This is Part 3 of our current series on Diabetes Device Recalls. You can read Part 1 on Recall Trends and Policy here, and Part 2 on the Patient Impact of Recalls here.

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In the world of medical device recalls and safety concerns, we sometimes forget that the legal system is an important part of the mix, that can play a big role in keeping people with diabetes safe.

Of course, we shrug off the sleazy-looking TV commercials by lawyers, with their injury hotlines and entire websites devoted to product liability claims. These attorneys are often referred to as “ambulance chasers” and generally aren't considered legit or trustworthy. But the fact is that the courts and lawyers are just as much a part of the system working to monitor medical device safety as the manufacturers, regulators and advocates in this country.

Naturally, it's the more dramatic and highly publicized recalls that are most often tied to litigation, like the lawsuits alleging wrongdoing that led to injury or wrongful death levied against diabetes companies Abbott, LifeScan, and Medtronic in the past.

Checks and Balances

Although we tend to think of the legal process as a quagmire, it can in fact be used to get additional information on recall situations than what’s typically available from manufacturers or the FDA (as in, why something happened and why it wasn’t caught earlier). Also, litigation can force a company to listen and even change its policies in order to help more people affected by the product problems at hand.

One attorney working in this space is in Georgia, who indeed sees an important role for the legal system in keeping tabs on medical device safety as well as the entire process of how device manufacturers are monitored and regulated. He says that sometimes FDA and industry both fail in keeping patients safe, and that’s when his law firm steps in.

“We serve as a sort of checks and balances, if you will,” the Atlanta attorney says.

Unfortunately, per definition by the time Harman's firm gets a phone call from a potential client about a medical device problem, it’s already too late; someone already has been hurt or even died. Often, the phone call comes from the family of someone with diabetes, reaching out to find out if they might have a case worth pursuing.

That’s what happened in the case of a prior problem with a Medtronic insulin pump and infusion set, which is the basis of at least two lawsuits that Harman Law has filed. They actually have an devoted to these types of pump and infusion set recalls, with Medtronic’s name listed prominently.

According to the firm’s site, one of the suits is on behalf of a mother whose college-aged daughter died in 2011 from DKA (diabetic ketoacidosis), following high blood sugars resulting from a malfunction of her Minimed Paradigm 722 pump and Quick-Set II infusion set.

That product issue led to a by the FDA in June 2013, for millions of infusion sets made between 2001 and 2013. In that recall, the FDA warned patients to not insert the affected infusion set and call for assistance if they noticed anything unusual, like insulin continuing to drip from the tip of the infusion set cannula after priming was completed.

Medtronic has faced other legal challenges by other law firms, most notably suits resulting from a similar problem in 2009 when the company because of incorrect insulin dosing concerns. More than one lawsuit came from that, as the media reported and . While you have to follow dockets to know how the litigation turns out, and often attorneys and company folk don’t publicly disclose the details of settlements, it’s clear that patterns can be found by looking at these lawsuits that arise from product problems.

Where There's Smoke...

“You often don’t even know a pump or device malfunctioned,” Harman says. “You might suspect it, but there’s no glowing error message that anyone can see at the time... or any trigger to think back on what happened 3 or 6 months ago, that this may be part of a bigger problem. We often see that a defect is eerily similar to something that happened before and was recalled, but apparently not fixed. That is why these recalls are good things, because they can help people start thinking about what happened.”

Often, the recall itself that makes patients aware there’s an issue they might want to call a lawyer about. For that reason, Harman’s firm refers to the recall system as “family awareness” tools.

“In certain circumstances, a recall can provide us with some smoke and then we have to dig further to figure out if it’s really smoke, just steam, or whether there’s a fire behind there,” Harman says. “I’d like to say there are no fires and everything is fine. But it’s been my experience that not everything is 100% on the level all the time. We’ve run across situations where there has been a design or manufacturing defect, and it’s caused some real heartache in people’s lives.”

