A Little Sunshine in Philadelphia

            The Sixers lost Game 5 to the Celtics last night while the Nationals beat the Phillies 2-1.  The Flyers have been eliminated, and it’s not football season yet.  Philadelphians can’t even look to soccer right now: the Union have only won 2 games this season.  So, we thought a good decision from the Eastern District of Pennsylvania might just lift all our Philly fans’ moods.  It’s not ground-breaking or earth-shattering – but it is another solid win in a prescription medical device case and a win is a win, so here you go.

            Even the facts are fairly routine.  Plaintiff undergoes knee replacement surgery.  A few years later, she experiences pain and is told one of the implants has loosened.  She has revision surgery and then sues the manufacturer of the artificial knee.  Kee v. Zimmer, Inc., 2012 U.S. Dist. LEXIS 68862 (E.D. Pa. May 17, 2012).  Plaintiff asserted all the standard product liability claims:  strict liability design defect and failure to warn; violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”) and fraud; breach of implied warranties; breach of express warranty; negligence; and punitive damages.  Id. at *2-3.  Defendant moved to dismiss all but the negligence claim and ultimately, that’s all that survived.

            The opinion reads like a checklist of Pennsylvania claims that cannot be brought and/or how not to plead them:

ü  As a matter of Pennsylvania law, strict liability and breach of implied warranty claims are barred against manufacturers of prescription medical devices. 

Is this really still open for debate?  The Pennsylvania Supreme Court adopted this hard line rule for prescription drugs in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), sixteen years ago.  And the Pennsylvania Superior Court extended it to prescription medical devices six years ago.  See Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006).  The reasoning of these courts also has been extended to implied warranty claims.  See Kee, 2012 U.S. Dist. LEXIS 68862 at *7-8, n.3.  So, why do Pennsylvania plaintiffs continue to file these claims?  Well, this plaintiff argued the Hahn line was actually quite soft.  Plaintiff claimed Hahn did not impose a “blanket exemption on medical device manufacturers” but rather required a “case-by-case, product-by-product analysis.”  Kee at *9.  But the court was quick to point out that plaintiff had no authority whatsoever for her interpretation of Pennsylvania law, which was at odds with the overwhelming majority of courts to consider the issue.  Id.   No strict liability and no implied warranty.  Check.

ü  For breach of warranty of claims, plaintiff is a buyer and must plead notice.

In order to maintain a breach of warranty claim, Pennsylvania law requires the buyer “within a reasonable time after he discovers or should have discovered any breach [to] notify the seller of the breach or be barred from any remedy.”  13 Pa. Cons. Stat. Ann. §2607(c)(1).  Plaintiff bears the burden of proving compliance with the statute.  Since plaintiff here failed to plead notice, she tried to get around the requirement by arguing that she was not a buyer, but rather a “third-party beneficiary of the relationship which existed between the plaintiff’s treating orthopedic surgeon . . . and the defendant enjoying standing to advance the instant theory of recovery.”  Kee at *12.  Wrong again.  The third-party payer case plaintiff attempted to rely on, in fact, held that third-party payers are buyers under the UCC.  Id.  No express warranty.  Check.

ü  Consumer fraud claims are barred by the learned intermediary doctrine.

We are going to give it to you straight from the decision – we don’t think we could sum it up any better:

     Under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL against the manufacturer of prescription drugs because prescription drug manufacturers do not have a duty to disclose information directly to consumers. Permitting a cause of action under UTPCPL would result in effectively making prescription drug manufacturers absolute guarantors of any anticipated effects of the drug.  This is so because a claim under the UTPCPL requires proof of causation and reliance, and the learned intermediary doctrine breaks the chain in terms of reliance, [because] the patient cannot obtain prescription drugs without the physician no matter what [the patient] believe[s] about them. In other words, a private right of action under the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient.  The same reasoning extends to manufacturers of prescription medical devices.

Id. at *13-14 (citations and quotation marks omitted).  No consumer fraud violation.  Check.

ü  Fraud and UTPCPL claims must be pled with particularity.

