Chapter Ten

Legal Aspects of Drug Information Practice

Martha M. Rumore

Learning Objectives

After completing this chapter, the reader will be able to

• Describe the legal issues related to the provision of drug information (DI).

• Apply various legal theories that impose liability on pharmacists providing DI.

• Describe how pharmacists can help protect themselves from malpractice claims resulting from the provision of DI.

• Explain the Doctrine of Drug Overpromotion as it pertains to the 1997 Food and Drug Administration (FDA) Modernization Act (FDAMA).

• Identify the liability concerns inherent with off-label drug use and informed consent.

• Describe United States (U.S.) copyright law as it pertains to the provision of DI.

• Identify copyright, liability, and privacy issues arising from the Internet and social media.

• Describe the legal and ethical challenges emerging in telemedicine and cybermedicine.

• Describe the DI plan that addresses the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

• Explain the legal issues involved with industry support for pharmaceutical educational activities.

Key Concepts

Introduction

An understanding of the legal aspects of drug information (DI) can help practitioners in day-to-day practice, as well as provide some possible ways to protect himself or herself in the legal system. This chapter is intended to examine legal issues and should not be considered legal advice.

There are a myriad of legal issues confronting the various facets of DI. These legal issues cross over a number of traditional legal specialties, including computer law, advertising law, privacy law, intellectual property law, telecommunications law, and tort law. This chapter provides an overview and discussion of the key legal issues involving intellectual property rights, torts, privacy, and advertising and promotion that may arise in the provision of DI.

Decades after the genesis of DI services, the legal duties of pharmacists providing DI are still evolving. Today, most pharmacy curriculums, board certifications, and postgraduate year one (PGY-1) residencies include DI, realizing that whether a student specializes in DI or not, it is an integral part of pharmacist-supervised patient care. Pharmacists can and will be held liable for their conduct relating to DI. This chapter begins with an examination of the expanded liability of the DI specialist, which is defined as those pharmacists who either work in DI centers or who spend the majority of their working day providing DI (e.g., clinical managers, DI specialists, and PGY-1 and postgraduate year two [PGY-2] residents). The liability inherent in the provisions of DI to patients as an integral component of pharmacist-supervised patient care will be covered in this chapter. The chapter will examine and provide recommendations for prevention and mitigation of liability for the non-DI specialist. The chapter then explores copyright, privacy, unique legal issues pertaining to the Internet, direct-to-consumer-advertising, off-label use, as well as industry support for educational activities.

Tort Law

DI is a specialized discipline of pharmacy practice. Specialists are held to the highest degree of care by the law. Because of the DI pharmacists’ greater expertise in the area of DI, it is likely that the courts would expand their legal and professional liability beyond that of other pharmacists. The liability of the DI specialist versus generalist differs for a number of reasons, the most obvious of which are the nature of the information provided and the recipients of the information. The DI specialist is most often providing DI to other health professionals and often has the title Drug Information Specialist or Clinical Manager.¹

Functions such as online searching, monitoring or recommending drug therapy, preparing drug alerts and pharmacy bulletins, participating in pharmacy and therapeutics (P&T) committees, conducting medication use evaluations (MUE), writing and revising medication policies, training residents, pharmacy students, and pharmacy staff, and identifying adverse drug events entail legal obligations of proper performance.

Minimal practice standards for specialists have been put forth to delineate functions and activities that may be considered essential to the provision of DI services and the expected competencies of DI specialists. Position papers and standards of the American Society of Health-System Pharmacists (ASHP) and The Joint Commission (TJC), as well as DI curriculum and residency standards, and literature regarding appropriate management of DI requests remove any doubt about the level of expertise needed for DI specialists and standards for DI centers.^2–4 Minimal standards of performance and a consistent level of competence must be ensured by pharmacists promoting or offering this service regardless of the practice site. Although there are no standards to accredit DI centers, professional standards of performance may be used by courts as an objective measuring tool for the standard of care.

In the latter part of the nineteenth century, the locality rule or community rule was followed. This doctrine stated that the local defendant practitioner would have his or her standard of performance evaluated in light of the performance of other peers in the same or similar communities.⁵ This is no longer the case and a DI center in a rural area will be held to the same standard as one in New York City. Creation of standards of practice and the disappearance of the locality rule make it easier for plaintiffs to prevail.

In addition to the DI specialist, the pharmacy profession is assuming an increased legal responsibility to provide DI in the daily practice of pharmacist-supervised patient care. The physician has been considered the learned intermediary, responsible for communicating the manufacturer’s warnings to the patient. However, failure to counsel or warn cases are showing a trend in pharmacist liability.⁶ Although most cases still maintain the pharmacist has no duty to warn, a minority of cases in various jurisdictions demonstrate the pharmacist’s duty to warn of foreseeable complications of drug therapy is becoming a recognized part of the expanded legal responsibility of pharmacists. Courts have been more willing to apply a duty to warn where the pharmacist voluntarily assumes the duty, or has special knowledge about a patient, or the prescription is dangerous as written.⁷

Where the patient is at higher risk than the general population, the courts have uniformly found liability. There are many such cases against physicians for failure to disclose material risks of medical procedures or treatments to their patients.^8–10 Today pharmacists providing DI, be they generalists or DI specialists, are more likely to be held to the same standards as physicians when determining standard of care.

Currently, most litigation concerning pharmacists involves negligence. Traditionally, physicians remain responsible for their patients and must exert due care; that is, a physician who knows or should have known that the information provided was improper may be held liable for negligence. Therefore, it is safe to assume that a legal cause of action pertaining to the provision of DI will be founded on the theory of negligence as the direct or proximate cause of personal injury or death. Malpractice liability based on negligence refers to failure to exercise the degree of care that a prudent (reasonable) person would exercise under the same circumstances. Elements of negligence include the four Ds: (1) duty breached, (2) damages, (3) direct causation, and (4) defenses absent. To establish a negligent failure, actual conduct must be compared to what is considered standard professional conduct. Typically, this is accomplished by introducing evidence of the relevant professional standards or testimony from expert witnesses such as college of pharmacy faculty or other DI practitioners. Once the duty of care is established, the plaintiff would need a preponderance of evidence to prove that (1) the information provided was materially deficient, (2) the deficient information was a proximate cause of injury suffered (or at least a substantial contributing factor), (3) the recipient reasonably relied on the information provided, (4) the information deficiency was due to failure to exercise reasonable care, and (5) the pharmacist knew or should have known that the safety or health of another may have depended on the accuracy of the information provided.

