We just returned from a four-night cruise that included a stop in Havana, Cuba.  We won’t bore you with too many details about the dinner tablemate who proclaimed, “Let’s kill all the lawyers,” when we told her what we do for a living.  And who commented, when we talked about an onboard trivia contest, “Well, cheating is in your DNA, since you are a lawyer.”  But we will tell you that there was something magical about Havana.  We toured the city in a cherry-red and white 1956 Chevy Bel Air.   We walked, on a gorgeous sunny day, through cobblestone streets framed by buildings unchanged for hundreds of years.  Change is now afoot, but its imprint is spreading slowly.  For now, large portions of the city appear frozen in time.

But time does not stand still in litigation.  Back in the summer, we published a guest post that included a 50-state survey of statutes of repose, those statutes that cut off the right to file suit a prescribed number of years after a product was manufactured or sold, regardless of whether a plaintiff’s cause of action has accrued when the repose period expires.  Today’s case, Nunn v. Biomet, Inc., 2018 U.S. Dist. LEXIS 215395 (N.D. Ind. Dec. 21, 2018), involves Indiana’s statute of repose.

In Nunn, the plaintiff filed suit in the Biomet hip implant MDL pending in the Northern District of Indiana.  The plaintiff’s claims accrued in Nebraska, so Nebraska law applied.  Nebraska product liability law borrows the statute of repose of the state in which the product was manufactured – in this case, Indiana.  Indiana’s statute requires suits to be filed within ten years after the product is delivered to the ultimate user.   The plaintiff’s artificial hip joint was implanted on March 8, 2004.  The plaintiff did not file her complaint until April 15, 2014, just over a month after the repose period expired.  The defendant moved for summary judgment, arguing that the statute of repose barred the plaintiff’s claims.  The plaintiff responded that her claims were tolled by the defendant’s fraudulent concealment of facts related to the prosthetic hip.

The court explained that, to survive summary judgment, the plaintiff was required to point to evidence supporting her fraudulent concealment claim.  The only exhibit attached to the plaintiff’s brief was a 2006 communication in which the defendant informed surgeons about the possibility of unknown side effects caused by metal-on-metal articulating surfaces of the defendant’s artificial hip devices.  But, the court held, “[N]either this statement, or [sic] any other statement that Ms. Nunn refers to, is accompanied by anything that would allow a reasonable trier of fact to find that it (or any other statement) caused her to delay filing suit.”  Nunn, 2018 U.S. Dist. LEXIS 215395 at *6-7.   Duh.  And because the record did not allow a finding that any concealment by the defendant induced any delay in the plaintiff’s filing of her complaint, there was no tolling, and the defendant’s motion was granted.

Short and sweet (like our cruise) and unassailable (unlike our tablemate).  We like this tidy little decision, and will keep you posted on others like it.

We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun.  Given our chosen line of work, we should not be surprised that we don’t get enough sunlight.  We should also not be surprised that dietary supplements—such as our daily chewable multivites—generate substantial litigation, usually based on the premise that the supplements don’t do what their sellers say they are supposed to do.

Plaintiffs often file these kinds of lawsuits in California because of California’s liberal consumer protection laws, but many of them find out that the FDA regulates dietary supplements as food.  Regular readers of the blog can see where this is headed.

That’s right.  Federal preemption.

Take for example the Ninth Circuit’s recent opinion in Dachauer v. NBTY, Inc., No. 17-16242, 2019 WL 150016 (9th Cir. Jan. 10, 2019).  In that case, the plaintiff purchased vitamin E supplements that claimed on their labels to “support cardiovascular health” and to “promote[ ] immune function.”  Id. at *1.  The court noted that the plaintiff “purchased one bottle of the supplements for health reasons.”  Id.  We think it is more likely that the plaintiff’s attorneys had an expert who questioned the value of vitamin E supplements and sent the plaintiff to buy his “one bottle” for litigation reasons, rather than “health reasons.”  But we don’t really know and are probably just being cynical.

