United States: Just What The Doctor Ordered: Package Insert Does Not Establish Standard Of Medical Care

Last Updated: February 15 2017
Article by Stephen J. McConnell

Like most Americans, we like our doctor.  We like doctors in general.  We are not looking to start another song battle with our friends over at the Abnormal Use blog, like when we competed to name as many law songs as possible, but there are certainly many excellent doctor songs.  Listen to this top 10, and we guarantee you'll feel better:

  • Doctor, Doctor (Thompson Twins)
  • Dr. Robert (Beatles)
  • Bad Case of Loving You (Robert Palmer)
  • Dr. Funkenstein (Parliament)
  • Calling Dr. Love (KISS)
  • Doctor My Eyes (Jackson Browne)
  • Good Lovin' (The Rascals)
  • Doctor Wu (Steely Dan)
  • Dr. Feelgood (Motley Crue)
  • I Need a Doctor (Dr. Dre/Eminem)

Bexis proposes adding the following songs to our medical play-mix: Mother's Little Helper (Rolling Stones), Go To The Mirror, Boy (Who), DOA (Bloodrock), and Comfortably Numb (Pink Floyd).  Yes, Bexis really does have a dark side.

In addition, we must admit that there have been many fine medical shows (Dr. Kildare, Ben Casey, Marcus Welby, St. Elsewhere, ER, Grey's Anatomy, House), whereas legal shows usually disappoint.  It is possible that we nitpick at legal shows too much.  Our experience and knowledge make us overly-demanding and cranky.  Even so, we thoroughly enjoyed LA Law.   Every Thursday night we gathered around a 19 inch tv (remember them?) with fellow clueless, struggling associates to watch the adventures of the McKenzie Brackman law firm, which had an odd mix of practice areas we have yet to see replicated in real life:  M&A, divorce, criminal law (blue collar, not white collar), tax, and anything to do with sex.  Richard Dysart, who played the part of presiding partner at McKenzie Brackman, once was the guest speaker at a legal charity dinner in L.A.  He told the audience we could all consider him as our senior partner, and he actually gave out his home phone number in case we ever needed to call him for advice.  Years later, another tv program showed us our curmudgeonly, crazy future as the Danny Crane character on Boston Legal, memorably portrayed by William Shatner.  Many of his victories were celebrated with a cigar on an outside deck.  (We'd hate to think of what would happen if all law firms had outside decks.)  And, while we're at it, we should blow a kiss at Goliath, a legal show currently running on Amazon.  It stars Billy Bob Thornton and was co-created and written by an old AUSA colleague, Jonathan Shapiro.  Give it a look.  It is a smart, smoky, surly show that grabs you by the briefs.

Doctors are often codefendants in our cases.  We try very hard to resist the temptation to point fingers in their direction.  In the last ten years of litigating physical injury cases, we can think of only one time when part of our defense was to suggest medical malpractice, and that was a case where the doctor had been the sole defendant initially, and then he claimed that the problem was with our client's medical device.  So after we were added to the case as a defendant, we really had no option but to return fire.  Much more often, we find that the interests of the doctor are well-aligned with those of the device or drug manufacturer.  The characterization of the underlying reality that works for doctors usually also works for our clients.  The legal defenses that work for the doctors are usually consistent with the ones that work for our clients.  Indeed, it is not unusual for us to find a medical malpractice case that has things to say that can end up being important and helpful for our clients.  That is true with the recent case of Doctors Co., insurer, for itself and for Annabell Torres, M.D. v. Plummer, 2017 Fla. App. LEXIS 599 (Fla. 5th D. Ct. App. January 20, 2017).  Doctors Co. is a wrongful death medical malpractice case.  The Florida appellate court overturned a plaintiff jury verdict, and at least one of the reasons why it did so is noteworthy for our practice area.

