Let’s say you get a Pacemaker, prosthetic, or another type of medical device from a doctor. These devices are responsible for helping you alleviate serious symptoms or pain, and in some cases even to help keep you alive.

So what happens if they don’t work? You should be able to sue the company that made them, right? Companies have to make products that work in general, so the standard for hugely important medical devices has to be even higher. It’s not a question of whether you will be compensated for the device failing, but how quickly.

Not so fast.

Tomaselli v. Zimmer Inc. and the Problem with Medical Product Liability Cases

In January, a New York magistrate judge closed the case on Tomaselli v. Zimmer Inc., a lawsuit that can teach us a lot about defective products and liability.

Here’s what happened: Tomaselli was given a Greater Trochanter Reattachment device (GTR) for a hip condition. It’s not a complete hip replacement. The device mainly consists of a plate and two cables that attach to the femur. GTRs are commonly installed after a fracture.

After the GTR was put in place, Tomaselli visited the doctor a handful of times for hip pain. X-rays eventually revealed that the cables in the GTR had broken, although it stayed in place.

Understandably, Tomaselli decided to file a lawsuit against the distributor of the GTR. Over the course of the suit, it was ruled that the device had broken and was defective… yet Tomaselli did not win the case.

Why not?

Defective product cases require a number of elements in order for compensation to be awarded to the plaintiff. These elements differ depending on what legal theory of product liability the case is based on: negligence, breach of warranty, and so on.

Most product liability cases, however, are strict product liability cases, and plaintiffs must prove the following:

• The product was sold in dangerous conditions or without an adequate warning
• The seller anticipated the product would reach the consumer without changes to the product
• The plaintiff was injured by the defective product

With the last point, the plaintiff has to prove causation. Not just that the product was defective, but that those defects caused the plaintiff’s injuries.

Sadly, Tomaselli was unable to prove this. Moreover, her pain was not even considered substantial by legal standards. She testified that stretching and walking helped to relieve her hip pain, and that she only had to visit the doctor for pain once every few months. Quite simply, legally speaking the pain wasn’t something to go to court over.

Worse, Tomaselli didn’t do herself any favors by filing her lawsuit on the grounds of failure to warn, a specific type of product liability case that includes the elements of product liability that she failed to prove.

The Difficulty of Failure to Warn Cases

Tomaselli’s case was made on the claim that before the GTR was surgically put in her hip, no one warned her of the possible defects and risks of the GTR. In this type of case, the plaintiff has to prove the following:

• The manufacturer of the device failed to warn the prescribing physician of reasonably knowable potential dangers
• Failure to warn caused the plaintiff’s injuries

You already know that Tomaselli was unable to prove that the defective GTR caused her injuries, so let’s look at the first point.

Physicians are the link between manufacturers/distributors and patients. Manufacturers are required to tell physicians about the possible defects, side effects, and risks that accompany medical devices or products.

The defendant offered the GTR’s Instructions for Use as evidence. In the Instructions for Use, which is given to prescribing physicians, the manufacturer warns the physician that cables could come loose or break. This risk isn’t mentioned just once in the Instructions for Use – it’s mentioned three times. Needless to say, legally speaking the company clearly did their job.

Now, the physician may or may not have warned Tomaselli about the possible defects, but that doesn’t matter within the context of Tomaselli v. Zimmer, Inc. Why? Because her lawsuit doesn’t involve the physician. Tomaselli filed a suit against Zimmer, Inc. If Tomaselli had sued the physician or hospital, or sued for medical malpractice, the case may have ended differently.

Explore All Angles before Filing a Product Liability Lawsuit

There are many things to consider before you file a product liability lawsuit. Who will you file the suit against? How did they break the law or fail to fulfill their duties? What evidence do you have to support your claim and the elements you need to prove your case? What pain or injury are you filing on behalf of, and what caused those conditions?

These questions don’t always have short or simple answers, and defendants may see the answer in a different light than a judge or jury. That’s why you need experienced and knowledgeable representation to guide you. A skilled New York product liability lawyer will not only be able to help you build your case and prepare you to answer questions before a judge, they can also tell you whether they believe you have a valid case in the first place and let you know what your options are.