Tuesday, December 11, 2007
Updated: Expansion of Duty for Doctors in Massachusetts
In an opinion with potentially broad implications, the Supreme Judicial Court here in Massachusetts has ruled (click on Coombes v. Florio) that a physician issuing a prescription has a duty not just to the patient but also to foreseeable injured parties. The facts:
Dr. Florio became Sacca's primary care physician in 1999. By 2002, when the accident occurred, Sacca was seventy-five years old and had been diagnosed with a number of serious medical conditions including asbestosis, chronic bronchitis, emphysema, high blood pressure, and metastatic lung cancer that had spread to his lymph nodes. . . . Shortly after the cancer was diagnosed, in July, 2000, Dr. Florio warned Sacca that it would not be safe for him to drive during his treatment for cancer. Sacca obeyed the warning and did not drive until the fall of 2001, when treatment for his cancer concluded. At that time Dr. Florio advised Sacca that he could safely resume driving.
At the time of the accident Sacca had prescriptions from Dr. Florio for Oxycodone, Zaroxolyn, Prednisone, Flomax, Potassium, Paxil, Oxazepam, and Furosemide. Potential side effects of the drugs include drowsiness, dizziness, lightheadedness, fainting, altered consciousness, and sedation. . . . According to the plaintiff's expert, when used in combination these drugs have the potential to cause "additive side effects" that could be more severe than side effects resulting from separate use. The plaintiff's expert also opined that the sedating effects of these drugs can be more severe in older patients, and that the standard of care for a primary care physician includes warning elderly or chronically ill patients about the potential side effects of these drugs, and their effect on a patient's ability to drive. Dr. Florio did not warn Sacca of any potential side effects. Before the accident occurred Sacca reported no side effects from the medication and had no trouble driving. Sacca's last visit to Dr. Florio before the accident was on January 4, 2002. At that visit, Dr. Florio did not discuss potential side effects and gave no warning about driving.
On the day of the accident, March 22, 2002, Sacca drove his automobile to do some errands. On his way home he lost consciousness and his automobile left the road and hit Coombes, who was standing on the sidewalk with a friend.
Coombes died from his injuries.
The majority, while recognizing that a number of cases go the other way due to concerns about excessive liability, concludes that ordinary negligence principles of foreseeability are sufficient to protect defendants.
I conclude that a physician owes a duty of reasonable care to everyone foreseeably put at risk by his failure to warn of the side effects of his treatment of a patient. [case citations]
Courts in other jurisdictions have imposed a duty on doctors in circumstances similar to this case. In McKenzie v. Hawai'i Permanente Med. Group, Inc., supra at 307-309, the court held that a doctor owed a duty to a person killed in an automobile accident caused by the doctor's patient who was driving after taking medication prescribed for him by the doctor. The court reasoned that "a logical reason exists to impose upon physicians, for the benefit of third parties, a duty to advise their patients that a medication may affect the patient's driving ability when such a duty would otherwise be owed to the patient." Id. at 308. [additional cites]
* * *
Sound public policy also favors a duty in these circumstances. The costs of imposing a duty owed to individuals other than a patient are limited because existing tort law already imposes on a doctor a duty to warn a patient of the adverse side effects of medications. See Cottam v. CVS Pharmacy, supra, citing McKee v. American Home Prods. Corp., 113 Wash.2d 701, 709 (1989). The duty described here does not impose a heavy burden because it requires nothing from a doctor that is not already required by his duty to his patient. See McKenzie v. Hawai'i Permanente Med. Group, Inc., supra at 306; Hardee v. Bio-Med. Applications of S.C., Inc., supra; Burroughs v. Magee, supra at 333. Meanwhile, the benefits of such warnings are significant. They serve to protect the public from the very harm that creates the parallel duty to the patient, the foreseeable risk that known side effects of a drug will impair a patient's ability to drive. See McKenzie v. Hawai'i Permanente Med. Group, Inc., supra at 307; Burroughs v. Magee, supra at 332-333.
