Medical Devices

Medical devices are an increasingly important part of the practice of modern medicine. We have moved from a scalpel that a doctor holds to a robotic surgeon that does the cutting itself; from a simple x-ray to the CT scan, which constructs a 3-D image of the body from a radiation-intense series of x-rays.

Like pharmaceutical drugs, they are also an increasingly profitable area of commerce. Even a defective device can be very profitable for its manufacturer—if the manufacturer can avoid paying out too much in damages to victims.

Litigation against manufacturers of medical devices serves to compensate victims of injury, expose the dangers of defective products, and make it less profitable to market defective medical devices.

The Dalkon Shield: Denial Is Deadly

Even before putting the Dalkon Shield birth control device on the market, executives at manufacturer AH Robins knew of the design flaw that would later prove deadly. In 1970, executives were informed that the retrieval string of the Dalkon Shield provided a route for bacteria to travel from the vagina, where the body has countermeasures to combat infection, to the uterus, which is supposed to be sterile.

Infections related to the Dalkon Shield began to pop up almost immediately after the product went on the market in 1971. In 1972, a paid consultant for Robins, wrote the company that of the six women who became pregnant while wearing the Shield (it was not a very effective contraceptive), five of them had lost the pregnancy to infection.

Although the FDA used its power to coerce the manufacturer into withdrawing the shield from the market, it was only under the weight of about 300,000 lawsuits, including numerous jury damages, that a Shield recall was initiated.

Medtronic v. Lohr (1996): When You Can Sue a Manufacturer

Unlike the FDA’s drug authority, its authority over medical devices specifically says the states have no authority to make laws concerning the safety of medical devices. This was often interpreted as meaning that claims against medical device manufacturers based on common-law claims that products should be generally safe for their intended use.

However, in this decision, the Supreme Court pointed out that most devices do not actually have their safety evaluated by the FDA. Most devices on the market are approved through the FDA’s 510(k) process, which allows new products to be marketed if they are “substantially equivalent” to a device already on the market. According to the decision, “the §510(k) process was intended to do anything other than maintain the status quo, which included the possibility that a device’s manufacturer would have to defend itself against state law negligent design claims.”

Riegel v. Medtronic (2008): When You Can’t Sue a Manufacturer

In contrast, the Supreme Court decided that if a device has undergone a full safety evaluation by the FDA, it cannot be considered defective. The argument is that the device’s safety has already been thoroughly evaluated using the best safety standards available, and that if it has been found to be safe, it cannot be alleged that the manufacturer was negligent.

Why We Need to Sue Medical Device Manufacturers

The US Supreme Court has made it very clear that in order to avoid litigation, medical device manufacturers only have to do one thing: evaluate the safety of a device thoroughly before putting it on the market. Unfortunately, only about 10% of medical devices on the market go through this more rigorous process. Many medical device manufacturers don’t want to take the time to properly evaluate the safety of a medical device before putting it on the market, preferring to take the 510(k) shortcut.

Unfortunately, the 510(k) process puts many dangerous devices on the market. In a recent study published in the Archives of Internal Medicine, 71% of recently recalled medical devices were approved through the 510(k) process. Examples of recent dangerous products that got 510(k) approval include DePuy metal-on-metal hip implants, and all transvaginal mesh products currently on the market.

Join the fight against dangerous and defective medical devices—tell device manufacturers to evaluate the safety of devices before they go on the market.