Don't avoid experimental treatments

September 7, 2007

Malpractice Consult

Key Points

What happens if there's overwhelming evidence that a procedure or treatment saves lives, but its use is still considered experimental? Should you recommend it anyway?

Not long ago, for example, researchers reported that annual spiral CT scans on patients at risk for lung cancer detected the lesions sufficiently early to improve the mortality statistics. This is a disease that's nearly always fatal within five years unless it's detected early. Indeed, early detection seems to have achieved about an 85 percent or higher five-year survival rate. But spiral CT scans for early detection of lung cancer are still considered experimental; that is, they're not yet recommended for general use.

So, what are your obligations to patients who might benefit from annual spiral CT scans or some other new technology, and what would your legal exposure be? Because this issue is the product of 21st-century science and technology, the courts haven't yet dealt with it directly. So there's no clear answer. The guidelines are based upon analogous case law, and the direction in which these decisions point.

Still, your responsibility to your patient is absolute-as is your obligation to use your best judgment regarding diagnosis and treatment. If I was representing the patient, and the evidence indicated that my client could have been saved if you had ordered such a test, I would probably file the lawsuit. Moreover, it would be against you, not the insurance company or hospital. They do not practice medicine, you do, and the decisions are yours. In my opinion, you should advise your patient to have the test or treatment regardless of the cost involved (with the full understanding that they might not be able to afford it) and make sure to document the discussion in your records. Also, document the patient's decision, and if he refuses, indicate why (e.g., cost).

Your next step as an advocate for your patient is a "good faith" attempt to get the insurance company to cover the procedure. In the case of spiral CT scans, you could write a letter (sent certified mail, with one copy for the patient and one for your records) to the insurer, detailing your patient's long history of smoking and family history of cancer. You might even include copies of studies showing that these tests have been successful. And be sure to document your advice to the patient, the reasons for it, and the steps you take to try to ensure your recommendation is carried out.

Finally, remember, scientific breakthroughs are occurring at a rapid rate, and you and your patients learn about them immediately thanks to the Internet and media coverage. Life-saving therapies are being "fast tracked" for FDA approval, and your patients probably are as aware of major new study results as you are. Failing to offer a patient lifesaving alternatives-even those currently considered "experimental" and "not cost-effective"-could have the nerve-racking consequence of moving you from the exam room to the courtroom.

The author is an internist and a health law attorney in Philadelphia. He can be reached by e-mail at eshore@KaneShore.com

. This department answers common professional liability questions. It isn't intended to provide specific legal advice. If you have a question, please submit it to Malpractice Consult, Medical Economics, 123 Tice Blvd., Woodcliff Lake, NJ 07677. You may also fax your question to 201-690-5420, or e-mail it to memalp@advanstar.com.