Expanding on the first element of negligence, duty breached, it is important to be aware of the fact that the duty must be a legal duty, not a moral or ethical duty. Although there are many ethical dilemmas pertaining to the provision of DI by pharmacists and they can sometimes give rise to a cause of action, an ethical breach is not necessarily a legal breach. Similarly, conduct that is considered unprofessional in the broad sense (e.g., rudeness) is distinct from legal duty. An example of an ethical breach that could result in liability for the pharmacist would be a breach of patient confidentiality, if that disclosure caused damages (e.g., loss of employment or the misuse of information gained in the course of employment).

In a study of DI requests, calls from consumers raised more ethical issues than calls from health professionals.¹¹ For example, should a pharmacist respond to a drug identification request for someone else’s medication? Is the situation different if the medication is a drug of abuse and the inquiry is from a parent, relative, teacher, or police officer? Current law provides little guidance for disclosure of DI for questionable purposes and pharmacists must exercise independent professional judgment and assume legal responsibility for that judgment when exercised.

Case Study 10–1

The anticoagulation clinical pharmacist receives an order for enoxaparin in a patient who is receiving warfarin. The patient’s current INR is 5.2. The anticoagulation pharmacist is a board-certified pharmacotherapy specialist (BCPS). The pharmacist dispenses the enoxaparin and the patient is harmed.

• What factors favor finding the pharmacist liable for negligence?

• Is the prescription dangerous as written?

• Is the specialist more liable than the generalist?

• Who may be liable in this situation—the pharmacist, the physician, or the clinic?

It is necessary to expand on the reasonable care aspect to provide a case of negligence. Reasonable care is that which would be considered acceptable and responsible. Suppose a patient develops a reaction that is believed to be caused by a drug, and the pharmacist is consulted to find any case reports of this drug causing the reaction. If the case is available online, but not in print, and the pharmacist had access to online databases, but did not consult them, was the pharmacist required to do so? Did the pharmacist exert reasonable care? What if the pharmacist searched MEDLINE^® but not Embase^® databases, or vice versa, and thereby failed to retrieve the case? Should the pharmacist have searched both? There are no clear answers here. Who can say what a reasonable search might have been on a given day? However, using outdated references or old editions of textbooks would more likely constitute an inadequate search. In a German case, a court held a Business and Patent Information Service to be responsible for not having used updated materials.¹²

In a highly publicized case involving a clinical trial being conducted at the Johns Hopkins University, a researcher conduced an incomplete search for lung damage from hexamethonium on PubMed^®, which was searchable only back to 1966 and an open Web search.¹³ Although articles published in the 1950s and other sources such as TOXLINE^® and Micromedex^® warned of such dangers, the researcher had not consulted these references resulting in a patient’s death.

Recent cases against pharmacists have held that pharmacists who gain information about the unique susceptibility of a patient are liable for failure to warn of the risks. In Dooley v. Everett, the court held the pharmacist liable for failing to warn a patient of the interaction of theophylline with erythromycin that produced seizures and consequent brain damage.¹⁴ Similarly, in Hand v. Krakowski, the pharmacist failed to alert either the patient or the physician of the drug interaction between the patient’s psychotropic drug and alcohol.¹⁵ The fact that the medication profile indicated that the patient was an alcoholic created a foreseeable risk of injury and, therefore, a duty to warn on the part of the pharmacist.

Case Study 10–2

The health system pharmacist receives a prescription order for metformin 500 mg twice daily for a 55-year-old male patient who has severe renal impairment. The pharmacist dispenses the drug without checking the patient’s renal function in the computer. The pharmacy department medication use manual policy for metformin requires the pharmacist to check and document the patient’s creatinine clearance prior to dispensing metformin.

• If the patient is harmed, did the pharmacist fall below the standard of care? Could the pharmacist be judged negligent?

In Baker v. Arbor Drugs, Inc., the court ruled that by advertising its drug interaction software, the defendant pharmacy voluntarily assumed a duty to use its computer technology with due care. The pharmacy technician had overridden the drug interaction between tranylcypromine (Parnate^®) and clemastine fumarate/phenylpropanolamine hydrochloride (Tavist-D^®) that the system detected from the patient’s medication profile. The patient committed suicide after suffering a stroke from the combination.¹⁶ In another case, the pharmacist chose to override the computer alert regarding an interaction between tramadol and methadone, resulting in the patient’s death. A $6 million verdict was returned against the pharmacy for failure to warn.¹⁷

There are a number of ways in which tort liability can relate to the provision of DI: incomplete information, inappropriate quality information, outdated information, inappropriate analysis, or dissemination of information.

INCOMPLETE INFORMATION

Is the pharmacist liable when the DI provided is incomplete? Should the pharmacist provide all the medication information via a DI sheet or patient package insert (PPI)? There have been several cases against pharmacists for failure to dispense mandatory PPIs for certain drugs that later caused harm. In Parkas v. Saary, the court addressed the issue of whether the pharmacist’s failure to dispense the FDA mandated PPI for progesterone was the proximate cause of a congenital eye defect that occurred.¹⁸ Because congenital defects, but not eye deformities, were specified in the PPI, failure to provide the PPI could not be proven to be the proximate cause. Therefore, judgment was in favor of the pharmacy. In Frye v. Medicare-Glaser Corporation, the pharmacist counseled the patient regarding drowsiness with Fiorinal^® (aspirin, butalbital, caffeine), but failed to provide a warning not to consume alcohol. The patient died presumably as a result of combining the drug with beer. Here, the DI provided was incomplete. The trial court did not find the pharmacist had a duty to warn in this instance.¹⁹ Although this case was decided before Omnibus Budget Reconciliation Act of 1990 (OBRA’90), with its mandatory patient counseling provisions in effect, its outcome would not seem to have changed as a result.

