[Excerpts from "Liability Of Physicians For Promoting The Off-Label Use Of Prescription Drugs" by Paul W. Shaw, Robert A. Griffith, and Benjamin M. Welch]
Although physicians may prescribe a drug for an "off-label" purpose, drug manufacturers cannot market or promote the drug for such unapproved uses. See 21 C.F.R. § 314.54. Additionally, manufacturers are strictly limited in what they can communicate to physicians about the off-label use of a drug. See, e.g., 21 U.S.C. § 396; Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001); Washington Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000); James M. Beck and Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 76-80 (1998). However, such limitations do not apply to physicians communicating with other physicians about their observations and experiences with the off-label use of a drug.
In addition to allowing doctors to prescribe approved drugs for “off-label” uses, the FDA has never sought to restrict the ability of third parties to publish and disseminate scientific information about “off-label” uses. The FDA has repeatedly recognized the importance of “open dissemination of scientific and medical information regarding these treatments.”
While physicians have a First Amendment right to discuss off-label uses, when those discussions are, or even appear to be, controlled by a pharmaceutical company, physicians can find themselves wrapped up in very expensive civil lawsuits, or facing criminal charges. The FDA has stated that discussions of off-label uses “are not permissible in programs that are or can be subject to substantive influence by companies that market products related to the discussion.”
In order to avoid potential liability, physicians who choose to speak about the various uses of certain drugs should only do so with a complete awareness of who is funding such presentations and who controls the agenda.
Friday, May 25, 2007
Monday, May 21, 2007
Joint Commission Revises Restraint and Seclusion Standard
The Joint Commission has revised its restraint and seclusion standard (PC.12.90) effective immediately to align with the Centers for Medicare & Medicaid Services final rule on patients’ rights. The CMS rule, issued in December 2006, applies to all hospitals that participate in the Medicare and Medicaid program. Among other provisions, it allows a registered nurse or physician assistant to conduct the "face-to-face" evaluation required within one hour after a patient is restrained or secluded, if the RN or PA is trained in accordance with CMS requirements and consults with the attending physician or a licensed independent practitioner as soon as possible.
Trends Affecting Hospitals and Health Systems, April 2007
The American Hospital Association releases its 8th annual TrendWatch Chartbook 2007, which provides charts and data on trends in the field.
- Trends in the Overall Health Care Market
- Organizational Trends
- Utilization and Volume
- Trends in Hospital Financing
- Workforce
- The Economic Contribution of Hospitals
- Trends in the Overall Health Care Market
- Organizational Trends
- Utilization and Volume
- Trends in Hospital Financing
- Workforce
- The Economic Contribution of Hospitals
"Toothless" HIPAA
The Health Insurance Portability and Accountability Act (“HIPAA”), adopted by Congress in 1996, aims to protect the security and privacy of health information. 45 C.F.R. §§ 160, 164 (2006). The regulations promulgated pursuant to this Act apply to “covered entities,” which include (1) health plans, such as health insurance companies, HMOs, Medicare, and Medicaid; (2) health care clearinghouses, such as billing companies and third party administrators; and (3) health care providers, such as hospitals and doctors. 45 C.F.R. § 160.103 (2006). These regulations protect patient privacy by restricting disclosure of health information to the “minimum necessary,” while also preventing unauthorized use by “downstream users.” See 45 C.F.R. § 164.502(e)(1) (stating that a covered entity may only release protected health information to its business associates if it receives satisfactory assurance that the business associate will take the appropriate steps to ensure the confidentiality of the information).
While HIPAA imposes a host of obligations on covered entities in an attempt to increase patient privacy, it does not explicitly create any individual rights for patients affected by medical privacy violations. Therefore, a patient who has been seriously harmed as a result of these privacy leaks cannot bring a lawsuit against the responsible party. Instead, a victim's only recourse is to file a complaint with the Department of Health and Human Services (“HHS”). 45 C.F.R. § 160.306. If HHS decides to pursue a victim's complaint, it may impose fines against the responsible covered entity. 42 U.S.C. § 1320d-6(b) (2006). However, since HIPAA's enactment, HHS has rarely imposed fines or criminal sanctions. [According to one report, HHS had not yet brought a single civil enforcement action under HIPAA as of November, 2005. Joseph Conn, Ruling Called HIPAA Barrier, Modern Healthcare, Nov. 14, 2005, at 16. There has only been one criminal conviction under HIPAA. United States v. Gibson, No. CR04-0374RSM, 2004 WL 2188280 (W.D. Wash. Aug. 19, 2004); Trial Pleading, United States v. Gibson, No. CR04-0374RSM, 2004 WL 2237585 (W.D. Wash. Aug. 19, 2004)]. Regardless of any enforcement action taken by HHS, the victim will not be compensated for the harm caused by this breach of privacy.