While diabetes device and other medical product cases represent a good chunk of the firm’s caseload, Harman says they don't take on all of these cases because some are just too difficult and expensive to pursue. These cases often take years to play out, in large part due to the heavy load of documents that must go back and forth -- although that’s often the process by which the lawyers discover important details that the FDA and sometimes even the manufacturer were not aware of.

“We do a lot of investigation into what happened and in many situations where we’ve found problems with the pump or some other part of the system. It’s often like CSI on TV, where we have to go back and recreate what happened," he says.

A Call for Better Recalls

Harman appreciates that recalls exist and that the FDA and manufacturers do what they do. But more effort is needed to make the system better, he believes.

“I’m no expert in administrative law, but I don’t think recalls are adequate,” he says. “Sometimes, like maybe with the ignition switch recall by GM, you see it in the newspaper or on CNN every day. You’re bombarded with that information. You can say ‘ignition switch’ to someone and they immediately have an idea of what you’re talking about. The problem is, most medical devices don’t have that kind of publicity unless it’s a dramatically large number or issue, so people who need to know don’t know about these recalls.”

His colleague Eric Fredrickson has a similar view, but puts more blame on the FDA and manufacturing industry than simply a lack of public knowledge. “The FDA’s not out there examining these things constantly, so if there’s going to be a recall, it’s going to come from patients or from the company,” he says.

“The company has 98% of all the data on a particular device at all times, and usually it’s the company that goes to FDA and reports the problem. But I feel like companies are under-reporting these issues to the FDA, and the company can easily say that it was a result of some user doing something wrong, or that there’s no larger device problem.”

Instead, Fredrickson believes more emphasis needs to be put on personal reporting -- something the FDA does urge the patient and medical community to do more often.

To wit, people with diabetes using these devices often don't realize that a particular issue they’re experiencing is part of a bigger problem. That’s why it's so important for individual patients to contact both the company that makes the product and the FDA about any malfunction they might experience, and any health-related issues stemming from that problem.

From there, it comes down to the system regulated by the FDA and governed by policies and laws, but ultimately put into practice by the manufacturers themselves. Ideally, the recall is dealt with quickly and efficiently, to prevent the need for legal action. But clearly that is often not the case.

If it does come to that, attorneys like Harman say an important aspect of these product liability cases is to ensure that the person filing the lawsuit keeps the device in question. Don't turn that over to the manufacturer! Harman points out that it's common practice among vendors to request the person reporting a product problem to return the device so they can examine and test it. However, that of course means a key piece of evidence is lost.

Also, when it comes to communicating about recalls, Harman and Fredrickson agree that manufacturers and regulators can and should be doing a much better job in this day and age of mobile phones and tracking apps. Why couldn't an app track all FDA or product safety alerts, and allow users to select notifications about specific products they use? These kind of personalized alerts shouldn’t be difficult to implement -- freeing patients from having to sift through huge, complex databases to find specific medical device info.

A Civil Justice Approach

Some experts also suggest the civil justice system could be used in the medical device surveillance process in much the same way it’s being used more often now in car accidents on the road.

For example, the National Highway Traffic Safety Administration recently started monitoring against car companies in order to get early info about vehicle defects. While that system is somewhat imperfect, it could be used as part of a solution in better tracking these issues -- serving as a sort of guidepost pointing to potential product defects.

Whether it ever gets to that point for medical devices remains to be seen. But it's an interesting train of thought.

Of course lawyers like Harman and team have a vested interest in lawsuits; it's how they make their living. At the same time, not all attorneys are sharks who chase after frivolous claims, and Harman makes a strong case that in the current environment we're faced with, litigation (as expensive and time-consuming as it can be), is an important tool in keeping manufacturers and the FDA on track. In other words, consumer attorneys can and do often effectuate change through the legal system.

“I absolutely think these tragic stories can be catalysts for change,” Harman says. “Civil litigation can supplement the FDA and other government efforts to hold medical device manufacturers accountable for their products. Whether my clients win or lose, we ensure that medical device companies must be prepared to stand in front of a judge or jury and defend their actions, with their profits at stake.”

 

Next up: Part 4 in our series on Diabetes Device Recalls, which addresses how the process can be improved and how the Diabetes Size now can help.