Thursday, August 9, 2012

Side Effects of Drugs: Who's Responsible?

     Court Ruling:  Doctors, not drugmakers, must warn patients 
         of risks.  Physician organizations worry that a Texas 
         decision shifts liability to doctors and removes
         accountability from drugmakers who market directly to

     The Supreme court of Texas has ruled that pharmaceutical 
manufacturers are not responsible for conveying drug risks 
to patients, even when the drugmakers advertise their
products directly to consumers.
                                                   American Medical News, July 23, 2012

     I wonder who "paid" to clinch this decision?  A lower court had already decided that drug manufacturers should be responsible for the side effects of their medicines.  But the lower court's decision was overturned, making physicians responsible, instead.  Now it will become case law. 
     Here are the details of the case.  A Texas woman suffered lupus-like side effects from Remicade, a medication used for Crohn's disease.  She sued Centocor, Inc., the manufacturer of the drug, for advertising the drug's benefits and omitting warnings about side effects.  The court ruled against Centocor, ordering a $4.7 million settlement.  But the appellate court has just reversed the decision, making the woman's physicians responsible for the adverse effects of the medicine.
      In reviewing the case, the appeals court examined the state's decades-old policy known as "learned intermediary doctrine."  The doctrine says a drug manufacturer satisfies its duty to warn the end-user of its product by providing an adequate warning to a learned intermediary.  The intermediary, generally a physician, assumes the duty to pass on the necessary warnings.  

     Here's what's really bad.  The appellate court cited an exception to the ruling when drugmakers advertise directly to consumers in a "fraudulent manner."  But the high court reversed this ruling, too, giving drugmakers carte blanche to advertise fraudulently.
     Therefore, drug companies may advertise their drugs to consumers--even in a fraudulent manner!--and rest assured that physicians will be held responsible for the side effects and bad outcomes referable to their products. 
     Decisions like this make me wonder who's operating behind the scenes to protect Big Pharma's financial interests.  Decisions like this make me want to withhold all prescriptions from patients.  Think about it:  the PDR (Physician's Desk Reference)--a compendium of drugs and their uses--enumerates hundreds of potential side effects--in some cases, death--for every medication approved by the FDA.  There are hundreds more drug-drug, drug-food, and drug-supplement interactions possible.  How can physicians be expected to apprise patients of every potential problem--except by handing them reams of paperwork at every visit, which is guaranteed to scare them into refusing treatment?  A sizable number of my patients cannot read and write.  Am I supposed to sit down and discuss every possible side effect?  And would doing this really protect me in a lawsuit?  
     Another advisory admonishes physicians not to use "boilerplate" statements.  This means we should recapitulate in a written chart note our conversations with patients about every side effect listed in the PDR for each medication we prescribe.  Is this humanly possible?
     My attorney tells me that lawyers and insurance reviewers are looking for "a unique medical record for each patient."  What's unique about the PDR?  The lists of side effects are identical for many medications--covering, as they do, every complaint made by subjects in experimental trials prior to release of the drug, and every report of adverse effects after the drug has been put on the market.  
     When I discuss a new medication with a patient my documentation of our conversation consists of med risks and SE rev'd ("medication risks and side effects reviewed with patient")--apparently this isn't good enough.  But if I don't advise patients of the risks their medications pose--preferring, instead, to use our time together for other purposes--I become liable for "bad outcomes."
     There is an astounding fact about the Centocor case.  The physician who prescribed Remicade for this Texas woman required her to watch an informational video made by the drug company, prior to starting the medicine.  The video overemphasized the benefits and downplayed the side effects of the drug; the physician had gone to the effort of presenting the manufacturer's warnings in an accessible format;  the court, nevertheless, held the treating physician entirely liable for the drug's shattering side effects.  Why wasn't the patient responsible--having been apprised of the risks and benefits of the drug?  Why wasn't Centocor responsible--having misled the patient with its educational video?
     I wonder how much more responsibility can we physicians handle.  Is it fair to place liability for drug effects on our shoulders?  A spate of recent settlements in lawsuits against doctors have been in the $50 million range, blowing most physicians and their insurance carriers out of the playing field.  Physicians who don't follow their malpractice carrier's advice to "settle" become personally responsible for the financial consequences of a court's decision.  This makes it unlikely that physicians will ever defend themselves in court, even if they could afford such expense against companies like Centocor, so case law like this one will stand forever. 
     A solo doctor does not have enough time in the day to review all the drug side effects listed by manufacturers, or to chart conversations with patients in a "unique" way.  Nor do our personalities manifest the combativeness necessary to defend ourselves against devastating accusations of wrongdoing by patients and lawyers.  
     Instead, we doctors live with baseline terror about lawsuits and allegations of misconduct--a terror that has become as rooted and erosive as that of hostages in enemy prison camps.  Can perpetual fear possibly serve the best interests of our patients?  It's no wonder we're flocking to huge corporate medical groups and teaching hospitals for a measure of immunity.  It's no wonder so many of us fantasize constantly about leaving the practice of American medicine altogether.  

1 comment:

  1. That's so cruel! How can pharmaceutical companies do these terrible things?