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
(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.
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Allan Rubin and Harold Rubin,
MS, ABD, CRC, Guest Lecturer
updated February 25, 2010
To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com