In what is likely to be generalized as a minor victory for the medical device industry, Lifecore Biomedical (Chaska, Minnesota) last month won its product appeal before the new scientific dispute resolution panel of the FDA's Center for the Department of Radiological Health (CDRH). The panel voted 4-0 to recommend clearance of the company's Intergel product for the treatment of adhesions following gynecological surgery. The product had been rejected for approval this past November, and LifeCore chose to appeal that decision before the new panel, set up by CDRH Ombudsman Les Weinstein. The appeal was thus the first case to be heard by the new group, specifically set up to tackle debates over the assessment of scientific data coming out of clinical trials of new products
The panel's "yes" vote will be forwarded to David Feigal, head of CDRH, for a final decision, expected later this month. Assuming a positive decision by Feigal, the panel's action indicates that the appeals route is a valid path for companies attempting to reach product commercialization. Such a path would seem increasingly necessary, given the development of new technologies that the FDA itself has acknowledged it cannot always assess because of their uniqueness and the lack of precedents.
The Intergel product is described as an isotonic, viscous solution of sodium hyaluronate which has been ionically cross-linked with iron. In his analysis, FDA statistician Richard Kotz said that Intergel had failed to demonstrate superiority over the control group for the primary endpoint. But Mark Carlson, a panel member, commented, "With the data that I had this morning when I walked in, I wasn't ready to approve. But after presentations, my questions were answered. The endpoint was not perfect, but it works." Carlson is an associate professor of medicine and vice chairman for clinical programs at the department of medicine at the University Hospitals Health System (Cleveland, Ohio). Karen Becker, presenter for Lifecore and worldwide managing director of health care products for the Weinberg Group (Washington), said the sale of 35,000 units in the past year offered added proof that the product does indeed work. Lifecore's marketing partner, Gynecare, a division of Ethicon (Somerville, New Jersey), sells the gel in other parts of the world under the name Gynecare Intergel. In the last year, 35,000 units have been sold in other countries.
Following the hearing, Jim Bracke, president and CEO of Lifecore, said he expects Intergel to be on the market in March 2002. "Remember, we're selling this in 25 other countries, so we've already got manufacturing set up and we've already got the product available." He added, "The real winners today are women. We've gotten phone calls and e-mails from women in pain asking us to get this on the market. We've been looking at adhesion since the 1980s."
Lifecore's journey through the regulatory agency began to get muddy in January 2000 when the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted not to recommend approval of the company's PMA. The committee said Lifecore failed to produce sufficient evidence supporting safety and effectiveness. The company responded that the panel had failed to fully comprehend the data. Six months later, Lifecore amended its original PMA, which was for general surgery, but that strategy failed also. In November, the FDA denied approval, prompting the company's appeal based on the amendment.
Lifecore said it believed the amended PMA demonstrates a statistically and clinically significant benefit in favor of Intergel solution as compared to control (lactated Ringer's solution) in reducing adhesion formation following gynecologic surgery. The benefit is achieved without exposing the patient to unacceptable risks, including infection, the company said. The results of the first clinical study (the pilot study) of this product in 23 patients identified no safety concerns and provided preliminary evidence of effectiveness, the company said. The pivotal trial of 281 patients evaluated the safety and effectiveness of Intergel in a multicenter, randomized, prospective, blinded, controlled trial of women undergoing pelvic gynecological surgery via laparotomy. Results of the pivotal trial provided adequate evidence to conclude that the product is effective in reducing non-surgical site adhesions, reformed adhesions, and adhesions at the surgical site, and the dispute panel concurred.
An estimate based on data from the National Center for Health Statistics indicates that more than 7 million abdominal and pelvic surgeries are conducted annually in the U.S. and the vast majority could be expected to result in cases of post-surgical adhesions, according to Lifecore, noting that no products are available in the U.S. for non-surgical site adhesion prevention.
Sulzer wins preliminary settlement okay
U.S. District Judge Kathleen O'Malley gave preliminary approval in late August to a landmark settlement proposal by Sulzer Medica (Winterthur, Switzerland) that provides nearly $800 million in compensation for all patients affected by the recall of faulty Inter-Op hip implants made by the company's Sulzer Orthopedics (Austin, Texas) subsidiary. If final approval is given after publication of the notice of the settlement and a fairness hearing in the judge's Cleveland, Ohio, courtroom, the settlement would bring some closure to a year-long ordeal for both Sulzer and plaintiffs in the class-action suit.