A second opinion (concurring in part and dissenting in part) disagrees that the duty should be so broad, but concludes that in this case, summary judgment was inappropriate, focusing on the fact that the alleged failure to warn related to precisely the same time of risk.
Extending the scope of liability for the benefit of third parties foreseeably put at risk by an uninformed patient's decision to drive alters neither the physician's medical decision to prescribe medication, nor the physician's legal duty under the Cottam decision to warn the patient about adverse side effects. Because the foreseeable risk of danger that the patient faces (here, death or bodily injury due to a motor vehicle accident) is the identical risk that the physician may anticipate others, such as the plaintiff's son, to encounter, there can arise no conflict of professional interest. Contrast Spinner v. Nutt, 417 Mass. 549, 553-554 (1994) (lawyer's primary duty owed to client bars imposition of secondary duty owed to third parties). The imposition of liability for a failure to warn a patient rests on a physician's superior knowledge of the risks (to the patient and to others) involved, and the physician's professional responsibility to ensure that a patient understands the risks involved in taking prescribed medications.
And two dissents reject the notion entirely, arguing that the majority ruling is mucking up the doctor-patient relationship too much to be acceptable. From the first one:
Today's result impedes not only the work of doctors. It impedes the work of our courts. On remand, the trial judge is left the unenviable task of divining from the vague generalizations of the concurring opinions the outer limits of a novel duty of physicians to third-party nonpatients. Because I agree with the trial judge that the physician's liability does not extend to the third-party decedent in this case, I would uphold the grant of summary judgment in Dr. Florio's favor, and not leave it to trial judges to puzzle their way through this thorny issue of public policy.
Updated to note discussion at Overlawyered and Decisionism. The Globe has coverage too.
How does this opinion change the doctor's incentives? The doctor already owes the same duty to his or her own patient. How will the doctor behave differently now that that duty attaches not only if the patient kills himself in a car, but also if he kills someone else?
Posted by: Tom T. | Dec 12, 2007 9:16:06 AM
The potential exposure is now massive rather than merely large. The rational response (if the tort system is the only thing influencing behavior) would be to never suggest that driving is appropriate -- i.e., to always (over-) warn against driving. When the personal exposure is limited, the doctor is more likely to be measured in the advice given.
I am not entirely convinced that it actually will result in that behavior, but that's the idea. Same idea for limiting duty in advising patients about whether they're contagious or not.
As for SC's post, I think it is facially absurd to suggest that a reasonable patient has the same information as a physician. I litigated package inserts for a living for a time and don't consider myself to be in the same shoes as my physicians.
Posted by: Bill Childs | Dec 12, 2007 9:32:49 AM
Bill: The physician has superior knowledge. It is restricted to experience in other patients of unreported, new adverse events from a treatment.
If an adverse effect has been listed in the package insert, the patient's knowledge is superior. The patient not only knows the report of the effect from the internet. He has a minute by minute knowledge of its effect on him, all day, every day. The doc sees him a few minutes, every so often, and has the least knowledge of any party. He has less knowledge of the effect than the deceased plaintiff.
The family's knowledge of the adverse effect is an intervening unforeseen factor that increases risk, with a superiority laying between the knowledge of the patient and of the doctor.
The claim of lack of informed consent is dead, assassinated by the internet. The latter is accessible to 100% of the plaintiff population. Its research has become a duty of the reasonable consumer. The courts will soon recognize the obvious.
Posted by: Supremacy Claus | Jan 19, 2008 8:03:21 AM
Bill: The physician has superior knowledge from experience in other patients of unreported, new adverse events from a treatment.
If an adverse effect has been listed in the package insert, the patient's is superior. The patient not only knows the report of the effect from the internet. He has a minute by minute knowledge of its effect on him, all day, every day. The doc sees him a few minutes, every so often, and has the least knowledge of the individual case of any party.
