Medical Equipment, Devices and Stents-Part II of a II Part Series

Editor's Note: To view Part I of this series please go to Medical Equipment Devices and Stents- Part I

(1/21/15)- As noted in our item dated 6/9/12, there has always been a vocal element calling for repeal of any tax on medical equipment. The tax imposed on medical devices under the Affordable Care Act has brought out the question as to how harmful is this tax?

A recent report from the Congressional Research Service, a nonpartisan arm of Congress concluded that many of the concerns were unfounded.

As a result of the tax, the report concluded that only 47 to 1,300 workers could lose their jobs. That accounts for only one one-hundredths to two-tenths of 1 percent of the jobs in the industry. In addition, the report went on to say, “innovation and research would be minimally affected.”

The tax, which took effect in 2013, is equal to 2.3% of the sale price of a medical device, and is expected to raise $29 billion over 10 years. It applies to such products as X-ray machines, MRIs, scanners, pace makers, artificial hearts, hips and knees.

The law exempts eyeglasses, contact lenses, hearing aids, wheelchairs and other devices that are “purchased by the general public at retail for individual use.”

(6/9/12)- The House voted 270-146 to repeal a tax manufacturers of medical devices that was intended to pay for expanding coverage to uninsured individuals under the new Patient Protection Act of 2010.

37 Democrats joined with their Republican colleagues in favor of ending the tax. The measure would apply a 2.3% tax on the sales of most medical devices, and is scheduled to take effect in January. The tax exempts goods such as contact lenses, hearing aids and eyeglasses.

(4/26/12)- Administration officials announced that they would expand the competitive bidding process for the purchase of medical equipment by Medicare beneficiaries to an additional 91 markets, from the 9 markets that have been part of the experiment until now.

Kathleen Sebelius, the secretary of health and human services, said the pilot program had reduced Medicare costs by 42%, or $202 million, by securing lower prices and curbing "inappropriate utilization" of personal medical equipment in the nine markets.

The greatest amount of the savings came from oxygen equipment, power wheelchairs and mail order test strips for people with diabetes.

The competitive bidding process represents a sharp break from the present system, wherein Medicare beneficiaries can purchase their needed medical equipment from any supplier that they themselves chose.

(3/21/12)- Researchers who analyzed data from more than 400,000 hip replacements for the National Joint Registry of England and Wales from 2003 to 2011 concluded that doctors should stop using metal-on-metal hip replacement devices.

Over 31,000 of the implants involved metal-on-metal products. After 5 years, about 6% of patients with the metal-on-metal product needed surgery to fix or replace them. That compares with 1.7% to 2.3% of patients with ceramic or plastic hip-replacement products.

The results of the study were published online in the Lancet, a British medical journal. The National Joint Registry financed the study.

(3/6/12)- Even though the results of the latest study published in a recent edition of The Archives of Internal Medicine that examined the value of stent implants concluded that it had no benefit over standard medical care in treating stable coronary artery disease, it does not mean that the argument is over.

Dr. David L. Brown, a professor of medicine at Stony Brook University, an author of the analysis stated that he believes one of the main reasons stent procedures are done is a financial. "In many hospitals, the cardiac service line generates 40% of the total hospital revenue, so there's incredible pressure to do more procedures," he said.

The researchers reviewed eight randomized trials comparing stent insertion patients with standard medical care patients. Standard medical care includes prescribing beta blockers, ACE inhibitors, statins and daily aspirin. The conclusion was that the standard medical care patients suffered less chest pain, heart attack, the need for future stent implants and even death.

The study followed the patients for an average of over 4 years. There were 7,229 patients in all, with half having the stent implant procedure done on them, and the other half being treated by standard medical care

(2/17/12)- The Government Accountability Office (GAO), conducted a study of the cost to hospitals of different medical devices that concluded that many hospital overpaid for this equipment, which in turn meant that Medicare and Medicaid programs also overpaid for the devices. The study was done at the request of Senator Max Baucus (Dem.-Montana), who is chairman of the Senate Finance Committee. The Senate Finance Committee oversees the Medicare and Medicaid programs.