In a number of cases where the plaintiffs asserted that the pharmacist breached a duty to warn as required under OBRA’90, the courts have held that OBRA does not create an independent or private cause of action.^20–22

Other cases are finding pharmacists have a responsibility for patient counseling and drug therapy monitoring.²³ In Sanderson v. Eckerd Corporation, the pharmacy promised in its advertising that its computer system would detect drug interactions or warn patients about adverse drug reactions; the pharmacists were held liable when they failed to detect and warn the patient of a potential adverse reaction.²⁴ In Horner v. Spalitto, the court imposed a duty on a pharmacist to alert the prescriber when the dose prescribed is outside the therapeutic range.²⁵ In Happel v. Wal-Mart Stores, the pharmacy’s computer system was overridden, and the pharmacist failed to warn a patient allergic to aspirin and ibuprofen of the potential for cross-allergenicity with ketorolac.²⁶ The court found the pharmacist has a duty to warn when a contraindicated drug is prescribed. In Morgan v. Wal-Mart Stores, where the plaintiffs alleged that the pharmacist’s failure to properly warn of the known dangers of desipramine was the proximate cause of the patient’s death, the court held that pharmacists have a duty beyond accurately filling a prescription “based on known contraindications, which would alert a reasonably prudent pharmacist to a potential problem.”²⁷ However, the court did not find for the plaintiff opining that pharmacists do not have knowledge that desipramine may cause hypereosinophilic syndrome.

Liability could also attach where there is a risk evaluation and mitigation strategy (REMS) requirement where either a pharmacist is required to provide a MedGuide or patient consent is required for failure to adhere to some other component of the REMS program, such as patient or provider enrollment.

Clearly, these cases demonstrate an expansion of pharmacist’s duties from the non-discretionary standard of technical accuracy to a discretionary standard which requires pharmacists to perform professional functions—that is, from a technical model to a pharmacist-supervised patient care model. Knowledge of, or access to, DI is becoming an important factor that courts consider in determination of the pharmacist’s duty to warn.

In a case of first impression, a court decided whether a hospital pharmacist contacting a physician regarding the dosage of colchicine had a duty of care to the physician to provide complete DI.²⁸ While the pharmacist advised what a correct oral dosage would consist of, he did not advise of the correct dose in a renally impaired patient. The plaintiff alleged that the hospital pharmacy’s voluntary undertaking to provide DI, and the pharmacist’s voluntary intervening between the patient and the physician created a duty on the part of the pharmacist to the physician. This is different from other duty to warn cases where plaintiff alleges the pharmacist has a duty to warn to the patient. In the present case, the plaintiff alleged the hospital’s pharmacy voluntarily undertook to be a DI resource and the hospital pharmacist voluntarily intervened between the patient and the physician, thereby creating a duty on the part of the pharmacist to the physician. The court, however, rejected the argument that a voluntary undertaking of a duty to a physician was created based on a pharmacist’s interaction with the patient’s physician. The court further held that the learned intermediary doctrine forecloses any duty of care on the part of the pharmacist to the patient, based on the pharmacist’s statements to the physician. Significantly, the court commented that even if such a duty were placed on the pharmacist, the duty was not breached inasmuch as the pharmacist correctly followed the hospital’s intervention policy.

While pharmacists are in a position to provide DI, providing the patient with all information may have a detrimental effect. In fact, it is the FDA’s position that the information contained in professional labeling can be safely used only under the supervision of the licensed prescriber. It has, therefore, been the practice not to provide the patient with the professional labeling unless the patient specifically requests it. With regard to the duty to disclose to the patient low percentage risks, the court rulings have been inconsistent. One court has allowed strict liability against a pharmacy. In Heredia v. Johnson, the pharmacist dispensed an otic solution without warning of the risk of tympanic membrane rupture and the need to discontinue the drug if certain symptoms appeared. The plaintiff claimed that because of the lack of warning he suffered from severe and permanent injury including brain damage.²⁹ However, in Marchione v. State, a prison inmate alleged lack of informed consent based on the failure of the prison physician to inform him about the adverse effects of prazosin (Minipress^®), which caused permanent impotence. The physician argued that his duty was only to warn of severe or frequent adverse effects. The Marchione court concluded that the physician need not disclose a laundry list of 31 remote drug adverse effects. The adverse effect had a reported incidence of only two or three cases out of several million prescriptions and was, therefore, rare. The plaintiff also did not have any unique risk factors that would increase the likelihood of the reaction occurring.³⁰ The courts seem to look at risk factors unique to the patient in deciding whether the health professional is required to indicate the likelihood of occurrence of the risks.

RISK ASSESSMENT AND RISK MANAGEMENT

Brushwood and Simonsmeier³¹ delineate two responsibilities with regard to patient counseling: risk assessment and risk management. Risk assessment is judgmental and occurs before prescribing when a decision is made to accept or forego drug therapy. Although this has traditionally been the responsibility of the physician, the current scope of pharmacy practice is expanding, as many states permit independent, dependent, and collaborative prescribing, the latter is also known as collaborative drug therapy management (CDTM).³² Each level of prescriptive authority is characterized by a specific level of liability. For example, independent prescribers are professionally accountable for their own prescribing decisions. Dependent prescribing, which involves the delegation of authority from an independent prescriber, as is typical of therapeutic interchange and CDTM protocols in health care facilities, involves a shared accountability. Similarly, in CDTM, where there is a collaborative practice agreement that allows pharmacists to initiate and/or modify patients’ medication regimens pursuant to an approved protocol, both the physician and pharmacists share accountability.³³ In addition, employers remain vicariously liable for the actions and decisions of their staff.

The authority granted via CDTM depends on the pharmacy practice acts of the individual states that recognize CDTM, as such specific risk issues are difficult to identify. Liability risks for CDTM include exceeding the scope of the agreement or beyond the scope of practice, malpractice, practicing medicine without a license, unlawfully prescribing controlled substances, committing Medicare or Medicaid fraud, HIPAA and patient consent issues. Pharmacists undertaking CDTM should be well trained, not exceed the scope of the agreement, document all activities completely, be certain patients signed an affirmative written consent, and are aware you are not a physician. Pharmacists involved with CDTM should ensure coverage under their malpractice insurance for such activity. Unfortunately, several lawsuits have already occurred regarding CDTM. In Reeves v. Pharmaject, Inc., a needleless injector was used to administer influenza vaccines and the patient developed swelling and hematomas at the injection site. FDA had, in fact, issued a warning advising against use of needleless injectors to administer vaccines. While the pharmacy had advertised needleless flu shots, it was not named in the lawsuit.³⁴

Risk management after prescribing is nonjudgmental and assists the patient in proper drug use to maximize benefits and minimize potential problems.^35,36 Drug risk management, but not drug risk assessment information, should be provided to patients. The drug management information provided to patients should be accurate and in a form that the patient understands.

