Do Sales Reps Who Provide Physicians with Product “Details” Owe a Legal Duty to Patients?
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. State the first element required for medical malpractice 2. Restate that providers cannot rely on detail representatives for medical opinions
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Feb 19 2019 through 07/15/2022, participants must read the learning objectives and faculty disclosures and study the educational activity.
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For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
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Continuing Nursing Education
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Pharmaceutical sales representatives who provide “details” to physicians, including approved scientific information, benefits, side effects etc. are also known as detail representatives and are becoming a new target in products liability and medical malpractice cases. They have been named as defendants alongside manufacturers or identified for deposition or trial testimony. Their job functions include arranging appointments with medical professionals to educate and spread awareness of medical devices the company is manufacturing. Courts in many jurisdictions have found that detail representatives owe no legal duty to patients or physicians under a medical malpractice negligence theory. The first element of a medical malpractice complaint is a professional duty owed to the patient. Detail representatives do not form a traditional physician relationship. They do not manufacture nor sell medical equipment. In addition, they are not required to train physicians because the FDA warning that comes with the device is sufficient. Therefore, they have no duty to patients on whom the medical equipment is used.
The following cases support the premise that detail representatives do not have a legal duty to patients nor to physicians. For example, in Wolicki-Gables v. Arrow International, 641 F. Supp. 2d 1270, 1291 (M.D. Fla. 2009), the court ruled against the plaintiff who alleged that the detail representative failed to instruct the surgeon how to connect the medical device in the middle of the surgical procedure. Although present at the surgery, the representative was there merely to carry ‘back up’ products in their sterile packages to have available for the surgeon’s use, if necessary, and to observe preparation of the products.” Id. at 1291. The detail representative did not “scrub in” to the surgery or otherwise interact with the physician during the surgery. An appeals court in Illinois also noted that providing a pacemaker and leads and attending a surgery does not create a duty to a patient to ensure that the product is used properly. Kennedy v. Medtronic, 851 N.E. 2d 778 (Ill. App. Ct. 2006).
Next, in Hall v. Horn Medical, Civ. Action No. 11-1032, 2012 WL 1752546, at *3 (E.D. La., May 16, 2012), the physician argued that he relied on the detail representative’s statements with respect to the use of a cage device during a spinal surgery. The court found it “unreasonable as a matter of law” that “a seasoned neurosurgeon [would] rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine.”
In summary, detail representatives usually do not have individual liability for medical malpractice and product liability.
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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