Medical device recalls seem to be increasing. In the past year, Medtronic, St. Jude, Boston Scientific / Guidant, Cardinal Health and a host of others have recalled medical devices – often putting patients at serious risk of injury or death. So, why are there so many recalls?

A legal expert’s opinion

To find out, we asked Neil Overholtz, a Florida attorney whose firm represents medical device patients. In a recent interview, Overholtz gave us his opinion:

Part of the reason why there are so many recalls has to do with the sheer volume of devices that are being implanted. The main reason why medical device manufacturers have been so successful over the last couple of years is that they have grown a market. They've done that by manipulating the science, or at least driving the science forward, to say that people that have various issues related to congestive heart failure or electrophysiology are better off having one of these devices than going through drug therapy.

Sales reps push products

Overholtz told us that manufacturers’ sales representatives often provide doctors with their own study information in order to sell more devices. He explained, “While we haven't litigated the validity of a lot of those studies and whether or not they're correct, sales representatives are putting those studies in front of the doctors and telling them, ‘You need to be implanting more of these, doctors.’ In the past, sales representatives would only call upon the electro physiologist, the doctor implanting the devices. However, they realized that no one's going to get a defibrillator or pacemaker put in unless they get referred by a specialist. So they’ve instituted multiple campaigns in the last few years targeting the specialists and sold a ton of them.”

Domino effect

Increased sales lead to additional demands – creating a domino effect that may result in the release of defective devices. Overholtz continued:

When sales increase, they also have to meet demand – and physicians started to want smaller devices with more comfortable wires that are easier to install. So, providing doctors with what they ask for allows them to implant more devices and everyone ends up making more money.

As a result, devices and wires have gotten smaller and smaller. In the Boston Scientific / Guidant cases where defibrillator batteries malfunctioned, the manufacturer really could not design a battery that was small enough to handle the types of charges that were needed – which resulted in shorting events. So, the pressure to make smaller products and make more products is why we’re seeing so many problems.

Lead wires may have been too thin

Lead wires in particular are made so thin that manufacturers are bound to experience problems without having perfect quality control procedures. According to Overholtz, “You're always going to have some leads fail – especially in young people that are more active. However, that should only happen every now and then. Lead wires shouldn't just crack on their own for a relatively older person that doesn't have a very active lifestyle. You just shouldn’t expect to see fractures in that type of patient.”

If you or a loved one has been injured by a defective medical device, contact an attorney whose practice focuses in this area of the law. To contact a qualified attorney for a free, no-obligation consultation, please click here.