Originally posted at Jim Beck and Mark Herrmann’s Drug & Device Law Blog

Charles R. Beans, of Goodman McGuffey Lindsey & Johnson, LLP, in Atlanta, contributed the following guest post. We thank him for his contribution, and present his words:

"Just another stupid thing that I done wrong."
-- Goldfinger, "Counting the Days" © 2000.

[Okay, okay. We started with
lyrics froms Goldfinger. But now we give you Chuck's words:]

Unless Congress acts otherwise -- and their plate ought to be full with other things -- on December 1, 2009, new changes to the Federal Rules of Civil Procedure will go into effect that will revolutionize the way time is calculated in federal court litigation. The changes are significant and sweeping.

The Federal Rules have featured a variety of due dates, calculated forward and backward, in days and sometimes even hours. How the days were counted, or not, depended on whether the time period was more or less than ten days, and so in some cases a deadline less than ten days was actually more than a corresponding deadline more than ten days, when weekends or holidays were omitted from the counting, and time added for service by mail. The new rules are intended to simplify and standardize the process.

The changes start with Rule 6 and are intended to extend to every other Rule dealing with calculating deadlines for action in Federal courts. Consistent with these amendments, time periods in a total of 91 federal rules and 28 federal laws were also adjusted. In addition to the Civil Rules, the Federal Appellate, Bankruptcy, Civil, and Criminal Rules have also changed correspondingly.

The new theme is "days are days." All days are to be counted. If a deadline falls on a weekend day, a federal holiday, or a day when filing is impossible because the Clerk’s office is closed or inaccessible, then the deadline falls to the next available day. Deadlines shorter than 30 days have been changed to multiples of seven (7) days, so that more often than not, the deadline will fall on a weekday. Other changes affect how to tell when the last day of a period ends, how to compute hourly time periods, how to calculate a time period when the clerk’s office is inaccessible, and how to compute backward-counted periods that end on a weekend or holiday. The rules also clarify the long held understanding that when e-filing is involved, a due date runs until midnight in the time zone of that court’s clerk’s office.

There are now new time periods in Rules 6, 12, 14, 15, 23, 27, 32, 38, 50, 52, 53, 54, 55, 56, 59, 62, 65, 68, 71.1, 72 and 81. Rules that previously called for 1, 3 or 5-day periods become 7-day periods. Deadlines that were previously 10 or 11 days become 14 days, and periods that were once 20 days become 21 days. For example, a response to a motion for summary judgment is now due 21 days later, and reply, where permitted, 14 days after that. Important exceptions are found in Rules 50, 52 and 59. Periods of 10 days in those rules become 28 days under the new rules.

Unremarked upon in the official commentary, and in all the blogging that this author has seen, is the deletion of the rule adding time for service by mail. The changes delete Rule 6(d) which provided for three extra days for response if service was accomplished by various methods listed in Rule 5. The rule, which used to provide extra time if service was by mail, rather than by hand delivery, has become somewhat anachronistic given the prevalence of e-filing and other methods of service. The change also removes an incentive to serve by hand delivery, which in some jurisdictions removed the three extra days for response that would accompany mail service.

The Committee has asked the district courts to revise their Local Rules accordingly, and to do so effective December 1. It remains to be seen if this will be done, and if any paradoxes will remain where and if it is not. The time-computation rules amendments are at
www.uscourts.gov/rules. PowerPoint presentations explaining the amended rules and their operation in court proceedings is available at www.uscourts.gov/rules/presentations.html. Chief Justice Roberts’ transmittal letter to President (of the Senate) Biden and the changed rules may be found here: http://bit.ly/rOcKt.

The previous rules have been around a long time, and though commentary on the new rules was not uniformly positive, the old system was one that nobody could be totally comfortable with. The new system ought to be more straightforward for litigators in federal courts.


Thanks again for publishing my guest column. Unfortunately, part of it was wrong.
Neville Boschert, a sharp lawyer in Jackson Mississippi, pointed out that 6(d), allowing three days for mail service, is still in the 2009 West edition of the rules. I went straight to the top, and spoke with a fellow at the US Courts Rule Committee, who confirmed 6(d), the three days for mail service, is still part of the rule. He said he gets that question a lot lately.

Caution: The texts of the revised rules that are being circulated around (including on Westlaw) are the "clean copy" from the U.S. Supreme Court to the U.S. Senate, which only
include the portions of each rule that contain changes. The omission of 6(d) means that it continues in the same form – I incorrectly assumed it meant that portion was not part of the new rule. My source did say that subsection was on the agenda and may not survive much longer, given the growing prevalence of efiling.

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Total Recall

Posted on September 28, 2009 03:31 by Mark Herrmann and James M. Beck

We received a copy of Ford Motor Co. v. Reese, ___ S.E.2d ___, 2009 WL 2951299 (Ga. App. Sept 16, 2009) (sorry, no slip opinion), from Charles Beans over at Goodman McGuffey the other day.

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. Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008); 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.

