Friday, October 24, 2014

Without Failure To Warn, Other Claims Collapse

The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:

The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn.  Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.

Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014).  Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches.  But what’s this?  The doctrine applied to negligent misrepresentation?  Some background is in order:  The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science.  As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades. 
The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014.  See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014).  This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud. 
We were not all that concerned.  With the failure-to-warn claims gone, we at the DDL observed that

. . . a plaintiff left with manufacturing defect, negligence, and fraud does not have much to work with going forward.  Manufacturing defects are extremely rare in pharmaceutical cases, and fraud is usually disposed of with one question posed to the plaintiff in written discovery or a deposition.  Question: “Have you ever had any contact or communication with the drug manufacturer?  Answer:  “No.”  Of course, negligence can raise a host of issues, but we would not be surprised if further exploration of negligence beats a path straight back to the adequacy of the warnings . . . .

Which brings us to the court’s latest order, which granted summary judgment and put an end to the case.  Brown, 2014 U.S. Dist. LEXIS 145415.  It turns out the plaintiffs had even less to work with that we thought.  On manufacturing defect and negligence, the plaintiffs merely cited the allegations in their own complaint, which obviously is not evidence.  The court saw it that way too, and summarily granted the defendant’s motion on those claims.  Id. at **5-7.  The plaintiffs converted their fraud claim into “deceit by concealment” and negligent misrepresentation, but they offered little to nothing in support of those claims either.  They based their concealment claim on a statute that did not apply.  The negligent misrepresentation claim failed because the plaintiff never communicated with the defendants, and there was no identifiable misrepresentation made to anyone else—such as the prescribing physician.  Id. at **9-10. 
The court’s order granting summary judgment therefore played out pretty much as we expected it might.  One of our mantras is that claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings and their impact (or lack of impact) on prescribing physicians.  Thus, once warnings-based claims are knocked out of a case, everything else tends to collapse.  That is what we foresaw with the Brown case, and that is what in fact came to pass, although it was predictable enough that we will not break our arms patting ourselves on the back for our prodigious prognostication. 
The citation to the learned intermediary doctrine in connection with negligent misrepresentation is still interesting.  Where the plaintiff has had no contact or communication with the defendant—which is almost always the case in prescription drug and medical device cases—he or she may try to base fraud and misrepresentation claims on communications with a physician.  We suppose you might call it misrepresentation by proxy.  We are not sure that should ever work, but even giving credence to such a concept, what representation has a drug manufacturer made to prescribing physicians?  At the risk of sounding like a broken record, claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings. 
So the court’s application of Tennessee’s learned intermediary doctrine to cut off alleged negligent misrepresentation is not as far-fetched as it seemed at the outset, but it still goes to show that defendants are in good stead when asserting warnings-based defenses as broadly as they can and across as many causes of action as conceptually possible.  The defendants in Brown appear to have done that, and with the help of the incredibly well developed blood-clot warnings that accompany hormonal contraceptives, they won. 

Thursday, October 23, 2014

On “Right To Try” Legislation

Since the beginning of 2014, five states that we know of have enacted what is called “Right to Try” statutes.  See Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§16221, 26451; V.A. Mo. S. §191.480.  “Right to Try” (a play on right to die) legislation addresses a serious subject as to which there is no easy answer.  There are still a lot of incurable diseases out there.  When somebody is afflicted with such a disease, all established treatments have failed, and that person is facing certain death, can that person have access to unapproved drugs – those that are still “investigational” in FDA parlance – on the theory that s/he has nothing to lose?

We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007.  For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs.  Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).

We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought.  Sure enough, that’s happened, too, even without the purported constitutional right.  We discussed a number of such cases (all, thankfully unsuccessful) here.

The “Right To Try” statutes seek to accomplish much the same thing, albeit with more consideration given to the rights of manufacturers (the earlier lawsuits mostly tried to get investigational drugs for free) and reasonable procedural steps included for health care providers as well.  One key feature of these statutes – we’ll pick the Arizona statute for no reason other than alphabetical order, but all the statutes are the same on this – is that participation by drug companies is voluntary:

A manufacturer of an investigational drug, biological product or device may make available the manufacturer's investigational drug, biological product or device to eligible patients pursuant to this article.  This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.

Ariz. R.S.A. §36-1312(A).

Right to Try statutes also typically include robust informed consent requirements (more on that in a minute), id. §1311(1)(d-e), see Colo. R.S.A. §25-45-103(4) (very detailed informed consent provision); Mich. C.L.A. §26451(d) (same), as well as provisions for payment of whatever the owner of the investigational product chooses to charge.  Ariz. R.S.A. §§36-1312(B)(2).  Nor are these statutes the equivalent of those infamous “Laetrile bills” that underwent a brief efflorescence in the late 1970s.  Those sought to legalize quackery.  These statutes are limited to investigational drugs that have successfully passed FDA Phase I trials.  Id. §1311(2).  In Phase I, investigational new drugs are tested on a few dozen human subjects (20-80) “to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.”  21 C.F.R. §312.21(a).

