[Plaintiffs] challenge the trial court's determination that their strict liability claim is barred by Restatement 2d of Torts section 402A, comment k. . . . [T]he trial court applied this section to the [medical device], citing our Supreme Court's decision in Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 890-91 (1996), in which the high court adopted comment k, to conclude that strict liability could not be applied to prescription drugs where adequate warnings of the drugs’ potential risks had been provided. In applying comment k here, the trial court reasoned that given the potential utility of [medical devices], no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn. The court concluded accordingly that strict liability could not be a basis for liability in this case. [Plaintiffs] contend that the trial court misconstrued Hahn, and that comment k does not apply to medical devices because the comment text does not mention them. They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.903 A.3d 30-31 (various citations omitted) (emphasis added).
Determining the product’s intended purpose is critical to the court’s legal conclusions about whether the product can be deemed defective. . . . [T]he intended use of a product is a conclusion of law, to be decided by the trial court. In other words, the trial court is not bound by any party’s legal conclusions as to the intended purpose of a product, even if those conclusions are couched as averments of fact or presented as expert evidence. To hold otherwise would force trial courts (and reviewing courts) to accept unrealistic, generalized, or distorted views of a product’s purpose simply because they are presented as factual evidence.774 A.2d at 773 (emphasis added). An inescapable fact of life where metallic implants are concerned is that, when a patient’s bones do not fuse together as expected, the metal will suffer fatigue from the body's repeated stress on it and eventually break. The more fatigue, the faster the break. The two most fatigue-prone areas of the body are the lower spine, and the hip – since they not only support the body’s full weight, but also anchor the biggest muscles in the body, which allow us to sit up, and to stand upright.
All parties agree that the [device] is designed to stabilize the spine “until” fusion takes place. It is also undisputed that the [devices] generally do stay in place forever if fusion takes place. Appellants would convert these statements of fact into a conclusion of law that the [device] is defective if it breaks before fusion takes place. . . . The trial court concluded that the [device] was never intended to last indefinitely in the absence of fusion. . . . We see no error of law in this statement of the [device’s] intended purpose. [Plaintiffs] presented no evidence that the [device] was intended to stabilize the spine indefinitely in the case of [non-union]. . . . Based on the trial court’s appropriately-limited statement of the [device’s] purpose. . ., we see no error in the court’s conclusion that the product was not unreasonably dangerous as a matter of law. JNOV was therefore appropriate.774 A.2d at 774-75 (emphasis added).
- “[W]e see in this particular case is those screws broke before [the hip healed] and, therefore, it was ineffective in doing its job.” 2011 WL 3524286, at *4.
- When we put an internal device. . ., what we’re saying is that – whatever we put in has to hold it together until the body takes over the job.” Id. at *5.
- “[I]f you, therefore, have a situation where the screws break, both of them break under this, when most of the time you only need one to hold, well, until the bone heals, what else can I infer other than that, that there was a defect in the screws?” Id.
- “[Plaintiffs’ expert] testified that the screws were supposed to keep the corrected hip in ‘position until the bone heals.’” Id.
- “[T]he failure was that the bone . . . did not unite before the screws broke." Id. at *7.
(Emphasis added throughout).