by Mark Bauman | May 19, 2023 | Health Care Law, Legal News
Act 169 of 2006, which provides a framework for making healthcare decisions on behalf of incompetent adult patients through advance health directives, went into effect on January 29, 2007. The Act allows physicians to initiate, continue, withdraw or withhold medical care based upon instructions contained in a patient’s living will, out-of-hospital do-not-resuscitate order, or by following the directions from a health care agent or health care representative.
Although the living will and out-of-hospital do-not-resuscitate order provisions largely follow existing statutory law, the Act attempts to clearly define the applicable standards and procedures that should be implemented when healthcare decisions for an incompetent adult patient are made by agents appointed through a health care power of attorney or by a health care representative.
An advance healthcare directive is a living will, a health care power of attorney, or a document that combines the features of both a living will and a health care power of attorney. A health care agent is appointed by the patient through a health care power of attorney. A health care representative can be designated by the patient or is authorized to act by default under the law. If a health care representative must be designated through default, the Act prioritizes the list of individuals to be considered. However, a patient of sound mind may modify the default designations or disqualify certain individuals. Additionally, upon petition, a judge may disqualify eligible individuals from being appointed a patient’s health care representative.
For an advance healthcare directive to be valid, it must be made by an adult patient who is of sound mind. It must also be in the form of a written document signed by the patient and two witnesses over 18-years-old. If the patient is unable to sign, the advance directive can be signed by another individual at the patient’s direction; however, neither health care providers nor their agents, including office staff, may sign on behalf of a patient whom they are treating. An exception to the requirement that the advance healthcare directive be in writing applies to the designation of a health care representative. In addition to appointment through a written document, a patient may also appoint a health care representative by personally informing the healthcare provider of the designation. Although a written advance healthcare directive need not be notarized to be valid in Pennsylvania, other states may require notarization. Additionally, advance directives executed under the prior law remain valid and advance directives executed in other states are recognized in Pennsylvania as long as the directions from the health care agent or representative are consistent with Pennsylvania law.
A patient can also change or revoke an advance directive. Changes can only be made if the patient is of sound mind and the changes are executed as stated above. A patient can also revoke an advance directive, but the requirements are different depending on whether the advance directive is a living will or a health care power of attorney. A patient may revoke a living will at any time and in any manner and does not need to be of sound mind to do so. The revocation of a living will is effective immediately upon communication to the health care provider by the patient or by a witness to the revocation. However, for a patient to revoke a health care power of attorney, he or she must be of sound mind and the revocation must be in writing or through personal communication by the patient to the health care provider.
When presented with an advance health directive, the health care provider is required to place a copy of the advance health care directive in the patient’s medical record and to also document any amendments or revocations that take place. If the individual claiming authority to make health care decisions on behalf of the incompetent adult patient is a health care representative, the healthcare provider can require the healthcare representative to produce a written declaration establishing the individual’s authority.
The authority granted to an health care agent or representative under an advance directive depends on the type of directive at issue. A living will is only operative if the patient becomes incompetent and is permanently unconscious or is diagnosed with an end-stage medical condition. However, the authority of a health care agent can be more broad and is defined by the language of the health care power of attorney, which may include all care and not just end of life decisions. Some limited restrictions to the health care agents authority apply in situations involving pregnant women and disabled patients. A health care representative holds authority similar to that of a health care agent except that the direction to withhold or withdraw life-sustaining treatment can only be made if the patient is permanently unconscious or has an end-stage medical condition. Furthermore, a patient of sound mind can countermand or reverse any decision made by a health care agent or representative by informing the health care provider. And a patient, regardless of mental capacity, may countermand the decision to withhold or withdraw life-sustaining treatment by personally informing the health care provider.
Under the Act, a physician must determine whether a patient is incompetent. If the patient is found to be incompetent, or conversely regained competence, it must be documented in the patient’s medical records and, to the extent possible, the patient and patient’s health care agent or representative must be notified. Additionally, a physician must also determine whether a patient is permanently unconscious or have an end-stage medical condition. Again, such a finding must be documented in the patient’s medical records and, to the extent possible, the patient and patient’s health care agent or representative must be notified. Although the Act does not require that the above determination be confirmed through a second opinion, a patient’s advance directive may require such confirmation before becoming effective.
