market leader in medication safety and infection prevention,” and that the company would put “substantial emphasis” on innovation and clinical differentiation.

“Patient safety has always been a moral obligation for hospitals, but with payers creating additional financial incentives to reduce errors, improving safety has become an economic mandate,” he added.

The new company, which will focus on systems for infusion, medication and supply dispensing, respiratory care, infection prevention, medical diagnostics and surgical procedures, will be headquartered in San Diego, Calif. Fiscal 2009 pro forma revenue for these businesses as a standalone entity is expected to be more than $4 billion, which would place the company among the world’s largest medical technology firms. Building on existing product lines, of course, helps. Its primary product line will include Cardinal Health’s Alaris IV infusion and Pyxis dispensing systems, AVEA and LTV series ventilators, V. Mueller surgical instruments and clinically differentiated offerings to reduce hospital-acquired infections through MedMined services and ChloraPrep preoperative skin preparation.

Cardinal Health will keep certain products made for the operating room, such as fluid management devices and surgical gloves.

CareFusion will have more than 13,000 employees worldwide. Cardinal Health has owned the CareFusion trademark since 2006 when the company acquired Care Fusion Inc., a maker of handheld barcode technology that provides positive patient identification for medication administration, lab specimen collection and blood transfusions.

The company expects to trade on the New York Stock Exchange under the ticker symbol CFN.

BSX Launches New Imaging Catheter

Boston Scientific recently launched its iCross coronary imaging catheter, a product designed to improve the deliverability of the company’s intravascular ultrasound (IVUS) technology, the iLab ultrasound imaging system. IVUS technology allows physicians to see detailed images inside the heart and coronary arteries. The device will be available immediately in the United States, according to the Natick, Mass.-based firm.

The iCross catheter incorporates Boston Scientific’s Bioslide hydrophilic coating, which, according to the company, has been shown in bench tests to provide a 28 percent improvement in “pushability” when dealing with challenging anatomy. Pushability refers to the ability to transmit force from a proximal end of the catheter to the distal end of the catheter.

This latest launch builds on the company’s Atlantis SR Pro catheter line.
“Boston Scientific’s iCross coronary imaging catheter is a powerful tool for visualizing coronary intravascular pathology, especially in patients with complex coronary artery disease,” said Augusto Pichard, M.D., director of the Cardiac Catheterization Lab at the Washington Hospital Center in Washington, D.C. “The combination of the iCross’ outstanding image quality and excellent deliverability should help physicians better identify lesion characteristics.”

More Deaths Attributed to Medtronic ICD Leads

The number of deaths as a result of Medtronic’s Sprint Fidelis leads for im-plantable cardioverter defibrillators (ICDs) is larger than the company originally estimated. The update is based on the review of an independent panel of physicians’ analysis of the data.

Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.

The Minneapolis, Minn.-based company pulled the Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five deaths that may have been caused by cracked wires. Approximately 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.
The company sent a letter to physicians raising the number of estimated deaths
to 13.

Medtronic officials noted that four of the deaths occurred when physicians tried to extract the wires. In the letter, Medtronic recommended four options. The “best choice for the majority of patients,” is that patients should leave the devices in because the risk of surgery may outweigh the risk of a device malfunction. The company also recommended replacing the ICD without extracting the existing one.
The third option noted is to place a pace sense lead without extracting the existing lead. According to Medtronic, this option reflects the observation that approximately 90 percent of Fidelis failures are related to fractures in the pace sense circuit. It is unknown what the failure rate of the high-voltage conductor would be should a pace sense conductor failure occur in the existing Sprint Fidelis lead, company officials said.

The fourth recommendation was that “unusual patient circumstances” could mean extracting and implanting a new ICD lead.

Factors to consider when making this decision, according to the company, include patient life expectancy, age and co-morbidities, number of implanted leads and duration of implant, and patient preference. Medtronic’s independent physician quality panel strongly recommended that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.

A new consensus document on lead extraction will be issued by the independent industry group, the Heart Rhythm Society, in May, according to the company.
The FDA received 107 reports of patient deaths as a result of the Fidelis leads, which the company said were not initiated by medical professionals.

“The majority were initiated by family members or attorneys with minimal supporting data,” Tim Samsel, Medtronic’s vice president for Quality and Regulatory for the company’s Cardiac Rhythm Disease Management unit, wrote in the letter. “Medtronic’s independent physician quality panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.”
In recent months, federal judges have thrown out close to 1,000 cases of patient lawsuits against Medtronic, citing federal regulations that protect the company from lawsuits filed at the state level.
According to a Supreme Court decision last year—Riegel v. Medtronic—the FDA is the final arbiter of medical device safety. Proposed legislation recently introduced in Congress, which has drawn the ire of industry, attempts to overturn that decision and hold device firms liable in state courts for their products.