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Richardson v. Miller8/16/2000
education programs, (3) case studies in professional journals, and (4) reports of the clinical results of the use of the drug in other countries. See Baker v. Danec Med., 35 F. Supp. 2d 865, 873 (N.D. Fla. 1998); Washington Legal Found. v. Friedman, 13 F. Supp. 2d at 56; Shapiro, 73 Nw. U. L. Rev. at 809-10.
C. Admissibility of Evidence That a Particular Use of a Drug is Off-Label
The next issue to be addressed is whether a prescription drug's labeling or parallel PDR reference is admissible with regard to the standard of care for using and administering the drug. Virtually every court addressing this question has concluded that the drug's labeling and PDR reference are relevant to the standard of care issue. The primary dispute among the courts involves the weight to be given to this evidence. The great weight of authority is that a drug's labeling or its parallel PDR reference is admissible, as long as it is accompanied by other expert evidence regarding the standard of care.
A plaintiff's burden of proof in a medical malpractice case is governed by statute. As a general matter, the law will not presume that a health care provider acted negligently simply because a treatment was unsuccessful. See Tenn. Code Ann. § 29-26-115(c) (1980); Roddy v. Volunteer Med. Clinic, Inc., 926 S.W.2d 572, 578 (Tenn. Ct. App. 1996). Thus, in order to make out a prima facie case of medical negligence, a plaintiff must come forward with evidence that complies with Tenn. Code Ann. § 29-26-115(a). This statute requires the conduct of health care providers to be judged by an objective community standard. Accordingly, Tenn. Code Ann. § 29-26-115(a)(1) requires the plaintiff to present evidence of " he recognized standard of acceptable professional practice in the profession and the specialty thereof . . . that the defendant practices in the community in which he [or she] practices . . . at the time the alleged injury or wrongful action occurred." Establishing this professional standard of care requires expert testimony. See Moon v. St. Thomas Hosp., 983 S.W.2d 225, 229 (Tenn. 1998); Cardwell v. Bechtol, 724 S.W.2d 739, 742 (Tenn. 1987); Jennings v. Case, 10 S.W.3d 625, 627 (Tenn. Ct. App. 1999).
Plaintiffs in other medical malpractice cases have argued that the instructions in a prescription drug's FDA-approved labeling or the parallel PDR reference should be sufficient, by themselves, to establish a physician's standard of care regarding the use of the drug. Several jurisdictions, believing drug manufacturers to be uniquely knowledgeable about the proper use of their products, have held that a drug's labeling or its parallel PDR reference amounts to prima facie evidence of the standard of care as far as the use of that drug is concerned. However, a majority of jurisdictions have determined that a prescription drug's labeling or parallel PDR reference is admissible to prove the standard of care, but only if the plaintiff also introduces other expert testimony regarding the standard of care. These jurisdictions have concluded that while the labeling and PDR reference provide relevant and useful information regarding the standard of care, they are not the sole determinant of the standard of care because, in any particular case, adhering to the manufacturer's recommendations and warnings in the labeling or the PDR may or may not have been within the standard of care when the alleged negligent act occurred.
Four considerations support the majority view governing the admissibility of a prescription drug's labeling or parallel PDR reference in a medical malpractice case. First, permitting the labeling or the PDR reference alone to establish a physician's standard of care would be in
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