We have been litigating medical devices cases for decades. One of KBA’s attorneys worked at FDA and served industry for several years; all of the KBA attorneys have litigated medical device lawsuits. We are passionate about these cases because they usually involve serious injuries to people who were simply following their doctors’ advice and trying to get better.
We have done well in this area of law because these cases involve complicated relationships between engineering, science, medicine, and the law, especially FDA regulations and other industry standards, and we thrive in challenging situations. Following is some background about our medical device litigation practice group.
A medical device is everything from crutches to an artificial hip. From FDA, “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” They also include diagnostics – testing kits and things like x-rays. The statutory definition of a medical device is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).
21 U.S.C. § 321(h). Each of us is exposed to many medical devices throughout our lives.
Patients do not get most medical devices by going to a pharmacy, although there are specialty shops that sell medical devices like prosthetics. A lot of times patients receive medical devices from their doctor or in a hospital.
The doctor or hospital gets the medical devices from a medical device company. They usually learn about the devices from company sales reps. They also hear about them at conferences and read about them in medical publications. There are literally thousands of medical devices, so it is a fast-paced frequently changing industry.
Companies can market to physicians by going through the FDA. At the Agency, they face a fork in the road. They can have FDA approve their medical device through the Premarket Approval Process (PMA). Alternatively, they can have their medical device cleared by the FDA through what we often refer to as the 510(k) process (that’s just lawyers and industry people trying to be cool by citing to that section of the law, which is the Food, Drug & Cosmetics Act).
The PMA process usually takes a lot longer because it is intended for devices that FDA does not have a lot of history about. The company has to do more extensive testing to make sure it is safe and effective. Note, the company does the testing, not the FDA. The FDA does limited testing sometimes, but very rarely; it is legally the company’s responsibility to make sure the device is safe and effective. The FDA is a check, but not a perfect one, in large part because it is impossible to fund it sufficiently to adequately evaluate the thousands of products that come before it.
When a company goes the 510(k) route, it basically says to the FDA, our device is pretty much like some other device that already went through the PMA process or that has been around for a long time, so we don’t need to do so much testing, we already know it’s safe and effective. Here’s how it is similar to the devices about which you’re already aware. So, please let us go marketing this new widget just like the company does the street gets to market its slightly different widget.
After FDA reviews the company’s paperwork regarding the device, it either approves it or clears it. The company can then sell it, which it does through advertising, sales reps, and many other methods, some of which are not always appropriate. The company can only market the device for the intended uses the FDA considered. For the most part, it cannot promote the product for “off label” uses – uses other than within the scope of its approved/cleared labeling or intended use.
Medical devices can save and improve lives, but medical devices can also be dangerous. Medical devices can injure people in many ways from cutting organs to infections. Injuries from medical devices happen for three basic reasons:
Manufacturing defects are pretty rare. When they happen, there is usually a recall of a limited number of devices. Those recalls often involve actual market withdrawals – the company tries to get the devices back to it and out of hospitals and doctor’s offices, or even patients. A lot of recalls are not recalls the way we would think of the word. The product remains on the market.
Many times the “recall” is really a change to the device’s labeling – the paperwork that comes with the device, as well as the advertising or promotional material regarding the devices. A good number of the cases we deal with have to do with these kinds of issues.
There are literally tens of thousands of medical devices. Doctors do not learn how to use all these devices during their medical training. Sales reps come in with the latest gadgets each week and it is the company’s responsibility to include written instructions or provide training to be sure doctors know how to use the device safety. Doctors should know how to use the device, but they rely on the company to provide the information. After all, the company knows its device best.
Medical devices can injure people because they were not used the right way. A physician may have been unaware that the device could not be used with some other commonly used device or drug, or the doctor may not have known that the device had to be put in the patient’s body in a specific way or using specific material. Often people are quick to blame the doctors, especially people at the medical device companies.
While doctors just like all of us make mistakes, it is the medical device company’s responsibility to make sure its device includes instructions or directions for how to use the product. Medical device companies are responsible for providing enough information – via labeling, instructions, or even training – to make sure the people using the device know how to use it safely. They must assess these materials before they market the device and after it is out for sale to see if it needs to be updated based on real work results. This is their legal duty and they can’t pass the buck.
Additionally, people get injured from medical devices when companies fail to disclose risks associated with the product. The product may be known to break down after a couple of years or to fail under certain conditions. It may not be intended for certain populations like pregnant women or children. Companies must warn about these risks. Warnings must be understandable and designed to actually be read, understood, and followed. Again, companies cannot just blame the user – they have to show they made sure the warnings were adequate in content (what they say) and design (how they say it, for example where they are, the font size, etc.)
In addition to manufacturing and design defect cases, the lawyers at KBA also litigate design defect cases. They are very complex cases because you are basically looking back and asking, was there a better way to make this device that could have prevented people from getting hurt. We have been successful in large part because of the experts we retain. These cases take a long time to resolve and cost a lot of money to do so because we have to hire engineering, medical device industry, toxicology, medical and other experts. We, along with these experts, spend months if not years pouring through millions of pages of documents regarding the devices – from the information they shared with FDA to the complaints they received about the device after it went on the market. We depose dozens of people, including corporate officers. Unfortunately that means our clients have to wait many years before obtaining some recovery. Trials can take months and cost half a million dollars to complete just one.
The way it usually works is someone gets the word out about a problem with a medical device. FDA announces a recall, a doctor publishes an article about problems she’s seeing in her patients, or an internal company memo gets leaked to the press. The cheesy lawyer ads begin. Law firms evaluate potential claims. Lawsuits get filed around the country.
Most times the lawsuits are not class actions. A class action basically involves one or a few people litigating a case on behalf of a bunch of other similarly situated people. But those other people, the class members, never file a lawsuit and are often unknown until later in the litigation.
The people who file the lawsuit are called class reps. They stand in the shoes of everyone else and manage the litigation for everyone else, including negotiating the settlement, through their lawyers of course. The other people never file any lawsuit and are not involved in the litigation. They often do not have to participate other than submitting some proof that they had the product or used the service at issue. They choose to “opt in” after it settles and they get a check in the mail.
By comparison, these medical device cases involve individually filed lawsuits. Each plaintiff must be involved, to varying degrees. They must settle their own lawsuits. Although they are different in terms of how they are set up, the law involved, and how they are litigated, in the past couple decades, class actions and these medical devices cases have become more similar.
When medical device cases get filed in various state and federal courts around the country, a group of lawyers consolidate the cases in one court or just a couple of courts to make it more efficient. They basically say, all these people were injured by the same product because the product failed in the same way. So, let’s litigate those common issues – whether the product was defectively designed because there was a safer way to make it and whether the product can actually injure people if it fails – in one court all at the same time once rather than have the same questions and the same evidence flying around dozens of courts at various different times. In this way, you can use one expert to the benefit of thousands of plaintiffs, for example.
In these lawsuits, the opposing sides exchange documents regarding the medical device and the patients’ medical and personal histories. They fight over those things. They take depositions of people involved with the product. They fight over those things. They hire experts who say opposing things. They fight over those things. The court decides and either the case goes away forever, or it continues to trial.
After those common issues are resolved, a group of individual plaintiffs (called bellwether cases) can present their specific case to show how they were injured. They go before a jury to see who is most likely right. Verdicts come down, the rest of the cases settle. Most of the time the cases get resolved after a couple of bellwether trials. That has been the model for decades, but it is changing, and the lawyers at KBA are actively involved in changing that outdated, inefficient model. But for now, that is generally how medical device companies sometimes err and the lawyers at KBA try to help people by the device companies’ failures.
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