But that’s not a drug or device case.
No it isn’t. But the issue raised in Reese, whether there’s a common-law duty to recall a product that’s being legally sold, is a question that can – and has – arisen in prescription drug/medical device cases. In fact that’s where these claims originated.
It’s also a topic that we haven’t addressed before – not an easy thing to find after almost three years and over 1,000 posts.
So here goes.
Reese v. Ford involved (surprise, surprise) a car. The plaintiff died when her two-door 1994 Tempo Coupe was hit from behind by a fully-loaded 58,000 pound dump truck. Her lawyers blamed, naturally enough, the car seat. Forget about being rear-ended by a 58,000 pound truck, and knocked over a 371-foot embankment.
One of the plaintiff’s more unusual claims is that Ford should have recalled the car because of the supposed seat back defect – even though no recall had ever been ordered by the federal agency in charge of such things. Fortunately, the Reese court said, “no way, no how,” and joined the vast majority of courts refuse to allow common-law claims for failure to recall a product in the absence of any governmental edict.
For one thing, failure-to-recall claims are barred by the state of the art defense:
[N]o common law duty exists. . .requiring a manufacturer to recall a product after the product has left the manufacturer’s control. Under our products liability jurisprudence, a manufacturer’s duty to implement alternative safer designs is limited to the time the product is manufactured, not months or years later when technology or knowledge may have changed.
2009 WL 2951299, at *3 (citation omitted).
Reese also followed the Restatement (Third) of Torts, Products Liability §11 (1997), which rejects duty to recall claims unless a government-mandated or voluntarily undertaken product recall is negligently conducted. 2009 WL 2951299, at *3.
Finally, the Reese court invoked “important policy concerns” that weighed against allowing common-law claims asserting liability for failure to recall a legally-marketed product:
Because the cost of locating, recalling, and replacing mass-marketed products can be enormous and will likely be passed on to consumers in the form of higher prices, the recall power should not be exercised without extensive consideration of its economic impact. Courts, however, are constituted to define individual cases, and their inquiries are confined to the particular facts and arguments in the cases before them. Decisions to expand a manufacturer’s post-sale duty beyond making reasonable efforts to warn product users about newly discovered dangers should be left to administrative agencies, which are better able to weight the costs and benefits of such action.
Id. at *4 (citation and quotation marks omitted).
The more or less mandatory (both for courts and us) “we aren’t the first court to do this” string citation is found in footnote 4 of the Reese opinion. It cites: Wallace v. Dorsey Trailers Southeast, 849 F.2d 341, 344 (8th Cir. 1988) (applying Missouri law); Stanger v. Smith & Nephew, Inc., 410 F. Supp. 2d 974, 982 (E.D. Mo. 2005); Eschenburg v. Navistar International Transportation Corp., 829 F. Supp. 210, 214-15 (E.D. Mich. 1993); Ostendorf v. Clark Equipment Co., 122 S.W.3d 530, 533-37 (Ky. 2003); Tabieros v. Clark Equipment Co., 944 P.2d 1279, 1295-1301 (Haw. 1997); Gregory v. Cincinnati, Inc., 538 N.W.2d 325, 334-37 (Mich. 1995); Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993); Modelski v. Navistar International Transportation Corp., 707 N.E.2d 239, 247-48 (Ill. App. 1999).