As if the learned intermediary doctrine wasn’t enough to get rid of the fraud claims, plaintiff also failed to meet the requisite standard of particularity under Rule 9(b).  Plaintiff’s claims of fraud were vague and general at best:   defendant knew of “risks” and “complications” that they failed to disclose; defendant misled customers by failing to notify them of an increased risk; defendant failed to disclose that the product did not perform safely.  Id. at *17-18.  The court found these allegations lacking:

     Plaintiff fails to allege facts supporting the nature of her reliance or specific representations Defendant made relating to the reliance. Plaintiff fails to allege facts indicating the date, time, and place of the alleged fraud, or, alternatively, inject any precision or measure of substantiation into her fraud allegations that would place the defendant on notice of the precise misconduct with which it is charged.

Id. at *18.  No fraud.  Check.

ü  No outrageous conduct equals no punitive damages.

This one is also very straightforward.  Plaintiff alleged she was injured from the malfunction of a prescription medical device.  That’s it.  She “failed to muster any facts indicating that Defendant acted with reckless indifference to Plaintiff’s rights.”  Id. at *19-20.  No allegations of intentional, willful, wanton or reckless conduct; no punitive damages.  Check.

So, under Pennsylvania law, plaintiff’s case was stripped of all but her negligence claim, which is all she should have pled from the beginning.  So, if Philadelphia’s sports scene doesn’t improve, maybe we can take our foam fingers and rally caps to the courthouse where, at least for today, we have something to cheer about.

 

Breaking News - Pain Pump State Of The Art Affirmed

As anyone following the Pain Pump litigation knows, the state-of-the-art issue - whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff's surgery - is critical.  Well, today the first court of appeals to consider that question has affirmed summary judgment.  Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).

The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable).  It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:

When all is said and done, not one of [plaintiff's] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage.  [Defendant] had no duty to understand what the relevant medical literature did not.

Rodriguez likewise founs that the plaintiff's expert couldn't make anything more out of the same 13 articles than the articles themselves:

[Plaintiff's] theory requires two speculative leaps.  It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm.  And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely.  Both are far too conjectural and too many steps removed from the problem that developed.

The court went on to demolish plaintiff's regulatory theory - that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.

The FDA’s action means only that no other device on the market carried that indication for use.  It does not mean that the pump was (or might potentially be) dangerous to use in the joint space.  The 510(k) process does not comment on safety.

Slip op. at 8.  Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Plaintiffs were thus prevented from having their cake and eating it, too.  That is, plaintiffs who deny preemption because a §510k clearance doesn't address safety, can't play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.

Rodriguez also becomes the last in a very long line of cases to confirm that an independent "duty to test" does not exist at common law.  Rather, such a duty "collapses into the failure-to-warn claim."   Slip op. at 8.  A plaintiff cannot resort to a "duty to test" to avoid the state-of-the-art defense.  "The law does not require a company to test for hidden risks that neither it nor the medical community had a reasonable basis to suspect."  Id.

Nor can a claim of off-label marketing succeed where plaintiff's other theories have failed.  The common law is unconcerned with mere off-label marketing.  It would be concerned with concealment of risks (regardless of on or off-label), but once again, the state of the art precluded the concealment claim:

[I]t makes no difference that [defendant] knew surgeons would use its pump in the joint space or even encouraged them to do so since [plaintiff] has failed to show that Stryker knew or should have known that the use was dangerous.

Slip op. at 9.

Next, putting state of the art and legal theorizing aside, the claim in Rodriguez failed independently on the facts of the case because the implanting physician knew all about this device (having used it many times) and thus did not rely on any of the defendant's warnings - so the opinion is also a good "already knew" learned intermediary warning causation case.  Slip op. at 10-11 (citing one of Bexis' Bone Screw summary judgment wins).

Finally, we've commented on plaintiffs' attempts in other cases to create some new duty to send a "Dear Doctor" letter in cases where their warning claims fail.  Well, last and least, the plantiff tried that tack in Rodriguez - and got nowhere. 

[Plaintiff] argues that [defendant] should have known that it needed to “revise its instructions or at least circulate a Dear Doctor Letter” when the FDA rejected its requests to approve the pump specifically for use in a joint.  As shown, however, the FDA position did not obligate [defendant] to send any such letter.

Slip op. at 11.  "Dear Doctor" letters are a regulatory invention.  If the FDA doesn't require them in a particular situation, the court in Rodriguez wasn't about to create some new, broader common-law Dear Doctor letter theory.