There were 31 hospitals that were included in the survey, which also concluded that the price variations paid for the same medical devices from one hospital to another was often the result of confidential negotiations between the hospitals and the device manufacturers. The choice of which device was used was frequently done as a result of the request for particular equipment by the orthopedists at the hospital.

The orthopedists in turn, may have tie-ins to the device manufacturer. Medicare spent $19.8 billion on procedures involving implantable devices in 2009, up from $16.4 billion in 2004.

The report "raises serious concerns over the prices hospitals and Medicare are forced to pay for implantable medical devices" according to a statement from Senator Baucus.

(2/8/12)- Beginning in September of last year, Clarimed LLC began a site that contains adverse event reports filed with the FDA on 130,000 medical devices.

Medical device companies and the Food and Drug Administration have reached a tentative deal, whereby in return for increased fees paid by the device companies, the agency will increase its staffing and speed up the approval process for medical equipment.

The proposed deal calls for the payment by the industry of $595 million over five years, which is more than double the current $287 million that the industry pays to the agency in "user fees".

The new agreement sets goals to complete the most complex approvals within 385 days on average, and abbreviated ones in 124 days on average.

The number of full time employees at the FDA's Center for Devices and Radiological Health considering applications for medical-device approval will be increased by about 200 employees, from the current 1,001, over the course of the agreement.

The talks between the device makers and the agency lasted for more than a year, and were particularly acrimonious. The deal was to have been completed by the mid- January, and then to be sent on to Congress for its approval.

(10/24/11)- The California Technology Assessment Forum reversed a position it had taken last year involving hip resurfacing being as effective as traditional hip replacement surgery. In its report, the forum cited recent findings by orthopedic registries overseas that some resurfacing devices are failing prematurely, and that metal fragments breaking off from the devices are unsafe.

In hip resurfacing, rather than traditional hip replacement surgery, more of a patient's thigh bone is preserved than in a standard operation. The components used in hip resurfacing devices, such as cobalt and chromium are the same as is used in metal-on-metal traditional hip replacement devices.

The author of the report, Dr. Judith Walsh of the University of California, San Francisco noted that there was a lack of clinical trials directly comparing the outcomes of patients who got hip resurfacing with similar patients who got a standard replacement.

Recent information from databases in England and Australia showed higher-than-normal failure rates for some resurfacing devices.

(9/14/11)- A government-funded study of 451 patients that compared the effectiveness of treating them with stents as opposed to cardiovascular drugs was halted early because the drug treatment was more effective and safer.

The drug regimen included a combination of aspirin and Plavex, as well as aggressive treatment with cholesterol, blood-pressure and diabetes drugs.

The study found that the rate of stroke recurrence or death within 30 days was 14.7% among patients getting the stent plus drug treatment, compared with 5.8% among those treated with the medications alone. Most of the adverse events with stents occurred within a day of the procedure, and all of them happened within 6 days.

The patients in the study had already suffered a stroke or ministroke.

A follow-up study done a year later found that 20% of the stent patients and 12.2% of those treated only with drugs had died or suffered another stroke.

The study was published in a recent article in the New England Journal of Medicine

(9/2/11)- A recent edition of the New York Times contained an article written by Barry Meier and Janet Roberts entitled: "Hip Implant Complaints Surge, Even as the Dangers are Studied" that points out the increase in the number of complaints to the Food and Drug Administration about the all metal hip replacement devices.

Under FDA rules, many of these devices were sold without testing as to their safety, since the requirement under the Rule 501(k) process for approval is the requirement that the devices only need show that it "is as good as an already approved medical device."

The Times analysis of federal data indicated that the FDA has received more than 5,000 complaints since January about the metal-on-metal hip replacement devices, "more than the agency had received about those devices in the previous four years."