Regardless, the plaintiff sued under California’s consumer statutes alleging that the supplements do not present cardiovascular disease and might increase the risk of all-cause mortality, rather than promote “immune function.”  Id.

Here is where the FDA’s regulation of dietary supplements comes into play, and there are only two things you really need to know.  First, the FDCA has an express preemption provision for certain food labeling claims, under which federal law preempts any state law that establishes “any requirement respecting any claim . . . made in the label or labeling of food that is not identical to [federal requirements].”  Id. at *3 (citing 21 U.S.C. § 343-1(a)(5)).  This is a strong preemption provision, and the “identical to” language is arguably even stronger than the “different from or in addition to” language that we are used to in the medical device context.”

Second, when it comes to dietary supplement labeling, the FDCA distinguishes between “disease claims” and “structure/function claims.”  A “structure/function claim” describes the role of a nutrient or ingredient intended to maintain the structure or function of the body.  By comparison, a “disease claim” claims to diagnose, mitigate, treat, cure, or prevent disease.”  Id. at *2.  An FDA guidance provides that structure/function claims can use general terms, such as “strengthen,” “improve,” and “protect,” so long as the claims “do not suggest disease prevention or treatment.”  Id. (quoting Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan. 6, 2000)).  Apropos to this case, the guidance identifies “helps maintain cardiovascular function” as an example of a permissible structure/function claim.  Id.

Having made labeling claims that are quite clearly permissible structure/function claims, the defendant moved for summary judgment on the basis that the plaintiff’s claims were preempted.  In other words, the plaintiff was asserting that state law required labeling different from the federally approved labeling.  The district court granted summary judgment, and the Ninth Circuit affirmed.  With regard to the labeling claim that the supplement “support[ed] cardiovascular health,” the plaintiff had an expert who disagreed, but the federal requirement was what it was, and the plaintiff’s expert could not just erase it:

The FDA allows manufacturers of supplements to make general claims—such as “promotes heart health”—and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body.  Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease.  Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it.

Id. at *3 (emphasis added, citations omitted).  The Ninth Circuit came to a similar conclusion with regard to the plaintiff’s arguments targeting the “promoted immune function” claims.  The FDCA does not require that manufacturers substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality.  Thus, “[b]ecause any such requirement under California law would differ from the FDCA’s labeling requirements, the FDCA preempts Plaintiff’s claim to the extent that he argues that Defendants make a false structure/function claim because their supplements fail to reduce the risk of all-cause mortality.”  Id. at *4.

The only claim that survived was the plaintiff’s claim that the defendant’s structure/function claim about immune health was misleading because the supplements actually increase the risk of all-cause mortality.  Because that claim would be misleading under either federal or state law, it was not expressly preempted.  Id.  The plaintiff, however, did not submit evidence sufficient to raise a triable issue of fact.  His expert cited four meta-analyses, but none concluded that vitamin E supplements caused an increased risk.  Id.  With no substantial evidence that the defendant’s “promoted immune function” claim was misleading, the plaintiff was not entitled to proceed.  Summary judgment affirmed.

The Dachauer opinion comes to the right result for the right reasons.  For our part, we will continue to take our daily multivitamin with modest expectations, and maybe we will try to get out into the sun more often.

We recently gave a talk on things in MDLs that drive us crazy. Discovery is front and center. The asymmetry of discovery is a huge source of unfairness. If plaintiffs have their way, all discovery would be about company conduct, and we’d never get to find out if those 8,000 plaintiffs used the product or suffered an injury. Mere details. And don’t get us started on a plaintiffs’ insistence that we “certify” that our discovery is complete. That certification is both an insult and a departure from the Rules. Plaintiff lawyers might seek such certification in any case, but they definitely will seek it in an MDL, where discovery is most difficult, one-sided, and expensive.

