Thanks for posting this, Jack.  Scary, isn't it?  The FDA needs to make some changes, but then, so do the pharmaceutical companies and the insurance companies, etc...

   
 
 December 15, 2004

 Flawed Device Places F.D.A. Under Scrutiny

 By BARRY MEIER
 The Red Rooster III was 90 miles out of San Diego on an afternoon in
 July when it came across a fisherman's dream, a school of albacore tuna.
 Suddenly, the charter boat's skipper, John Grabowski, saw a rod flying
 in the air as a passenger, a 72-year-old man, seized up with a heart
 attack. Mr. Grabowski ran to get the portable defibrillator kept on
 board.
 Shocked with the device, the man appeared to revive, but more shocks
 were needed. They never came. The device signaled that it was out of
 power and failed to work again. A replacement battery did not help
 because its power had been drained. Soon afterward, the man died.
 Last month, Mr. Grabowski learned more about the device. Its maker,
 Access Cardiosystems, of Concord, Mass., recalled all 18,500
 defibrillators it had produced since going into business two years
 earlier.
 The company insists that actual product failures were few and that most
 patients were never endangered. But an executive acknowledged there was
 a component failure in the device on the Red Rooster III.
 A look at the history of Access Cardiosystems raises questions about its
 products. But the Food and Drug Administration's oversight of the
 defibrillator may reveal shortcomings in its regulation of medical
 devices, a category that includes products as diverse as blood-oxygen
 monitors and artificial hips.
 An executive of the company, which ceased operating last month, said
 that more than 50 percent of the units might have defects.
 Months earlier, in January, Access Cardiosystems' former chief
 executive, who had just been forced out, wrote the F.D.A. and accused
 Access of shipping potentially defective units. When F.D.A. inspectors
 visited the factory days later, they found no major defects and cleared
 the company of serious problems.
 But as complaints about the device, and deaths possibly associated with
 it, began to increase over the summer, the inspectors never returned to
 learn what they might have missed.
 Already under scrutiny for what some critics say is lax oversight of
 prescription drugs, the F.D.A. may have similar fault lines in its
 medical devices unit. Each year, the agency approves hundreds of
 devices, including dozens of so-called high-risk products. That category
 includes defibrillators, whose failure almost by definition is
 life-threatening.
 With the sales of high-risk medical devices soaring, some experts say
 that the F.D.A may soon have an even bigger problem on its hands: The
 growing use of such devices in settings like offices, schools and homes
 puts them outside the agency's problem-reporting system.
 Under F.D.A. rules, only manufacturers and health care facilities like
 hospitals and nursing homes are required to report patient deaths or
 serious injuries that are potentially related to device defects. But
 individual consumers and even many emergency units like police and fire
 department rescue squads are not covered by the rule.
 The result, some experts fear, is that faulty equipment may go
 undetected and uncorrected. "We are depriving the regulatory system and
 the manufacturers of critical input," said Mark E. Bruley, a vice
 president at ECRI Inc. of Plymouth Meeting, Pa., which evaluates medical
 devices.
 Dr. Daniel G. Schultz, the director of the F.D.A.'s Center for Devices
 and Radiological Health, disputed any suggestion that the agency failed
 to aggressively regulate medical devices. He also said that the F.D.A.
 "responded appropriately to the information" it had about Access
 Cardiosystems.
 But Dr. Schultz acknowledged that the growing use of emergency
 defibrillators in public places and homes was likely to create new
 challenges. "It is fair to say that when there is widespread use of a
 device outside of the formal health care system," he said, "it does make
 tracking of problems more difficult."
 In addition, the agency, while demanding that manufacturers of some
 high-risk devices follow their products' performance, has permitted the
 sale of devices before receiving study proposals from companies on how
 they intend to do this.
 In September, for example, the F.D.A. approved for the first time the
 over-the-counter sale of emergency defibrillators, but it has yet to
 receive an after-sale study proposal from the manufacturer, a unit of
 Royal Philips Electronics. A Philips spokeswoman said her company
 planned to submit a study proposal soon.
 No one questions that emergency defibrillators, when they work properly,
 save lives. And because a patient must be shocked within minutes of
 going into cardiac arrest, it makes sense that defibrillators are
 increasingly found in public settings like planes, offices and shopping
 centers.
 Both federal law and public funds have stimulated the growing use of
 emergency defibrillators. In 2000, for example, President Bill Clinton
 signed a law requiring that portable defibrillators be available in
 federal office buildings. That year, Congress allocated $25 million for
 rural emergency units to buy defibrillators and be trained in their use.
 Access Cardiosystems was just one entrant into this market. Formed in
 2000, the company received F.D.A. approval in 2002 to sell its device
 through a commonly used regulatory procedure for devices that allows a
 manufacturer, rather than running clinical trials, only to show that its
 product is "substantially equivalent" to ones already offered for sale.
 The company's defibrillator was one of the smallest on the market and