Still, we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.  For one thing, there’s the FDA.  States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen.  It's called "preemption."  You may have read a bit about that on this blog.

But putting the FDA to one side, even if states could start their own compassionate use programs, these statutes aren’t likely to help much.


The reason, as is the case for so many things these days, is the threat of liability.  Nothing in any Right to Try statute allows companies to insist upon ironclad releases of liability as a condition of their participation, and absent that state courts (which tend to read releases parsimoniously) could well hold such releases invalid as coercive.  “If you don’t sign this release, you’re sure to die” isn’t exactly a situation calling for the unfettered exercise of equal bargaining power.  A Right to Try statute could override other law in this limited circumstance by expressly allowing such releases, but none of them do.

The other way to eliminate the liability disincentive to the provision of drugs/devices of unknown safety and effectiveness (for any use) to desperately ill people is through statutory preclusion of liability.  Once again the Right to Try statutes come up short.  Some of these statutes have no limitations on tort liability at all (at least as to manufacturers, we’re not discussing doctors and other health care providers).  Arizona’s doesn’t.  Neither does Louisiana.  In fact Louisiana is worse, since it's statute provides blanket tort immunity to any “physician who prescribes an investigational drug, biological product, or device to an eligible patient pursuant to the provisions of this Part.”  La. R.S. §1300.385.  The practical result of such immunity would be that, should anyone in Louisiana sue for injuries caused by the unknown risks of an “investigational” drug, the manufacturer would stand alone in the cross-hairs, without even the right to join the physician that made the prescribing decision, no matter how negligent that decision might have been.  You won't induce a manufacturer to participate in a voluntary program by painting a target on its back.

The Colorado and Michigan statutes provide that the Right to Try law itself doesn’t “create a private cause of action.”  Sort of:

This article does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, so long as the manufacturer or other person or entity is complying in good faith with the terms of this part 1, unless there was a failure to exercise reasonable care.

Colo. R.S.A.§ 25-45-107 (emphasis added); see Mich. C.L.A. §26457 (identical language).  Let’s break that down.  There’s not a private cause of action created under the Colorado or Michigan Right to Try statutes unless:  (1) the defendant doesn’t act in “good faith,” whatever that is, or (2) “fail[s] to exercise reasonable care,” in other words, is negligent.

So not only do the Colorado and Michigan statutes fail to give any relief to a participating manufacturer from any pre-existing common-law tort liability, but they create new statutory causes of action for “bad faith” and negligence (with no statute of limitations stated) against any participating manufacturer.  That’s a particular drawback in Michigan, which otherwise has a statute (blogged about here) that precludes ordinary negligence (let alone bad faith) liability against makers of FDA-approved drugs.  Historically, negligence is already quite capacious in what “reasonable care” encompasses, and the experience of the insurance industry is that “bad faith” can mean just about anything.  Any rational economic actor would think long and hard about distributing a product having – by definition – an unknown risk/benefit profile under these conditions.

The Missouri statute is better.  It does not purport to create a private statutory cause of action under any circumstances, although it doesn’t expressly preclude such new liability either (as you may have guessed, it’s silent).  Even more importantly, it does eliminate some common-law liability:

Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device to an eligible patient with a terminal illness in accordance with this section shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:

(1) The design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or

(2) The safety or effectiveness of the drug or device.

V.A. Mo. S. §191.480.8 (emphasis added).  In other words a participating manufacturer can still be liable to any plaintiff who can plead gross negligence or wilful conduct under Missouri’s ostensible fact pleading rules.  That’s better than any other extant Right to Try statute, but is still dependent on how strictly pleading requirements are enforced.

On the other hand, Missouri uniquely requires the manufacturer of an investigational drug – not just the prescribing physician – “notify the patient” directly in the event that the drug’s “clinical trial is closed due to lack of efficacy or toxicity.”  V.A. Mo. S. §191.480.7.  Where that fits into the partial immunity from suit provided by §191.480.8 is unclear, but a plaintiff’s lawyer could certainly be expected to argue that if this direct-to-patient notice were not given, then the manufacturer was not acting “in accordance with this section” as required by the immunity provision.  If such an interpretation were accepted, such plaintiffs could further argue that the statutory requirement of direct-to-patient notice vitiates the learned intermediary rule, also not a happy situation for a defendant.

In fairness, it must also be acknowledged that proving causation would not be easy in any civil action concerning investigational products dispensed under Right to Try statutes, given their augmented informed consent requirements.  Nor would such cases otherwise be attractive to our opponents, since the damages that could be recovered on behalf of persons by definition already in terminal condition are not likely to be very large.

Conversely, it must also be kept in mind that Right to Try statutes are seeking to get manufacturers to take actions – voluntarily, since no statute requires an participation at all – that they don’t ordinarily do, and that are well outside their comfort zone.  They are not allowed by the FDA to “promote” such products for any use, so even providing routine information to those outside of FDA-regulated clinical trials is fraught with difficulty.  What warning could a manufacturer give, anyway?  “CAUTION:  This drug may not be safe or effective for any use and has unknown risks, that may include death or serious injury of any sort.”  What good would that do?