Okay, now you went and got us started. Federal Rule of Civil Procedure 26(g)(1) requires that “every discovery request, response, or objection must be signed by at least one attorney of record … [to certify] that to the best of the person’s knowledge, information, and belief formed after a reasonable inquiry (A) with respect to disclosure, it is complete and correct as of the time it is made …” Although some enterprising plaintiff lawyers have argued that this language should mean parties are required to certify that discovery responses are complete, this Rule is limited to disclosures required by Rule 26(a)(1) – not discovery responses.

The comments to subsection (g)(l) tell us that Rule 26(g) “imposes an affirmative duty to engage in pretrial discovery in a responsible manner that is consistent with the spirit and the purposes of Rules 26-37.” Fed. R. Civ. P. 26(g) advisory committee’s note. Additionally, “the signature certifies that the lawyer has made a reasonable effort to assure that the client has provided all the information and documents available to him that are responsive to the discovery demand.” Id. Although there is a duty to make a reasonable inquiry to ensure that discovery responses are complete, there is no duty to certify complete discovery. United States v. Fresenius Medical Care Holdings, Inc., No. 1:10-CV-1614-AT, 2014 WL 11517841, at *5-6 (N.D. Ga. May 13, 2014). The “complete and correct” language applies only to initial disclosures required by Rule 26(a) (l). Moore v. Publicis Groupe, 287 F.R.D. 182, 188 (S.D.N.Y. 2012).

In Moore, the plaintiff relied on Rule 26(g)(l )(A) to argue that the defendant’s counsel was required to certify that the client’s document production was complete and correct at the time it was made. Id. The court disagreed, pointing out that Rule 26(g)(l)(A) specifically applies “with respect to disclosure” and that Rule 26(g)(l)(B) applies to discovery responses and does not call for certification. Id. The court acknowledged that “[i]n large-data cases … no lawyer using any search method could honestly certify that its production is ‘complete.”‘ Id. True enough.

Similarly, in Fresenius, the plaintiff argued that the defendant’s counsel was required to certify complete document production and that the court must impose sanctions under Rule 26(g)(3) for providing a certification that violates the Rule. Fresenius, 2014 WL 11517841, at *5-6. Looking at the language of Rule 26(g)(l), the court stated that there is no certification requirement for complete document production. Id. at *6.

In conclusion, while lawyers should make a reasonable effort to ensure that a client has provided all the information and documents available that are responsive to the discovery demand, there is no requirement to certify complete document production. Such certification finds no support in the law. Let’s call such certification what it truly is: a sanctions trap.

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.

That part of this title is borrowed from a fellow blogger’s post does not at all detract from its fundamental truth.  Attention to personal jurisdiction wins cases – particularly in MDLs in which lawyers are out there recruiting clients, rather than the other way around.  The latest example is In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2019 WL 121199 (E.D. Pa. Jan. 7, 2019).  Zostavax also underscores why a case we recently discussed, In re Biomet M2A Magnum Hip Implant Products Liability Litigation, ___ F. Supp.3d ___, 2018 WL 6426830 (JPML Dec. 6, 2018), is significant.

Zostavax is not one of your typical litigation tourist MDL cases.  Both of the two plaintiffs, whose cases were ultimately dismissed, were residents of the forum in which they initially brought suit – Florida.  However, indicative of how lawyer solicitation scrapes the bottom of the barrel in MDLs, both plaintiffs had used the product quite a few years earlier before they (probably retired and) moved to Florida.  One plaintiff used the product in July, 2011, and the other a year later in July 2012.  Zostavax, 2019 WL 121199, at *1.  Suit was not filed until 2018, according to the docket numbers.

