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Skin in the game.  Horse in the race.  Dog in the hunt.  Whatever “it” is – we don’t have “it” in today’s case.  Ansley v. Banner Health Care is a suit brought by plaintiffs who had received damages awards for injuries that required treatment at various hospitals seeking to enjoin those hospitals from enforcing liens against those tort recoveries. 2019 WL 1121374 (Ariz. Ct. Apps. Mar. 12, 2019).  If any pharmaceutical or medical device companies were involved in the original tort claims, their role is over by the time Ansley gets teed up.  But just because we don’t have a seat at the table, doesn’t mean we aren’t interested in what’s being discussed.  Phantom damages.

We’ve written before about the concept of “phantom damages” – plaintiffs seeking recovery for the face value of health care provider bills when they (or their insurers) in fact got huge discounts.  Courts are actually divided on the issue and cases generally go one of three ways — actual payment only; let it all in; billed amount only.  We are fairly enamored of the actual payment only method of computing recovery of medical expenses.  Anything else provides a windfall to plaintiffs.  And that’s really where we have chum in the water.  There should be no windfall in the first place.  Plaintiffs should only recover what they (or their insurers) actually paid out of pocket.

But, in Ansley, we are in a horses already out of the barn situation.  Only, we can’t get the horses back.  We just have to watch the neighboring ranchers fight over who’s going to get them.  Arizona was identified in our earlier post as one of the states allowing plaintiffs to recover this windfall.  Lopez v. Safeway Stores, Inc., 129 P.3d 487, 495 (Ariz. App. 2006) (“plaintiffs are entitled to claim and recover the full amount of reasonable medical expenses charged, based on the reasonable value of medical services rendered, including amounts written off from the bills pursuant to contractual rate reductions”).  So the hospitals tried to collect this windfall for themselves through liens on plaintiffs’ tort recoveries for the face value of their discounted bills.

Each plaintiff was a member of the Arizona Health Care Cost Containment System (“AHCCCS”), Arizona’s Medicaid insurance provider.  Each hospital contracted with AHCCCS agreeing to accept certain rates for hospital care provided to AHCCCS members that was less than the hospitals would charge non-AHCCCS patients.  The hospitals wanted plaintiffs to reimburse them for the difference – the balance – between what they already received from AHCCCS and the face value of the services they provided.  Talk about a windfall.  Absent the underlying tort recovery, the hospitals would have to live with the contractual deal they struck.  But, since there was a tort recovery, the hospitals want to recover the full cost that they were never entitled to.

The court decided the plaintiffs get to keep the windfall.  In a bizarre twist, plaintiffs won by asserting, of all things, federal preemption.  The hospitals based their liens on two state court statutes that (1) allow a health-care provider to file a lien for its “customary” charges against a patient’s tort recovery and (2) allow a hospital to “collect any unpaid portion of its bill from other third-party payors.”  Id. at *1.  However, federal law governs the relationship between state Medicaid agencies and the hospitals they contract with.   Pursuant to 42 C.F.R. § 447.15, “a state may contract only with providers that agree to ‘accept, as payment in full, the amounts paid by the agency plus any deductible, coinsurance or copayment required by the plan to be paid by the individual.’”  Id. at *3.  This is a case of conflict preemption.  Despite state law providing a means to record a lien for recovery of a patient’s tort damages, federal law states that “[b]ecause the patient does not owe the hospital the balance between what AHCCCS has paid the hospital and the hospital’s customary rate, the hospital may not collect that balance by imposing a lien on the patient’s property.”  Id. at *4.

The court also ruled that the plaintiffs were third-party beneficiaries of the contracts between the hospitals and AHCCCS.  Id. at *10-12.  And there were rulings about the scope of the injunction and attorneys’ fees.  But, those rulings are even more remote to our primary areas of interest.

To quote Alexander Hamilton – actually Lin-Manuel Miranda – “When you got skin in the game, you stay in the game.”  We may not have had any skin on the line in this one, but we’re determined to stay in the game because the game – phantom damages – needs to change.

Child:  “Can I have ice cream before dinner?”

Parent:  “No”

Child:  “What if it’s strawberry ice cream?”

Parent:  “Still, no”

Child:  “What if my teacher told me I had to eat ice cream for homework?”

Parent: “Still, no”

Child:  “What if a monster ran in here right now and said I had to eat ice cream or he’d take me away to his evil lair forever?”

Parent:  “…..”

Child:  “Well”

Parent:  “Give me a minute, I’m thinking.”

            That’s the “What if” game.  If you’ve been a parent, you’ve played it in some form.  It’s a close cousin of the “Why” game or the “But” game.  It’s also possible that you played What If” during a late-night college cram session that led to a serious conversation about a zombie apocalypse.  Come to think of it, late-night camping, late-night tequila, or late-night horror movies are all stimuli for the zombie apocalypse “What If” game.

