We’ll get to today’s case in a moment, but first, a few words about SCOTUS and expiration dates.

 
One hundred and one years ago tomorrow saw the birth of Lewis Powell, who served as a United States Supreme Court Justice from 1972 to 1987.  Powell succeeded Hugo Black.  More interesting, considering current events, is that Powell was succeeded by Anthony Kennedy. Whether Judge Brett Kavanaugh succeeds Justice Kennedy is a matter of some some controversy.  One reason for that controversy is that Justice Kennedy was often a swing vote.  In a prior post, we recounted our one close encounter with Anthony Kennedy.  He impressed us a smart jurist who was determined to do the right thing.  Still, it must have seemed somewhat vexing to SCOTUS litigants that everything likely turned on the predilections of one Justice.  The other eight Justices often seemed predictable, almost a done deal.  But Justice Kennedy, at least on some issues, was the wild card.  We have no evidence that Justice Kennedy purposely positioned himself as the swing vote, or that he reveled in his inflated importance, but his importance as a swing vote was undeniable.
 
We have also seen no evidence that Justice Kennedy patterned himself after his predecessor, but it is remarkable how similar they were in locating themselves right at the center of the Court.  Justice Powell was often a swing vote.  If our affirmative action jurisprudence is a bit of a mess, some of the blame for that must go to Justice Powell, whose controlling opinion in the 4-1-4 landmark Bakke decision created a slippery standard that sprung from Powell’s idea of the perfect academic affirmative action program – the Harvard College admissions system.  Even back in 1978, it was pretty obvious that the Harvard system was not quite the holistic, individual-respecting scheme that Powell portrayed. (The legal defense of U.Cal Davis Medical School’s affirmative action program was entrusted to the great Archibald Cox.  During oral argument, Justice Blackmun asked whether the set-aside seats could be compared to athletic scholarships.  Cox replied, “Well, I’m from Harvard … “ – laughter intervened – “I don’t know whether that’s our aim, but we don’t do it very well.”)  Given the current lawsuit challenging Harvard admission policies, the Bakke compromise and its progeny seem even more fragile.  

The story of how Powell came to be appointed to the High Court was told in Bob Woodward’s book, The Brethren. (We hear Woodward has another book out.)  President Nixon was politically hobbled in 1972.  In trying to fill an earlier SCOTUS vacancy, Nixon had two of his selections rejected by the Senate.  Powell was an interesting choice.  He was from Virginia, which fit in with Nixon’s southern strategy.  But Powell would not fit into what we now consider the usual mold.  He had never been a judge. (Black had been a senator, not a judge.  Chief Justice Warren had also been a politician.  Douglas headed the SEC. It used to be acceptable for Justices not have to have a judicial track record.  Why the change?). Powell was a corporate lawyer. He represented the tobacco industry. He was a leader in the ABA.  He wrote a famous memo about how corporate America should deal with a hostile media.  There were plenty of reasons why Nixon would have liked Powell.  But there was one important reason why Powell would be acceptable to Senators who weren’t enamored with Nixon: Powell was 64 years old.  Woodward reported that a Senator waved a cigar and told Powell why he would be confirmed: “We think you’re going to die.”  (Powell himself was not all that fired up to join SCOTUS.  He had turned down an earlier offer.  He did not think he had the constitutional law chops of a Douglas, Black, or Brennan.  Plus, he was not eager for the huge pay cut.)

