Hospice news

Abstract

As more and more healthcare products that patients at one time could only get through hospitals for use under a doctor’s supervision become available for home use, manufacturers, insurers, and physicians face an increased risk of potential litigation. Patients are now able to self-administer once complicated treatments and operate medical devices, such as dialysis machines or blood testing kits. However, along with the convenience and reduced healthcare costs associated with these products comes the likelihood that some patients will use them incorrectly. If injuries occur, lawsuits are likely not far behind. “It’s a fairly challenging type of risk to underwrite for us,” said Jill Wadlund, vice-president and casualty manager with Chubb & Son, Whitehouse Station, New Jersey. According to Ms. Wadlund, at-home healthcare products have been in use for decades, but the segment has grown substantially over the last three or four years. “It’s not going to go away. If anything, it’s going to get bigger.” Ms. Wadlund said manufacturers need to keep a number of factors in mind when designing products for use in patients’ homes. Chubb works with clients through the testing and clinical trials, FDA approval process, and product introduction phases. “We like to start with them at the very beginning when they’re in the R & D phase,” Ms. Wadlund said. “They need to demonstrate to us when they design the product that they understand the environment in which it’s being used. In a hospital setting, they can be a little more attentive.” Pete DeComo, CEO of Renal Solutions Inc., a manufacturer of kidney dialysis products, said insurance can be a tricky issue for companies that make medical products for home use. Since premiums are usually based on revenue generated, the more units that are sold, the greater the potential liability exposure will be. “I think any company coming into a market like this needs to realize your premiums are going to be high,” Mr. DeComo said. “It is one of the challenges any time you’re using a device that’s considered to be high risk.” Tom Sweeney, a product liability attorney with Eckert Seamans Cherin & Mellott in Pittsburgh who works with manufacturers such as General Motors, warns that litigation can still result when something goes wrong, no matter how much care a manufacturer puts into development or the warning labels that accompany it. “When you have a product like that, in the hands of the consumer . . . you are exposed to being sued, even if it’s that person’s fault,” Mr. Sweeney said. Companies looking to reduce their exposure to litigation should look for ways to build good relationships with their consumers before potential problems arise. “That goodwill tends to reduce, more than anything, litigation,” Mr. Sweeney said. Mr. DeComo realizes having to defend against litigation is a possibility for many companies that make medical products for at-home use. “It’s one of those situations where we’re stuck between a rock and a hard place,” he said. “You’re trying to help patients, and you’re trying to make products as safe as possible, but anyone can come after a company.” (Source: Pittsburgh Business Times, April 14, 2003.)