In the recent case of McDonald v. Schriner, 2019 U.S. Dist. LEXIS 34514 (W.D. Tenn. Mar. 5, 2019), the court allowed plaintiff to play the “What If” game on a motion to dismiss.  In this context, it’s probably more appropriately titled the “Assuming Arguendo” game.  This is how it went.

Plaintiff:  “Can I keep my claim?”

Court:  “No, you don’t have subject matter jurisdiction.”  Plaintiff’s complaint failed to allege the place of incorporation or principal place of business for any defendant, but rather only provided the address of their registered agents.  Id. at *7.  Because that doesn’t establish the residence of any defendant, the court could not determine if the parties were diverse and could not just assume they were.  Id.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I fixed that and showed you there was diversity, can I keep my claim?”

Court:  “Still dismissed because you also don’t have personal jurisdiction.”  The court shot down general jurisdiction, but we don’t need to cover that since post  Daimler AG v. Bauman, 571 U.S. 117 (2014) we know “merely doing business” isn’t sufficient for general jurisdiction.  McDonald, 2019 U.S. Dist. LEXIS 34514, *10-12.  As to specific jurisdiction – jurisdiction only over claims that arise out of or relate to the defendant’s contacts with the forum – plaintiff couldn’t satisfy the first prong of the test, showing that defendant purposefully availed itself of acting in the forum.  Id. at *12.  In the Sixth Circuit, courts use a “stream of commerce plus” approach to determine purposeful availment.  Id. at *13.  The “plus” concerns things like the amount of control a defendant had over the flow of the product into the state or the quantity sold in the state.  But all plaintiff’s complaint alleged was the drug was sold in Tennessee.  Not enough.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I added more allegations that satisfied the purposeful availment test, can I keep my claim?”

Court:  “Still dismissed because you’ve also failed to state a claim.”  In addition to the manufacturers of the drug at issue, plaintiff sued the pharmacy where he filled his prescriptions.  But claims against pharmacies in Tennessee are governed by the Tennessee Health Care Liability Act (“THCLA”) which requires both that plaintiff provide pre-suit notice and a certificate of good faith – neither of which plaintiff did.  Id. at *16-17.  Pharmacy case dismissed.

Plaintiff’s claims against the manufacturer are governed by the Tennessee Products Liability Act (“TLPA”).  First and foremost, the TLPA provides that FDA-approved products are “presumptively not defective or unreasonably dangerous.”  Id. at *17.  But plaintiff’s only allegation of defect was a conclusory statement that the drug used to treat his restless leg syndrome induced his gambling.  That wasn’t enough to rebut the presumption or to show that the alleged defect existed at the time the drug left the manufacturer’s control.  Id. at *18.  Plaintiff also failed to state a claim for failure to warn.  He didn’t allege any facts about the warnings.  In fact the complaint only included a conclusory allegation that his losses were caused by a failure to warn.”  Id. at *19.  Manufacturer case dismissed.

But, there was one last “What if.”  Plaintiff never bothered to respond to defendants’ motions to dismiss.  Instead, only after the magistrate issued his report and recommendations and after the time allowed for objections to the magistrate’s findings did plaintiff file an objection.  Id. at *20.  So,

Plaintiff:  “Assuming, arguendo, I had timely raised any of my responses or objections, would I get to keep my case?”

Court:  “Still dismissed.”  In fact, the only new facts plaintiff’s objections added was that he couldn’t remember any effective warnings.  What he still didn’t allege was that he read or attempted to read the warnings when they were provided to him.  Id. at *22.  So, plaintiff’s claims failed for lack of proximate cause.

Having running out of “assuming, arguendo” propositions, the Court had the last words:  “Dismissed with prejudice.”

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog.  Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing.  But there are cases involving exposure to the branded product as well.  And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant’s warnings were adequate as a matter of law.  Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims.  Plaintiff’s wife suffered from fatal pulmonary disease caused by the administration of amiodarone.  Id. at *2.  While the complaint does not state why plaintiff’s wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug’s label, of which it took judicial notice.  The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed “because of the life-threatening side effects and the substantial difficulties associated with its use.”  Id. at *5.  The label further states that the drug has “several potentially fatal toxicities, the most important of which is pulmonary toxicity,” which is fatal about 10% of the time.  Id.  The court noted that label discussed pulmonary toxicity at least 15 times.  Id. at *2.

While plaintiff argued that the adequacy of a warning is “generally” a jury question, generally doesn’t mean alwaysId. at *6.  In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff’s wife suffered – they were adequate.  Id.  Moreover, plaintiff’s complaint contained no allegations that explain why the warning provided was inadequate.  Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can’t be overlooked.  Nor could the court overlook plaintiff’s lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff’s wife’s death.  Id. at *5.  Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the “ordinary consumer.”  But that’s not the standard.  The manufacturer’s duty to warn runs to the physician, not the patient.  Id.  Whether the warning was sufficient to inform plaintiff’s wife’s physician is the appropriate question.  One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on.  But failure to read does not equal failure to warn.  “The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning.”  Id. at *6.  Aside from the implication that physicians aren’t people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied.  A core element of breach of warranty of fitness for a particular purpose is the buyer’s reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient’s expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.  For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer.  [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted).  In this case, plaintiff did not allege what information his wife’s physician considered when deciding to prescribe the drug.  What the evidence does show is that risk of pulmonary toxicity was adequately warned about.  Id.  And, the only inference that the court could draw was that plaintiff’s wife was relying on the skill and judgment of her physician, not defendant.  Id. at *8.