We can only hope that other courts are as sensible as the Sixth Circuit was in Rodriguez. Slip op. at 7 (emphasis added).  The expert had improperly attempted to substitute "hindsight negligence" for "common law negligence.  Id.Slip op. at 5. Actually, the court had a lot more to say, but that's the bottom line.

No, That's Not Justifiable Reliance

Sometimes we feel like pulling our hair out − those of us who still have some, anyway.  One things that gets us in that mood is the other side claiming that the prescribing physician (who went to med school and typically has loads of experience with the relevant product) would have treated as gospel this or that piece of information, if only s/he had been told about by the sales rep (no med school, no clinical experience).  It just doesn’t work that way.  Most doctors think quite highly of their own abilities and knowledge and aren’t about to listen to a sales rep on a medical question.


But try finding a decision anywhere that makes this rather obvious point.

We found one.

There’s a new case, Hall v. Horn Medical, L.L.C., 2012 U.S. Dist. Lexis 68482 (E.D. La. May 16, 2012), that makes this point − in a case with a rare prescriber willing (or desparate enough) to say what the plaintiff wanted.

As you might guess, Hall was a medical malpractice case, or at least had a strong medmal component.  The product was a spinal fusion device, and the surgeon who implanted it ignored an explicit statement in the package insert only to use the device with bone grafting material.  The doc didn’t and guess what?  The fusion failed.

When asked why he ignored the manufacturer's warning, the doctor said that he performed the procedure the way he did because the sales rep told him that the device was OK for this particular “off-label use.” 2012 U.S. Dist. Lexis 68482, at *9-10 (prescriber “emphasized that he ‘would not use it without bone graft unless the rep said that it could be used without bone graft’”).

The sales rep, of course, flatly denied ever recommending the device for a use that was not only off-label, but positively contraindicated by the aforementioned warning.  Id. at *9.  For one thing, promotion of off-label use is a major regulatory sin for which the FDA can, and has, prosecuted sales reps.

For his part, the plaintiff sued the sales rep for negligent misrepresentation.  Justifiable reliance is an element of that tort.

The rep moved for summary judgment.

But, there’s a he-said-she-said conflict here that prevents summary judgment, innit?  One says yes; the other no.  Classic credibility dispute, right?

Nope.

The court held that a physician cannot justifiably rely on anything a sales rep might have said with respect to a medical issue:

Even if [the rep] told [the doctor] a that he could use the [product] without a bone graft, the Court finds that any reliance by [the doctor] on that statement to be unreasonable as a matter of law. These representations . . . addressed what type of spinal procedure [the doctor] should perform on [plaintiff]. As a seasoned neurosurgeon, it is patently unreasonable for [the doctor] to rely on a sales representative's opinion about the type of procedure that should be employed in operating on a patient’s spine.

2012 U.S. Dist. Lexis 68482, at *10 (emphasis added).

Sw, while it’s not 100% on point, since a product liability claim was not involved in the litigation, this excerpt from Hall is as good a statement as we’ve seen for the proposition that doctors do not − and legally cannot − rely on sales reps for medical information.

Not A WIn, Not A Loss

The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss.  Like Gaul, the decision contains three parts, and we have comments as to each.


Very briefly, the case involves a total hip implant constructed from titanium.  After being implanted for over three years, it broke.

Design Defect

The first part of the opinion denied summary judgment on design defect claims.  The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”).  Mims, 2012 WL 1681810, at *2.  Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.

The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough.  Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:

One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.

Id. at *2.

Frankly, we don’t mind that particular ruling too much.  We could even see using this quote in one of our cases.

The real problem in Mims was that the defendant hadn’t separately moved to exclude the plaintiffs’ expert under Daubert.  The court latched onto that and refused to “consider the reliability” of the expert testimony on summary judgment.  Id. at *3.  This procedural two-step is worrisome in that it allows an expert opinion that may well be inadmissible to defeat summary judgment.  The general rule has been that only admissible evidence counts on summary judgment, and the court’s wielding of a procedural fine-toothed comb undercuts that rule.  One take-away from Mims is to make sure to file Daubert motions separately and in advance of summary judgment, depending of course on the pre-trial schedule in any given case.

Another more unusual suggestion:  We’ve had some success using preemption against this type of claim, see Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2-3 (Pa. C.P. Philadelphia Co. June 9, 1999) (claim that implant should not have been made from stainless steel held preempted), but it depends on the classification regulation.  We’ll explain.  There’s usually no preemption in Class II metallic implants like hip implants under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), but there can be − if there’s a “device-specific” regulation, and the plaintiff’s particular claim is “different from or in addition to” something in that regulation under 21 U.S.C. §360k(a).

