Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
PA Court Declines to Apply 'Heeding Presumption' to Pharmaceutical Failure-to-Warn Cases
Last December, the Pennsylvania Superior Court handed a sharp blow to pharmaceutical liability plaintiffs' lawyers in the state who have consistently argued that a 'heeding presumption' should apply to their failure-to-warn claims and, in effect, relieve them of the burden of proving causation. A unanimous three-member panel upheld the decision of the trial court awarding summary judgment to the defendant because the plaintiff 'presented no evidence that a different warning would have changed [the prescribing physician's] decision to prescribe [the drug at issue] for Appellant.' Lineberger v. Wyeth, 2006 PA Super. 35, at *24 (Pa. Super. Ct., Feb. 23, 2006). Relying on the appellate court's 1996 decision in Demmler v. Smith Kline Beecham, 671 A.2d 1151 (Pa. Super. Ct. 1996), the panel reasoned that failure-to-warn claims in the pharmaceutical context require the plaintiff to come forward with evidence showing that the alleged inadequate warning was the proximate cause of the resultant injury in order to state a prima facie case. Id. at *12, 23-24. Evidence that the manufacturer breached its duty to warn the medical community of the risk of harm associated with its product is insufficient in and of itself to impose liability on the manufacturer, the Pennsylvania appellate court explained, because under the standard articulated in Demmler, proximate cause is not presumed. Id. at *23. Hence, traditional negligence principles prevail in drug liability cases in Pennsylvania ' pharmaceutical plaintiffs cannot get their case before a jury unless they are able to make a prima facie showing as to each element of their negligence claims, including proximate cause.
Pennsylvania, like the majority of states, recognizes the 'learned intermediary doctrine' in all claims involving prescription drugs. See Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971). The learned intermediary doctrine operates to direct the pharmaceutical manufacturer's duty to warn to the prescribing health care professional, who, by virtue of specialized training and expertise, is uniquely qualified to decide whether the patient is an appropriate candidate for treatment with any given pharmaceutical drug. Id. at 220. Under this doctrine, there is no duty on the part of the pharmaceutical manufacturer to warn individual patients of the risks of harm attendant to the use of its drugs. Id.
In ruling that the 'heeding presumption' does not apply to pharmaceutical failure-to-warn cases, the trial court in Lineberger relied heavily on the fact that in Pennsylvania, theories of liability are predicated on negligence principles alone; the appellate court did not disturb this reasoning. See Lineberger, 72 Pa. D.&C.4th 35, 39 (Pa. Com. Pl. Ct. 2005); aff'd, 2006 PA Super. 35. Negligence, not strict liability, provides the exclusive basis for imposing liability on a drug manufacturer in Pennsylvania. Id. at *25 (affirming the trial court's grant of summary judgment). The liability inquiry in negligent failure-to-warn claims, therefore, centers on the reasonableness of the conduct of the manufacturer as it relates to the warning and its adequacy, ie, what the manufacturer knew or should have known about the drug's dangers at the time the plaintiff ingested the drug, and how that information was conveyed to the learned intermediary. Conversely, the primary focus in strict liability warning claims ' ie, the dangerousness of the drug risks in question relative to the drug's beneficial effects ' has little if any relevance in the liability analysis employed in negligent failure-to-warn cases.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?