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Third Quarter 2009 |
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The Learned Intermediary
Do you rely on the knowledgeable laser company technician to apply the correct settings for an office procedure? Do you depend on the consultant of a pacemaker company for the programming options? In recent cases, courts have deemed that liability for medical decision making rests with the physician. These courts applied the “learned intermediary” doctrine.
The Federal Food, Drug, and Cosmetic Act of 1938 established, among many things, the Food and Drug Administration, the Department of Health and Human Services, and the regulation of the manufacture, distribution, and sale of drugs. Later, the 1962 Kefauver-Harris Drug Amendments added drug testing standards for effectiveness and safety. An examination of the legislative history reveals that the purpose of the bill was to give physicians information about drugs and reduce false and misleading advertising to them. The bill was silent on misleading advertising to consumers.
The phrase “learned intermediary” came about in the Eighth Circuit case Sterling Drug Inc. v. Cornish (370 F.2d 82) in 1966. The court stated: “We are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser’s doctor is a learned intermediary between the purchaser and the manufacturer.” It was later held that the doctor is in the best position to evaluate risks and benefits. Manufacturers were not able to communicate with patients effectively, and imposing that duty would interfere with the physician-patient relationship (Larkin v. Pfizer, Inc., 153 S.W. 3d 758, Kentucky, 2004).
These cases established the learned intermediary doctrine. The manufacturer of a prescription drug or device fulfilled its duty to warn the user of potentially harmful effects by informing the prescribing physician, the learned intermediary. The manufacturer did not have an obligation to warn the user as long as the drug or device was available only by a doctor’s prescription and it was prescribed in the context of a physician-patient relationship.
The underlying theory was that despite attempts at “plain language” drug and device descriptions, patients typically do not read and are unable to comprehend package inserts. They rely on their doctors (and pharmacists) to understand, evaluate, and relay warnings. Doctors understand the warnings and pass on information about precautions, contraindications, and adverse reactions, and they sometimes provide informed consent.
From 1966 to the present, 47 states and the District of Columbia and Puerto Rico have explicitly adopted the learned intermediary doctrine, and courts have held that the drug or device manufacturer’s duty to warn applies only to doctors.
The learned intermediary doctrine remained a most important legal defense available to manufacturers of medicines and devices until the recent popularity of direct-to-consumer advertising.
The Omnibus Budget Reconciliation Act of 1990 (OBRA) placed pharmacists as learned intermediaries between doctors and patients. It required pharmacists to provide special directions and precautions, as well as information on storage and refills, and it asked them to keep patient profiles. Pharmacists could question doctors prescribing drugs and even refuse to fill the prescriptions.
In 1999, the New Jersey Supreme Court in Perez v. Wyeth Labs, Inc. (161 N.J. 1) adopted an exception to the learned intermediary doctrine for products directly advertised to consumers. The court held that there was a presumption that manufacturers complying with FDA regulations for direct-to-consumer ads had satisfied their duty to warn.
In 2007, the West Virginia Supreme Court declined to adopt the learned intermediary doctrine. It held that the justification for the doctrine was outdated given the prevalence of direct-to-consumer advertising (Johnson & Johnson Corp. v. Karl 220 W. Va. 463). Both the New Jersey and West Virginia courts noted that the drug marketing had altered the physician-patient relationship.
After the Karl decision, the trial lawyers sponsored legislation in California, A.B.2690 (Krekorian), to codify a Perez-type exception to the learned intermediary doctrine. They argued that the rise of direct-to-consumer ads on television and the Internet undermines the central premise of the learned intermediary doctrine. The bill was placed on the inactive file last May.
The future of the learned intermediary doctrine is unclear. Legislatures across the states will try bills similar to the one in California, and appeals courts will be asked to revisit the doctrine in light of new trends in drug and device marketing. Meanwhile, in many jurisdictions, the doctrine remains as both a shield to manufacturers and as a kind of funnel, collecting the liability of consultants, technicians, and manufacturers and placing it on the learned intermediary—the physician.
National Health Care Reform
Washington, DC, is more active than usual for parties watching the health care reform debate. Four measures that The Doctors Company supports are essentially reintroductions of former bills that propose California’s MICRA model: S.45 (John Ensign, R-NV), H.R.1086 (Phil Gingrey, R-GA), and H.R.2975 (John Campbell, R-CA). H.R.1468 (Michael Burgess, R-TX) proposes the Texas model of liability reform. It is doubtful that any measure with a cap on noneconomic damages will be passed.
President Obama indicated early on that health care reform is a top priority. The goals were insuring all Americans, less health care spending, and better health outcomes. While few would disagree with these goals, there is significant disagreement about the details. To pay for insuring all Americans, the following proposals have been made: increased taxes for recipients of health benefits and no corporate deductions for providing health benefits. Polls show that most Americans want to overhaul health care but are less enthusiastic about the proposals to pay for it.
The dilemma is that Congress needs to look at ways to save on the spending side and also insure more people. The Congressional Budget Office indicated in July that none of the bills would significantly reduce health care costs or even contain them over time.
The Health, Education, Labor, and Pensions (HELP) Committee bill cleared its policy committee on a 13-to-10 party-line vote in mid-July. Ensuing votes on bills will most likely be along party lines.
The House Energy and Commerce Committee approved its version of health care reform on July 31. The final vote on the bill was 31–28 with five Democrats joining all committee Republicans in voting against the bill. Amendments on tort reform were rejected.
At press time, a number of serious issues remain unresolved. For example, how directly will a public model compete with private insurers? Will “universal coverage” morph into “single payer”? If the legislation establishes practice parameters or “best practices,” will there be a safe harbor from liability for good doctors, or will these new standards be used to justify more lawsuits?
The House bill is not yet in final form, and the Senate bill has not been released to the public. We are monitoring the situation closely, and your Government Relations Department is working hard to assess each proposal to make sure new causes of action are not hidden in adopted language and to try to add meaningful tort reforms to whichever version becomes the vehicle for federal health care reform.
State Legislation
Efforts to erode current medical liability reform statutes were thwarted in legislative sessions in Colorado, Florida, Georgia, Nevada, Oregon, and Texas. Ohio’s legislature continues to hear S.B.86 (Buehrer, R), which would raise the negligence standard in emergency room settings. Virginia Governor Tim Kaine signed H.B.2057 (Hamilton, R), expanding the list of sympathy expressions that are inadmissible in court.
Oklahoma Governor Brad Henry signed H.B.1603 (Sullivan, R) into law. The bill is a comprehensive tort reform measure that includes positive changes in joint and several liability, definitions of junk science, expert witness standards, and a $400,000 cap on noneconomic damage awards.
The California Court of Appeals upheld MICRA in Van Buren v. Evans. Van Buren had sued Dr. Evans and won a judgment for noneconomic damages that was reduced to $250,000. Van Buren claimed MICRA violated the state and U.S. constitutions. The Doctors Company defended Dr. Evans on appeal and contributed to amicus curiae briefs.
For more on this topic, visit our Knowledge Center at www.thedoctors.com/knowledgecenter.
The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.
The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.
The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
The Doctor’s Advocate is published quarterly by Corporate Communications, The Doctors Company. Letters and articles, to be edited and published at the editor’s discretion, are welcome. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of The Doctors Company. Please sign your letters, and address them to the editor.