Thursday, September 29, 2011

Twice Nice?

Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmsourceBergen litigation involving the then novel concept of liability of non-counterfeitors for injuries caused by counterfeit drugs.

We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.

Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.

The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.

Futile Dear Doctor letters:  In a claim analogous to what we’ve been seeing post-Mensing against generic drug manufacturers (indeed, the court references generic drugs explicitly, 2011 WL 4470701, at *24), the plaintiff claimed that the original manufacturer should have issued a Dear Doctor letter warning against use of reprocessed products.

The court assumed a duty and then assumed that such a letter was permissible under FDA regulations – but still blew out the claim.  There was no possible causal effect in warning heart surgeons to be especially careful during heart surgery:

[I]f a plaintiff's proposed warning would not have changed anyone’s behavior, a product cannot be defective for lacking that warning.  Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.
2011 WL 4470701, at *24.  Whoop!  Whoop!  Common sense alert!

There was also “not a shred of evidence” that this kind of content-free advice would have changed the result, id., particularly since, after learning the hard way the very information the Dear Doctor letter would have provided, the surgeons in question hadn’t changed their behavior in any way.  Id. at *25.

Regulatory informed consent asserted against a manufacturer. Say what?  We've seen plaintiffs sue doctors claiming that they wouldn’t have consented to a treatment if they knew it was off-label.  That’s one of the claims we killed in Bone Screw.  In Kapps, however, the plaintiff tried to turn the same argument on a manufacturer, claiming that since the prescriber testified he wouldn’t have used the product had he known there was no FDA approval (this argument assumes that minor modifications = unapproved), then the learned intermediary rule gives him a cause of action against the manufacturer.  2011 WL 4470701, at *20.

Umm....  No it doesn't.

First we find a ringing endorsement of the learned intermediary rule as a shield, not a sword:

The learned-intermediary doctrine is a defensive doctrine, not an offensive one.  It is raised by makers of drugs or medical devices who are accused of failing to warn about the dangers associated with their products.
2011 WL 4470701, at *20.  The court follows with equally good language about the limits of the duty to warn under the rule:

A manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products.  For example, a manufacturer does not have to communicate that the product was made with child labor or that the manufacturer’s president has been convicted of fraud, even though such “warnings” might induce customers not to use the product.  The duty to warn is much narrower . . . .:  (1) The duty to give adequate instructions for safe use; and (2) the duty to warn of dangers inherent in improper usage.  [Defendant’s] alleged failure to warn that its reprocessing techniques had not been approved by the FDA breached neither of these duties.
Id. (citation and quotation marks omitted) (emphasis added).  We love it when FDA-regulatory-status claims get dismissed.

Buckman-FDCA private right of action.  In a unique setting, plaintiffs challenged the reprocessor’s decision to “extend” its line of reprocessed products to include the catheter in question by means of a “minor modification” procedure (it wasn't one of the 68 that the FDA actually approved for reprocessing).  We’ve always had some liability worries about the minor modification process, where the device manufacturer decides to act, essentially unilaterally, by means of its own memo to file.  The court refused to allow the claim, first finding that approval-related violations couldn’t possibly prove a tort:

Whether [defendant’s] reprocessing procedures damaged the failed catheter is an entirely separate question from whether [it] sought FDA approval for those procedures through the proper route.  That is, even if [defendant] had received 510(k) approval for reprocessing [the] catheters, [it] could still be liable for selling a defective . . . catheter if, in reprocessing a particular catheter, [defendant] damaged the catheter and rendered it defective.  And, conversely, if [defendant] did not damage a catheter during reprocessing, then even if [it] should have sought 510(k) approval for its reprocessing procedures, [its] failure to seek such approval would not render an undamaged catheter defective.
2011 WL 4470701, at *19. This is an important point, since practically any claim founded on a “you didn’t get the right FDA approval” argument will fail under the same analysis.  The court went on to hold that allegations of misuse of the minor modification procedure were nothing more than an improper attempt to enforce the FDCA despite its lack of a private right of action.  Id.

Meeting a similar fate is an alleged duty to warn doctors about the purported FDA lack of approval.  Such a warning has nothing to do with a state-law tort claim, but rather is “superfluous,” since if the product was defective, no FDA regulatory status warning could save the manufacturer, and if it’s not defective, then the FDA regulatory status couldn't create liability.  2011 WL 4470701, at *21.

Negligence per se. You can’t have negligence per se under the FDCA unless there’s an analogous state law claim.  We’ve harped on this, so we’re always pleased to encounter additional supportive precedent.

In a negligence per se case, the plaintiff seeks to hold the defendant liable because the defendant violated a statute.  And that is why a claim of negligence per se cannot be based on a violation of the FDCA . . . .  [T]o avoid preemption under Buckman, a state-law tort claim must be premised on the type of conduct that would traditionally give rise to liability under state law – and that would give rise to liability under state law even if the FDCA had never been enacted.  A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment.  Such a claim is preempted under Buckman.
2011 WL 4470701, at *19.  The context may be new, but the principle isn’t.  Approval-based claims can’t be negligence per se because they’re a form of licensing claim, and tort law has nothing to do with licensing.

Warning claims in a reprocessing situation:  The opinion offers some interesting dictum that, since the reprocessor had removed the original manufacturer’s warnings and substituted its own, the reprocessor had “usurped” the manufacturer’s “function” and any prior failure to warn would be non-causal:

[I]f [plaintiff’s] claim depended on an argument that [defendant] negligently failed to include certain warnings in its instructions for use, [that] warning-defect claim against [defendant] would fail for lack of causation:  [Plaintiff’s] damages could not have been caused by the omission of a warning from [defendant’s] instructions for use, because [the reprocessor] replaced [the manufacturer’s] instructions with its own, and thus [the original] instructions did not accompany the catheter that injured [Plaintiff].
2011 WL 4470701, at *23.

Nor was the original manufacturer obliged to warn that reprocessing was dangerous.  The label already explicitly stated that the devices were intended for single use only:

Even if it is true that reprocessing renders [defendant’s] catheters unsafe, the Court finds, as a matter of law, that in light of the fact that [defendant] warned doctors not to use reprocessed catheters at all, [it] had no duty to emphasize that it was serious about its warning or to elaborate on the reasons for its warning.
2011 WL 4470701, at *25.  More common sense.

Can someone become a manufacturer by estoppel?  The reprocessor gave its own manufacturer’s warranty and had marketing materials in which it stated “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”  2011 WL 4470701, at *4.  Even though the reprocessor claimed that it only provided a service, and had contracts to that effect, the court held that it could be considered a manufacturer for purposes of strict liability:

[S]everal aspects of [the reprocessor’s] business strongly suggest that it should be treated as a manufacturer.  First, [it] removed [the manufacturer’s] instructions for using the . . . catheter and substituted its own instructions. . . .  Second, [the reprocessor] removed [the manufacturer’s] lot number from the catheter, thus preventing subsequent users from learning about the catheter’s manufacturing history.  Third, [the reprocessor’s] entire marketing strategy depended on convincing customers that devices reprocessed by [it] were exactly equivalent to, and perfect substitutes for, devices made by original equipment manufacturers. . . .  Fourth (relatedly), [the reprocessor] warranted the functionality of the catheter. And finally, [the reprocessor] tells doctors that “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”
Id. at *30. If it quacks like a duck, it’s a duck.  We don't begrudge the plaintiff this one.

The expert who didn’t do his homework.  The court blew out most of a really horrible expert report.  The expert invented some pretty wild hypotheses about a smear of polyurethane glue on the recovered part of the product, but didn’t bother to learn anything about polyurethane or how it interacted with the chemicals useds in reprocessing.  There’s nice “ipse dixit” language.  2011 WL 4470701, at *16.  Ultimately some of the expert’s testimony was allowed in support of a res ipsa manufacturing defect theory – which, since oftentimes an expert’s testimony isn’t needed at all – is just about the lowest and worst use of an expert.  Id. at *18.

Punitive damages:  Reprocessing a single use medical device isn’t enough to support a punitive damages claim, since the FDA allows this to be done:

Given that the FDA regulates the medical-device-reprocessing industry and [finds benefit to reprocessing], the fact that [defendant] reprocesses catheters that [the original manufacturer] markets for a single use cannot be a basis for awarding punitive damages.
2011 WL 4470701, at *33.  We like decisions that find FDA regulatory approval preclusive of punitive damages.  Nor was a mere “regulatory mistake” (plaintiff’s attack on the minor modification process) anything suggesting “deliberate disregard” for patient rights.  Id. We like that even better.

Res ipsa: You can’t bring a res ipsa claim against the original manufacturer of a reprocessed medical device, because the reprocessing and reuse, contrary to labeling, are an obvious other cause for any post-reprocessing malfunction.  2011 WL 4470701, at *22.

Heeding presumption:  Minnesota doesn’t recognize a heeding presumption, but in any event, warning someone to be careful, when they probably already are, doesn’t show any different result whether the warning is heeded or not.  2011 WL 4470701, at *25 n.22.

Some of the issues in Kapps are completely novel.  None of them have (as far as we know) been raised in the context of the reprocessing of single use devices.  For this reason, Kapps should be required reading for anyone defending a case involving a reprocessed device – whether representing the original manufacturer or the reprocessor.

Wednesday, September 28, 2011

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal.  Here's one.  Today, in Degelmann v. Advanced Medical Optics, Inc., No. 10-15222, slip op. (9th Cir. Sept. 28, 2011), the Ninth Circuit held that a claim that a contact lens solution manufacturer should have tested its product against a particular microorganism was preempted.