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(Reprinted with permission from Jim Beck and Mark Herrmann's Drug and Device Law Blog)

Earlier in the week we got tagged by Amlaw for one of our posts about how boilerplate design and manufacturing defect claims recently got dismissed under Twombly/Iqbal.

That’s cool. Amlaw drives a lot of traffic to little blogs like ours when it says “you’re it.”

But we were a little surprised by the attention given that post. We’ve been writing about applying Twombly/Iqbal pleading rules in our sandbox for some two years. We
spotted the significance of Twombly itself – the case that started all that – a week after that decision came down back in 2007. We predicted then that Twombly would apply to pleading in all actions, almost two years before the Supreme Court removed all doubt on that score in Iqbal. We brought to you the first case that we found applying the Twombly pleading standard in a drug/device product liability case. That case was Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008), decided well over a year ago. And we’ve discussed a number of times, most recently here, about how Twombly/Iqbal doesn’t let plaintiffs get away with bare “defendant violated the FDCA” allegations any more. Even our critics seem to agree with us about that kind of allegation being bad.

So the timing of the AmLaw tag leads to wonder – is this really big news? Haven’t there been a bunch of Twombly/Iqbal dismissals of vague (the new legal buzz word is “formulaic”) pleadings in other product liability cases before now? So we decided to find out. We’re taking the blinders off for the time being and looking for recent examples of product liability cases generally getting thrown out under the Supreme Court’s tightened pleading standards.

It’s not rocket science. The research is no more sophisticated than throwing “Twombly” and “Iqbal” (we’re glad both cases have relatively unusual names) in a Westlaw (allfeds) search along with “product liability” (with an after 2006 date restriction for good measure) and seeing what the computer spits out.

Here goes.


There’s 354 cases on Westlaw. Not all of them will be valid hits, of course. A lot of them won’t even be product liability cases. But that looks like a lot of work just to prove a point.

Still, that’s more than we thought. Simply on the basis of that number, we have to say that it’s the legal press that belatedly getting interested in the issue - not the courts and certainly not the lawyers.

Anyway, that size of a number means we’ll have to figure out how we want to do this. We’re going to try categorizing what we find by the type of claim that’s been dismissed. We’ll give cites and parentheticals if there’s anything particularly interesting.

As far as what we’re not doing. . . . Since we’re dealing only with Twombly/Iqbal dismissals here, we’re not getting into fraud or consumer fraud, since those claims are not governed by Rule 8 – what Twombly/Iqbal construes – by rather under the tougher Rule 9(b) standard requiring fraud to be pleaded with “particularity.” Nor are we getting into medical device cases where the dismissal is primarily based upon federal preemption, and only incidentally on pleading grounds. Those cases were covered last week in our
preemption post.

Well, here goes:

Dismisssal of Everything

O'Neil v. Simplicity, Inc., ___ F.3d ___, 2009 WL 2168891 (8th Cir. July 22, 2009) (failure to allege physical injury); Watkins v. Safety-Kleen Systems, Inc., 2009 WL 2240556 (E.D. Ky. July 27, 2009) (product identification); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2009 WL 1921902 (D. Minn. July 1, 2009) (causation, injury); Whitson v. Bumbo, 2009 WL 1515597 (N.D. Cal. April 16, 2009) (failure to allege physical injury); In re Bausch & Lomb Inc., 2007 WL 3046682, at *7 (D.S.C. Oct. 11, 2007) (damages).

Product Liability Generally

Stearns v. Select Comfort Retail Corp., ___ F. Supp.2d ___, 2009 WL 1635931, at *3 (N.D. Cal. June 5, 2009) (damages); Sherman v. Stryker Corp., 2009 WL 2241664, at *5 (C.D. Cal. March 30, 2009) (product identification); Chappey v. Ineos USA LLC, 2009 WL 790194, at *5 (N.D. Ind. March 23, 2009) (product identification; manufacturer status); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *6 (N.D. Cal. July 28, 2008) (numerous deficiencies); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (numerous deficiencies); Taylor v. Shetler Lincoln Mercury Ltd., 2007 WL 4551935, at *4 (W.D. La. Dec. 18, 2007) (manufacturer status); Provencio v. Armor Holdings, Inc., 2007 WL 2814650, at *2 (E.D. Cal. Sept. 25, 2007) (numerous deficiencies).

Design Defect Claims

Lewis v. Abbott Laboratories, 2009 WL 2231701, at *4 (S.D.N.Y. July 24, 2009); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *7 (D. Minn. July 24, 2009); Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471, at *7 (S.D. Ohio July 23, 2009).

Manufacturing Defect Claims

Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 283-84 (E.D.N.Y. 2009); Lewis v. Abbott Laboratories, 2009 WL 2231701, at *5 (S.D.N.Y. July 24, 2009); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *8 (D. Minn. July 24, 2009); Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471, at *7 (S.D. Ohio July 23, 2009); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6-7 (D.N.J. March 5, 2009); Rice v. Kawasaki Heavy Industries, Ltd., 2008 WL 4646184, at *10 (E.D.N.Y. Oct. 17, 2008).

