Charlottesville Personal Injury Lawyer - Medical Devices & Implants

Controversial Medical Device - Menaflex - Approved By FDA

Greg Webb — Wed, 07 Oct 2009 17:11:15 GMT

In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to Congress and the FDA. One consultant previously worked as the FDA’s associate chief counsel for medical devices and had regular contact with the agency about the device; the device was approved last December despite staff objections. Another top ReGen consultant is the former chief of staff to Senator Robert Menendez, who was among four lawmakers that signed a letter urging the FDA to review the case. Campaign finance records also show that one of these consultants contributed about $40,000 to Menendez and the other three New Jersey politicians that signed the letter.

The two consultants were part of an aggressive campaign by ReGen to obtain approval for Menaflex, which is a surgical mesh used to aid in repairing torn knee tissue. FDA staff scientists rejected Menaflex three times, citing concerns that patients may experience adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery. However, in late 2008, ReGen appealed to Andrew von Eschenbach, the FDA Commissioner, who ordered an expedited review by a panel of independent advisers, allowed ReGen input regarding the composition of the panel and refused to permit FDA staff scientists who had been reviewing the Menaflex applications to address the panel. An internal probe found ReGen had remarkable access to von Eschenbach and approval came after he met with the New Jersey legislators who asked von Eschenbach to handle the matter personally. According to the Center for Responsive Politics, ReGen has spent $500,000 lobbying in Washington since 2007. Three of the company’s executives also gave substantial sums of money to the campaigns of the lawmakers that signed the letter to the FDA, though the congressmen’s aides claim the contributions played no role in their decision to approach the FDA.

The exposure from this ReGen case and how the FDA is now considering approving the Menaflex has alarmed not only public interest groups seeking FDA reforms, but also the $200 billion medical device industry, which is also seeking changes to health-care reform legislation making its way through Congress.

Originally posted at InjuryBoard by Greg Webb

Hospitals In VA, MD, DC Must Report Avoidable Mistakes

Greg Webb — Thu, 06 Aug 2009 14:11:50 GMT

Over the past year, there have been hundreds of incidents of death or serious medical harm that were disclosed by hospitals in the Washington DC area, preventable errors that until recently have not required public reporting. Under laws that took effect last year in Virginia and a few years earlier in DC and Maryland, hospitals must report to health officials the many serious injuries that patients may suffer in the course of treatment. For example, in one case in DC, a patient was readmitted to the hospital complaining of serious leg pain after the surgeon operated on the wrong part of his spine.

While the public record in Virginia discloses the names of the hospitals involved, DC’s and Maryland’s do not. All three regions, however, give the American public a glimpse into the mistakes health experts call “never events”, because they should never happen: operations on the wrong body part, sponges being left in patients after surgery, and medication errors. At least twenty states require hospitals to report any incidence of hospital-acquired infection as well.

Patients, insurers and regulators are beginning to use this information to nudge health-care providers to ensure that such events never happen. In the past, insurance companies were billed when a doctor, nurse, or technician was responsible for injuring a patient; Maryland health regulators estimate that insurance companies paid $522 million last year to cover preventable complications in hospitals, which occurred in 55,000 of the state’s 800,000 inpatient cases. Now, however, many private and public insurers are following Medicare’s lead by refusing payment as a punishment to hospitals. They hope this act will encourage hospitals to make improvements in their system of care. For example, they will not pay for treating a urinary tract infection caused by a catheter.

In Maryland, the hospital association has agreed not to bill insurance companies for eight mistakes, such as transfusions using the wrong blood type and surgery on the wrong side. As part of a new initiative program, the state commission will begin ranking its hospitals on how often they commit fifty-two preventable mistakes; hospitals that commit the most mistakes will be required to bill insurers at a lower rate than hospitals who commit fewer mistakes. Fines will also be implemented as punishment for mistakes.