That left only plaintiff’s fraud and misrepresentation claims which were all based on representations that the drug was “safe, fit, and effective for human use.”  Id. at *9.  Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b).  Id.  Which the court informed him applied equally to negligent misrepresentation and concealment.  The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made.  Id.  As to the “what” was misrepresented – safety and effectiveness – the court expressed “serious concerns over the plausibility of this allegation,” given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years.  Id.  And, plaintiff’s lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims.  Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument.  Because plaintiff had no allegation that the generic defendant’s label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was.  However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder.  In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court.  Id. at *11.  “However, context is key.”  Id.  Outside the removal/remand situation, courts have applied Mensing to distributors.  “[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.”  Id. at *12.  The Supreme Court’s concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors.  Id.  Mensing requires dismissal of all of plaintiff’s claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation.  It would not apply to a manufacturing defect claim if plaintiff was bringing one.  Id.

Despite the court’s “serious concerns” with the plausibility of plaintiff’s claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile.  But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff’s case.

Earlier this month we explained that a “wrinkle removal,” was one that capitalized on a “wrinkle” in the language of 28 U.S.C. § 1441(b)(2), which provides that a case cannot be removed on the basis of diversity if any “properly joined and served” defendant is a citizen of the forum state.  But if the forum defendant has not yet been served, that “wrinkle” doesn’t apply.  Defendants, in our never-ending quest to get cases into federal court, argue that such pre-service removal is consistent with the plain language of the statute.  Plaintiffs counter that this interpretation leads to an “absurd result” that refutes the plain language rule.  Just last year, the Third Circuit held that in this battle of “plain meaning” versus “absurd result” – plain meaning wins.  Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147 (3d Cir. 2018).

That was in important decision because since remand is unappealable (28 U.S.C. §1447(d)), appellate review is rare in remand situations.  It also meant that it was a foregone conclusion that Encompass Ins. would be applied in the District of New Jersey cases we discussed a few weeks ago.  When we see it cited and relied upon in the Central District of California, we think that’s important enough to warrant another pre-service removal post this month.

The case is Dechow v. Gilead Sciences, Inc., 2019 WL 517624 (C.D. Cal. Feb. 8, 2019).  Plaintiffs from four different states sued defendant, a resident of California and Delaware, in state court.  Two weeks after the complaint was filed, but before it was served, defendant removed the case to federal court.  Id. at *1.  As the court noted, the issue is “primarily an exercise in statutory interpretation.”  Id. at *2.  And in this instance, the statutory text is “unambiguous. Its plain meaning precludes removal on the basis of in-state citizenship only when the defendant has been properly joined and served.”  Id. at *3.  With no Ninth Circuit decision on point, the court looked to Encompass Ins.

Plaintiffs did try to argue that this literal interpretation of the statute should be rejected because it would lead to absurd results.  For this, they relied on a single case – Vallejo v. Amgen, Inc., 2013 WL 12147584 (C.D. Cal. Aug. 30, 2013).  But Vallejo involved a situation where defendants removed the case before the state court issued the summons to plaintiff.  In other words, removal occurred before it was possible for plaintiff to effectuate service.  Allowing removal in that situation, “would effectively circumvent Congress’s entire statutory scheme and render § 1441(b)(2) superfluous. Such an application could not have been intended by Congress.”  Id. That was not the situation in Dechow where service could have been made but was not.

The district court found additional support in the Ninth Circuit’s interpretation of 28 U.S.C. § 1446(b)(2)(A) which provides that “all defendants who have been properly joined and served must join in or consent to the removal of the action.”  Another removal provision with the same “properly served and joined” language.  To this provision the Ninth Circuit has applied the plain meaning interpretation.  Id. at *4.  What’s good for one, is good for the other.  And plain meaning interpretation is good for the defendants.

MDLs are complicated.  MDLs are chaotic, messy, and ugly unless they have structure and order.  Bringing order to chaos.  Something this blogger has championed for what’s starting to be more years than she wants to readily discuss.  But without order, think of The Blob (the original 1958, Steve McQueen flick).  It creeps.  It crawls.  It eats you alive.  Same can be said of MDLs.  They have a way of growing at an alarming pace.  The number of plaintiffs.  The number of defendants.  The number of depositions.  The number of documents produced.  Just oozing out in every direction.  Eating up time, money, resources.  And, most of the creeping and crawling is directed at defendants.  Plaintiffs want to depose dozens of company witnesses (hundreds if you get into sales representatives).  Plaintiffs want millions of pages of documents, along with native productions of large databases.  And what do the individual plaintiffs have to do?  Usually no more than fill out a Short Form Complaint, a Plaintiff Fact Sheet, and sign some medical release authorizations.  And while they do that, very little is done to curb the mounting mass of lawsuits.