There are device-specific regulations for essentially all medical devices − but unfortunately they’re usually one-paragraph long and thus don’t cover many aspects of the device.  These are the FDA’s identification and classification regulations.  However, they do frequently say something about the metallic composition of implants. There are several hip implant I&C regs, see 21 C.F.R. §§888.3300-3350, and we don’t know which one applies specifically to Mims.  Most of them mention only “cobalt-chromium-molybdenum,” which was the plaintiff’s proposed design alternative in Mims, so the preemption argument wouldn’t fly.

However, if §888.3310 were applicable to this implant, or if some plaintiff’s expert offered the same opinion against the manufacturer of a §888.3310 implant, there’s a decent preemption argument.  That’s because this section states, as to composition, that such devices are “made of alloys, such as cobalt-chromium-molybdenum and titanium alloys.”  Emphasis added.  In this device-specific regulation, the FDA has expressly stated that “titanium alloys” are okay.  Thus, our preemption argument in such a situation would be that since a device specific regulation specifies “titanium” as acceptable composition, a common-law claim that titanium construction alone is a defect would be preempted even under Lohr.

Warning Defect

The second part of the Mims opinion also denied summary judgment as to the plaintiffs’ warning claim.  2012 WL 1681810, at *4.  The defendant moved based solely on the warning’s adequacy.  That’s hard to do unless the relevant part of the warning is really detailed.  The description of the warnings in Mims suggests otherwise in that case.

We find it much easier to win summary judgment in warning cases on causation − that the prescriber already knew the allegedly omitted information or that the information wouldn’t have changed what the prescriber did or the warnings.  Supporting facts would also include the prescriber continuing to utilize the device, with no change in procedure, after the plaintiff’s injury.

The lesson from Mims is that warning summary judgment motions ideally should have a double-barreled approach of both adequacy and causation.

The court in Mims seemed to assume, without any evidence (at least none was cited) that a different warning might have led to a different outcome.  Maybe the issue simply wasn’t raised in the Mims motion, but again the court’s willingness to rely on less than admissible evidence is troubling, since summary judgment can be sought on the grounds that the plaintiff has no evidence on an essential element where the plaintiff bears the burden of proof.

Punitive Damages

The final third of the Mims opinion dismissed punitive damages claims as a matter of law because the defendant demonstrated that the implant complied with FDA regulations:

[T]he Court concludes that the Plaintiffs would not be able to establish by clear and convincing evidence culpable tortious conduct that would authorize the imposition of punitive damages. Moreover, punitive damages are typically not appropriate where the manufacturer has complied with regulatory standards.

Mims, 2012 WL 1681810, at *5 (citing Stone Man, Inc. v. Green, 263 Ga. 470 (1993); Welch v. General Motors Corp., 949 F.Supp. 843 (N.D.Ga.1996)).

This part of Mims almost makes up for the rest of it.  Preclusion of punitive damages by regulatory compliance is something we’ve advocated before, here.  We prominently mentioned the Stone Man decision that the court followed in Mims.  So we take this opportunity to applaud the third part of Mims.

More Nails in the Coffin of Third Party Payor Actions

In a pair of precedential opinions, the Third Circuit affirmed today the dismissal - for lack of standing- of the Intron off-label promotion RICO class action.

See:  In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3046, 3047, slip op. (3d Cir. May 16, 2012), and In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3047, slip op. (3d Cir. May 16, 2012).  You don't need to read both.  They're the same opinon

In both cases the court affirmed dismissal for want of standing. Third party payers aren't legally injured by off-label promotion. 

[T]o establish standing, [plaintiff] must allege facts showing a causal relationship between the alleged injury - payments for [the drug] that was ineffective or unsafe for the use for which it was prescribed - and [defendant's] alleged wrongful conduct.

3046, slip op. at 21.  Can't be done, held the unanimous court:

Local 331 must allege facts sufficient to show that the [the drug] which it paid for was prescribed to its members for ineffective off-label uses because of [defendant's] alleged misconduct.  There are no averments that come close to satisfying this standard.

 Id. at 23 (emphasis original).

