When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), manufacturers of PMA medical devices are in the power position in products liability litigation.  Very little slips by the double-edge sword of express and implied preemption in PMA cases.  The same can, and should be said for IDE cases as well.  And that’s what the Kentucky Court of Appeals said in Russell v. Johnson & Johnson, — S.W.2d –, 2018 WL 5851101 (Ky. Ct. App. Nov. 9, 2018).

Defendant manufactures medical catheters.  The catheter was approved by the FDA via the PMA process in 2004.  Id. at *1.  In 2015, the FDA approved use of the catheter under the Investigational Device Exemption (“IDE”) to the MDA which allowed the catheter to be used in a clinical trial to evaluate its safety in certain cardiac ablation procedures.  Plaintiff underwent a cardiac ablation procedure as part of the clinical trial in which defendant’s catheter was used.  Id.  After plaintiff’s procedure the catheter did receive full pre-market approval.  Id. at *4.

Plaintiff suffered complications during the procedure and subsequently filed suit alleging defendant was liable for strict liability, negligence, lack of informed consent, failure to warn, breach of warranties, fraud, and unjust enrichment.  Id. at *2.  Defendant moved to dismiss all claims on the grounds of preemption and the trial court, relying on Riegel, granted the motion.  Id.  Plaintiff later asked the court to set aside its ruling based on defendant’s voluntary recall of other catheters, but not the one used on plaintiff.  The court denied that motion.  Plaintiff appealed both rulings.

Not surprisingly, plaintiff’s primary argument was that the court should discount Riegel because at the time of plaintiff’s surgery, the device had not yet received pre-market approval.    Id. at *4.  But the court found the argument contradicted by numerous courts to have considered the issue.  Some courts find that timing of the grant of PMA to be immaterial.  Id.  While others find IDE approval to be synonymous with PMA.  Id.  This certainly follows the logic of Riegel.  Riegel adopted a two-step test for preemption and the first step is whether the FDA has established requirements applicable to the device.  Riegel concludes that a PMA does in fact establish such requirements.  Well, so does an IDE.

[b]ecause IDE devices are subject to a level of FDA oversight and control that is, for the purpose of a preemption analysis, identical to that governing PMA devices, the body of preemption law governing PMA devices applies equally to the IDE device at issue in this case.

Id. (citing Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir. 1997).

Thwarted by authorities from other jurisdictions on the issue, plaintiff next urged the court to rely on a Kentucky Supreme Court case decided before RiegelNiehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997).  Id.  Niehoff rejected preemption in an IDE case relying on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  But as we all know, Lohr dealt with a device approved via the §510k “substantial equivalence” process.  As pointed out above, the IDE process is more analogous to the PMA process and therefore, in a post-Riegel world, Riegel is controlling.   In Niehoff, the manufacturer also stopped the clinical trial before the FDA considered its PMA application.  Id.  Whereas in Russell, the device was granted PMA just over one year after plaintiff’s procedure.  Id. at *5.

In deciding the preemption question in the current case, the court started its analysis with the clear cut statement that “there is no presumption against preemption” in an express preemption case.  Id.  After checking that box, the court looked at the device at issue and concluded that “approval after being subject to both the IDE and PMA processes, satisfies the first prong of Riegel.”  Id. at *6.  So, to survive preemption, plaintiff cannot be alleging a claim that is different or additional to FDA’s requirements regarding safety and effectiveness.  Id.  That means, plaintiff in his complaint must allege three things: “violation of a federal requirement; violation of an identical state violation; and a link between the federal violation and [plaintiff’s] injury.”  Id.  Plaintiff went 0 for 3.

The court could find no allegations of federal violations, or even a cite to a federal regulation.  No factual support for any alleged violation.  No allegations that his injury was caused by a federal violation.  All plaintiff did was allege the device was defective – “in other words, the FDA should have imposed more stringent requirements – an attack precisely prohibited by the MDA.”  Id. at *7.

Failure to allege a parallel violation required dismissal of plaintiff’s strict liability, negligence, failure to warn, and fraud claims.  Id. at *7, *8.    Plaintiff’s informed consent claim failed because plaintiff signed a detailed consent form that was approved by the FDA.  Any claim that the consent was inadequate would impose a different or additional requirement on the defendant.  Id. at *7.  Claims that the device breached warranties regarding safety and effectiveness “directly contradict the FDA’s conclusion that the catheter was safe and effective.”  Id. at *8. As would an unjust enrichment claim premised on a claim that plaintiff did not receive safe and effective medical care.  Id.  Finally, plaintiff failed to allege a parallel federal statute to the Kentucky Consumer Protection Act.  Id.  So, all of the claims were properly dismissed as preempted.  The appellate court also upheld the trial’s court’s decision that any attempt at amendment would be futile.  “Additional time would not have transformed [plaintiff’s] claims into parallel state claims.”  Id.

As for the motion to set aside the dismissal based on the recall, the court again upheld the trial court’s decision.  A final judgement can be set aside based on newly discovered evidence which could not have been learned via due diligence in time for a new trial.  Id. at *9.  But new evidence is not events that occur after entry of a final judgment – such as the recall here.  Id.  Moreover, the new evidence needs to be relevant.  The recall was of different catheters, not the one used in plaintiff’s procedure.  Id.  Next, the voluntary recall “negated neither federal preemption nor FDA approval.”  Id.  The FDA was aware of adverse events and of the recall, but did not withdraw its approval of the device.  And, a recall is not a presumption that FDA regulations have been violated.  A recall doesn’t turn a “preempted claim into a parallel cause of action.”  Id.

             No doubt defendant had pocket aces going into this appeal, but Jim Murdica and Kara Kapke from Barnes & Thornburg and Lori Hammond from Frost Brown Todd deserve a shout out for knowing when to go all in!

Some of your favorite Drug and Device Law bloggers will be presenting at Reed Smith’s Life Sciences CLE Day, which will be presented live in Reed Smith’s Philadelphia office and via videoconference to our Pittsburgh office on Thursday, November 15. This is a free, full-day CLE program designed for in-house counsel at life sciences companies.

Bexis will be covering “Key Issues Currently Before the Supreme Court and Other Supremely Interesting Cases,” discussing cases teed up for the current Supreme Court term that could have significant implications for preemption in prescription drug cases, class action strike suits, and even basic product liability law.

Steve McConnell and Rachel Weil will be discussing “Games People Play: Decision Points in MDLs,” which will examine recent trends in multidistrict litigation, particularly in life sciences and product liability cases. The focus will be on strategies for being in the right court, reasonably cabining the scope of discovery, facilitating federal-state and joint defense cooperation, and avoiding adverse trial scenarios.

In between, some of our Reed Smith colleagues will discuss:

  • Ethics “do’s and don’t’s” in-house counsel can learn from some real stories of questionable ethics and sanctionable conduct
  • The recent N.J. Supreme Court decision where the Court unanimously upgraded the state’s standards for admission of expert testimony, and wider discussion around expert testimony
  • Health tech developments affecting drug and device companies
  • Unexpected issues that are arising for life sciences and health companies in a post-GDPR world, despite companies’ careful preparedness for GDPR implementation
  • Key State AG enforcement activities relevant for life sciences companies, and likely new trends in this area
  • Pharmaceutical pricing and contracting compliance and the potential impact of the Trump administration’s “Blueprint” to address concerns over pricing

The good people at Reed Smith are also providing a networking breakfast and lunch, with a reception immediately following the CLE day in Philadelphia.

This program is presumptively approved for 5.0 general CLE credit and 1.0 Ethics credit in Pennsylvania, California, Texas and Florida. The program is also approved for 6.0 general CLE credit and 1.0 Ethics credit in New Jersey. It is presumptively approved for 5.0 general CLE credit and 1.0 Ethics credit under New York’s approved jurisdiction policy. Applications for general and Ethics CLE are pending in Delaware, Illinois, and West Virginia.

Interested? You can register here. (Please note that space is limited.)

Happy birthday, Aubrey Drake Graham.  Most people know Mr. Graham strictly by his middle name.  The Canadian rapper Drake has carved out a hugely successful career for himself.  He sells lots and lots of records – or whatever it is that they sell in the music business these days.  Surprise: Drake’s music isn’t exactly our thing.  We still play the Beatles more than anything else, we sing along with Crosby, Stills, & Nash in the car, and we have difficulty naming songs post-dating Nirvana.  (Seinfeld once famously asked, “How could you not like the Drake?”  He was talking about somebody else.  Still, it’s a question we hear frequently from friends and family, chiding us for our retrograde taste in music.) Nevertheless, it’s impossible to swim in this culture without getting at least a little wet from Drake’s songs.  With “Worst Behavior,” for example, we got doused with language that you won’t hear in “Hello/Goodbye,” “Suite: Judy Blue Eyes,” or even “Come as You Are.” The main lyrics in “Worst Behavior” are about remembering how some bad, um, person, didn’t love Drake enough.  Anyway, thinking about that song made us review instances of the worst behavior by plaintiffs we have known and not loved.  There’s outright lying, cheating, and stealing.  And that’s looking only at the Plaintiff’s Fact Sheet.  Sometimes it goes beyond that.  Way beyond that.  Sometimes there’s hiding assets, including one’s pending tort claims, in bankruptcy.  It’s a swell way to stiff creditors.

