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.
The PA Superior Court has held that a hospital waived the attorney-client and work-product privilege by forwarding correspondence written by their counsel regarding the naming of the doctor accused of performing medically-unnecessary stents, to a public relations firm the hospital hired to manage the public announcement concerning the overuse of stents.
In BouSamra v. Excela Health, 2017 PA Super 66 (Pa. Super. Ct. Mar. 13, 2017), the hospital hired an outside peer review organization to evaluate the stent utilization by physicians at the hospital. The organization’s report revealed that appellee doctor had performed unnecessary stent implants and the doctor subsequently heard about the report and resigned before his staff privileges were suspended. A second outside peer review corporation, hired by the hospital concluded that the doctor had overestimated arterial blockage and inappropriately treated mild narrowing with stents. The hospital then publicly announced the results and informed the affected patients.
The doctor sued alleging that the two peer review proceedings were pretextual and conducted in bad faith and assisted intentional interference with an existing and potential contractual relationship with defamation. During the discovery phase, appellee doctor sought production of documents related to planning and reasoning on the disclosure to the media of the peer review reports and naming the doctor. The hospital objected on attorney-client privilege and work-product doctrine grounds.
The doctor learned that a principal of the public relations firm hired by the hospital had received a letter written by outside counsel for the hospital concerning the public naming of the doctor. The doctor filed a motion to compel and the discovery master held that the attorney-client privilege applied. The doctor subsequently filed exceptions to the master’s ruling and the trial court held that the hospital had waived the attorney-client privilege by disseminating the letter to a third party – the public relations firm. The hospital appealed.
The hospital’s reliance on United States v. Kovel, 296 F.2d 918 (2d Cir. 1961) failed because the hospital could not show that the public relations firm was hired to aid in rendering legal advice on whether the doctor could be named or not. The hospital also failed to show that the public relations firm was an agent of the attorney and gave legal advice. The work product privilege was also waived by disclosing the correspondence to a third party, the public relations firm.
The state Supreme Court recently held that arbitration agreements that include a clause specifically designating the National Arbitration Forum as sole arbitrator are invalid. In Wert v. Manorcare of Carlisle PA, LLC,[1] Evonne Wert, on behalf of the decedent, signed an arbitration agreement along with admission paperwork upon admission to Golden Living Center. Following the decedent’s death, her daughter brought a medical malpractice claim against the nursing home alleging abuse and neglect inflicted upon the decedent throughout her stay, which eventually resulted in her death. Golden Living Center filed preliminary objections seeking to enforce the arbitration agreement; however, the trial court overruled the preliminary objections finding that the agreement was unenforceable because it relied, in part, on the National Arbitration Forum (NAF) Code procedures, which were void at the time with respect to consumer arbitration disputes. Golden Living Center appealed the decision arguing that the NAF provision was not integral to the agreement at issue. In reviewing the testimony, the Superior Court found that the arbitration agreement was signed under the belief that all the paperwork needed to be signed in order for the decedent to obtain treatment and care. Therefore, the Superior Court found that the NAF provision was an integral to the agreement and affirmed the trial court’s ruling. Golden Living Center filed a petition for allowance of appeal to the Pennsylvania Supreme Court, which was granted.
On appeal, Golden Living Center argued that the NAF provision of the agreement was ancillary and severable based upon the plain text of the agreement, terms and policy guidelines of the Federal Arbitration Act, and testimony of the plaintiff. They further argued that while the agreement merely agreed to the NAF code of procedure, it did not make the participation of the NAF forum itself essential, i.e., the arbitration could be conducted in any forum, by an agreed upon arbitrator, so long as the NAF code of procedure mandated the proceedings. Further, Golden Living Center argued that the Federal Arbitration Act (FAA), which was incorporated into the agreement, should have been invoked to appoint a replacement arbitrator.
Ms. Wert argued that the NAF provision of the agreement was essential to the agreement because, by its own terms, only the NAF can administer its rules and procedures, therefore making NAF the sole forum of arbitrations under the agreement. She further argued that the FAA section referenced by Golden Living Center is limited to the appointment of an alternative arbitrator, not an alternative arbitration forum and cannot supersede the terms of the agreement.