Nor could another plaintiff (an individual - what a terrible plaintiff) establish standing when that plaintiff didn't even use the drug alleged in the complaint:

[T]he allegedly phony trial did not even concern a treatment regimen that [plaintiff's] doctor prescribed to her is dispositive.  There is no allegation of fact that supports a connection between [defendant's] unlawful conduct of involving [the prescriber] in a phony trial, and [his] prescription for a different drug therapy.

Id. at 31.

In addition, the opinion makes a couple of interesting procedural points:  (1) a plaintiff cannot incorporate by reference lengthy documents into its complaint since that would make answering the complaint impossible.  Id. at 29.  (2) "Information and belief" allegations, where the basis for the information and belief is not stated, "allege insufficient facts" to support any cause of action.  Id. at 33.  These will be useful rulings in obtaining dismissal of similarly poorly pleaded complaints in the future.

Tiptoeing Through TwIqbal

First, Bexis wishes to welcome the Blog's readership from his new office at Reed Smith.  A fair amount of PR occurs with significant lateral hires in the law biz, but Bexis promises that it won't go to his head, even though the folks at 360 decided he deserved a promotion to "guru" status.

Ommmmmmmm.....

Anyway, enough of that.  Let's get back to our blogging.  The other day we saw a TwIqbal article on a BNA news letter written by a couple of Arnold & Porter lawyers (Agneshwar  and Sharpe).  We had to read it, if only because it used the term “TwIqbal,” since the Blog has, if not outright invented the term (we heard it used at a PLAC meeting years ago) at least popularized it.  It turns out that the A&P article cited heavily to the blog − in particular our 2009 survey of TwIqbal law and our TwIqbal cheat sheet.


So reading the A&P article, and its reliance on the blog, got us thinking.  In particular, it got us thinking about a dirty little secret.  That secret is that our TwIqbal cheat sheet is probably not as comprehensive as our other cheat sheets and scorecards.  We haven’t done a thorough TwIqbal review in over six months.  That’s partially because there are simply so blasted many TwIqbal opinions and partially because we’re particularly selective on that scorecard.  We don’t put cases in our TwIqbal cheat sheet if they deny dismissal of any significant TwIqbal issue, even if a particular opinion is favorable on other pleading points.

Anyway, the A&P article has spurred us into action to find cases that we may have missed through our somewhat catch-as-catch-can updating process for the TwIqbal cheat sheet.  We’ve done some research into drug/device related TwIqbal cases (all product liability cases is just too much work, now) and here’s what we’ve found:

Cases TwIqballed for failure to allege any facts in support of the claims.

Deese v. Immunex Corp., 2012 WL 463722, at *5-7 (S.D. Miss. Feb. 13, 2012); In re Pamidronate Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 272889, at *3 (E.D.N.Y. Jan. 30, 2012) (all arguably unpreempted claims); Fullington v. PLIVA, Inc., 2011 WL 6153608, at *5 (E.D. Ark. Dec. 12, 2011) (all arguably unpreempted claims); Callaway v. American Medical Systems, Inc., 2011 WL 7724268, at *4 (W.D. La. Dec. 8, 2011).

Cases TwIqballed for failure to allege the identity of the manufacturer.

Callaway, 2011 WL 7724268, at *4; Esposito v. I-Flow Corp., 2011 WL 5041374, at *4-5 (E.D. Pa. Oct. 24, 2011).

Cases TwIqballed for failure to allege causation.

Bartlett v. Pfizer, Inc., 2012 WL 718782, at *3 (D.R.I. March 5, 2012); Callaway, 2011 WL 7724268, at *4.

Cases TwIqballed for failure to allege injury.

Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352, 1360-66 (11th Cir. 2011) (plaintiff had not pleaded recoverable economic injury); Polk v. KV Pharmaceutical Co., 2011 WL 6257466, at *6, 8 (E.D. Mo. Dec. 15, 2011).

Cases TwIqballed for failure to plead the nature of claimed FDA violations.

Metz v. Wyeth LLC, ___ F. Supp.2d ___, 2012 WL 1058870, at *6 (M.D. Fla. March 28, 2012) (negligence per se claim); Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19-22 (W.D. Pa. March 14, 2012); Viserta v. St. Jude Medical, Inc., 2012 WL 667814, at *3-4 (D.S.C. Feb. 29, 2012); Erickson v. Boston Scientific Corp., ___ F. Supp.2d ___, 2011 WL 7036060, at *6 (C.D. Cal. Dec. 12, 2011); Tierney v. AGA Medical Corp., 2011 WL 7400469, at *4 (D. Neb. Nov. 18, 2011); Rhynes v. Stryker Corp., 2011 WL 5117168, *5 (N.D. Cal. Oct. 27, 2011).

