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No Breach of Duty to Disclose Heart Drug Risks; Optical Neuropathy Injury


For about eight months, a cardiologist treated a woman for her heart problems. During the course of treatment, the cardiologist prescribed the woman Cordarone (amiodarone). After she started taking Cordarone, she noticed that her vision began to blur. The condition worsened, and she consulted a neuro-ophthalmologist, who believed her loss of sight was related to the Cordarone.

 

The woman filed a lawsuit against the cardiologist alleging medical negligence. She retained the services of an internist, practicing primarily in the field of pulmonology, to review her records and offer his opinion on whether the cardiologist had breached the standard of care by: (1) failing to warn her of the potential vision problems caused by Cordarone; and (2) failing to advise her to schedule regular eye examinations with an ophthalmologist.

 

The internist testified at his deposition that a physician who prescribes a drug should possess knowledge of the drug and its side effects. He further testified that the physician should not only warn patients about the side effects but should also advise them of any follow-up they might need. According to the internist, this standard did not vary from specialty to specialty. Therefore, although not a cardiologist, he testified that in his opinion the cardiologist breached the standard of care by failing to refer the woman for periodic eye examinations. The internist also testified that a physician should make sure to inform patients of any potentially severe side effects that a drug might have, and he stated that he considered blindness to be a severe side effect.

 

When asked whether he agreed with the neuro-ophthalmologist's deposition testimony that no medical literature existed to indicate a direct causal relationship between amiodarone and optic neuropathy, the internist responded, “I would certainly defer to [his] opinion and would agree with that.” The internist further testified that he based his opinion regarding the proper standard of care on medical literature he read. He could not remember any specific literature other than the 2002 version of the Physicians' Desk Reference (PDR), which he considered to be very authoritative and “the primary reference that physicians use about medications.” The PDR, which provided a compilation of drug manufacturers' medication package inserts, stated the following:

 

Cases of optic neuropathy and/or optic neuritis, usually resulting in visual impairment, have been reported in patients treated with amiodarone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and/or neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. If symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision, prompt ophthalmic examination is recommended. Appearance of optic neuropathy and/or neuritis calls for re-evaluation of Cordarone therapy.... Regular ophthalmic examination, including fundoscopy and slit-lamp examination, is recommended during administration of Cordarone.

 

Physicians' Desk Reference 3489 (2002).

 

Although both the neuro-ophthalmologist and the internist would be unavailable for trial, the woman planned to introduce their deposition testimony during the proceedings. However, the cardiologist defendant filed a motion in limine to strike the internist's expert testimony and an ore tenus motion to strike the neuro-ophthalmologist's causation testimony. In support of his motion, the cardiologist argued that neither expert's opinion was supported by peer-reviewed literature.

 

The cardiologist also provided a journal article to the circuit court, which he attempted to offer into evidence. A summary at the beginning of the journal article provided:

 

Amiodarone is one of the most effective antiarrhythmic drugs currently available. Although a subject of intense controversy, a causal link between amiodarone and optic neuropathy has never been firmly established. Indications for treatment with amiodarone are outlined, and features of the optic neuropathy in patients on amiodarone are compared with those of nonarteritic anterior ischemic optic neuropathy. An approach to patients treated with amiodarone who present with optic neuropathy is outlined, and suggestions for a registry and prospective study of such patients are presented.

 

Marjorie A. Murphy & John F. Murphy, Amiodarone and Optic Neuropathy: The Heart of the Matter, 25 J. of Neuro–Ophthalmology 232, 232 (2005).

 

The woman objected to the motion and to the admission of the journal article, but the Coahoma County Circuit Court overruled her objection and allowed the article into evidence. The trial court found that both the neuro-ophthalmologist and the internist testified there was no medical literature indicating a direct causal relationship between amiodarone and the optic neuropathy the woman suffered. At the hearing on the motion, the cardiologist offered evidence from the PDR that a causal relationship to the drug and optic neuritis had not been clearly established. The cardiologist also offered evidence of a peer-reviewed article that stated there was no causal connection between amiodarone and optic neuritis. The woman was unable to refute the peer-reviewed article. The trial court made no ruling on the qualifications of the internist as an expert. However, the trial court excluded the causation testimony of the woman’s experts based on the fact the neuro-ophthalmologist’s and the internist’s opinions were not supported by peer-reviewed literature, the arguments of counsel, and the woman's inability to rebut the testimony.