Right to Try statutes seek to induce manufacturers to make available to desperate persons products with no track record and that have not had their safety or effectiveness established for any purpose, and indeed that have not been studied adequately so that their risk/benefit profile is known to anyone, even to the manufacturer.  Manufacturers are not heartless, regardless of what our opponents might say, but they are usually rational economic actors.  They are not going to go out of their way unless assured that, at least, they are not going to get sued for their trouble.  The five statutes enacted to date do not provide that assurance.  The Colorado, Louisiana, and Michigan statutes would leave participating manufacturers in a worse position than the plain common law (much worse than under Michigan’s statutory presumption of non-defectiveness).  Arizona doesn’t address the common-law at all.  While Missouri’s statute does, it leaves a significant hole in its protections – and creates a potentially scary exception to the learned intermediary rule for participants.  Thus, we doubt that Right to Try statutes are going to be any more effective than previous litigation in making investigational drugs available to terminally ill patients who are willing to try them.

In closing, we should mention that we do find one possible benefit to Right to Try statutes – especially those like Colorado and Michigan that have very detailed informed consent prerequisites to participation.  Such informed consent provisions demonstrate that a legislature knows how to impose detailed informed consent requirements when it wants to.  Since we still see occasional common-law attempts to create novel informed consent duties concerning FDA regulatory status in cases involving off-label use, statutes like these Right to Try laws are useful to defendants.  They demonstrate that expansion of informed consent should be left to the legislature, and further that lawmakers are quite capable of strengthening informed consent standards if and when they see fit.

But in terms of achieving their intended purpose, we don’t think that Right to Try statutes, as currently drafted, are going to save any lives.  That's unfortunate.

Daimler (Bauman) As a Removal Tool in Multi-Plaintiff Cases

Here’s another guest post, by Richard Dean and Peter Reed of Tucker Ellis.  They describe a successful combination (what we might call a “one-two punch” if that phrase were not already taken) of lack of personal jurisdiction under Bauman (also called Daimler) with removal, once the non-diverse (and fraudulently misjoined) plaintiffs lost their defendants.  We mentioned the state court ruling a while ago, here, but this post puts it in greater perspective.  As always all credit and blame go to our guest posters.


Plaintiffs like to use multi-plaintiff filings to defeat federal diversity jurisdiction and keep cases in state court in contravention of the spirit, if not the technical language, of the Class Action Fairness Act (“CAFA”).  That’s why a recent set of decisions from the Oklahoma state and federal courts is so heartening.  First, an Oklahoma state court properly recognized that the bright-line jurisdiction rule of Daimler AG v. Bauman, 124 S. Ct. 746 (2014), precluded the non-forum plaintiffs from obtaining jurisdiction over non-forum defendants, resulting in the dismissal of their suits.  Second, those non-forum plaintiffs were the only non-diverse parties, so dismissal of their suits presented a second opportunity for defendants to remove the remaining cases to federal court.  Third, a federal court held that the subsequent removal was not barred by the infamous voluntary-involuntary dismissal rule, which is often used to send “other paper” removals back to state court.  See Kathleen Teague v. Johnson & Johnson, et al., No. Civ-14-702-L, slip op. (W.D. Okla. Oct. 14, 2014).
This saga began with 11 filings with under 100 plaintiffs each (approximately 650 total) in a single-judge state county court in Oklahoma.  In each of the 11 cases, only one or two plaintiffs were from Oklahoma and all the other plaintiffs were from out of state (including one or two jurisdictional spoilers).  Defendants removed under principles of fraudulent misjoinder and CAFA.  They lost.  The District Court remanded the case, see Halliburton v. Johnson & Johnson, 983 F. Supp.2d 1355 (W.D. Okla. 2013), and the Tenth Circuit affirmed that decision, see Parson v. Johnson & Johnson, 749 F.3d 879 (10th Cir. 2014).  Defendants argued that filing several hundred cases before a single state court judge constituted an implicit proposal for a joint trial under CAFA, but the Tenth Circuit held that the statute’s technical language required a more express statement of any such requeset from plaintiffs.
The cases were then sent back to state court where defendants challenged the court’s personal jurisdiction over the claims of the out of state plaintiffs based upon Daimler.  The state court agreed and dismissed all the claims of the out of state plaintiffs because general jurisdiction over the defendants they sued was not available, and out-of-state plaintiffs could not resort to “specific” jurisdiction.  Teague v. Johnson & Johnson, 2014 WL 5343318, Order at ¶1 (Okla. Cir. Pottawatomie Co. July 2, 2014).  This shows the power of Daimler to challenge multi-plaintiff filings where most of the plaintiffs are from other states, and how CAFA removals aren’t the only vehicle to deal with mass filings.  Out of the original 650 plaintiffs, the state court ruling left 12 remaining plaintiffs in 11 cases, all from Oklahoma.  None of the defendants was from Oklahoma, so there now was complete diversity between those remaining plaintiffs and the defendants..
[Editor’s note:  this was the decision we discussed in our earlier post – the rest is new]