Hall and Honey³⁷ divided the risks associated with a particular drug into two groups: inherent or noninherent. Inherent risks are unavoidable, unique to the drug, and usually identified in the package insert (PI), but do not include probable or common adverse effects. However, well a drug is researched, manufactured, and prescribed, it still may have the ability to produce certain adverse effects. Examples of inherent drug risks are stroke from oral contraceptives or teeth discoloration from tetracyclines. Noninherent risks are created by the particular drug in combination with some extrinsic factor about which the pharmacist should reasonably know, and include maximum safe dosages, interactions, patient characteristics influencing pharmacokinetics, and probable or common adverse effects. Examples of noninherent risks would be nephrotoxicity from aminoglycosides in patients with renal impairment. The responsibility of the pharmacist to provide DI about noninherent risks is expanding.

What liability does the pharmacist incur for information outside of the PI? Physicians may prescribe drugs as they see fit, without adhering to the specific therapeutic indications or dosing guidelines within the labeling. The FDA regulates the manufacture and promotion of drugs, not the practice of medicine. However, it has been held that a physician’s deviation from the PI was prima facie (i.e., not requiring further support to establish validity, on its face value) evidence of negligence if the patient’s injury resulted from the failure to adhere to the recommendations.³⁸ However, the states appear to be split on whether recommendations in a PI are prima facie evidence of the standard of care. It would be prudent for the pharmacist to consult the PI when responding to an inquiry and include such information in the response, especially if the response is contrary to what is contained in the PI.

A disciplinary action by a state pharmacy board highlights the importance of checking the PI or literature concerning the proposed use of a product. In re Michael A. Gabert,³⁹ a pharmacist received a prescription for 5% silver nitrate for bladder instillation. The pharmacist contacted a DI center and was told there was no literature supporting the proposed use of the product. The pharmacist then asked the physician what evidence he had for such use and the physician referred to a published Mayo Clinic newsletter. The pharmacist did not ask to see a copy of the letter, or have a copy of it for the pharmacy records. Significant patient harm resulted when the solution was instilled into the patient’s bladder. The Mayo Clinic newsletter pertained to silver argyrol, not silver nitrate.

INAPPROPRIATE QUALITY INFORMATION

It has long been recognized by law that false information provided to another could result in harm to the recipient if the recipient acted relying on the false information. Although negligent misrepresentation has not been applied to DI, there is no guarantee that it will not be in the future.⁴⁰ The relevant law is the Restatement (Second) of Torts, §311, Negligent Misrepresentation Involving Risk of Physical Harm, which states:

    “One who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information[…] Such negligence may consist of failure to exercise reasonable care in ascertaining accuracy of the information, or in the manner in which it is communicated.”⁴¹

Thus, the DI itself may be faulty for one or more reasons: it may be dated; it may simply be wrong; it may be incomplete and, therefore, misleading; or none may have been provided because of an incomplete search or incompetent searcher. Information negligence may occur because of (1) parameter negligence (failure to consult the correct source) or (2) omission negligence (consulting the correct source, but failure to locate the correct answer[s]). A study evaluated the accuracy of a drug identification response by 56 DI centers. Approximately, 30% correctly identified the investigational drug product; 67% could not make the identification; most importantly, 3.6% (two DI centers) made an incorrect identification. The study found inconsistencies in responses of DI centers.⁴² Another study evaluated the quality of DI responses provided by 116 DI centers to multiple queries. The correct response rates varied from 5% for a question pertaining to erythromycin for diabetic gastroparesis to 90% for a drug interaction question pertaining to didanosine-dapsone. For each of three patient-specific questions, the percentages of centers eliciting vital patient data were 5%, 27%, and 86%. The findings suggest that many DI centers continue to fail to elicit patient-specific information necessary for informed responses and focus instead on procedural and technical matters.⁴³ As an example, despite the peer-review process, the structure of bilirubin was found to be incorrect in an article and the three leading biochemistry textbooks in the United States.⁴⁴

Inappropriate quality information may be the result of ghostwriting or publication marketing. Ghostwriting occurs when a pharmaceutical company develops the concept for an article to counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft the article, retains a health professional to sign off as the author, and finds a publisher to unwittingly publish the work. In a recent product liability case, the court ordered the pharmaceutical company to disclose its documents pertaining to its ghostwriting practices.⁴⁵ In some instances, posters and meeting abstracts may actually be pharmaceutical industry generated or incomplete and lacking in peer review. For example, the reader has no way of knowing whether the abstract results are reflective of the entire study population or merely a small subset.

Can pharmacists providing DI be held responsible for retrieving information that is itself inaccurate? What responsibility does the information producer incur for errors in information sources? An unskilled searcher or one with insufficient searching knowledge may not find correct or complete information, which can lead to the wrong answer. The fault can lie anywhere in the information dissemination chain, publication, collection, storage, retrieval, dissemination, or utilization. Errors are often encountered in DI databases.⁴⁶ DI pharmacists are constantly finding errors and reporting the errors to the vendor or publisher. For example, when completing a class review of potential probiotic agents for the drug formulary it was noted that only capsules were listed for one of the products, although the product was available as a liquid and granules. Although very few cases have been brought before courts concerning the liability of print or online information sources, there is some case law to guide (see below). The issue concerns strict liability.

Strict liability applies where a defective product proximately causes physical harm. Where the service rendered is deemed to be a professional service, the courts exhibit a reluctance to impose strict liability. With exceptions, persons physically injured because of their reliance on defective and unreasonably dangerous information have only negligence as a cause of action, and only against the author, not the publisher⁴⁷; only if the publisher is negligent or offers intentionally misleading information could it be held liable. This was tested in Jones v. J.B. Lippincott Co., where a nursing student was injured after consulting and relying on a nursing textbook that recommended hydrogen peroxide enemas for the treatment of constipation. The courts rejected the plaintiff’s claim that strict liability should be applied to the publisher.⁴⁸ Similarly, in a German case, a misprint in a medical textbook resulted in the injection of 25% rather than 2.5% sodium chloride solution, injuring a patient. Again, the court rejected strict liability for the publisher on the basis that any medically educated person should have noticed the misprint.⁴⁹ In Roman v. City of New York, the plaintiff sued for an alleged misstatement in a booklet distributed by a Planned Parenthood organization that resulted in a “wrongful conception.” The court found that “a publisher cannot assume liability for all misstatements, said or unsaid, to a potentially unlimited public for a potentially unlimited period.”⁵⁰ In Winter v. G.R Putnam’s Sons, two people required liver transplants after collecting and eating poisonous wild mushrooms. They had relied on an Encyclopedia of Wild Mushrooms in choosing to eat the mushrooms that caused this severe harm.⁵¹ The court refused to hold the publisher liable and found that a publisher has no duty to investigate the accuracy of the information it publishes.