Here's the reasoning, in a nutshell.  (1) there can be "specific requirements," even in 510k, Class II cases; (2) an FDA guidance document (significantly, not a formal regulation) allowed contact lens solutions to come to market under 510k provided the manufacturer did certain specific things; (3) one of those things was the "primary performance criteria" of a "stand alone procedure" - that the solution "show[] the prescribed level of efficacy in killing five representative microorganisms"; (4) the defendant's solution undisputably met this test in wiping out the five specified bugs; (5) plaintiff's claim demanded that the solution also kill a different microorganism that was not on the FDA's list; (6) since plaintiff's demand related to a different microorganism, it was "different from" and "in addition to" the FDA's device specific requirement; (7) all claims "different from" or "in addition to" a device specific requirement" are expressly preempted.  Degelman, slip op. at 18567-70.

So if you're a 510k, Class II device manufacturer, and the FDA's tagged your product with a device-specific guidance document, you may be able to assert preemption after all, at least against some claims.

Given the strength of the preemption defense, it's something worth looking into.

We're Jealous

Plaintiff, suffering from pain and nausea, goes to the hospital and is administered an injection of promethazine HCL (otherwise known as Phenergan).  The injection was accidentally put in plaintiff's artery instead of her vein.  The resulting vascular injury required amputation of plaintiff's right arm.  If this sounds very familiar -- it should.  So you may think this is another post about Wyeth v. Levine.  But, these are the facts of the recent decision in Schork v. Baxter Healthcare Corporation, 2011 U.S. Dist. LEXIS 107687 (S.D. Ind. Sept. 22, 2011). 
So why are we blogging about it?  Because there are two major differences -- 1) Schork involved a generic drug and 2) because of #1, the court found plaintiff's claims preempted.  The  court's legal analysis is just that simple.  The Supreme Court decided Mensing, this case involves a generic drug, therefore preemption.  It is difficult to imagine two cases more similar factually and more divergent legally.   And this is only the beginning. 
Our thanks to Mike Suffern at Ulmer & Berne  and Alan Klein  at Duane Morris  for forwarding us this decision.

Tuesday, September 27, 2011


With our focus on prescription drug and medical device product liability litigation, we sometimes overlook developments that occur outside the boundaries of our own little sandbox.  While that’s necessary to restrict the blog’s scope to something manageable, nonetheless it’s somewhat artificial.  Drug and device law doesn’t exist in some kind of vacuum, cut off from the rest of tort law.  What we do here sometimes affects other types of cases, and what goes on in other types of cases certainly can have significant impact on our clients.

One of the other things that Bexis does around here to make himself useful is to prepare monthly memoranda that summarize newly decided cases involving Pennsylvania tort and product liability law generally (he's a glutton for punishment).  In that capacity, he came across Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011), which on its face has nothing to do with prescription drugs or devices.  Instead, it has to do with injury allegedly suffered from a child car seat.

The accident apparently happened when, for unknown reasons, the child’s mother plowed her minivan headlong into a tree.  The father originally brought the suit, but also for unknown reasons – possibly due to the parents’ questionable actions – a bank ended up as guardian ad litem.  See Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 2789336 (E.D. Pa. July 18, 2011) (parents sanctioned for recklessly spoliating the product); Waltman v. Dorel Juvenile Group, Inc., 2009 WL 2877153 (E.D. Pa. Aug. 28, 2009) (parents entered into secret release, and then hid it during discovery).

The Dorel opinion at No. 3740472 addressed with a plethora of "in limine" (that means evidentiary matters presented before trial) motions.  We're old enough to remember when in limine motions were thought of as unusual; but they've propagated faster than rabbits since we've been practicing - but back to the point.

In deciding these in limine motions the interconnectedness of the law becomes blatantly apparent in Dorel.  First off, in an extremely odd decision, the court threw the case into suspense, and refused to decide a large number of the motions.  We’ve blogged before about the uncertainty now at the heart of Pennsylvania product liability law, as to whether the Commonwealth will continue its peculiar brand of strict liability or else move to the more negligence-friendly Restatement Third of Torts.

As lauded in our most recent post on that subject, the Third Circuit reaffirmed its prediction that Pennsylvania would move to the Restatement Third approach.  Covell v. Bell Sports, Inc., ___ F.3d ___, 2011 WL 2690396 (3d Cir. July 12, 2011).  Well, the court in Dorel decided to stage the judicial equivalent of a sit-down strike, placing the case in “suspense pending resolution of this conflict”:

A petition for review en banc is currently pending in Covell.  Meanwhile, the Pennsylvania Supreme Court has indicated that it may take up the question again.  See Lance v. Wyeth, 15 A.3d 429 (Pa. 2011).
2011 WL 3740472, at *1.  We presume that counsel in the case have already informed the court that the Third Circuit, without dissent, denied en banc rehearing on August 8 – more than two weeks before the suspense order in Dorel.

The other (Lance) citation demonstrates the interrelatedness of tort law.  Lance is a prescription drug case.  We know it well; some of us even worked on the current appeal.  What we don’t understand is how the court in Dorel thought that, in Lance, the Pennsylvania Supreme Court somehow had before it anything relating to the Covel/Restatement Third issue.  The issues that the Supreme Court agreed to hear in Lance are available both on this blog and on the Supreme Court’s website, and they have nothing whatever to do with the future of strict liability in Pennsylvania.

So right off the bat, neither of the excuses given for putting the Dorel case into suspense hold water – and they’re both subjects already covered on this blog.  Dorel could be in suspense for a long time.

But there’s more to the seamless web of tort law at work in Dorel than an inexplicable suspense decision.  Despite that order, the court went on to decide quite a few of the motions in limine.  Some of them, we think the court got wrong; some we think the court got right.

One of the defense experts wanted to testify that the product in Dorel complied with a federal automobile regulation (called an “FMVSS”).  The plaintiff claimed that “such testimony would constitute an impermissible legal conclusion.”  2011 WL 3740472, at *4.  Shocking as it may sound, we agree with the plaintiff on that one.  We don’t see any conceptual difference between that proffered testimony, and an expert testifying that a product complied – or didn’t comply – with an FDA regulation.  In a series of posts, here, we’ve argued until we’re blue in the face that the ultimate conclusion that a product complied or didn’t comply with a statute or regulation is a legal conclusion that an expert witness should not be allowed to give.  The proper way to go about it is to have the expert testify that the product had X, Y, and Z features (all of which were in compliance with the law), and then ask the judge to instruct the jury that the product in fact complied.  The judge is where the jury should look for legal conclusions during trial, not either sides’ paid experts.

In a ruling we agree with, the Dorel court ordered the exclusion of “foreign regulatory actions and labeling.”  2011 WL 3740472, at *9.  This issue also arises frequently in drug and medical device litigation, and we’ve blogged on it a number of times, most recently here.  The court held, citing drug/device precedent, that foreign standards are irrelevant and prejudicial:

Evidence of foreign labeling requirements is inherently prejudicial and presents a substantial risk of jury confusion.  See In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1336 (S.D. Fla. 2010) (citing In re Seroquel Products Liability Litigation, 601 F.Supp.2d 1313, 1318 (M.D. Fla. 2009)); see also In re Baycol Products Liability Litigation, 532 F. Supp.2d 1029, 1054 (D. Minn. 2007) (collecting cases).  Plaintiff has also failed to show that [defendant’s] obligations under Canadian law are relevant here.  As Plaintiff observes, [defendant] “simply placed whatever labels conformed to the location where the [products] were sold.”  Standing alone, this difference in American and Canadian labeling requirements does not speak to the wisdom or safety of the product’s design.
2011 WL 3740472, at *10.  Again, a recurrent issue where drug/device law and other types of product liability cross-fertilize.

The same thing occurred in the next motion, where the plaintiff was trying to have the jury hear about product risks in other types of accidents (roll-overs) that didn’t happen to this particular plaintiff.  The court granted the motion because:  (1) such accidents were of little relevance, and (2) it was “cumulative” in light of studies done concerning the same type of crash.  2011 WL 3740472, *10.  Once agaain we see this sort of thing in our neck of the woods, as we discussed at some length here.  Indeed, not too long ago a Pennsylvania court rejected the contention that plaintiffs could claim that a drug maker’s failure to warn of a much less serious condition could possibly be causal where the product’s warnings contained adequate warnings of a much more serious risk (the one the plaintiff actually had).  Cochran v. Wyeth, Inc., 3 A.3d 673, 679-81 (Pa. Super. 2010) (see our post about Cochran here).

Finally, the last motion in limine that the court granted excluded the defendant’s ultimate decision to cease production of the product – taken after the accident in question – as a subsequent remedial measure.  Dorel, 2011 WL 3740472, at *16 (not proper impeachment where evidence intended to establish that the product “was in fact unreasonably dangerous and unsafe for its intended use”).  Again, we see plaintiffs in our cases try to do the same thing with subsequent drug recalls.  A subsequent drug recall (or labeling change) is equally a subsequent remedial measure, as we’ve argued here, among other places.

That’s five, count ‘em, five ways that rulings in the Dorel case – involving an infant car seat – can have impact on issues pertinent to prescription drug/medical device litigation, or vice versa.  We here at the Drug and Device Law Blog try not to wear the blinders too tightly for precisely this reason.  We recommend that our readers keep their eyes and ears open as well.  It may not be drug/device decision that helps us win our next case.

Monday, September 26, 2011

Gibberish Alert

It was twenty years ago today … we were driving down the 5 ("the 5" is the California way of saying I-5), on a stretch in Orange County where the Pacific Ocean kisses the highway, a persistent, teasing beauty. Well, except for the San Onofre nuclear reactor. We were arguing over the lyrics to Nirvana's "Smells Like Teen Spirit." Nevermind -- maybe the last truly great piece of rock art -- had just come out. Grunge had shown up on the scene wearing a dirty flannel shirt and mumbling. The debate was whether Cobain was singing, "here we are now/give us taters." He wasn't. But it did sound that way to some of us, and one could dream up a crazy world where those lyrics would work just fine.

