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FDA Wants National Network of Orthopedics Registries

The goal is to enable the agency to more rapidly find connections between medical products and adverse events, enabling faulty products to be fixed or pulled off the market sooner, so they affect fewer patients. The agency plans to get quotes from companies that would be able to evaluate implant registries for participation in the program. Products it is looking to monitor include total hip implants, total knee implants, hip resurfacing, intervertebral disc implants, and ankle devices. -- From PrecisionTalk.

Former Boston Scientific Division Unveils New Identity

Its CEO is Ron Sparks, who was named in 2004 as one of MD&DI's 100 Notable People in the device industry, for his orchestration of the merger between contract manufacturers UTI Corp. and Medsource Technologies, which became Accellent.

CMS Approved Fake Vendors

One of the fake companies was even given the passwords necessary to bill Medicare. CMS has said that about 10% of the $10 billion it spent on durable medical equipment from March 2006 to March 2007 was improper, partly because of fraud.

Trial for Early Melanoma Detection Device Underway

Algorithms analyze these data against a database of melanomas and benign lesions. Based on the analysis, the system generates an objective, detailed report with an immediate recommendation of whether the lesion should be biopsied.

Task Force: Prostate Cancer Screening Not Needed for Men over 75

Risks include erectile dysfunction and bladder and bowel problems, while benefits are "slim to none." This could be a blow for firms who make the PSA test, the standard of care, and the alternative tests being developed to potentially replace it. The issue is that most prostate cancers grow so slowly that they never become life-threatening. However, there is not yet a way to distinguish which tumors will fast enough to be a threat and which won't. The laissez-faire approach is already in practice to some extent. About 10 years ago, my grandfather developed prostate cancer in his 80s and his doctors decided not to treat it, figuring his heart problems would kill him well before the prostate cancer would. This unfortunately turned out to be correct. -- Erik Swain UPDATE: The New York Times has a piece questioning "our seemingly endless quest to detect cancer in otherwise healthy people." It says that tests may not be too helpful if they mostly diagnose tumors that wouldn't become fatal during a patient's expected lifespan.

Implant Alternative to LASIK Surgery Gains Steam

ICL procedures are becoming more popular for people who are nearsighted, because laser surgery isn't always effective in those cases. Patient are more aware of questions being raise about refractive laser surgery and are asking their doctors for other options. The downfall to ICL surgery is that it costs between $500 and $1000 per eye, and isn't permanent. Last year 5,000 ICL procedures were performed, versus 1.5 million LASIK procedures. Staar Surgical has been struggling during the past few years, but its new CEO, Barry Caldwell, is getting the company back on track. Since Caldwell came on board, the company's shares have risen more than 60%, and its last quarter's sales were the company's best thus far.

China Eyes High-Tech Manufacturing

Right now, Chinese firms aren't major players in medical device manufacturing, save for a few commodity products, though some global firms have been using Chinese labor to produce devices for the Asian market. But now Chinese industry is tired of sticking to low-cost, low-margin manufacturing, and the Chinese government is enacting policies to encourage high-tech manufacturing and discourage low-tech. One major stumbling block remains: China's weak intellectual property laws. But if progress is made there, China could become a major player in medical device manufacturing, and perhaps push prices lower.

Medtech Industry Asserts Value and Effectiveness of FDA 510(k) Classification as GAO Readies Assessment Report


Under the provisions of the FDA Amendments Act of 2007(FDAAA), the Government Accountability Office (GAO; Washington, DC) is scheduled to issue a report to Congress on the "appropriate use" of FDA's 510(k) premarket notification process for the evaluation and approval of medical devices. The provision calling for such a report grew out of Congressional hearings during the Summer of 2007, before the bill was approved and signed into law by President Bush last September.

Several consumer groups, including Public Citizen (Washington, DC) and the National Research Center for Women and Families (NRC; Washington, DC) questioned the wisdom and validity of the 'substantially equivalent' predicate device concept, which is a core tenet of the 510(k) process.