In Delmuth Development Corp. v. Merck & Co., the plaintiff claimed lost sales because of the publication of erroneous information in the Merck Index. The court considered the duty of a publisher to a reader to publish accurate information in a compendium.⁵² The court noted a publisher’s right to publish without fear of liability is guaranteed by the First Amendment and societal interest. It further held that even if it had a duty to publish with care, the plaintiff could not claim it suffered damages because of reliance on this information.

What liability is incurred by an author or publisher for publication of product comparisons? Recently, a pharmacy journal publisher and article author were sued for defamation by a device manufacturer where the publication compared and opined on the performance of devices for compounding sterile products.⁵³ The court granted the defendants motion to dismiss stating lack of actual malice (a necessary element of defamation). In this ruling, the court protected the First Amendment rights of scientists to report product comparisons and the rights of publishers regarding the peer-review process and publication of such comparisons.⁵⁴

In Libertelli v. Hoffman La Roche, Inc. & Medical Economics Co., the plaintiff became addicted to diazepam (Valium^®) and sued the publisher of the Physician’s Desk Reference (PDR).⁵⁵ The claim was based on the absence of warnings in the PDR regarding the addictive nature of the drug. The court dismissed the case against the publisher. Under a long line of cases, a publisher is not liable for matters of public interest if it has no knowledge of its falsity. Although some effort should be made to verify search results, the pharmacist cannot be held responsible for knowing and verifying the contents of all sources, whether in print or online. However, checking a second reference to verify information is prudent.

Strict liability would appear applicable to software that is licensed without significant modification as a standard packaged system, as has been found with defective medical computer programs.⁵⁶ Pharmacists providing DI should be aware of computer-related lawsuits that have arisen involving defects (or bugs) in software that caused erroneous results. These cases result in greater damage awards based on consequential damages (i.e., special as opposed to actual) suffered. An example of consequential damages would be damage to a firm’s reputation. Perhaps the most widely cited software-related accidents involve malfunctioning computerized radiation machines where overdosages have caused patient deaths.⁵⁷ Radiation overdosages from faulty software continue to occur today; grim reminders of the problems faced by reliance on software.⁵⁸ In one particularly relevant case, the court held that the National Weather Service was liable for the deaths of four fishermen off Cape Cod, Massachusetts. The Weather Service had forecasted calm weather because of faulty software. Although the verdict was overturned on technical grounds, the U.S. District Court let stand the precedent holding an entity liable for information it provides.⁵⁹

In another case, Jeppesen, an information provider, was held liable for an airplane crash caused by faulty data from the Federal Aviation Administration on flight patterns. A pilot used one of the faulty charts and crashed into a mountain, killing the crew and destroying the plane. The company paid $12 million in damages.⁶⁰ The court held the information provider strictly liable because the charts were considered a product. In Jeppesen, the mass production and mass marketing of the charts rendered them a product. Similarly, in Greenmoss Builders v. Dun & Bradstreet, the issue involved the erroneous listing of Greenmoss Builders as a company in bankruptcy in Dun & Bradstreet Business Information Report database. A jury awarded $350,000, including $300,000 in punitive damages. The case was appealed all the way to the Supreme Court, where Dun & Bradstreet lost the case.⁶¹

In Daniel v. Dow Jones & Co., Inc., where a subscriber brought action against a provider of a computerized database alleging that he relied on a false news report in making investments, the court found that the subscriber did not have a special relationship with the database provider necessary to impose liability for negligent misstatements. First Amendment guarantees of freedom of the press also protected the provider from liability.⁶²

As mentioned previously, DI provided may be inaccurate because it is dated, incomplete or wrong. For example, inappropriate quality information may occur because references are updated differently. Even electronic references are updated differently—some monthly, others weekly. Most DI services require documentation of an answer in at least two difference sources. The double-check procedure is common practice when preparing chemotherapy and avoiding drug administration errors. In many of the cases described above, liability could have been prevented by checking the information in more than one reference or source. Thus, checking a DI response in several references is the standard of practice.

INAPPROPRIATE ANALYSIS/DISSEMINATION OF INFORMATION

Is liability for providing DI a rhetorical supposition or a real possibility? The responsibility of pharmacists providing DI goes beyond that of mere information intermediary, the person between the information producer and the user. Published studies for DI centers have reported that 41% to 83% of requested information is patient specific or judgmental in nature.⁶³ In addition to liability for the negligent information retrieval and dissemination, the pharmacist’s role involves information interpretation, evaluation, and giving advice. This role falls into a consultative model and differs greatly from that of librarians. Librarians are not equipped to give advice. The pharmacist’s role as an evaluator and interpreter of the information creates a duty sufficient to sustain liability.

The paucity of case law in the area does not negate liability. The issue deserves consideration because of the potential for harm caused by the DI provided by the pharmacist. There have only been two cases involving poison information centers, one of which also was a DI center. In Reben v. Ely, the plaintiffs filed suit against the DI center for injuries sustained by inadvertent administration of cocaine solution instead of acetaminophen to a 10-year-old patient. The local pharmacy had colored the 10% cocaine solution red and labeled it red solution to thwart abuse. When the nurse realized the mistake she contacted the Arizona Poison and DI Center. The DI pharmacist described the symptomatology of cocaine overdose, but did not go far enough in recommending that the patient seek emergency care. The patient developed seizures and cardiopulmonary arrest with brain damage that required lifetime nursing care. At the trial, the expert witness testified that the DI center operated below the standard of care. The issue was not erroneous information, but whether the center went far enough in its responsibility in handling the call. The plaintiff was awarded $6.5 million; the DI center was held liable for $3.6 million.⁶⁴