The list of misheard rock lyrics is long and honorable: "there's a bathroom on the right," "'scuse me, while I kiss this guy," "then I told you about our kid/how he's not a tomato." Early critics of rock decried nonsensical or puerile lyrics. That "It was twenty years ago today" opening line to this post is obviously cribbed from "Sgt. Pepper's Lonely Hearts Club." The Beatles' lyrics were usually clear, but not always. Bob Dylan thought that in "I Wanna Hold Your Hand" the Beatles were singing "I get high." Apparently, that mattered a lot at the time. Lennon corrected Dylan, telling him that the lyrics were actually "It's such a feeling, that my love/I can't hide/I can't hide." Dylan's response? Those lyrics make no sense. Why hide your love? Lennon later wrote a song that sort of answered that question. The point is that even the best writers are capable of descending into gibberish. This weekend's Wall Street Journal furnished examples of anti-Beatles criticism over the years, including insults from Noel Coward, William F. Buckley, and even James Bond. Most of those criticisms now seem as nonsensical as the lyrics they attacked.

What's wrong with dopey lyrics? We learned this weekend that REM was breaking up. First, we didn't know they were still together. Second, we have to admit that we liked them better in their early years, when we could never understand what their lead singer, Michael Stipe, was saying. After REM tidied up their production values and rendered their lyrics understandable, the songs became a lot less interesting. In music, sound trumps sense. Not all song lyrics need intelligence or even intelligibility.

We were reminded last week that it's different in the law. In Stanard v. Nygren, No. 09-1487 (7th Cir. September 19, 2011), the Seventh Circuit administered a judicial whupping to a lawyer who could not author an intelligible complaint. It's not a drug or device case. Actually, it's not easy to say what the case is about, which is part of the problem. The interesting thing about the case for us is the standard of review for a district court's refusal to permit an amended complaint. The plaintiff argued for de novo review and the defendant argued for abuse of discretion. The defendant prevailed, and rightly so. Leave to amend under Fed. R. Civ. P. 15(a)(2) is discretionary. The ruling in Stanard is good news for all of us who spend most of our time representing defendants. It should be just a little bit easier for us to argue that it's time for the court to pull the plug on a case and dismiss with prejudice.

Of course, Stanard is a pretty unusual case. The plaintiff lawyer filed complaints that not only flunked TwIqbal, but they were so unintelligible that they did not come close to supplying the "short and plain statement of the claim showing that the pleader is entitled to relief" as required by Fed. R. Civ. P. 8(a)(2). The complaints did not give the defendant fair notice of the claims against it and the grounds supporting such claims. Note that we said "complaints" in the plural. The plaintiff lawyer had multiple opportunities to cobble together a decent complaint and utterly failed. The court actually called the complaints "gibberish."Slip op. at 15. The court listed the following problems:

* Lack of punctuation
* Near incomprehensibility
* Failure to follow basic directions
* Failure to put defendants on notice
* Grammatical and syntactical errors

Ouch. There are good ways to get famous and bad ways to get famous. This is a bad way. The court quoted a 345 word sentence from the complaint that leaves one dizzy. The plaintiff lawyer also invoked absurd legal theories. For example, the complaint cited the Constitutional proscription against cruel and unusual punishment. That probably won't get one very far in a non-criminal case. Moreover, the plaintiff lawyer repeatedly blew deadlines.

The Seventh Circuit concluded that the district court had bent over backward to give the plaintiff lawyer a chance to comply, and had no difficulty in deferring to the district court's decision that enough was enough. The appellate court's decision was made almost comically easy because the plaintif lawyer "failed to file a reasonably coherent brief on appeal." Slip op. at 20. He "cites 81 cases, but almost all of them are completely irrelevant to the issues presented here." Id. at 21. In short, the plaintiff lawyer's performance was "alarmingly deficient." Id. Thus, the Seventh Circuit not only held that "the district court was well within its discretion to deny leave to filed the second amended complaint and to dismiss the case with prejudice," but also referred the plaintiff lawyer for possible discipline. Id.

Let's face it, we see bad, vague, overlong, substance-less complaints every week, but few are as execrable as the monstrosities filed in Stanard. That being said, the Seventh Circuit has announced a useful principle: the district court can exercise reasonable discretion to see that there's no there there, and then end the case once and for all. A Court of Appeals is unlikely to reverse. Rock lyrics can consist of little more than "yeah, yeah, yeah," and they can even be "stupid and contagious." But we have a right to expect something more from court filings.

Friday, September 23, 2011


            Today we look at a common topic – sales representatives – in a slightly different light.  We are all well-versed in the learned intermediary doctrine.  More and more often, plaintiffs’ failure to warn claims in pharmaceutical and medical device cases are thwarted by knowledgeable physicians who apply their independent medical judgment in deciding whether a course of treatment is in the best interests of their patients.  This is a good thing – and often relegates the role of the sales rep in a products case to the back burner.
Of course, when we think about sales reps we typically picture a rep standing in a doctor’s office with a sample case and some handouts trying to get a few minutes of a doctor’s time to laud our clients’ products.   But there is another arena in which sales reps play a critical role – the operating room.  A modern surgical suite can look something like a cross between a NASA command center (if they were still in business) and your local auto repair shop.  Because of both the high tech nature of surgical equipment and the vast array of options available to surgeons, it is increasingly common for medical device manufacturers to have representatives attend surgeries.  Often this is just to observe the use of the company’s product, but sometimes the sales rep can “assist” the medical team by making sure the right product is available, helping nurses locate the proper instruments, or calibrating a product before use.  From our experience in the Bone Screw litigation, for instance, we know that sales reps often stand outside the sterile field  and use laser pointers to help nurses pick out the size instrumentation the doctor asks for.
Indeed, the AMA Code of Medical Ethics states:
Manufacturers of medical devices may facilitate their use through industry representatives who can play an important role in patient safety and quality of care by providing information about the proper use of the device or equipment as well as technical assistance to physicians.
AMAssociation. Opinion 8.047 Industry representatives in clinical settings. Code of Medical Ethics. 
With new and more complex medical devices and equipment entering the market each year, it is easy to understand why surgeons favor the availability of consulting technicians or medical device specialists.  But, from a legal standpoint, the presence of medical device sales reps in the OR raises issues of proximity and temporality that are not typical in a pharmaceutical case (although there have been cases in which plaintiffs have tried to argue that a pharmaceutical representative should be held to an affirmative duty to take action.  See Labzda v. Purdue Pharma L.P., 292 F.Supp.2d 1346, 1354 (S.D. Fla. 2003) (sales rep and pharmaceutical manufacturer have no duty to control doctor’s prescribing practices)).
While we have dipped our toe into this pond in the past (see prior post Riegel Toothpaste (Adkins v. Cytyc)), we decided to wade in a bit further and gather what we could find from courts that have addressed the issue.  What we found were essentially two types of cases – those in which a plaintiff accuses the sales rep of the unauthorized practice of medicine (less common) and those in which plaintiff attempts to impose on the representative, and therefore on the manufacturer, a heightened duty based simply on the representative’s presence in the OR.  The results in both categories of cases are split and appear to be largely fact sensitive – in other words, there is a fine line that when crossed turns the sales representative from a valuable asset to the surgical team into a potential liability for the manufacturer.  While there are few reported decisions on this topic, the takeaway, despite some of the favorable outcomes, is that there is real risk of liability – for both the sales rep and the manufacturer – if the sales rep gets too involved in the actual treatment of the patient or use of equipment during surgery.
            Unauthorized Practice of Medicine:  Any discussion of this topic would be incomplete without talking about one of the oldest and most extreme cases – the grandfather of the genre so to speak – People v. Smithtown General Hospital, 93 Misc.2d 736 (Suffolk County NY, 1978).  Yes, this is a criminal action brought against the surgeons and the hospital.  The surgery at issue was a hip replacement during which the sales manager who sold the hospital the hip prosthesis was present.  Smithtown, 93 Misc.2d at 738.  An x-ray taken after the surgery revealed that the hip was dislocated, so the surgeon called the sales manager back in.  First no-no -- the sales manager scrubbed in.  Next problem, after the surgeon couldn’t remove the prosthesis, the sales manager “offered to and did take it out.”  Don’t think it can get worse?  Think again.  The sales manager volunteered that he could fix the “thing” and “put it back.”  And so, with the surgeon’s consent, the sales manager finished the rest of the three and a half hour surgery, including reinsertion of the hip prosthesis.  During which time the surgeon sometimes left the table and maybe even left the OR once.  Id. at 739.   We said this was an extreme case.
            Not surprisingly, the court held that the doctor “abdicated his role as surgeon in that operating room and permitted the judgment and skills of a layman to prevail,” and that the sales manager’s “involvement in the surgical procedure extended beyond instruction as to the use or manner of implant of the device.”  Id.  While this case was brought against the hospital and the medical personnel, the court did also state:  “From the evidence presented, the Grand Jury could conclude that the salesman . . .unlawfully engaged in the practice of medicine without the prior informed consent of the patient under circumstances which did not constitute an emergency.”  We would have to agree. 
            Fortunately, we have not uncovered any other cases involving such a blatant surgeon-sales rep role reversal – but there are other examples where plaintiffs have attempted to hold sales reps and manufacturers liable on the theory of the unauthorized practice of medicine.  At the opposite end of the spectrum is Disbrow v. Smith & Nephew Richards Inc., 1996 WL 593780 (Tx. App. Oct. 17, 1996).  During another hip replacement surgery, a handle broke on a tool being used by the surgeon.  Plaintiffs sued the surgeon for medical malpractice and the device manufacturer and its sales rep for “practicing medicine without a license.”  Disbrow, 1996 WL 593780, *1.  The sales rep -- who was present during the surgery and who was responsible for locating a new handle for the tool -- did not scrub in, was “positioned at the back of the table”, and his only role was assisting the scrub nurse get equipment.  Finding no evidence of the practice of medicine without a license, the court granted defendants’ summary judgment motion.  Id. at *2. 
            We also found a more recent case that gave us pause because it started off sounding more like Smithtown.  The case was dismissed on the pleadings on statute of limitations grounds, but we include it to demonstrate that these type of allegations persist and as a word of caution to our medical device clients.  In Wilkerson v. Christian, 2008 WL 483445 (M.D.N.C. Feb. 19, 2008), plaintiff underwent a procedure to remove tumors from her liver by burning them with an electrode, a procedure known as ablation.  Within a week of the surgery, plaintiff’s liver failed, a transplant was unsuccessful and she died.  Wilkerson, 2008 WL 483445, *1.  Plaintiff brought a wrongful death action against the manufacturer of the electrode and its sales representative alleging that the sales representative “personally performed the ablation procedure when she operated medical equipment that was directly, by way of a continuous circuit, inserted into [plaintiff’s] body.”  Id.  Because the case was dismissed early on before discovery, there is no further discussion of what role the sales rep actually played during the surgery.  The court, however, while finding the case barred by the statute of limitations did have this say:
Plaintiff alleged facts, in good faith, that raise serious questions regarding the propriety of sales representatives in the operating room.  The gravity of Plaintiff’s allegation that a sales representative performed, or participated in, [plaintiff’s] tumor ablation procedure is not lost on this court.
Id. at *13.
            Duty to Protect the Patient:       These cases are more common and closer to traditional failure to warn cases – but again, there is something about the reps’ actual presence in the OR during surgery which has allowed some courts to find a duty that seems to trump the learned intermediary doctrine.  Since the case law is split largely based on fact sensitive issues, we’ll lead with one where we think the court got it right -- Kennedy v. Medtronic, 851 N.E.2d 778 (Ill. App. 2006).  The case involved medical malpractice and products liability claims stemming from the surgical implantation of a pacemaker in an outpatient facility (as opposed to a hospital).  Kennedy, 851 N.E.2d at 780-781.  Present at the surgery was the manufacturer’s clinical specialist whose primary responsibility was “to provide technical support and ensure that the [pacemaker’s] lead parameters were correctly calibrated and the lead was functioning properly.”  Id. at 787.  So, plaintiff’s theory against the manufacturer was that it owed a duty of care to the plaintiff (1) to “refrain from providing a pacemaker” to the surgeon when she knew the procedure would not be performed in a hospital, (2) to warn of the dangers of the procedure under those conditions and (3) “to assist with the insertion in a reasonable manner once it voluntarily undertook to participate.”  Id. at 782. 
            Affirming the trial court’s granting of defendant’s summary judgment motion and relying on the learned intermediary doctrine, the appellate court found:
a licensed physician . . .has the knowledge of his patient's medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient's needs and what medical care should be provided. It would be unreasonable, and potentially harmful, to require a clinical specialist . . . to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified. To hold otherwise would place a medical device manufacturer . . . in the middle of the doctor-patient relationship.
Id. at 786.    The court also rejected plaintiff’s claim that based on her limited role, the defendant’s clinical specialist voluntarily assumed a duty under section 324A of the Restatement (Second) of Torts.  Id. at 787. 
            We’ve previously discussed Wolicki-Gables v. Arrow International, Inc., 641 F.Supp.2d 1270 (M.D. Fla. 2009), aff’d on other grounds, 634 F.3d 1296 (11th Cir. 2011) favorable preemption ruling here.  But the court also was unwilling to find that a sales representative’s presence in the OR during implantation of a pain pump created a duty for the medical device manufacturer.  Plaintiff’s negligence action against the sales rep alleged “breach of the duty to use reasonable care in the instruction and education of physicians.”  Wolicki-Gables, 641 F.Supp.2d at 1279.  Sounds like failure to warn, right?  So, quite correctly the court kicked the claim based on the learned intermediary doctrine:
The undisputed facts show that [the sales rep] did not participate in the decision-making during [the] procedure. [His] role was limited to carrying “back up” products in their sterile packages to have available for the surgeon's use, if necessary, and to observe preparation of the products. [He] did not “scrub in” for the procedure . . . and did not enter the sterile field. . . . [The surgeon] testified that the decisions made while he performed surgery were his own decisions.