Additionally, the hospital association in Virginia has agreed not to bill insurance companies for several errors caused by hospital staff. Anthem Blue Cross and Blue Shield, Virginia’s largest private insurer, has stopped paying hospitals for four surgical mistakes: when the wrong body part is operated on; when the wrong procedure is done; when a foreign object is left in the patient requiring additional surgery, and when the wrong patient is operated on.

Finally, in DC, hospitals, nursing homes and clinics have reported 529 mistakes form July 2007 to June 2008; fourteen of these led to the death of a patient. So far, the District has tried not to use financial incentives to affect the hospitals’ behavior.

Originally posted at InjuryBoard by Greg Webb

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

Congressmen Push To Nullify Supreme Court’s Medical Device Decision

Greg Webb — Tue, 03 Mar 2009 08:00:00 GMT

Some members of Congress are attempting to remove a 2008 Supreme Court decision that stands as a barrier against suing medical device manufacturers. This ruling has barred patients, or their survivors, from suing manufactures of complex medical devices if the Food and Drug Administration (FDA) has approved the products sale. Since this ruling, judges from around the country have cited it in dismissing cases against a wide range of manufacturers. For example, situations in which a woman was burned internally by a device that was meant to reduce menstrual bleeding, and numerous patients who claim they were injured by faulty heart implants or joints.

Recently, however, some members of Congress have decided they want to give potential plaintiffs a chance at legal action. Two House Democrats plan to reintroduce legislation that will nullify the Supreme Court Decision. A similar bill introduced in the Senate last year is also expected to be reintroduced. The legislators, as well as patient advocates, say the Supreme Court’s decision has left patients legally powerless against “spotty oversight of products” by the FDA. With the Supreme Court ruling, patients are facing a dangerous situation in which the FDA is incapable of keeping dangerous products off the market and patients cannot sue companies for restitution.

The House Energy and Commerce Committee is expected to hold hearings this session to determine whether the FDA’s process for device approval is adequate after numerous claims that it does not have the necessary resources to asses all risks that a device poses once it gets on the market. Opposition to the legislation claims the FDA is the appropriate body to set national safety standards and allowing juries to undermine its decisions will hinder product innovation.

Many believe the Supreme Court’s decision does not reflect the unpredictability of the FDA review process. Recently, for example, when doctors extracted a faulty electronic cable from a patient’s heart, a vessel was punctured causing excessive bleeding. The patient died two days later and a lawsuit against Medtronic, the manufacturer of the faulty device, was thrown out. This cable, called a lead, was never tested in humans before it went on the market and before Medtronic could recall the product, it was implanted in more than 235,000 patients; five of these patients may have died due to the problem.

The Supreme Court is currently deciding whether it should give the same type of legal protections to drug manufacturers in the case of Wyeth v. Levine. Hopefully, the Court will not grant such broad-reaching immunity for drug manufacturers. Drug companies, like all persons and entities in our country, should be held responsible for wrongful conduct, especially when such conduct sacrifices safety in the name of profits.

Originally posted at InjuryBoard by Greg Webb

FDA May Not Have Adequately Tested Heart Devices for Short-Circuiting, Physician Says

Greg Webb — Sun, 28 Dec 2008 21:51:28 GMT

The Food and Drug Administration is about to approve the use of a new electrical component for heart device implants, but it may not have adequately tested the device for potential risks, said Dr. Robert G. Hauser of the Minneapolis Heart Institute in an article he wrote with Dr. Adrian K. Almquist, published in The New England Journal of Medicine.

The problem, Dr. Hauser says, is in the design of a new way of connecting defibrillators to the wires that carry high-voltage electrical volts between the units and the heart. Currently, the two high-voltage wires enter the housing of a device through separate, insulated channels. In the new design, they effectively enter together and are insulated in a different way. This could increase the risk of short-circuiting, which could prevent the defibrillator from giving an electrical jolt to restore an erratically beating heart to a normal rhythm.

The new design will also be used in cardiac resynchronization therapy units, which combine defibrillators and pacemakers.