 

Following the ruling on his motion, the cardiologist presented a motion for summary judgment. The trial court granted the cardiologist's motion for summary judgment because the woman no longer had admissible expert testimony to prove causation.

 

The Court of Appeals of Mississippi affirmed. The court held that the trial court did not err in admitting the journal article into evidence over the woman’s objection, granting the cardiologist's motion in limine to strike the testimony of her expert witness, and granting the cardiologist's motion for summary judgment.

 

The trial court did not err in admitting the journal article into evidence over the woman’s objection as the court reasoned that the trial court’s admission of the journal article into evidence neither caused unfair surprise nor resulted in trial by ambush. The cardiologist offered the journal article as evidence upon the trial court's consideration and hearing of his motion in limine, which asserted that the internist's testimony lacked sufficient basis for admission into evidence. Specifically, the cardiologist argued that the internist's expert opinion testimony lacked support by any peer-reviewed literature and otherwise failed to meet the requirements of Rule 702 of the Mississippi Rules of Evidence. Rule 702 provides:

 

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

 

The journal article was consistent with the basis of the previously filed motion in limine and the previous deposition testimony of the woman's own experts, the neuro-ophthalmologist and the internist. As acknowledged by the trial court, both of the woman's experts testified that no medical literature supported a finding of any direct causal relationship between amiodarone and the optic neuropathy she suffered. Rather than amounting to trial by ambush, the article offered merely served to reinforce the deposition testimony provided by the woman's experts and to support the basis for the cardiologist's motion in limine. The woman possessed notice of both the cardiologist's motion in limine and his basis for making the motion. Further, she already possessed knowledge of the information contained within the cardiologist's motion from the deposition testimony of her own experts. The court concluded the trial court did not abuse its discretion when it admitted the article into evidence at the motion hearing.

 

The trial court did not err in granting the cardiologist's motion in limine to strike the testimony of her expert witness as the trial court found that the woman and her proffered expert, the internist, failed to show that the internist's testimony relied upon sufficient facts or data. The internist's opinion testimony was based on articles that lacked peer-review. The internist's opinion, though based on the PDR, was not supported by the PDR. The testimony at issue failed to meet the requirements for admission into evidence under Rule 702. The trial court thus found that the woman failed to show the internist's testimony was derived from reliable principles and methods. Moreover, the internist's opinion testimony failed to establish that the cardiologist failed to disclose a material known risk and also failed to create a dispute of material fact as to proximate causation since his opinion lacked Rule 702's requirements for admission into evidence. The court concluded that the trial court did not abuse its discretion when it excluded the internist's testimony.

 

The trial court did not err in granting the cardiologist's motion for summary judgment. Mississippi jurisprudence established that a physician possesses a duty to disclose only material known risks, and the plaintiff possesses the burden to present evidence sufficient to show a dispute of material fact for each element—duty, breach of duty, proximate causation, and injury. A physician may not be required to disclose immaterial or unexpected risks. The woman failed to present evidence that showed the cardiologist breached his duty by failing to disclose a material known risk. The woman also failed to present expert testimony sufficient to show a dispute of material fact on proximate causation. Without the internist's expert testimony, the woman failed to show the existence of material facts to dispute the cardiologist's claim that he conformed to the applicable standard of medical care in treating her.

 

The Court of Appeals of Mississippi affirmed the trial court’s grant of both the cardiologist's motion in limine to strike the testimony of the woman's expert witness and the cardiologist's motion for summary judgment.

 

See: Bolton v. Weiner, 2014 WL 2853733 (Miss.App., June 24, 2014) (not designated for publication).

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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