In another case, a lawsuit named a poison information center that was called for assistance when a student died after swallowing a toxic substance during a laboratory experiment. The poison center was named in the $2.5 million suit because it refused to release proof of its claim that the person who called had given the wrong name for the solution that the student drank.⁶⁵

From a liability standpoint, there are disadvantages to the formal combination of poison control and DI centers. For example, poison inquiries usually require immediate answers in critical situations without written documentation and sometimes without supporting references.^66,67 The outcomes of poisonings (e.g., overdoses and suicide attempts) are more likely to result in patient morbidity and mortality and require medical backup for acute treatment decisions. Some states (e.g., Arkansas, Oregon, Washington, Arizona, New Jersey) have statutory provisions for joint poison control and DI centers. In several of these states, such as Arkansas, immunity from personal liability in judgment (in contrast to carelessness or inadvertence) would not be actionable as malpractice unless a lack of due care can be shown. However, not all DI centers are protected from liability. Additionally, there have been other lawsuits involving poison control centers but these have mostly involved medical toxicologists serving as poison control center consultants, not DI pharmacists.⁶⁸

Defenses to Negligence and Malpractice Protection

Even if the plaintiff can establish all the necessary elements of negligence, legal defenses can avoid or reduce liability. Some defenses might include a statute of limitations, comparative or contributory negligence, informed consent, or governmental immunity. It is important to keep in mind that there may be differences in both types of defenses to negligence and insurance coverage for individuals and employers. Further information on defenses will be described in the following sections.

DEFENSES FOR INDIVIDUALS

Assumption of the risk via informed consent and comparative or contributory negligence are defenses to negligence for individuals. Under informed consent, the defendant could assert that the patient knowingly assumed the risk for a new or experimental therapy or regimen. However, the risks the patient assumes does not include negligence on the part of the physician or pharmacist. There is no assumption of the risk for negligent behavior.

Comparative negligence is the allocation of responsibility for damages incurred between the plaintiff and the defendant, based on the relative negligence of the two. Concurrent negligence is the wrongful acts or omissions of two or more persons acting independently, but causing the same injury. Under comparative or concurrent negligence, the pharmacist may also be held liable, either alone or together with the information requestor (e.g., physician and nurse), for inaccurate information or information that does not ensure maximal protection for the patient.

In the landmark case Harbeson v. Parke Davis, a federal court ruled that the doctrine of informed consent required a physician to furnish a patient contemplating pregnancy with information concerning the teratogenicity of the phenytoin she was taking. The physician had a duty to provide information reasonably available in the medical literature, but failed to do so. Even though the physician was not aware of the potential effects of phenytoin, studies were reported in the medical literature.⁶⁹ This case represents the only case in which a lack of a literature search resulted in liability.

Cases of vicarious liability are not new to medical malpractice. Vicarious liability is the attribution of liability on one person for the actions of another. Through the doctrine of vicarious liability, a pharmacist could become associated with professional liability actions as part of a case against a hospital or physician. Physicians have been found negligent for the negligence of nurses, therapists, and others working under their supervision. Significantly, no cases were found where physicians were found negligent from the negligence of pharmacists working under them. If a physician requests DI, he or she would also be held liable if a patient suffers because the search was deficient or the information incorrect. For example, in the Harbeson case, if the physician had requested the pharmacist to search for information about the teratogenicity of phenytoin and no references were found because of a faulty search, the pharmacist would share in the negligence together with the physician. The institution would probably also be named as a party in such legal action.

Delegation of authority does not mean abdication of responsibility. Under vicarious liability, a pharmacist who has not been personally negligent could be held responsible for the negligence of others. Supervision and adequate training of subordinates (e.g., interns, pharmacy technicians, other employees) are essential. Incompetence and substandard training of these individuals can lead to liability. An example might include a breach of confidentiality (e.g., revealing someone has a loathsome disease) by one of these employees.

From a legal standpoint, does charging a fee increase liability for the DI provider? Fee-based providers would appear to be at greater malpractice risk, especially if the relationship is a contractual one. If any of the contractual expectations are not met, the client has a contractual cause of action against the DI center. The courts will look to the terms of the agreement and the reasonable expectations of the parties. However, where bodily injury results, tort law may impose liability even where the defective information is given gratuitously and the DI provider derives no benefit from giving it.

Does providing DI services to consumers increase liability exposure? Many DI centers provide services to consumers; some via a hotline or health information lines, some via the Internet. Several studies have reported that more ethical questions to DI centers arise from consumers than any other group.^70–72 Such ethical questions may involve drug abuse and toxicologic effects, the safety of drugs in pregnancy or nursing, experimental therapy, or the appropriateness of prescribing decisions. A decision to comment on a physician’s therapeutic recommendations, even if factually correct and in the patient’s best interest, may result in a legal liability. The answers to this and other questions that the pharmacist providing DI encounter are not found in the legal precedent.

DEFENSES FOR EMPLOYERS

Is the provider the hospital, university, or pharmacy where the DI center is located, or the pharmacist providing the DI? The vast majority of DI centers are located in hospitals and universities. In addition, many pharmaceutical companies have DI departments staffed by pharmacists who handle inquiries on the company’s products. There also exist independent information brokers who have liability under contract law, as well as tort law. The employer–employee relationship is a significant factor under either common law respondeat superior doctrine or, alternatively, a theory of negligent hire or supervision. Respondeat superior refers to the proposition that the employer is responsible for the negligent acts of its agents or employees. The injured party may also sue the employer for its negligence in hiring or supervising the employee. Under a negligent hire theory, it must be shown that the employee was unfit for the position and that a reasonable, preemployment interview or postemployment supervision would have discovered this fact.⁷³

Although the person who provides the information is liable for the harm caused by it, the employer may also be held liable in the absence of sovereign or charitable immunity. For pharmacists providing DI employed by the government (e.g., Veteran’s Administration [VA] or Public Health Service [PHS]), there are statutes providing governmental immunity, also called sovereign immunity, from civil liability. Such immunity, however, will not protect an intentionally or grossly negligent person.

