Apparently fearing the worst in looming patient lawsuits related to its defective Inter-Op hip implant products, Sulzer Orthopedics (Austin, Texas) stepped up its public relations campaign last month, this time directing its PR efforts to orthopedic surgeons, as well as the general public. In mid-May, the company published a letter to the surgeons in the form of full-page ads in Sunday newspapers apologizing for the defective implants but blaming attorneys and the media for encouraging patients to pursue litigation instead of seeking direct restitution from the company.

The ads ran in about 30 newspapers, a spokesman for Sulzer told The BBI Newsletter, but he declined to say how much they may have cost the company. The strategy was not lost on attorneys pushing the patient lawsuits, one firm charging that the company had spent "hundreds of thousands of dollars" on the ad campaign, money it said would have been better spent on payments to patients. Legal firms also have noted the expense that the company must have gone to in producing a videotape about the implant problems and offering it free to the public. (It should be noted that the lawyers made no mention of the costs their firms have incurred in running their own newspaper ads across the country, recruiting patients who had been implanted with the Sulzer device.)

The company's increased urgency may be the result of new numbers concerning how many people have had implant revisions, plus its admission that its insurance may not be able to cover the increased totals. Originally, Sulzer Orthopedics and its parent company, Sulzer Medica (Winterthur, Switzerland), had predicted up to 1,000 revision procedures, but they now say the total is more than 1,700. In reporting the new total, Sulzer Orthopedics issued a statement acknowledging the possible shortfall in its insurance coverage. On top of that, it said it has told U.S. regulators that it has found additional problems with materials used in some of its knee implant products: specifically, leg bone plates. Those problems were discovered as part of a comprehensive review of manufacturing processes and clinical outcomes associated with the defective hip devices, it said.

The updated, higher number of hip revisions reported was the result of "several internal and external databases registering information on surgeries performed over the past five months," according to a company statement. It said that inconsistencies in hospital and surgeon reporting of the revisions had forced the development of a new database to collect all of the reports. The ongoing revision procedures have not ended, but their frequency "is declining," according to the company statement, which added that Sulzer Orthopedics "continues to investigate intensively all potential causes of the recall."

The recall was originally launched in early December of last year, and Sulzer said that it believed that most of the problems already had occurred, as opposed to an expectation of many more. But despite its assurances that the number of revisions is declining, statistics suggest that they will continue to climb past the 1,700 total cited. The company has said that more than 12,000 of the implants could be defective, and unofficial estimates of patients that might be effected is closer to 17,000.

Gary Sabins, president of Sulzer Orthopedics, said, "We are aware of the tremendous difficulties that some of our patients have experienced due to the unforeseen problems." He added that the company is attempting to handle these problems "openly, honestly and responsibly." Attorneys representing the many plaintiffs, claiming they want punitive damages as well as restitution for the revision procedures, are saying that the company may have known about the problems for several months before issuing its recall.

While acknowledging the distress the implants have caused patients, last month's full-page ad campaign emphasized how the issue is impacting orthopedic surgeons as well. In addition to the pain of having to inform patients concerning the defective implants, surgeons are being contacted "by patients whose implants were manufactured by other companies or were made long before the Inter-Op problem arose." These contacts, the ad said, are the result of a "negative campaign" that has been "broad and indiscriminate." Sulzer also encouraged patients – as it has previously – to deal with the company directly rather than filing lawsuits. This, it said, will avoid "the costly legal fees that the plaintiffs' lawyers want to charge [patients]."

Boston Scientific wins German stent decision

In a period marked largely by negative news for the company, Boston Scientific (Natick, Massachusetts) received a positive boost last month. A German court ruled that the BX Velocity stent manufactured by Cordis (Miami Lakes, Florida), a Johnson & Johnson (J&J; New Brunswick, New Jersey) business, infringes patented technology registered as a utility model in Germany and exclusively licensed to Boston Scientific. The technology in question is owned by Medinol Ltd. (Tel Aviv, Israel), developer and maker of the stent, and sold worldwide by Boston Scientific. The decision was announced in court, with a written decision to come later.