For the sake of completeness (being the compulsive types we are) we’d have to add to the Reese court’s list the following cases that also reject duty to recall (sometimes masquerading as a “duty to retrofit”) claims: Brown v. Crown Equipment Corp., 501 F.3d 75, 78 (1st Cir. 2007) (applying Maine law); Ahlberg v. Chrysler Corp., 481 F.3d 630, 633 (8th Cir. 2007 (applying Iowa law); Menz v. New Holland North America, Inc., 440 F.3d 1002, 1005 (8th Cir. 2006) (applying Missouri law); Kinser v. Gehl Co., 184 F.3d 1259, 1270 (10th Cir. 1999) (applying Kansas law); Horstmyer v. Black & Decker, (U.S.), Inc., 151 F.3d 765, 883-74 (8th Cir. 1998) (applying Missouri law); Anderson v. Nissan Motor Co., 139 F.3d 599, 602 (8th Cir. 1999) (applying Nebraska law); Burke v. Deere & Co., 6 F.3d 497, 508 n.16 (8th Cir. 1993) (applying Iowa law); Romero v. International Harvester Co., 979 F.2d 1444, 1450 (10th Cir. 1992) (applying Colorado law); Habecker v. Copperloy Corp., 893 F.2d 49, 54 (3d Cir. 1990) (applying Pennsylvania law); Smith v. Firestone Tire & Rubber Co., 755 F.2d 129, 135 (8th Cir. 1985) (applying Missouri law); Syrie v. Knoll International, 748 F.2d 304, 311-12 (5th Cir. 1984) (applying Texas law); Kladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sep. 2, 2008); Bear v. Ford Motor Co., 2007 WL 870344, at *3 (E.D. Wash. Mar. 20, 2007); Robinson v. Brandtjen & Kluge, Inc., 2006 WL 2796252, at *8 (D.S.D. Sep. 27, 2006); Hammes v. Yamaha Motor Corp. U.S.A., Inc., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006); Campbell v. Gala Industries, Inc., 2006 WL 1073796, at *5-6 (D.S.C. Apr. 20, 2006); Wicker v. Ford Motor Co., 393 F. Supp.2d 1229, 1236-37 (W.D. Okla. 2005); Morales v. E.D. Etnyre & Co., 382 F. Supp.2d 1285, 1287 (D.N.M. 2005); Hernandez v. Ford Motor Co., 2005 WL 1574474, at *1 (S.D. Tex. June 28, 2005); Padilla v. Black & Decker Corp., 2005 WL 697479, at *7 (E.D. Pa. Mar. 24, 2005); Eberts v. Kawasaki Motors Corp., U.S.A., 2004 WL 224683, at *2 (D.N.D. Feb. 2, 2004); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1006 (D. Minn. 2003); Citizens Insurance Co. of America v. Sears Roebuck & Co., 203 F. Supp.2d 837, 843 (W.D. Mich. 2002); Flock v. Scripto-Tokai Corp., 2001 WL 34111725, at *8-9 (S.D. Tex. Sep. 11, 2001); Smith v. BOC Group PLC, 2001 WL 477237, at *5 (N.D. Ill. May 4, 2001); Efting v. Tokai Corp., 75 F. Supp.2d 1006, 1010-11 (W.D. Mo. 1999); Davidson v. Besser Co., 70 F. Supp.2d 1020, 1027 (E.D. Mo. 1999); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999); Langehennig v. Sofamor, Inc., 1999 WL 1129683, at *8 (D. Kan. May 28, 1999); Boyer v. Case Corp., 1998 WL 205695, at *2 (E.D. Pa. Apr. 28, 1998); Leslie v. United States, 986 F. Supp. 900, 913 (D.N.J. 1997); McAlpin v. Leeds & Northrup Co., 912 F. Supp. 207, 212 (W.D. Va. 1996); Buettner v. Super Laundry Machinery, 857 F. Supp. 471, 477 (E.D. Va. 1994), aff’d, 47 F.3d 116 (4th Cir. 1995); Spence v. Miles Laboratories, Inc., 810 F. Supp. 952, 958-59 (E.D. Tenn. 1992); Strunk v. Lear Siegler, Inc., 1992 WL 295042, at *3-4 (D. Kan. Sep. 22, 1992); Butler v. Navistar International Transportation Corp., 809 F. Supp. 1202, 1209-10 (W.D. Va. 1991); Girard v. Allis Chalmers Corp., 787 F. Supp. 482, 486 n.3 (W.D. Pa. 1992); Kimmel v. Clark Equipment Co., 773 F. Supp. 828, 829-30 (W.D. Va. 1991); Moorehead v. Clark Equipment Co., 1987 WL 26158, at *2-3 (N.D. Ill. Dec. 2, 1987); National Women’s Health Network, Inc. v. A. H. Robins Co., 545 F. Supp. 1177, 1181 (D. Mass. 1982); Loredo v. Solvay America, Inc., 212 P.3d 614, 632 (Wyo. 2009); Lovick v. Wil-Rich, 588 N.W.2d 688, 696 (Iowa 1999); Ramirez v. Plough, Inc., 863 P.2d 167, 177-78 (Cal. 1993); Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993); Rogers v. Clark Equipment Co., 744 N.E.2d 364, 370 (Ill. App. 2001); Winn v. Pollard, 62 S.W.3d 611, 617 (Mo. App. 2001); Bragg v. Hi-Ranger, Inc., 462 S.E.2d 321, 331 (S.C. App. 1995); Dion v. Ford Motor Co., 804 S.W.2d 302, 310 (Tex. App.1991); Lynch v. McStome, 548 A.2d 1276, 1281 (Pa. Super. 1988); Smith v. Daimlerchrysler Corp., 2002 WL 31814534, at *6 (Del. Super. Nov. 20, 2002); Grant v. Bridgestone/Firestone, Inc., 55 Pa. D. & C.4th 438, 445-46 (Pa. C.P. Philadelphia Co. 2001) Engle v. BT Industries AB, 41 Pa. D. & C.4th 25, 27 (Pa. C.P. Dauphin Co. 1999).