Justice Stevens wrote the opinion for a plurality of the court. The Court first found that Ms. Wert’s testimony regarding her understanding of the agreement was irrelevant as her failure to read the agreement did not implicate the importance of its NAF provision. The court found that, “premising the integrality of a contractual term on the subjective understanding of a far less sophisticated non-drafting party is ill-advised public policy that would further distort an already lopsided balance of power.”[2] Further, the court noted that a non-drafting party could not use her failure to read as a means of disavowing an otherwise valid arbitration agreement.[3] The court held that because the agreement did not make the NAF’s availability non-essential by specifically varying the terms of the agreement to appoint a replacement arbitrator should there be a lapse in naming an arbitrator, the FAA did not apply to do the same. Further, the court found the agreement unambiguous and, by its own terms, specified that the NAF must administer its code unless the parties agreed to the contrary, which the they did not do in this case. Therefore, the court affirmed the Superior Court’s ruling and remanded for further proceedings.
Justice Eakin wrote a dissenting opinion in which he found that the NAF’s Code of Procedure could have been applied in this case as it is still in existence even though the NAF no longer accepted arbitrations. He found that, even if the NAF provision was found to be unenforceable, the remainder of the agreement should have been enforced and the parties should have been bound to arbitrate the underlying lawsuit by an agreed upon arbitrator applying the NAF Code.
Justice Baer also wrote a dissenting opinion stating that the court’s holding was contrary to the plain language of the agreement, which provided that disputes be adjudicated in binding arbitration, not in the court system. Like Justice Eakin, Justice Baer found that the agreement to arbitration in accordance with the NAF Code of Procedure was valid, even without the NAF’s availability to serve as arbitrator.
The court’s ruling further subjects nursing home arbitration agreements to scrutiny and indicates a necessity for clear and unambiguous language in order for courts to enforce such agreements against non-drafting parties.
Each year, on a state-by-state basis, Super Lawyers selects attorneys using peer nominations and evaluations along with third party research. Each candidate is evaluated on 12 indicators of peer recognition and professional achievement, and those selected represent the top five percent of the total lawyers in each state.In 2022, five OBR partners were selected to PA Super Lawyers & four associates were selected to the Rising Stars list.
In an opinion authored by the Honorable J. McLaughlin, the Superior Court of Pennsylvania recently vacated an entry of summary judgment based on The Medical Care Availability and Reduction of Error Act’s (“MCARE”) equitable tolling of the statute of limitations provision.
In Reibenstein v. Barax, et al.[1], Ms. Whitman (“Decedent”) passed away on April 28, 2010 as a result of a ruptured abdominal aortic aneurysm. Five days prior to her death, at the request of her primary care physician, Dr. Conaboy, Decedent underwent a CT scan. The scan was reviewed by Dr. Barax who prepared a report stating that Decedent had an abdominal aortic aneurysm that was poorly visualized. Dr. Barax did not document an aneurysm rupture or concern of possible rupture. Dr. Barax’s report stated that Dr. Conaboy was contacted with the study and findings. One year after Decedent’s death, the adminstratrix of Decedent’s estate, Ms. Reibenstein, commenced an action against Dr. Barax and his employer asserting causes of action under the Wrongful Death Act and Survival Act. During his deposition, Dr. Barax testified that he spoke with Dr. Conaboy and explained to him that the CT scan showed a previously undocumented abdominal aortic aneurysm, but he could not visualize the aneurysm very well and he could not confirm that it was not bleeding or rupturing. Based on Dr. Barax’s testimony, Ms. Reibenstein initiated a sperate action against Dr. Conaboy and his practice. The trial court consolidated the two cases.
MCARE provides a statute of limitations requiring a claimant to commence a wrongful death or survival action asserting a claim for medical professional liability claim within two years of death[2]. However, the statute of limitations is subject to equitable tolling for affirmative misrepresentation or fraudulent concealment of the cause of death[3].