This is not the first time we’ve encountered a case where a plaintiff neglected to list a mass tort claim as an asset in a bankruptcy proceeding.  See our blogposts here and here, for example.  Such neglect can have serious consequences, including staying or even dismissing the tort claim.  In today’s case, Kinderline v. Accord Healthcare, Inc., (In re Taxotere Prod. Liab. litigation), 2018 WL 5016219 (E.D. Louisiana Oct. 16, 2018), the plaintiff declared bankruptcy first, and two months later brought the mass tort action.  The plaintiff did not amend the bankruptcy papers to identify the claim.  The mass tort being an MDL, it dragged on, and the plaintiff’s bankruptcy closed with the trustee not hearing about the pending mass tort claim.  The plaintiff received a “no asset” discharge from bankruptcy. A fresh start! The plaintiff’s failure to include the tort claim in the bankruptcy proceeding was caught only after she was deposed by the defendant in the MDL.  (See – there’s a reason why that bankruptcy question shows up in your depo outlines.). The plaintiff then belatedly reopened the bankruptcy proceeding to list the tort claim.  The issue was whether the plaintiff was collaterally estopped from pursuing the tort claim in the MDL.

First things first.  Which law governed the estoppel issue? The plaintiff wanted to apply the law of her home jurisdiction, Ohio.   But the application of judicial estoppel is a matter of federal common law, and the case had been transferred to the MDL court in Louisiana, which is part of the Fifth Circuit.    There is precedent, though not by the Fifth Circuit, holding that application of federal (Constitutional, statutory, or common) law is governed by the law of the transferee court.  Judge Fallon in E.D. Louisiana went that route in the Vioxx MDL.  It certainly makes administration of the MDL easier.  (That’s not the same thing as saying it is right.) Even without Fifth Circuit precedent squarely on point, the Taxotere MDL court was convinced that the circuit law of the transferee court held sway, and therefore applied Fifth Circuit, not Sixth Circuit, law.  We’re not sure there is any difference in terms of application of judicial estoppel.  That is usually the threshold issue in a choice of law analysis.  Not so here.

This choice of law rule might be important to you when you are deciding what court you will argue for when it comes to creating an MDL.  Most lawyers tend to focus on the particular judge and district court they like better (or which particular judge and district court most terrifies them), but we should also think about the circuit court.   For instance, we recently argued for sending an MDL to the district of New Jersey.   The judge there seemed quite good.   But we were not blind to the fact that Third Circuit Law on preemption, in the form of the dreaded Fosamax decision, was bad bad bad.  We ended up concluding that Fosamax was so obviously bad that SCOTUS would reverse it.  That’s a heck of a gamble.  Right now, as we mentioned recently when we reviewed the Solicitor General’s amicus brief in Fosamax, it looks like a good gamble.  To quote a musician much more likely to be found in our playlist (and much more likely to be found in the Third Circuit), Fosamax is “going down, down, down, down.”

Back to Kinderline.  The court held that the plaintiff was, indeed, estopped.  Fifth Circuit law on estoppel, like the law in most places, looks at three elements: (1) the party against whom estoppel is sought has asserted a position plainly inconsistent with a prior position; (2) a court accepted the prior position; and (3) the party did not act inadvertently.  The first element was met here because the plaintiff failed to amend her bankruptcy petition to disclose a claim pursued after filing the petition.  The duty to disclose claims/assets in bankruptcy is an ongoing obligation. The second element is straightforward and obviously satisfied, because the court accepted the prior position – hence the no-asset discharge.  Now comes the third element, inadvertence.  To establish a defense of inadvertence, a party must prove (1) that she did not know about the inconsistency, or (2) that she lacked a motive for concealment.  There is no help for the plaintiff in Kinderline there, as there is no evidence she was oblivious to the inconsistency between the filing of the lawsuit and the failure to list it in bankruptcy, and the motive for concealment, keeping creditors away from any proceeds of the lawsuit, is undeniable and has, in fact, been recognized by the Fifth Circuit in another judicial estoppel case.  The plaintiff “would have reaped a windfall if she had been able to pursue this claim and collect a judgment from Accord without having to share the judgment with her creditors.”

The best fact the Kinderline plaintiff had going for her was that she reopened the bankruptcy proceeding before the defendant managed to move for estoppel.  She won the race to the courthouse.  Whoopee.  Not good enough.  The plaintiff did not seek to correct the record until being caught at her deposition and until almost a year after she knew of the lawsuit as asset.  Borrowing from Fifth Circuit precedent, it is clear that to bless the plaintiff’s gamesmanship by allowing the debtor to “back-up, reopen the bankruptcy case, and amend [her] bankruptcy filings, only after [her] omission has been challenged by an adversary, suggests that a debtor should consider disclosing personal assets only if [she] is caught concealing them.”   In other words, there must be consequences for the plaintiff’s bad behavior.  The plaintiff claimed that her delay was caused by her decision to wait to confirm product identification to ensure she was suing the correct party.  Hmmm. Such carefulness on the part of the plaintiff and her attorneys!  Yet it did not stop her from filing the tort lawsuit.  Nor did it account for all of the year-long delay. The plaintiff is not innocent.  For that reason, judicial estoppel means that she cannot pursue her lawsuit in the MDL.

But the Chapter 7 trustee is innocent and is the real party in interest.  The Trustee did not hide assets.  For that reason, the bankruptcy trustee could pursue the plaintiff’s claim.   But here’s an odd wrinkle:  the rejection of the plaintiff’s right to claim on her own behalf meant that her husband’s consortium claim was extinguished, as it was purely derivative of his wife’s claim.  To allude to the title of another Drake song, the husband’s claim was “Over.”

Did you know that October is National Cybersecurity Awareness Month?  Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks.  We also learned that National Cybersecurity Awareness Month has been observed each October since its inception in 2004.  Observed by whom?  We’re not exactly sure.  We picture our IT consultants walking office to office handing out hats and stickers with catchy slogans like “A password is like underwear. Change it!”  Or some lame pun involving the work “phishing.”  If it were up to us, we would default to the simple and classic “Ctrl-alt-delete before you leave your seat.”

All kidding aside, cybersecurity threats have moved in recent years from theoretical to very real, and while there remains no reported instance of anyone hacking into a medical device being used to treat a patient, the potential vulnerability is one to which we need to pay attention.

That includes the FDA.  The FDA has published guidance on cybersecurity with regard to both premarket submissions and post-market submissions.  (You can see our take on the postmarket guidance here)  Based on the FDA’s press release, updates are coming to the premarket guidance, specifically to “highlight the importance of providing customers and users with a ‘cybersecurity bill of materials,’ or in other words, a list of commercial and off-the-shelf software and hardware components of a device that could be vulnerable to attack.”  This jibes with the FDA’s general approach to cybersecurity, which is to undertake a risk-based analysis that identifies vulnerabilities, assesses the potential frequency and severity of the risk, identifies mitigations, and proceeds accordingly.  Such a risk-based analysis should be familiar to anyone who operates in the medical device space, where risks and benefits are weighed on a daily basis.

The other news of the press release is the publication of a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which “describes the types of readiness activities that’ll enable HDOs [healthcare delivery organizations] to be better prepared for a cybersecurity incident involving their medical devices.”  This Playbook was prepared by the MITRE Corporation, a government-sponsored research and development organization.  You can get a copy of the Playbook here, and you can that it is aimed at healthcare providers and critical healthcare infrastructure in which medical devices operate.

The purpose of the Playbook is to help HDOs get ready for cybersecurity threats affecting medical devices that could impact continuity of care and patient safety.  More specifically, the playbooks objectives are to:

  • Provide baseline medical device cybersecurity information that can be incorporated into an HDO’s emergency preparedness and response framework;
  • Outline roles and responsibilities for responders to clarify lines of communication “across HDOs, medical device manufacturers (MDMs), state and local governments, and the federal government”;
  • Describe a standardized approach to response efforts;
  • Serve as a basis for enhanced coordination activities among medical device cybersecurity stakeholders;
  • Inform decision making and the need to escalate response;
  • Identify resources HDOs can leverage as a part of preparedness and response activities; and
  • “Serve as a customizable regional preparedness and response tool for medical device cyber resiliency that could be broadly implemented.”

