Category Archives: Legal Liability

Medical malpractice in the age of AI: Who will bear the blame?

Posted on by • Posted in Artificial Intelligence, Artificial Intelligence Generative, Clinical Decision Making Software, Clinical Diagnosis, Clinical Failure, Legal Liability, Malpractice, Patient Safety, Physician • Leave a comment

https://www.linkedin.com/pulse/medical-malpractice-age-ai-who-bear-blame-robert-pearl-m-d–g2dec/

More than two-thirds of U.S. physicians have changed their mind about generative AI and now view it as beneficial to healthcare. But as AI grows more powerful and prevalent in medicine, apprehensions remain high among medical professionals.

For the last 18 months, I’ve examined the potential uses and misuses of generative AI in medicine; research that culminated in the new book ChatGPT, MD: How AI-Empowered Patients & Doctors Can Take Back Control of American Medicine. Over that time, I’ve seen the concerns of clinicians evolve—from worries about AI’s reliability and, consequently, patient safety to a new set of fears: Who will be held liable when something goes wrong?

From safety to suits: A new AI fear emerges

Technology experts have grown increasingly certain that next-gen AI technologies will prove vastly safer and more reliable for patients, especially under expert human oversight. As evidence, recall that Google’s first medical AI model, Med-PaLM, achieved a mere “passing score” (>60%) on the U.S. medical licensing exam in late 2022. Five months later, its successor, Med-PaLM 2, scored at an “expert” doctor level (85%).

Since then, numerous studies have shown that generative AI increasingly outperforms medical professionals in various tasks. These include diagnosis, treatment decisions, data analysis and even expressing empathy.

Despite these technological advancements, errors in medicine can and will occur, regardless of whether the expertise comes from human clinicians or advanced AI.

Fault lines: Navigating AI’s legal terrain

Legal experts anticipate that as AI tools become more integrated into healthcare, determining liability will come down to whether errors result from AI decisions, human oversight or a combination of both.

For instance, if doctors use a generative AI tool in their offices for diagnosing or treating a patient and something goes wrong, the physician would likely be held liable, especially if it’s deemed that clinical judgement should have overridden the AI’s recommendations.

But the scenarios get more complex when generative AI is used without direct physician oversight. As an example, who is liable when patients rely on generative AI’s medical advice without ever consulting a doctor? Or what if a clinician encourages a patient to use an at-home AI tool for help interpreting wearable device data, and the AI’s advice leads to a serious health issue?

In a working paper, legal scholars from the universities of Michigan, Penn State and Harvard explored these challenges, noting: “Demonstrating the cause of an injury is already often hard in the medical context, where outcomes are frequently probabilistic rather than deterministic. Adding in AI models that are often nonintuitive and sometimes inscrutable will likely make causation even more challenging to demonstrate.”

AI on trial: A legal prognosis from Stanford Law

To get a better handle on the legal risks posed to clinicians when using AI, I spoke with Michelle Mello, professor of law and health policy at Stanford University and lead author of “Understanding Liability Risk from Using Health Care Artificial Intelligence Tools.”

That paper, published earlier this year in the New England Journal of Medicine, is based on hundreds of software-related tort cases and offers insights into the murky waters of AI liability, including how the courts might handle AI-related malpractice cases.

However, Mello pointed out that direct case law on any type of AI model remains “very sparse.” And when it comes to liability implications of using generative AI, specifically, there’s no public record of such cases being litigated.

“At the end of the day, it has almost always been the case that the physician is on the hook when things go wrong in patient care,” she noted but also added, “As long as physicians are using this to inform a decision with other information and not acting like a robot, deciding purely based on the output, I suspect they’ll have a fairly strong defense against most of the claims that might relate to their use of GPTs.”

She emphasized that while AI tools can improve patient care by enhancing diagnostics and treatment options, providers must be vigilant about the liability these tools could introduce. To minimize risk, she recommends four steps.

  1. Understand the limits of AI tools: AI should not be seen as a replacement for human judgment. Instead, it should be used as a supportive tool to enhance clinical decisions.
  2. Negotiate terms of use: Mello urges healthcare professionals to negotiate terms of service with AI developers like Nvidia, OpenAI, Google and others. This includes pushing back on today’s “incredibly broad” and “irresponsible” disclaimers that deny any liability for medical harm.
  3. Apply risk assessment tools: Mello’s team developed a framework that helps providers assess the liability risks associated with AI. It considers factors like the likelihood of errors, the potential severity of harm caused and whether human oversight can effectively mitigate these risks.
  4. Stay informed and prepared: “Over time, as AI use penetrates more deeply into clinical practice, customs will start to change,” Mello noted. Clinicians need to stay informed as the legal landscape shifts.