The FDA reasons that the new wiring connectors are a design modification, and not new technology, so human testing is not required. Instead, producers must carry out mechanical stress tests of the new connectors, and study testing done in animals. The FDA will also require manufacturers to carefully monitor the performance of the new units once they go on sale and are implanted. But Dr. Hauser believes testing should be done before the devices have gone into many patients. “Let’s test it first, before we put it into tens of thousands of people,” he said.

The FDA said in a letter published on the New England Journal of Medicine’s website that the required mechanical and animal testing was adequate to determine the unit’s risks. “Sometimes, nonclinical studies can be more informative than clinical evaluation with regard to device safety and effectiveness,” said the letter. Medtronic, the leading maker of heard devices, said the method of testing the new connectors was the same as the procedure used to develop the models currently in use.

Medtronic had some problems with the adequacy of their testing in 2007, however, when it recalled a new electronic lead for defibrillators called the Sprint Fidelis. The FDA approved the lead in 2004 on the basis of stress tests and animal studies, rather than human trials. The new leads, however, began to fracture and fail at high rates, leading to the recall after 235,000 people had them implanted. Dr. Hauser was one of the first to note a problem with Fidelis.

Dr. Hauser was also one of two cardiologists to go public years ago about short-circuiting problems in defibrillators made by former Guidant Corporation, now Boston Scientific. Those problems resulted in at least six deaths.

FDA officials said they would require manufacturers to conduct post-marketing studies of patients as soon as the sale of the units begins. Dr. William H. Maisel, a heart device expert in Boston, said, “[m]y concern is that the FDA does not have a great history of performing post-marketing studies on a timely basis.”

Originally posted at InjuryBoard by Greg Webb

HeartMate II Heart Pump Recalled After 5 Deaths

Greg Webb — Mon, 24 Nov 2008 08:00:00 GMT

The HeartMate II, a medical heart pump implant manufactured by Thoratec Corp., is being recalled after five people died while using the device.

In five years of clinical studies with 1,972 implants, wear and fatigue to an electrical wire have been reported in 27 cases, requiring the implants to be replaced. Five deaths occurred when the implant could not be replaced.

The recall affects two batches, catalog numbers 1355 and 102139, which were distributed to 153 hospitals and distributors both nationwide and internationally since November 2003. The pump was approved in April as a temporary treatment for patients awaiting heart transplants, but in the future may be used in “destination therapy,” or patients with end-stage heart failure who are too ill for a transplant.

Thoratec Corp. is urging patients to have their implants checked.

Originally posted at InjuryBoard by Greg Webb

US Senators Probe Cardiac Foundation’s Relationship To Device Makers

Greg Webb — Mon, 27 Oct 2008 08:00:00 GMT

Much to the dismay of cardiac doctors and medical device manufacturers meeting for their annual convention, two Senators from different sides of the aisle asked questions about the financial ties between the two parties. The lawmakers sent a letter to the sponsor of the convention, the Cardiovascular Research Foundation, asking the companies to disclose any financing received since 2003 from Abbott Laboratories, Medtronic, Boston Scientific, Johnson & Johnson and Medinol. They also asked for documentation of any payments or benefits the foundation paid to researchers. They also sent a letter to Columbia University, a longtime affiliate of the foundation. The senators are also proposing legislation that would require the industry to disclose such financial ties.

At the conference, doctors from around the world gather to view new products from major drug or medical device manufacturers; in this case, most products were focused on stents and other related surgical devices and drugs. At the same conference, researchers released the results of a new study, which indicates that a drug-coated stent called Endeavor, made by Medtronic, was linked to more heart attacks and deadly blood clots than the Cypher stent manufactured by Johnson & Johnson. The Cardiovascular Research Foundation has since agreed to cooperate fully with the information request; Columbia University said it would respond to the request as well. According to the Research Foundation’s most recent filings, it had revenue in 2005 of $47.2 million.

Originally posted at InjuryBoard by Greg Webb