Cases TwIqballed because res ipsa loquitur was too vaguely pleaded to establish negligence.

Gross, 2012 WL 876719, at *10.

Warning claims TwIqballed for failure to plead what was inadequate about the warning.

Reed v. Pfizer Inc., ___ F. Supp.2d ___, 2012 WL 859729, at *3-4 (E.D.N.Y. March 14, 2012).

Warning claims TwIqballed for failure to plead causation as to the

prescribing physician under the learned intermediary rule.

Deese, 2012 WL 463722, at *5; Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962, at *4 (D. Md. Dec. 30, 2011).

Warning claims based on failure to provide any FDA mandated package insert
TwIqballed for failure to plead any facts to support the claim.

Salvio v. Amgen, Inc., 2012 WL 517446, at *3 (W.D. Pa. Feb. 15, 2012).

Failure to update warning claims TwIqballed for failure to plead any facts to support the claim.

In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618, at *4 (E.D. Ky. March 5, 2012); Bowman v. Wyeth, LLC, 2012 WL 684116, at *7 (D. Minn. March 2, 2012); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *4 (S.D. Ga. Jan. 19, 2012); Del Valle v. PLIVA, Inc., 2011 WL 7168620, at *7 (S.D. Tex. Dec. 21, 2011) (all generic drug preemption cases).

Design defect claims TwIqballed for failure to plead risk-utility.

Grinage, 2011 WL 6951962, at *6.

Design defect claims TwIqballed for failure to plead alternative design.

Reed, 2012 WL 859729, at *5; Salvio, 2012 WL 517446, at *7.

Manufacturing defect claims TwIqballed for failure to nature of defect.

Eckhardt v. Qualitest Pharmaceuticals Inc., ___ F. Supp.2d ___, 2012 WL 1511817, at *5 (S.D. Tex. April 30, 2012) (generic preemption case); Cooley v. Medtronic, Inc., 2012 WL 1380265, at *4 (E.D. Ky. April 20, 2012) (PMA preemption case); Reed, 2012 WL 859729, at *5; In re Fosamax Products Liability Litigation, 2011 WL 5903623, at *5 (D.N.J. Nov. 21, 2011).

Implied warranty of fitness for a particular purpose claims
TwIqballed due to failure to allege any facts to support the claim.

Reed, 2012 WL 859729, at *6; Grinage, 2011 WL 6951962, at *6-7

Express warranty claims TwIqballed for failure to plead the language of the warranty.

Gross, 2012 WL 876719, at *26; Reed, 2012 WL 859729, at *6; Deese, 2012 WL 463722, at *6.

Express warranty claims TwIqballed for failure to plead failure to plead basis of the bargain.

Gross, 2012 WL 876719, at *27; Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *4 (W.D. Pa. Nov. 10, 2011).

Res ipsa loquitur claims TwIqballed for failure to plead how
possible alternative causes are ruled out.

Gross, 2012 WL 876719, at *24-25.

FDCA violation claims TwIqballed for failure to plead causation by the violation.

Bartlett, 2012 WL 718782, at *4; Viserta, 2012 WL 667814, at *4.

We've simultaneously updated the cheat sheet to reflect these cases.  You might ask if that's redundant information but (aside from wanting to maintain our lists), the cheat sheet is set up in a fundamentally different fashion from this post.  This post is organized by subject, whereas the cheat sheet is strictly chronological by case.

Anyway, there's the newest TwIqbal ammunition.  Now get out there and win us some more cases to put on the list.

Another Homework Failure By Plaintiffs

            Yesterday, we blogged about a case where plaintiff failed to do even the most basic investigation to identify the product at issue before filing suit.  She was hoping her case would survive with some vague pleadings in the alternative and a request for discovery.  Unfortunately, for now it is.  So, since that case left us feeling a little down, we decided to focus today on a case that similarly suffered from a lack of facts -- but this one got tossed out.  Happy faces back in place. 

