To recover on the basis of negligence per se, a plaintiff must establish three elements. Smith v. Owen, 841 S.W.2d 828, 831 (Tenn. Ct. App. 1992); see also Harden v. Danek Med., Inc., 985 S.W.2d 449, 452 (Tenn. Ct. App. 1998). "First, it must be shown that the defendant violated a statute or ordinance which `imposes a duty or prohibits an act for the benefit of a person or the public.'"
vice utilizing pedicle screws, it does not ipso facto mean that a device is defective because a screw becomes loose, Savage v. Danek Medical, Inc., 31 F. Supp.2d 980, 984 (M.D.Fla. 1999) (pedicle screw which was loose two weeks after being implanted "may have . . . been placed improperly . . . or loosened of its own accord"), or because a screw breaks, Minisan, 79 F. Supp.2d at 977 ("It is a known fact in the medical community that bone screws may break due to a number of factors unrelated to any defect."). Additionally, unless there is a showing that the particular defect or dangerous condition proximately caused the plaintiff's injury, the manufacturer is not liable. The inability of plaintiffs in numerous other pedicle screw claims to satisfy the requirement of proximate cause has resulted in summary judgments being granted on behalf of defendants. See Minisan, 79 F. Supp.2d at 975-76; Danford v. Danek Medical, Inc., Nos. 95-2690, 95-2542, 1999 WL 613409 (W.D.Tenn. Mar. 22, 1999); Harden v. Danek Medical, Inc., 985 S.W.2d 449 (Tenn.App. 1998), perm.app. denied (Tenn. 1999); Jastrebski v. Smith Nephew Richards, Inc., No. 02A01-9803-CV-00068, 1999 WL 144935 (Tenn.App. Mar. 18, 1999); Jordan v. Sofamor Danek Group, Inc., No. 02A01-9803-CV-00067, 1999 WL 74214 (Tenn.App. Feb. 16, 1999).
............................................................ 7, 9 Fornoff v. Parke Davis & Co., 105 Ill. App. 3d 681 (1982) ..................................................................................................... 18 In re Fosamax Prod. Liab. Litig., 924 F. Supp. 2d 477 (S.D.N.Y. 2013) ........................................................................................ 7 Frausto v. Cooper Tire & Rubber Co., 2014 WL 581724 (M.D. Tenn. Feb. 13, 2014) .......................................................................... 2 Gentry v. Hershey Co., 687 F. Supp. 2d 711 (M.D. Tenn. 2010) .................................................................................... 3 Goins v. Clorox Co., 926 F.2d 559 (6th Cir. 1991) ..................................................................................................... 3 Hale v. Ostrow, 166 S.W.3d 713 (Tenn. 2005) .................................................................................................. 15 Harden v. Danek Med., Inc., 985 S.W.2d 449 (Tenn. Ct. App. 1998) ................................................................................. 4, 6 Harrison v. Addington, 955 N.E.2d 700 (Ill. App. Ct. 2011) ........................................................................................ 15 Heft v. Moore, 351 F.3d 278 (7th Cir. 2003) ..................................................................................................... 1 Hodge v. Craig, 382 S.W.3d 325 (Tenn. 2012) .................................................................................................... 7 Hollymatic Corp. v. Holly Sys., Inc., 620 F. Supp. 1366 (N.D. Ill. 1985) ............................................................................................ 8 Holt v. Am. Progressive Life Ins. Co., 731 S.W.2d 923 (Tenn. Ct. App. 1987) ..................................................................................... 9 Home Sav. & Loan Ass'n of Joliet v. Schneider, 483 N.E.2d 1225 (Ill. 1985) .....................................................
This also appears to be the law in Tennessee. Smith v. Pfizer, Inc., 688 F.Supp.2d 735, 746 (M.D.Tenn.2010) (“[A] pharmaceutical company can escape liability if it can show that additional warnings would not have changed the prescribing doctor's actions.”) (emphasis added); Harden v. Danek Medical, Inc., 985 S.W.2d 449, 451 (Tenn.Ct.App.1998) (“In order to recover for failure to warn under the learned intermediary doctrine, a plaintiff must show: (1) that the defendant failed to warn the physician of a risk associated with the use of the product not otherwise known to the physician; and (2) that the failure to warn the physician was both a cause in fact and proximate cause of the plaintiff's injury.”) (emphasis added). It is this aspect of the doctrine that has led to application of similar proximate cause analyses in the prescription drug context, such as the “independent knowledge” defense whereby a drug manufacturer is not liable for a patient's injury if the physician was aware of the risks when he prescribed the drug.