The Conaboy defendants sought summary judgment citing the general two-year statute of limitations for personal injury actions and argued that the discovery rule did not apply. The trial court granted summary judgment in favor of the Conaboy Defendants, concluding that the action was commenced more than two years after death and there was no evidence of affirmative misrepresentation or fraudulent concealment of the cause of death. Reibenstein filed a timely appeal arguing that the trial court erred in granting summary judgment on the ground that pursuant to MCARE, the statute of limitations governing Reibenstein’s wrongful death claim against Dr. Conaboy could be equitably tolled.
Reibenstein argued that Dr. Barax’s concealment of his communication with Dr. Conaboy concerning Decedent’s aneurysm was directly related to the cause of death and therefore, based on MCARE, the two-year statute of limitation should have been equitably tolled. Reibenstein asserted that MCARE does not define “cause of death” or explain how a defendant must conceal the cause of death for equitable tolling to apply. Therefore, according to Reibenstein, the phrase affirmative misrepresentation or fraudulent concealment of the cause of death should encompass those acts that were part of the chain of causation leading to the patient’s death. In response, Conaboy asserted that because Decedent died of a ruptured abdominal aortic aneurysm, and because it was recorded as the cause of death on her death certificate, the statute of limitations may not be tolled.
The Superior Court explained that “cause of death” was not defined by MCARE. Further, “cause of death” could mean the immediate, medical cause of death, such as is ordinarily listed on the decedent’s death certificate, or “cause of death” could also mean the conduct leading to the decedent’s death but that is not the immediate medical cause of death. As both interpretations of “cause of death” were reasonable, the Superior Court found Section 1303.513(d) of MCARE to be ambiguous as to the meaning of “cause of death”.
The Superior Court then turned to the Statutory Construction Act[4] to resolve the ambiguity. The stated purpose of MCARE is to insure, inter alia, that high quality health care is available and to provide a person who has sustained injury as a result of medical negligence by a healthcare provider with fair compensation, while controlling the costs of medical malpractice insurance rates[5]. Subsection 1303.513(d) of MCARE is the statute of limitations for medical professional liability wrongful death and survival actions. In drafting this statute of limitations, the Pennsylvania General Assembly included a provision to allow for the equitable tolling of the two-year period in cases where there has been affirmative misrepresentation or fraudulent concealment of the cause of death. The General assembly included the equitable tolling provision to protect patients who have pursued their rights, and despite this, extraordinary circumstances prevent them from bringing a timely action. In such extraordinary circumstances, the restrictions imposed by the statute of limitations does not further the statute’s purpose.
The General Assembly’s inclusion of such an exception recognizes that wrongful death and survival actions may involve situations where the patient’s interest in fair compensation outweighs the interest in limiting malpractice insurance costs. Therefore, it is in the furtherance of the purpose of fair compensation that the Superior Court interpreted affirmative misrepresentation or fraudulent concealment of the cause of death to encompass those acts which caused the patient to die. Where a medical practitioner hides an action that was directly related to the cause of the patient’s death, the Commonwealth’s interest in redress outweighs the interest in controlling the cost of medical malpractice insurance. The Superior Court held that affirmative misrepresentation or fraudulent concealment of the cause of death means affirmative misrepresentations about or fraudulent concealment of conduct that a Plaintiff alleges led to the Decedent’s death.
The Superior Court in Reibenstein noted that the trial court, in its order granting summary judgment to the Conaboy Defendants, held that because Decedent died of an abdominal aortic aneurysm, and the death certificate listed aortic aneurysm as the cause of death, Reibenstein was not entitled to equitable tolling of the statute of limitations. Based on section 513(d) of MCARE, the Superior Court was constrained to conclude that the trial court erred in concluding that Reibenstein’s claims were barred by the statute of limitations, and therefore erred in granting summary judgment in favor of the Conaboy Defendants.
[1] Reibenstein v. Barax, et al., 2020 Pa. Super 179.