For more information read 60 Vand. L. Rev. 199.
While HIPAA imposes a host of obligations on covered entities in an attempt to increase patient privacy, it does not explicitly create any individual rights for patients affected by medical privacy violations. Therefore, a patient who has been seriously harmed as a result of these privacy leaks cannot bring a lawsuit against the responsible party. Instead, a victim's only recourse is to file a complaint with the Department of Health and Human Services (“HHS”). 45 C.F.R. § 160.306. If HHS decides to pursue a victim's complaint, it may impose fines against the responsible covered entity. 42 U.S.C. § 1320d-6(b) (2006). However, since HIPAA's enactment, HHS has rarely imposed fines or criminal sanctions. [According to one report, HHS had not yet brought a single civil enforcement action under HIPAA as of November, 2005. Joseph Conn, Ruling Called HIPAA Barrier, Modern Healthcare, Nov. 14, 2005, at 16. There has only been one criminal conviction under HIPAA. United States v. Gibson, No. CR04-0374RSM, 2004 WL 2188280 (W.D. Wash. Aug. 19, 2004); Trial Pleading, United States v. Gibson, No. CR04-0374RSM, 2004 WL 2237585 (W.D. Wash. Aug. 19, 2004)]. Regardless of any enforcement action taken by HHS, the victim will not be compensated for the harm caused by this breach of privacy.
For more information read 60 Vand. L. Rev. 199.
Sunday, May 20, 2007
Medical Malpractice Cause of Action
Visit this site for a good up-to-date overview medical malpractice law in Tennessee.
Duties of Care Owed By Hospital
The hospital has a duty to provide a sanitary environment to avoid sources and transmission of infections including a duty to eradicate pests such as spiders. Pullins v. Fentress County General Hospital and All-American Exterminating Co., 594 S.W.2d 663 (Tenn. 1979).
Hospitals owe a general duty to prevent patients from injuring themselves following surgical procedures. Clearly, a duty is owed to an intubated and restrained patient to maintain a clear and unobstructed breathing passage through an endotracheal tube. The particular harm need not have been foreseeable if another harm of like general character was reasonably foreseeable. Moon v. St. Thomas Hosp., 983 S.W.2d 225 (Tenn. 1998).
The extent and character of the care that a hospital owes its patients depends on the circumstances of each particular case. Keeton v. Maury County Hosp., 713 S.W.2d 314 (Tenn. Ct. App. 1986).
Duty of hospital is to exercise that degree of care, skill, and diligence used by hospitals generally in community and required by express or implied contract. Perkins v. Park View Hospital, Inc., 456 S.W.2d 276 (Tenn. Ct. App. 1970). See also Thompson v. Methodist Hospital, 367 S.W.2d 134 (Tenn. 1962).
Hospitals owe a general duty to prevent patients from injuring themselves following surgical procedures. Clearly, a duty is owed to an intubated and restrained patient to maintain a clear and unobstructed breathing passage through an endotracheal tube. The particular harm need not have been foreseeable if another harm of like general character was reasonably foreseeable. Moon v. St. Thomas Hosp., 983 S.W.2d 225 (Tenn. 1998).
The extent and character of the care that a hospital owes its patients depends on the circumstances of each particular case. Keeton v. Maury County Hosp., 713 S.W.2d 314 (Tenn. Ct. App. 1986).
Duty of hospital is to exercise that degree of care, skill, and diligence used by hospitals generally in community and required by express or implied contract. Perkins v. Park View Hospital, Inc., 456 S.W.2d 276 (Tenn. Ct. App. 1970). See also Thompson v. Methodist Hospital, 367 S.W.2d 134 (Tenn. 1962).