Defendants once again removed, this time citing the “other paper” provision.  28 U.S.C. §1446(b)(3) (removal timely when effected 30 days after an “other paper” creating diversity).  Plaintiffs again sought remand, this time arguing that the voluntary-involuntary dismissal rule barred removal.  The judicially-created rule, which precludes “other paper” removals when the dismissal of the non-diverse party is “involuntary” as to the plaintiff, is often cited to bar such removals because many state-court orders do not reflect “voluntary” actions on the part of the plaintiff.  But, as Defendants argued here, the rule has only ever been applied to the dismissal of non-diverse defendants, and the justifications for the rule do not apply when non-diverse plaintiffs are dismissed because they can’t sue any of the defendants they named.  After all, no action, either voluntary or involuntary, was taken as to the cases of the remaining (Oklahoma) plaintiffs, who still maintained all of their claims against all of the defendants they sued. 

The court agreed, noting that it had seen no cases where the voluntary/involuntary rule was applied after the dismissal of suits brought other, non-diverse plaintiffs based on those plaintiffs’ failure to obtain personal jurisdiction over the defendants they sued.  The court explained that the rule’s significance lies in “the involuntary dismissal of a defendant without the assent of the plaintiff,” and since that situation was not present here, the rule did not bar the removal.  Slip op. at 9-10.  The rule thus had no application to actions taken concerning the claims of other plaintiffs in multi-plaintiff complaints.

Plaintiff also objected that the state court order was not final or appealable, and that, until it was, the non-diverse plaintiffs were still part of the case.  The Court made short shrift of this argument, noting that the “other paper” provision is in no way limited to final, appealable orders.  Slip op. at 6-7.

The combination of these two rulings provides a roadmap for handling multi-plaintiff misjoinder cases designed to defeat federal diversity jurisdiction in venues that do not recognize fraudulent misjoinder.  First, in state court, Daimler provides a quick, bright-line basis for dismissal of non-forum plaintiffs who are unable to obtain personal jurisdiction over the defendants they sue.  Second, in the remaining cases involving resident plaintiffs, a defendant can then remove any now-diverse cases to federal court, as the federal court’s order here rightly decides that the voluntary-involuntary rule does not apply to the dismissal of other, non-diverse plaintiffs.

Wednesday, October 22, 2014

M.D. Fla. Double Trouble on Fraudulent Joinder

What the deuce is it about today?  The date is made up of two 2’s.  Today is the 76th birthday of two of our favorite, though couldn’t-be-more-different, actors:  Derek Jacobi (I, Claudius/Last Tango in Halifax) and ChristopherLloyd (Back to the Future/Taxi).  This day in 1978 saw the papal inauguration of John Paul II.  And, after much hand-wringing and soul-searching, today we have decided to drop two tv shows from our viewing rotation:  Homeland and Masters of Sex.  Sorry, Showtime, but those programs jumped a shark swimming in a pool of implausibility. (Boozy, sexy, sometimes thrilling implausibility, to be sure, but implausibility nonetheless.)

It’s only fitting that today we address a pair of stinkpot cases. Fronczak v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146347 (M.D. Fla. October 14, 2014) and Wier v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146353 (M.D. Fla. October 14, 2014) were decided on the same day by the same judge, involve the same issues, and offer the same lame fraudulent joinder analysis. 

The plaintiffs in both cases (represented by the same attorneys) alleged injuries from the implantation of artificial hip prostheses manufactured by DePuy and distributed by Bayside Orthopaedics.  The plaintiffs asserted claims for negligence, negligent failure to warn, strict liability failure to warn, strict liability, and breach of warranty.  The cases were filed in state court in Sarasota, Florida.  The inclusion of Bayside as a local defendant wrecked diversity. Nevertheless, DePuy removed the cases to federal court and argued that Bayside had been fraudulently joined.     

DePuy argued that the claims against Bayside were preempted.  Its reasoning was clever, compelling, and correct.  It was also futile.  The federal court followed the argument, up to a point:  “In Mensing, the Supreme Court held that all state-law tort claims based on an alleged failure to warn of the risks of generic medications are preempted by federal law because it is impossible to comply with both a jury’s charge to strengthen a generic drug warning under state law, and the federal mandate that a generic drug’s labeling be the same as that of the brand-name drug.  Bartlett extended this reasoning in design defect claims, holding that redesigning a generic drug was also impossible because federal drug regulations require a generic drug to have the same active ingredients, route of administration, dosage form, and strength as the brand-name drug on which it is based.”  Wier, 2014 U.S. Dist. LEXIS 146353 at *5-6 (citations omitted).   So far so good.  DePuy then took the logic a little further and argued that the Mensing-Bartlett impossibility line should apply to other failure to warn cases, such as these two, and should preclude an action against a distributor that clearly had no ability to change any device warning.    