That is until it’s not just defendants who have to put up or shut up.  There is no doubt that requiring individual plaintiffs in an MDL to do something – anything – to justify his/her claim actually works to shrink the mass.  In the DDL biz, we call it Lone Pine, named for Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Sup. Ct. Nov. 18, 1986) in which a New Jersey state court judge ordered plaintiffs to offer proof connecting the defendant’s product to the plaintiff’s alleged injury.  We keep track of the entry of Lone Pine orders in our cheat sheet, here.  And it should be no surprise that we are strong proponents of the Lone Pine orders, especially when entered early on in litigation.  They help clean house; shake off free-riders hoping to hang in until a settlement.

A decision last week from the Abilify MDL shows just how effective Lone Pine can be.  In re Abilify (Aripiprazole) Products Liability Litigation, MDL 2734, was created in October 2016.  Almost two years later, the court entered an order requiring every plaintiff to complete a Supplemental Plaintiff Profile Form (“PPF”) and supporting documentation by October 31, 2018.  That order provided that failure to comply would result in sanctions, “up to and including dismissal of a case.”  In re Abilify, MDL 2734, Order, at p.1 (N.D. Fla. Jan. 31, 2019).  As of last week, “over 400 plaintiffs” had failed to submit a PPF or submitted an incomplete PPF.  Id. at p. 2.  So the court issued an order to show cause why these deficient plaintiffs should not be dismissed.  Plaintiffs were given one week to respond – and just submitting the PPF and supporting documents isn’t going to be enough.  Id.

So, how is this Lone Pine? It’s a matter of substance over form.  The court doesn’t call the PPF process Lone Pine, but if you look at what plaintiffs were being asked to do – it’s all there:

Proof of use:  Plaintiffs had to state whether they had records documenting use of the product.  If so, they had to produce them and if not, they had to explain why not.  Why not indeed.  No lawsuit should be filed without first obtaining proof of product usage.  Production of pharmacy/dispensation records should not be a hardship for any plaintiff 2 years into a litigation.

Proof of injury:  Plaintiffs had to state whether they had ever been diagnosed with their alleged injury.  If they were diagnosed, they had to produce the records confirming the diagnosis.  If they did not have such records, they had to produce a “physician certification attesting that you have been diagnosed with [your alleged injury] and that your symptoms began while on Abilify, and identifying all information and records on which the physician relied.”  In re Abilify, Order, MDL 2734, Dkt. 986-1 (N.D. Fla. Aug. 31, 2018).  Definitely Lone Pine territory.  If you claim you suffered your injury, you have to have proof.  Again, we think that’s something plaintiffs should have before they file suit, so it is completely reasonable to ask for it well after that point.

The PPF process is a common one in MDLs, but it has to have teeth and it has to have an enforcer.  If a PPF only requires plaintiffs to reiterate their allegations and not back them up with documentation, it really doesn’t do anything to weed out meritless claims.  Likewise, the court has to be willing to dismiss plaintiffs who don’t comply.  If you don’t do the work, you don’t get your case.  The next step is more difficult and one we wish more courts would take – diving into the ooze.  For the hundreds of plaintiffs who did complete the PPF, does the documentation support the allegation?  This starts to get too close to Daubert and summary judgment for many courts to feel comfortable, but from experience we know complete PPF/Lone Pine submissions are not the same as non-deficient submissions.  We also know assessing deficiencies is a lot of work.  Not fun work.  Not pretty work.  But the kind of work that brings order to chaos.  Lone Pine may just be to MDLs what a blast of cold air was to the The Blob.  It wasn’t dead, but at least it was stopped (“as long as the Arctic stays cold!”).

Having three experts couldn’t save plaintiff’s claims in Robinson v. Davol Inc., 2019 WL 275555 (7th Cir. Jan. 22, 2019).  Plaintiffs’ decedent underwent surgery involving a surgical mesh patch and approximately one year later, she developed an abdominal wall abscess that led to various infections that ultimately led to her death.  Id. at *2.  The model of the mesh patch used in the surgery was the subject of a recall a few months after the decedent’s surgery.  Id. The reason for the recall was that the design of the patch caused it to adhere to the bowel or to break and perforate organs.  Id. at *1.

An autopsy concluded that decedent’s death was caused by pneumonia and complications therefrom.  The autopsy report also reported abdominal adhesions but noted that the “small bowel and colon [were] intact without perforation.”  Id. at *2.  Despite that conclusion, plaintiffs filed suit under the Indiana Products Liability Act alleging that decedent’s injuries were caused by the mesh patch.  The district court granted summary judgment after excluding all three of plaintiffs’ experts and the Seventh Circuit affirmed.