In the event a patient’s advance health care directive becomes effective, the Act defines the obligations a health care agent or representative. The agent or representative’s first duty is to collect information regarding diagnosis and treatment options. Health care decisions for the incompetent adult patient are then made following a prescribed criteria. First, the oral or verbal instructions made by the patient while competent are to be followed. If no such instructions were made or apply, the agent or representative should make any health care decisions based on the patient’s preferences and values, which include religious and moral beliefs. Lastly, the health care decisions made on behalf of the incompetent adult patient should take into account the best interests of the patient.
Although the Act provides that a health care provider must generally comply with the decisions of a health care agent or representative, it also addresses situations where the health care provider has religious or moral objections to the health care decision made by the health care agent or representative or has concerns regarding providing medically inappropriate care. The Act also provides guidance regarding various other issues that may arise when a health care agent or representative must make health care decision on behalf of an incompetent patient such as privacy issues, rules regarding documentation of discussions, disclosures and consents between the health care agent or representative and the health care provider, and special rules regarding artificial nutrition and hydration.
by Mark Bauman | May 18, 2023 | Legal News, Medical Malpractice
An opinion from the Allegheny County Court of Common Pleas helped further shape the Peer Review Protection Act (“the Act”) analysis by focusing on hospitals’ efforts to improve the care they provide in ways that may not involve a traditional committee.
In the underlying matter, the plaintiffs alleged that the patient sustained a deep tissue injury during a hospital admission. After receiving a copy of the incident report, a registered nurse created a chronology of the patient’s treatment based on his medical records and the discussions she had with the physicians involved. Then, with the help of another nurse, she created a re-education plan. The plaintiffs sought both the chronology and the reeducation plan. The defendants, however, contended they were protected because they were created in order to improve care. Judge R. Stanton Wettick, Jr. agreed.
Judge Wettick began with addressing the Act’s purpose of protecting candid evaluations of health care providers, which requires confidentiality to allow for a comprehensive, honest assessment. Documents that contain information that can be found from original sources, such as medical records, are not given the same protections. Original sources are documents prepared solely in connection with the recording events of a patient’s treatment.
Here, however, the original source exception did not apply because the registered nurse testified that it was assumed that she would review any event on her unit, regardless of whether a supervisor directed her to do so. Judge Wettick noted that each document, “was generated for the purpose of evaluating the conduct of the medical staff and, if necessary, re-educating the staff regarding future procedures.” The fact the documents contained some information from original sources did not mean they were discoverable. Moreover, although the Act does not define the term “review organization,” Judge Wettick pointed to the Superior Court’s interchangeable use of the terms “committee” and “individual.” Accordingly, an individual may constitute a review committee on her own. Therefore, Judge Wettick found that both documents fell within the Act’s confidentiality provision based on the nurses’ desire to self-assess and re-educate.
by Mark Bauman | May 18, 2023 | Health Care Law, Legal News
The standards by which the IRS determines whether a worker is classified as an “employee” or an “independent contractor” have been modified. Prior to the modification which was made early in 2006, the IRS used a complex “20 factor” test, which proved difficult to use. In an attempt to simplify the test, the IRS created three primary categories, which encompass 11 factors for consideration.
The three main categories that the IRS now considers are: (1) behavioral control, (2) financial control, and (3) the type of relationship between the health care entity and worker. The behavioral control factor analyzes facts that show whether the business has a right to direct and control. For example, if the business instructs the worker when, where, and how to work, or if they dictate what tools or equipment to use, and what other workers to hire, this tends to show control and indicates that the worker is an employee.
The financial control factor looks for facts that show whether a business has a right to control the business aspects of that worker’s job. For example, an independent contractor is more likely to have expenses that are not reimbursed, and is more likely to have a significant investment in what is needed to get the job done. The third and final category looks to the type of relationship. For this category, the IRS looks for facts that show the parties’ relationship. For example, the IRS will look for a written contract describing the relationship and benefits offered.