We put that last one in quotes because we’re not exactly sure what “cyber resiliency” means, but we assume it means the ability to fend off a cybersecurity event or at least mitigate its impact.  Toward that end, the Playbook suggests a four phase approach:  (1) Preparedness; (2) Detection and Analysis; (3) Containment, Eradication, and Recovery; and (4) Post Activity.

“Preparedness” means exactly what it says, with an emphasis on mindfulness of cybersecurity when procuring medical devices and keeping an inventory such that the HDO is always aware of what connected devices it has on hand.  HDOs should engage in “hazard vulnerability analysis” (again, a focus on risk) and plan for communicating and responding during an event.  That includes medical device manufacturers, whom the Playbook places squarely within the communication loop with the HDO and the FDA.

“Detection and Analysis” focuses on identifying when an incident has occurred and assessing its priority on a numerical scare that strangely assigns “Emergency” events to “Category 0.”  Analysis and documentation are important parts of the process, too.

The core of the response falls under “Containment, Eradication, and Recovery,” which appropriately focused on patient safety.  Is the device safe to use?  Is there a reliable way to test the device and confirm it is working correctly?  Are there spare or backup devices?  How quickly can the problem be fixed, and has there been collateral damage to the broader healthcare system?  These are the questions that HDO should be asking.

Finally, the “Post Activity.”  The Playbook recommends attention to lessons learned, including possibly retaining a digital forensics expert and updating the plan.

As we have said before, medical device cybersecurity is here to stay, and the FDA has been busy.  In addition to the Playbook (which is not an FDA document, but still, you get the gist), the FDA has entered into memoranda of understanding to form information sharing analysis organizations (“ISAOs”), which are “groups of experts that gather, analyze and disseminate important information about cyber threats.”  The Agency has participated in cybersecurity exercises and summits, and has engaged discussions with other government agencies, including the Department of Homeland Security.  It has proposed a Center of Excellence for Digital Health, which “would help establish more efficient regulatory paradigms, consider the building of new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.”  We will keep you posted.

Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us.

But that’s not really the point of this post.

The alleged “facts” are downright bizarre:  The plaintiffs were sore losers in previous litigation against the same defendant.  They had managed, through the use of now-discredited legal gamesmanship – a nationwide class action involving the extraterritorial application of the Illinois consumer protection statute – to obtain a verdict of over a billion dollars on claims involving State Farm and allegedly inferior replacement parts used in car repairs.  Thankfully, plaintiffs couldn’t hold it.  In Avery v. State Farm Mutual Automobile Insurance Co., 835 N.E.2d 801 (Ill. 2005), the court rejected extraterritoriality and nationwide consumer fraud class actions. Id. at 855 (“we conclude that the circuit court erred in certifying a nationwide class that included class members whose claims proceedings took place outside Illinois”).  The nominal vote was 4-2, with one justice not participating, but even the dissent agreed on this issue.   Id. at 864 (“I agree with the ultimate result reached by my colleagues − I, too, would find that the circuit court erred in certifying the nationwide class”) (concurring and dissenting opinion).  There were a slew of other issues in this contentious case, but with rejection of the nationwide extraterritorial class, any basis for the boxcar, billion-dollar verdict disappeared.

But plaintiffs (or their lawyers) didn’t give up.  Instead they filed a RICO action alleging that State Farm was “racketeering” when it gave large amounts of campaign contributions – Hale contains nothing to suggest that any state-law campaign finance violations were involved − to support the election of a particular “pro-business” candidate to the Illinois Supreme Court, while the Avery appeal was pending:

In essence, plaintiffs allege that defendants secretly recruited [the candidate] to run for an open seat on the Illinois Supreme Court, where the Avery . . . appeal was pending; that defendants organized and managed his campaign behind the scenes; that defendants covertly funneled millions of dollars to support his campaign through intermediary organizations over which [defendants] exerted considerable influence.

Hale, 2018 WL 3241971, at *1.  You get the drift.  Next came the predictable allegations that everything was covered up so no recusal occurred.  Id.  The new justice supposedly “broke” a “deadlock” – yeah, right, in a case where the main result was unanimous − and “voted to overturn the judgment.”  Id.  All this purportedly nefarious politicking supposedly “deprived [plaintiff plaintiffs] of their constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics.”  Id.

It’s not the point of this post to debate the intricacies of RICO causation, damages, or enterprises.  We don’t think Hale should ever have gone that far.  We’ve previously advocated the First Amendment protection of purely scientific speech, because we don’t believe that one side to a scientific debate should be allowed to sue the other into submission.  That was our primary interest when Citizens United v. Federal Election Com’n, 558 U.S. 310 (2010), was handed down.  We frankly didn’t dream that core political speech of the sort at issue in Hale could give rise to private prosecutions under RICO.

But be that as it may. If it’s open season on the opposition’s campaign contributions, can the defense side play, too?  After all, in most judicial elections, contributions from the defense are dwarfed by what our politically minded adversaries are able to raise and spend.  It’s no secret.  Here, for example, is the “Campaign Finance Online Reporting” of the Pennsylvania Secretary of State.  You can type in the name of your most (or least) favorite judge and relevant election year and see everybody from whom s/he reported receiving contributions.  Or you can click on “contributions made” and track the donations by your favorite plaintiffs’ lawyer or firm.  Our clients have just as much of a “constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics” as do plaintiffs.  Are there RICO violations here?

But maybe that’s not enough.  Perhaps it’s too diffuse to assert a RICO violation just because the other side’s contributions made up 90%+ of the total contributions to a particular judge sitting on a particular case.  Maybe there needs to be a “pending” matter to focus things more precisely.  Still, our side might be able to play.  Consider all of those “civil enforcement” actions nominally brought by cities, counties, and states against our clients – where the real vigorish goes to the contingent fee, private counsel brought in to prosecute the action for the government.  We’ve complained about those actions, as well, without much success.  If it turns out that contingent fee counsel (or those acting in concert with counsel) made large political contributions to the particular politicians who later authorized the filing of one of those suits against a client, does the client have a RICO counterclaim under the same rationale as Hale?

Our bottom line is that suits like Hale are abuses of the judicial system and attempts to sue over the other side’s First Amendment protected political activity.  We’re, frankly, shocked that Hale survived summary judgment.  But if plaintiffs insist on opening up that Pandora’s Box, our side should consider whether it wants to play, too.

When we sit around the table this Thanksgiving, we’ll have another thing to be grateful for this year: ACI’s 23rd Annual Drug and Med Device Conference will be just days away on November 28-30, 2018 in New York City. We’re looking forward to the usual interesting and informative content, networking opportunities with clients and colleagues – and maybe even the chance to catch up with some of our loyal readers.

Bexis expects to be in his usual front and center seat if you want to chat (somebody’s got to ask questions). And you can also catch him presenting on November 29 on “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health and 3D Printing.”

Other sessions we have earmarked on our agendas include: “MDLs: Their Intended Purpose, What Attempts Have Been Made at Improving the MDL System, and Effective Ways for Wrapping Them Up,” and “Engaging the Courts in the Right Way: What Does It Mean to Be an Innovative Thinker as an Outside Counsel?” and breakout sessions on personal jurisdiction and innovator liability.

If you want to register, you can do so here. We look forward to seeing you in New York!

We had occasion not long ago to reread closely Lexecon v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), the Supreme Court decision that clipped the wings of transferee judges in multi-district (“MDL”) litigation by reminding them that the MDL statute, 28 U.S.C. §1407, conferred no authority to try cases.  Except for one justice on one section, Lexecon was unanimous.  While the result came as something of a shock to the MDL insider community, to the Supreme Court, Lexecon was not a hard case.

While the facts of Lexecon (more accurately, the procedural history, since the issue was wholly procedural) involved a MDL judge’s so-called “self-transfer” of a case originally filed in another state, it’s important to examine what the Lexecon court actually held.

First, the MDL statute “authorizes the Judicial Panel on Multidistrict Litigation to transfer civil actions with common issues of fact ‘to any district for coordinated or consolidated pretrial proceedings,’ but imposes a duty on the Panel to remand any such action to the original district ‘at or before the conclusion of such pretrial proceedings.’”  523 U.S. at 28.

Second, at the time the JPMDL had a rule that, despite the explicit language of the MDL statute of coordination being for “pretrial purposes,” allowed self-transfer for trial.  Id. at 32-33.  While appellee (which had won at trial – Lexecon is also a poster child for why the MDL system needs interlocutory appeals as of right, see id. at 31) tried to argue that rule as a basis for authority to self-transfer, the Supreme Court held that the JPMDL lacked authority to authorize by rule an action that was ultra vires under its organic statute.  The import of such arguments “is simply to ignore the necessary consequence of self-assignment by a transferee court: it conclusively thwarts the Panel’s capacity to obey the unconditional command of §1407(a).  Id. at 36 (emphasis added).  “[T]he statute places an obligation on the Panel to remand no later than the conclusion of pretrial proceedings in the transferee court, and no exercise in rulemaking can read that obligation out of the statute.”  Id. at 36-37.