Id. at 1291.  More importantly, the court went on to say that “[e]ven if . . .[the sales rep] did have some interaction with [the surgeon] during that surgery”, the sales rep did not have “a duty to affirmatively tell” the surgeon how to use the device.  Id.   In other words, the surgeon is still in charge of the surgery – he is the captain of the ship.
We picked up this expression from O’Connell v. Biomet, Inc., 250 P.3d 1278, 1283-84 (Colo. App. 2010) in which the court found that plaintiff’s claims against a sales rep were discharged by the surgeon’s settlement agreement which included “agents” based on Colorado’s “captain of the ship doctrine.”  Id.  The description of the roles of the surgeon and sales rep was too good not to include:

The sole purpose of [the sales rep] being in the operating room was to provide [the surgeon] with information about the fixator, which information [the surgeon] then used to make his medical judgments. That is, [the surgeon] remained in control of the surgery vis-à-vis [the sales rep] and all other non-physicians in the operating room. Because [the surgeon] remained in control of the surgery, anything [the sales rep] might have done during that surgery, including any advice he allegedly gave or should have given to [the surgeon], was done as a crew member, so to speak, of the surgical ship.

Id.  We wish the next few courts shared Colorado’s understanding of the sales rep-surgeon relationship.

So as to not give the false impression that that defendants win all these cases, we give you the case of Zappola v. Leibinger, 2006 WL 1174448 (Ohio App. May 4, 2006), in which a jury found both plaintiff’s surgeon and the medical device manufacturer and sales rep liable for negligence.  During surgery to remove a brain tumor, based on the size and location of the tumor, plaintiff’s surgeon concluded that he could not use the manufacturer defendant’s device to reattach the plaintiff’s bone flap as planned.  Zappola, 2006 WL 1174448, *2.  The surgeon asked the sales rep “to observe the size of the cranial defect in [plaintiff’s] skull.”  Id.  The two then discussed possible methods of closing the skull, and the sales rep suggested another of his employer’s products.  The doctor expressed some concerns based on his past experience with similar products.  The sales rep told the surgeon that the product “had been improved.”  Id.  The surgeon decided to use the product.  The product fragmented and plaintiff suffered a cerebrospinal fluid leak resulting in four additional surgeries.  Id. at *3. 
The written warnings that accompanied the product provided specific instructions and guidance for using the product to close a cranial defect the size of plaintiff’s.  Id. at *2-3.  So, the defendant manufacturer argued that it satisfied its duty to warn the surgeon under the learned intermediary rule.  The court disagreed:
Although the written instructions [provided recommendations for use], [the sales rep] did not make these recommendations to the doctor. Despite the fact that he was professionally obligated to inform [the surgeon] about the use of the product and personally observed the size of [plaintiff’s] cranial defect, [the sales rep] did not uphold his duty of ensuring that the product was used properly.
Id. at *6.  The pivotal factor for the court seemed to be the fact that the sales rep was present and observed the plaintiff’s condition.  That appears to have been enough to impose on the sales rep and the manufacturer a heightened duty to warn – despite the fact that the learned intermediary in this case was a neurosurgeon who had past experience with the product. 
            Although not a case involving the operating room, Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006) is worth a quick mention regarding the interplay between the learned intermediary rule and the “hands on” sales rep.  Here, plaintiff’s cardiologist asked a pacemaker sales rep to attend an examination of plaintiff “to test the battery in her pacemaker” and “to make adjustments” as needed.  Hurley, 898 A.2d at 780.   Because the battery was low, the cardiologist and the sales rep discussed options regarding the downward adjustment to the rate of the pacemaker.  Id. at 780-81.  After the pacemaker was adjusted, plaintiff suffered a cardiac event and resulting permanent brain damage.  Plaintiff admitted that the pacemaker’s manual contained an adequate warning – so, the trial court granted defendant manufacturer’s motion for summary judgment based on the learned intermediary doctrine.  Id. at 779, 786.  In reversing that decision, the Connecticut Supreme Court focused on the sales rep’s presence at and involvement with the adjustment of the pacemaker:
What is at issue …is whether, notwithstanding the FDA approved written pacemaker replacement warnings, [the sales rep], by his oral communications to [the physician] that turning down the pacemaker was an option, accompanied by his physical adjustment of the pacemaker . . ., actually contradicted the manual, thereby vitiating and nullifying the manual's warnings. 
Id. at 786-87.  Did the sales rep’s suggestion also vitiate and nullify the cardiologist’s medical judgment?  Finding a question of fact, the case was remanded for trial on this issue.  We are happy to report that a jury eventually found in favor of the defendant and that verdict was upheld on appeal.  See Hurley v. Heart Physicians, P.C., 3 A.3d 892, 899-900 (Conn. 2010).  But we are again left wondering, if a sales rep had discussed downward adjustment with the cardiologist at some earlier time and then the cardiologist later decided to turn down the pacemaker – would this case have ever reached a jury?
            Temporality and proximity also won out in Chamian v. Sharplan Laser, Inc., 2004 WL 2341569 (Mass. Super. Sep. 24, 2004) in which defendant’s technician was present during plaintiff’s plastic surgery “to test the [laser] to ensure that it is working properly and to assist the physician by entering and adjusting settings as directed by the physician.”  Chamian, 2004 WL 2341569, at *3.  Again, there was evidence that the surgeon consulted with the sales rep on the appropriate settings during surgery.  Id. at *5.  The court found
[Defendant] provided a technician to assist in the surgery, and, by doing so, assumed a duty to [plaintiff] to ensure that the technician . . . was knowledgeable about the equipment and competent to provide technical assistance to physicians using the equipment. . . . The fact that [the surgeon] had the responsibility to exercise his clinical judgment to determine appropriate settings and was required by the standard of care to confirm that the settings he selected had been entered does not preclude negligence on the part of [the technician] from being a substantial contributing cause of [plaintiff’s] injuries.
Id. at *8.  Doesn’t it?  Isn’t that what the learned intermediary doctrine (and the captain of the ship doctrine) is all about?  The surgeon has the specialized medical training and knowledge of his/her patient to make informed and independent treatment decisions.  Unfortunately, at least a few courts have been swayed by the sales reps presence in the OR to forego the learned intermediary doctrine.  So, while the advantages of having a device representative present are readily apparent, so too are the risks.

