What Matters: February 2006
Innovation and Its Pitfalls: What the MIT Curriculum Should Address
By Charles A. Homsy '53, ScD '60
Photo: ©istockphoto.com.
Medical devices and implants are among the modern marvels that alleviate pain and suffering, prolong life, and add to the quality of life. Those devices are the products of years of research and development by inventors, physicians, and surgeons. The U.S. Food and Drug Administration is charged with certifying that the devices are safe and effective. Unfortunately, the FDA often acts, not principally to protect public safety, but rather to persecute the producers of devices, thus keeping those devices from the public and discouraging their development. MIT students need to understand the pitfalls of litigation and how it can impact their entrepreneurial efforts.*
Manufacturers of medical devices face a triple threat in their efforts to develop products. The FDA can drive manufacturers out of business, even when the FDA itself certifies their devices. The personal injury liability system makes it easy for predatory lawyers to force manufacturers of safe products into bankruptcy. And sensationalist media accounts of allegedly dangerous devices add to manufacturers' problems.
Three examples illustrate those problems. In 1974, on the basis of unsubstantiated media reports and lawsuits, and without legislative authority, the FDA forced A.H. Robins to remove the contraceptive Dalkon Shield from the market. Though later reports showed the shields to be safe, A.H. Robins was driven into bankruptcy. Beginning in 1988, Dow Corning's silicone breast implants became the subject of FDA accusations, liability suits, and media hysteria. Although no sound science has ever shown the devices to be dangerous, the manufacturer was driven out of business.
My company, Vitek, manufactured out of the patented material Proplast® implants that were used successfully in some 100,000 patients with distorted, damaged, or destroyed facial structure; joints of the jaw, thumb, and hip; and other body parts. In 1986, reports surfaced about particular jaw implants wearing out. In fact, the problems occurred when underlying conditions were not treated or when patients refused to follow the prescribed treatment. But the FDA and liability lawyers waged a campaign against those implants, driving Vitek out of business. Worse, the FDA also targeted Novamed, a company established to produce other FDA-approved Proplast® implants that were not under suspicion, and used questionable court tactics to drive it out of business.
The only implant products containing Proplast® to be targeted in multi-plaintiff suits were those for TMJ, particularly the Interpositional Implant (IPI), which was a cushion in the joint. The FDA approved the IPI for marketing in early 1983. "You may market your device subject to the general controls provisions of the Federal Food, Drug and Cosmetics Act…until such time as your device has been classified under section 513." Under the Device Amendments of 1976 to the Food, Drug, and Cosmetic Act, the FDA should have classified those products in a timely manner as either Class I, de facto safe; Class II, safe and effective after review of data and sellable; or Class III, in need of data to show safety and effectiveness before sales could commence.
As was the case with breast implants, the FDA delayed classifying the IPI and all other TMJ implants until 1992, four years after Vitek stopped selling them. Such delays are part of the problem with the FDA process. If adverse publicity or lawsuits arise concerning a product, the FDA often will act against the product and its manufacturer, even if the evidence of a real problem is questionable and patients who rely on those devices suffer if the products are pulled from the market.
For example, from the mid-1970s to the late 1980s, oral surgeons made great strides in the use of TMJ implants. A major lesson that they had learned from years of treating patients was that conservative treatment of TMJ dysfunction was not very effective because of the complexities of the disease and patients' difficulties in complying with treatment plans. In light of those facts, surgeons realized that the next step after failed conservative treatment should be replacement of the entire joint. This is analogous to what orthopedists came to understand regarding hip dysfunction. Partial hip joint replacement has been displaced by the total hip implant.
Many of the Proplast products have no comparable substitutes. Surgeons continue to request them since the bankruptcy of the companies that produced them. The Proplast-coated hip implant, which has undergone clinical trials in the Netherlands for seven years, has proven itself to be a major advance over the technology available in the United States.
Today many surgeons have returned to the old procedure for joint replacement, which involves transfer of a rib. By steamrollering Vitek, the FDA set back the care of patients with severe TMJ disorders.
European governments allow private companies that meet certain objective criteria to certify medical devices. That approach is less subject to abuse, better ensures patients' access to devices, and could be an alternative to the malfunctioning American approach.
The European Union maintains a set of rules for regulating devices in a clearly written and highly specific Medical Device Directive, which is based on widely accepted international standards and requires device manufacturers to demonstrate conformity with its requirements for a full-quality system. This covers all aspects of manufacture: certification of raw materials; factory design; manufacturing and quality assurance protocols, including periodic and timely audits both internal and by third-party consultants; design verification and validation; labeling; risk analysis; employee competence and training; complaint handling; and post-market surveillance. Moreover, compliance with the directive must be demonstrated at least yearly.
Unlike the system in the United States, the certification of compliance is performed by private firms that themselves have been certified by the EU to perform this task. Device manufacturers thus can choose a certifying company with particular knowledge of the medical problems that their devices address. The EU mandates that at least one member of a certification team must be a professional bioengineer with experience in the general area of the company's business. By contrast, FDA inspectors often do not have expertise to match the facilities they are certifying.
The FDA's approval regime, threats of liability suits, and unfounded media horror stories have a particularly adverse effect on smaller, innovative companies. For the device industry, and the patients who may benefit from its products, the bell is tolling; the ringing lesson of their plight is that reform of the system is needed now.
When a competent patient authorizes the doctor, in writing before a witness, to use a device and when the device is implanted by a surgeon duly licensed and trained to perform the procedure, the law should mandate arbitration before litigation.
All parties should be immune from a personal injury lawsuit until arbitration among the patient's representatives, bioengineers, physicians, scientists, and manufacturers concludes that malpractice by the surgeon and/or malfunction of the device has occurred. The right to file a lawsuit is preserved, but at trial, the jury must be told the results of the arbitration.
Until the FDA and the liability system are changed, this sad situation will continue.
*Editor's note: The MIT Enterprise Forum Web site lists programs, courses, publications, and student groups that address a wide range of entrepreneurial issues.
About the Author
Charles A. Homsy '53, ScD '60 received both a bachelor's degree and an ScD in chemical engineering from MIT. In 1966, after five years with the DuPont Company, he established the first US hospital-based bioengineering laboratory at the Texas Medical Center, which he directed until 1990. He was the founder and CEO of Vitek (1971-90) and Novamed Inc. (1988-92), which made surgical implants.
What Matters is a guest opinion column written by a different MIT alumnus or alumna. The views expressed are entirely those of the author and do not necessarily represent the views of the Alumni Association or MIT. Interested in writing a column? Email whatmatters@mit.edu.