As this blogging team is made up of parents with children of varying ages, we are all too familiar with homework.  So, we are also familiar with phrases such as:  “Take your time;” “show all your work;” “follow the directions;” and most importantly – “do your best!”  We tell our children that we understand they want to go to the park, text their friends, or drive to the mall -- but they have to do their homework.  Why?  Not just because it is required, but because they will learn something.  That’s the point of homework, isn’t it?  Not just to torture kids (and parents), but to teach them something.  Well, the same is true for lawyers – we need to do our homework.  For plaintiffs’ lawyers that means learning the basic facts that support their clients’ claims before they file their lawsuits.  And, just like kids who don’t do their homework get zeros – so should plaintiffs.

That is precisely what recently happened in the Darvocet MDL in the context of personal jurisdiction – or lack thereof.  The Darvocet litigation involves injuries alleged to have been caused by the prescription pain medication propoxyphene, which is manufactured by several pharmaceutical companies (brand and generic).  Shortly after propoxyphene was withdrawn from the market, Endo Pharmaceuticals purchased three companies that had previously manufactured or distributed the drug.  In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226 (E.D. Ky. Apr. 18, 2012), slip op. at 2.  Plaintiffs filed suit against both Endo and its newly purchased subsidiaries.  Id.  

As one of several reasons why these cases should be dismissed (including our new one-two preemption punch, see prior post re: Darvocet MDL), Endo asserted lack of personal jurisdiction.  While plaintiffs bear the burden of proving personal jurisdiction, as this court recognized, the burden is “relatively slight.”  Slip op. at 4.  But slight is at least one degree up from nothing, which is what plaintiffs had. 

On specific jurisdiction, plaintiffs argued that it could be established over Endo “through successor liability or other liability theories.”  Slip op. at 6.  Plaintiffs’ sole support for their argument was the following statement in their complaints:

The extent to which Defendant [Endo] may have assumed responsibility for the acts, omissions or liability of other . . .  Defendants, contractually or otherwise, is unknown at this time, and Plaintiff requires discovery as to this issue.  

Slip op. at 7.   The court had the same question we do:  “But what facts?”  Id.   Accepting that statement as true all it establishes is that Endo “may have somehow assumed the liabilities of their subsidiaries.”  Id.  OK.  And there “may have” been a second shooter on the grassy knoll.  And “maybe” John Lennon, Elvis Presley, Andy Kaufman and Tupac Shakur are all hanging out on a deserted island in the South Pacific.  Oh, the power of “maybe.”  But it isn’t good enough to state a legal claim:

[T]he only factual assertion [plaintiff’s allegation] contains is that the plaintiffs do not have the information they need to establish personal jurisdiction.  Thus, even if the plaintiffs were permitted to stand on their pleadings, they would fall woefully short of the necessary prima facie showing.

Slip op. at 7 (quotation marks and citation omitted).         

            More to our liking than yesterday’s case, this court didn’t leave the door open:  “Nor is the Court persuaded by the plaintiffs’ insistence that jurisdictional discovery is needed, since the lenient prima facie standard is premised on the assumption that plaintiffs will not have had the benefit of such discovery.”  Slip op. at 8.  As an aside, plaintiffs’ reliance on successor liability was also misplaced because there is no successor liability if the original entity still exists.  Slip op. at 7-8.  You’ve got to do your homework, people.

            Having failed on specific jurisdiction, plaintiffs turned to general jurisdiction.  After making basically the same erroneous successor liability arguments, plaintiffs also argued that jurisdiction exists because Endo has pharmaceutical representatives in the forum states.  Slip op. at 10.  Plaintiffs seemed to think that this fact alone was sufficient to confer jurisdiction under Goodyear Dunlop Tires Operations, S.A. v. Brown, 131 S. Ct. 2846 (2011).  But, since in that decision the Supreme Court rejected “a sprawling view of general jurisdiction,” “the fact that some (non-proproxyphene) products manufactured by [Endo] may have been sold in the forum states is not dispositive, as such products did not give rise to the plaintiffs’ alleged injuries.”  In re: Darvocet, slip op. at 10-11.  Thus, “the mere presence of a corporation’s sales representatives in a forum state is insufficient to establish personal jurisdiction over the company.”  Slip op. at 11.   