Plaintiffs’ first expert was Dr. William Hyman, a biomedical engineer who opined that the device was “inherently dangerous” and then speculated that the device caused decedent’s injuries.  But Dr. Hyman had to concede that he had never examined the images of the mesh patch used in decedent’s surgery and that he wasn’t qualified to offer an opinion “on the microbiology of her infection.”  Id. at *3.  In other words, he wasn’t offering a causation opinion.  First strike.

Plaintiffs’ second expert was the coroner who had performed decedent’s autopsy.  He tried to distance himself from his original findings by testifying that “there could have been superficial breaches scarred over with additional inflammation” and the adhesions “suggested the possibility of a breach.”  Id.  As it turns out, plaintiffs neglected to disclose that they would be relying on the coroner as an expert and so his opinion was excluded on that ground.    Id.  Strike two.

That left only plaintiffs’ medical expert, Dr. Stephen Ferzoco.  Dr. Ferzoco had testified in other mesh cases where the device broke or adhered to the intestines.  But because those things didn’t happen to decedent, Dr. Ferzoco came up with a new suggestion of causation – that the device didn’t break, but “buckled,” rubbed up against the bowel, and caused a perforation that “sealed up” prior to the explantation of the device.  Id. at *2.

New theories may be OK, but they still have to pass Daubert.  Dr. Ferzoco’s causation theory had never been presented in any formal or professional setting and was not published in any medical literature.  His only support for his theory was that he had seen it in other patients, but he was unwilling to identify those patients or provide their medical records for corroboration.  He also admitted, there was no support for his conclusions in either the decedent’s medical records or the autopsy report.  Id. at *3.  So the district court excluded his opinion as failing to meet the reliability threshold of FRE 702.

On appeal, plaintiffs only challenged the court’s ruling as to Dr. Ferzoco without whom they could not establish medical causation, an essential element of their claim.  The Seventh Circuit agreed with the district court’s reasoning based on the facts identified but they also had one more to consider.  Plaintiffs argued for the first time on appeal that Dr. Ferzoco’s conclusion was the “equivalent of a differential diagnosis.”  Id. at *4.  Putting aside the procedural argument that you can’t raise issues for the first time on appeal, do we really need to bastardize differential diagnoses any further?  Doctors perform differential diagnoses to diagnose disease in their patients so they can eliminate possibilities and prescribe the most effective treatment. They do not use differential diagnoses in the regular course of clinical practice to determine substantial factor causation, which is a litigation-driven concept.  You can find plenty of our thoughts on differential diagnosis in prior posts.   We certainly don’t welcome any equivalents.

Fortunately, the court didn’t have open arms either.  An expert’s decision “to rule in or rule out potential causes must itself be scientifically valid.”  In other words, you can’t “rule in” an unsupported causation theory.  “Dr. Ferzoco needed to establish the reliability of his [buckling] theory in order to rule [it] in as a potential cause of [decedent’s] death.”  Id.  “Differential diagnosis” isn’t a magic incantation that gets a causation opinion over the Daubert hurdle.  All the standard scientific processes must be in place.

And with strike three . . . plaintiffs are out.

A complaint gets filed in California naming hundreds of plaintiffs, only 20 of whom reside in California, against out-of-state manufacturers.  Sound familiar?  Sound like something the Supreme Court rejected in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  It should.  So, why are we here again?  I guess you can credit plaintiffs’ counsel with persistence.  But you what they say about the definition of insanity?  Well, it’s getting close to that point.

In BMS, the Supreme Court held that California’s courts could not exercise specific personal jurisdiction over an out-of-state defendant unless there is “an affiliation between the forum and the underlying controversy, principally, [an] activity or an occurrence that takes place in the forum State.”  Id. at 1781 (2017).  That means there must be a causal link between the defendant’s forum contacts and the alleged injury to the plaintiff.  Contacts with other people do not count.  And while BMS primarily focused on the contacts of resident versus non-resident plaintiffs, it also says that the presence of a California distributor – equally uninvolved with the plaintiffs who brought the suit – does not change the result one iota.  “The bare fact that BMS contracted with a California distributor is not enough to establish personal jurisdiction in the State.”  Id. at 1783.

But plaintiffs in In re Amiodarone Cases, No. JCCP 4956, slip op. (Cal. Super. Jan. 10, 2019) may not have been paying close enough attention to that portion of the decision.  When defendant manufacturers challenged the lack of personal jurisdiction over the claims of non-residents, plaintiffs relied exclusively on the manufacturers’ relationship with an in-state distributor.  BMS wasn’t decided that long ago as to have been forgotten already?  No, the court remembered it quite accurately.