Rather than embrace DePuy’s admirable syllogism, the federal court lunged for the 11th Circuit “no possibility of recovery” standard for testing fraudulent joinder arguments, and held on fast.  We’ve bemoaned this standard before.  If the TwIqbal standard for testing fraudulent joinder is the state-of-the-art, Peyton Manning-level standard, and the TwIqbal-light standard favored by some courts is Nick Foles (pretty good, but makes us nervous), then the no-possibility-of-recovery standard is Joe Pisarcik (look up “Miracle in the Meadowlands” on your browser).  (By the way, when a federal court decides whether there was fraudulent joinder by applying some dreadfully permissive state law pleading standard, that is like slapping an old leather helmet on your friendly neighborhood barista and sending him in against JJ Watt.)  The no-possibility standard inspires more indolence than insight.  

We’re used to all sorts of lax standards that give plaintiffs the benefit of the doubt on what the facts might be.  But what is so pernicious about the no-possibility-of-recovery standard is that it tells the court to “resolve uncertainties about the applicable law in favor of the plaintiff.”  Wier at *4.  If that isn’t an invitation to lazy-thinking, then we’ll turn in our bar cards and spend the rest of our days watching Claire Danes cry-a-thons and Lizzy Caplan-Michael Sheen, um, hug-a-thons.

In both Weir and Fronczak, the court previews its conclusion thusly:  “Because uncertainties exist as to the applicability of Mensing’s preemption with regard to distributors of medical devices, the Court concludes that remand is appropriate.”  Weir at *2; Fronczak at *2.   Then we get this:  “Mensing and Bartlett are arguably distinguishable because they both addressed federal preemption in the specific context of generic drug manufacturers, rather than medical device distributors.”  Wier at *5; Fronczak at *5.  Why would that factual distinction matter in terms of applying the Supreme Court’s impossibility analysis?  Either way, the defendant at issue cannot change the label/IFU. 

Now in defense of the Wier and Fronczak courts (really “court” singular, since it is the same judge), there was a precedent out there that jabbered at this issue:  “The Court has previously acknowledged this distinction in the context of Mensing, explaining [we cannot resist inserting a sic here] ‘[t]here is a marked difference between a duty requiring a drug manufacturer to physically change its federal approved label and a duty requiring a distributor to warn a third party of what the federal approved label or warning on a file with the FDA says.  Accordingly, whether Florida law imposes a duty to warn upon device distributors such as the [d]istributor [d]efendants is a determination best left to State court.’  See Zaremba v. Orthopedics, Inc. 8:14-CV-1016-T-33TGW, 2014 U.S. Dist. LEXIS 91762, 2014 WL 3057400, at *4 n. 2 (M.D. Fla. July 7, 2014).”   If you can explain what that quote means, or why it calls off a Mensing-Bartlett impossibility analysis, then maybe you can also explain how the main character in Homeland was not tried for treason at the end of  season 2.     

What exactly did the distributor do in this duet of sad cases besides, you know, distribute?  The plaintiff in Wier alleged that Bayside “disseminated literature to the orthopedic community in Florida” and provided the plaintiff’s orthopedic surgeon information “including, but not limited to, the advantages of the ASR System compared to its competitors, information regarding the design rationale for the ASR System, surgical techniques on how to implant the ASR System, and demonstrations on how to implant the ASR System and the components that could best be mated with the ASR System” with the “intended purpose of convincing and inducing Plaintiff’s orthopedic surgeon to use the ASR System.”  Wier at *8-9.  We can discern nothing actionable in any of that.  Then:  “Plaintiff also alleged that in preparation for his surgery, ‘Defendants (or their employees or agents) selected and provided the specific components to be used during the surgery and delivered them to the operating room where Plaintiff’s implant surgery took place.”  Id. at *9.  Aha!  Well, actually, nope, we still do not see anything actionable.  

Maybe the plaintiff in Fronczak came up with something juicier.  Let’s see:  “Plaintiff alleged that Bayside ‘disseminated literature to the orthopedic community in Florida stating that the ASR components were ‘large diameter, high performance metal-on-metal bearings designed and manufactured within fine tolerances to facilitate a state of fluid film lubrication’ and ‘designed to reduce wear and provide high function for all patients.’  Plaintiff also alleged that in preparation for his surgery, ‘Defendants (or their employees or agents) selected and provided the specific components to be used during the surgery and delivered them to the operating room where Plaintiff’s implant surgery took place.  Thus, Plaintiff has stated a colorable claim against Bayside for strict liability.”  Fronczak at *8-9 (citations omitted).  Somewhere between that last sentence, where the court concluded there was a colorable claim, and everything that led up to it, there must be some sort of legal cogitation.  Or is it a leap of faith, inspired by the “no possibility” standard’s requirement that if any interpretation or mutilation of the law might keep the non-diverse defendant in, then the federal court can push the remand button with a clean conscience and a slightly lighter docket?

Is it possible that reading a pair of cases can make you dumber?  (Some uncharitable wag will inevitably point out that we cannot get any dumber.)  These opinions on fraudulent joinder leave us thirsty for something better.  Perhaps we will reach for a beverage.  Perhaps we will reach for two. 