The article goes on to point out that this problem probably will become the most costly medical implant problem since Medtronics recalled one of the heart implant devices back in 2007 because of a component defect issue that resulted in 7,700 complaints.

Although the problem is not life threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Medical data experts estimate that about 250,000 hip-replacement operations take place in the United States each year.

The largest number of complaints are about Johnson & Johnson's Articular Surface Replacement (ASR) hip replacement product that was recalled by the company last year.

To conduct it analysis, the Times reviewed complaints filed with the FDA from 2007 through this June for several implants, including the ASR and the Durom cup, a component sold by Zimmer Holdings.

Under present rules, the medical equipment companies must file reports of complaints about its devices with the FDA, but doctors and patients do not have to file such reports.

(8/5/11)- A 227-page report by a 12-member panel of experts at the Institute of Medicine (IOM) called for a sweeping revision in the approval process for medical devices and medical products by the Food and Drug Administration.

The FDA commissioned the report in September 2009 to examine whether its supervision of medical devices could be improved. The report in particular singled out the approval process known as "510(k) approvals" wherein the medical device manufacturer merely had to show that its medical equipment was "substantially equivalent" to a medical device that had been previously approved by the agency.

Under the 501(k)-approval process the safety of the new device does not have to be studied through clinical trials.

"Reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective", the IOM report concluded. The report estimated that about one third of the approval for medical devices is done under the 501(k) exception rule.

The FDA said that it would now seek public comment on the IOM recommendations.

(6/23/11)- Johnson & Johnson announced that its Cordis subsidiary would cease manufacturing drug-coated heart stents by the end of the year. The company expects to take a $500 million to $600 million restructuring charge this quarter and to cut between 900 to 1,000 employees as a result of the move.

The worldwide market for coronary stents dropped to $4.2 billion last year, from $5.3 billion in 2006, according to the investment firm of Leerink Swann. Cordis' Cypher stent was the first drug-coated stent approved by the FDA in 2003, and J&J will stop research on its latest version of a drug-coated stent the Nevo.

There were 2.3 million stent procedures last year, a 3.2% decrease from the 2009 according to J.P. Morgan. Sales peaked in the drug-coated stent market in 2006 at an estimated $6.3 billion. The average stent procedure cost $1,664 in 2010.

Research in recent years, especially a report issued in 2007 suggested that stents are overused by doctors and that drugs are a cheaper, safer and more effective way for many heart patients to avoid repeat heart attacks and strokes.

Cordis launched the initial stent in 1994, and the drug-coated version nearly a decade later. Boston Scientific Corp., Abbott Laboratories and Medtronic Inc dominate the market for stents today.

(5/12/11)- The Food and Drug Administration has the power to require manufacturers of medical devices to conduct post-market studies as to safety as well as efficacy of their products even after the agency has given approval to market the device

Acting under this power the FDA sent a letter ordering about 20 manufacturers of a popular category of artificial hip to undertake postmarket studies of their implants. Under the order, producers of "metal-on-metal" hip implants will have to conduct these studies to see if any "shedding" is occurring of the devices.

Dr. William H. Maisel, the deputy director for science at the FDA's Center for Devices and Radiological Health, said the order left the particulars for conducting the study up to the individual manufacturer. "Our concern is the product, not about the manufacturer, said Dr. Maisel. The manufacturers have 30 days to file a proposed plan with the FDA. Of especial interest will be the taking of blood samples of the patients to determine the levels of metallic ion in their blood system.

(1/25/11)- Bowing to pressure from the medical equipment industry, President Barack Obama and the Food and Drug Administration retreated from its announcement to change its regulations for applications for approvals of medical devices under the so-called 510(k) process.

Under the withdrawn proposal, medical equipment devices would have had to undergo testing of their devices and not just claim that the device was "just as good" as an already approved device.

About 3,000 medical devices are cleared annually through the 510(k) process. For additional information on this matter please see our item dated 10/21/10 below.

