The Food and Drug Administration oversees strict requirements on pharmaceutical suppliers who are obligated to include adequate directions for use of the inherently dangerous prescription medications they market in the United States. Those directions must include data on indications, dosage, and the hazards of use, which is directed to the prescribing physician as the learned intermediary between the manufacturer and the consumer. Martin v. Hacker, 83 N.Y.2d 1 (1993).
The information is published and accompanies the product in the form of a package insert, the content of which requires FDA approval. The extent to which this information is relevant in the determination of malpractice claims against those prescribing the products is a source of interest which has been addressed on the federal level and in the state courts over the past 60 years.
In the evolving world of tort law, the potential liability for injuries sustained by consumers of prescription drugs has involved both the law of product liability directed toward the manufacturers and the law of medical malpractice, particularly informed consent, as to the prescribers. There is often reliance placed on the Prescriber’s Digital Reference, formerly known as the Physicians’ Desk Reference, a compilation of those package inserts, as evidence of both liability and causation in the trial of cases against the prescribers whose patients claim to have been injured by prescription products. Where that reliance is misplaced, defense counsel needs to be ready to respond.
Ordinarily, an out-of-court statement by an unavailable speaker, relied upon for the truth of its content, would be excluded from evidence on basic hearsay grounds. It takes no imagination to comprehend how the often anecdotal data which a manufacturer collects on a product’s risks involves layers of hearsay. On the other hand, it has been observed that protecting consumers by obligating the manufacturers to educate their prescribers as to the proper use of prescription pharmaceuticals is pointless if the prescriber has no obligation to abide by the information.
The value of the information in the package insert is assumed, based upon the time and expense invested by the pharmaceutical industry, under the supervision of government agencies, which is required to bring the product to market. There are various reasons, however, why the information in the PDR is not dispositive or perhaps even relevant to the determination of liability of the prescriber for injury to a consumer, which are helpful for defense counsel to understand.
The legal duty of the prescribing professional to the patient is to abide by the applicable community standard of care. New York courts are careful to assure that witnesses advancing opinion testimony on the standard of care (and whether it was met) are qualified to do so. When qualifications become an issue, the testimony of the witness is suspended while the trial court makes a determination of the scope of the allowable opinion testimony based upon voir dire questioning of counsel. Mustello v. Berg, 44 A.D.3d 1018 (2d Dept. 2007).
Separate evidentiary rulings may be required as to whether a foundation exists for the admission of the package insert as evidence, but assuming a foundation is laid, there are substantive questions regarding the admissibility of the insert for the truth of its content. These factors are discussed in the widely read cases of Mulder v. Parke-Davis & Co., 288 Minn. 332 (1970) and Salgo v. Leland Stanford, 154 Cal. App. 2d 560 (Dist. Ct. App., 1957).
The Mulder case, often cited by New York courts, illustrates that a manufacturer’s disclosure on indications, precautions, and warnings may have evidentiary value, but a finder of fact must have the support of competent expert testimony to determine the issues of adherence to the standard of care, causation, and damages. Paul v. Boschenstein, 105 A.D.2d 248 (2d Dept. 1984). Even where those issues are addressed in the product information, the package inserts are written for the learned intermediary who is expected to interpret them in light of other knowledge to apply the information to the treatment of the individual patient. If the law does not expect the lay consumer to be able to use the data, how can it expect the lay juror to give it appropriate weight?
Clinical medical practice is in a constant state of development, as improved products, revised procedures, and new discoveries advance the approach of medical professionals at all levels. Changes to the standard of care understandably occur at different rates in different settings. The fact that the package inserts reflect knowledge at a specific point in time on the spectrum of scientific advance illustrates the difficulty of applying information in the package insert to the determination of standard of care issues.
The recent trove of available information on the role of the pharmaceutical industry in the evolution of the opioid crisis provides insight into the shortcomings of reliance on the industry for evidence of pharmaceutical risk.
Stakeholders including the American Medical Association have pointed out the inadequacy of package inserts as a determinant of appropriate medical care, based upon the competing influence of product marketing, regulatory compliance, products liability, and government oversight of consumer safety. For the most part, no pretense is made by the drug manufacturers toward dictating medical practice, as seen in their disclaimers on that subject.
All things considered, the courts should therefore favor other sources of evidence besides the PDR as to the appropriate practice of medicine. In evaluating this hearsay information, the circumstantial evidence of trustworthiness is simply insufficient to qualify package inserts as admissible, with or without a limiting instruction. The potential for prejudice from misuse of the text of the insert cannot be eliminated.
The New York courts were not among the leaders in developing the evidentiary approach to the PDR in malpractice cases, but our courts have frequently been called upon to resolve issues related to prescriber liability. Cooper v. Bronx Cross County, 259 A.D.2d 410 (1st Dept. 1999). There was a time in New York when a deviation from the manufacturer’s instructions was the basis for a claim of prima facie negligence (see Armstrong v. State, 214 A.D.2d 812 (3d Dept. 1995) and Gatto v. Cooper, 201 A.D.2d 455 (2d Dept. 1994)), but the Court of Appeals reversed course in Spensieri v. Lasky, 94 N.Y.2d 231 (1999), holding that expert testimony should be required to support a claim that a prescriber’s acts did not conform to community standards, causing injury to a claimant.
The court has furthered its position on this issue as seen in Hinlickey v. Dreyfuss, 6 N.Y.3d 636, 647 (2006). Expert testimony which incorporates data from the PDR will only be sufficient to support a malpractice claim if it establishes a basis for the jury to determine that the standard of care was violated, beyond the language of the PDR. See also Thaler v. Varlotta, 194 A.D.2d 504 (1st Dept. 2021). It is separately required that the expert opinion evidence support the claim that the prescriber’s deviation from accepted standards was a proximate cause of injury to the patient, also independent of the text of the PDR. Paul v. Boschenstein, 105 A.D.2d at 250.
The PDR has also had a role in litigation of claims involving off-label use of approved prescription products. Much has been written regarding the use by the medical profession of FDA-approved products for indications besides those for which the products were originally approved. Once the product passes the FDA requirements for safety and efficacy in the approval process, the medical profession is free to prescribe it for other indications without the need for the manufacturer to revisit the approval process.
New York recognizes the value of widespread off-label use, and the fact that a product is employed for an off-label use is not relevant to the issue of liability after the patient claims to have been injured by the product. Furthermore, off-label use does not have to be disclosed to the patient by the prescriber, as may be required when a patient is offered treatment which is still in the process of clinical investigation. Sita v. LIJ-HMC, 22 A.D.3d 743 (2d Dept. 2005). Given the fact that the law sanctions the varying indications and dosages of off-label uses not mentioned in the PDR, it is easier to understand why the package insert information cannot be used to establish liability without adequate supporting expert testimony.
Parenthetically, the prescriber is frequently protected in the converse situation when an off-label use was not offered as an alternative in the approach to a patient’s treatment. Where the efficacy or dosage protocols for the off-label use have not been established, the fact that the off-label alternative was not offered does not violate the standard of care as a matter of law. Castillo v. Mt. Sinai Medical Center, 140 A.D.3d 619 (1st Dept. 2016).
Pharmaceutical manufacturers do not have a role in establishing the prescriber’s standard of care, even with respect to the use of products they have researched and developed. In developing the defense of the prescriber, it is important to recognize the limited evidentiary role of the product manufacturer’s information in the PDR.
This article is also on Law.com: The Limited Role of the PDR in Proof of Malpractice