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.
by Mark Bauman | May 16, 2023 | Legal News, Medical Device, Mass Tort and Pharmaceutical Litigation
The United States District Court for the Middle District of Pennsylvania recently dismissed a “failure to warn” case against a drug manufacturer, holding that the manufacturer was not required to provide physicians with detailed instructions about the monitoring of signs and symptoms that were related to the drug’s potential side effects.
The underlying case, Bergstresser v. Bristol-Myers Squibb Co., No. 12-1464 (M.D. Pa. 2013), involved a patient who was prescribed Abilify by his psychiatrist for ongoing depression. After his psychiatrist increased the dosage, the patient developed a neurological disorder known as dystonia, which is characterized by symptoms of involuntary muscle contractions and abnormal posturing.
In May 2013, the patient filed suit against Abilify’s manufacturer, Bristol-Myers Squibb Co. The complaint alleged that the label for the drug was deficient, as it failed to provide instructions to physicians on how to monitor for signs and symptoms of dystonia. The plaintiff also claimed that the label failed to provide directions to physicians on how to properly increase or decrease a patient’s dose of Abilify, so that the development of dystonic symptoms could be avoided.
Counsel for Bristol-Myers Squibb filed a motion to dismiss plaintiff’s claim, which was subsequently granted by the court. In its opinion, the court found that the label for Abilify actually did “identify the contraction of dystonia as a possible reaction to taking Abilify.” However, because this condition was listed only as a potential “adverse reaction,” the court held that the label was not required to include instructions pertaining to the monitoring of dystonic side effects. Rather, with regard to patient monitoring, the court stated that only the “most clinically significant information” had be included in the label.
In support of its holding, the court also relied on the doctrine of the learned intermediary, noting that a drug manufacturer’s duty to the consumer may be discharged if the manufacturer provides a proper warning to the consumer’s physician. Recognizing that “judgments as to specific monitoring are better left to the physicians’ discretion,” the court thereby concluded that the manufacturer was not required to provide such detailed information as alleged by plaintiff. According to the court, to do so would essentially supplant the medical judgment of the physician, who the court deemed to be “in the best position to monitor and treat [his or her] patient.”
by Mark Bauman | May 15, 2023 | Legal News, Medical Malpractice
In an opinion filed June 11, 2013, a three judge panel of the Commonwealth Court of Pennsylvania affirmed the State Board of Medicine’s imposition of civil penalties upon a physician for failure to maintain medical records as required by the Medical Practice Act of 1985.
In the underlying case, a physician contracted with a commercial company for the purpose of reviewing online prescription requests. Under the terms of the contract, from 2009 to 2011, the physician filled the requests based on online questionnaires completed by customers of the company. The questionnaires set forth information such as the reason for the request and the patient’s medical history. Additionally, the company also provided the physician with access to an online database that contained copies of the patients’ medical records.
During the course of his contract, the physician conducted his reviews solely from the online documents and did not print or retain in his own personal office any of the patients’ medical records, questionnaires, or files.
In April 2011, the State Board of Medicine issued an order to show cause alleging that the physician had engaged in unprofessional conduct by failing to maintain medical records relating to the patients for whom he filled prescriptions. Under the relevant provisions of the Medical Practice Act of 1985, a physician is required to “maintain medical records for patients which . . . reflect the evaluation and treatment of the patient.” 63 P.S. 422.1-422.51(a). Because the physician did not personally keep his own medical records with regard to his patients, the Board alleged that he violated the Act and in turn, imposed a $2,500 civil penalty. The physician was also required to complete ten hours of continuing education in the area of medical recordkeeping.
The physician subsequently appealed to the Commonwealth Court, stating that the Board misinterpreted the portion of the Act which addressed the maintenance of patient medical records.
On review, the court affirmed the Board’s order, holding that the pertinent section of the Act could reasonably be interpreted to require the physician to have “possession” of his patient’s medical records. While the physician argued that the Board’s interpretation of the Act ignored the realities of modern medical practice “where the employers and not the physicians maintain patient medical records,” the court noted that such circumstances were already contemplated by the Act, as part a provision excusing this requirement where the records “are retained by a health care facility.”