Recently John Oliver’s Last Week Tonight show argued for eliminating life tenure for judges.   Oliver supported a proposal for staggered 18 year terms.  (Powell served 15 years on SCOTUS.)  Every four year presidential term would include an opportunity to appoint at least two SCOTUS justices.  The system would permit reasonable turnover.  It would avoid the dangers of a gerontocracy.  It might somewhat reduce the temperature of SCOTUS confirmation hearings, since there wouldn’t be a multigenerational impact at stake.  Such a change would require a constitutional amendment.  Spoiler alert: it won’t happen.  But while we’re just dreaming, we have another reason for cuddling up to this idea.  When presidents harbor the hope of appointing a Justice who will support certain policies/rules for thirty years, that means they will select relatively young people.  That elevate-them-when-they-are-young approach also offers the advantage of proffering someone with a limited paper record and a limited target area for skeptical senators. Thus, instead of a SCOTUS appointment being the capstone of a long, distinguished career, it is more and more conferred on jurists in mid-career.  As we slouch toward dotage, we less and less like the idea of such important jobs going to juveniles.  Frankly, we hate seeing presidents and Supreme Court Justices younger than ourselves.  It is an annoyance almost as painful as being forced by some website to enter our birth year in a drop down menu, and scrolling down and down.  And down. 
[Quick quiz: Which Supreme Court Justice served the longest term?  Answer below.]

Why are we pondering these issues at this moment?  Obviously, the ongoing Kavanaugh kerfuffle is top of mind.  We also find ourselves ruing life tenure when we read a judicial decision that seems gruesomely wrong-headed.

And now we get to today’s case.  
 
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In Sumpter v. Allergan Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), the plaintiff brought suit over ruptured silicone breast implants.  The implants were premarket approval (PMA) medical devices.  As the Sumpter court acknowledges, the Medical Device Amendments Act “preempts claims challenging the safety and effectiveness of … PMA devices.”  Federal law dislodges any state laws (including via jury verdicts) that are “different from, or in addition to, any requirement applicable under [federal law].”  In the face of this rather clear preemption, the plaintiff in Sumpter ditched her design defect and failure to warn claims.  All that was left was the claim for manufacturing defect.  And here begins the Sumpter court’s descent into sheer awfulness.  As a preliminary matter, the Sumpter court tells us that, “[g]enerally, manufacturing defect claims that allege the ‘manufacturer failed to adhere to the specifications imposed by a device’s PMA’ are not preempted at the pleading stage.”  That quote is from the 2009 Hofts decision out of the Southern District of Indiana.  More than once, this blog has derided Hofts for its mangling of Riegel and Twombly and Iqbal.  Hofts made our list of the ten worst decisions of 2009.  Most courts that have considered Hofts have rejected it.  But not the Sumpter court.  If anything, Sumpter manages to multiply Hoft’s errors.  First, the plaintiff, as is all too typical, never comes close to specifying what the manufacturing defect was.  Second, the Sumpter court’s standard for assessing what constitutes a manufacturing defect is altogether wrongheaded.  A manufacturing defect happens when the product is out of spec from its design,  Something about the particular product is different from a product that is manufactured correctly.  Maybe something is in there that shouldn’t be, or something is missing.  Ot a component was flawed.  But that is not the Sumpter court’s test.  No, the Sumpter court concludes that a claim for manufacturing defect will lie when plaintiffs say that the products differed from the “intended result.”  What does that mean?  Presumably, a case was brought because someone was injured.  That is never the “intended result.”  Does “intended result” end up requiring a perfection that exists nowhere in the law, on any assembly line, in any product portfolio, or, indeed, on our planet? Moreover, the mere existence of a malfunction cannot, by itself, give rise to an inference that the manufacturer violated the FDCA.  Where is there any basis to invoke the infernal Riegel “parallel violation”?  Through the Sumpter looking-glass, every product liability case contains a manufacturing defect claim destined for a jury.  
 
The closest the plaintiff came to articulating a semi-specific manufacturing defect claim was an allegation of “material fatigue.”  Was there any hint in the case that the materials in the implants at issue were in any way out of spec, or different from the norm?  Nope.  Rather, the plaintiff “extrapolated from the injuries” that “there must have been a manufacturing defect.”  Goodbye TwIqbal.  Goodbye whatever is the relevant state law on manufacturing defect.  Hello, new-fangled res ipsa loquitur theory, even though the Sumpter court never uses those magic Latin words.  Under the Sumpter court’s reasoning, once one claims injury from a product, there’s a manufacturing defect that is immune from a motion to dismiss.  (Unless, one supposes, one is in an outlier case where the product was intended to inflict injury.  And then, surely, there is another legal claim at hand.)  The Sumpter court has defectively manufactured a tort claim that, by all rights, should be dismissed based on well-established, clear SCOTUS precedent.
 