Naturally, we’re most interested in the recall cases involving prescription medical products. There are five of them. The oldest is National Women’s Health Network from way back in 1982. That’s the oldest duty-to-recall decision of any sort that we’ve found – so it looks like our neck of the woods originated both duty to recall claims and their judicial rejection. NWHN first examined state (Massachusetts) law and concluded “[n]o court has ever ordered a notification and recall campaign on the basis of state law.” 545 F. Supp. at 1181. The court also invoked preemption – holding that the power to recall federally-approved products (the case involved a pre-1976 medical device) properly rested solely with the FDA:
I am also persuaded that even if there were state law authority for a notification and recall campaign, such authority would be preempted by the FDCA for the same reasons that there is no implied right of action. . . . Especially in view of the 1976 amendment to the FDCA which specified the powers of the Secretary in regulating medical devices, any state law which would put these same powers in other hands must be deemed foreclosed. . . . Congress intended the Secretary of the FDA to have discretion as to when to seek recall. Since the federal interest in this area is “dominant” and the regulatory scheme is “pervasive,” preemption must follow.
Id. at 1181 (citations omitted). See also Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (“[a]ny claim. . .that Defendant. . .failed to recall a product” would “not parallel federal safety requirements” and was preempted) (applying Ohio law); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1159 (D. Minn. 2009) (finding failure to recall claim preempted without determining its viability under state law); Hunsaker v. Surgidev Corp., 818 F.Supp. 744, 755 (M.D. Pa. 1992) (failure to recall claim preempted). Of course, the non-existence of state law failure-to-recall claims impacts modern “parallel claims” preemption analysis – if there’s no analogous state-law failure to recall claim, then a “violation” claim making the same claim has no state law parallel, and it’s merely an improper (and preempted) attempt to assert an FDCA violation under the guise of state law. We discussed that concept at some depth here, among other places.
The Ramirez decision by the California Supreme Court, we hasten to point out, deals with an OTC – not a prescription – drug. But key facts demonstrate its relevance to prescription drugs. Specifically, the court declined to recognize any common-law duty to withdraw a product from the market where the relevant federal agency, the FDA, had not ordered such an action:
We conclude, however, as a matter of law, that defendant may not be held liable for failing to withdraw its product from the mark . . . . A few scientific studies had shown an association between [the product] and [the condition] but the methodology of those studies had been questioned and the FDA had determined that further studies were needed to confirm or disprove the association. Pending completion of those studies, the FDA concluded that product warnings were an adequate public safety measure. Although the FDA’s conclusion is not binding on us, we think it deserves serious consideration.
863 P.2d at 177-78. Thus the California Supreme Court opted for the rule later embraced by Third Restatement §11, that unless and until the relevant federal agency orders a recall, there’s no common-law duty to anticipate that action. Notably, the salience of the FDA’s action in Ramirez was not mandated by preemption, but rather by the court’s deference to the Agency as a matter of state-law jurisprudence. Ramirez is doubly important because it demonstrates the error, at least with respect to the drug/device area, of an outlier decision by one of that state’s intermediate courts (sound familiar?) that purported to recognize a duty to retrofit. See Hernandez v. Badger Construction Equipment Co., 34 Cal.Rptr.2d 732, 754 (Cal. App. 1994).
The Spence case involves an FDA-regulated biological product – human blood. The state of Tennessee passed an AIDS testing statute for blood products, and the plaintiff argued that the passage of the statute created some implied duty to recall all blood that had been collected before the advent of the subsequently mandated tests. Despite that statutory hook, the court refused to recognize a common-law duty to recall:
[The defendant] supplied the [blood product] to the hospital before the effective date of [the statute]. There is nothing in the language of the statute that evidences an intent to require manufacturers and suppliers of blood products to recall and test a product already on the market before the statute took effect.