 sold for about $1,500 a unit, substantially less than competing models.
 Access Cardiosystems eventually had about 5 percent of the market.
 "We had a product that people wanted and a price that was competitive,"
 Randall Fincke, the Access founder and former chief executive, said in
 an interview.
 But troubles quickly developed. In November 2003, investors effectively
 forced out Mr. Fincke, asserting in a lawsuit filed this year in a
 Massachusetts court that he had misled them about the company's
 financial condition.
 Late that year, Access recalled 143 of the devices because of a
 suspected problem in the units' control board.
 Mr. Fincke, who had also been locked out of the company, wrote
 executives and the F.D.A. that he believed Access was continuing to ship
 potentially defective units.
 "Management's decision to ship these units creates a significant
 potential liability," he wrote in early January to a company investor
 and the new chief executive, James Radley. "I can't let that happen."
 A lawyer for Access Cardiosystems, Jerry E. Benezra, said that Mr.
 Radley was out of the country and unavailable for comment. But both he
 and the vice president for finance and administration, Michael Grosberg,
 said that the company was not aware of any problems at the time and that
 Mr. Fincke was embittered by the terms of his departure.
 Mr. Fincke denies that.
 In response to the accusations, the F.D.A. sent two inspectors to the
 plant. The agency declined to make the officials available for an
 interview. But their 17-page report, which was provided to The New York
 Times by Access Cardiosystems, showed that while the inspectors had
 found some manufacturing and procedural violations, they were not
 sufficient to require a recall.
 The ultimate evaluation, the report said, would be provided by
 "complaint trending of devices." It noted that such a review would take
 place during the next F.D.A. plant inspection.
 At the time, the agency had received relatively few reports about
 problems by patients associated with the Access Cardiosystems device.
 But whether that reflected the actual number of episodes is unclear. A
 recent study in the October issue of The American Journal of Preventive
 Medicine found that the number of device-related deaths and injuries
 might be four times as great as reported to the F.D.A.
 Whatever the case, events involving Access Cardiosystems took a negative
 turn starting in June, five months after the F.D.A. inspection. Mr.
 Grosberg said that the company began receiving a number of complaints of
 possible failures, including one involving the fisherman aboard the Red
 Rooster III.
 Serious complaints were forwarded to the F.D.A., and officials there
 contacted the company for more information. But despite being put on
 notice about potential problems at the plant, inspectors never returned.
 Dr. Schultz said there might have been a lack of communication between
 headquarters officials monitoring complaints and inspectors in the
 field.
 It was also in June that the chief executive, Mr. Radley, and other
 investors in Access Cardiosystems filed their lawsuit accusing Mr.
 Fincke of fraud. The suit asserts that Mr. Fincke oversaw the production
 of defibrillators using components purchased from "second-tier and
 third-tier" suppliers. "As a result of Access's payment problems, at
 Fincke's direction," the suit said, "Access was forced to obtain parts
 on the black or gray markets, which were less reliable, and more costly
 than parts obtained from established first-tier suppliers."
 Mr. Fincke denied the suit's accusations. Mr. Benezra, the lawyer
 representing both the company and investors in the lawsuit, sought to
 play down the assertions of shoddy manufacturing. He said it had been a
 mistake for him to use the term "black" market in the suit. He and Mr.
 Grosberg insisted that the term "gray" market was meant to refer to Mr.
 Fincke's use of parts brokers to acquire top-quality parts at higher
 cost.
 Mr. Benezra said Access Cardiosystems did not contact the F.D.A. or
 recall devices in June, when it filed its suit, because the problems
 cited in court papers were unrelated to those that led to last's month
 recall.
 The company said that the devices had one or two potential problems: the
 shock delivery circuit could fail, and the button that turns the device
 on could fail. Mr. Grosberg said Access undertook the recall because it
 could not figure out the cause of the problems, not because it thought
 the devices were unsafe.
 When Access Cardiosystems alerted customers to the recall, it simply
 shut its doors and did not offer replacement devices or refunds. Since
 then, the company has been contacted by attorneys general in Arkansas,
 Connecticut, Washington and Wisconsin, Mr. Benezra said.
 The company's abrupt action has left emergency units around the country
 scrambling. Steve Bane, an assistant fire department chief in West
 Allis, Wis., said he was stuck with 13 Access Cardiosystems
 defibrillators, including two that had been given to local schools'
 sports teams. He said one unit saved a life in an emergency but another
 failed during a recent demonstration.
 "I have never heard one word from that company or the sales rep that
 sold them to us," Mr. Bane said.
 Mr. Grabowski, the captain of the Red Rooster III, said he could not say
 if a working defibrillator might have saved the fisherman on his boat.
 But without it, there was no chance. He said he was outraged when a
 distributor for Access Cardiosystems insisted that the device was not at
 fault. "I couldn't believe it because I had to stand there and watch
 this guy die," Mr. Grabowski said. "I told him, 'Your unit was supposed
 to save him, and it didn't.' "
 Copyright 2004 The New York Times Company >>>