The only consolation is that, as we have pointed out many times before, manufacturing defect claims are hard to win.  The odds are long against the likelihood that the plaintiff will ever demonstrate a true manufacturing defect.  Then again, erroneous jury instructions could wreak havoc in favor of even an empty claim, and how can we predict that won’t happen?
 
Justice Powell once said that history “teaches us tolerance for the human shortcomings and imperfections which are not uniquely of our generation, but of all time.”  Tolerance, indeed.  Plus, unlike with SCOTUS, the Sumpter court might some day get reviewed by a higher court.  And then there is the highest authority of all: the DDL blog ten-worst list at the end of this year.  
[Answer to question:  William O. Douglas sat on the High Court for 36 years and 211 days.  He was confirmed at the age of 40.  The judge we clerked for had clerked for Douglas, and could never utter WOD’s name without a growly follow-up along the lines of “…that bastard.”  Apparently Douglas, while being brilliant and charismatic, was not always very nice.]

Although they have nothing to do with the Affordable Care Act, health-care-related so-called “death panels” do exist.  These panels are operated by state agencies and private health insurance companies, and they decide whether to reimburse as “medically necessary” (or some similar definition) any type of medical care that comes into question.  They’re an unfortunate necessary – quackery should not be reimbursed.  But such panels used to reject any form of off-label use, until states and the federal government passed laws and regulations telling them that they couldn’t.  As we’ve explained elsewhere, off-label use can frequently represent the medical standard of care.

But in Harborth v. State, ex rel. Dep’t of Workforce Services, ___ P.3d ___, 2018 WL 4011635 (Wyo. Aug. 22, 2018), we ran into one of the limits to those protections – and to off-label use – that we haven’t seen in a published opinion in quite some time.  Something isn’t “off-label” when there is no FDA-approved label at all. The Wyoming Supreme Court affirmed a coverage denial of therapy involving the implantation of a medical device that had never been approved by the FDA for labeling and marketing for any intended use whatsoever.

How could that happen?

The FDA only regulates prescription medical products in the United States.  In Harboth, the claimant had a history of chronic back problems.  Ultimately the state worker’s compensation panel approved a rather expensive and involved surgical procedure:

a foraminotomy at L4-5 and transforaminal lumbar interbody fusions (TLIF’s) at both L5-S1 and T12-L1.  [Claimant] testified that [the recommended] surgery would cost approximately $400,000.

2018 WL 4011635, at *1.

Before agreeing to cover this surgery, the state required “two peer reviews.”  Id.  That took some time, and in the interim, the claimant got cold feet.  Id. at *2.  She was also in “excruciating pain” waiting for worker’s comp. to make up its mind.  Id. at *3.  The claimant investigated various treatments for her condition online, and learned about “artificial disc replacement surgery using the ‘M6’ artificial disc.”  Id. The surgeon who performed this procedure was in Germany.  The claimant crossed the pond and had the surgery.  Not only was it “successful,” but it cost a fraction of the $400,000 that the “death panel” was prepared to pay for the other type of surgery.  Id. at *4 (surgery was “appeared to be a success”), *10 (“surgery cost[] $340,000 less than [the initially proposed] procedure”).

The state’s version of a “death panel” nonetheless “denied compensation for the surgery, finding that it was not reasonable and necessary medical treatment.”  Id. at *3.

Why?

Because it could. The relevant reimbursement guidelines authorized payment for “off-label use,” but the M6 device had only received governmental approval for use in the European Union, and not from the FDA. Id. at *3 (“there has been no United States FDA approval of the M6-L disk replacement system”).