Zuckerman

Testifying before the health subcommittee of the House Committee on Energy and Commerce, in July 2007, NRC president Diana Zuckerman, PhD, called upon the legislators to seek a detailed analysis of how devices are evaluated and approved under the 510(k) protocol.

"Although the standard of 'substantially equivalent' for devices sounds almost like the standard for a generic drug, the reality is completely different," Zuckerman testified. "Many medical devices approved by the FDA through the 510(k) process are not like any medical devices already on the market, and are instead made of different materials, used for different purposes, use a different technology, or are otherwise 'new and different' rather than slightly improved."

Zuckerman and spokespersons for other consumer and pubic interest groups would like to see more rigorous evaluation of all medical devices, which would typically require greater use of clinical trials similar to medical products that are subject to FDA's premarket approval (PMA) process.

The 510(k) protocol was initially codified in the Medical Device Amendments of 1976, which significantly strengthened FDA's authority to regulate medical devices. The protocol has continued to evolve through agency guidance documents and legislation. The concept of substantial equivalence was acknowledged in the 1976 legislation and subsequently became codified in the Safe Medical Devices Act of 1990.

Concerned that FDA's 510(k) protocol is misunderstood, AdvaMed issued a report titled The 510(k) Process: The Key to Effective Device Regulation earlier this month. The organization described the report as a white paper that "outlines the history and evolution of FDA's 510(k) program from its inception with the Medical Device Amendments of 1976 to the present day, explains why the program is an appropriate and effective regulatory approach for the vast majority of medical devices, and dispels some common misconceptions about the program."

Trunzo
AdvaMed's Trunzo: A proven track record.

"The 510(k) process has a proven track record in ensuring the safety and effectiveness of medical technology while encouraging device development and meeting the needs of American patients, said Janet Trunzo, AdvaMed executive vice president of technology and regulatory affairs. "Unfortunately, this key regulatory process and the important role it plays in ensuring the integrity of medical devices in the U.S. market is not well understood."

AdvaMed says that 90% of all medical devices are evaluated and approved through the 510(k) process.

Leahey
MDMA's Leahey: Solid framework.

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC) said, "We vigorously support the 510(k) protocol. We believe it provides both a solid framework and flexibility for evaluating particular kinds of medical devices. FDA already has—and frequently exercises—its authority to require additional information and action steps before a device is approved via the 510(k) protocol. Of course, FDA always has the option of requiring a manufacturer to submit the device under the PMA standard."

The GAO report will review both 510(k) and PMA data over the five-year period of 2003–2007. In preparing the report, the agency met with representatives from AdvaMed, MDMA, FDA, and various other stakeholders. Although the report is due September 27, a GAO spokesperson has indicated that a written document will not be available at that time, but the agency will brief both the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee on the salient findings.

The AdvaMed white paper, The 510(k) Process: The Key to Effective Device Regulation is available via www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/PR-81908-FDA510K.htm.

© 2008 Canon Communications LLC

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IP Watch: Medtronic Cites NuVasive for Patent Infringement


Earlier this month, Medtronic Inc. (Minneapolis) brought suit against NuVasive Inc. (San Diego), alleging that the company has infringed on 12 Medtronic patents in four product categories. Medtronic and NuVasive vie in the highly competitive $6.2 billion global market for spine surgery instruments, implants, and related devices. Medtronic, the world's largest pure-play medical device manufacturer, dominates the spine space with a 35–40% market share.

Medtronic has not issued any press release or official statement on its action. NuVasive says that it was not informed about the matter in advance of the filing and only became aware of it when the company received a copy of the complaint, which was filed in a San Diego court. In an Associated Press article, Medtronic spokesperson Mary Beth Thorsgaard commented that "Medtronic respects the patents of others and we expect others to respect our patents."

Lukianov
NuVasive chairman and CEO Alex Lukianov expressed confidence in his company's response to the suit. "It is not surprising that Medtronic would attempt to intimidate NuVasive with this suit, since NuVasive represents a growing threat to Medtronic's spine business," he said.