When Can a Court Infer that a Health Care Provider Acts with Apparent Authority for the Hospital?
A physician who is in control of the treatment of a patient may at the same time be the agent of a hospital. A physician, however, does not become an agent of a hospital merely by admitting or treating patients in that hospital.
Where a hospital offers a service, such as the care of an anesthesiologist, [radiologist, emergency room physician, the operating room setting] and the patient has no part in choosing the individual who will perform the service, a court may infer that the patient reasonably relied on the health care provider's apparent authority to act for the hospital. White v. Methodist Hosp. South, 844 S.W.2d 642 (Tenn. App. 1992).
Related Note: A medical facility that selects a competent physician for the care of a patient is not liable for mistakes made by the selected physician in the treatment rendered. However, a medical facility is liable for the negligence of the physician selected by the medical facility if, before the injury, the medical facility knew, or should have known, that the physician was incompetent to perform those duties the physician was reasonably expected to undertake.
Where a hospital offers a service, such as the care of an anesthesiologist, [radiologist, emergency room physician, the operating room setting] and the patient has no part in choosing the individual who will perform the service, a court may infer that the patient reasonably relied on the health care provider's apparent authority to act for the hospital. White v. Methodist Hosp. South, 844 S.W.2d 642 (Tenn. App. 1992).
Related Note: A medical facility that selects a competent physician for the care of a patient is not liable for mistakes made by the selected physician in the treatment rendered. However, a medical facility is liable for the negligence of the physician selected by the medical facility if, before the injury, the medical facility knew, or should have known, that the physician was incompetent to perform those duties the physician was reasonably expected to undertake.
Court Grants Summary Judgment for Defendant Physicians' Corporation in Medical Malpractice and Negligent Supervision Action
David Prewitt v. Semmes-Murphey Clinic, P.C., et al. - W2006-00556-COA-R3-CV
Shelby County - The plaintiff was rendered a quadriplegic after a car accident, and he received care at The Regional Medical Center at Memphis. The hospital staff included University of Tennessee School of Medicine residents, private physicians who were dual employees of a private corporation and the University of Tennessee as part of its residency training program, and nurses employed by another private corporation. The dual employee physicians treated patients independently in their capacity as employees of the private corporation and supervised resident physicians in their capacity as employees of the University of Tennessee. A University of Tennessee resident physician intended to perform a lumbar puncture procedure on the plaintiff, and he left a written request for a nurse for a lumbar puncture kit for said procedure. The nurse provided this kit, but did not include an antiseptic. The day of the procedure, the resident physician lowered the plaintiff’s bed rail and placed the plaintiff on his side in anticipation of performing the lumbar puncture, but when he noticed that an antiseptic was missing from the kit, he briefly left the plaintiff unattended to obtain the antiseptic. When the resident physician returned to the room, the plaintiff had fallen off the bed onto the floor. The plaintiff ruptured his spleen from the fall, requiring major surgery which resulted in subsequent complications. The plaintiff filed suit in both the Tennessee Claims Commission and the circuit court against the resident, the University, the hospital, the nurse, and the present corporate defendants, alleging claims of medical malpractice and negligent supervision. The liability of the resident and the University was stipulated by the parties in the Claims Commission, and these parties were dismissed from the circuit court proceeding on the basis of immunity. The present defendant corporations remained in the circuit court action. After discovery, the plaintiff moved for summary judgment in the circuit court. The defendant physicians’ corporation moved for summary judgment based upon immunity and the plaintiff’s lack of expert testimony, and the defendant nurse’s corporation moved for summary judgment based upon the plaintiff’s lack of expert testimony. The trial court granted both defendants’ motions for summary judgment and certified the judgments as final. The plaintiff filed a timely notice of appeal to this Court. We affirm.