Tuesday, October 21, 2014

Georgia Court Takes a Holistic Approach to Pleading

            Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right. 

            A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations.  You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

            The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves. 

            The first 6 “defects” plaintiff alleges are that the mesh degrades; harbors infections; migrates; erodes; shrinks; and causes inflammation.  Schmidt v. C.R. Bard, Complaint at ¶ 11a-e, i, No. 6:14-cv-62.  Nowhere in the complaint, however, will you find a single factual allegation to support those general conclusory statements.  Moreover, nowhere is there any allegation that the plaintiff actually suffered from any of these alleged “defects.”  Did plaintiff suffer from an infection or inflammation; did his mesh shrink or migrate?            

            We can only surmise that the remaining 3 “defects” the court identified in the complaint were:  (1) the mesh regularly fails to perform its intended purpose; (2) due to its defects, the mesh causes injury; (3) if the mesh needs to be removed due to its defects it is often difficult and poses additional risks.  Id. t ¶ 11f-h.  These aren’t defects.  The first two are simply legal conclusions and the third is an alleged potential injury.  An injury that is again not tied to plaintiff’s particular condition in this case.  Simply listing numerous speculations doesn’t make them any less speculative.  This is something holism can’t cure.

            From here the court moved on to find that the plaintiff also alleged a safer alternative design – the element at “the heart” of design defect under Georgia law.  Schmidt, 2014 U.S. Dist. LEXIS 146459 at *9-10.  What plaintiff actually alleged wasn’t an alternative design of the device, but an alternative method of surgically repairing hernias that doesn’t involve the use of the mesh device.  Id. at *9.   This argument, of course, is a disguised form of absolute liability, that is, it’s another way of saying that the product should simply not have been used at all, that “nonuse” is the alternative design.  Fortunately, there is an extensive body of law recognizing that altogether different products or different procedures are not alternative designs.  You can read about it here  

            Not only should plaintiff’s design defect claim have been dismissed under TwIqbal, so should have his failure to warn claim.  The complaint simply alleges that the warnings provided were inadequate.  What isn’t alleged is what warnings were given to the plaintiff’s surgeon and how they were in any way inadequate.  The court accepts as true plaintiff’s completely unsupported assertion that plaintiff’s surgeon wasn’t warned of any of the “defects” identified in the complaint.  Incorporating everything we said above about those “defect” allegations, plaintiff was already well-behind the starting line if they are the basis for his failure to warn claim too.  Not to mention there is no allegation that plaintiff suffered from any of the allegedly unwarned about risks and no allegation about what information was in fact conveyed to the surgeon or what knowledge the surgeon had at the time of the surgery.  All are information within plaintiff’s ability to ascertain before filing his complaint.   

            Finally, defendant also moved to strike plaintiff’s request for punitive damages.  Here the court engages in a nonsensical analysis that seems to result in the inability to ever have punitive damages dismissed at the pleadings stage.  First the court says that a motion to strike is “proper only where the relief requested is not available as a matter of law.”  Id. at *16.  That is neither true nor the crux of defendant’s argument in this case.  Rather, defendant challenged the factual basis for plaintiff’s request for punitive damages.  That, the court agreed, sounds more like a Rule 12(b)(6) motion to dismiss.  However, a motion to dismiss is also improper.  Rule 12(b)(6) can only be used to dismiss a “claim” in its entirety and a request for punitive damages isn’t a “claim” but rather is part of the relief requested.  Id. at *18-19.  The court, therefore, concludes that plaintiff’s request for punitive damages is “subject neither to dismissal nor striking.”  Id. at *19. 

            So, how do you dismiss a punitive damages claim?  Do you have to wait until summary judgment to challenge it?  The mere presence of the claim could be used as the basis for significant discovery of defendant that is completely unwarranted, including the disclosure of sensitive financial data.  Here, the court was willing to at least say that the allegations that defendant was aware of the “defects” and represented that the device was safe sufficiently supported a potential punitive damages award if proven.  Since that conclusion is still based on plaintiff’s insufficient and unsupported conclusory allegations, it suffers from the same problems as all of the other conclusions reached in this decision. 

            The bottom line is this -- you can read this complaint backwards, sideways, up-side down or holistically and it just isn’t good enough to survive TwIqbal.       

ACI’s Drug & Medical Device Litigation Conference – Shameless Plug

In a first for the DDLaw Blog, we’re an official "Media Partner" for the American Conference Institute’s 19th Annual Drug & Medical Device Litigation Conference, to be held December 8-10, in New York City.

That means we’re going to be there – and you can be too. More cheaply than usual, it turns out. Anybody who signs up with ACI can get $200 off of the conference price when registering if they mention the Drug and Device Law Blog. ACI gave us a discount/promo code for that – it’s "DD200."

Still, why would you want to do that?

Here’s why:

1. The agenda’s been revamped, relying on customer research and on recommendations from the insights of an Advisory Board with 10 in-house members, from litigation-savvy companies like Johnson & Johnson, W.L. Gore, and others.