Lukianov said the company is in the process of reviewing the complaint and assessing its defenses. "Based on our initial review, we do not expect our existing operations to be significantly disrupted as we respond to this lawsuit." Suggesting the possibility of a countersuit, he said the company was analyzing the potential for action "based on our own significant patent portfolio and intellectual property rights."

NuVasive is among a number of emerging companies vying for market share in the spine sector. Medtronic recently acknowledged the challenge of such a competitive environment, telling investors that its market position in the spine sector "remains under pressure, primarily from the proliferation of smaller, privately held companies". In the most recent reporting period, Medtronic's spine sales increased by a respectable 8.1%, while revenues at NuVasive soared by 61%.

NuVasive and industry analysts questioned the timing of the Medtronic suit, noting that the allegedly infringing products have been on the market for several years. The company's product portfolio includes a minimally disruptive surgical platform called Maximum Access Surgery, in addition to other spine products focused on motion preservation.

Medtronic's spine division is headquartered in Memphis, TN, where it employs 1540. Spine unit sales for the fiscal year ending on April 25, 2008, were $2.98 billion, an increase of 23% over the year-earlier period. NuVasive, with 345 employees, posted 2007 revenues of $98.1 million, a 57% increase over 2006.

Other IP News in Brief

  • Masimo Corp. (Irvine, CA), a manufacturer of monitoring technologies and equipment for patient care announced earlier this month that it had settled pending litigation initiated by Shaklee Corp. (Pleasanton, CA) and NIR Diagnostics Inc. (Campbellville, Ontario, Canada). The initial claim, alleging that Masimo's pulse oximeters included patented calibration methods licensed by Shaklee to NIR, was filed in July 2007. At the time of the filing, the litigants sought an injunction against Masimo and compensation for financial damages.
  • On August 13 of this year, Masimo and Shaklee filed a joint stipulation with the United States District Court for the Central District of California, dismissing their litigation. On August 22, Masimo and NIR followed with a similar action. The settlements were reached without Masimo incurring any liability to either Shaklee or NIR. None of the three parties had any official comment on their actions or the nature of their settlement.

  • Earlier this month, Candela Corp. (Wayland, MA) announced that the United States District Court for the Eastern District of Texas, Lufkin Division, had issued its Markman ruling on the company's patent lawsuit against Palomar Medical Technologies Inc. (Burlington, MA). In a Markman ruling, a district court interprets and rules on the scope and meaning of disputed claim language relating to the patents in an infringement case. In a prepared statement, Candela observed that "a Markman decision is often a significant factor in the progress and outcome of patent infringement litigation."
  • According to Candela, the court's Markman order adopted interpretations favorable to the company on all claim terms in dispute in the litigation. "We remain confident in our position concerning Palomar's infringement of the patents at issue, and look forward to proceeding to trial," said Candela president and CEO Gerard Puorro.

    Palomar has not officially commented on the case since the initial filing in December 2006. At that time, Palomar described Candela's action as a "defensive maneuver," since Palomar had filed suit against Candela for alleged patent infringement in August of that year. Of that action, Palomar president and CEO Joseph P. Caruso said, "Palomar's lawsuit against Candela is part of our ongoing patent enforcement strategy. The patents Palomar has asserted against Candela include the same patents that Palomar has successfully asserted against others with the same technology. We have received approximately $60 million to date from these efforts and intend to continue with this successful strategy."

    Candela and Palomar manufacture products using light and laser technology to treat both medical and cosmetic conditions.

  • I-Flow Corp. (Lake Forest, CA) has announced the initiation of a lawsuit against Apex Medical Technologies Inc. (San Diego) for infringing the company's patents and misappropriating I-Flow's trade secrets in the development of Apex Medical's Solace Pump. In a separate but related action, I-Flow said it has brought suit against two distributors of the Solace Pump.
  • In a prepared statement, I-Flow said that Judge Dana Sabraw of the United States District Court for the Southern District of California interpreted the patent claims "in a manner consistent with I-Flow's position in the case."

