PDR Precautions: Ignore Them at Your Peril

Whether the Physicians’ Desk Reference sets out a “standard of care” is vigorously debated among professionals. When a rare complication from a prescribed medication occurs and the treating doctor does not follow the PDR’s advice, however, the subtleties of that debate will likely be lost on a jury.

Dr. I-G is an internist and gastroenterologist who began treating a 28-year-old man for ulcerative colitis in late 1996. Dr. I-G prescribed Asacol, which releases mesalamine, an anti-inflammatory, in the colon. Based on reports of some Asacol patients developing interstitial nephritis, the PDR “recommend(s) that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.”

Dr. I-G did not order pre-therapy renal function tests on his patient, but did obtain kidney studies on him in July and December 1997 and August 1998. None of these studies showed abnormal results.

Though Dr. I-G had no more kidney studies performed for his patient, he did respond to complaints consistent with anemia by obtaining other tests. These blood studies, taken nearly monthly from mid-1999 to early 2000, showed that the patient was clearly anemic. Even Dr. I-G’s referral to a hematologist in March failed to help the patient progress. In May, the patient’s hemoglobin of 5 prompted his hospitalization, where the consulting nephrologist considered possible interstitial nephritis related to the Asacol.

A percutaneous kidney biopsy showed acute and chronic interstitial nephritis and arteriolar nephrosclerosis. The nephrologist’s opinion was that the patient would most likely require dialysis. The patient sued Dr. I-G and the hematologist for his kidney damage.

Expert reviewers were critical of Dr. I-G not obtaining baseline renal function studies prior to the Asacol therapy. Even more troublesome was Dr. I-G’s failure to discern that the patient’s particular type of anemia in mid-1999 was inconsistent with colitis: Such an appreciation would have led to an earlier suspicion that the anemia was being caused by the declining kidney.

But, defense attorneys deal with such “retrospective scope” criticisms all the time, often with success. Complicating this case – and leading to a decision to resolve the matter before trial – was the likelihood that a jury would seize on the PDR’s plain-English advice on baseline and regular renal testing for Asacol patients to find negligence and causation against Dr. I-G.

While the PDR may not necessarily establish a standard of care, physicians should at least treat the specific advice contained in its pages as a school of thought. When the physician chooses to deviate from such advice, he or she should document the plan of care and the rationale behind it. That way, the treating physician can later explain the basis for the judgment call. Without such documentation, the medicine surrounding the rare complication will be difficult to defend.

Gordon Ownby is CAP-MPT’s general counsel. Comments on Case of the Month may be directed to gownby@cap-mpt.com.