2. This year’s conference co-chairs from Bayer, Eli Lilly, and Medtronic who have created a cutting-edge program.

3. Dynamite in-house faculty speakers – more than 20 of them − including Actavis, Biomet, Bard, GSK, du Pont, Endo, McKesson, Merck, Novo Nordisk, Olympus, Roche, and Teva. They’re litigating what we write about here on DDLaw.

4. The kind of up-to-the-minute things you need to know: e-discovery post-Actos, social media in litigation; the latest creative theories on removal (including CAFA), third-party payors, and third party litigation funding.

5. A bunch of judges – we count seven – from California (Kramer), Illinois (Herndon), Indiana (Nuechterlain), Louisiana (Methvin), Minnesota (Tunheim), New Jersey (Pisano), and New York (Keenan). In other words, judges you’ve heard of.

6. FDA-related topics, including the keynote speaker, along with topics near and dear to our hearts, such as off-label use/promotion, and lots of preemption (generic and medical device).

7. "Meet-Ups" facilitated by in-house counsel, included in the conference registration, an opportunity to swap litigation war stories, and product-specific updates on mesh, anti-psychotics, and blood thinners. More stuff you can use.

8. In-house insights − What do General Counsel really want from their defense teams − in the pre-conference session, "View from the General Counsel’s Office: Limiting Liability and Managing and Reducing Costs in Drug and Med Litigation."

9. Ethics CLE – This year’s topics being, Inclusion, Diversity, and the Products Credits Liability Bar (don’t come to places like Philly without ‘em); and Dealing with the Increasingly Aggressive Plaintiffs’ Bar Without Sinking to Their Level.

10. Networking, networking, and more networking – ACI has sponsored cocktail receptions, luncheons, and other organized activities designed to encourage mingling with hundreds of peers throughout the country.

See you there.

Friday, October 17, 2014

Louisiana Liability For A Sales Representative's Sizing Error

            Those of us whose childhood had low tech play options and at least a touch of OCD recall playing with dominoes.  Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.”  No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over.  If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains.  There is probably some app for this now.

            The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes.  (We do try to have our non-legal introductions have something to do with our purported point.)  The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used.  The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up.  The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later.  Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract.  The defendants eventually moved for and were granted summary judgment.  The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon.  In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship.  On appeal, all the tiles fell to bring the deep pockets back into the case.  (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)

            To impose any liability on the defendants in the absence of any allegation of failure to warn, mislabeling or product defect, first there had to be a duty owed by the rep to the plaintiff to “insure the proper implant was used in Mrs. Grabowki’s surgery.”  Id. at *18.  That sounds like part of practicing medicine to us and the evidence was that the surgeon “determined that Mrs. Grabowski required a size 5 implant . . . inserted the poly insert into the tray and tested it to verify that the dovetail mechanism of the implant held the tray and insert together in place [and] then completed the surgery.”  Id. at *3.  Regardless of what size insert the rep handed over to the nurse, it was the surgeon who did or did not perform the surgery correctly, including using the right devices.  Drawing largely on a distinguishable case where a physician’s answering service owed a duty to patients to promptly and accurately relay information from the patients to the physician, the appellate court found that the rep owed a duty “to provide the appropriate size poly insert for the size 5 implant that Dr. Collins determined Mrs. Grabowski required.”  Id. at *26.  That the duty was owed to the patient—with whom the rep never interacted—as opposed to the doctor or hospital staff—with whom the rep did have interaction—was glossed over.  The novel duty was rationalized largely on economic terms:

We do not see that imposition of this duty will result in an unmanageable flow of litigation . . . . [T]he nature of [the rep’s] activities, his experience, and his expected conduct in the OR made it clearly foreseeable that his failure to provide the proper size implant and corresponding poly insert would result in harm to the patient in whom it was being implanted.  Mrs. Grabowski was not at fault.  The economic impact is that all parties that contributed to Mrs. Grabowski’s harm share in the responsibility for her damages.  Surgeries, especially ones like Mrs. Grabowski’s, are becoming more and more technologically advance, requiring technological assistance from sales representatives who are specially educated and trained with respect to the medical devices they sell.  Accordingly, it is reasonable for these sales representatives to be responsible for their negligent acts.
Id. at **26-27.  Among other things, this rationale seems to ignore that the consequence of imposing potential liability for reps and entities that may be responsible for their acts or omissions is that it would deter the provision of this necessary technical assistance unless liability can be reallocated to the doctors and hospitals.  If we start with the assumption that “more technologically advance[d]” surgeries appeal to surgeons because they might improve the care provided to patients, then expansion of liability like this does not seem like a good idea, as we have said before. 