No basis existed to subject the defendant to general jurisdiction in Florida, id. at *3, and since the plaintiffs both took the product and were diagnosed with their alleged injuries before they moved to Florida, neither did the facts support specific, case-linked jurisdiction in the state.  “For purposes of personal jurisdiction, we must look to the place where the injury occurred, not to the place where it was diagnosed.”  Zostavax, 2019 WL 121199, at *4.  Rather:

The relevant activity or occurrence with respect to [the first plaintiff] took place in Edgartown, Massachusetts when she received the [product].  The relevant activity or occurrence with respect to [the second plaintiff] took place in Connecticut where she was injected with [the product].  The torts which allegedly caused their injuries happened in places other than Florida.  While plaintiffs were long-time residents of Florida, [defendant] did nothing to and had no interaction with either of them in that state.  [Defendant] was not at home in Florida, and plaintiffs’ injuries did not arise out of and were not related to any contact it had with Florida, regardless of what [defendant’s] other activities in the state may have been.

Id..  That’s straight out of BMS – where the product did not injure the plaintiff in the forum state, no matter how extensive the defendant’s non-case-related in-state activities are, they cannot establish specific jurisdiction.  You’ll have to go somewhere else.

Nor does personal Jurisdiction turn on how “convenient” the forum might be:

Florida’s power does not extend to [defendant] in these actions even if Florida would be a convenient place for plaintiffs to sue and would not be inconvenient or burdensome to large corporations such as defendants.

Id.

Zostavax underscores a jurisdictional point defendants need to keep in mind.  Personal jurisdiction motions are not limited to litigation tourists.  Once Bauman took out the old notion of general jurisdiction everywhere a major corporation did business, plaintiffs either have to sue corporate defendants where they are “at home” or where they can obtain specific jurisdiction.  Specific jurisdiction is necessarily quite commonly where the plaintiff resides – but not always.  Plaintiffs who change their states of residence in between injury and filing suit can create, as in Zostavax, jurisdictional problems for themselves.  In these non-litigation-tourism cases, defendants might choose to waive the jurisdictional defect.  However, in prescription medical product cases, where the “learned intermediary” prescriber is often the most important witness, such a waiver can create discovery problems for defendants (can’t subpoena the prescriber), so there is good reason to stand on a valid jurisdictional defense.

Equally interesting is the discussion about what happens once the absence of personal jurisdiction is established.  In Zostavax, plaintiffs alternatively sought a transfer.

Denied.  Cases dismissed.

Why?  That involves the issue decided in the Biomet M2A Magnum case we discussed previously.  That case established that an MDL judge can only remand cases to the courts from which they were originally filed.  Zostavax, 2019 WL 121199, at *5.  MDL courts are “preclude[d] . . . from transferring a case to any other district, whether under §1404(a), §1406(a) or §1631.”  Id. (citing various statutes allowing transfer in various circumstances).  This means that if an MDL plaintiff’s initial filing is in a court without personal jurisdiction, it’s curtains.  The action must be dismissed, because it cannot be remanded to the transferor court – because cases can’t be sent to a court that was just determined to lack jurisdiction – nor can they be transferred anywhere else, given the terms of the MDL statute.

If the case (as in Zostavax) has to be dismissed, then see our post here about savings statutes.  In some states the MDL dismissal may bar the claim from being refiled under the applicable statute of limitations.

Finally, the transfer discussion points out another consequence of Bauman/BMS personal jurisdiction:  in some cases, plaintiffs simply might not be able to join all the defendants they want to in the same lawsuit:

[T]here does not appear to be any one forum where general jurisdiction could be exercised over all defendants.  As to specific jurisdiction, there is nothing in the record pointing to any ties between causation of plaintiffs’ injuries in Massachusetts and Connecticut and any activity of [the non-moving defendant] in those states.  In sum, the court is not able to determine . . . in what district or districts, if any, either of these actions could have been brought at the time they were filed.

Zostavax, 2019 WL 121199, at *5.

If you’ve ever wondered why so many of the post-Bauman personal jurisdiction cases have involved asbestos plaintiffs, this is why.  The Bauman/BMS personal jurisdiction regime is fatal to asbestos litigation tourists (or plaintiffs who, like the plaintiffs in Zostavax, just didn’t sue where they were injured) because without “case-linked” personal jurisdiction tied to the place of injury it’s impossible to obtain jurisdiction over scores of unrelated corporations.  Because we (at least Bexis) also dabble in asbestos litigation, we’re careful to specify in our cheat sheet which cases involve asbestos.

