Every physician knows what a black box warning is. This is a special Food and Drug Administration (FDA) requirement to warn doctors about potentially severe drug reactions. Most medicines do not have any black box warnings. Wyeth, a pharmaceutical company, will have to place a black box warning for their drug Phenergan, a medication routinely given for nausea. Phenergan has been on the market for over 50 years. I’ve prescribed it for years with excellent results, and I have never witnessed an adverse reaction.
The catalyst for the black box development was a tragic side-effect that a woman experienced in 2000 after receiving an injection of the drug. A physician’s assistant injected the medication improperly into her arm. As a result, she developed gangrene and her right forearm had to be amputated. She argued in court that she was not sufficiently informed about the drug’s risk and the jury awarded her $6.7 million. This past week, the U.S. Supreme Court rejected Wyeth’s appeal.
What will a black box warning accomplish? The currently published product information on Phenergan already addresses the proper dosing and method of administering the drug. Would a higher level warning have saved the plaintiff’s arm? If she knew in advance about a catastrophic side-effect that occurs in far less than 1% of injections, would she have refused the drug? I don’t think so.
Of course, patients should be advised about potential side-effects of drugs we prescribe. But, how much information is reasonable to impart? I confess that I do not warn patients before prescribing Phenergan about risks of gangrene and limb amputation. Should I? (I also don’t mention the risks of death from penicillin.) Look up the list of known or suspected side-effects of any prescription drug. You will discover pages of small print that list dangerous, and even deadly drug reactions, most of which are far more serious than the medical condition being treated.
If physicians reviewed these side-effects with patients, including extremely rare events such as Phenergan-induced gangrene, then patients would be too spooked to take any medication. How would you respond to this caveat from your physician?
“Here’s an antibiotic for your sore throat. I should warn you that this drug has caused severe colitis that has resulted in emergency surgery to remove the entire colon, leaving patients with a bag. A few folks have died, but this is very rare. Have a nice day and remember, don’t skip any pills!"
If patients were excessively informed about the harm that drugs could inflict, then they wouldn’t take them. This would be bad news for many patients, pharmacies and drug companies. It would also be an unwelcome development for lawyers, who troll the countryside for bad medical outcomes and try to concoct a pathway leading back to a doctor, a hospital or a pharmaceutical company. They prevailed against Wyeth, who had nothing to do with the improper injection of Phenergan. We physicians, who are similarly victimized with unfair allegations of medical malpractice, can empathize with their plight. Tort reform can’t come soon enough, but we won’t see it under President Obama’s watch. The president and the Democrats candidly admit that they don’t believe that medical malpractice reform is necessary.
Tragic outcomes are tragedies, not a priori evidence of medical negligence. True, the Phenergan medication may have been improperly injected, but how far should the shadow of blame extend?
The catalyst for the black box development was a tragic side-effect that a woman experienced in 2000 after receiving an injection of the drug. A physician’s assistant injected the medication improperly into her arm. As a result, she developed gangrene and her right forearm had to be amputated. She argued in court that she was not sufficiently informed about the drug’s risk and the jury awarded her $6.7 million. This past week, the U.S. Supreme Court rejected Wyeth’s appeal.
What will a black box warning accomplish? The currently published product information on Phenergan already addresses the proper dosing and method of administering the drug. Would a higher level warning have saved the plaintiff’s arm? If she knew in advance about a catastrophic side-effect that occurs in far less than 1% of injections, would she have refused the drug? I don’t think so.
Of course, patients should be advised about potential side-effects of drugs we prescribe. But, how much information is reasonable to impart? I confess that I do not warn patients before prescribing Phenergan about risks of gangrene and limb amputation. Should I? (I also don’t mention the risks of death from penicillin.) Look up the list of known or suspected side-effects of any prescription drug. You will discover pages of small print that list dangerous, and even deadly drug reactions, most of which are far more serious than the medical condition being treated.
If physicians reviewed these side-effects with patients, including extremely rare events such as Phenergan-induced gangrene, then patients would be too spooked to take any medication. How would you respond to this caveat from your physician?
“Here’s an antibiotic for your sore throat. I should warn you that this drug has caused severe colitis that has resulted in emergency surgery to remove the entire colon, leaving patients with a bag. A few folks have died, but this is very rare. Have a nice day and remember, don’t skip any pills!"
If patients were excessively informed about the harm that drugs could inflict, then they wouldn’t take them. This would be bad news for many patients, pharmacies and drug companies. It would also be an unwelcome development for lawyers, who troll the countryside for bad medical outcomes and try to concoct a pathway leading back to a doctor, a hospital or a pharmaceutical company. They prevailed against Wyeth, who had nothing to do with the improper injection of Phenergan. We physicians, who are similarly victimized with unfair allegations of medical malpractice, can empathize with their plight. Tort reform can’t come soon enough, but we won’t see it under President Obama’s watch. The president and the Democrats candidly admit that they don’t believe that medical malpractice reform is necessary.
Tragic outcomes are tragedies, not a priori evidence of medical negligence. True, the Phenergan medication may have been improperly injected, but how far should the shadow of blame extend?