Thursday, September 22, 2011

The New One-Two

As you can tell from our old drug preemption cheat sheet (before we split off generic preemption after Mensing), the Smith/Morris/Wilson trilogy out of Kentucky has been hanging fire for quite awhile, since before Levine, actually.  No longer.  Today the Sixth Circuit ruled and delivered a one-two punch that's precisely the winning combination that we're looking for.  Smith, et al. v. Wyeth, Inc., ___ F.3d ___, slip op. (6th Cir. Sept. 22, 2011).

It's a situation we've seen a lot in generic drug cases.  These plaintiffs, having taken nothing but the generic product (actually one did not fit that scenario here), claim some sort of injury and sue not only the maker of the generic drug that actually injured them, but also sue the original brand name manufacturer (who never made a penny from selling the plaintiff anything) under some woolly, attenuated reliance theory.

Well, the Sixth Circuit had none of it in Smith.  First, without any trouble at all, the court held that the warning claims against the generics were preempted:
Just as in the present case, the plaintiffs in Mensing alleged that their long-term use of generic [drug] caused [injury], and they predicated the manufacturers’ liability under state law on the failure to provide adequate warnings on the product’s label.  The Supreme Court held unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims. The plain language of the Pliva decision compels the same result here.
Smith, slip op. at 4 (6th Cir. Sept. 22, 2011).  That's the right hook to the jaw.

The Sixth Circuit also refused to have anything to do with allegations that branded manufacturers could be liable for defects in drugs they did not make or sell - but were in fact sold by their competitors.  "Just because a company is in the same business as a tortfeasor, the company is not automatically liable for the harm caused by the tortfeasor’s product."  Slip op. at 5 (quoting district court).  Kentucky law, the court held, did not allow that.  "A threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury."  Smith, slip op. at 5 (citing Kentucky Supreme Court case).  The other, pure foreseeability, theories have been rejected almost anywhere, the court observed, and then agreed, deciding that Kentucky would not permit anything so adventurous under its product liability statute:
The plaintiffs’ argument – that the name-brand defendants’ liability stems from the fact that the regulatory structure governing name-brand and generic drugs makes it foreseeable that patients and their physicians will rely on the name-brand labels to use and prescribe generic drugs – has been rejected by all but one of the courts that have considered it. [discussing and agreeing with Foster v. AHPC, 29 F.3d 165 (4th Cir. 1994) as "the leading case"; identifying Conte as exception]  As have the majority of courts to address this question, we reject the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company.  Moreover, and most significantly, the plaintiffs have not convinced us that the state courts of Kentucky would adopt their vicarious-liability argument under the Kentucky Products Liability Act.
Smith, slip op. at 6 (emphasis added).  That's the left cross to the temple, and plaintiffs are down for the count.

As the first court of appeals ruling post-Mensing on both issues, Smith promises to be an important case.

We'll be adding Smith to the relevant scorecards in a moment.

Thanks to Alan Klein of Duane Morris and Dave Schaefer at Dinsmore & Shohl, both for independently tipping us off within about ten minutes of each other.

Wednesday, September 21, 2011

Guest Post - The Best Defense Is A Good Offense

The following guest post about a couple of recent generic preemption opinions is written by Dylan Carson & Avril Love, of Tucker Ellis & West (a firm headed by Bexis' old Bone Screw compatriot Bob Tucker).  They get all the credit and or blame as the case may be for what follows


The start of the pro football season reminds us of the old adage, attributed to Vince Lombardi, that the best defense is a good offense. (Especially when watching Tom Brady and our beloved Patriots put up video game numbers on offense while the defense does its best to allow the same pinball numbers by the other side).

That adage comes to mind in two recent rulings out of the Northern District of Georgia, which dismissed an eight-count products liability complaint against two generic pharmaceutical manufacturers based on the one-two punch of TwIqbal and Mensing.  See Henderson v. Sun Pharmaceuticals Indus., Ltd., No. 4:11-cv-00060-HLM, 2011 WL 4024656 (N.D.Ga. Jun. 9, 2011); Henderson v. Sun Pharmaceuticals Indus., Ltd., No. 4:11-cv-00060-HLM, 2011 WL 4015658 (N.D.Ga. Aug. 22, 2011).  Yes, that’s more scores for the TwIqbal Cheat Sheet and Post-Mensing Generic Drug Preemption Scorecard.

In Henderson, Plaintiff alleged that he took several generic anticonvulsant medications (phenytoin and fosphenytoin) manufactured or distributed by the various defendants and that, as a result, he sustained severe skin reaction, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).  Plaintiff brought claims for (1) failure-to-warn, (2) strict liability, (3) fraud, (4) breach of warranties, (5) negligence, (6) gross negligence, (7) joint and several liability, and (8) punitive damages.  Boiled to its essence, this was a failure-to-warn case about generic medication.

Confronted with the complaint, the defendants went on the offensive.  One generic manufacturer, Caraco, threw long, taking aim at every cause of action.  The other generic, Mylan, looked only for a short gain, moving to dismiss only the fraud and breach of warranties claims.

In his first order, Judge Murphy winnowed down the allegations in the complaint, dismissing without prejudice all but the failure to warn and joint and several liability claims.  On the warnings claim, the court found a plausible claim that the defendants failed to warn plaintiff’s doctors of a risk of SJS/TEN from the medications.  Fair enough, but plausibility stopped there.  The court TwIqballed the claims for strict liability, negligence, and punitive damages.  Plaintiff had not alleged:  "any specific design or manufacturing defect"; "a specific list of injuries"; whether the defendants were manufacturers, distributors, suppliers or sellers of the product at issue; whether any specific product caused his injuries or contained a defect; or "the causal connection between the breaches [of duty] and Plaintiff's injuries.”

Particularly useful for those of us who see boilerplate complaints with scant facts about a plaintiff's injuries is the court's note that “the Complaint lists every possible side effect of phenytoin and alleges that Plaintiff 'suffered serious bodily injury including, but not limited to' those side effects.”  2011 WL 4024656 at *8.  "Such general, conclusory allegations, devoid of any specific, factual content to support the legal conclusions, are plainly insufficient under Iqbal."  Id. at *5.  The court also held that Plaintiff's "general, conclusory allegations" regarding punitive damages - basically a recitation of the elements - were insufficient without "any factual support for those allegations."  Id. at *8.

The court picked off the fraud claim for failure to plead with particularity, relying on the Eleventh Circuit's requirement to "plead the who, what, when, where, and how of the allegedly false statements."  Id. at *6.  In so doing, the court distinguished a contrary ruling in a similar phenytoin SJS/TEN case, which involved only one defendant – Mylan (Gainer v. Mylan Bertek Pharmaceuticals, Inc., Civil No. 09-690 (JNE/JSM), 2010 WL 2519988 (D. Minn. June 15, 2010).  In Gainer, that district court had found sufficient fraud allegations in a one-defendant case, but the Henderson court required more specificity when multiple defendants and multiple products were involved.  (Flagged for too many men on the field?)

The court also disposed of the breach of warranties claim based on Georgia's requirement for privity between the parties.  Because Plaintiff alleged to have purchased medications from retailing pharmacies, not the pharmaceutical defendants, there was no privity.  Some states have a food and drug exception to the privity requirement when warranties are involved; Georgia is not one of them.

With two counts surviving the initial blitz, the court dismissed the remaining claims without prejudice, allowing Plaintiff to draw up a new offensive strategy, er, complaint.  Two weeks after the court’s first order, however, the Supreme Court decided the Super Bowl, Pliva, Inc. v. Mensing. It is hard to score points against generics with a failure-to-warn game plan in a post-Mensing world.

Within days of the Mensing decision, Caraco’s parent, Sun Pharmaceuticals, moved to dismiss the remaining failure-to-warn and joint and several liability claims on preemption grounds.  Plaintiff moved for leave to file an amended complaint with just four counts: (1) strict liability, (2) negligence, (3) joint and several liability, and (4) punitive damages.  The amended complaint dropped the failure-to-warn claim and Plaintiff opposed the new motion to dismiss, arguing that the amended complaint would make it moot.  The defendants responded that the amended complaint did not address the failures of the original, and that amendment would be futile. The court agreed.

The court first evaluated Plaintiff's motion to amend, finding that, although it contained “some more detailed allegations,” it failed to state a claim and that amendment would thus be futile.  Plaintiff had added allegations about regulatory action suggesting product failures and manufacturing compliance problems, but these allegations were not specific to a phenytoin or fosphenytoin product, nor did they “provide a causal link between any manufacturing or design defect and SJS....”  2011 WL 4015658 at *4.  This failure to allege a causal link was a fatal short-coming in the strict liability and negligence claims, so Plaintiff's proposed derivative claims for punitive damages and joint and several liability were insufficient as well.  Id. at *5.

Because the court found that amendment would be futile (and denied Plaintiff's motion for leave to amend), the original complaint's two surviving claims remained.  Thus, the court evaluated the new motion to dismiss and found that Mensing barred the remaining failure-to-warn claim against all the generic defendants.  Because Plaintiff was arguing that the labeling was inadequate under state tort law, not that the label was inconsistent with the branded product’s warnings, the claim was preempted.  “[T]his is exactly the type of state tort failure to warn claim that the Mensing Court found was preempted...”  Id. at *7.