The announcement was hinted at in an opinion article by President Obama in the Wall Street Journal edition dated January 18, 2011.

(10/21/10)- The Food and Drug Administration (FDA) announced that it was taking steps to revoke its approval of ReGen Biologics Inc's. knee device Menaflex. The announcement came about a year after the agency acknowledged that its decision to approve the device was influenced by outside pressures. For more info on this matter please see our items dated 4/8/10, 4/3/10, 2/25/10/ 9/28/10 and 9/22/10 below.

At the same time the FDA announced that it would meet with ReGen to discuss what data would be needed to prove the device is actually safe and effective. Approval for the device to be marketed was granted under the so-called 510(k) system, which procedure is currently under review by the agency.

An FDA spokesman said the agency has revoked device approvals before, although the step was rare.

A pilot program will get underway shortly to create a registry to monitor problems with hip and knee replacements. It is an offshoot from the American Academy of Orthopaedic Surgeons, and will involve 15 hospitals that will track basic details about patients, doctors, hospitals and implants.

The registry intends to expand its coverage next summer, with the exact details to be worked out later.

Sweden and Australia already have well-regarded national registries, and the state of Illinois has created its own registry also.

(8/8/10)- The Food and Drug Administration announced its proposals for new regulations of medical-equipment device approval under its so called 510(k) process.

Jeffrey Shuren, the agency's head of the medical device unit rejected suggestion that the changes would result in fewer devices being eligible for 510(k) approval or raise the need in general for extra medical studies.

The FDA began reviewing its medical-devices rules in September, 2009, after it had issued a critical report saying that its regulators had bowed to political pressure in approving a ReGen Bilogics Inc. knee device in 2008.

The aim of the proposed rules changes is to clarify the approval pathway for 510(k) applications, under which companies can get an accelerated approval decision if they can show a new product is similar to an already approved device. The proposals will be open for public comment.

The FDA said it wants to develop guidance that would clarify when older devices should not be used as a benchmark, or "predicate" for new products.

(5/31/10)- The results of a study that pitted Medtronics Inc. drug coated stent Endeavor Resolute against Abbott Labs stent called Xience Prime came away at just about a draw. The results of the study called "Resolute All Comers" was presented at the EuroPCR conference held recently in Paris.

The trial involved 2,300 patients with a wide variety of problems, including complex heart-artery clogs.

One of the study's main goals was a comparison of major events, such as death or recurring heart attacks. The rate was 8.2% with the Medtronic Endeavor versus 8.3% with Abbott's Xience Prime.

Abbott estimates that its Xience stents lead world-wide stent sales with about a 30% share of the market.

(4/30/10)- Should corporate executives be criminally prosecuted if they knowingly fail to notify recipients of their medical equipment products that contains what maybe-fatal defects?

The two prominent Minneapolis cardiologists who publicized the fatal defects in heart defibrillators once made by the Guidant Corporation, which is now part of Boston Scientific, are pursuing this interesting question.

A federal judge has rejected a plea agreement between the Justice Department and Guidant in which the company would plead guilty to two criminal misdemeanors charges and pay a $296 million fine.Judge Donovan W. Frank of the United States District Court in Minnesota said the provisions of the agreement were "not in the best interest of justice and do not serve the public's interest because they do not adequately address Guidant's history and the criminal conduct at issue."

The judge said that the prosecutors should have sought probation for Guidant and its parent, Boston Scientific.Probation requires the companies to take certain steps to insure safety, and also charitable giving by the companies.

The two cardiologists, Dr. Robert G. Hauser and Dr. BarryJ. Maron, have written a letter to judge Donovan W. Frank of the U.S. District Court in Minneapolis urging him to reject the deal.

The problem involving the defibrillators came to light in 2005 when the N.Y. Times published an articled based on interviews with Dr. Hauser and Dr. Maron. Gidant had known of the defect in two of its models that could have fatal consequences in patients who had the device implanted.