Plaintiffs, whose claims were premised on allegations of off-label use and failure to provide the Medication Guide, argued that the supply agreements entered into by the drug manufacturers and the California-based distributor conferred specific personal jurisdiction because they contained provisions agreeing the contracts were governed by California law.  But that didn’t amount to a contact related to plaintiffs’ lawsuit that would give rise to personal jurisdiction.  The choice of law provision applied to disputes over the contract, not plaintiffs’ products liability claims.  Id. at 7.  Additional provisions of the supply agreements provided that California law applied and California was the appropriate venue for disputes regarding the indemnification requirements of the agreements.  Those provisions even said that for such disputes, the parties agreed to waive personal jurisdiction and inconvenient forum arguments.  Id. at 7-8.  Despite the plain language of the agreements, plaintiffs tried to argue that those provisions should equally apply to the underlying claims that may trigger the indemnification provisions.  And once again the court reiterated that the contractual obligations between the manufacturers and distributor was “not evidence of a contact for jurisdictional purposes.”  Id. at 8.

But plaintiffs pressed on.  They also argued that they were third-party beneficiaries under the supply agreements and therefore could enforce the personal jurisdiction waiver.  Id.  But just because the supply agreements set up the chain of distribution that may have ultimately led to plaintiffs ingesting the drug did not make plaintiffs third-party beneficiaries.  Moreover, the waiver was “expressly limited” to indemnification disputes and so wouldn’t apply to products liability actions anyway.  Id.

Choice of law didn’t work.  Third-party beneficiary didn’t work.  What about compliance clauses?  The supply agreements contained compliance clauses that stated that the drugs shall comply with all governing laws and regulations, will not be adulterated or misbranded, and will comply with the Prescription Drug Marketing Act.  Id. at 8-9.  But again, the court found those clauses don’t run to plaintiffs or their claims and so can’t be used to establish specific personal jurisdiction.

If not the supply agreements, what about compliance with regulations?  Plaintiffs argued that manufacturers were required to provide the California distributor with the Medication Guide which it in turn was required to distribute to physicians and pharmacies.  This, they claimed, evidenced a sufficient connection between California and the non-resident plaintiffs’ claims.  Id. at 9.  But, going back to BMS, that a manufacturer has business transactions with third-parties isn’t sufficient.  To satisfy due process, a defendant must be “haled into court in a forum state based on its own affiliations with the State, not based on the ‘random, fortuitous, or attenuated’ contacts he makes by interacting with other persons affiliated with the State”  Id.  Here, plaintiffs have more than enough evidence to establish a relationship between the manufacturers and their supplier, but they’ve offered no evidence to take the leap of a connection to the non-resident plaintiffs.  There is no evidence that any non-resident plaintiff took Amiodarone distributed by any California-based distributor.  Id.

What about derivative liability?  Plaintiffs argued, but offered no authority to support, that the indemnification provisions in the supply agreement create derivative liability by manufacturers for conduct of McKesson.  Id. at 10.  The best plaintiffs could come up with here was to rely on California’s old sliding scale approach to personal jurisdiction.  But that was expressly rejected by BMS.

Finally, what about the fact that the manufacturers sold the drug to the distributor in California?  It’s irrelevant because it’s completely unconnected to the plaintiffs.

Call it persistence.  Call it “E” for effort.  Call it insanity.  If the question of personal jurisdiction via third-party contacts wasn’t sufficiently answered in BMS (by the way, it was), In re Amiodarone should be viewed as shutting the door for good in California.

We did a search of the DDL Blog for “continuing violation” and found only one other reference and that was simply to note that the court rejected the theory without explanation.  So, it’s not the first time a plaintiff has tried to argue the continuing violation theory to avoid the statute of limitations in a pharmaceutical case, but this time the Eighth Circuit gave it just a little more attention and fortunately found it equally unpersuasive.

The continuing violations doctrine is an exception to the statute of limitations that allows a plaintiff to recover for acts which if treated individually would be time-barred by treating them as either a pattern of violations or a single violation.  At its core, the doctrine is fairly simple, where a defendant’s conduct is deemed to be continuing in nature, the court can toll the statute of limitations.  For instance, in the case of an environmental tort, the continuing violations doctrine considers each day an illegal dump site remains a new and separate act.  And as long as one of those related acts falls within the limitations period, plaintiff’s claim is not time barred.  The doctrine is also often used in employment discrimination cases where the discriminatory or harassing conduct occurs over a significant period of time.

But in a pharmaceutical products liability case?  That is what plaintiff argued in a case dismissed as barred by the statute of limitations in In re Mirapex Products Liability Litigation, 2019 U.S. App. LEXIS 849 (8th Cir. Jan. 10, 2019).  Mirapex is a drug used to treat Parkinson’s disease.  Plaintiff alleged that he suffered gambling and other financial losses as a result of developing obsessive compulsive disorder from taking the drug.  Id. at *1.  Plaintiff started taking Mirapex in January 2006 and started reporting compulsive behaviors to his prescriber in January and April 2008.  At which time, his prescriber discussed the association between Mirapex and such behaviors and recommended cutting back on plaintiff’s dosage, which plaintiff resisted.  Plaintiff continued taking the drug until July 2010.  Plaintiff filed suit in December 2010.  Id. at *2-3.