The determination of whether a worker is an “employee” or an “independent contractor” is important because the employer-entity is responsible for the withholding and/or paying of several employment taxes, such as federal income taxes, social security and Medicare taxes, and federal unemployment taxes. However, this determination is of even greater significance to those in the health care field because several other agencies (i.e. Office of Inspector General and the Centers for Medicare and Medicaid Services) have adopted the IRS’s definition of “employee.”
Generally speaking, if the status of the worker is questionable, the IRS takes the position that the worker is treated as an employee, as opposed to an independent contractor. However, if an entity would like to receive a determination on the status of the worker, the employer-entity may complete a FORM SS-8, Determination of Worker Status for Purposes of Federal Employment Taxes and Income Tax Withholding, which can be found HERE.
by Mark Bauman | May 17, 2023 | Legal News, Medical Device, Mass Tort and Pharmaceutical Litigation
In its recent decision, Terrell v. Davol, Inc., et al., the Eastern District of Pennsylvania dismissed both a strict liability claim based on a manufacturing defect and a claim alleging a breach of the implied warranty of merchantability for a medical device. In doing so, the Court reaffirmed state court extensions of protections for prescription drugs to medical devices.
The plaintiff in this matter underwent bilateral ventral hernia repair surgery using Marlex Mesh in 1996. Following her surgery, the plaintiff experienced years of abdominal complications that physicians did not link to the mesh until 2011. Finally, during an exploratory surgery, her surgeons discovered that the mesh had adhered to her abdominal wall. Surgeons removed the plaintiff’s appendix and resected part of her bowel in order to remove as much of the mesh as possible. Parts of the mesh had adhesed so densely with the patient’s abdomen that not all of it could be removed.
After learning the root of her medical issues, the plaintiff sued the manufacturers in federal court, alleging that the mesh was “unreasonably susceptible to shrinkage and contraction inside the body” and that prolonged tension allowed the mesh to become deformed. Defendants maintained that despite its risks, Marlex mesh was both safe and reliable. The plaintiff’s complaint included, among others, counts for strict liability based on manufacturing defect and a breach of the implied warranty of merchantability. The Court held that Pennsylvania law bars both these claims.
Although the state Supreme Court and the Federal Court do not always see eye to eye in product liability cases, U.S. District Judge Joel Slomsky relied on the Pennsylvania Supreme Court’s 2014 ruling in Lance v. Wyeth, which declined to extend strict liability to the prescription drug arena to avoid stifling “the incentive to produce new products.” Lance thus propagated the Supreme Court’s original holding in Hahn v. Richer, which originally established this strict liability ban based on the Restatement (Second) of Torts. The Pennsylvania Supreme Court has not yet explicitly ruled whether this prohibition includes medical devices; however, Judge Slomsky noted that the state Superior Court held in 2006 that it does. In turning to the Western District of Pennsylvania, Judge Slomsky quoted the 2004 case Parkinson v. Guidant Corp., which discussed the caveats contained in comment K of Section 402A of the Restatement concerning unavoidably unsafe products. In Parkinson, the Western District held, “the Pennsylvania Supreme Court has ruled that §402A strict liability is precluded entirely for prescription drugs, and, by extension, prescription medical devices.” Judge Slomsky similarly permitted this extension for medical devices and dismissed plaintiff’s strict liability claim.
Likewise, Judge Slomsky pointed to several cases to hold that Pennsylvania law also bars claims based on the implied warranty of merchantability. Generally, purchased goods include an implied warranty that the goods will be fit for their intended use. Judge Slomsky noted that the Pennsylvania Supreme Court had also not yet ruled whether this implied warranty extended to medical devices, but that federal courts had followed an approach set forth in Makripodis v. Merrell-Dow. The 1987 Pennsylvania Superior Court ruling in Makripodis held that prescription drugs should be exempt from the implied warranty of merchantability for the same reasons they were exempt from strict liability claims. Judge Slomsky looked to the progeny of Makripodis and its treatment in federal courts to predict, “the Supreme Court of Pennsylvania would come to the same conclusion with respect to medical devices.”