Zostavax demonstrates that blanket personal jurisdiction can also be impossible for litigation tourists in prescription medical product MDLs.  Multiple defendants – be they physicians, hospitals, distributors, affiliates, whatever – may well not be amenable to personal jurisdiction in the same forum, unless the plaintiff sues where s/he allegedly was injured.  There’s now a real downside to litigation tourism, in that cases can be dismissed without ability to refile.  To us, that’s the most interesting aspect of Zostavax:  judicial recognition that in multi-defendant cases, litigation tourism itself may not be possible.

Last week Bexis published a Legal Backgrounder for the Washington Legal Foundation, entitled “Recent Rulings Establish New Beachheads For Preemption In Drug And Device Product Liability Litigation.”  It discusses several 2018 prescription medical product liability preemption rulings and what they portend for future litigation concerning the most powerful defense that our clients have.  If you’re interested, you can read it here.

We may not know much about skin care, but we know a thing or two about labeling claims.  Whether for a drug, a device, a food, a cosmetic, or some other product, it is necessary to apply some common sense in determining what is or is not in a product’s labeling should give rise to liability.  The court in Browning v. Unilever U.S., Inc., No. SACV 16-02210, 2018 WL 6615064 (C.D. Cal. Dec. 17, 2018), applied a healthy dose of common sense in granting summary judgment for the defendant against consumer fraud and warranty claims by a purported of deceived purchasers.  The product at issue was St. Ives Apricot Scrub and allegations centered on the presence in the product of a powder from the crushed shells of walnut to lend exfoliating power to the scrub.  We will try to keep the nuttiness to a minimum as we discuss the decision.

The court’s introduction gets to the kernel of the dispute:

This “Scrub” is an exfoliant and like all such products is necessarily abrasive. Plaintiffs claim that the Scrub causes “micro-tears” and speeds up the aging process. Plaintiffs allege Unilever failed to disclose the scrub’s negative side effects before selling it to the public and misled consumers into believing it was dermatologist recommended.

Id. at *1.  Before we crack into the analysis, we have a little detour into some things not really spelled out in the decision.  This is probably obvious, but the scrub is used by gently rubbing it into the skin on your wet face and then washing it off.  Under the directions section on the tube of scrub are the ingredients section, which lists “Juglans Regia (Walnut) Shell Powder” right after water.  For those who are curious, these shells come from one of twenty-one species of walnuts.  If a reader or potential consumer were curious enough to look at the website for the product, then it would not be hard to see that Walnut Shell Powder is identified as the second “key ingredient” of the product (after apricot extract) and that the “exfoliation factor” of the product is characterized as “deep.”  With that extra-judicial context, we get back to the meat of the decision. (OK, we will stop with the gratuitous nut references.)

We will start with the second of plaintiffs’ basic claims, that the label was misleading in saying it was “Dermatologist Tested.”  Plaintiffs claimed that statement somehow suggested the product was “recommended” or “approved” by dermatologists, but they acknowledged that the product was tested by dermatologists and the court could read.  Id. at *4.  So, plaintiffs went to a back-up argument that references to testing were misleading without disclosing an alleged risk of the product.  That brings us to the first argument.

The first argument was that the walnut shell powder made the product too abrasive and caused indiscernible micro-tears in the skin that increase the incidence of acne, infection, and wrinkles, which in turn make the skin of users look older faster.  Because this was in the posture of summary judgment, plaintiffs actually offered up evidence like expert declarations, deposition testimony, and even published articles and a study done for litigation by their retained expert.  Viewed in a light favorable to plaintiffs, this evidence “at best show[s] that St. Ives Scrub could, in theory, alter the skin’s surface.”  Id. at *3 (emphasis in original).  However, under California law, “the alleged unreasonable safety hazard must describe more than merely conjectural and hypothetical injuries.”  Id. (internal citation and quotation omitted).  Plaintiffs did not show “that the alleged microtears are a safety hazard” and their experts did not contend the product was “dangerous.”  Id.  So, no injury.

