Mobile Health Apps, Part 4: Life, Death and Lawsuits
Apps have just hit the medical world and have yet to be scrutinized by juries or regulated by lawmakers. Unknown legal territory means shaky legal footing for the players; in fact, it means the players are at the mercy of the courts. "This is an area of the law in which there frankly is not very much law at all, and the courts are going to craft it as they go along," said plaintiff attorney Gerald Sterns of Sterns & Walker.
May 5, 2011 5:00 AM PT
While mobile healthcare apps are certainly handy now, they are soon destined to take point in the fight to control healthcare costs. Everything from electronic medical records to diagnostics will pulse across mobile apps on devices ranging from smartphones to tablets. The goal is to put quality medical care at your fingertips and thus cut down on the number of expensive doctor office and emergency room visits. But who's butt will be in a sling when, inevitably, someone gets hurt from this newfangled way of doctoring?
In other words, who is likely to be sued -- the app developer, the keeper of the app marketplace, the carrier, or all of the above?
"In theory, they all could be sued," Georgia Sen. Josh McKoon, an attorney at Day Crowley, a firm that specializes in healthcare law for large healthcare organizations and hospitals, told TechNewsWorld. "Right now, there are no hard and fast rules -- and where there are no set rules, the risks run very high."
Help - I've Been Apped!
The struggle to balance the harm to society from frivolous lawsuits against adequately repairing genuine harm to the public or a patient through the court systems continues to this day. It is exceedingly difficult to devise laws in such a way that the one can be sifted from the other.
However, it is imperative not to assume that lawsuits against app use would be frivolous. Why? Because apps will become central to medical care. In other words, we aren't just discussing the impact of a weight loss ditty or a stop smoking tip list. As discussed in Parts 2 and 3 of this series, apps are increasingly striving to replace or enhance existing diagnostics both for home, hospital and provider use.
There are even future possibilities to consider, such as an app enabling a mobile device in combination with an outside power source to deliver on-the-spot heart defibrillation, or remote robotic examinations and surgeries. Yes, the future is a strange, wonderful and decidedly scary place. And yes, people can get hurt just like they can get hurt in many a fully equipped and professionally staffed hospital and surgical suite. It happens all the time.
When someone gets hurt, intentionally or not, someone else has to pay.
"The reality in this day and age is that both the healthcare provider and the manufacturer/creator of the app or device will likely be sued if the use of an app or device leads to serious injury or death," J. Carter Thompson, an attorney who leads the Baker, Donelson product liability and mass tort group, told TechNewsWorld. Thompson is also co-chair of the drug, device and life sciences industry group.
"This is especially true in the wake of tort reform for healthcare providers," he said. "We are seeing more and more instances in which a manufacturer is also sued along with a healthcare provider in what use to be a garden variety malpractice case."
That is because many state legislatures have imposed caps on non-economic damages against healthcare providers, he says, but no such caps are in place for manufacturers. "In my view, this new reality is unfortunate since, among other things, it drives up the cost of cutting-edge, life-saving technology."
Die Developer, Die
In other words, if healthcare providers are protected from paying the full damages, then app developers, app marketplace owners and even carriers (especially those like Sprint and Verizon that are actively involved in app development) are at greater risk of being sued.
The app developer is likely to be first to face the chopping block, but app marketplace owners and carriers involved in app development are very close behind.
"It's very much like other litigation, where a plaintiff can sue a car manufacturer but also the dealer and parts suppliers, for example," explains McKoon. "If you have created an app marketplace, you have created certain expectations that the apps therein are of a certain quality and value to the user. So, yes, app marketplace owners and app development partners such as certain carriers are legally exposed."
For those salivating at the idea of soaking millions from the app supply chain, think again.
"It's a pretty far-fetched argument to make -- especially when it comes to diabetic sugar testing or blood pressure -- because either of those injuries alone would not be the cause of injury or death," Steve Knowlton, a partner at Locks Law Firm and a former intensive care and emergency room nurse, told TechNewsWorld.