Shelby County - The plaintiff was rendered a quadriplegic after a car accident, and he received care at The Regional Medical Center at Memphis. The hospital staff included University of Tennessee School of Medicine residents, private physicians who were dual employees of a private corporation and the University of Tennessee as part of its residency training program, and nurses employed by another private corporation. The dual employee physicians treated patients independently in their capacity as employees of the private corporation and supervised resident physicians in their capacity as employees of the University of Tennessee. A University of Tennessee resident physician intended to perform a lumbar puncture procedure on the plaintiff, and he left a written request for a nurse for a lumbar puncture kit for said procedure. The nurse provided this kit, but did not include an antiseptic. The day of the procedure, the resident physician lowered the plaintiff’s bed rail and placed the plaintiff on his side in anticipation of performing the lumbar puncture, but when he noticed that an antiseptic was missing from the kit, he briefly left the plaintiff unattended to obtain the antiseptic. When the resident physician returned to the room, the plaintiff had fallen off the bed onto the floor. The plaintiff ruptured his spleen from the fall, requiring major surgery which resulted in subsequent complications. The plaintiff filed suit in both the Tennessee Claims Commission and the circuit court against the resident, the University, the hospital, the nurse, and the present corporate defendants, alleging claims of medical malpractice and negligent supervision. The liability of the resident and the University was stipulated by the parties in the Claims Commission, and these parties were dismissed from the circuit court proceeding on the basis of immunity. The present defendant corporations remained in the circuit court action. After discovery, the plaintiff moved for summary judgment in the circuit court. The defendant physicians’ corporation moved for summary judgment based upon immunity and the plaintiff’s lack of expert testimony, and the defendant nurse’s corporation moved for summary judgment based upon the plaintiff’s lack of expert testimony. The trial court granted both defendants’ motions for summary judgment and certified the judgments as final. The plaintiff filed a timely notice of appeal to this Court. We affirm.
TN Court of Appeals Upholds Constitutionality of Sanctions Against Physicians Who Fail to Disclose Patient Records Upon Request by the Board
Frank H. McNiel v. Susan R. Cooper - M2005-01206-COA-R3-CV
(Originally filed on March 30, 2007)
Davidson County - This appeal involves the authority of the Tennessee Board of Medical Examiners to review the medical records of a physician’s patients. After the Board requested access to his patients’ records in accordance with Tenn. Code Ann. § 63-1-117 (2004), the physician filed a declaratory judgment action in the Chancery Court for Davidson County challenging the constitutionality of the statute. The physician asserted that the statutory procedure for gaining access to medical records amounted to an unreasonable search and seizure because it failed to provide him with pre-enforcement judicial review of the reasonableness of the Board’s request. He also claimed that the statute’s notice provisions violated due process. Both the physician and the Board filed motions for summary judgment. The trial court concluded that the physician received adequate notice of the purpose of the request for medical records. It also determined that Tenn. Code Ann. § 63-1-117(a)(3), the portion of the statute authorizing disciplinary sanctions against physicians who willfully fail to produce requested records, was unconstitutional and awarded the physician $20,916 in attorney’s fees. The Board perfected this appeal. We concur with the trial court’s conclusion that the physician received adequate notice of the reasons for the request for medical records. However, we have determined that physicians in Tennessee have no reasonable expectation that they can shield their patients’ records from the Board’s regulatory oversight and that the Board may discipline physicians who willfully refuse to comply with lawful requests for patient records that comply with Tenn. Code Ann. § 63-1-117.
(Originally filed on March 30, 2007)
Davidson County - This appeal involves the authority of the Tennessee Board of Medical Examiners to review the medical records of a physician’s patients. After the Board requested access to his patients’ records in accordance with Tenn. Code Ann. § 63-1-117 (2004), the physician filed a declaratory judgment action in the Chancery Court for Davidson County challenging the constitutionality of the statute. The physician asserted that the statutory procedure for gaining access to medical records amounted to an unreasonable search and seizure because it failed to provide him with pre-enforcement judicial review of the reasonableness of the Board’s request. He also claimed that the statute’s notice provisions violated due process. Both the physician and the Board filed motions for summary judgment. The trial court concluded that the physician received adequate notice of the purpose of the request for medical records. It also determined that Tenn. Code Ann. § 63-1-117(a)(3), the portion of the statute authorizing disciplinary sanctions against physicians who willfully fail to produce requested records, was unconstitutional and awarded the physician $20,916 in attorney’s fees. The Board perfected this appeal. We concur with the trial court’s conclusion that the physician received adequate notice of the reasons for the request for medical records. However, we have determined that physicians in Tennessee have no reasonable expectation that they can shield their patients’ records from the Board’s regulatory oversight and that the Board may discipline physicians who willfully refuse to comply with lawful requests for patient records that comply with Tenn. Code Ann. § 63-1-117.