The company fixed the flaw in the newer models of the devices, but never alerted doctors or regulators about the problem. The defective models that were on the shelves of hospitals continued to be used, since regulatory authorities were never notified of the problem.

(4/8/10)- The inspector general for the U.S. Department of Health and Human Services, which oversees the FDA found that FDA managers did not engage in criminal actions against scientists who opposed approving several medical devices. For more background on this matter please see our item dated 9/28/09 below.

Ralph Tyler, the FDA's chief counsel said the agency does not plan to refer the matter to the Justice Department.

The allegations concerned approvals of some medical devices over the objections of veteran doctors and scientists inside the agency. One of the allegations brought by some of the FDA scientists was that political influence was used to get the approval for ReGenBiologic's Inc.Menaflex knee device by 4 U.S. Senators.

The FDA said it had hired a management-consulting firm to investigate workplace issues and allegations of management problems not addressed by the inspector general. Several former FDA officials in the device division have called that division out as being dysfunctional.

(4/3/10)- As a follow-up to our items dated 2/25/10j and 9/22/09 below, a Food and Drug panel found that there is not enough scientific evidence to come to a firm conclusion about the benefits of ReGen Biologics Inc's. knee device Menaflex, which is used to repair torn meniscus tissue in the knee.

"There is evidence of reasonable efficacy, but we have concerns about inadequacies of scientific proof" was the comment from the chairman of the panel, orthopedic surgeon John Kelly of the University of Pennsylvania Medical School.

Menaflex was approved under an abbreviated process called 510(k) that applies to products similar to devices already on the market. A major question in this matter is whether or not the FDA can revoke an approval granted by the agency in the absence of scientific evidence showing that the device is unsafe for usage.

Jeffrey Shuren, the FDA device division director said the agency had several possible courses of action it could take in this matter. One of them would be to reclassify Menaflex as a high-risk device, which could require a new application. Menaflex is currently classified as a lower-risk product.

(3/26/10)- Medical equipment companies can pay third-part companies to review their products for approval without having to go to the FDA itself for their approval. There are currently 12 companies on the FDA's list of approved third-party reviewers.

This process has come under fire, and the agency is weighing whether or not to end the process.

In the year ended September 30, 2008, about 300 medical devices went through third-party review examiners, compared with 185 five years earlier Jeffrey Shuren, the device division director, said the agency would release proposed changes later this year.

To qualify for an outsourced review, a new device must be similar to a device already on the market, and it must carry low or moderate risk to the patient. The outside reviewers do not have access to the whole file that the FDA has on the product, and one of the proposals under consideration is that the outside examiner be able to see all the material that exists in the agency's file on the device.

(3/17/10)- Why should federal law and regulations pre-empt state laws and regulations in regards to medical equipment matters, while the opposite is true for pharmaceutical questions? We may see an end to this incongruity when the U.S. Supreme Court rules in a recent case brought before the justices.

The case in question is Bruesewitz v. Wyeth, which has come up through the Pennsylvania state court system. In this case the parents allege that their 6-month old daughter developed residual seizure disorder after receiving a diphtheria, tetanus and pertussis vaccine manufactured by Wyeth, now a unit of Pfizer Inc. Wyeth denies its vaccine caused the disorder, and also claims that since the vaccine was approved for usage under federal rules, it is immune from being sued if anything goes wrong.

The Supreme Court has previously ruled that federal law pre-empts suits against medical-device manufacturers filed under state liability statutes, but different language must be applied against pharmaceutical lawsuits.

(2/25/10)- In our item dated 9/8/09 below, we discussed the possible abuse of the fast-track process known as 501(k) by the medical equipment manufacturing company ReGen Biologixs Inc. to get its knee replacement product Menaflex approved by the FDA.

According to an article published in the February 18, 2010 edition of the Wall St. Journal, the FDA may "tighten or eliminate several pathways for getting a medical device approved quickly" because of possible abuses to the system.