If the surgery had really been “off-label use” (ironically, a basis for the denial of the claim by the panel), then the claimant may have had a chance:

Rules recognize optional approaches to verifying that a procedure or device lacking FDA approval is reasonable and necessary. . . .  For “off-label use of medical services,” the health care provider must submit a comprehensive review of the medical literature supporting the off-label use, including “at least two (2) reliable prospective, randomized, placebo-controlled, double-blind trial[s].”

Harborth, 2018 WL 4011635, at *5 (citations to various rules omitted).

But the procedure had to involve “off-label use” in order to fit under these rules.  “‘Off-label use of medical services’ is defined as:  ‘Medications, treatments, procedures or other medical services used for other than the approved Food and Drug Administration (FDA) indications.’  Id. at *6 (citation and quotation marks omitted).  Off-label use is OK:

[O]nce the FDA has cleared a device for introduction into the stream of commerce, physicians may use the device in any manner they determine to be best for the patient, regardless of whether the FDA has approved the device for this usage.  This practice by physicians is known as “off-label” usage.

Id. (citation and quotation marks omitted).  But for the use of a device to be “off-label,” that device must first have been approved for marketing and labeling by the FDA for something.  The M6 wasn’t:

“[O]ff-label” medical service [i]s one that deviates from a use that has been approved by the FDA. . . . Under . . . the Division Rules, the plain definition of “off-label” use does not encompass the surgical implantation of an M6 artificial disc adjacent levels. The M6 artificial disc is not approved for any use by the FDA.  Thus, there is no “label” from which a medical provider may deviate.

Id. (citations and quotation marks omitted) (emphasis added).

Because the rules and regulations under which the state’s workers compensation system operated were “clear and unambiguous” in defining off-label use, nothing else mattered.  It didn’t matter that the claimant appeared to have a better prognosis (she returned to work, which was questionable under the other surgical alternative).  It didn’t matter that the surgical option the claimant pursued saved the state hundreds of thousands of dollars.

[Claimant] urges us to consider the success of her surgery as documentation of its safety and effectiveness. . . . [I]t may be tempting to weigh the actual outcome of surgery into the determination of compensability. Because [she] underwent surgery costing $340,000 less . . . and returned to her previous work duties with no restrictions and no pain medication, the evidence of her outcome is especially compelling. However, . . . it would be unreasonable to view the outcome of a medical procedure as a factor that trumps all others. [The] . . . Rules do not award compensation for medical treatments only if they are “successful” . . .; instead, in order to receive medical benefits, a claimant must show that his treatment is “reasonable and necessary.” A patient might fail to respond to reasonable and necessary medical treatment; and, likewise, a patient may benefit from elective, “unnecessary” medical treatment.

Id.  Anecdote, unfortunately for this claimant, is not data.  “A claimant’s successful surgery is only a single instance of success, and is not a substitute for objective and verifiable medical data demonstrating the procedure’s overall record for safety and effectiveness.”  Id.

It’s been a long time since we’ve seen a court draw this distinction.  In Gaston v. Hunter, 588 P.2d 326, 330 (Ariz. App. 1978), the court held that informed consent rules applicable to off-label use do not apply to an “experimental” medication that had not yet received FDA approval for anything, and was still under clinical investigation.  Similarly, in Retkwa v. Orentreich, 584 N.Y.S.2d 710 (N.Y. Sup. 1992), it was not off-label use to employ “liquid injectable silicone” in surgery where the material was not being sold as a medical device at all (a prior opinion in the same case called it “non-medical grade”).  “It is a reasonable assumption that most patients, confronted with a doctor’s recommendation for injection of a foreign substance, presume that such substance has been the subject of official testing, consideration, and approval.”  Id. at 712 n.6.

Whatever ones opinion of the third-party payor would-be “death panels,” and whether or not the “ends” in Harborth should have justified the means, the decision is a reminder that not everything that doctors do with FDA-regulated prescription medical products fits neatly into the two categories of “labeled use” (called “intended use” by the FDA) and “off-label use.”  With the Internet making ever more medical information (and disinformation) available without regard to national borders, we would not be surprised to encounter more cases where the distinction drawn in Harborth is relevant.