            From here, the analysis of whether there was a genuine issue of material fact as to whether the alleged breach of the new duty caused plaintiff’s injuries was brief.  The defendants went as far as introducing expert evidence that the implanting surgeon and hospital acted below the standard of care in connection with the implant.  Id. at *28.  Based on no evidence from plaintiff we see beyond that the rep did provide the implant after the surgeon specified the size, the court found a genuine issue of material fact.  We understand that joint tortfeasor law varies and not everywhere has the concept of last clear chance, but there should be some evidence that what the rep did caused the injury when the surgeon is the one who determined that the implant he received was the size he wanted to use in the surgery he performed.
            With potential liability for the rep established, the court turned to imposing liability on the distributor and manufacturer for the rep’s alleged breach of a novel duty.  To its credit, it rejected the argument that the basic reciprocal indemnity provisions in the contract between the rep and the distributor made plaintiff a third party beneficiary of the contract.  Id. at **29-32.  The handling of the argument that the rep acted with apparent authority for the manufacturer, with whom he had no direct relationship at the time of the implant surgery, is more problematic.  The court set out several “facts” that collectively established a genuine issue as to the existence of apparent authority.  While having a business card saying he was the representative of the manufacturer and the manufacturer’s name on a badge the hospital gave him to allow him to enter the operating room may be relevant facts, others were not “facts.”  The implanting surgeon offered that he “believed” the rep represented the manufacturer and “opined” that the manufacturer should be liable for failing to train the rep who no longer had any direct relationship with it.  That all sounds more like a justification for why the manufacturer should be liable than facts supporting apparent authority, but it was enough for the appellate court.  Id. at **35-37.

            Similarly, the last piece to fall was that the distributor’s contract with the rep created a “master-servant” relationship even though it purported to create an independent contractor relationship.  The basic question is whether the contract gave the distributor the right to supervise and control how the rep performed his contractual responsibilities.  The contractual provisions that were sufficient to deem the rep an employee of the distributor included “the payment of commissions for his sales, the number of causes for termination [of the rep], the lack of consequences in the event [the distributor] breaches the contract, and the ownership of the rep’s] product ideas without evidence of what training [the distributor] provided [the rep] that equipped him with special knowledge needed to formulate product ideas.”  Id. at *43.  We are not so sure how these all go to supervision or control, but what troubles us more is that provisions requiring the rep to be accurate and complete in communicating on the products, to use only written materials he was provided, and to comply with applicable laws were also seen as evidence of employment.  Id. at **40-41.  These provisions, of course, are necessary given various FDA requirements on the marketing of medical devices.  We suspect that absence of such requirements as to reps who market a medical device, regardless of whether the manufacturer, distributor, or nobody employs the rep, could be seen as a lack of appropriate marketing practices by the manufacturer.  In effect, manufacturers would need to have reps bound by such provisions, even when the reps are set up as independent contractors of distributors.  The presence of such provisions, in turn, makes reps employees of the distributors (or, of the manufacturer in instances where there is a similar independent contractor agreement with the manufacturer).  Combined with the potential liability of the rep for breach of a novel duty running to the patient, this, in turn, greatly decreases the chance of complete diversity in an ensuing injury lawsuit.  This, in turn, greatly increases the chance for bad rulings and new ways to impose liability.  Like a Mรถbius strip of perpetually falling dominoes. 

Thursday, October 16, 2014

A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)

A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases.  That’s a good place to be when you’re defending a medical device company.  Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts.  Showing a safer alternative design isn’t enough.  And that’s important, because there are often alternative designs for medical devices.  Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Restatement (Third) of Torts § 6(c).  In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.  

The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work.  The plaintiff had knee replacement surgery, but later needed revision surgery.  He was allergic to the cobalt and nickel contained in the knee replacement system.  So he sued, claiming, amongst other things, that the system was defectively designed.  Id. at *1, 2, 7.  

But the question under § 6(c) is not whether the device could have been designed without cobalt and nickel so that it is better suited for a particular patient or class of patients.  It’s whether the device, as designed, would be used by a reasonable doctor with “any” class of patients.  In other words, would it be prescribed for a class of patients without such allergies?  That question will often answer itself.  The Haffner court answered it for us:

Prescription medical devices are not the same as ordinary consumer products. A variety of similar devices made with different materials can be developed and manufactured to address the needs of different classes of patients. Simply because a product would not be compatible with a certain class of individuals--in this case, those with cobalt and nickel allergies--does not mean the medical device is defectively designed. The Restatement (Second) considered the possibility that certain drugs could be unavoidably unsafe while still remaining beneficial. The Restatement (Third) took this conclusion one step further, reasoning that medical devices can be safe for certain patient populations and not others without their risk outweighing their utility. It is for this reason that these devices can only be sold to doctors and administered by prescription. The plaintiff has failed to state a plausible claim that the Knee System is defectively designed. Therefore, this claim is dismissed.

Id. at *7-8.  That’s the crux of it.  Under § 6(c), the device need only be of a type that a reasonable doctor would prescribe to some patients.  That is almost always the case with a device approved or cleared by the FDA.  And therein lies the power of § 6(c).  

Now, § 6(c) is not all protective.  It does not necessarily protect against failure to warn claims, and so the Haffner court allowed plaintiff’s strict liability and negligent failure to warn claims to go forward.  

But the defendants are in a better place.  They no longer have to deal with, arguably, the most difficult claim to defend – design defect – particularly if they had to conduct that defense under law that allows consideration of alternative designs.  With that in mind, this was a very good result.