Warning Defect Claims

Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597, 608-09 (11th Cir. 2008) (failure to plead the label available to the doctor under the learned intermediary rule); Lewis v. Abbott Laboratories, 2009 WL 2231701, at *5 (S.D.N.Y. July 24, 2009) (inadequacy of warnings to doctors); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *9 (D. Minn. July 24, 2009) (against one of two defendants); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 642-43 (E.D. Pa. 2008).

Implied Warranty

Lewis v. Abbott Laboratories, 2009 WL 2231701, at *6 (S.D.N.Y. July 24, 2009); Stearns v. Select Comfort Retail Corp., ___ F. Supp.2d ___, 2009 WL 1635931, at *7 (N.D. Cal. June 5, 2009) (fitness for particular purpose); American International Insurance Co. v. Gastite, 2009 WL 1383277, at *3-4 (S.D. Ind. May 14, 2009); Great West Casualty Co. v. Volvo Trucks North America, Inc., 2009 WL 588432, at *5 (N.D. Ill. Feb. 13, 2009) (unconscionability); In re Saturn L-Series Timing Chain Products Liability Litigation, 2008 WL 4866604, at *13-14 (D. Neb. Nov. 7, 2008); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *5-6 (N.D. Cal. July 28, 2008); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (numerous deficiencies).

Express Warranty

Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *10 (D. Minn. July 24, 2009); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009); In re FEMA Trailer Formaldehyde Products Liability Litigation, 2008 WL 5217594, at *10 (E.D. La. Dec. 12, 2008) (reliance); Simmons v. Stryker Corp., 2008 WL 4936982, at *1-2 (D.N.J. Nov. 17, 2008); Stearns v. Select Comfort Retail Corp., 2008 WL 4542967, at *4-5 (N.D. Cal. Oct. 1, 2008) (reliance, breach); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *5-6 (N.D. Cal. July 28, 2008); Stratford v. SmithKline Beecham Corp., 2008 WL 2491965, at *7 (S.D. Ohio June 17, 2008); Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *6 (D.N.J. Jan. 14, 2008).

Negligence Generally

Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597, 609 (11th Cir. 2008); Hagen v. U-Haul Co., 613 F. Supp.2d 986, 993-94, 999 (W.D. Tenn. 2009) (special relationship allowing a duty, product identification); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 643 (E.D. Pa. 2008) (duty, foreseeability); Adkins v. Cytyc Corp., 2008 WL 2680474, at *3 (W.D. Va. July 3, 2008) (sales rep duty; causation); Wolicki-Gables v. Arrow International, Inc., 2008 WL 2773721, at *2 (M.D. Fla. June 17, 2008) (product identification); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (duty, breach).

Negligent Manufacturing

Gibbs Patrick Farms, Inc. v. Syngenta Seeds, Inc., 2008 WL 822522, at *6 (M.D. Ga. 2008).

Negligence Per Se

Chappey v. Ineos USA LLC, 2009 WL 790194, at *3 (N.D. Ind. March 23, 2009) (failure to specify violation).

Gross Negligence

Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208, 217 (E.D. Va. 2008).


Southeast Laborers Health and Welfare Fund v. Bayer Corp., 2009 WL 2355747, at *3-12 (S.D. Fla. July 30, 2009) (predicate acts, pattern, causation, damages).


Lewis v. Abbott Laboratories, 2009 WL 2231701, at *7 (S.D.N.Y. July 24, 2009) (piercing corporate veil); Norfolk Southern Railway Co. v. Trinity Industries, Inc., 2009 WL 362437, at *8 (N.D. Tex. Feb. 13, 2009) (piercing corporate veil); Sprouse v. American Tire Distributors, Inc., 2009 WL 111601, at *2 (E.D. Va. Jan. 14, 2009) (negligent installation); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 644 (E.D. Pa. 2008) (intentional infliction of emotional distress); Tyco Safety Products Canada, Ltd. v. Abracon Corp., 2008 WL 4753728, at *2 (S.D. Fla. Oct. 28, 2008) (negligent misrepresentation).

So what do we conclude from all this?

First, the courts started applying the Twombly standard to dismiss “formulaicly” pleaded product liability litigation within weeks of the Supreme Court’s decision. Like us they immediately recognized that Twombly’s logic wasn’t limited to any particular type of case.

Second, the legal press didn’t pick up on pleading issues until recently – probably because of the publicity given to Sen. Specter’s
legislative proposal. But lawyers and judges sure did.

Third, there’s precedent out there for dismissing virtually any product liability-related claim under Iqbal/Twombly – provided the complaint is vague enough.

Fourth, the pace and scope of Iqbal/Twombly dismissals in product liability cases is increasing.

Fifth, there seem to be a disproportionately large number of drug/device cases applying Iqbal/Twombly when compared to the universe of product liability. If we flatter ourselves, maybe our early and frequent advocacy helped bring that about. If we don't, maybe we've just been harping on something that's obvious to anybody.

Sixth, we weren’t as good as we thought. There were several Twombly dismissals in drug/device product liability cases before the Heck case that we proudly paraded around as the first of its kind.

Seventh, we really don’t want to look through 350 cases again – just to make a point.

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