    I-Flow manufactures drug-delivery devices and surgical products for postsurgical pain relief and surgical-site care. Products include portable infusion pumps; catheters; kits used to administer local anesthetics directly to the wound site; and disposable infusion pumps used to administer chemotherapies, antibiotics, and other medications.

    Apex Medical is an FDA-registered contract medical device manufacturer. The company has not commented on the case.

    © 2008 Canon Communications LLC

    Return to MX: Issues Update.

    Update on Pending Congressional Medtech Legislation


    When Congress returns to session this September, it is expected to begin addressing a number of bills that directly affect the medtech industry. Legislation already introduced includes bills relating to medical device safety, transparency with regard to both physician relationships with medtech manufacturers and the pricing of devices, and consumer advertising.

    Medical Device Safety Act of 2008 (HR 6381; S 3398)

    Generally considered to be the pending legislation of greatest concern to medtech manufacturers is the Medical Device Safety Act of 2008, which, if it became law, would set aside the recent Supreme Court decision upholding the federal preemption clause contained in the Medical Device Amendments of 1976. The preemption clause stipulates that a state cannot enact device requirements that are different from the federal standards imposed by FDA. In the case of Riegel v. Medtronic Inc., the Supreme Court, in an 8–1 decision, ruled that FDA was the exclusive authorizing body for the market approval of medical devices, thereby preempting product liability lawsuits in state courts.

    Scalia

    In his majority opinion, Justice Antonin Scalia said that permitting state courts to impose liability on the manufacturer of an approved device "disrupts the federal scheme" which stipulates that FDA has the sole responsibility for evaluating the safety and efficacy of a new device. Justice Scalia wrote that state tort law, in effect, was an additional and different requirement from that authorized by FDA.

    Opponents of the court's interpretation of the federal preemption clause assert that it limits the right of injured patients to sue medical device manufacturers and that corrective legislation is needed. The proposed Medical Device Safety Act explicitly preserves the right of medical product liability lawsuits to be adjudicated in state courts: "Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

    Pallone
    Pallone: Reversing the Court.

    The House bill was introduced on June 26, by representatives Frank Pallone (D–NJ), chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman (D–CA), chairman of the House Oversight and Government Reform Committee. In introducing the bill, Pallone said, "Congress should pass this legislation to help protect patients from defective and dangerous medical devices. This bill reverses the [Supreme Court] decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product."

    At the time the bill was introduced, Waxman sent a letter to FDA commissioner Andrew C. von Eschenbach, MD, requesting all agency records and correspondence relating to the preemption doctrine dating back to January 21, 2001.

    On July 31, Senator Patrick Leahy (D–VT) introduced similar legislation in the Senate (S 3398) on behalf of Senator Edward M. Kennedy (D–MA) and himself. Leahey is chair of the Senate Judiciary Committee; Kennedy is chair of the Senate Health, Education, Labor and Pensions Committee.

    Kennedy
    Kennedy: Basic fairness.

    Commenting through a spokesperson, Kennedy said, "The issue is a matter of basic fairness. Medical device companies should responsibly design and manufacture safe products and they should be held accountable when these products injure consumers. Congress never intended in the 1976 Act to protect manufacturers from liability for injuries caused by flawed devices. This bill rightly protects consumers and makes Congressional intent crystal clear."

    The proposed legislation has the support of several public interest and consumer groups, including the Alliance for Justice (Washington, DC) and Public Citizen (Washington, DC).

    Zieve
    Zieve: Invaluable incentive.

    "The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels as soon as they become aware that they are inadequate, and to remove unsafe products from the market," said Public Citizen lawyer Allison Zieve.

    Both national medtech industry associations oppose the legislation.

    Ubl
    AdvaMed's Ubl: Needless delays.

    "This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits, and ultimately higher healthcare costs," said Stephen Ubl, president and CEO of AdvaMed (Washington, DC). "If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices. It would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in lifesaving, life-enhancing technologies simply not being available for patients. Congress provided express authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans."

    Leahey
    MDMA's Leahey: Congressional intent.

    Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC), said, "MDMA continues to believe that the FDA approval process, as intended by Congress, should determine the safety and effectiveness of medical devices. The Waxman-Pallone legislation would open up the regulatory process to multiple state entities, leading to inconsistent product indications and labeling. The legislation would also prohibit patient access to innovative and lifesaving medical technologies." In connection with the Riegel v. Medtronic Inc. case, MDMA filed an amicus curiae brief with the Supreme Court in support of preemption.

    The preemption of lawsuits in state courts does not apply to 510(k) products, or to PMA products that have been adulterated or misbranded.

    The House bill, currently with 67 cosponsors, has been referred to the House Committee on Energy and Commerce, where there has been no further action since the date of introduction.

    The Senate bill currently has 13 cosponsors. Following introduction, it was referred to Senate committee, where it was read twice and subsequently referred to the Committee on Health, Education, Labor, and Pensions.

    Transparency in Medical Device Pricing Act of 2007 (S 2221)

    The Transparency in Medical Device Pricing Act of 2007 would amend Title XVIII (Medicare) of the Social Security Act to require manufacturers of implantable medical devices to report annually to the Secretary of Health and Human Services on sales prices and related data about such devices.

    Specter
    Specter: Show us your prices.

    The pending legislation was cointroduced on October 23, 2007, by senators Charles Grassley (R–IA) and Arlen Specter (R–PA). If the bill becomes law, it would require medtech manufacturers seeking payment under Medicare and related programs to issue quarterly reports about the average and median sales prices for all of their implantable medical devices used in inpatient and outpatient procedures. Manufacturers that misrepresent or fail to report pricing data would be subject to fines up to $100,000.

    In introducing the legislation, Grassley said, "Both parties to a transaction need information in order for the free market to properly work. If only one party has information, the market does not properly function because you have a one-sided negotiation. The purpose of this legislation is to bring transparency to medical device pricing so that there will be sufficient information available for market forces to truly work."

    The bill would require that medical device pricing information be posted on a Web site maintained by the Department of Health and Human Services (HHS; Washington, DC). "By making important information available in a readily useable manner and in collaboration with similar initiatives in the private sector and nonfederal public sector, we can help control government spending on healthcare," said Specter. "This bill says that if you want to do business with the federal government, you have got to show us your prices."

    AdvaMed (Washington, DC) said it was extremely concerned with the proposal, asserting that it would not assist patients, interferes with free-market negotiations between device makers and hospitals, and offers no discernible benefit in reducing healthcare costs. AdvaMed also noted that a study it commissioned and reported on earlier this year revealed that overall medical device prices grew at a slower rate than either the consumer price index (CPI) for medical services or the overall CPI during the study period. The study found that medical device prices have increased about 1.2% annually from 1989 through 2004, compared with 5% for the medical consumer price index and 2.8% for the CPI.

    "Medical device prices, on average, have grown at less than half the rate of overall CPI and less than one-quarter the rate of other medical goods and services," said Stephen Ubl, AdvaMed's president and CEO.

    Commenting on the proposed legislation, Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC), said, "Medical devices represent—at most—about 4–6% of healthcare costs. The proposed legislation no doubt has populist appeal, particularly in an election year, but if the concern is truly about healthcare costs, then we need to look at Medicare and private insurance funding."

    Since its introduction on October 23, 2007, the bill has been read twice and referred to the Committee on Finance. There has been no other action reported.

    Most industry analysts believe that this bill is dead in the water, since it has no other sponsors and there is no companion legislation in the House.

    Physician Payments Sunshine Act of 2007 (S 2029; HR 5605)

    This bill would amend Part A of Title XI of the Social Security Act to require quarterly transparency reports to the Secretary of Health and Human Services of payments to physicians or their employers by manufacturers of covered drugs, devices, or medical supplies under titles XVIII (Medicare), XIX (Medicaid), or XXI (State Children's Health Insurance Program [SCHIP]) of the Social Security Act.