They also did not prove causation:  “Evidence is lacking that St. Ives, and not other products or lifestyle or sun damage or any other factor, produced acne, wrinkles, inflammation, or loss of moisture (even if these were actionable safety hazards).”  Id.  The court considered the consumer complaints offered by plaintiffs to say nothing about causation, especially because they occurred at a low frequency.  Id.  The court also was not impressed by the plaintiffs’ for-litigation study:  “Plaintiff’s short-term clinical study does little to advance Plaintiff’s causation theory or prove their allegations of longer-term skin conditions.”  Id.  Bringing the evidence back to the context of alleged omissions of unreasonable safety hazards of the product from labeling, the court stated:

Again, Plaintiffs haven’t shown that micro-tears themselves (as distinct from potential resulting symptoms, such as wrinkles or acne) are counter to the product’s central function. Indeed, the Scrub was marketed as an exfoliant (Mot. at 25), which implies some intended resurfacing or abrasion. Plaintiffs do not address this issue or offer a description of the central function of a facial exfoliant. There is far too little for a reasonable jury to conclude that the presence of walnut shells neuters that undefined function.

Id.  Contraction notwithstanding, we think this is fine analysis.  As noted above, a little broader look would indicate that this product was not just marketed as an exfoliant, but one for deep exfoliation with the ground up walnut shells as a key ingredient.  People who might want to use a scrub—any scrub, pre-packaged or homemade—might consider in advance whether scrubbing the skin on their face with something with sufficient grittiness to accomplish a scrubbing is what they want.  That is not really a labeling issue.

To cap it off, the purported class reps did not have any injuries.  They just “assume[d] they suffered from micro-tears which they could neither see nor feel.”  Id. at *4.  We have seen uninjured class reps before and the need for a cognizable present injury clearly applies in a range of contexts, including medical monitoring and consumer fraud.  There is nothing nutty about that requirement.

 

We’ve reviewed the transcript of the oral argument in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.), e.g., the United States Supreme Court appeal from the horrible decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), which we ranked as the worst case in all of 2017.  Our one sentence reaction – We’d rather be us than them.

The Fosamax plaintiffs have a lot of problems with their position in Albrecht, chief among them that the FDA itself, as amicus curiae in this case, disputes their interpretation of what the Agency knew and did.

Briefly, plaintiffs argued that:  (1) the FDA’s rejection of the defendant’s “stress fracture” warning was because stress fractures and the injury at issue in the litigation – now called “atypical femur fractures” (or “AFF” for short) − were two different things; (2) the FDA only rejected the imprecise term “stress fracture,” and didn’t reject an AFF warning, and (3) the rest of the regulatory record consists of FDA “musings” that plaintiffs are free to contradict and juries would be free to disregard.  Albrecht Tr. at 35-38, 42-44, 61-63.

Equally briefly, defendant argued that:  (1) its rejected “stress fractures” warning encompassed AFF (a term only created later), demonstrated by language about “complete” and “non-traumatic” fractures; (2) the FDA’s rejection was based on insufficient data about AFF, since a short time later the Agency set up a task force to study AFF before changing labels for this drug class (bisphosphonates); and (3) the FDA does not simply reject scientifically valid warnings for grammatical reasons.  Albrecht Tr. at 3-5, 10-12, 16-19, 65-66.

The FDA, represented by the Solicitor General’s office, agreed with the defendant’s depiction of its regulatory actions regarding AFF, arguing that the Agency obeyed the law and did not reject the defendant’s label for imprecise language, but rather because the link between AFF and bisphosphonates was not supported by sufficient scientific data at the time  Albrecht Tr. at 20-22, 27-30.