Plaintiff’s claims were governed by California’s two-year statute of limitations.  It was undisputed that plaintiff’s claims initially accrued no later than April 2008.  Id. at *4.  So, without a tolling or other exception, the claims would be time barred.  Plaintiff made two arguments to overcome the limitations period.  His first argument was that the limitations period was tolled due to insanity.  The argument is very fact sensitive and tied to the allegations that the drug caused behavior that caused plaintiff to be financially irresponsible and unable to understand the nature of his actions.  We aren’t going to go through the details of this argument, but suffice it to say that since at the time his claims accrued plaintiff was a full-time college professor and chair of his department who earned extra income from numerous speaking engagements, owned and operated two rental properties, and who had never been treated for mental illness or any psychological disorder – the court found he was not insane under California law.  Id. at *7-10.

That brings us to plaintiff’s continuing violation theory.  Plaintiff alleged that each ingestion of the drug was a separate and distinct claim.  In fact, 5,000 separate and distinct claims from January 2006 to July 2010.  Id. at *10.  Under plaintiff’s theory, he would be able to sue for damages caused by each ingestion within 2 years of December 2010 regardless of when his claim first accrued.  The court noted that under federal law, the “critical question” in determining whether there has been a continuing violation “is whether a present violation exists.”  Id. at *11 (citation omitted).  And there’s the rub.  Plaintiff’s claims are based on an alleged failure to adequately warn him of the side effects of Mirapex.  That failure to warn is a “single wrongdoing” that accrued when his prescriber advised him of the relationship between compulsive behavior and the medication.  Id. at *11-12.  A new failure to warn cause of action did not arise with every pill plaintiff took.  As the court noted, because the drug was FDA-approved for the treatment of Parkinson’s disease and prescribed for that purpose, “the wrongdoing isn’t taking the pill.”  Id. at *12.  While his alleged injuries continued as a result of his voluntarily continuing to take the drug, his earlier gambling losses were “appreciable and actual harm” that triggered the running of the statute of limitations.

If each ingestion was considered a separate act triggering a new limitations period, the continuing violations doctrine could essentially swallow the statute of limitations in prescription drug litigation.  And since we can’t conceive of any other outcome for this argument, we hope this is the second and last time we need to address this issue.

While 2019 is solidly under way, we’re still catching up on a sizable number of favorable decisions to have come down right before the new year.  That’s certainly not a complaint.  We love a full plate of defense wins.  So, for today’s post we’re reaching back a few weeks to tell you about a decision coming out of Middlesex County Superior Court in New Jersey in what we believe is the first ever decision on a motion to dismiss in a case alleging breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).  BIA-ALCL has been receiving a decent amount of publicity recently as well as significant regulatory activity since 2011.  And this is one of several BIA-ALCL cases pending in New Jersey.  So, the decision is significant as a case of first impression with hopefully trend-setting implications.

The case is Cashen v. Johnson & Johnson, 2018 WL 6809093 (N.J. Super. Law Div. Dec. 24, 2018).  Plaintiff underwent surgery in 2008 during which defendant’s breast implants were implanted.  In 2016, plaintiff was diagnosed with ALCL requiring surgery to remove infected lymph nodes and chemotherapy.  Id. at *2.  The parties agreed that Ohio law governed plaintiff’s claims as that is where the alleged injury arose.  Plaintiff brought claims for fraudulent misrepresentation, fraudulent concealment, consumer protection, design/warning/manufacturing under the Ohio Products Liability Act (“OPLA”), and express warranty.  Defendant moved to dismiss all claims on both preemption and substantive state law grounds.  Id.

Because the breast implants are pre-market approved medical devices, they are subject to express preemption under Riegel v. Medtronic, 552 U.S. 312 (2008) if plaintiff’s claims seek to impose state law requirements that are different from or in addition to the federal requirements imposed as part of the PMA process.  Id. at *5.  The court found that was the case with respect to plaintiff’s fraudulent misrepresentation and concealment claims:

Inherent in the FDA’s approval of the product is its finding that the product and its label have met the federal requirements as a Class III medical device. Therefore, it stands that any claims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements. The former would make the claims expressly preempted while the latter would be impliedly preempted.

Id. at *7.  Plaintiff attempted to bypass preemption by arguing that her fraud claims were “not based on the safety or effectiveness of the implants.”  Id.  Which was belied by the allegations of the complaint that focus on “serious physical harm” and misrepresentations about “safety” of the product.

The court also found that under Ohio law, plaintiff’s fraudulent misrepresentation and fraudulent concealment claims were abrogated under the OPLA.  The text of the OPLA provides that it abrogates all common law products liability claims.  Id. at *8.  And Ohio courts have determined that fraud claims premised on a failure to warn or a duty to make additional warnings are products liability claims subsumed under the OPLA.  Again, plaintiff attempted to re-write her complaint and argued that her fraud claims were premised on a general duty not to deceive rather than on a duty to warn.  Id.  But the court again found that argument contradictory to the allegations of the complaint which were clearly focused on concealments regarding safety – like a failure to warn claim.