Thus, once §1407 is used to transfer a case, not even a formal JPMDL rule can oust the statutory requirement to remand back to the original court at the end of coordinated pre-trial proceedings.  The Court was clearly in no mood to tolerate gamesmanship in derogation of express statutory language – not even by the JPMDL.

Third, appellees also argued that nothing in the MDL statute precluded the MDL judge from subsequently re-transferring an action to himself under the general transfer statute, 21 U.S.C. §1404.  523 U.S. at 34.  The Court relied on the restrictive, and mandatory, language of §1407 to deep-six that argument:

§1407 not only authorizes the Panel to transfer for coordinated or consolidated pretrial proceedings, but obligates the Panel to remand any pending case to its originating court when, at the latest, those pretrial proceedings have run their course.

“Each action so transferred shall be remanded by the panel at or before the conclusion of such pretrial proceedings to the district from which it was transferred unless it shall have been previously terminated.”  §1407(a) (proviso without application here omitted).

The Panel’s instruction comes in terms of the mandatory “shall,” which normally creates an obligation impervious to judicial discretion.

Id. at 34-35 (citation omitted) (emphasis added).  In short, there is only one place a case can go after being initially transferred pursuant to the MDL statute – back to the “originating court.”

Fourth, appellees argued that, once a self-transfer for trial occurred, the §1407 obligation to re-transfer the case to its original court magically vanished, “because the self-assignment ‘terminates’ the case insofar as its venue depends on §1407.”  Id. at 37. The Court was having none of that too-cute-by-a-half argument either:

The trouble with this creative argument, though, is that the statute manifests no such subtlety.  Section 1407(a) speaks not in terms of imbuing transferred actions with some new and distinctive venue character, but simply in terms of “civil actions” or “actions.”  It says that such an action, not its acquired personality, must be terminated before the Panel is excused from ordering remand.  The language is straightforward, and with a straightforward application ready to hand, statutory interpretation has no business getting metaphysical.

523 U.S. at 37 (emphasis added).

Last and least, appellees argued that because §1407 allowed one type of action (Clayton Act antitrust cases) to be transferred for trial as well as pretrial purposes, power was implicitly conferred to do the same for all MDL cases.  No dice.  That special exception actually cut the other way, because it “demonstrate[d] that Congress knew how to distinguish between trial assignments and pretrial proceedings in cases subject to §1407,” id. at 38 – and did not allow transfers for trial purposes to any other type of case.

Lexecon also examined the legislative history of §1407 (which is why Justice Scalia, the scourge of legislative history, did not join that section).  That history reinforced that §1404 general-purpose transfers were not available as long as the case involved was part of an MDL proceeding:

But the question is not whether a change of venue may be ordered in a case consolidated under §1407(a); on any view of §1407(a), if an order may be made under §1404(a), it may be made after remand of the case to the originating district court.  The relevant question for our purposes is whether a transferee court, and not a transferor court, may grant such a motion.

523 U.S. at 39 (footnote omitted) (emphasis added).  And even such a post-remand §1404 transfer would have to comply with general venue requirements.  Id. at 39 n.2. Among other things, as we pointed out here, that would require personal jurisdiction in the district where the MDL judge sat, which depending on where the MDL was situated, might not be the case.

Beyond that, §1407’s “legislative history tends to confirm that self-assignment is beyond the scope of the transferee court’s authority.”  Id. at 39.  “The bill does not, therefore, include the trial of cases in the consolidated proceedings.” Id. at 40 (quoting House Report at 3-4).

The Court concluded in Lexecon that the statute meant what it said, and that if trials in MDL actions were “desirable,” Congress would have to amend the MDL statute to allow them:

In sum, none of the arguments raised can unsettle the straightforward language imposing the Panel’s responsibility to remand, which bars recognizing any self-assignment power in a transferee court and consequently entails the invalidity of the Panel’s Rule. . . .  [Appellee] may or may not be correct that permitting transferee courts to make self-assignments would be more desirable than preserving a plaintiff’s choice of venue . . ., but the proper venue for resolving that issue remains the floor of Congress.

Id. at 40 (emphasis added).

We have engaged in this detailed exegesis on Lexecon as much to demonstrate what the Court didn’t say, as what it did.  What is absent from Lexecon’s absolutist reading of §1407 is any mention of state boundaries.  Rather the Lexecon court focused entirely on what was allowable in any MDL case initially transferred under §1407, whether that case was first filed in another state or not.

We think that’s critically important.  In their zeal to use the threat of trials to bludgeon defendants into settling, some MDL judges have relied upon territorial distinctions that are wholly absent from Lexecon itself.  They have sought to create a pool of “bellwether” trial cases from actions originally filed in the same state, or the same judicial district, as the MDL itself.

We think that this questionable practice could be the next Lexecon.  Frankly, we don’t think Lexecon allows that.

The basis for the Court’s unanimous holding in Lexecon is what the MDL statute “straightforward[ly]” requires – cases that come to the MDL through to §1407 remain subject to the statute’s absolute remand requirement.  There is no exception in Lexecon for trial (as opposed to remand) of cases transferred under §1407 from other district courts in the same state, or even from other judges in the same judicial district.  Unless the MDL judge happens to have received such a case through ordinary random assignment, s/he can’t try it – unless it’s first transferred out of the MDL and then retransferred back, if that is possible, under §1404.

No gimmicks allowed; the Court came down hard on gimmickry in derogation of §1407’s express limits in Lexecon.

And even if an MDL judge were able to cajole, or pressure, another judge to retransfer a case back to it for a “bellwether” trial, that case would no longer be part of the MDL.  MDL case management orders, MDL scheduling orders, MDL lead counsel (on both sides) would no longer be applicable – otherwise the transfer starts to look like another gimmick to get around the express limitations on allowable MDL activity that Congress wrote into the statute.  In particular, we don’t think that the plaintiff’s counsel in such a bellwether-after-retransfer trial can be compensated from MDL common benefit funds.  The MDL statute straightforwardly limits MDL proceedings to “pre-trial.”

Along these lines, the Lawyers for Civil Justice has a proposal to condition the conduct of “bellwether” trials in MDLs upon the voluntary – and confidential – consent of all parties.  That’s what prompted us to reread Lexecon in the first place.  Since a voluntary consent/waiver appears to be the only way to conduct MDL trials (whether called “bellwether” or anything else) consistently with what Lexecon actually held, we recommend that proposal as a possible way to avoid the next Lexecon.

Otherwise we wouldn’t be surprised to see the Supreme Court, when presented with the opportunity, to make MDL “bellwether” trials go the way of the dinosaurs.

This guest post is by Reed Smith‘s Matt Jacobson.  Matt is interested in the intersection between 3D printing and product liability, and the article he discusses is just too much to pass up.  As always our guest posters are 100% responsible for their content, deserving of all the credit and any blame.

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Walter White, the high school chemistry teacher turned methamphetamine “manufacturer” and main protagonist in the TV show Breaking Bad, has been called a lot of things.  Drug king pin.  Villain.  Criminal mastermind.  Heisenberg.  Visionary?

For the handful of you who have not seen Breaking Bad or are not regular readers of this blog (Walter White appears in at least three prior posts), Walt was a depressed high school chemistry teacher diagnosed with stage III lung cancer. Wanting to ensure his family’s financial security after his death, he gets into the business of manufacturing methamphetamines and drug dealing.  Before he is pulled deeper into the illicit drug trade and his character evolves from teacher/family man into murderer/crime lord, Walt turns an RV into a rolling meth lab.

So visionary may not be the right word, at least not until now. Spoiler alert—it’s been almost seven years since Walter White’s death (yes we believe he really did die) and now a group is following in Walt’s footsteps, manufacturing drugs at home using a micro (not meth) lab—well that is not exactly what it is doing, but it provides good imagery.  So imagine, that instead of meth, Walt manufactures a drug for opiate overdose (might actually be good for his business) or to treat infections in HIV patients.  And instead of beakers in the RV, Walt uses a few mason jars and a 3D printer.  If this had been the story’s line, the show’s creators may have had to change the title to Breaking Good, which doesn’t seem to have as nice of a ring to it.

Ok, back to reality.  Recently, an article appeared in 3D Printing Industry about a group trying to do just that.  The group calls itself Four Thieves Vinegar Collective (taking the name from an alleged plague cure) and according to its website, its mission is “free medicine for everyone.”  Following the footsteps of 3D printed gun proselytizer Defense Distributed, Four Thieves recently released instructions for building an “Apothecary MicroLab,” a DIY kit claimed to be able to synthesize a variety of medications.