Until the government injects some sanity into the medical malpractice system, then we will never achieve the health care reform that we all deserve. This is my black box warning.
Yes, I think it's a good idea for physicians to become the face for not just the insurance industry and tobacco industry, but also the drug industry in their attempts to keep juries of ordinary citizens from possibly holding them liable. That will surely benefit physicians - won't it?
ReplyDeleteThis is a prime example of why some kind of tort reform (and I do not advocate for caps on damages) is needed. The lawyers clearly went after Wyeth because they are the deep pockets.
ReplyDeleteIn my business, some of the products we sell have so many warnings printed on the packaging, you have to wonder if anyone will read all of them. If they are not on the package, then the mfr is guilty of a failure to warn. Either way a field day for lawyers.
Rep Tom Price of GA introduced a bill to deal with tort reform which has some merits. Of course it will not go anywhere at least until 2013 if not later depending on the next presidential election (as well as Congressional ones in the interim).
Dr. Kirsch- appreciate your comments on my blog, Political Policy, recent post on health care reform comparisons of ObamaCare & BaucusCare. I agree wholeheartedly on your points re: tort reform. Tort reform must be addressed directly in any new health care legislation. Any cost data you have on the escalation of medical procedures and tests performed to ward off malpractice suits would be greatly appreciated.
ReplyDeleteTo Political Policy, it is very problematic to determine the cost of defensive medicine. How can you quantify it? You may wish to review this article from yesterday's New York Times.
ReplyDeletehttp://www.nytimes.com/2009/09/23/business/economy/23leonhardt.html?_r=1
Appreciate your comment.
I’ve prescribed it for years with excellent results, and I have never witnessed an adverse reaction.
ReplyDeleteWell, that's certainly be enough to satisfy me. There's absolutely no need to talk about the matter further.
Move along, people. Move along.
Most warnings you see are required by federal or state laws. Not in response to any lawsuit. More in response to consumer group lobbying. I realize that doesn't fit the "lawsuits are responsible for the downfall of simply everything" narrative though.
ReplyDeleteFederal tort reform is a pointless exercise as malpractice actions are state law matters. And, if you federalize health care totally malpractice becomes a nonissue.
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ReplyDeleteMany of us have always believed that greed is one of the factors that make our healthcare system the most expensive in the world.. Government has a place in keeping businesses…lawyers, drug companies, doctors, insurance companies…from making excessive profits off of people who can least afford it.
ReplyDeleteEven Republicans are starting to get behind the concept that government intervention on behalf of consumers is not only necessary…it is also good.
If we can put arbitrary caps on jury awards, we can put those same caps on the profits that drug companies, hospitals, doctors and insurance companies make.
Tort reform in itself will only save our 2 trillion dollar a year healthcare system about 0.5%
In itself...not a significant amount. But if you take the concept further and start putting caps not only on lawyers, but doctors, hospitals , insurance companies and drug companies...now you are talking real savings.
Government limits to jury awards. Yes.
Government limits to doctors fees. Yes
Government limits to drug companies profits. Yes
Government limits to insurance companies profits. Yes
Now we are all talking the same language
The FDA is not allowed to determine if a new drug is any more effective then a new drug. So who makes out with this deal, drug companies and of course doctors will just go along for the ride. Sorry, but rhetoric is to easy.
ReplyDeleteIn a Medical negligence claims case, it's likely a medical expert will be hired to examine your records to determine if there is negligence and how you have been affected. The medical expert is typically a doctor with many years of experience in that specialty. The expert will prepare a report detailing the extent of the negligence and the injuries suffered. The expert may also testify in court. When you meet the lawyer, you need to bring your medical records to be reviewed. In fact, detailed medical records are vital to any successful medical negligence claim. You simply cannot bring TOO MUCH information. Include everything: personal details of the claimant, name of the doctor or doctors who provided treatment, the clinic or hospital where the treatment was carried out, the dates of treatment, the kinds of treatment, the medications prescribed, the blood tests, etc..
ReplyDeleteFrom the prospective of a patient who has been on the receiving end of medical malpractice, with all due respect the issue is far greater than that of malpractice lawsuits. I suffered a ureter stricture in 2007 from a hysterectomy. My surgeon placed three stitches around my left ureter completely closing the flow from my left kidney. 10 days later after several visits to the emergency room I had to demand further tests and refuse to leave the hospital until the cause of the pain was diagnosed and treated. I have had several stints placed in that ureter since 2007. The last stint placement was this past August at a highly recommend surgery center. The procedure went well enough but coming out of anesthesia is difficult for me, for some reason I always get very ill. I went to leave after being in recovery for 8 hours against my wishes. I wanted the team to admit me to the hospital. Uncontrollable vomiting ensued and a new IV had to be placed. Unfortunately, the IV was placed in my right wrist and phenergan was administered in a manner that broke all reasonable methods of protocol. Now I have limited use of my right arm. The basilica veins in my lower forearm are dead and I have suffered nerve damage. I have been out of work since August. I may never return to my profession as a mechanic again. At what point does corrective action and continuous improvement take its place in Dr-patient care?
ReplyDelete