    The proposed legislation would require drug and device manufacturers with at least $100 million in annual revenue to disclose to the Secretary of Health and Human Services (HHS), on a quarterly basis, any gifts, payments, travel, honoraria, or other items valued at $25 or more, that are given to doctors. Companies would be required to disclose the amount or value of the gift or payment, the name of the receiving physician, the date and purpose of the activity, and what, if anything, was received in exchange.

    The bill would also require the Department of Health and Human Services to make the information available to the public through a searchable Web site.

    The Senate bill was introduced on September 6, 2007, by senators Charles Grassley (R–IA) and Herb Kohl (D–WI).

    "This bill sheds light on these hidden payments and obscured interests through the best disinfectant of all: sunshine," said Grassley. "This is a short bill, and a simple one. And this bill has some teeth, too. If a company fails to report, the Physician Payments Sunshine Act imposes a penalty ranging from $10,000 to $100,000 for each violation."

    The House bill was introduced by representatives Peter De Fazio (D–OR) and Pete Stark (D–CA) on March 14, 2008.

    Stark
    Stark: Changing behavior.

    "Patients deserve to know if doctors are on the take," said Stark. "Gifts and payments change doctors' behavior. If they didn't, drug, device, and medical supply companies wouldn't bother. The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients' best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."

    Keenly aware of the popular perception that manufacturers and physicians seem to sometimes enjoy an all too cozy relationship, both AdvaMed and MDMA support the transparency aspects of the legislation. Concerns remain, however, and each organization is recommending changes to the legislation that would decrease the burden of manufacturer compliance and increase the level of context in which information regarding physician payments is reported.

    White
    White: Qualified support.

    Christopher White, AdvaMed's executive vice president, general counsel, and secretary, said, "With some reasonable modifications to ensure a fair and level playing field for our companies, to provide clear, meaningful information to patients, and to preserve the relationships beneficial to patients and continued medical innovation, we believe our industry could support this legislation."

    Both industry organizations are pleased with some revisions in the bill, which would override physician sunshine laws at the state level by establishing national rules and regulations for ensuring and facilitating uniform compliance.

    The Senate bill currently has six sponsors. It was referred to Senate committee following its introduction and is undergoing review and analysis by the Committee on Finance.

    The House bill has 18 cosponsors and is currently at the Subcommittee on Health.

    Responsibility in Drug and Device Advertising Act of 2008 (HR 6151)

    DeLauro
    DeLauro: The rush to promote.

    Introduced on May 22, 2008, by representatives Rosa L. DeLauro (D–CT), and Jo Ann Emerson (D–MO), this bill would immediately implement safeguards in direct-to-consumer advertising following FDA approval of a new drug or device.

    "While we recognize the livesaving capabilities of new drugs and devices, the rush to promote new drugs and devices often occurs before there is any opportunity to examine potential public health and safety risks," said DeLauro. "This is about ensuring that physicians and patients have scientific evidence—collected from a larger population, rather than the small clinical trials—about the drugs and devices on the market. The FDA has important drug oversight responsibilities; and the push to promote new drugs and devices should not get in the way. Public relations should never trump public health."

    The Responsibility in Drug and Device Advertising Act of 2008 would:

  • Establish a three-year moratorium on DTC ads with a possible waiver if the secretary of HHS agrees that the product is of affirmative value to public health.
  • Provide authority to require corrective materials to be distributed if the companies violate the advertising moratorium.
  • Include strong civil penalties that apply to the first and subsequent violations of the ad provisions or other requirements of the act.
  • Require DTC advertising to prominently display information about potential drug and device side effects.
  • Call for a public education campaign on the risks of certain drugs.
  • The bill has five cosponsors, but does not yet have companion legislation in the Senate. It was referred to House committee following introduction, and is currently with the House Committee on Energy and Commerce.

    For the latest information on Congressional legislation, go to either of these sites: GovTrack at www.govtrack.us/congress/; or Thomas Library of Congress, at http://thomas.loc.gov/home/bills_res.html.

    © 2008 Canon Communications LLC

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