Next up was plaintiff’s claim for violation of the Ohio Consumer Sales Practices Act (”OCSPA”).  Here the court opted not to decide the federal preemption question, instead relying on the abrogation of the claim by the OPLA.  The court noted that under Ohio law, medical devices are not considered consumer goods under the OCSPA.   Id. at *9.

Which then brings us to the plaintiff’s OPLA claims for design, warning, and manufacturing defect.  Because the implants were PMA approved, they have “satisfied the FDA’s strictest requirements for medical devices.”  Id. at *10.  Therefore, any claim for design defect must be preempted “because any alternative design would violate the product’s PMA.”  Id.  As for plaintiff’s manufacturing defect claim, it was premised on “generic allegations” lacking the specificity required to overcome preemption.  Plaintiff’s warning claim likewise failed because the FDA had already approved the implant’s warnings, making any state law finding that the warning was inadequate a different requirement.  Id.

Plaintiff’s breach of express warranty claim suffered the same fate.  The claim would ask the jury to find that the product was not safe and effective as labeled – which would be in direct conflict with the FDA’s PMA conclusions.  Id. at *11.

As if that wasn’t enough – the icing on this cake is that the dismissals were with prejudice.  Plaintiffs had sought leave to amend but it appears the court concluded that amendment would be futile given the preemption analysis.

Congratulations to Dustin Rawlins, Peter Choate, Monee Hanne, and Rachel Byrnes at Tucker Ellis and Michael Zogby and Jessica Brennan at Drinker Biddle on this excellent decision.

You can waive remand.  That’s Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998).  But, if you agree to remand, you’re going back whence you came.  So said the Judicial Panel on Multidistrict Litigation earlier this month in In re: Biomet M2A Magnum Hip Implant Products Liability Litigation, 2018 WL 6426830 (JPML Dec. 6, 2018).

That’s pretty much all the 4-paragraph opinion says on this issue of first impression.  The JPML cannot “redirect the remand” to a non-originating court.  What the opinion doesn’t tell is why the request was being made in the first place.  So, we did a little digging.  At issue were three cases selected for remand from this MDL.  The Chadwick case had been originally filed in state court in New Jersey and subsequently removed to federal court.  Plaintiffs included as a defendant a company whose sole role in relation to the device at issue was to supply raw materials.  That company, a New Jersey company, was the only thing establishing venue in New Jersey.  Memo. Of Law in Support of Motion of Defs. To Vacate Conditional Remand Order, No. TXS/4:14-cv-00232, Dkt. No. 12-1 (JPML), at 2-3.  Plaintiff is a resident of Wyoming and Biomet is an Indiana company.  The New Jersey defendant filed a motion to dismiss based on the immunity afforded raw material suppliers under the Biomaterials Access Assurance Act (“BAAA”).  Feels like the New Jersey company was present simply to allow some forum shopping by plaintiff.  Prior to remand, however, plaintiff agreed to dismiss the raw material supplier and with that dismissed the only link to New Jersey.  Id.

The second case, Carter, was filed in the Southern District of New York before being transferred to the MDL.    Plaintiff Carter, however, lived in Virginia and had surgeries in Virginia and North Carolina.  Her complaint does not include any allegation why venue would be appropriate in New York.  Id. at 3-4.  Similarly, the plaintiff in the Richards case filed suit in the Southern District of Texas, but she resides and had surgery in cities that fall in the Northern District of Texas.  Id. at 4.

At the time of remand, the MDL judge was willing to grant the parties’ request that these three cases be transferred to appropriate venues that were not their originating courts.  However, in the suggestion of remand, the judge concluded that he had no authority to grant the relief requested by the parties and listed the remand jurisdiction for each case as the original transferor courts.  Id. at 5.

Defendants argued that the logic of Lexecon should apply.  In effect, that there was no difference between waiving remand to the transferor court to allow trial to take place in the MDL and waiving remand to the transferor court to allow trial to take place in a different, but appropriate venue.  Id. at 6.  Defendants also made the points that denying the request now was simply inefficient because they would file change of venue motions post-remand that were highly likely to succeed and that at least as to New Jersey and New York there were also personal jurisdiction issues.  Residents of Wyoming and Virginia were suing Indiana companies in New Jersey and New York.  And that hasn’t been allowed since Daimler AG v. Bauman, 571 U.S. 117 (2014).

But the JPML was unpersuaded finding that the statute, 28 U.S.C. § 1407(a), afforded it “no discretion.”  The only remand destination allowed is the original transferor court, even if the parties agree that jurisdiction is improper.  In re: Biomet, at *1. 

So, other than this now being the rule of law, to us it is also indicative that Congress did not contemplate the current forum shopping practices.  Cases should be remanded from where they came because they should have been filed in appropriate jurisdictions from the outset.  But, we know that’s not the reality.  We are optimistic that the issue will be resolved correctly post-remand, but where venue is so clearly not present, we don’t see the harm in arming the JPML with the tools to get the job done.