Even if the lawsuit is nonmeritorious, DI centers affiliated with hospitals or universities provide another deep pocket for contribution to the settlement. With exceptions, suing the pharmacist alone would fail to provide a windfall settlement for plaintiffs. The board of directors/trustees of the hospital or university or director of the DI center or pharmacy department where the DI center is located would be jointly liable. Joint and several liability refers to the sharing of liabilities among a group of people collectively and also individually. If the defendants are jointly and severally liable, it means that the injured party may sue some or all of the defendants together, or each one separately, and may collect equal amounts or unequal amounts from each. In states where joint and several liability applies, the pharmacist provides additional assurance that there will be sufficient assets to recover. The DI provider will be held responsible for the standard of care in the response to DI inquiries and may be found negligent.

PROTECTING AGAINST MALPRACTICE

Methods to protect against lawsuits include contracts covering financial arrangements, adequate documentation, disclaimers, and insurance.⁷⁴ For example, a disclaimer can be placed on results of online searches stating that the data being provided are from a source believed to be reliable and factually correct.⁷⁴ The best way to avoid omission negligence is to learn from experience, anticipate mistakes that may appear in databases, and keep abreast of changes in DI sources. Even if the delivery of false information is the result of inaccurate information itself, the pharmacist would likely be named as a defendant if the database producer were sued.

Adequate documentation may spell the difference between refuting or not refuting an unfounded claim of malpractice. Such documentation includes responses to inquiries, as well as a record of steps taken in a search. Designing and following procedures to document the research process can help avoid negligence. In Fidelity Leasing Corp. v. Dun & Bradstreet, Inc., the court looked at the operation procedures and adherence to them in the particular instance to determine liability for providing false information.⁷⁵

The key to provision of quality DI in an information service is the availability of current, objective information. Procedures should be in place to ensure that data are continually reviewed and updated. Quality assurance (QA) standards for the timeliness, thoroughness, and accuracy of information could also insulate against liability. QA programs, although they exist, are inconsistent among DI centers.

Problem areas common to DI centers regardless of practice site include files not updated and incomplete documentation of responses to requests. With regard to inquiries about adverse reactions, details of the adverse event should be taken and reported to the FDA reporting program. Cases may be clinically urgent and the physician or nurse may have a patient waiting. Response via e-mail, even with alerts attached, is not prudent in such situations as there is no guarantee that the caller is at their desk to receive such e-mails. All statements made should be traceable to the literature. Additionally, information should be confirmed with other references to ensure consistency between various resources. DI centers should address at least some of the items in Table 10–1.

TABLE 10–1. QUALITY ASSURANCE AS A LIABILITY REDUCING FACTOR

Insistence on a good educational background for entry-level positions including PGY-1 and, ideally PGY-2 residencies in DI, followed by the continuing education of DI professionals, certification in online training courses, and good interpersonal communication skills may also protect against malpractice. Several studies have shown that physicians who were sued frequently had poor interpersonal skills, i.e., patients did not like them.⁷⁶ It is also important to keep abreast of changes in sources of DI via regular advanced training, conferences, and reading. All courses in DI should teach situations in ethical conflict that will assist in the decision making and value judgments encountered in the provision of DI.

Under the tort law doctrine of respondeat superior, both the pharmacist providing DI and the employer are jointly and severally liable for the damages. This enables the plaintiff to have access to the pharmacist’s personal assets where the employer’s assets are not sufficient to cover an adverse judgment. Professional liability insurance provides protection to cover exactly this kind of liability. Consideration should be given to obtaining professional indemnity insurance for the DI pharmacist.

Most policies now provide coverage on either an occurrence or claims-made basis. Occurrence means any incident that occurs during the policy period, no matter when the claim is filed, within the applicable statute of limitations. Claims-made policies cover only claims that are filed while the policy is active. To cover claims that are filed after a claims-made policy is terminated, the DI pharmacist can purchase tail coverage from the insurer. Tail coverage insures for an incident that occurred while the insurance was in effect but was not filed by the time the insurer–policyholder relationship terminated. It is important to be aware of the limitations and exclusions in these policies, such as some policies no longer covering intravenous compounding. Many do not require the carrier to obtain the consent of the insured before settling a claim. In these policies, the right to protect one’s reputation may conflict with the economic interest of the insurer to dispose of the claim as inexpensively as possible. Therefore, it is imperative that individuals obtain insurance coverage policies separate from those of their employers. Most common exclusions are coverage for dishonest, fraudulent, criminal, or malicious acts; property damage; and personal injury coverage. In these cases, the pharmacist faces such liability alone, and in certain situations can be ruined financially.

Finally, limiting language in subscriber contracts (i.e., exculpatory clauses) may serve to restrict monetary awards in certain circumstances. Such clauses could be included in either contracts for subscribers or signed on acceptance of responses to inquiries. A provision could be included that specifically disclaims any responsibility to a third party who might rely on the information. Written information (e.g., a bulletin) should carry a disclaimer specifying that the information provided is issued on the understanding that it is the best available from the resources available to the service at a particular time.

An attorney could draft a standard agreement providing that the application of the research by the recipient would not be subject to any implied warranty of fitness for that purpose. However, certain jurisdictions have held that contracts that purport to exculpate a party from negligence will be subjected to strict judicial scrutiny. Courts in certain jurisdictions have declared contracts that attempt to exempt a party’s willful or grossly negligent conduct to be void. Further, no exculpatory clause will protect a pharmacist who is grossly or intentionally negligent.

Labeling and Advertising

The FDA defines labeling as written or oral information used to supplement or explain a product regardless of whether the information accompanies the product. As such, even literature, textbooks, reprints of articles, and scientific seminars may constitute labeling. Labeling requires full disclosure. Advertisements, on the other hand, require a fair balance, meaning there must be a discussion of both benefits and risks, so as not to be misleading, and substantial evidence from clinical trials must be included for comparative claims.⁷⁷

There are at least three key areas of labeling and advertising liability: the learned intermediary rule, which is a defense to failure to warn actions; the doctrine of overpromotion, under which adequate warning is alleged to have been diluted by communications failing to adequately convey the full impact of the warning; and promotion of off-label use or FDA-unapproved indications.

DIRECT-TO-CONSUMER DRUG INFORMATION AND EROSION OF THE LEARNED INTERMEDIARY RULE

In 1997, the FDA relaxed the standards for direct-to-consumer advertising (DTCA).⁷⁸ DTCA involves magazine, television, Web site, cell phone, and text advertisements, suggesting the use of various prescription drugs for medical conditions the viewer might experience and also suggesting the viewer ask their physician if the medication would be appropriate for them.