As they say on TV, do not try this at home. Beyond a glass of warm milk for insomnia and salted water to gargle when your throat is sore, making your own medicine at home is a really bad idea, with potentially adverse consequences.  For those, however, with a (morbid) curiosity, the article explains the kit’s makeup:

[A] small mason jar mounted inside a larger mason jar with a 3D printed lid. Furthermore, the kit contains a 3D printed stepper motor, syringe pump, coupler and shredded shaft which are connected using small plastic hoses.  A thermistor is then attached through the lid to circulate fluids to induce the chemical reactions necessary to manufacture various medicines.  The whole process is automated using a computer.

Apparently, “the 3D printed chemical reactor kit has successfully produced Naloxone (aka Narcan), a drug for opiate overdoses, Cabotegravir and Daraprim, drugs used to treat infections in people with HIV, and Mifepristone (aka RU486), and misoprostol,” two pharmaceuticals that can be used to terminate pregnancies.

Four Thieves Vinegar Collective is not selling the drugs itself—it is providing instructions on how to make the medications. The drugs themselves are also not 3D printed—although some of the parts in the kit are made using a 3D printer.  So maybe this is not a modern day Walter White situation after all.  But this article did raise questions.  There is already one pharmaceutical drug being (legally) manufactured using a 3D printer.  With an aging population and disease not going away anytime soon, 3D printing of medicines in our own homes might be in our future.  Some might even say it is only a matter of time.  Will the law—both regulatory and the product liability system—is ready for it?

Because this blog not only geeks out about good TV shows, but also about the law and 3D printing, consider some of the product liability implications that are raised by 3D printing drugs out of a person’s home.

Manufacturing defects

Injuries caused by an improperly manufactured or tainted 3D printed drug is an issue. This may be the result of an error in the instructions being used, problems with the 3D printer, quality control issues in the person’s home where the drug is “printed,” or how the person synthesizes the drug—in other words, any situation in which a mistake occurs at any point in the process used to print the drug can create a manufacturing defect.  Manufacturing defects are an infrequently litigated product liability claim where FDA-approved drugs are at issue.  However, in the case of 3D printing homemade drugs, it may very well be the main focus of litigation.  If a person makes a drug in his or her house using a 3D printer, who does that person blame if the drug causes injury?  Would the person making the drug be considered the manufacturer for strict liability purposes?  Under section 402A of the Restatement (Second) of Torts, the seller or manufacturer must be engaged in the business of selling the product. The home drug maker may or may not be in the business of drug manufacturing.  It would depend on whether the that person also distributes the basement drugs to others. So who would be liable?  A potential defendant may be the manufacturer of the 3D printer with a plaintiff claiming the “defect” arose because of some aspect of the printer. Another potential party may be the entity who provided the instructions for making the drug with a claim for “defective instructions.”  That could include the Four Thieves Vinegar Collective itself.  Product liability law may need to evolve to address these issues, but it is clear that printing drugs from your home will blur the distinctions between the user and the manufacturer of the drugs.

Warnings

Injuries could be caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect or a failure to provide adequate instructions regarding the safe and appropriate use of the drug—or possibly the above-described “Micro Lab,” or even the 3D printer.  For FDA-regulated prescription drugs and medical devices, the learned intermediary doctrine provides that a manufacturer need only warn a prescribing doctor about known or knowable risks.  It is not obligated to warn the end user.  Because physicians are typically warned about drugs through medical literature and via manufacturer-created warning labels/disclosures that accompany the drugs, the learned intermediary doctrine will not apply to 3D printed homemade drugs.  Such drugs would need to be accompanied by adequate warnings directed to the consumers themselves.  These warnings should disclose the reasonably foreseeable risks of the medication (e.g., adverse reactions) and dosage requirements.  In the 3D printing context, if no traditional product “manufacturer” exists, it is likely that a duty to warn (perhaps only in negligence) will ultimately be imposed on some other entity involved in the supply chain.   But if a person is 3D printing drugs from home who would be responsible for providing the warnings? Would it be the person or company who is providing the instructions on how to synthesize the drug?  If the instructions are downloaded from a website, a plaintiff may find it virtually impossible to identify this person, let alone find them to effectuate a lawsuit.

FDA

As far as we can tell, the FDA has not yet issued any statements about the “Apothecary MicroLab” or 3D printing drugs from your home.  The FDA did issue a statement about Four Thieves Vinegar Collective’s other product, the EpiPencil (a homemade epinephrine autoinjector that can be built for $30), saying with remarkable understatement that it was a “potentially dangerous practice.” For the most part, the FDA has been silent on the 3D printing of drugs (no matter where it happens), with the exception of the one 3D printed drug that it approved.

As to 3D printing drugs at home, how the FDA intends to approach this subject is very unclear. A lot of questions are raised with no answers as of yet.  If manufacturing occurs at a non-traditional “manufacturing” site, such as a person’s home, how will or should the FDA regulate that site? Should the site be subject to all of the FDA’s requirements and standards and will the FDA take enforcement action because a 3D printed drug is technically adulterated when it is not manufactured under quality compliant conditions?  Will instructions to print drugs have to be FDA approved?  Will the FDA regulate the printer or just the finished product?  To resolve these and other issues, the FDA may need to modify its regulations, and in the short term issue a few guidance documents and exercise its enforcement discretion for some FDA rules and regulations.  FDA’s requirements will be key for safety, but also for preemption purposes, which may depend on the FDA imposing requirements on 3D printing of medications.

 

Quality Control

There likely would be no way to have quality control measures in place for every home that is 3D printing medications. Certainly, the FDA could not enforce its inspection procedures in every household that was 3D printing drugs. On its website, Four Thieves Vinegar Collective says that quality control issues are not the same when making small quantities of a drug as opposed to an industrial scale. That is doubtful, at best. While it may be easier to control quality if you are only making one pill, quality control is still a huge issue when it comes to medications. A person’s home is not nearly as clean as a drug lab. A person likely would not have records of the formulation of the product, synthesis of the substance, and the specifications of the products readily available to ensure all are met. Also each drug that is 3D printed, or even a sampling, would not be tested, let alone retested, before use. Each 3D printer would have to be calibrated before use. Microbiological factors may also come into play, such as evaluating the raw material for sterility, endotoxins, and environmental concerns. These same issues also effect recalls, and recalls probably would be limited to 3D printers and centrally manufactured products or become voluntary. There are good reasons why the FDA exists.

 

Like the fictional character Walter White, 3D printing drugs from your home is still not a reality. Four Thieves Vinegar Collective and other organizations like it are making it more likely that it could happen sometime in the future, whether legal or not. A lot of potential uses of 3D printing drugs exist, from helping soldiers on the battlefield to people in less developed countries.  Until the technology and legal issues are dealt with, there are still a lot of risks and dangers associated with 3D printing medications. Right this moment, making any kind of drug yourself is far from advisable. But for now, thinking about all these product liability issues is what get us high. And we can only wonder if Walter White’s lawyer Saul Goodman would have advised him of these risks? Certainly not.

 

 

We are on vacation this week.  The aim was to stay in this hemisphere, yet get the feel of being in an old European city.  Less air travel, but still with the overcharging and the hard stares in response to our dodgy foreign language skills.  So with that hint, guess away as to our present location.  As part of vacation prep, we downloaded a bunch of movies on our Netflix account for viewing on the plane and in case of a rainy day.  A couple of days ago, with gritted teeth, we hit the play button for a documentary film called “The Bleeding Edge.”  We deal all the time with claims of failure to warn, but in this instance we have no such claim.  We had been fully warned that the film was a thoroughly one-sided screed against the medical device industry.  Pity the poor defense lawyer picking a jury tainted by this particular work of art.  The case studies in the film involve hip implants, a contraceptive, vaginal mesh, and robotic surgery.  Rotten Tomatoes gives the film a score of 100%.  This film must be a banger, right?

 

Well, it is certainly effective.  True to its title, it draws blood – emotionally, anyway. It conveys a series of stories, it makes you feel sorry for victims, and it makes you mad.  It feels very much like an extended 60 Minutes segment.  60 Minutes has been on the air for 50 years.  That’s 50 years of confronting corporate and government malefactors. 50 years of crooks scurrying away from cameras.  50 years of righteous indignation.  Many times over those 50 years, 60 Minutes worked its forensic magic on us.  We were just as swept up in the disillusionment and the urge to punish as any other viewer. 

 

And then, when we began our stint at a law firm, we worked on a case that received lots press coverage.  To our shock, the press got at least half the story wrong.  The account of who, what, where, when, why, and how was terribly tilted – more a morality play than factual reportage.  Eventually, it occurred to us that perhaps the press didn’t distort reality only for stories about our cases.  Maybe, just maybe, flaws riddle press stories fairly (or unfairly) often. 