According to German custom, the decision gives Boston Scientific the right to obtain an injunction against continued sales of the BX Velocity stent, as well as damages. In a company statement, Jim Tobin, Boston Scientific president and CEO, said the decision "confirms our belief that J&J has violated the intellectual property rights protecting the NIR stent." Tobin noted that Boston Scientific has sued J&J for infringement by the BX Velocity stent in the U.S. as well as the Netherlands, with the trial in the U.S. case scheduled to start Aug. 23.

The court in the Netherlands earlier this year declined to grant a preliminary injunction, as requested by Boston Scientific, but Tobin said that the lawsuit there is continuing.

In its own statement, Medinol said it views this victory as a "further confirmation'"of the strength and enforceability of its patents.

TCPI shuts down glucose monitor R&D

Point-of-care diagnostics company TCPI (Pompano Beach, Florida) said in mid-May that it has put on hold any further work on its noninvasive TD Glucose Monitoring system after reviewing results of what it called a "limited clinical study" carried out at the Washington University School of Medicine (St. Louis, Missouri). Elliott Block, PhD, president of TCPI, said that the study had been designed to look at systems critical to the device's combination of monitor and membrane patch. He said that the results of the study were "better . . . than those previously obtained," but that even more improvement was required. He added that the company did not have the funding to pursue the effort needed to make those improvements. "Thus, further activity would be conducted only when sufficient funding is available."

This is the second major roadblock for the system that was being developed by TCPI. The company last year shut down clinical trials of the device after determining that it needed to improve the system's "electronic, optical and software components," it said in a statement. The work at Washington University was the result of that determination.

The TCPI meter is a noninvasive transdermal technology that uses a patch to measure the color produced by changes in the levels of blood glucose and therefore was seen as having the potential for taking this measurement without a blood sample, a key goal for this type of testing in the management of diabetes. The company had appeared to be making progress on product development, issuing positive research reports in 1998 at the European Association for the Study of Diabetes conference, and again, this past November, at the 17th International Diabetes Federation Congress in Mexico City. It also had said it was in discussions with several companies for marketing and distribution rights for the product.

Alliance moves LiquiVent to back burner

In another stalled product development report, Alliance Pharmaceutical (San Diego, California) said it will change direction in developing its oxygen-carrying liquid LiquiVent (perflubron) after it failed to meet either primary or secondary endpoints. Alliance said it is abandoning its Partial Liquid Ventilation (PLV) with LiquiVent studies and pursue the use of the product for other indications at a later time. While endpoints were not reached, preliminary data from the Phase II/III clinical study in adult patients with acute respiratory distress syndrome showed that LiquiVent was well tolerated, said Gwen Rosenberg, Alliance's vice president of corporate communications. The company now will put "immediate focus . . . on our previously stated priorities, which are FDA approval for our Imavist ultrasound contrast agent and the resumption of clinical development of Oxygent, both of which are expected later this year," said Duane Roth, chairman and CEO, in a statement.

The Phase II/III LiquiVent study enrolled 311 adult patients at 56 medical centers in the U.S., Europe and Canada. The primary endpoint was improvement in "ventilator-free days" and the secondary endpoint was improvement in 28-day mortality. The PLV with LiquiVent achieved a 19% mortality rate compared to 15% in the control group. Prior to the study, a 40% or higher rate of mortality in acute respiratory distress syndrome patients was acceptable. However, a National Institutes of Health (Bethesda, Maryland) study, which was not complete at the time Alliance's study began, showed an improvement in mortality by using "lung protective strategy" (low pressure ventilator) in mechanical ventilation.

Mark Wedel, LiquiVent program director, said LiquiVent may be tested for other uses, including delivery of therapeutic agents such as antibiotics or genes directly into the lungs or as a lung washing agent.

HIMSS, CHIM seek reunification

The boards of directors of the Healthcare Information and Management Systems Society (HIMSS; Chicago, Illinois) and the Center for Healthcare Information Management (CHIM; also Chicago) said they will seek to bring the two organizations together by year-end. HIMSS President/CEO H. Stephen Lieber and Carla Smith, CEO of CHIM, made the joint statement to recommend the consolidation which has been approved by their individual boards.

CHIM was founded within the structure of HIMSS 15 years ago when HIMSS was operated within the American Hospital Association (AHA). And CHIM then split off in 1990, though the two groups maintained collaborative relations. HIMSS members will be asked to vote late this month on approving the necessary amended bylaws.

No Comments