Can Medical Device Companies Face Criminal Charges For Product-Related Deaths?

Many studies show that IVC filters are associated with an increased risk of death, particularly among elderly patients. Family members can file a wrongful death lawsuit in an attempt to hold medical device manufacturers responsible for their loved one’s death. Beyond potential financial liability for a defective product that allegedly causes debilitating injuries and deaths, are there any other consequences a medical device company might face?

Can manufacturers be held criminally liable for injuries and deaths relating to their products? It’s unlikely. A medical device company would have to have the requisite criminal intent, act with a reckless disregard for consumer health, or intentionally defraud a regulatory agency to be charged with a crime.

No Laws Directly Target Product Liability Deaths

While all states have product liability laws, those rules simply provide injured patients (and families of loved ones killed by dangerous products) with the right to sue a company. These are tort laws, not criminal laws. There are currently no criminal product liability laws on the books. In order to be charged in an injury or death related to a medical device like an IVC filter, a manufacturer would have to violate a specific criminal law at the state or federal level.

Let’s say a woman in Los Angeles is killed because one of the legs on her Bard IVC filter broke off and traveled to her lungs, causing a pulmonary embolism. Her family contends that C.R. Bard, the company for designing, manufacturing, and selling the device, should be held criminally responsible for her death. They believe that the company acted with criminal negligence.

In California, criminal negligence is much more than acting carelessly. Criminal negligence occurs when:

• A person acts in a reckless way that creates a high risk of death or great bodily injury, AND
• A reasonable person would have known that acting in that way would create such a risk.

In other words, behavior that’s criminally negligent isn’t, in and of itself, against the law. However, the conduct is performed with the knowledge that it poses a significant risk to others.

The woman’s family argues that Bard has been on notice about the dangers of their IVC filters for years. Several studies suggest their device is dangerous. Thousands of lawsuits echo this claim. Is it criminally negligent for Bard to continue selling its IVC filters, knowing that there’s a potential risk of severe injury or death?

That’s the question that would be litigated at trial if Bard – or another IVC filter manufacturer – was ultimately charged with a crime.

Criminal negligence can be the grounds for several crimes in California, including involuntary manslaughter.

Families Can Still Get Justice Even If No Charges Are Filed

It’s unlikely that Bard or any other medical device manufacturer will face criminal charges. However, this doesn’t mean that victims and their families can’t hold medical device companies responsible for the harm they cause. There’s always the option of filing an injury lawsuit or wrongful death claim.

Through a civil personal injury case, a victim or family could potentially recover compensation for things like medical bills, pain and suffering, and lost income or support. In addition to compensatory damages, victims and families might also be entitled to seek punitive damages.

Punitive damages are awarded when a defendant’s conduct is malicious, oppressive, or fraudulent. In other words, a company is sanctioned financially if there’s clear and convincing evidence to show that they knew what they were doing was wrong or could cause harm, but did it anyway.

Roundup litigation is a perfect example. To date, three Roundup injury lawsuits have gone to trial. The juries in all three cases have ordered Monsanto – now Bayer – to pay millions of dollars in punitive damages. Why? The California juries believed that the company knew that its pesticide was dangerous, decided to conceal that information, and marketed its product, anyway.

Was Bayer charged with a crime for this? No. At least, not yet. However, juries in civil cases decided that the company should be punished. Now Bayer has to contend with multi-million dollar losses in court for its deceitful actions.

Some IVC filter lawsuits have also yielded punitive damages for injured patients.