 

We have worked on litigation involving only one of the products at issue in “The Bleeding Edge.” All of the stories are compelling, with human beings who earn sympathy.  Some suffered terrible physical injuries.  Even beyond that, some of their lives were ruined in other ways, with awful impacts on family members.  You’d have to have a heart of stone to be unmoved.  For the story dealing with the product we know a little something about, vaginal mesh, the story turns out to be a half-story.  The viewer will see nothing about the vast majority of patients who had their lives bettered by mesh – whose stress urinary continence, which had devastating, embarrassing consequences for quality of life, had been fixed. Instead, we hear from a plaintiff lawyer who delivers a mini-closing argument against mesh. He says that when the science conflicts with the marketing, “the marketing always wins out.”   That’s catchy, but that’s also a canard.  From what we have seen, medical device marketing claims must run the gauntlet of careful medical, regulatory, and legal scrutiny before any member of the public sees them.  We also hear from ubiquitous plaintiff expert David Kessler, a former head of the FDA, who rips into the 510(k) “loophole”.  You will not hear a hint of why that provision was deemed necessary and how there was at one time enormous discontent about undue delays in making beneficial medical devices available to patients.  If there is a legitimate, nuanced debate about whether the scope of the 510(k) process should be adjusted, or whether that regulatory pathway should be bolstered or adjusted when the underlying predicate devices are withdrawn, you won’t hear that nuanced debate here.  It’s all black and white, albeit in cinematic color.  Then we hear from another plaintiff expert who wields a rhetorical axe, not scalpel, against mesh.  Immediately afterward, we hear from a plaintiff. When she mouths a critique of vaginal mesh, she says she has heard it is like trying to remove rebar from concrete.  Guess where she heard that?  That is precisely the imagery used by the plaintiff medical expert in his trial testimony.  To our jaundiced eyes, these interviews were cleverly curated and assembled for maximum negative impact.  That is not documentary; it is choreography.

 

If “The Bleeding Edge” is one-sided – and it is – its defenders will say that is the fault of the companies.  At the end of the film, we get the typical screen notification that the filmmakers invited the companies to appear, but the invitation was declined.  Can you blame the companies?  First, it was clear that the filmmakers was dead set on putting scalps on the wall.  It was inevitable that the questioning and editing (more on the latter in a moment) would be deployed to make the companies look bad.  The filmmaker, not the interviewee, has final cut. Second, companies in litigation know that any public statement could be used against them.  By contrast, a plaintiff lawyer can say whatever he wants without worrying that an inaccurate statement might be used against one of his clients.  Thus, there is a structural reason why public reporting on matters in litigation usually favors plaintiffs.  There is also the same bias one sees in scientific journals in favor of finding significant results.  “Product Injures Thousands” will attract more eyeballs or clicks than “Company Responsibly Pursues Innovation.”  For good reason is the film entitled “The Bleeding Edge.”  If it bleeds, it leads.  

 

There is an appearance in the film by the CEO of AdvaMed, the medical device industry association.  We first see him making a presentation to the MedTech Conference.  In the excerpt selected by the Bleeding Edge filmmakers, the CEO says that medical device makers “have more power in this room than most governments around the world.”  End of excerpt.  As placed in the film, it sounds a wee bit sinister.  It is as if the documentary is trying to depict the CEO as a Bond villain.  Cue the terrifying henchmen, the white cat, the trap door, and the plan for world domination.  But context is all.  The speech was actually about the industry’s power to innovate.  Rather different, isn’t it?  Not that it makes a difference to the filmmakers.  After all, in more than one place in the film, the concept of innovation is belittled, even ridiculed. And yet, would anyone really prefer that the government stifle innovation?  We’ve read reviews of the film that conclude by advising viewers to question their doctors when innovative treatment is proposed.  It is good for patients to ask questions.  But it is not so good for them to be cynical.  Hello, vaccine-avoiders.  And it is not so good for patients or doctors to harbor preconceptions against innovation.  Later in the film, the AdvaMed representative submits to an interview by the filmmakers.  What he says is appropriate and above reproach.  But, again, something interesting happens with the editing.  After the AdvaMed rep answers the questions, the camera holds on him for an uncomfortable pause.  The fellow looks at the camera.  Then he looks around.  Then he lifts his paper cup of coffee.  Only after the camera plays its little trick of creating discomfort does it finally cut away. What is the purpose of that?  Whose bias is actually being exposed?  We are reminded of the scene in the Michael Moore movie where a government official is shown combing his hair before the interview.  Context can convey skepticism and derision.   

 

Needless to say, the film-makers employed no such editing maneuvers during the interviews of the plaintiff litigation team. 

 

Again, the film is effective at doing what it wants to do.  It makes a case.  But do not for a moment mistake it for what it is not – a balanced examination of the truth. 

 

[P.S.: Happy Birthday to the Drug and Device Law Son.  We will always be hopelessly biased in his favor.]

 

 

 

 

 

What follows is a rather involved guest post by Reed Smith‘s Kevin Hara.  Actually, Kevin has contributed enough to the Blog over the last couple of years that he’s more of a crypto-blogger than a guest.  Instead of the more common case-specific post, Kevin has put together his own 50-state survey on state statutes of repose.  A lot of states have a variety of different statutes of repose.  Some of these statutes (such as those based on useful life) can be useful in prescription medical product liability litigation, others (like those involving fixtures to real property) – not so much.  Anyway, in this guest post Kevin endeavors to sort things out on a nationwide basis.  As always our guest bloggers deserve 100% of the credit, and any blame, for their work.

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Although this relatively recent Law360 article discussed statutes of repose, this powerful affirmative defense remains underutilized, so this post revisits it and digs a little deeper.  This defense, where applicable, provides a potentially swift conclusion to an action with accompanying cost savings for the client.  Further, defense counsel may move to dismiss at the pleading stage, where the applicability of the defense is apparent from the complaint.  Many courts view statutes of repose as substantive, rather than procedural, unlike statutes of limitation – so the plaintiff cannot escape by becoming a litigation tourist.

The state of Tennessee’s statute of repose serves as a perfect example of a bright line application in a prescription product liability action, regardless of a plaintiff’s knowledge wherein “a delay, even without knowledge of the hazard involved in the delay, may preclude the bringing of an otherwise meritorious claim.”  Montgomery v. Wyeth, 580 F.3d 455, 463, 466 (6th Cir. 2009) (applying Tennessee law).  Tennessee courts have explained this rule succinctly:

A statute of limitations governs the time within which suit may be brought once a cause of action accrued. A statute of repose limits the time within which an action may be brought, but it is entirely unrelated to the accrual of a cause of action and can, in fact, bar a cause of action before it has accrued.

Jones v. Methodist Healthcare, 83 S.W. 3d 739, 744 (Tenn. App. 2001) (emphasis added).

The Texas Supreme Court provided a thoughtful analysis of that state’s clear-cut statute of repose:

Indeed, the key purpose of a repose statute is to eliminate uncertainties under the related statute of limitations and to create a final deadline for filing suit that is not subject to any exceptions, except perhaps those clear exceptions in the statute itself.  In recognizing the absolute nature of a statute of repose, we have explained that while statutes of limitations operate procedurally to bar the enforcement of a right, a statute of repose takes away the right altogether, creating a substantive right to be free of liability after a specified time.  The whole point of layering a statute of repose over the statute of limitations is to fix an outer limit beyond which no action can be maintained.  One practical upside of curbing open-ended exposure is to prevent defendants from answering claims where evidence may prove elusive due to unavailable witnesses (perhaps deceased), faded memories, lost or destroyed records, and institutions that no longer exist.

Methodist Healthcare Sys. of San Antonio v. Rankin, 307 S.W.3d 283, 286-87  (Tex. 2010 ) (internal citations and marks omitted) (emphasis added)

The Tennessee and Texas statutes of repose are elegant in their simplicity:  you are either in, or you’re out.  Period.  No ifs, ands, or buts.  Iowa, Connecticut, and North Carolina are a few of the states with similarly straightforward statutes of repose.  However, perhaps because they are so unyielding – and unlike statutes of limitation, the vast majority of which are subject to the discovery rule – statutes of repose are often more limited in scope, and therefore not uniformly applicable to manufacturers of prescription medical products.

That said, statutes of repose add a significant item to any defense practitioner’s toolbox because they can take a case, and simply “nip it in the bud,” a common expression that is illustrative here.  Indeed, it is a phrase that sometimes gets mixed up, such as with the malapropism “nip it in the butt,” which got us to thinking about something else that often leads to confusion: music.  All too often, people misapprehend the words to a song, and there are a multitude of websites with compilations of some of the more notable – and incidentally, most humorous – misheard song lyrics, including Mentalfloss , Huffington Post, and New Musical Express, but here are some of the best.  Perhaps the most famous example is the Jimi Hendrix classic “Purple Haze,” with famous phrase “Excuse me while I kiss the sky,” interpreted erroneously as: “Excuse me while I kiss this guy.”