The facts of the case are sad and more than a little unsettling.  Over the course of several months the decedent had visited several doctors, complaining of ear pain.  Those doctors treated the decedent for sinusitis and middle ear infection.  They prescribed antibiotics and steroids.  One of those doctors, the one who was eventually sued for malpractice, also provided the decedent with samples of Levaquin, an antibiotic.  The decedent later saw other doctors, still complaining of ear pain.  Eventually, the decedent collapsed at his home and was taken to a hospital for a CT scan.  The scan revealed "effacement of the cerebral hemispheric sulci as well as the basilar cisterns, concerning for cerebral edema." An ENT doctor believed that the Decedent's ear infection had progressed to an infection of the brain.  Subsequent to his hospital admission, the decedent stopped breathing, was placed on a ventilator, and ultimately passed away. The cause of death was meningitis.

The decedent's estate alleged medical malpractice against the defendant doctor, claiming she breached her duty of care to the decedent in various ways, including misdiagnosis, failure to obtain a specialist ENT consult, etc., — and by providing the Levaquin sample.  The plaintiff's claim was that Levaquin was the wrong drug, and part of the support for that claim was the Levaquin package insert did not include an indication for ear infections, plus the insert advised that doctors obtain a bacteria culture before prescribing.  The plaintiff's argument and evidence to this effect came into trial as a surprise. The Levaquin-as-the-wrong-choice theory was not in the amended complaint.  Prior to trial, the plaintiff failed to disclose her intent to present evidence that the defendant's decision to provide Levaquin to the decedent constituted a breach of her duty of care. Rather, shortly before trial, the plaintiff filed a motion in limine to preclude the defendant from presenting any evidence that Levaquin would have cured or eliminated the infection discovered during one of the decedent's visit.  Thus, it was an unpleasant bolt from the blue when the plaintiff's opening statement told the jury that Levaquin was not an FDA-approved drug for the treatment of ear infection and that the defendant should not have given samples of the drug to the decedent.  The defendant timely objected and argued that there had been no pretrial expert testimony regarding Levaquin and that it constituted an "unfair surprise" and "a new opinion." The defense counsel moved for a mistrial. The trial court denied the motion, which the appellate court held to be error.  On the surprise ground alone, the plaintiff verdict was reversed.

But there was another, independent ground for reversal.  Consistent with the plaintiff counsel's opening statement, and over the defendant's continued objection, the plaintiff's two standard of care experts testified that the Levaquin package insert did not indicate that it was intended for the treatment of otitis media or a middle ear infection. These experts also testified that the defendant departed from the label's instructions regarding dosing and taking a culture prior to dispensation.  On appeal, the doctor argued that she was unduly prejudiced by the plaintiff's argument and evidence regarding Levaquin.  The appellate court agreed and concluded that the trial court erred in permitting the plaintiff to argue and present evidence that the defendant breached her duty of care by providing Levaquin samples to the decedent and further erred by allowing the Levaquin package insert to be admitted into evidence.

Although section 90.706, Florida Statutes(2014), permits statements of facts or opinion on a subject of specialized knowledge contained in a learned treatise, pamphlet, or other writing to be used in cross-examination of an expert witness, it does not permit those statements to be used as substantive evidence. If an expert can serve simply as a conduit for an opinion expressed in some writing, such as a treatise or a product label, the opposing party would be deprived of the opportunity to cross-examine or impeach the source of the statement of fact or opinion.  It is hearsay.  Even if a prescription drug package insert may have some significance in identifying a doctor's standard of care in the administration and use of a prescription drug, it cannot be used as "stand-alone proof" of the standard of care.  The point in the Doctors Co. case is consistent with a point we have made in the context of off-label discussions in several prior posts (such as this Bexis ditty from 2007): the package insert cannot, by itself, delineate a physician's standard of care.  That point is proved every day by doctors in their medical practice.  Sometimes the standard of medical care requires a doctor to do something that is not in the product insert.  The FDA does not govern the practice of medicine, and its labelling decisions cannot set the standard for medical malpractice.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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