The high cost of hesitation: AI and patient safety

While concerns about the use of generative AI in healthcare are understandable, it’s critical to weigh these fears against the existing flaws in medical practice.

Each year, misdiagnoses lead to 371,000 American deaths while another 424,000 patients suffer permanent disabilities. Meanwhile, more than 250,000 deaths occur due to avoidable medical errors in the United States. Half a million people die annually from poorly managed chronic diseases, leading to preventable heart attacks, strokes, cancers, kidney failures and amputations.

Our nation’s healthcare professionals don’t have the time in their daily practice to address the totality of patient needs. That’s because the demand for medical services is higher than ever at a time when health insurers—with their restrictive policies and bureaucratic requirements—make it harder than ever to provide excellent care. Generative AI can help.

But it is imperative for policymakers, legal experts and healthcare professionals to collaborate on a framework that promotes the safe and effective use of this technology. As part of their work, they’ll need to address concerns over liability. Ultimately, they must recognize that the risks of not using generative AI to improve care will far outweigh the dangers posed by the technology itself. Only then can our nation reduce the enormous human toll resulting from our current medical failures.

Threats of prison time put gynecologists in impossible circumstances

Posted on by • Posted in Abortion, Dilemma, Ethics, Health Policy, Legal Challenges, Legal Jeopardy, Legal Liability, Physician, Pregnancy Care, Prison Sentence, Uncertainty, Unclear Laws, Womens Health • Leave a comment

https://mailchi.mp/9e0c56723d09/the-weekly-gist-july-8-2022?e=d1e747d2d8

In states with laws that criminalize performing abortions, physicians are facing the dilemma of having to wait until a pregnant patient’s death is imminent to perform a potentially lifesaving procedure. Reporting from STAT News reveals how these laws are disrupting care. A physician in Missouri, which outlaws all abortions unless the life of the mother is in danger, described having to spend hours getting clearance from a hospital ethics team to perform the procedure on a patient with an ectopic pregnancy.

Even non-pregnancy care is being impacted. An arthritis patient taking methotrexate, which can also be used for abortion, was told by her doctor that all prescriptions for the drug are on pause due to legal uncertainty.

The Gist: Doctors and hospital legal counsel are dealing with a new legal landscape, marked by restrictive, ill-defined anti-abortion laws that fail to clarify what constitutes a medical emergency.

Physicians are forced to interpret unclear laws, often written without help from medical professionals, and many feel compelled to wait until patients are in dangerous, life-threatening situations to provide care—the opposite of what was instilled in them during years of training.   

Why Your Hand Sanitizer May Be Ineffective Or Tainted By Cancer-Causing Chemicals

Posted on by • Posted in Cancer Causing, Coronavirus, Food and Drug Administration (FDA), Hand Sanitizer, Health System, Hospital, Hospital Industry, Impurities, Lawsuit, Legal Liability, Occupational Safety and Health Administration (OSHA), Public Health, Public Safety, Supply Chain • Leave a comment

https://www.forbes.com/sites/ericmack/2020/09/10/why-your-hand-sanitizer-may-be-ineffective-or-tainted-by-cancer-causing-chemicals/?utm_source=newsletter&utm_medium=email&utm_campaign=coronavirus&cdlcid=5d2c97df953109375e4d8b68#115d2e346241

Since the start of the coronavirus pandemic, hand sanitizers have become a sought-after staple of life in a Covid-19-afflicted world. But supply chains have been turned upside down in our new normal, and some sketchy suppliers have at times stepped in to fill the vacuum. The result for consumers could be hand sanitizer that doesn’t work as advertised and might even be filled with impurities that can cause cancer.

When the pandemic set in during the spring, New Mexico’s Rolling Still Distillery began switching gears from making its trademark green chile vodka and other spirits to producing hand sanitizer for sale and free distribution during the early days of lockdown.

In the middle of May, Rolling Still founder Dan Irion (disclosure: Irion and I have lived in the same small town for years and occasionally hang out socially) began to receive a number of emails from bulk ethanol producers, offering up the alcohol for sanitizer production at prices as low as $1.60 a gallon, quite a deal over the $9 per gallon or more Rolling Still normally pays for its key ingredient.

To take advantage of the steep discount, Rolling Still would need to come up with $60,000 and take possession of a huge tank of the stuff.

Irion balked at the offer after he couldn’t get a straight answer about the quality of the ethanol. He asked one of the suppliers if organic alcohol was available and was told simply: “It’s all good. Don’t worry about it.”

He called Brian Coutu from Rolling Still’s regular alcohol supplier, Greenfield Global, who warned him away from what he says is fuel-grade ethanol potentially loaded with chemicals that are known to cause cancer.

Coutu knew this because Greenfield was getting the same cold calls Irion received, but as a large corporation, it could easily test samples.