Who can forget the San Francisco Bay Area’s own all-time great rock band Creedence Clearwater Revival’s song “Bad Moon Rising,” with part of the chorus, “There’s a bad moon on the rise,” replaced with “There’s a bathroom on the right.”  (In fact, this error became prominent that front man John Fogerty was known to purposefully sing that rendition and gesture to the proverbial restroom.)  Another prime example is the upbeat Johnny Nash song “I Can See Clearly Now,” with the line from the refrain “I can see clearly now, the rain is gone,” somehow thought to be: “I can see clearly now, Lorraine is gone.”  It would be remiss not to mention The Monkees, and their hit “I’m A Believer,” with the eternally ecstatic line, “Then I saw her face, now I’m a believer!” instead substituted with the diametrically opposed – and frankly cruel, but evocative – “Then I saw her face, now I’m gonna leave her!”

Bexis pointed out that one could interpret the chorus of British band ELO’s chart topper “Evil Woman,” “Evil woman,” as “You need a woman.”  He also misunderstood for years (until the advent of lyrics services on the Internet) the line in Steppenwolf’sFrom Here To There Eventually” as “cause benign, rather than “caused by man.”

These faux pas are fitting metaphors for failing to comprehend the importance of statutes of repose.  While it is easy enough to have a chuckle when a friend butchers a line in a favorite song, failing to seize an opportunity to secure a dismissal with prejudice is no laughing matter.  Defense counsel should thoroughly consider and explore all possible options for resolving a case quickly in the name of expediency and client satisfaction.

To assist with those aims, here is a rundown of the applicable statutes of repose for all 50 jurisdictions, including discussions of which states apply the discovery rule, which utilize presumptions rather than complete defenses, and other subtle variations, beginning with those states whose statutes are most likely to apply to prescription product claims.

States With Statutes That Are Applicable To Prescription Product Liability Claims

 Alabama – Alabama applies a unique, common law, 20 year rule of repose which “arose within the context of property disputes,” but according to the Alabama Supreme Court “the rationale underlying the rule is not so limited and, accordingly, the rule has been applied in other contexts, including those alleging tort claims.”  Ex parte Liberty National Life Insurance Co., 825 So. 2d 758, 763-64 (Ala. 2002); see also Owens-Illinois, Inc. v. Wells, 50 So.3d 413, 420 (Ala. 2010) (ruling that “Alabama’s 20-year common-law rule of repose does not begin to run on a claim until all the essential elements of that claim, including an injury, coexist so that the plaintiff could validly file an action”).

Colorado – Col. Rev. Stat. § 13-21-403(3).  Applies a presumption of non-defectiveness more than “[t]en years after a product is first sold.”  See Mile Hi Concrete, Inc. v. Matz, 842 P.2d 198, 205 (Colo. 1992).

Connecticut – Conn. Gen. Stat. § 52-577a.  An action is foreclosed “more than 10 years after the manufacturer relinquished “possession or control of the product,” absent fraud or express warranty.

Florida – Fla. Stat. § 95.031(b).  A products liability action is barred “more than 12 years after delivery of the product,” with exceptions for latent disease or injury, and fraudulent concealment.

Georgia – O.C.G.A. § 51-1-11(b)(2).  Precludes any action “after ten years from the date of the first sale for use or consumption” of a product that causes injury.

Idaho – Idaho Code § 6-1403(b).  Rebuttable presumption that injury “caused more than ten (10) years after time of delivery” occurred after product’s safe life, rebuttable “by clear and convincing evidence.”

Illinois – 735 ILCS 5/13-213(b).  Forbids any “product liability action” on any theory after 12 years from the first sale or 10 years after the purchase by an initial consumer, unless brought within two years of discovery of alleged injuries.   Davis v. Toshiba Mach. Co., 710 N.E. 2d 399, 401 (Ill. 1999) (weakening statute of repose by allowing discovery rule in cases not involving latent injuries).

Indiana – Ind. Code § 34-20-3-1(b).  Action must commence within “10 years after delivery of the product to initial user,” but may be brought within two years after accrual. See, e.g., Land v. Yamaha Motor Corp., 272 F.3d 514, 515-516 (7th Cir.2001) (ruling that where it was “undisputed” that injury and filing suit occurred more than 10 years after product purchase by initial user, statute of repose barred product liability action.) (emphasis added).

Iowa – Iowa Code § 614.1(b). Bars product liability action on any theory 15 years after purchase of a product absent express warranty or concealment. See Albrecht v. GMC, 648 N.W.2d 87, 95 (Iowa 2002) (the “allegations of the petition establish[ed] that the present suit falls with the scope of section 614.1(2A)(a) and was brought more than fifteen years after the product in question was first purchased,” precluding plaintiff’s action); Cf. Merner v. Deere & Co., 176 F. Supp.2d 882, (E.D. Wis. December 18, 2001) (under Wisconsin’s borrowing statute that 15 year Iowa statute of repose barred plaintiff’s claims).

Kansas – Kan. Stat. Ann. § 60-3303(a)(b)(1).  A presumption arises that a product’s “useful safe life,” expires 10 years after delivery, rebuttable by “clear and convincing” evidence; see also Kan. Stat. Ann. § 60-513(b), barring claims more than 10 years old.  The useful safe life statute of repose applies to prescription drugs.  Baughn v. Eli Lilly & Co., 356 F. Supp. 2d 1166, 1172 (D. Kan. 2005).  In Ehrenfelt v. Janssen Pharms., ___ F. Appx. ___, 2018 WL 2945911 (6th Cir. June 11, 2018), a prescription drug product liability case, the Court of Appeals for the Sixth Circuit held “that the exceptions in Kan. Stat. Ann. § 60-3303(b)(2)(D) [for latent injuries] appl[ied] even when the harm was caused less than ten years after delivery.”   Id. at *2.  Therefore, the plaintiff’s claims for alleged injuries from use of a drug was not barred under the general 10 year statute of repose, § 60-513(b).

Kentucky –  K.R.S § 411.310(1).  Presumption that a product was not defective for injury “more than five (5) years after the date of sale . . . or more than eight” years after manufacture, rebuttable by a preponderance of evidence.

Michigan – Mich. Comp. Laws § 600.5805(13).  Technically not a statute of repose, but after a product has “been in use for not less than 10 years,” the plaintiff is not entitled to any presumption improving his case.  But see Hall v. GMC, 582 N.W.2d 866, 867 (Mich. App. 1998) (“claim could be pursued under Michigan law, which has no statute of repose,” and where statute of limitations did not prevent claim).

Minnesota – Minn. Stat. § 604.03.  Provides an affirmative defense for injuries occurring after “the expiration of the ordinary useful life of the product,” which is a jury issue.   Hodder v. Goodyear Tire & Rubber Co., 426 N.W.2d 826, 830 (Minn. 1988) (“We hold, therefore, that … [product’s useful life] is a factor to be weighed by the jury in determining the fault of the manufacturer and the fault of the user.”).

Nebraska – Neb. Rev. Stat. § 25-225.  Bars claims filed more than 10 years after product manufactured in Nebraska, otherwise the statute of repose of the state of manufacture applies, not to exceed 10 years, or 4 years from date of injury if no statute exists, applicable to prescription products.  King v. Pfizer, Inc., 2016 U.S. Dist. Lexis 111456, 17-18 (D. Neb. Aug. 19, 2016) (fraud based claims for injuries allegedly resulting from prescription drug are “grounded in product liability,” such that the substantive right of the statute of repose cannot be removed “by court action,” whereby passage of the 10-year period, following  plaintiff’s first prescription “vested the Defendants with a substantive right under § 25-224(2),” barring the action).

North Carolina – N.C. Gen. Stat. § 1-46.1.  Prohibits product liability claims “more than 12 years after . . . initial purchase for use or consumption.”  See Willoughby v. Johnston Memorial Hosp. Authority, 2016 WL 4091370, at * 13-14, 791 S.E.2d 283 (table) (N.C. App. Aug. 2, 2016) (affirming summary judgment for manufacturer of surgical table, including indemnity claim, notwithstanding that alleged injuries occurred in 2009, and actual loss in 2015); In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2016 WL 4385846, at *3 (M.D. Ga. Aug. 15, 2016) (applying North Carolina law) (plaintiff suffered alleged injuries when she experienced mesh erosion, which foreclosed claims per statute of repose).

Ohio – Ohio Rev. Code § 2305.10(C)(1).  Precludes claims more than 10 years after product delivery to first consumer, but applies discovery rule to prescription drugs, which reduces the provision’s utility.