To succeed on a negligence per se claim a plaintiff must prove: (1) that the defendant violated a statute, ordinance, or regulation that requires or prohibits a particular act for the benefit of the plaintiff or the general public; (2) that the injured person was within the class of individuals the legislature intended to benefit and protect by enacting the statute, ordinance, or regulation; and (3) that the defendant's negligence was the proximate cause of the injury. Harden v. Danek Med., Inc., 985 S.W.2d 449, 452 (Tenn. Ct. App. 1998); Smith v. Owen, 841 S.W.2d 828, 831 (Tenn. Ct. App. 1992). The threshold questions essential to every negligence per se case are “whether the plaintiff belongs to the class of persons the statute was designed to protect and whether the plaintiff's injury is of the type that the statute was designed to prevent.” Rains v. Bend of the River, 124 S.W.3d 580, 591 (Tenn. Ct. App. 2003).
............................................................. 8 Fuesting v. Zimmer, Inc., 448 F.3d 936 (7th Cir. 2006) ............................................................................................... 6, 19 Gentry v. Hershey Co., 687 F. Supp. 2d 711 (M.D. Tenn. 2010) .................................................................................... 5 Georges v. Novartis Pharms. Corp., 2012 WL 9064768 (C.D. Cal. Nov. 2, 2012) ........................................................................... 19 Goins v. Clorox Co., 926 F.2d 559 (6th Cir. 1991) ..................................................................................................... 5 Gray v. Hoffmann-La Roche, 82 F. App'x 639 (10th Cir. 2003) ............................................................................................ 20 Hagen v. Richardson-Merrell, 697 F. Supp. 334 (N.D. Ill. 1988) ............................................................................................ 23 Harden v. Danek Med., Inc., 985 S.W.2d 449 (Tenn. Ct. App. 1998) ..................................................................................... 6 Hazelwood v. Illinois Cent. Gulf R.R., 450 N.E.2d 1199 (Ill. App. Ct. 1983) ...................................................................................... 25 Heitz v. Hogan, 480 N.E.2d 185 (Ill. App. Ct. 1985) ........................................................................................ 17 Hodge v. Craig, 382 S.W.3d 325 (Tenn. 2012) .................................................................................................... 7 Hollymatic Corp. v. Holly Sys., Inc., 620 F. Supp. 1366 (N.D. Ill. 1985) ............................................................................................ 8 Home Sav. & Loan Ass'n of Joliet v. Schneider, 483 N.E.2d 1225 (Ill. 1985) ..................................................................................................... 12 Honda Motor v. Oberg, 512 U.S. 415 (1994) ...........................................................
Both parties are in agreement, however, that there are instances where a statutory violation may give rise to a negligence per se claim even where no private right of action exists. In Harden v. Danek Medical, Inc., 985 S.W.2d 449 (Tenn. Ct. App. 1998), app. denied (Feb. 8, 1999), the Tennessee Court of Appeals addressed the issue of whether the federal Food, Drug and Cosmetic Act, which did not provide for a private right of action, nonetheless permitted negligence per se claims based on violations of the statute. Harden, 985 S.W.2d at 452.
In Tennessee, the learned intermediary doctrine is applicable in failure to warn suits where a physician is the intermediary between a defendant pharmaceutical or other medical product manufacturer and an injured patient. See id.; King v. Danek Med., Inc., 37 S.W.3d 429, 452-53 (Tenn. Ct. App. 2000); Harden v. Danek Med., Inc., 985 S.W.2d 449, 451 (Tenn. Ct. App. 1998). North Brothers, relying on Ford Motor Co. v. Wagoner, 192 S.W.2d 840 (Tenn. 1946) and Whitehead v. Dycho Co., 775 S.W.2d 593 (Tenn. 1989), argues that the learned intermediary doctrine applies not just to pharmaceutical or other medical product cases, but to other product liability cases.
1975). Therefore, the court should freely grant the amendment, so long as prejudice to the opposing party can be avoided. Harden v. Danek Med., Inc., 985 S.W.2d 449, 454 (Tenn.Ct.App. 1998); Campbell County Bd. of Educ. v. Brownlee-Kesterson, Inc., 677 S.W.2d 457 (Tenn.Ct.App. 1984). The court, however, retains discretion to condition the amendment in order to minimize prejudice to the opposing party in maintaining his or her action or defense. For example, the court may condition the amendment on the granting of a continuance or the posting of a bond.
“Generally, a manufacturer will be absolved of liability for failure to warn for lack of causation where the consumer was already aware of the danger, because the failure to warn cannot be the proximate cause of the user's injury if the user had actual knowledge of the hazards in question.” Harden v. Danek Med., Inc., 985 S.W.2d 449, 451 (Tenn.Ct.App.1998) (internal quotation marks omitted).Bradley argues that there are genuine issues of material fact surrounding the adequacy of the warnings included with the ratchet strap.