“They send us a sample and it’s just God awful…it’s got acetaldehyde and benzene and all kind of nasty stuff in it; it’s not pure,” Coutu told me over the phone. “What (fuel producers) are trying to do is dump it off to these companies that run it through charcoal and try to do a million other things to make it USP grade (safe for food, drug or medicinal use), which it’s still not.”

Irion and Coutu both told me that the cold calls had largely stopped by the end of June. The price of ethanol cratered at the end of March as the pandemic took hold and fuel demand dropped. It stayed low through May before edging back near pre-pandemic levels at the end of June.

“Because of the fast and furious nature of the hand sanitizer industry at that time, we might have done it,” Irion says. “I’m sure there are others who saw this as a way to do something good and make money.”

And this is the big question for right now. How much of the sanitizer that made it to warehouses, store shelves and ultimately into our homes, cars and hands was produced from industrial fuel-grade ingredients rather than safe medical or food grade alcohol?

“You’re seeing less pure forms get into the market because there is a shortage of ethanol,” says Mike Sandoval, President and Chief Operating Officer of Santé Laboratories. “We see tert-butyl impurities, we see methanol, we see benzene in many of the hand sanitizers we test… We’ve seen some tequila grade ethanol that when you open the bottle it smells terrible, unless you like tequila… we’re seeing a lack of transparency in this space.”

 

Not just distilleries

Santé Labs works primarily in the hemp and CBD markets, providing quality testing and other services. CBD manufacturers can work with large amounts of ethanol and also turned to making hand sanitizers in the spring.

Sandoval says he began seeing CBD manufacturers and related companies using “untraditional sources” of ethanol from places like Mexico, Guatemala, South America and the fuel industry. The raw alcohol often came with a certificate of authenticity claiming 100 percent purity, but in reality it might actually contain chemical impurities and a significant amount of water.

“They come from a price sensitive market where no one wants to pay for high quality tests… They’re not used to operating in sophisticated manufacturing where you are required to test incoming raw material. For example the ethanol or isopropyl alcohol that goes in a hand sanitizer. You’re supposed to test (according to Food and Drug Administration rules) the purity of that ingredient before you formulate it, and that’s just not happening.”

For its part, the FDA has recently made public guidance on a testing method to detect impurities in hand sanitizers like those seen by Greenfield and Sante Labs.

“The agency’s investigation of contaminated hand sanitizers is ongoing,” the FDA said in an email. “Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated.”

The takeaway from all this is that the ethanol market for manufacturers new to the production of hand sanitizer was flooded with sketchy raw alcohol that could be diluted or tainted with carcinogens. If that raw material isn’t tested on the front end, the resulting final product can come out with those impurities and an alcohol concentration that doesn’t meet the claims stated on the label.

The FDA maintains a list of hand sanitizers to avoid because they’ve been found to contain dangerous amounts of methanol, or an insufficient amount of its actual sanitizing ingredient, such as ethanol or isopropyl alcohol. However, the FDA’s enforcement powers are limited. A new waiver program created in response to the pandemic makes it easier for manufacturers to get around substantiating their label claims.

“Nine out of ten people are not meeting the label claim,” Sandoval says. “So most of the hand sanitizer you’re using from stores – and I even saw one from Wal-Mart that was a big brand… their hand sanitizers were crystallizing and turning green. I guarantee that they’re at 50 percent ethanol when they need to be at 70 percent.”

This brings up yet another concern, which is the shortage of proper plastic bottles and containers for sanitizer. Sandoval suspects that some manufacturers may have resorted to using the wrong type of containers, which then react with the alcohol, leaching chemicals into the sanitizer and turning its color.

“This entire supply chain is upside down because there’s a shortage of everything.”

 

Covering the stink of subpar sanitizer

Coutu at Greenfield Global says he’s aware of companies that have purchased their alcohol from unconventional sources, lured by prices as much as 90 percent lower than what Greenfield would charge.

The FDA relaxed the allowable limit of impurities like acetaldehyde and benzene that can make it into hand sanitizer, but Coutu says the limits still only allow a very small amount, whereas the samples Greenfield was testing had levels of contamination ten to 100 times higher than the new limits.

“And the odor on it is just not acceptable. It smells like burnt tequila… there’s some pretty nasty stuff out there and it’s dangerous.”

New services have even popped up this year, with fragrance manufacturers offering up products to help reduce the bad odor of some ethanol-based hand sanitizers.

Irion feels like he dodged a bullet by not jumping at the deeply discounted supply of ethanol others may not have been able to resist.

Rolling Still continued buying the organic alcohol it uses in both its spirits and sanitizer. It’s now ramping up production of sanitizer, which Irion says has no need for added fragrances to mask any ethanol odors, but some local osha and sage is infused to lighten the scent.

The alcohol used is also distilled five times just to make sure all impurities are removed.