Plaintiff Fails to Show Causation in Medical Malpractice Action
James H. Kelley, Surviving Spouse of Lillie Donnette Kelley, Deceased, et al. v. Middle Tennessee Emergency Physicians, P.C., et al. - M2006-00517-COA-R3-CV
Davidson County- The appeal arises from the summary dismissal of a medical malpractice action against a cardiologist and his cardiology group. The decedent’s surviving family alleges the decedent’s death was the result of medical malpractice. The trial court dismissed the claim finding the plaintiff failed to prove the element of causation as required by Tenn. Code Ann. § 29-26-115 (a)(3) . The plaintiff contends the evidence was sufficient to survive summary dismissal. Finding no error, we affirm.
Davidson County- The appeal arises from the summary dismissal of a medical malpractice action against a cardiologist and his cardiology group. The decedent’s surviving family alleges the decedent’s death was the result of medical malpractice. The trial court dismissed the claim finding the plaintiff failed to prove the element of causation as required by Tenn. Code Ann. § 29-26-115 (a)(3) . The plaintiff contends the evidence was sufficient to survive summary dismissal. Finding no error, we affirm.
Court Orders New Trial in Medical Malpractice Action Due to Unqualified Expert under TCA § 29-26-115(a)(1)
Patrice Allen, et al. v. Methodist Healthcare Memphis Hospitals, et al. - W2006-01558-COA-R3-CV
Shelby County - This is a medical malpractice action in which the jury found in favor of Defendant hospital. Plaintiff asserts Defendant’s expert was not qualified under Tennessee Code Annotated § 29-26-115(a)(1), and that the matter accordingly should be remanded for a new trial. We reverse the trial court’s order denying Plaintiff’s motion for new trial, vacate the judgment on jury verdict, and remand for a new trial.
Shelby County - This is a medical malpractice action in which the jury found in favor of Defendant hospital. Plaintiff asserts Defendant’s expert was not qualified under Tennessee Code Annotated § 29-26-115(a)(1), and that the matter accordingly should be remanded for a new trial. We reverse the trial court’s order denying Plaintiff’s motion for new trial, vacate the judgment on jury verdict, and remand for a new trial.
Surgeon Sues Hospital for Revoking Hospital Priviliges
Joseph C. Curtsinger, Jr. M.D. v. HCA, Inc. - M2006-00590-COA-R3-CV
Davidson County- Surgeon filed action against hospital and other related persons and entities seeking injunctive relief and monetary damages for the allegedly improper revocation of his hospital privileges and the false reporting of such to the State Medical Board and the National Practitioner Data Bank. The trial court granted Defendants partial summary judgment on all monetary claims asserted by surgeon pursuant to the Health Care Quality Improvement Act (HCQIA) and the Tennessee Peer Review Law. Having found that surgeon failed to show by a preponderance of the evidence that Defendants did not satisfy the four prong test for immunity provided under HCQIA, we affirm the decision of the trial court in all respects.
Davidson County- Surgeon filed action against hospital and other related persons and entities seeking injunctive relief and monetary damages for the allegedly improper revocation of his hospital privileges and the false reporting of such to the State Medical Board and the National Practitioner Data Bank. The trial court granted Defendants partial summary judgment on all monetary claims asserted by surgeon pursuant to the Health Care Quality Improvement Act (HCQIA) and the Tennessee Peer Review Law. Having found that surgeon failed to show by a preponderance of the evidence that Defendants did not satisfy the four prong test for immunity provided under HCQIA, we affirm the decision of the trial court in all respects.
Healthcare Research Institutions Receive Immunity
TN HB0640, Pub. Ch. No. 43, extends limited liability to all healthcare research institutions, and employees thereof, for injuries caused in the development, testing, or administration of certain vaccines except in cases of willful misconduct resulting in death or serious bodily injury. - Amends TCA Title 53 and Title 68.