After Plaintiff turned it over on downs, the court will still allow a future Hail Mary.  Despite Mensing and a tough uphill battle attacking the defective design of an FDA-approved medication, the court dismissed without prejudice, noting that it could not “find that it would be impossible for Plaintiff to state a claim against any Defendant.”  Id. at 7 n.7.  So in the end, as Vince Lombardi might say, Plaintiff didn’t lose the game; he just ran out of time.

Tuesday, September 20, 2011

Deal on Medical Device Treatise

Reading our blog can have more benefits than just getting smarter.

The Practising Law Institute has a new book out - Onel & Becker Medical Devices Law and Regulation Answer Book (2011).  The book is a predominately practical guide to current FDA regulatory requirements for medical devices, including the Agency's various premarket requirements for specific types of devices through postmarket regulation, as well as places you'd rather not end up, such as ongoing government enforcement and investigation.  Here's a link to a more fulsome description of it.

It strikes us I that this is the kind of book that the device side of our readership might find useful.  So we've talked to the PLI and they've agreed to give anybody who mentions this blog a 25% discount.  PLI contact information for obtaining the discount is:  Andrew Given 212.824.5887

Generic Drug Preemption Scorecard

We’ve decided that, since PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), product liability preemption in the context of generic drugs has come into its own and should no longer be lumped in with the overall topic of drug/vaccine preemption.  Thus we’re bestowing a new scorecard on post-Mensing generic drug preemption decisions. We’ll start with Mensing itself and go from there:

  1. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. June 23, 2011) (metoclopramide).  Hatch Waxman Act's requirement that generic drug labeling must stay the same as branded labeling preempts failure to warn claims against generic drug makers.  Generic drug manufacturers cannot change their labels without prior FDA approval.  Dear Doctor/DHCP letters cannot vary from generic drug labeling.  The bare chance that the FDA, if approached, might agree to change both the generic and branded labels simultaneously, is insufficient to prevent preemption.
  2. Sacks v. Endoscopy Center, 2011 WL 4915174 (Nev. Dist. July 28, 2011) (propofol).  Motion for summary judgment denied.   Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Design defect and implied warranty claims are not preempted.
  3. Brown v. Actavis Elizabeth LLC, 2011 WL 5826022, slip op. (E.D. La. Aug. 10, 2011) (metoclopramide).  Motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Minute order.
  4. Keck v. Endoscopy Center, 2011 WL 3921690, slip op. (Nev. Dist. Aug. 19, 2011) (propofol).  Granting partial summary judgment against preemption defense.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Plaintiffs cannot argue that the label on the drug itself should be changed.  Refusing to defer to FDA view that generic manufacturers could not unilaterally send any such letters.  State law failure to warn claims are preempted.
  5. Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir. Aug. 22, 2011) (metoclopramide).  Per curiam order on remand from the Supreme Court, vacating and remanding for entry of judgment in favor of defendant on grounds of preemption.
  6. Henderson v. Sun Pharmaceuticals Industries, Ltd, 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011) (phenytoin and fosphenytoin).  Motion to amend denied; motion to dismiss granted.  Manufacturing-related warning letter sent to defendant did not relate to drug in question or to the plaintiff’s alleged injury.  None of the allegations plead causation.  State law failure to warn claims are preempted.
  7. Scott v. Baxter Healthcare Corp., 2011 WL 4007675 (S.D. Ala. Sept. 9, 2011) (phenergan). Unopposed summary judgment granted.  State law claims challenging the adequacy of generic drug labeling are preempted.
  8. Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., 2011 WL 4025734 (S.D. Ala. Sept. 12, 2011) (metoclopramide).  Motion to amend granted in part and denied in part.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  At the time of the prescription, the FDA did not require pre-approval of such letters. State law claims challenging the adequacy of generic drug labeling are preempted.
  9. Beck v. Teva Pharmaceutical Industries Ltd., 2011 WL 4062219 (E.D. La. Sept. 13, 2011) (methotrexate).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.
  10. Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. Sept. 22, 2011) (metoclopramide).  State law claims challenging the adequacy of generic drug labeling are preempted.  Cert. denied, 132 S.Ct. 2103 (2012).
  11. Schork v. Baxter Healthcare Corp., 2011 WL 4402602 (S.D. Ind. Sept. 22, 2011) (promethazine HCL).  State law claims challenging the adequacy of generic drug labeling are preempted.
  12. Fisher v. Pelstring, 817 F. Supp.2d 791 (D.S.C. Sept. 30, 2011) (metoclopramide), reconsideration denied, (Jan. 11, 2012) (see below).  Motion to dismiss on preemption grounds denied due to uncertainty whether generic drug labeling at the time of plaintiff's prescription timely included the most recent update to branded warnings.  Summary judgment on failure to warn, implied warranty, consumer fraud, and emotional distress denied because, inter alia, the defendant could have sent a "Dear Doctor" letter about the label changes it failed to include.  Express warranty, fraud, and misrepresentation claims preempted because they would have required a non-identical label change.  Plaintiff's claim for breach of a duty to keep current with scientific literature is preempted because without a non-identical label change, the duty could not be causal.
  13. LaBruyere v. Actavis, Inc., 2011 WL 5826018, slip op. (E.D. La. Oct. 4, 2011) (metoclopramide).  Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Minute order.
  14. Stevens v. Community Health Care, Inc., 29 Mass. L. Rptr. 153, 2011 WL 6379298 (Mass. Super. Oct. 5, 2011)  (clarithromycin).  Summary judgment granted.  An distributor of a generic drug has no ability to change the warnings on generic drugs.
  15. Hutchinson v. Endoscopy Center, 2011 WL 6688744 (Nev. Dist. Oct. 5, 2011) (propofol).  Motion for summary judgment denied in part and granted in part.  State law claims challenging the adequacy of generic drug labeling are preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.
  16. Guilbeau v. Wyeth, Inc., 2011 WL 4948996 (W.D. La. Oct. 14, 2011) (metoclopramide).  Motion for judgment on the pleadings granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  No facts are pleaded to support any other claim.
  17. Phillips v. Wyeth, Inc., 2011 WL 5826035, slip op. (W.D. La. Oct. 14, 2011) (metoclopramide).  Unopposed motion for judgment on the pleadings granted on same grounds as Guilbeau.
  18. Morris v. Wyeth, Inc., 2011 WL 4973839, slip op. (W.D. La. Oct. 19, 2011) (metoclopramide).  Motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Express preemption cases do not control.  Claims based upon alleged failure to use other "FDA-recommended communication tools," such as "Dear Doctor" letters are preempted.  Plaintiff alleged no facts in support of any non-warning claim.  Motion to amend denied, 2012 WL 601455 (W.D. La. Feb. 21, 2012), plaintiff's failure-to-update claims claims that all pre-2009 labeling was defective, which is preempted; pre-Mensing cases recognizing less preemption are overruled.  Express warranty claims are preempted.  A reference listed drug designation does not convert the defendant into a branded manufacturer for purposes of preemption.
  19. Richardson v. Wyeth, Inc., 2011 WL 5402184, slip op. (W.D. La. Oct. 20, 2011), adopted, 2011 WL 5402396, slip op. (W.D. La. Nov. 6, 2011) (metoclopramide).  Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.
  20. Metz v. Wyeth, LLC, 2011 WL 5024448, slip op. (M.D. Fla. Oct. 20, 2011) (metoclopramide).  Motion to dismiss granted.  All warning claims are preempted.  All non-warning claims are inadequately pleaded.  Causation must be pleaded in any non-preempted claim.  Claims that the defendant failed to monitor developments, or notify the FDA, relate to warnings and are preempted.  Design claims must allege that the generic defendant designed the product.  Warranty and fraud claims relate to information about the product and are preempted.  Negligence per se claims based on labeling are preempted.
  21. Waguespack v. PLIVA USA, Inc., 2011 WL 5826015, slip op. (E.D. La. Nov. 3, 2011) (metoclopramide).  Motion for judgment on the pleadings granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Plaintiff did not plead an identical Dear Doctor letter claim.
  22. Sincoskie v. West Ward Pharmaceuticals, No. MEL-L-2643-10, transcript (N.J. Super. Law Div. Mercer Co. Nov. 4, 1022).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  That the defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings. 
  23. Guarino v. Wyeth LLC, 823 F. Supp.2d 1289 (M.D. Fla. Nov. 7, 2011) (metoclopramide).  Motion to dismiss granted.  All warning claims are preempted.  Mensing does not include an exception for parallel violation claims.  "Failure to communicate" claims, based on Dear Doctor letters, are preempted. Reconsideration denied, 2012 WL 28810 (M.D. Fla. Jan. 5, 2012), second reconsideration denied, 2012 WL 1890516 (M.D. Fla. May 23, 2012).
  24. In re Accutane Products Liability Litigation, 2011 WL 6224546, slip op. (M.D. Fla. Nov. 9, 2011) (isotretinoin).  Judgment on the pleadings granted.  All warning claims are preempted.  (Unspecified) arguments that plaintiffs claims are not warning claims are "devoid of merit."  Warning-based claims against a pharmacist selling generic drugs are also preempted.
  25. Stevens v. PLIVA, Inc., 2011 WL 6224569, slip op. (Mag. W.D. La. Nov. 15, 2011) (metoclopramide). Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Design defect claims are preempted. Adopted, 2011 WL 6224556 (W.D. La. Dec. 2, 2011).
  26. In re Reglan/Metoclopramide Litigation, 2011 WL 6259558, slip op. (Pa. C.P. Philadelphia Co. Nov. 18, 2011) (metoclopramide).  Master preliminary objections denied.  It is not shown with certainty that there can be no legal recovery in 2000 cases brought under the laws of numerous states.  Mensing "carve outs" must be decided on a state-by-state basis.  The same is true for claims involving the injectible form of the drug.
  27. In re Fosamax Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (alendronate sodium).  Judgment on the pleadings granted as to all generic defendants (some defendants' status as generic manufacturers was disputed and could not be resolved on the pleadings).  No factual allegations support any sort of manufacturing-related claim.  The design of a generic drug, like its warnings, must be the same as the branded reference drug.  Therefore design defect claims and negligent design claims are preempted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Taking alleged increased risk evidence to the branded manufacturer rather than the FDA does not change the preemption analysis because any label change would still be dependent upon the act of an independent third party.  Nothing in the 2007 FDAAA changes the generic preemption analysis.  There is no evidence that generic labels were not updated promptly.  Negligence claims related to warnings are preempted.  Implied warranty claims are founded on changing the design of the drug, and are therefore preempted.  Express warranty, fraud, misrepresentation, and consumer protection claims all attack the drug's labeling and are therefore preempted.  Dependent claims are also dismissed.
  28. Gross v. Pfizer, Inc., 825 F. Supp.2d 654 (D. Md. Nov. 22, 2011) (metoclopramide).  Judgment on the pleadings granted.  Negligence claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Such a claim, if it existed at all, would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.  Claims for concealing information are warning claims and are preempted.  Failure to test/inspect are warning claims and are preempted.  Claims alleging failure to update do not exist at state law, and in any event are preempted.  Reconsideration denied, 825 F. Supp. 2d 661 (D. Md. Jan. 27, 2012).  Plaintiffs have not pleaded that the allegedly unupdated warning was adequate, so that claim is also preempted.
  29. Phelps v. Wyeth, Inc., 2011 WL 7629569 (Mag. D. Or. Nov. 30, 2011) (metoclopramide).  Motion to dismiss granted against all claims, including  post-marketing failure to monitor, with the exception of failure to update warnings after the branded label was changed.  Failure to update may be asserted as negligence per se.
  30. Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011) (metoclopramide).  Judgment on the pleadings granted in part and denied in part.  Nothing in the 2007 FDAAA affects the preemption rationale in Mensing.  Off-label use does not defeat preemption.  Any additional warning about an off-label would create a label that is not the same as the branded label.  If plaintiffs want to assert some claim based upon illegal off-label promotion, they must amend their complaint.  On reconsideration at, 2012 WL 3948797 (E.D. La. Sept. 10, 2012).  Conceivably illegal off-label promption could also violate state law so the claim will not be dismissed on the pleadings.  The 2007 FDAAA made no changes in generic labeling, thus nothing in FDAAA bars preemption of post-2007 claims.
  31. Schrock v. Wyeth Inc., 2011 WL 6130924 (W.D. Okla. Dec. 8, 2009) (metoclopramide).  Motion for leave to amend denied.  Express and implied warranty claims are preempted.
  32. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011) (metoclopramide).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Non-warning claims not adequately pleaded.  Failure to update labeling claims not adequately pleaded.  Claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Amended complaint dismissed except for one count, 2012 WL 1893749 (E.D. Ark. May 23, 2012).  Alleged design defect claim alleging improper use of bulk packaging was actually a warning claim and was preempted.  Bartlett is distinguishable because it was pure risk-utility rather than involving only one use.  Failure to update claims are preempted to the extent that the updated label was allegedly still defective.  Other failure to update claims will be addressed on summary judgment.  Reconsideration denied, 2012 WL 2918711 (E.D. Ark. July 17, 2012).
  33. Del Valle v. PLIVA, Inc., 2011 WL 7168620, slip op. (Mag. S.D. Tex. Dec. 21, 2011) (metoclopramide).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Claims for failure to add label changes that plaintiffs claim were still defective do not state a claim, as there can be no causation for failing to add labeling that was still defective.  adopted 2012 WL 2899406 (S.D. Tex. June 22, 2012).
  34. Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. Dec. 30, 2011) (allopurinol).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  All forms of communication between manufacturers and doctors, "Dear Doctor" letters, physician training, and professional publications, are labeling and preempted if different from branded labeling.  To the extent plaintiff argues for other communications bearing identical information, no causation is pleaded.  Taking alleged increased risk evidence to the branded manufacturer rather than the FDA does not change the preemption analysis because any label change would still be dependent upon the act of an independent third party.  Consumer expectation-based design defect claims are based on warning information and are preempted.  No alternative design or lack of utility is pleaded that could support a risk-utility design defect claim.  Implied warranty claims are either preempted or inadequately pleaded.  Fraud claims implicating the label are preempted, any others are inadequately pleaded.
  35. Yamane v. Wyeth, 2101 WL 1120367 (Haw. Cir. Jan. 3, 2012) (phenergan).  Summary Judgment granted.  All plaintiff's state law claims, including warranty, consumer fraud, and design defect, are really warning claims.  All warning claims involving a generic drug are preempted.  That no branded equivalent drug remains on the market does not affect preemption.  That the generic manufacturer purchased the brand name for the drug does not affect preemption.
  36. Moore v. Mylan, Inc., 840 F. Supp.2d 1337 (N.D. Ga. Jan. 5, 2012) (phenytoin).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  That the defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Negligence claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Such a claim, if it existed at all, would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.
  37. Huck v. Trimark Physicians Group, 2012 WL 553492, slip op. (Iowa Dist. Jan. 5, 2012) (metoclopramide).  Motion for summary judgment granted.  State law claims challenging the adequacy of generic drug labeling are preempted. 
  38. Fisher v. Pelstring, 817 F. Supp.2d 791 (D.S.C. Jan. 11, 2012) (metoclopramide).  Motion to dismiss denied with respect to preemption arguments.  An implied warranty claim not premised on warnings is not preempted.  Motion to dismiss denied on negligence, fraud, consumer fraud, and emotional distress claims relating to failure to update generic drug labeling to include FDA-approved changes. The changes relate to the plaintiff's claim.  A negligence action in which the standard of care is defined by statute is not necessarily the equivalent of private enforcement of the FDCA. Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.
