On April 5, 2022, attorneys Michael Pitt and Mary Kay Plyter-Eigner received a defense verdict on behalf of an anesthesiologist and pain management physician after a one week trial in Montgomery County. Plaintiff alleged that her epidural steroid injection was performed using a steroid with preservatives and that the epidural needle entered the thecal sac, causing her to suffer chemical meningitis, manifesting as significant migraine headaches and associated symptoms. The evidence supported the defense that Plaintiff had a significant pre-existing headache condition and that the procedure was performed properly using a well-known, widely used and accepted steroid medication. After four days of evidence and closing arguments, the jury deliberated for an hour and a half, finding for the defendant anesthesiologist.
According to statistics recently published by the Administrative Offices of Pennsylvania Courts, 1,508 medical malpractice cases were filed in Pennsylvania in 2012, down 167, or approximately 10%, from the previous year.
This number represents a 44.8% decline from the average number of filings seen from 2000 to 2002, which was right before the Supreme Court’s enactment of several reforms aimed to curtail medical malpractice filings across Pennsylvania. These reforms consisted of requiring such cases to be brought in the venue where the cause of action arose, and a certificate of merit from a medical professional to be obtained prior to filing.
Overall, 133 cases were tried to verdict throughout Pennsylvania, with a total defense verdict rate of almost 80%. Of those cases, 27 were tried in Philadelphia County, with 14 being found in favor of the defense, representing a defense verdict rate of 52%. A 100% defense verdict rate was seen in Montgomery and Chester Counties, which tried 19 and 7 cases, respectively. 6 of 8 cases tried in Delaware county found in favor of the defense, representing a 75% defense verdict rate. Allegheny County saw 10 cases tried to verdict, with 9 finding in favor of the defense.
A comparison of the year-to-year filings in Pennsylvania’s largest counties is as follows:
In an opinion authored on May 17, 2012, by the Honorable Eduardo C. Robreno, Jr., the United States District Court for the Eastern District of Pennsylvania held that under Pennsylvania law, strict liability cannot be imposed on manufacturers of prescription medical devices.
The underlying case of Kee v. Zimmer, Inc., 817 F. Supp. 2d 405, 89 A.L.R. 6th 785 (E.D. Pa. 2012), involved a plaintiff who underwent knee replacement surgery in both knees for treatment of arthritic pain. Integral to the surgeries was a medical implant device manufactured by defendant. Following the surgery, plaintiff experienced persisting knee pain secondary to a loosening of the implant’s component parts. As a result, plaintiff was forced to undergo a revision surgery to correct the implant.
Plaintiff subsequently brought suit against the defendant manufacturer, alleging defective design, failure to warn, negligent design and manufacture, and fraud. Pursuant to diversity jurisdiction, defendant removed the case from Pennsylvania state court to the Eastern District of Pennsylvania. Thereafter, defendant moved for dismissal of all non-negligence claims, including those sounding in strict liability, pursuant to comment k of the Restatement (Second) of Torts § 402A.
On review of defendant’s motion, the Court noted that while Section 402A imposes strict liability on sellers of “unreasonably dangerous products,” an exception is provided for those products which are designated as “unavoidably safe.” Specifically, the Court drew upon the articulation of this exception within Pennsylvania state law, in particular its application to prescription drugs, noting that “where the adequacy of warnings associated with prescription drugs is at issue . . . the manufacturer’s negligence is the only recognized basis of liability.” n v. Richter 3 A.2d 888 (Pa. 1996).
According to the District Court, while the Supreme Court of Pennsylvania had not yet extended the Section 402A exception to prescription medical devices, the Pennsylvania Superior Court, as well as many courts outside Pennsylvania, had already done so. The Court thereby found such precedent sufficient to conclude that “as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices.” Notably, in recognizing what it termed as a “blanket exception” within Section 402A, the Court refused to allow for a “case-by-case, product-by-product analysis” to determine whether the medical device at issue was unavoidably unsafe. Thus, defendant’s motion was granted and plaintiff’s claims for strict liability were dismissed.
In an opinion issued on April 18, 2012, District Judge Arthur J. Schwab of the United States District Court of the Western District of Pennsylvania ruled that a plaintiff’s claim under Pennsylvania’s Unfair Trade Practices Act and Consumer Protection Law (UTPCPL) was sufficiently pled to withstand defendant’s motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6).
The underlying case, Schiff v. Hurwitz, M.D., et al., involved a patient plaintiff who underwent plastic surgery at the hands of the defendant physician who maintained an office in Pittsburgh, Pennsylvania. During the initial consultation with plaintiff on April 23, 2009, defendant planned that the forthcoming surgery would be performed in two stages consisting of a “tummy tuck” and a lower body lift, respectively. However, at this time, according to plaintiff’s complaint, defendant did not discuss or document the potential risk of the device to be used in these procedures: a Radio Frequency Assisted Lipolysis (RFAL).
Almost one year later, on March 2, 2010, plaintiff presented to defendant again for placement of pre-operative markings. Again however, plaintiff alleged that the specific risks of the procedure were not discussed. The following day, defendant performed the first stage of the procedure using the RFAL device. Notably, while plaintiff was presented with an informed consent document prior to the procedure, plaintiff averred that this form was not reviewed by defendant and the risks and alternatives were not discussed. According to plaintiff’s complaint, plaintiff also happened to be unaware at this time that defendant was a paid investigator for the RFAL device, and that the device was being used for his surgery as part of a non-FDA approved clinical trial.
On March 9, 2010, approximately six days following the surgery, plaintiff began to experience pain in the areas in which the surgery had been performed. Even with prescribed medication, plaintiff alleged that the pain was uncontrollable, and that as a result of the procedure, he had been left with scarring and a residual demylinating condition.
On review of defendant’s motion to dismiss pursuant to F.R.C.P. 12(b)(6), the court noted that under the Federal Rules, plaintiffs bringing a claim are required only to provide “a short plain statement of the claim showing that [the plaintiff] [is] entitled to relief . . . .” Recognizing that there was no Pennsylvania Supreme Court precedent which applied the UTPCPL to plaintiff’s claims, the court nonetheless acknowledged that the UTPCPL was intended to protect the public and “eradicate unfair and deceptive business practices” by “plac[ing] consumers and sellers on equal terms.” Accordingly, under the UTPCPL, a plaintiff “must show that she justifiably relief on defendant’s wrongful conduct or representations and that [they] suffered harm as a result.”
With regard to plaintiff’s complaint, the court determined that such “deceptive conduct” was encompassed in the affiliation, connection, and association which defendant had with the RFAL device and its manufacturers, as well as plaintiff’s unawareness of the clinical trial with which he had been involved. Thus, because the complaint contained allegations that defendant had failed to warn plaintiff of the risks regarding the RFAL device, and that defendant misrepresented that the clinical trial had been FDA-approved, the court held that plaintiff had made a valid claim under the UTPCPL, and accordingly, denied defendant’s motion.
Back L to R: M.Schwartz, M. Pitt, D. Ryan, M. Martillotti, A. DeMichele, H. Hansen Front L to R: T. Vizza, B. Littman, D. Duffy, J. Brien, A. O’Dea
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