Despite having two of her claims dismissed, Judge Slomsky allowed the plaintiff’s claims for negligent manufacturing and negligent failure to warn as they were sufficiently pled.
by Mark Bauman | May 17, 2023 | Legal News, Medical Malpractice
In an order issued July 25, 2013, a Philadelphia County Court of Common Pleas judge dismissed a loss of consortium claim raised in a medical malpractice case by a same-sex couple.
The underlying case of Wolf v. Associates of Podiatric Medicine and Surgery was based on damages sustained after a metal object was left in a patient’s foot after surgery. The patient subsequently filed suit with her female partner, who set forth a claim for loss of consortium as a co-plaintiff.
Defense counsel filed preliminary objections, stating that under Pennsylvania law, a loss of consortium claim may only be brought by an individual who is married to the injured plaintiff. According to the defendants, this has been a strict rule throughout Pennsylvania precedent, as courts have traditionally dismissed claims arising out of “nonmarital cohabitation.” Since Pennsylvania law does not currently recognize marriage between same-sex couples, the defendants argued that the co-plaintiffs were not actually married, and that the loss of consortium claim was therefore invalid. While the plaintiffs argued that the consortium plaintiff, much like a married spouse, shared many of the household responsibilities such as child-rearing, payment of expenses, and assisting and comforting her partner, the court concurred with the defendants’ analysis and dismissed the loss of consortium claim.
by Mark Bauman | May 16, 2023 | Legal News, Medical Malpractice
A Court of Common Pleas judge in Monroe County granted a hospital’s protective order in part, holding that Plaintiffs may inquire about statements made by a medical quality officer to a patient concerning inconclusive results from peer-review proceedings. Plaintiffs, however, are prohibited from questioning the officer about any peer-review materials and discussions. Judge Arthur L. Zulick further held that discussing peer-review conclusions with patients does not waive the confidentiality afforded by the Peer Review Protection Act (“the Act”) to review committees.
The underlying case involved a surgery that resulted in the patient losing his left kidney. Following the hospital’s internal investigation, its chief medical quality officer met with the plaintiffs to discuss the review committee’s opinion as to what transpired during the patient’s operation. Once the suit began, Plaintiffs noticed the officer’s deposition, and the hospital responded with a motion for protective order in which it argued that the plaintiffs should be prevented from asking about the hospital’s internal review proceedings. Plaintiffs in turn contended that the chief medical quality officer’s meeting with the plaintiffs waived the Act’s confidentiality provision and thus rendered the review materials and discussions discoverable. Judge Zulick found otherwise.
Judge Zulick relied on the Superior Court’s ruling in Dodson v. DeLeo, 872 A.2d 1237 (Pa. Super. Ct. 2005) in making his ruling. In that case, the Superior Court overturned a trial court’s decision that had held that a defendant physician’s credentialing reports were not protected by the Act because that information could be found elsewhere in the patient’s medical records. In finding that the reports were indeed within the Act’s scope of protection, the Superior Court stated that “[holding] otherwise would have a chilling effect on the peer review process and would clearly run afoul of the purpose of the statute.” Id. at 1244.
As the Dodson court described, the Peer Review Protection Act was promulgated in 1974 to “facilitate comprehensive, honest, and potentially critical evaluations of medical professionals by their peers.” Id. at 1242. The Act further reflects the legislature’s determination that, “because of the expertise and level of skill required in the practice of medicine, the medical profession itself is in the best position to police its own activities.” Id. (quoting Young v. The W. Pa. Hosp., 722 A.2d 153 (Pa. Super. Ct. 1987)). As such, the Act states in relevant part that “proceedings and records of a review committee shall be held in confidence and shall not be subject to discovery or introduction into evidence in any civil action against a professional health care provider.” 63 P.S. § 425.4.
In the matter before Judge Zulick, he found that the facts before him paralleled those in Dodson. Accordingly, he held that allowing discovery of the hospital’s entire peer-review materials would undermine the Act’s intentions of safeguarding health care professionals’ ability to police themselves and conduct root cause analyses, morbidity and mortality meetings, and other confidential investigations in order to promote patient safety. Notwithstanding that finding, the plaintiffs were free to question the chief medical quality officer about his statements to them concerning the review’s determination.