Oregon – Or. Rev. Stat. § 30.905(2).  An action “must be commenced before the later of 10 years after” product’s purchase, or the expiration of the statute of repose in state of manufacture.  Wrongful death actions must be brought within 3 years after death or 10 years after product purchased, whichever occurs sooner.  O.R.S. § 30.905(3)-(4).  Dortch v. A. H. Robins Co., 650 P.2d 1046, 1052-53 (Or. App. 1982), overruled on other grounds, (IUD manufacturer properly dismissed; statute of repose limited “manufacturer’s liability to ten years and [gave] each plaintiff a full two years to commence an action after the cause of action accrue[d],” and finding that the claim was barred.); Philpott v. A.H. Robins Co., 710 F.2d 1422, 1425 (9th Cir. 1983) (plaintiff’s claims “barred by ORS 30.905,” where “she did not learn of a causal connection between her pelvic disorders and the Dalkon Shield until . . . nine years and eight months after she purchased and began using” the product).

Tennessee – Tenn. Code Ann. § 29-28-103(a).  An action must be brought “within ten (10) years” from purchase, or “one (1) year after the expiration” of product life. See, e.g., Jenkins v. Novartis Pharmaceutical Corp., 2013 WL 1760762, at *3 (E.D. Tenn. Apr. 24, 2013) (implied warranty claim against prescription drug manufacturer was prohibited by statute of repose where motion to amend was filed more than 10 years post injury “by both the six-years-from-injury provision of § 29-28-103(a) and the ten-years-from-purchase provision of § 29-28-103(a)).” Tennessee case law bars any discovery rule or fraudulent concealment exception to the statute. Greene v. Brown & Williamson Tobacco Corp., 72 F. Supp.2d 882, 886 (W.D. Tenn. 1999) ( “[a]n equitable ‘discovery rule’ is not available to toll the statute of repose” and holding that “the Tennessee Supreme Court would decline to create an equitable exception for fraudulent concealment”).

Texas – Tex. Code Ann. § 16.102(b) cuts off actions 15 years “after the date of the sale of the product” with exceptions for latent disease and express warranty, but is not subject to tolling.  See Methodist Healthcare System v. Rankin, 307 S.W.3d 283, 290 (Tex. 2010) (“the essential function of all statutes of repose is to abrogate the discovery rule and similar exceptions to the statute of limitations” and a “statute of repose, by design, creates a right to repose where the applicable statute of limitations would be tolled or deferred”); Salgado v. Great Dane Trailers, 2012 WL 401484, at *2 (S.D. Tex. Feb. 6, 2012) (“[a] statute of repose … does not run from the time a cause of action arises, but from some other date or event selected by the Legislature,” and is “not subject to judicially crafted rules of tolling or deferral”) (internal citations and quotations omitted).

Washington – Wash. Rev. Code Ann. § 7.72.060(1)(b)(i-iii).  Rebuttable presumption that an injury “more than twelve years after . . . delivery,” occurred after expiration of a product’s useful life, with exceptions for express warranty, concealment, and latent injuries.

Wisconsin – Wis. Stat. § 895.047(5-6).  Precludes action for products manufactured “15 years . . . or more” before a claim with exceptions for negligence, latent disease, and express warranty, and asbestos actions).

States With Statutes That Are Not Applicable To Prescription Product Claims

By contrast, the following states have statutes of repose that are inapplicable to prescription product liability actions, generally because they have statutes that pertain only to real property improvements or the statutes contain exclusions for defective products.

Alaska – Alaska Stat. § 09.10.055(2).  Actions must be brought “within 10 years,” of the “last act alleged to have caused the personal injury,” property damage, or death, but expressly excludes defective products.

Arkansas – Ark. C. Ann. § 16-56-112.  Applicable to property actions only; Brown v. Overhead Door Corp., 843 F. Supp. 482, 490 (W.D. Ark. 1994) (ruling that statute of repose was limited to real property improvements, holding that “Arkansas courts when called upon to do so will hold that the manufacturers of mass produced fungible goods do not fall within the protection of the statute, particularly when the defendant manufacturer is not involved in the installation of the product and had nothing to do with the design of the improvement within which it is installed”).

California – Cal. Civ. Proc. Code § 337.15 (10 years for latent deficiencies).  See McCann v. Foster Wheeler LLC, 225 P.3d 516, 529 (Cal. 2010) (finding that California’s statute of repose was applicable to latent deficiencies in real property improvement, “not to personal injury actions.”).

Delaware – 10 Del. C. § 8127.  Applicable only to claims pertaining to real property improvements, within six years of substantial completion.

District of Columbia – D.C. Code § 12-310.  Real property claims only, within 10 years of substantial completion of project.

Hawaii – Haw. Rev. Stat. § 657-8.  Available only for claims within 10 years of substantial completion of improvement to real property, and two years after accrual.

Maine – 14 M.R.S.A. § 752-A.  Statute applicable only to real property, within 10 years of the project or services rendered, but no more than 4 years after discovery.

Maryland – Md. Code Ann. § 5-108.  Does not apply to product liability, but for property improvements within 20 years and 10 years against architect or engineer.

Massachusetts – Mass. Ann. Laws Ch. 260 § 2B.  Allows claims within 6 years of substantial completion of improvement, and owner taking possession.

Mississippi – M.C.A. § 15-1-41.  Claims must be brought within 6 years of acceptance or actual occupancy for real property improvement.

Missouri – Mo. Rev. Stat. § 516.097.  Applicable to real property improvement claims within 10 years of substantial completion.

Montana – Mont. Stat. § 27-2-208.  Statute allows claims within 10 years of improvement, including to damage caused by a defective product related to the improvement.

Nevada – N.R.S. § AB 125, § 2.  Applies to real property improvements, six-year statute of repose.

New Jersey – N.J.S.A. § 2A: 14-1.1.  Real property improvements only, within 10 years of substantial completion.

New Mexico – N.M.S.A. § 37-1-27.  Repose only for improvements to real property, 10 years of substantial completion.

New York – While New York has no true statute of repose, courts require notice of an action to any party responsible for professional performance, such as architects and engineers, after 10 years have elapsed.  Six year statute of limitations for construction defects, N.Y. C.P.L.R. § 214-d.

Oklahoma – 12 Okla. Stat. Ann. Tit. 12 § 109.  Claims for real property improvements must be brought within 10 years of substantial improvement.

Pennsylvania – Although the statute of repose, 42 Pa. C.S.A. § 5536(a), is generally applicable only to real property improvements, it may apply to product manufacturers in certain cases, such as to manufacturers of asbestos.  See, e.g., Graver v. Foster Wheeler Corp., 96 A.3d 383, 386-87 (Pa. Super. 2014) (granting j.n.o.v., applying the 12 year statute of repose relating to real property improvements to 13 story boiler in asbestos action because statutes of repose are substantive, and may bar actions before they accrue).

South Carolina – S.C. Code Ann. § 15-3-640.  Must be brought within 8 years of substantial completion of improvement to real property.

South Dakota – S.D.C.L. § 15-2A-3.  Applicable to real property improvements only, within 10 years of substantial completion.

Utah – U.C.A. § 78B-2-225.  Actions for real property improvements may not be brought later than nine years after completion.

Vermont – Vt. Stat. Ann. Tit. 27A, § 4-116(a).  Applicable only to Common Interest Ownership claims within six years after the cause of action arose.

Virginia – Va. St. § 8.01-250.  Claims must be brought within five years for injuries resulting from improvements to real property, but does not apply to manufacturers of equipment.

West Virginia – W. Va. Code § 55-2-6a.  Applies to claims related to real property, construction or design within 10 years of occupancy or acceptance, but excludes product manufacturers.

Wyoming – Wyo. Stat. § 1-3-111.  Applicable only to real property improvements, if a claim is brought within 10 years of substantial improvement.

States In Which Courts Ruled That Statutes Of Repose Were Unconstitutional

New HampshireHeath v. Sears, Roebuck & Co., 464 A.2d 288, 296 (N.H. 1983) (statute of repose unconstitutional where plaintiffs were “deprived arbitrarily of a right” to sue).

North DakotaDickie v. Farmers Union Oil Co., 611 N.W. 2d 168, 173 (N.D. 2000) (product liability statute of repose violated equal protection clause).

Rhode IslandKennedy v. Cumberland Eng’g Co., 471 A.2d 195, 201 (R.I. 1984) (holding that state “Constitution forbids absolute bars to recovery” prior to accrual).

ArizonaHazine v. Montgomery Elevator Co., 861 P. 2d 625, 630 (Ariz. 1993) (holding statute of repose unconstitutional, ruling “A.R.S. § 12-551 abrogated that constitutional right [to bring action] by barring the action even before the injury occurred,” and that “the attempted statutory abrogation of their claim fails.”).

 

Statutes of repose can be a defense counsel’s best friend by providing an inexpensive and decisive avenue for disposal of an action, even before the claims have accrued in certain jurisdictions. However, each state is different, and practitioners need to research potentially relevant provisions thoroughly.  After all, a missed opportunity to end the case before it begins is no song and dance.