The Journal article said that the proposals came up in a December 22 briefing involving officials in the FDA's device division.

A public hearing will be held on Thursday February February 25th at which time the industry will be given an opportunity to express its viewpoint.

The article went on to state that more than 3,000 medical devices have been approved under the 501(k) process, wherein a third party approves a medical device, meaning that the FDA does not thoroughly examine the device within its own evaluation standards. In the Menaflex matters, as you can see from the item about it below, it was alleged that political pressure was brought on the agency by 4 U.S. senators.

(2/9/10)- Boston Scientific, the medical equipment manufacturing company, announced recently that it would pay $1.725 billion to a unit of Johnson & Johnson to settle a long-running patent dispute between the two companies over patents for coronary stents. This would be the largest sum ever paid to settle a patent litigation, surpassing the payment by Medtronic of $1.35 billion to Dr. Gary K. Michelson, the developer of spinal implants in a deal reached in 2005

In that deal, Medtronic paid $550 million to settle a lawsuit and also paid $800 million to acquire Dr. Michelson's patents.

Boston Scientific said it would pay $1 billion to Cordis, the unit of J&J involved in the dispute, with the balance of $750 million to be paid early in January of next year.

The settlement between Boston Scientific and J & J is in addition to a $716 million payment by Boston to J & J under a September settlement on 14 other patent-infringement lawsuits.

(10/15/09)- Two years ago, five of the major medical equipment manufacturing companies agreed to disclose payments that they make to physicians and other health professionals. The agreement to release this information was part of a settlement agreement the companies made with the U.S. Justice Department, as part of a Medicare fraud investigation.

The five companies are Zimmer Holding Inc and Biomet Inc. of Warsaw Ind.; Stryker Corp. of Kalmazoo Michigan; Smith & Nephew PLC of London, Eng.: and the DePuy Orthopedics division of Johnson & Johnson, New Brunswick, N.J.

The results of a study that was published in a recent edition of the New England Journal of Medicine concluded that surgeons were failing to report over 20% of these payments when presenting research related to the companies product.

The researchers in the study compared the disclosures made by surgeons who presented research at the March 2008 annual meeting of the American Academy of Orthopedic Surgeons against a similar list published by the five companies.

The researchers found that among 344 payments disclosed by the companies in their agreement with the government, only 245 were disclosed by the recipients making presentations at that meeting. Looking only at payments "directly related" to the topic of a doctor's presentation, the study found that 165 of 208 such payments were properly disclosed.

In total more than $4 million in directly related payments were not disclosed.

Both Massachusetts and Vermont have state laws that require surgeons to reveal these payments, and on a federal basis a law, the Physicians Payment Sunshine Act, is pending a vote in the U. S. Senate as part of the health-care reform bill.

(10/3/09)- The results of several studies of stents that was presented at a recent meeting of the Transcatheter Cardiovascular Therapeutics meeting in San Francisco gave the edge to the products from Medtronic Inc and Abbott Laboratories over Boston Scientific's Taxus Liberte stents.

In a trial of 1,800 patients at the Maasstad hospital in Rotterdam, the Netherlands, Xience from Abbott saw that about 5.4% of patients with Boston Scientific's stent had a nonfatal heart attack in the first year, compared with 2.8% with Xience.

There was no difference in the percentage of deaths, but patients with Abbott's stent needed fewer returns to the operating room for a repeat operation to reopen a re-clogged artery.

Another study funded by Medtronic found that its Endeavor stent resulted in a 3.6% of deaths and heart attacks after three years, versus 7.1% for an older Boston Scientific stent, Taxus Express.

A study funded by Abbott measuring the same occurrences found a 2.8% rate for Xience versus 4.1% for Taxus Express after one year.