  39. Couick v. Wyeth, Inc., 2012 WL 79670 (W.D.N.C. Jan. 11, 2012) (metoclopramide). Motion to dismiss granted in part and denied in part. Without a showing establishing that the defendant's label actually mirrored the branded label, state law warning and express warranty claims may not be preempted. An implied warranty claim not premised on warnings is not preempted. No cause of action exists for failure to test. FDCA violation claims are preempted under Buckman.
  40. In re Fosamax Litigation, 2012 WL 181411 (D.N.J. Jan. 17, 2012) (alendronate sodium).  Motion for judgment on the pleadings granted.  An authorized distributor of a generic drug has no more ability to change warnings than any other generic drug manufacturer.
  41. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, slip op. (S.D. Ga. Jan. 19, 2012) (phenytoin).  Motion for summary judgment granted.  State law claims, including fraud, challenging the adequacy of generic drug labeling are preempted.  Various warning theories were not pleaded.  Claims that generic manufacturers had a duty to cease selling their product at all are preempted.  Such claims  would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.  Generic preemption is not dependent on any way on conduct of branded manufacturers or other third parties.  Nonwarning claims are inadequately pleaded.
  42. In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. Jan. 30, 2012) (pamindronate).  Motion to dismiss granted.  All state law claims are preempted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Design defect claims are preempted because the same requirement of "sameness" applied to the design of generic drugs.  Negligent testing and breach of express warranty claims are warning claims in disguise and are preempted.  Implied warranty claims are design defect claims in disguise and are preempted.
  43. Kellogg v. Wyeth, 2012 WL 368658, slip op. (D. Vt. Feb. 3, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All state law warning claims are preempted.  All claims alleging a duty to provide additional information are preempted, whether for promotional or educational purposes, and whether involving on or off-label use, as they would be different from the approved labeling.
  44. Lyman v. Pfizer, Inc., 2012 WL 368675, slip op. (D. Vt. Feb. 3, 2012) (metoclopramide).  Motion for judgment on the pleadings granted in part and denied in part.  All state law warning claims are preempted.  Design defect claims are preempted because the same requirement of "sameness" applied to the design of generic drugs.  Claims that generic manufacturers had a duty to cease selling their product at all are preempted.  Claims that generic manufacturers engaged in inadequate post-marketing surveillance are preempted.  Claims relating to failure to update generic drug labeling to include FDA-approved changes are not preempted but are inadequately pleaded.
  45. Moretti v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2012 WL 465867, slip op. (D. Minn. Feb. 13, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All state law warning claims are preempted.  Claims alleging inadequate post-marketing surveillance are warning-related claims and are preempted.   Claims that generic manufacturers had a duty to cease marketing their product at all are preempted.
  46. Bell v. PLIVA, Inc., 845 F.Supp.2d 967 (E.D. Ark. Feb. 16, 2012) (metoclopramide).  Motion to dismiss granted.  All state law warning claims are preempted.  While failure to update generic warning claims might violate the FDCA, it was still impossible for a generic manufacture to communicate different information to plaintiff's private physician.
  47. Gaeta v. Perrigo Pharmaceuticals Co., ___ Fed. Appx. ___, 2012 WL 605678 (9th Cir. Feb. 27, 2012). Summary affirmance of pre-Mensing decision holding claims against generic manufacturer preempted. Follows remand from the Supreme Court.
  48. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  Claims alleging false information, concealment, and knowingly marketing an unreasonably dangerous product are warning claims and are preempted.  Failure to update claims were not pleaded and fail to state a cause of action because plaintiff claims the later warnings are inadequate, and there is no duty to provide an inadequate warning.
  49. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, slip op.  (E.D. Ky. March 5, 2012) (propoxyphene).  Motion to dismiss granted.  Wrongful marketing claims that generic manufacturers had a duty to cease selling their product at all are preempted.  The sameness obligation applies to design as well as warning.  Both design and warning claims are preempted.  "Information and belief" pleading that the defendants did not update their warnings in a timely fashion is pure conjecture insufficient under TwIqbal to state a claim.  "Dear Doctor" letter-based warning claims are inadequately pleaded and would be preempted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Fraud, consumer fraud, and express warranty claims seek to change the label and are preempted.  Claims based on alleged violations of the FDCA are preempted as improper private rights of action.  Motion to amend denied 2012 WL 1478798 (E.D. Ky. April 27, 2012).
  50. Cooper v. Wyeth, Inc., 2012 WL 733846, slip op. (M.D. La. March 6, 2012) (metoclopramide).  Motion to dismiss granted in part and denied in part.  Claims that the defendant manufacturer failed to update its generic drug labeling to include FDA-approved changes are not preempted.  It is not impossible to comply with federal law.  Claims for failure to communicate strengthened labels via "Dear Doctor" letter following an FDA label change are not preempted.  These claims fit within existing tort causes of action and thus are not barred as private rights of action.  Claims of inadequate post-marketing pharmacovigilance are preempted.  Claims that generic manufacturers had a duty to cease selling their product at all seek repudiation of the FDA approved label and are preempted.  Claims of failure to use additional forms of communication to provide warnings are preempted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Express warranty claims based on labeling are preempted.
    Design defect claims are do not really challenge the design, only the warnings, and thus are preempted.  Manufacturing defect claims are inadequately pleaded.
  51. Metz v. Wyeth, ___ F.Supp.2d ___, 2012 WL 1058870 (M.D. Fla. March 28, 2012) (metoclopramide).  Motion to dismiss granted in part and denied in part.  Summary judgment motion granted.  Negligence and warranty claims escape preemption to the extent they allege that the defendant should have taken additional steps to warn about information recently added to the FDA-approved label.  Claims that the drug should have been redesigned or removed from the market are preempted.  Inadequate testing and failure to report claims are preempted.  Summary judgment granted on grounds that the warnings were adequate as a matter of law.
  52. Fulgenzi v. PLIVA, Inc., ___ F.Supp.2d ___, 2012 WL 1110009 (N.D. Ohio March 31, 2012) (metoclopramide).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  All non-warning claims were insufficiently pleaded.  Allegations that the defendant failed to update warnings flow from federal, rather than state, law and no private enforcement of the FDCA is allowed.  If adequately pleaded, design defect claims would be preempted under the statute's sameness requirement.  Claims for breach of express and implied warranties, misrepresentation, breach of undertaking, fraud, constructive fraud, fraudulent concealment, and intentional infliction of emotional distress all assert warning claims and are preempted.  A claim that the drug should have been removed from the market is preempted.
  53. Phelps v. Wyeth, Inc., ___ F.Supp.2d ___, 2012 WL 1499343, slip op. (D. Or. April 24, 2012) (metoclopramide).  Summary judgment granted.  All warning claims preempted.  FDCA-based claims fail for lack of any private right of action.  Testing and monitoring claims cannot stand independently of a duty to warn.  Parallel claims cannot avoid implied preemption. 
  54. Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F.Supp.2d ___, 2012 WL 1511817, slip op. (S.D. Tex. April 30, 2012) (metoclopramide).  Motion to dismiss granted.  Preemption is unaffected by the 2007 amendments to the FDCA.  The fraud on the FDA exception to the Texas presumption of adequacy statute is preempted.  Failure to test or monitor is noncausal unless it results in a changed warning, and all warning claims are preempted.  Failure to update claims are preempted, to the extent pleaded, and not pleaded to the extend unpreempted.  Withdrawal from the market claims are a fortiori preempted.  Design defect and consumer fraud claims are preempted.  Defendant cannot be liable on theories Texas law has not recognized.
  55. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. May 2, 2012) (suldinac).  Jury verdict for plaintiff affirmed.  A no-alternative design design defect claim is not preempted.  State law may impose liability on a generic drug manufacturer for not removing an FDA-approved drug from the market based on the jury's independent re-evaluation of the product's risks and benefits.  Second-guessing the FDA is permissible under Levine.
  56. In re Reglan Litigation, 2012 WL 1613329, slip op. (N.J. Super. Law Div. May 4, 2012) (metoclopramide).  Motion to dismiss granted in large part.   All plaintiffs' claims are warning-based and are preempted, except for failure to update labels when required by the FDA.  Nothing in the 2007 FDAAA changes the generic preemption analysis.  Claims of failure to use additional forms of communication to provide warnings are preempted.  Withdrawal from the market claims do not exist under state law and would be preempted if they did.
  57. In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012) ("Reglan II") (metoclopramide).  Motion to dismiss granted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings. 
  58. Brinkley v. Pfizer, Inc., 2012 WL 1865402 (W.D. Mo. May 22, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All claims, including failure to communicate with doctors in other ways and failure to update, are merely back-door warning claims that are preempted.
  59. Johnson v. Teva Pharmaceuticals USA, Inc., 2012 WL 1866839 (W.D. La. May 21, 2012) (metoclopramide).  Judgment on the pleadings granted.   All warning claims preempted.  Claims of failure to use additional forms of communication to provide warnings are preempted.  Failure to update claims are not preempted, but fail to state a claim because plaintiff pleaded that even the updated warning would have been inadequate.  Express warranty and design defect claim asserting an alternative package design are really warning claims and are preempted.  Regular design defect claims are preempted because prior FDA approval is required.  A claim that the drug should have been removed from the market is preempted and does not state a claim under state law.
  60. Kriesmer v. Upsher-Smith Laboratories, Inc., 2012 WL 2003945 (Ohio C.P. May 24, 2012) (warfarin).  Motion to dismiss granted in part and denied in part.  All warning claims preempted.  Design/manufacturing defect claim that doses were subject to a recall because they contained more of the active ingredient than they were supposed to were not preempted.  Consumer fraud action survived because it did not have to be pleaded with specificity.
  61. Whitener, v. PLIVA, Inc., 2012 WL 1995795 (E.D. La. June 4, 2012) (metoclopramide).  Claims that the defendant passively knew its drug was being used off label are preempted.  Claims that the defendant actively promoted its drug for off-label use in violation of the FDCA might not be preempted and survive a motion to dismiss.
  62. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 2457825, slip op. (E.D. Ky. June 22, 2012) (propoxyphene).  Motion to reconsider denied.  The Bartlett remove the product from the market theory is unpersuasive and is rejected.
  63. Lashley v. Pfizer, Inc.___ F. Supp.2d ___, 2012 WL 2459148 (S.D. Miss. June 27, 2012) (metoclopramide).  Motion to dismiss granted.  All warning and design claims preempted. 
  64. Lyman v. Pfizer, Inc., 2012 WL 2970627 (D. Vt. July 20, 2012) (metoclopramide). Motion to dismiss granted. All warning claims preempted.  Claims of failure to use additional forms of communication to transmit later changed warnings are not preempted.  A failure to update claim is not preempted.  Claims that the product should have been packaged differently to discourage certain uses are preempted.  Design claim was preempted as a disguised attack on the product's warnings.
  65. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012) (tramadol). Motion to dismiss granted.  A claim that the drug should have been removed from the market is preempted as they necessarily repudiate the FDA approved label.  Design defect claims are preempted as generic designs are subject to the same "sameness" requirements as generic warnings. 
  66. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation,  2012 WL 3109424 (E.D. Ky. July 31, 2012) (propoxyphene).  Judgment on the pleadings granted.  All claims against a contract manufacturer of generic drugs are either preempted by Mensing or barred by product identification.
  67. In re: Accutane (Isotretinoin) Products Liability Litigation, 2012 WL 3194952 (M.D. Fla. Aug.7, 2012) (isotretinoin).  Judgment on the pleadings granted in part.  All warning claims preempted.  Design defect claims preempted under the statute's sameness requirement.  Plaintiff may replead a manufacturing defect claim.
  68. Strayhorn v. Wyeth Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3261377 (W.D. Tenn. Aug. 8, 2012) (metoclopramide).  Motions to dismiss granted in seven cases.  All warning claims preempted.  The Bartlett remove the product from the market theory is rejected.  Conte is unpersuasive and rejected.  Express preemption cases are irrelevant to implied preemption.  Dear Doctor letters are labeling so claims based on them are preempted.  Failure to conform claims are preempted as private attempts to enforce the FDCA.  Conspiracy claims are preempted.
  69. Truddle v. Wyeth, LLC, C.A. No. 2:11-CV-00207-GHD-SAA, 2012 WL 3338715 (N.D. Miss. Aug.14, 2012) (metoclopramide).  Motion to dismiss granted.  All warning claims preempted, including consumer fraud.  A duty to test claim is a preempted warning claim because the test results would have to be communicated.  Fraud on the FDA claims are preempted.
  70. Jacobsen v. Wyeth, LLC, 2012 WL 3575293 (E.D. La. Aug. 20, 2012) (metoclopramide).  Motion to dismiss granted.  To the extent a failure to monitor claim exists under Louisiana law, it is a warning claim and is preempted.  Monitoring must result in a label change to have any effect.  A "unit of use" design defect claim is really a warning claim and is preempted.  Design defect claims are also preempted by federal "sameness" requirements.  All warning claims, including Dear Doctor letters, are preempted.  Requiring a generic drug to be removed from the market is preempted as a repudiation of the label.  No failure to update claim was pleaded, and leave to amend is not sought.  An express warranty claim based on generic labeling is preempted, and no other warranty is alleged.
  71. Phares v. Actavis-Elizabeth LLC, No. B:11-63, 2012 U.S. Dist. Lexis 123858, (S.D. Tex. Aug. 30, 2012) (metoclopramide).  Motion to dismiss granted.  All warning claims preempted.  The fraud on the FDA exception to the Texas statutory presumption of adequacy is preempted, therefore the statutory presumption applied.  Fraud and suppression of evidence are inadequately pleaded.