The family's knowledge of the adverse effect is an intervening unforeseen cause that increases risk, with a superiority laying between the knowledge of the patient and of the doctor, the least knowledgeable of all possible defendants.
The claim of lack of informed consent is dead, assassinated by the internet. The latter is accessible to 100% of the population. Its research has become a duty of the reasonable consumer. The courts will be starting to recognize the obvious.
Posted by: Supremacy Claus | Jan 19, 2008 8:08:48 AM
Bill: What do you mean, facially? Is there a statute to that effect?
Posted by: Supremacy Claus | Jan 19, 2008 12:51:37 PM
By "facially absurd," I mean what I said: your suggestion is absurd on its face.
Let's take Lipitor, one of the best selling drugs ever. In its package insert, a reader finds this sentence: "Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin and with other drugs in this class. "
I understand that sentence, having been deeply involved in statin litigation while in practice. What percentage of people on Lipitor would understand it as compared to the percentage of physicians?
If you really believe that access to a package insert written and regulated for the use of physicians makes it so that patients no longer can claim ignorance of a side effect, then I guess I'll just shake my head and disagree.
Posted by: Bill Childs | Jan 19, 2008 2:45:59 PM
Bill: What do you think of the readability of this passage?
"Stop using Lipitor and call your doctor at once if you have any of these serious side effects:
* muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine."
It says the same thing as your passage, from here:
It arose third on a google search for lipitor, and first if one is looking for general information.
I thought "facial" meant discriminatory in the words of a statute or rule, as opposed to discriminatory in the application of a non-discriminatory rule. And facial discrimination triggers a level of harsh scrutiny by a court.
My proposal is not even inside anyone's head, let alone facial. But watch for its coming in appellate holdings in the next five years. Some judge will do what I just did. He will google something on his bench laptop, and say, "I learned about that risk in less than a minute. You should have as well. The count of failure to warn or failure to obtain informed consent is dismissed."
Posted by: Supremacy Claus | Jan 25, 2008 9:06:25 PM
"Facial challenge" to a statute means that it's on its face problematic -- discriminatory, unconstitutional, etc. That's not the context I used it in, and the word is not at all limited to the statutory context.
As for the risks, yes, that's readable. And yes, there will be certain situations in which access to information will make a difference. But that statement doesn't tell patients about the nature of rhabdomyolysis (the side effect in question), its frequency, what else causes the risks, or its relative dangers compared to the danger of hyperlipidemia.
If your point is that the internet has the potential to change the contours of some lawsuits relating to risk information, I agree, though that's not what you said. If your point is that it's going to eliminate the doctor's role (medical and legal) in prescribing decisions, I think you're wrong. Patients may have access to the same words but not the tools to understand a substantial proportion of them.
Posted by: Bill Childs | Jan 26, 2008 1:20:28 PM
The lay person's version asks the patient to stop Lipitor upon noticing the dark urine. It is actually more informative, and has greater likelihood of preventing harm, than the doctor's version. The patient does not really need to understand the pathophysiology of rhabdomyolysis. Even if the doc presented an extensive lecture on this rare side effect, the patient is unlikely to recall much of it, after a few minutes. If the sign of this side effect, dark urine, is hidden in a long lecture, the patient might forget it. The above warning is at the eighth grade level.
The simple statement is actually more informative, and eliminates the camouflaging verbiage. The internet provides the best expression of the warning. It does not depend on the clarity of expression of a doctor, nor on incomprehensible accents, nor on rushing, by someone better suited to operating than to teaching the public. Let the FDA or a professional society write the very best, clearest warnings, and post them to the public. This question awaits its first appellate decision.
Posted by: Supremacy Claus | Jan 26, 2008 6:12:48 PM
You are conflating warnings with instructions. It's a good instruction to patients. It's okay at telling patients that there exists something serious about urine. It does nothing to inform the patient of the magnitude or frequency of the risk, or how that risk might compare to the benefit of the drug in treating hyperlipidemia.