(9/28/09)- The Food and Drug Administration issued a report, which sharply criticized the agency for approving ReGenBiologic's Inc.Menaflex knee device. The report stated that top FDA officials at that time repeatedly deviated from established procedures because of pressure from four Democratic congressmen from New Jersey to get the device approved.

The four congressmen were Senators Frank Lautenberg and Robert Mendez, and Representatives Steve Rothman and Rrank Pallone Jr. ReGen is based in New Jersey.

Joshua Sharfstein, the agency's principal deputy commission, said in a conference call that the report shows that there were "definite threats" to the integrity of the FDA's medical device review process. He also said that there is presently no reason that the agency is aware of that show that the product is defective in any way.

The report also questioned the agency's fast-track process know as 510(k) under which the Menaflex product was approved. Under this fast-track process device makers do not have to conduct extensive clinical trials to win approval of their product.

The agency has asked the Institute of Medicine to independently study the effectiveness and safety of the Menaflex knee device.

(5/17/09)- Anne Milgram, the New Jersey attorney general announced a settlement with Synthes, a West Chester, Pa., unit of a Swiss company with the same name that she accused of failing to disclose financial conflicts of interest among doctors researching its products. At the same time she announced that her office was continuing to investigate 5 other medical equipment companies for similar conflicts of interest violations.

The settlement called for the company, the maker of the ProDisc artificial spinal disk, to disclose any future payments or investment held by docotrs involved in researching its products. The company would also pay $236,000 to reimburse the attorney general's office for its investigation. The state pursued the case as a matter of consumer fraud.

To see more on this matter please see our item dated 3/27/0 in the article Low Back Pain: Does Treatment Help?

(5/2/09)- When the U.S. Supreme Court rejected Wyeth's claim of "preemption" as a defense in the lawsuit involving its drug Phenergan, it left it up to Congress to overturn that defense in regards to medical equipment lawsuits. The court upheld the $6.7 million verdict in favor of a Vermont woman who lost her arm after when she was improperly injected with the drug.

In our item dated 1/18/09 in Part I of this series of articles, the court therein ruled that the doctrine of "preemption" is a valid defense available to defendants when sued in connection with medical equipment items that had been approved by the FDA. In February 2008 the Supreme Court by 8-1 vote ruled that a plaintiff might not sue under state law to challenge the safety or effectiveness of a medical device to which the FDA has given "premarket approval." Riegel v. Medtronic, Inc., 2008 WL 440744 (Feb. 20, 2008) unless fraud was proven in getting the approval.

Some Democratic congressmen have moved to reintroduce the Medical Safety Act, a bill that would allow lawsuits against companies that make heart devices, catheters, replacement hips and other medical equipment items. Representative Frank Pallone Jr (Dem.-NJ) who is chairman of the health subcommittee of the Energy and Commerce Committee introduced the legislation in the House, and Sen. Edward M. Kennedy (Dem.-Mass) introduced companion legislation in the Senate.

(2/28/09)- Two former salesmen for Stryker Inc., a leading manufacturer of medical equipment devices, have pleaded guilty to charges that they had promoted off-label use of some of the company's products even though they knew that such use had caused problems in some patients.

The United States attorney's office in Boston said the investigation in this matter was still continuing.

The two company products over which the matter arose are OP-1 and OP-1 putty. OP-1 is a naturally occurring protein that promotes bone growth and OP-1 putty, is a moldable compound that includes the protein. The Food and Drug Administration has not formally approved either product for sale to the public.

The FDA allowed limited use of OP-1 in patients whose broken shin or thigh bones had failed to heal properly in 2001, and in 2004 it allowed limited use of OP-1 putty in patients who had failed spinal fusion.

The FDA grants a "humanitarian device exemption" when it believes that a small number of patients may benefit from a treatment whose effectiveness has not been fully proved. A device can be used in up to 4,000 patients a year under this type of approval.

Court filings indicate that the Justice Department may be seeking to determine whether Stryker knew the products were being promoted for unauthorized, or off-label use.


Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated January 21, 2015

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