810 F. Supp. at 958-59.
Most recently a duty to recall claim got the boot under Missouri law in Stanger:
[T]here is no cause of action for negligent recall. There is no indication, by case law, statute, or otherwise, that. . .create[s] a common law duty to recall. Moreover, in light of the fact that there is no recognized duty to recall, we hold such a duty cannot arise as a result of defendant’s voluntary undertaking to recall certain of its products. . . .[I]n order for [plaintiffs] to pursue a negligent recall claim, the defect in the product would have had to exist at the time the product left defendant’s control and entered the stream of commerce. Absent a mandated recall by a governmental agency, defendants had no duty to recall.
401 F. Supp.2d at 982 (citation and quotation marks omitted).
Lastly, Langehennig, holding that there was no duty to recall a prescription medical device after supposedly “discovering” its “dangerous nature,” was pretty much a run-of-the-mill application of state law. The relevant state supreme court (Kansas) had already rejected any duty to recall in another context. 1999 WL 1129683, at *8 (citing Patton, 861 P.2d 1299).
So while we’re on the subject of recalls, what else can we say about them in the context of prescription medical products? Well, for one thing, a product recall that occurs after the time of a plaintiff’s injury is subject to exclusion as a subsequent remedial measure. Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 622 & n.7 (8th Cir. 1983) (manufacturer instituted recall; admission allowed under pre-1997 version of Fed. R. Civ. P. 407); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4-5 (S.D.N.Y. June 27, 2003) (FDA mandated recall); In re Propulsid Products Liability Litigation, 2003 WL 1090235, at *2 (E.D. La. March 11, 2003) (manufacturer instituted recall); Kociemba v. G.D. Searle & Co., 683 F. Supp. 1579, 1581-82 (D. Minn. 1988) (manufacturer instituted recall); Richardson-Merrell, Inc. “Bendectin” Products Liability Litigation, 624 F. Supp. 1212, 1239 (S.D. Ohio 1985), aff’d, 857 F.2d 290 (6th Cir. 1988) (manufacturer instituted recall); Wolf v. Procter & Gamble Co., 555 F. Supp. 613, 623 (D.N.J. 1982) (manufacturer instituted recall); Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293, 1296-97 (Idaho 1989); Hardin v. Upjohn Co., 47 Pa. D. & C.3d 66, 70 (Pa. C.P. Philadelphia Co. 1986) (FDA mandated recall).
There’s law that private plaintiffs cannot supplant the FDA and demand court-ordered recall notices or similar statements be sent to members of the public. These cases are usually decided on grounds of FDA primary jurisdiction. Clark v. Actavis Group hf, 567 F. Supp.2d 711, 716-17 (D.N.J. 2008); In re Human Tissue Products Liability Litigation, 488 F. Supp.2d 430, 431-32 (D.N.J. 2007), Bernhardt v. Pfizer, 2000 WL 1738645, at *3 (S.D.N.Y. Nov. 22, 2000).
We’ve also seen precedent stating that the mere fact of a product recall does not establish non-compliance with FDA regulations. Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 282 (E.D.N.Y. Feb. 20, 2009); Sprint Fidelis, 592 F. Supp.2d at 1162. Nor does a recall, by itself, create a state law cause of action. Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026, at *4 (N.D. Cal. April 22, 2009) (on grounds of “the shortness of life”); Loomis v. Medtronic, Inc., 2005 WL 1828763, at *5 (N.D. Ohio Aug. 1, 2005); Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp.2d 672, 683-84 (M.D.N.C. 2003) (recall can’t establish causation); Drury v. Cardiac Pacemakers, Inc., 2003 WL 23319650, at *4 (M.D. Fla. June 3, 2003) (same); Jensen v. Bayer AG, 862 N.E.2d 1091, 1098-99 (Ill. App. 2007); Arons v. Rite Aid Corp., 2005 WL 975462, at *10 (N.J. Super. L. Mar. 23, 2005) (breach of warranty).
Finally, there’s precedent that, for purposes of preemption, a recall does not deprive a prior pre-market approval of a medical device of its preemptive force. Sprint Fidelis, 592 F. Supp.2d at 1155-56; Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008); Theofanis v. Boston Scientific Corp., 2003 WL 24049229, at *2 ¶16 (S.D. Ind. June 24, 2003); Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr.3d 566, 579-80 (Cal. App. 2008); Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. Apr. 9, 2009).
Anyway, now we’ve got all our recall-related material in one place so we can find it easily whenever we need it.
And so do our readers.