"For example, if a mobile diabetic sugar app malfunctions to the point where someone relied on the reading to not seek care -- because that's the only way that it would happen -- it would read normal, or somewhere near normal, and the person's real sugar level would be extremely high or extremely low," explains Knowlton. "In either one of those situations, where it was extreme enough to cause damage, there would be other symptoms that would alert someone to go get medical help right away."
Indeed, many of the proof requirements are pretty tough to meet. But just in case, what can app developers do to try to shield themselves from at least some of the legal liability?
"Liability will not be assigned without regard to circumstance, and the smart health app providers rain down disclaimers like a summer thunderstorm," Theodore F. "Ted" Claypoole, attorney at Womble Carlyle Sandridge & Rice, told TechNewsWorld.
"Any plaintiff looking to pin liability on the application companies would have to swim through all these disclaimers and explain why she relied on the app for serious health information when the instructions specifically told her not to," he pointed out.
Pocket Doctors and Kangaroo Courts
Apps have just hit the medical world and have yet to be scrutinized by juries or regulated by lawmakers. Unknown legal territory means shaky legal footing for the players; in fact, it means the players are at the mercy of the courts.
"This is an area of the law in which there frankly is not very much law at all, and the courts are going to craft it as they go along," plaintiff attorney Gerald Sterns of Sterns & Walker, told TechNewsWorld.
"However, an educated prediction would be based on several well-settled rules, and we can sort of extrapolate from there," he said. Here are his specific extrapolations:
- All medical devices are regulated by the federal government, much the same as Rx prescriptions; this would be the FDA and there are specific statutes as to certain medical devices, and also court rulings on when there is federal statute preemption on what or who may be responsible, which can limit what the common law might otherwise do.
- No one may prescribe any of the regulated medical devices (such as pacemakers, morphine pumps, C-pap breathing machines, things of that type) unless that person is a licensed M.D. qualified to prescribe drugs.
Using the example of blood sugar monitoring devices, these may be on the cusp; some available over the counter and others only by prescription, but I would be inclined to think more likely the latter. Thus sale and hyping of these over the Internet could violate federal FDA law and regulations, as well as state medical licensing laws. Maybe. As noted, we are in very unchartered waters here.
Regarding passing on info gleaned from the maybe-legal-and-maybe-not devices to medical facilities and personnel, who may base diagnoses and treatment on same, this is very troublesome and shaky ground. My best shot at this point -- absent time to do some extensive research on all this -- would be that such practice for sure violates somebody's law or regulations; either FDA, state medical board, or state licensing for dispensing pharmacies, where one would normally go to get something like a blood sugar monitoring device.
- Lastly, would there be liability of the medical providers under state law for prescribing or treating based on information provided by essentially unknown sources, from the Internet or apps, or whatever? Maybe, maybe not. A physician is entitled to rely on all sorts of outside info in treating a patient, such as statements from the patient or info provided by the family, or lab results from someone the M.D. does not know personally, and so on. The question probably will become one of what is reasonable and accepted and what is not.
One example would be the perfusion CT scanning machines manufactured by General Electric and used in Cedars Sinai medical center. Somehow, it malfunctioned, and over a hundred patients were over-radiated. GE has filed court papers claiming that California's product liability laws cannot apply to these machines insofar as plaintiffs allege they were defectively designed with software defects. That is precluded under the federal statutes they cite, as well as a California Supreme court case; there must be proof of negligence, not just defect. That case is in active litigation.
Not that these legal worries are slowing app development any at the moment. Today, developers, app marketplace owners and carriers are churning apps out as fast as they can make them. The legal shockwave won't hit for another year or so -- not until the first problem is printed on a court docket and then answered in a court judgment. Such is the American way -- first the problem then the fix. We just haven't fully caught on to the concept of preventive care yet. Give it a minute. Surely there's an app coming for that too!