Skip to main content

Accutane Users Win Huge Verdict Against Roche. Who's the Winner?

I was engaged in one of my pleasures, sitting in a coffee shop leafing through medical journals. Usually, I am perusing newspapers. I spend many hours each week combing through various newspapers and routinely forward items of interest to folks of interest. No newspapers today. I have a few gastroenterology journals to look through. My professional reading habits have evolved over my career. I am more interested in reading about medical ethics, health care policy and the art of medicine than in studying hard science or clinical research, which used to be my required reading years ago.

I read an essay entitled, Irritable Bowel Syndrome (IBS) Patients’ Willingness to Take Risks with Medications published in the June 2012 issue of the American Journal of Gastroenterology. The article stated that IBS patients would accept a small chance of death if there were an overwhelming likelihood of cure. This caught my attention. Of course, IBS can be a debilitating illness. But, it is not cancer and poses no threat to life. Nevertheless, patients who are desperate for succor, would accept a small risk of a premature journey to the hereafter. While many physician would not be comfortable with these odds, if patients make an informed judgment, then it is their call to make.

Patients need to know the material risks of a medicine or treatment in order to provide informed consent. For example, many successful medical malpractice lawsuits prevail because the plaintiff claims that the physician ‘failed to warn’ of a known complication. The plaintiff alleges that if he been properly warned of a potential rare complication, then he would have rejected the risky and reckless treatment. These cases often suspend disbelief. Do we believe that a patient with a serious medical condition would have declined a treatment if informed about a 1 or 2% chance of a dangerous complication? Give me a break.

In New Jersey, a cauldron for medical malpractice litigation, a jury awarded damages of $18 million to two plaintiffs who developed colitis after taking the drug Accutane. They claim that the company, Roche, failed to warn about this complication. There remain over 7000 cases of alleged Accutane induced colitis that are pending.  Roche has paid out nearly $80 million in verdicts and denies that their medication causes this complication. I wonder how much medical research could have been funded with this incomprehensible amount of cash.

I am a gastroenterologist who has never seen a case of colitis linked to Accutane. I am not certain that this complication truly exists, even though a jury of ordinary folks accepts this, particularly when an ailing person is seeking ‘justice’ from a rich and heartless pharmaceutical company. The first I ever learned of a supposed connection between Accutane and colitis was when I read about a medical malpractice case in a newspaper years ago.

Does this drug truly cause colitis? Who knows? Is the company responsible for not warning about a complication that it doesn’t believe exists? Do we believe that a patient with disfiguring acne (Accutane was prescribed for severe acne, not typical teenage blemishes.) would decline a highly effective medicine because there might be an extremely small risk of developing severe colitis? I would suggest that these patients, like suffering IBS patients, would accept considerable risk in return for considerable relief.

In 2009, Roche took Accutane off the market after enduring tens of millions of dollars in verdicts. Who emerges victorious here? Choose the best answer.

  • The public
  • The medical profession
  • Roche
  • Trial Lawyers
Would trial lawyers abandon a case if there was a 1% chance they would lose?



Comments

  1. Roche made Accutane for severe acne; doctors prescribed it for all kinds of acne. Don't forget that if the pimple is on your own face, it is more severe than the same pimple on someone else's face. I don't agree with the verdict - what will happen to these cases under Obamacare?

    ReplyDelete
  2. Lisa, I don't think Obamacare will change this. He and his Democratic confederates dodged tort reform. It's up to the states. Interesting phrasing in your comment regarding a 'pimple being more severe on your own face'. Thanks for commenting.

    ReplyDelete
  3. Derms prescribe this for even small cases of acne. They promote it as a pill to cure all. I took it I'm 20078 and developed ibs soon after. Cramping so bad I doubled over in pain for weeks. It did not come about on its own. Read up on ibs and ibd related to accutane. It's a strong and serious drug

    ReplyDelete

Post a Comment

Popular posts from this blog

Why Most Doctors Choose Employment

Increasingly, physicians today are employed and most of them willingly so.  The advantages of this employment model, which I will highlight below, appeal to the current and emerging generations of physicians and medical professionals.  In addition, the alternatives to direct employment are scarce, although they do exist.  Private practice gastroenterology practices in Cleveland, for example, are increasingly rare sightings.  Another practice model is gaining ground rapidly on the medical landscape.   Private equity (PE) firms have   been purchasing medical practices who are in need of capital and management oversight.   PE can provide services efficiently as they may be serving multiple practices and have economies of scale.   While these physicians technically have authority over all medical decisions, the PE partners can exert behavioral influences on physicians which can be ethically problematic. For example, if the PE folks reduce non-medical overhead, this may very directly affe

Should Doctors Wear White Coats?

Many professions can be easily identified by their uniforms or state of dress. Consider how easy it is for us to identify a policeman, a judge, a baseball player, a housekeeper, a chef, or a soldier.  There must be a reason why so many professions require a uniform.  Presumably, it is to create team spirit among colleagues and to communicate a message to the clientele.  It certainly doesn’t enhance professional performance.  For instance, do we think if a judge ditches the robe and is wearing jeans and a T-shirt, that he or she cannot issue sage rulings?  If members of a baseball team showed up dressed in comfortable street clothes, would they commit more errors or achieve fewer hits?  The medical profession for most of its existence has had its own uniform.   Male doctors donned a shirt and tie and all doctors wore the iconic white coat.   The stated reason was that this created an aura of professionalism that inspired confidence in patients and their families.   Indeed, even today

Electronic Medical Records vs Physicians: Not a Fair Fight!

Each work day, I enter the chamber of horrors also known as the electronic medical record (EMR).  I’ve endured several versions of this torture over the years, monstrosities that were designed more to appeal to the needs of billers and coders than physicians. Make sense? I will admit that my current EMR, called Epic, is more physician-friendly than prior competitors, but it remains a formidable adversary.  And it’s not a fair fight.  You might be a great chess player, but odds are that you will not vanquish a computer adversary armed with artificial intelligence. I have a competitive advantage over many other physician contestants in the battle of Man vs Machine.   I can type well and can do so while maintaining eye contact with the patient.   You must think I am a magician or a savant.   While this may be true, the birth of my advanced digital skills started decades ago.   (As an aside, digital competence is essential for gastroenterologists.) During college, I worked as a secretary