            While we don’t like when our kids don’t do their homework, we are generally OK when plaintiffs don’t if the result is a dismissal at the pleadings stage (well, we like a dismissal at any stage really).  Congratulations to Mark Cheffo, Katherine Armstrong, and Rachel Passaretti-Wu of Skadden, Arps, Slate, Meagher & Flom LLP   for this win and to Lincoln Wilson  for forwarding it along. 

Product Identification Problems at the Pleading Stage

As another work-week starts, we thought we’d talk about beginnings – in particular, beginnings to adversarial contests.  They almost always begin after the adversaries and the stakes have been identified.  In the NHL, for instance, the New Jersey Devils learned this weekend that they will play the Rangers in the next playoff round.  The teams have been identified and we know what they’re playing for – a spot in the Stanley Cup Finals.  So now their series begins (tonight).  In the world of reality TV, America’s Got Talent begins tonight.  The contestants have been identified and we know what’s at issue . . . . whether America will accept Howard Stern on prime-time TV!

But unfortunately product liability lawsuits don’t always begin this way.  Sometimes plaintiffs will sue and name particular defendants without even knowing what product may have hurt them or who manufactured it. 

In Parker v. Howmedica Osteonics Corp., 2012 U.S Dist. LEXIS 62477, at *4-5 (May 3, 2012), for instance, the plaintiff brought product liability claims against three manufacturers of knee replacement hardware, claiming that hardware used during her knee surgery was defective and injured her.  Her allegations against the three defendants were in the alternative.  Id.  In other words, she didn’t know which defendant manufactured the hardware.  In fact, she didn’t seem to know whether any of the defendants manufactured the hardware.  So she also sued four fictitious corporations and individuals.  Id. at *5 n.1. 

That hardly seems like a fair way for three defendants to begin a lawsuit.  Now, maybe, one could envision a scenario in which such a scattershot beginning to a lawsuit might be proper.  But the facts in Parker sure don’t seem to indicate that it is such a case.  The plaintiff didn’t even review all of her own medical records before suing the three defendants:

The present record suggest that [the plaintiff] has not yet obtained a copy of all of her medical records, which may include a more precise description of the knee replacement product that was implanted during [the plaintiff’s] surgery.

Id. at *7.  That sure seems like something the plaintiff should have done before beginning her lawsuit.  Even if the medical records didn’t offer an answer, the plaintiff had other options.  She could have, for instance, asked her doctors or the hospital to identify the hardware implanted in her knee. 

In any event, and not surprisingly, the defendants moved to dismiss.  There’s mostly good news in the court’s decision but there’s also some not-so-good news.  The good news is that the court found plaintiff’s complaint “deficient because it fails to identify the product that allegedly caused her injuries.”  Id. at *8.  That is certainly good news.  A plaintiff shouldn’t be allowed to roll forward into full-blown discovery based on guesstimates of who the defendants are.  In fact, the court had already stayed discovery in this and a related case.  Id. at *11-12.  That’s more good news. 

The not-so-good news is that the court “decline[d] to dismiss [plaintiff’s] complaint.”  Id. at 8.  The court instead granted a motion under FRCP 12(e) for a more definite statement of plaintiff’s complaint.  Id.  The court gave plaintiff 30 days to review her medical records and amend her complaint to name the right product.  Id. at *8-9.  We would have preferred a dismissal, even if it was without prejudice.  With that, in the least, the statute of limitations may have run further while the plaintiff conducted the review that she seemingly should have conducted before filing suit.

The court also held that, if plaintiff still cannot identify the product after reviewing her own medical records, she could file a motion with the court describing limited discovery that she believes is necessary for her to identify the product and its manufacturer.  Id. at *9.  During this time, the stay on general discovery would remain in effect.  Id. at *12.  This part of the opinion doesn’t thrill us either.  We aren’t enamored of the notion that a plaintiff can begin a lawsuit unsure of whether she is suing the right defendants, yet still somehow get discovery from those defendants – limited or not. 

That said, the court did give the defendants the opportunity to respond/object to any motion by plaintiff for discovery on the identity of the product.  That opportunity should include the chance to argue that the plaintiff is entitled to no discovery whatsoever.  The plaintiff should not be allowed discovery unless she can show that she conducted a proper review of her medical records and exhausted other avenues available to her to identify the product – something that seemingly should have happened before she began the lawsuit. 

It will be interesting to see how the case proceeds, and we may know more after plaintiff’s 30 days are up.  And by that time we may also know how prime-time America and Howard Stern mix.