At the oral argument another problem for the plaintiffs was evident:  Justice Stephen Breyer.  A member of the majority in Wyeth v. Levine, 555 U.S. 555 (2009), and an anti-preemption dissenter in the more recent PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, Justice Breyer is a “must get” vote for plaintiffs in Albrecht.  They don’t have him:

JUSTICE BREYER: I’m leading to this, that, when you talk about the standard, drugs are important to people.  They cure millions, or thousands, anyway, of people who need to be cured or helped.

Now, when you put on, and at the same time there will be a smaller subset that can be hurt, so our solution to that is labels.

Now, when you say displacing state law or something, you’re talking like a lawyer, which is what you’re supposed to do, but what worries me is, if you go too far in allowing the tort jury to find mislabeling by not including things, you are hurting the vast majority of − of women here or −or whatever who can benefit from this medicine.

On the other hand, if you don’t go far enough, you will hurt that minority. Now that’s the general framework in which I’m trying to figure out the answer to the question.  And that’s why Justice Gorsuch’s question was − was quite relevant.

All the earmarks here are that Merck took this as a letter saying we’re not certain enough this is really going to hurt people and we don’t want you to put it on.

Now, obviously, somebody must have picked up the phone when they got that letter and they must have phoned somebody in FDA and say:  Do you really mean that? What do you mean?  Because I can change those words, “stress fracture,” in two seconds.  Or do you mean you don’t know enough about it?

Now the appointment of the later task force suggests that they felt they didn’t know enough about it, and, therefore, Merck couldn’t have done it.

Albrecht Tr. at 40-41 (emphasis added).  That wasn’t so much a question as it was a speech, and one that we very much applaud.  But that’s not all.

JUSTICE BREYER: . . .  But what’s actually bothering me about the approach that you’re taking is that, in this particular area, in this particular area of medicines, I don’t really see how we’re going to benefit by 50 different states really giving different signals to the manufacturers, and I can see a lot of ways in which, from a health point of view, we’re going to lose.

That doesn’t mean the law is wrong.  It doesn’t mean − you know, it’s just a question of emphasis. And, here, we have an emphasis.

The next page from the one you cited, the FDA says in 2010, FDA’s review of the data did not show an increase in this risk, the relevant risk, in women using these medications.

So there are indications in this record . . . that they thought that it is more dangerous to put the label − to put the risk in the label than it is to leave it out. . . . And then they set up a task force and decide they were wrong.

Albrecht Tr. at 51-52 (emphasis added) (attempts by plaintiffs’ counsel to get a word in edgewise omitted).

To us defense counsel, these comments by Justice Breyer were the highlight of the argument.

We were also paying attention to Justice Gorsuch, a conservative, but known skeptic of the administrative state, who might not have much deference to the FDA’s actions.  Indeed, Justice Gorsuch had some tough questions for defense counsel about creating a “moral hazard” that might encourage submission of “inartful” warnings, about the availability of unilateral CBE warning changes, and about when “new information” existed.  Albrecht Tr. at 13, 18-19.  But in each instance, counsel provided persuasive answers: (1) that the FDA’s actions belied any such “moral hazard” here; (2) that CBE scientific support standards are identical to the pre-approval process the defendant used; and (3) that new evidence in this instance meant the findings of the FDA task force announced shortly after Agency’s rejection of the warning at issue. Id. at 13-14, 18-19.  If skeptical of the FDA, Justice Gorsuch didn’t show it, not speaking during the SG’s argument. Justice Gorsuch’s later comments, during the plaintiffs’ argument, were clearer:

We have, though, the March 2010 safety statement from the FDA which pretty clearly says that they do not think that there is science enough to support a causal link between the drug and atypical femoral fractures.

So whatever was missing in the complete response letter from the FDA seems to come in March of 2010.

Albrecht Tr. at 34-35.

[T]hat’s why it [the FDA] set up the task force at the same time to go study the issue, and it said up to that point we don’t have enough, but we’re going to go study it. . . . And so why isn’t that − tell us everything we need to know about what its complete response letter was about, as a matter of law?

Id. at 36-37.