Attorneys for Sulzer Orthopedics and a nationwide plaintiffs' group submitted a term sheet on Aug. 13 for a settlement of the class-action claims against Sulzer. The term sheet provided for an agreement to petition the U.S. District Court in Cleveland, Ohio, to certify a class comprised of all patients who received a recalled Inter-Op acetabular shell. Effectively, the approved settlement combines together all pending lawsuits stemming from the recall of the hip shells at the federal level. Created in negotiations with representatives of the class-action participants, the term sheet outlined substantial payments for the affected patients to be spread out over several years.
Terms of the agreement call for, among other things, Sulzer Orthopedics to pay affected patients and their attorneys with a mix of two-thirds cash and one-third Sulzer Medica stock issued through American Depository Receipts (ADRs) over a period of several years, for a total outlay by the Sulzer Medica companies of up to $800 million in product liability claims. A patient who has undergone one corrective surgery, for example, will receive $37,500 in cash and $20,000 in stock (approximately 3,922 ADRs); a patient who has undergone more than one corrective surgery will receive $63,500 in cash and $34,000 in stock (approximately 6,667 ADRs). These payments will be made over and above reimbursements for medical costs.
Additionally, Sulzer Orthopedics will cover legal costs so that the patient will not have to share the settlement with any legal representation they may have hired. The settlement also includes payments to each patient's spouse, a $30 million extraordinary injury fund to compensate patients in special cases, and a $20 million monitoring fund to pay for diagnostic tracking of patients over five years. It also grants members of the class action a lien on Sulzer Medica assets and intellectual properties until 2008.
Sulzer Orthopedics recalled the hip implants last December after learning that the Inter-Op devices had been contaminated by machine oil during the manufacturing process, which, in many cases, caused the implant to fail to bond properly with the bone. The company's problems with the hip implants spread to its knee implant products in May. Similar to the Inter-Op unit, the problems with the tibial baseplate in the knee implants consist of an oil leak in the shell of the product, which results in improper bonding and forces a subsequent revision procedure.
Sulzer said earlier this summer that it did not have sufficient insurance to cover the anticipated costs of the hip-implant claims. Company officials said that the terms proposed under its term sheet are financially bearable because the payments would be spread over several years. The amount of stock proposed as part of the settlement, approximately 4 million shares, represents about a third of the company's current value.
"We applaud Judge O'Malley for approving this innovative settlement that creates a new benchmark in product liability cases," Dr. Stephan Rietiker, the new CEO of Sulzer Medica, said in a press release. "We have worked diligently to find a positive solution that provides just compensation to all affected patients. While the financial burden is a heavy one, it is bearable when distributed over the agreed-upon time frame." Rietiker said that the bottom line was that the company would be able to remain in business and meet its obligations to affected patients. The company has asked Judge O'Malley's court to put on hold all lawsuits filed in state courts for an undetermined period.
2nd AbioCor implant at Jewish Hospital
Though it happened with less fanfare, the second implant of the AbioCor implanted artificial heart took place last month, marking an important milestone not only for Abiomed (Danvers, Massachusetts), manufacturer of the device, but also Jewish Hospital (Louisville, Hospital) and two surgeons from the University of Louisville. The Louisville hospital also was the site of the first implant in the company's FDA-approved clinical trial, and the second procedure was again led by Laman Gray and Robert Dowling.
News of the second implant was overwhelmed by the attention focused on the terrorist attacks on New York and Washington, which occurred the same week, and the hospital and Abiomed continued to maintain their policy of releasing only limited information in order to protect the patient's family and to maintain focus on treatment.
The second patient was a 70-year-old retired businessman, Tom Christerson, from the western Kentucky town of Central City. Like Robert Tools, the first recipient, Christerson was reportedly in failing health and had little chance for more than 30 more days of life, one of the criteria established for potential recipients of the AbioCor. The implant came about 2 1/2 months after the first implant in early July, with Tools having been moved earlier in September from the hospital's intensive care unit into a recovery unit and showing progress.
The remaining implants in the trial are expected to come before year's end, according to statements by Abiomed officials.