Posted by: Bill Childs | Jan 27, 2008 5:09:18 AM
If the aim of consent or warnings is to reduce harm, the plain, simple sentence does that. If the aim is to set up or prevent a lawsuit, then telephone book size consent does that better.
Consent is process, people say, a permanent, lawyer bullied unending procedure. No patient can remember a thing about it, not even docs outside the treating specialty. It annoys patients who want relief, not a medical education. When their doc forgets their pain, and pulls out the one hour Powerpoint, the patient gets a disturbing message, this doc and I are legal adversaries, and he is more interested in covering his rear than in treating me. Warnings scares and deters patients. They fail to weigh the risk of the rarity of side effects against the certainty of their diagnosed condition.
The writer of warnings and the plaintiff lawyer claiming failure to warn have an affirmative duty to do no harm. (I just invented it, here.) If a warning deters a patient from treatment by unwarranted alarmism, if the consent never ending process takes up valuable clinical care time, then the warning writer, the lawyers who bullied the provider into the harmful writing, all should get named in cross claims by both plaintiff and defendant. The Federal Tort Claims Act does not preclude such claims, not facially, at least.
The lack of warning claim is a stalking horse for strict liability in medmal. The number of warnings not given is infinite in every prescription. For example, you failed to warn that a warning could harm the patient by deterring care.
The warning line of reasoning and the above case violate the dozens of Supreme Court holdings granting deference to clinical judgment.
Posted by: Supremacy Claus | Jan 27, 2008 12:08:25 PM
I'm just about done on this subject; you've made your point, I think you're wrong, and now we're both repeating ourselves. I think you have an excessively narrow view of what the warnings are about. If you're right about what they're about, then you may be right about the impact of the internet. But I think you're wrong about both.
And, incidentally, I say this as someone who both in the past and today represents pharma companies in warnings claims.
Posted by: Bill Childs | Jan 27, 2008 12:52:07 PM
Bill: Could you, at least, keep an open mind? Raise the subject of the internet in a deposition, then maybe in a motion. It's common sense. First appellate judge that buys it, you have a new defense. You can make law, not just write about it.
As a consumer of medications, I have a vested interest in the subject. Money that does not go to the plaintiff helps to develop the next improved medication.
Posted by: Supremacy Claus | Jan 27, 2008 10:22:20 PM
Mind's open, I have raised internet issues in deps, and information obtained from such deps has gone into motions.
My view is not that it's irrelevant. Instead, it's that it's now and will always be incorrect to say that the patient has the same information as the doctor, which is how you started. A more modest suggestion -- that sometimes access to information via the internet or otherwise should mean the plaintiff can't win on a warning claim -- is relatively uncontroversial, and not significantly different than saying that the plaintiff reading the PI in hard copy can be relevant. But you can't go from that to saying that a patient has all of the information that a doctor does.
Posted by: Bill Childs | Jan 28, 2008 7:56:47 AM
Bill: I am claiming the patient has superior knowledge to any party, second by second facts of bodily sensations and functioning, reaction to a medication. That should become part of the contributory negligence defense, including the failure to communicate every gurgling and twinge in contemporaneous, time stamped emails.
Next, the ongoing process of informed consent is literally impossible if delivered by the doctor, even if an hour is spent reading the surgery text word for word together. The patient will forget it all 15 minutes after leaving. Only repetitious review helps people understand and remember.
See p. 2 below for an establishment review of the nascent case law on the duty to Google. This idea is not even new nor creative. It just awaits application by the defense bar.
Posted by: Supremacy Claus | Feb 7, 2008 12:23:21 AM
With the Internet, no reasonable patient fails to receive warning about any available medication, and at the same depth as a physician. The reasonably prudent patient has all the information that the physician has.
Posted by: Supremacy Claus | Dec 11, 2007 5:10:04 PM