As for the two specific holdings that the Third Circuit made in Fosamax – that “clear evidence” means preemption is decided under a “clear and convincing evidence” standard, and that determining what the FDA would have done is a question for the jury – the first was, surprisingly, not mentioned at all. Since plaintiffs abandoned this argument in their briefing, it will be interesting to see what (if anything) the Court holds about the standard of proof. The judge/jury issue received some scrutiny during the plaintiffs’ argument, with plaintiffs backpedaling furiously in response to a question from Justice Alito.:

We agree with Merck that, because of the complete response letter . . . was a legal document that a judge can interpret.  We believe that, based on a sound interpretation of the letter, it doesn’t prove impossibility.

Albrecht Tr. at 58-59.  Then the some other justices got into the discussion, after plaintiffs tried to have it both ways, with the remarkable statement that “the warning that the FDA has to reject has to be adequate to address the risks under state law.”  Id. at 59.  Then was what the FDA had to do a legal question (for the judge) or a factual question (for the jury)?

JUSTICE KAGAN: . . . But that’s the question. And that’s a legal question, is that correct?

[Plaintiffs’ Counsel]: It is a legal that question, but it has factual components.

JUSTICE KAGAN: But a judge can decide that question.

[Plaintiffs’ counsel] : A judge can decide the core legal question, but in all constitutional questions, there are usually fact issues, and we consign those to juries to decide what the fact issues….

JUSTICE BREYER: Not always. There are a lot of mixed issues where, because they’re predominantly legal, the judge does it; patents, for example, Markman [v. Westview Instruments, Inc., 517 U.S. 370 (1996)] is a case of that, and does coerced confessions. I mean, there are a number. . . .  It seems to me that this is in that number because it’s predominantly a legal question and there could be factual disputes on the brute [sic] facts. But, here, I don’t think there are really.

Id. at 59-60 (plaintiffs’ counsel’s attempt to get a word in edgewise omitted). If, in the end, both Justices Kagan and Breyer are skeptical of the idea of preemption/FDA actions as a jury question as they seemed at the oral argument, then the defendant will prevail on this issue as well.

Finally, we’d be remiss not to mention the plaintiffs’ “swing and a miss,” where counsel missed a softball from Justice Sotomayor so badly that the Justice had to provide the right answer:

JUSTICE SOTOMAYOR: Well, we know that the FDA − assuming the theory that the FDA doesn’t believe the label is adequate, what could they have done −

[Plaintiffs’ Counsel]: They could −

JUSTICE SOTOMAYOR:   − absent the study?

[Plaintiffs’ Counsel]: They –

JUSTICE SOTOMAYOR: Meaning because the study obviously changed the FDA’s mind. You’re saying, you, [defendant], could have done it.

[Plaintiffs’ Counsel]: Yes. . . .

Albrecht Tr. at 57.  When that happened to Rick Perry, his response was “Oops.” At least counsel recovered to answer the question more thoroughly.

Justice Ginsburg was absent, and Justice Thomas, as usual, asked no questions.  The usual split would have Justice Ginsburg voting against preemption and Justice Thomas voting for it.

Anyway, we’re not in the business of predicting Supreme Court results. But all in all, after the oral argument, I’d much rather be on our side than not.

A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff’s claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff’s proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber’s deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit’s recent affirmance of the district court’s decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff’s claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff’s two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have “thought twice” and would have been “much more thoughtful” about prescribing Avandia and would not have prescribed the drug to the plaintiff “in the middle of all these heart attacks” if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff’s heart attacks, not “in the middle” of them, and (b) for the prescriber to say he would have been “much more thoughtful” and would have “thought twice” about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that “the vague and highly speculative nature” of the prescriber’s testimony “suggests no concrete action and it is tied to hypothetical knowledge in 2003.” That is an important ruling, because it is exactly that sort of general, speculative, might’ve-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed “inevitable.” The Third Circuit saw it the same way.

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.