A Class-Action Nightmare : Wide-ranging suits against manufacturers may keep lifesaving medical devices on the shelf and out of reach.

The other day, while examining a 10-year-old for a sports physical, I felt a tubular structure under his scalp and smiled at his father. “Doesn’t need it anymore,” the dad said, “Hasn’t had a problem with his hydrocephalus in quite a while.” This child’s intelligence had been saved by a silicone drainage device implanted in infancy, when the excess fluid pressing on his baby brain had caused problems.

Sooner than we imagine, the supply of silicone for such medical devices--and for heart pacemakers, intraocular lenses, artificial finger and wrist joints and implantable drug-delivery pumps--may be severely threatened. The willingness of biomedical companies to create new products with the lifesaving potential of a hydrocephalus shunt may be even more jeopardized, and all because of a glitch in our legal system called the class-action suit.

The first suit over silicone breast implants hit the courts almost two decades ago, but it wasn’t till the 1980s that lawyers realized the gigantic financial potential of combining claims in class-action suits. These suits alleged various autoimmune symptoms such as fatigue, joint discomfort and memory loss in thousands of the more than 1 million women who have had silicone breast implants. Yet none of the medical studies done by Harvard Medical School, the Mayo Clinic or the University of Michigan substantiated any such association. Although the original class-action settlement fell through, legal and other costs to Dow-Corning, the leading manufacturer of medical-quality silicone, drove it into Chapter 11 bankruptcy.

Companies like Dow-Corning make the raw materials, and other companies fashion the silicone into the actual products used in patients’ bodies. But many of the companies manufacturing medical devices from Dow-Corning’s silicone are small and don’t have those “deep pockets” lawyers love so well. So when there is a problem, the lawyers haul Dow-Corning, a company with more financial reserves, into court too.

Dow-Corning, which has spent more than $800 million in legal and administrative fees just on the breast implant issue, decided on some rigorous rules governing who can buy its silicone. Rule No. 1 calls for the purchasing companies to have enough assets to accept all the financial risks their devices could possibly engender. Dow-Corning, once a supplier for thousands of buyers, now sells its medical-grade silicone to fewer than 20 companies.

So a small company that comes up with a brilliant new idea may no longer be able to purchase the silicone to manufacture a potentially life-enhancing product. Though there are a few other companies making medical grades of silicone, their strategy has been to raise prices. One company’s went up about 700%. And with a limited number of companies able to make medical implantables, monopolies could be created at the same time that innovation is curtailed.

It would be nice if we could find another product with the in-body utility of silicone, but even if we did, it would take a long time getting Food and Drug Administration approval and would probably attract the same kind of emotionally based litigation.

Will there come a time when your doctor has trouble getting a heart pacemaker for you? When there’s no tubing available for your child’s dialysis machine? Will the medical innovations of the future remain unused because companies are too scared of class-action litigation to take a chance on their manufacture?

The legal system plays an important role in protecting all of us from harmful products. But most medical class-action suits, with their often weak to nonexistent standards for proof of harm, may end up costing those in need of medical devices and implants dearly. Thank goodness my 10-year-old patient’s hydrocephalus shunt was invented and marketed before some trial lawyers began marketing their newest device, that deep-pocket siphon known as the medical class-action suit.