Passed: April 9, 2007
Effective: July 1, 2007
Passed: April 9, 2007
Effective: July 1, 2007
TN New Rules - Medical Necessity 1200-13-16
Rules of Tennessee Department of Finance and Administration Bureau of TennCare
- Chapter 1200-13-16 Medical Necessity
- Chapter 1200-13-16 Medical Necessity
TN New Rules - TennCare Medicaid 1200-13-13
Rules of Tennessee Department of Finance and Administration Bureau of Tenncare
- Chapter 1200-13-13 TennCare Medicaid
- Chapter 1200-13-13 TennCare Medicaid
TN Medical Malpractice Act
Look at the following site for information on the Tennessee Medical Malpractice Act, including related information and RSS feeds.
Promulgation of Regulatory Standards
State and federal regulators, as administrative agencies, are bound by the procedural requirements of the relevant administrative procedures act. The substantive standards developed by the regulatory agency must not be arbitrary and capricious and must fall within the agency’s statutory authority.
Issue of contention: whether rules and standards issued by the agency have legislative effect (requiring notice and comment under § 553 of the Administrative Procedures Act [5 U.S.C.A. § 553]), or are merely interpretative or procedural (which doesn’t require notice and comment)
Plaintiffs may challenge regulatory standards as:
- arbitrary and capricious
- inconsistent with the authority granted the agency by the statute
- unconstitutional delegation of legislative authority to an administrative agency (plaintiffs have generally not succeeded in this approach)
- unconstitutionally vague (question is one of adequate notice) (rarely successful)
Issue of contention: whether rules and standards issued by the agency have legislative effect (requiring notice and comment under § 553 of the Administrative Procedures Act [5 U.S.C.A. § 553]), or are merely interpretative or procedural (which doesn’t require notice and comment)
Plaintiffs may challenge regulatory standards as:
- arbitrary and capricious
- inconsistent with the authority granted the agency by the statute
- unconstitutional delegation of legislative authority to an administrative agency (plaintiffs have generally not succeeded in this approach)
- unconstitutionally vague (question is one of adequate notice) (rarely successful)
The Source of State and Federal Regulatory Power
State Regulation
The source of the state’s power to regulate health care institutions is the police power, which is retained by the states in our federal system. Under the police power, the state’s regulation of health care institutions must further health, safety and the general welfare. In reviewing legislation challenged as lying beyond the scope of the state’s police power, courts will uphold the legislation if its contribution to health, safety and general welfare is at least fairly debatable.
Licensure is the primary mechanism chosen by state legislatures to regulate health care facilities, though certification is also sometimes used. In addition to its regulation of health care providers through licensure, the state also regulates health care providers through the enforcement of the requirements of the federal-state Medicaid program. The state’s authority under Medicaid, however, is dependent upon and subject to the federal authority.
Federal Regulation
While the states have authority to regulate health care facilities under their police power, the federal government’s primary authority arises from its financing authority exercised as purchaser of health care. The federal government, as purchaser, regulates through provider certification. In order to receive payments under Medicare or Medicaid, the major current federal health care programs, an institutional provider must be certified and must sign a provider agreement with the Health Care Financing Administration for Medicare and with the state Medicaid agency for Medicaid.
The source of the state’s power to regulate health care institutions is the police power, which is retained by the states in our federal system. Under the police power, the state’s regulation of health care institutions must further health, safety and the general welfare. In reviewing legislation challenged as lying beyond the scope of the state’s police power, courts will uphold the legislation if its contribution to health, safety and general welfare is at least fairly debatable.
Licensure is the primary mechanism chosen by state legislatures to regulate health care facilities, though certification is also sometimes used. In addition to its regulation of health care providers through licensure, the state also regulates health care providers through the enforcement of the requirements of the federal-state Medicaid program. The state’s authority under Medicaid, however, is dependent upon and subject to the federal authority.
Federal Regulation
While the states have authority to regulate health care facilities under their police power, the federal government’s primary authority arises from its financing authority exercised as purchaser of health care. The federal government, as purchaser, regulates through provider certification. In order to receive payments under Medicare or Medicaid, the major current federal health care programs, an institutional provider must be certified and must sign a provider agreement with the Health Care Financing Administration for Medicare and with the state Medicaid agency for Medicaid.
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The Tennessee Health Law Update is a blog designed to keep track of developments in health law in
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