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 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 Device, Mass Tort and Pharmaceutical Litigation
In US v. Caronia, 703 F. 3d 149 (2d Cir. 2012), a pharmaceutical sales representative, Alfred Caronia, appealed a judgment of the United States District Court for the Eastern District of New York, which convicted him of conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act (FDCA). Caronia contended that he was convicted for his promotion of the off-label use of an approved prescription drug (Xyrem). According to Caronia, he was convicted for his speech, in violation of this right to free speech under the First Amendment.
The United States Court of Appeals for the Second Circuit, in an opinion authored by Circuit Judge Denny Chin on December 3, 2012, agreed with Caronia and vacated the judgment of conviction. In reaching this decision, the Court reviewed and considered the Supreme Court’s opinion in Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).
In determining whether there was speech restrictions on pharmaceutical marketing, the Court in Sorrell engaged in a two-step inquiry. First, the Court considered whether the government regulation restricting speech was content- and speaker-based. If it was, the regulation was subject to heightened scrutiny and “presumptively invalid.” The second prong the Court considered was whether the speech was protected by the First Amendment.
In applying this inquiry in Caronia, the Court determined that the FDCA’s misbranding provisions to prohibit off-label marketing is both content-based and speaker-based, and thus, subject to heightened scrutiny. The second prong required applying a four-part test, originally set forth in Central Hudson v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980). More specifically, in order to warrant First Amendment protection: (1) the speech in question must not be misleading and must concern lawful activity, (2) the asserted government interest must be substantial, (3) the regulation must directly advance the governmental interest asserted, and (4) the regulation must be “narrowly drawn” and may not be more extensive than necessary to serve the interest.
Although the majority found that the government’s construction of the FDCA as prohibiting off-label marketing meets the first two parts of the Central Hudson test, the majority found that it does not withstand scrutiny under the third or fourth part. Thus, the majority held that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Circuit Judge Debra Ann Livingston, finding, among other things, that the third and fourth part of this test was met, filed a vigorous dissent.
by Mark Bauman | May 13, 2023 | Legal News, Medical Device, Mass Tort and Pharmaceutical Litigation, Uncategorized
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.
by Mark Bauman | May 12, 2023 | Legal News, Medical Device, Mass Tort and Pharmaceutical Litigation
The Supreme Court of the United States heard argument in several pharmaceutical cases involving the issue of failure to warn consumers about the risks of certain drugs. The petitioners are generic drug manufacturers. The respondents are individual plaintiffs asserting state law failure to warn claims against the generic drug manufacturers. The United States, as amicus curiae, supports the respondents.
The petitioners are facing state law claims that the labels they are using fail to properly warn consumers about the risks associated with the use of their drugs. Several circuit courts of appeal held that the plaintiffs could pursue state law claims because federal law did not preempt those claims.
In front of the Supreme Court, the petitioners argued that respondents cannot pursue state law claims because federal law preempts the state law claims. According to the petitioners, federal law requires generic drugs to have the same warnings as their brand name equivalent drugs. Petitioners concede that they, and all generic drug manufacturers, have a duty to disclose to the Food and Drug Administration adverse results from the use of their drugs. However, since the Hatch-Waxman Amendments require generic drug manufacturers to have the same warnings as their brand name equivalent, generic drug manufacturers do not have a duty to request a change in the language being used on the label. This area, according to petitioners, is under the exclusive authority of the Food and Drug Administration, which is a federal agency. Therefore, state law claims are preempted as the Food and Drug Administration is the agency that controls disclosure of information and warnings provided by drug manufacturers.
Respondents argued that federal law does not preempt the state law claims because petitioners did not submit requests to the Food and Drug Administration to change the labels that were being used by the brand name equivalent drugs. Had petitioners submitted a request to change the labels and the Food and Drug Administration affirmatively rejected the request, then, according to respondents, the state law claims would be preempted. In other words, respondents contend that petitioners had a duty to request a change in the language used in the label and the Food and Drug Administration had to act upon that request before petitioners could assert preemption as an affirmative defense. According to respondents, state law requires an adequate warning to be provided to consumers and if the warning is inadequate, state law requires the petitioners to pursue a change in the label. Since petitioners failed to request a label change, state law still applies to respondents’ claims.
The United States, in support of respondents, argued that the Hatch-Waxman Amendments were designed to facilitate the entry of generic drugs into the market. The Amendments were not designed to absolve a manufacturer of its responsibilities to maintain the safety of the drug and the adequacy of the label after the drug has been entered into the market. According to the United States, there is no conflict between state and federal law until the Food and Drug Administration rejects a request for a label change. It is at that point that preemption would apply. However, until the conflict between state and federal law comes into play, there is no preemption and respondents should be allowed to pursue their state law claims.