Today, prescription drug advertising is a multibillion dollar industry. Prescription drug advertising is governed by the Food, Drug & Cosmetic Act (FDCA) and 21 U.S.C. §331, which prohibits the misbranding of a prescription drug.⁷⁹ The primary regulation aimed at pharmaceutical product advertising is found at 21 C.F.R. § 202.1 that pertains to all “advertisements in published journals, magazines, other periodicals, newspapers, and other advertisements broadcast through media such as radio, television, and telephone communication systems.” These implementing regulations specify that prescription drug advertisements cannot omit material facts, and must present a fair balance between effectiveness and risk information. Further, for print advertisements, the regulations specify that every risk addressed in the product’s approved labeling must also be disclosed in the advertisements. The regulations further require that the advertisement contain a summary of “all necessary information related to adverse effects and contraindications” or provide convenient access to the product’s FDA-approved labeling and the risk information it contains.” DTCA of off-label uses of prescription drugs is prohibited.⁸⁰

There is evidence that DTCA is becoming more aggressive.⁸¹ The FDA has cited unsubstantiated safety claims and minimization of risk, including “websites that omit or bury important safety information,” as areas of particular concern.⁸² In some cases, the advertising does not focus on a product but rather on patient education. One company has developed a campaign to bring mental health educational forums to college campuses featuring free screenings for depression. In another case, a 24-hour television network directed to a captive audience (i.e., hospitalized patients) was launched. As federal regulations require patient education, this programming may be used by hospitals for patient education. Other manufacturers offer monetary rewards or gifts (e.g., free exercise video) to patients who visit their physician regarding the product or offer a rebate or sweepstakes opportunity if the patient completes a questionnaire. Manufacturers are also sending out video press releases about drugs that are often aired as news stories. Many advertisements provide an 800 number to encourage consumers to seek additional information about the products; others offer free videotapes, brochures, and information packets discussing the product.⁸³ There also exist DI search tools for use directly by consumers (e.g., PDR.net; http://www.pdr.net).⁸⁴

Another popular DTC vehicle is blog posts. For example, YouTube™ videos about products from patients are being posted on pharmaceutical company Web sites without review. Often these patient testimonials go well beyond what a company is permitted to advertise about the product. In general, patient testimonials minimize product risks and adverse events and are unbalanced. However, the FDA has yet to establish formal regulations or guidance on such activity, even where the pharmaceutical company is hosting the blog.⁸⁵ In March 2012, the FDA issued a draft guidance on DTC television advertisements, but has not issued a final guidance. Nor has the FDA issued formal guidelines regarding online DTCA.

The advent of DTCA bypasses the advice of the physician. In 1999, the first lawsuit was brought against a pharmaceutical company in connection with DTCA. Other DTCA cases have followed where the attorney for plaintiffs have made some footholds in convincing courts to abandon the learned intermediary doctrine, greatly impacting pharmaceutical product liability law.⁸⁶

In Perez v. Wyeth Laboratories Inc.,⁸⁷ the New Jersey Supreme Court created an exception to the learned intermediary doctrine on the ground that foundational tenets of the doctrine are no longer applicable in the context of DTCA. The court wrote, “…we believe that when mass marketing of prescription drugs seeks to influence a patient’s choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or the adverse effects of the product.” Perez involved Norplant^®, an implantable contraceptive that provided contraception for up to 5 years, but was removable. The plaintiffs alleged personal injury and failure to warn of the contraceptive’s adverse effects, including removal complications, which resulted in pain, and scarring. The plaintiffs asserted that based on the mass advertising campaign to women that the pharmaceutical manufacturer had a duty to warn patients directly. According to the majority in Perez., the learned intermediary doctrine has four theoretical premises: (1) a reluctance to undermine the physician–patient relationship, (2) an absence for the need for the patient’s informed consent, (3) the inability of drug manufacturers to communicate with patients, and (4) the complexity of the subject matter. The court asserted that each of these bases, except the fourth, is obviated in DTCA of prescription drugs. According to Perez, when direct advertising influences a patient to request a particular drug, and the physician does not adequately consult with the patient, “neither the physician nor the manufacturer should be entirely relieved of their respective duties to warn.”⁸⁸

It is important for pharmacists providing DI to be aware of the emerging legal issues relating to DTCA, such as the erosion of the learned intermediary doctrine and the shifting of liability to pharmaceutical manufacturers.⁸⁹ Additionally, the erosion of the learned intermediary rule, as demonstrated in Perez, and the shifting of liability away from physicians has broad implications for pharmacists. Increasingly, the courts are holding that the pharmacist has a duty to warn patients and intervene on their behalf. In 1991, Pharmacists Mutual reported no claims involving drug utilization review. In 1999, drug review claims accounted for 9% of all pharmacist liability claims. A 2002 study by the same firm found that drug review claims were continuing in a straight-line increase.⁹⁰ In 2010, drug review claims at 7.9% represented the largest category of intellectual errors (as opposed to mechanical or dispensing errors). Counseling claims account for 1.6% of all claims.⁹¹

Multiple constitutionality issues have been raised regarding any government interference with DTCA of prescription drugs. In Thompson v. Western States Medical Center, the U.S. Supreme Court upheld the rights of pharmacists to advertise compounded prescription drugs.⁹² In doing so, the court held that the Food and Drug Administration Modernization Act (FDAMA) prohibition of the promotion or advertisement of compounded drugs by pharmacists violated the First Amendment and that proposed restrictions would limit the First Amendment rights of pharmaceutical manufacturers as well as the implied constitutional right of patients to receive the information.

In any event, pharmacists must remain vigilant to ensure that DTCA does not promote false expectations. Clearly, DTCA achieves its goals of encouraging consumerism, whereby patients go to seek prescription information from health professionals. DTCA increasingly lead patients to seek information that will confirm or refute the manufacturer’s claims that differentiate a product from its competitors. When confronted with the influences of such advertising, pharmacists are on the front lines educating patients regarding these products, including the cost-effectiveness of prescription drug options. Pharmacists have a responsibility to provide objective information, to educate the patient, and to serve as a DI resource.⁹³ Refer to Chapter 23 for additional information.

DOCTRINE OF DRUG OVERPROMOTION

Stay updated, free articles. Join our Telegram channel

Join