We have always had a soft spot for zebras.   They are the equine world’s version of some of our favorite acquaintances — the ones who always dress a little outlandishly and always stand out from the crowd. (Fun facts:   1. Although most zebras have black stripes on a white background, a white-on-black specimen shows up every now and again.   2. All zebras have dark-pigmented skin under their coats, and the stripes are only hair-deep. Compare Dalmatians, whose spots are visible on their skin from the birth, though the spotted fur comes later.)   Zebra fondness aside, we often find ourselves, in our ongoing occupation of the mass tort space, arguing that plaintiffs hearing hoof-beats should have thought “horses,” not “zebras.” Less obtusely, we mean that judges should apply the discovery rule correctly and should hold that suits are time-barred when plaintiffs with adequate information fail to make obvious causal connections within the correct limitations period.

That is why we were so happy to read today’s case. We rarely report on statute-of-limitations decisions, but Adams v. Zimmer, 2018 U.S. Dist. LEXIS 136707 (E.D. Pa. Aug. 14, 2018), is a worthy exception.   In Adams, the plaintiff underwent surgery to replace her right hip joint, and was implanted with the defendant’s prosthetic hip, in January 2011. Eight months after surgery, in September 2012, she began experiencing pain in the region of the artificial hip. When the pain didn’t abate, the plaintiff’s doctor performed blood tests to test her metal ion levels because there had been reports of adverse local tissue reaction to the metals used in the artificial hip. There was no definitive diagnosis at that time, but the plaintiff’s doctor testified that, by February 2013, he informed the plaintiff that the prosthetic hip might be causing her symptoms.

The plaintiff dislocated her right hip in November 2014.   She testified in deposition that she knew that the prosthetic hip had dislocated and that this was “abnormal.” On January 7, 2015, her doctor noted in his records that he recommended “further investigation of the right hip,” and that the plaintiff might require surgery to replace the femoral head. 2018 U.S. Dist. LEXIS 136707 at *9. In deposition, the doctor testified repeatedly that he had informed the plaintiff of his recommendation and of the possible need for revision of the artificial hip. Testing performed on January 12, 2015 confirmed a tissue reaction to the artificial hip, and, by January 30, 2015, the plaintiff had decided to proceed with hip revision surgery. In her deposition, she testified that she understood that the surgery would involve replacing the defendant’s device with a new prosthesis. She underwent surgery on February 12, 2015 and filed her complaint on February 10, 2017. The defendant moved for summary judgment, arguing that Pennsylvania’s two-year statute of limitations barred the plaintiff’s claims.

The plaintiff argued that she “did not make the factual connection” between her injury and the defendant’s device until the date of surgery.  Id. at *20. If this were true, then she would have beaten the statute by two days. But the judge wasn’t buying it. Explaining that “as soon as, through the exercise of reasonable diligence, the injured party should be able to link her injury to the conduct of another, the clock begins to run,” id. at *23-24, the court held that the plaintiff “knew or should have known that the [defendant’s device] was a factual cause of her injury by the time she decided to proceed with hip revision surgery on January 30, 2015.” Id. at *26. In other words, “once [the plaintiff] knew for certain that [her doctor] needed to remove the [device], she had received enough facts to make the connection between her injury” and the device, and “no reasonable juror could conclude otherwise.” Id. at *27. Nor was the court swayed by the plaintiff’s argument that, even if she knew that the device was causing her symptoms, she did not know it was “defective” until it was removed. The court emphasized, “This misstates the legal standard,” which required only that the plaintiff connect her injuries to the device to start the clock running on her claims. Id. at 31. Finally, while the court acknowledged that the plaintiff hadn’t missed the running of the statute by much, and that granting summary judgment would deny the plaintiff recourse for serious injuries, it held that it could not “arbitrarily enforce the statute of limitations,” however sympathetic the plaintiff, and that it was “constrained to grant the motion for summary judgment.” Id. at *33-34.

We have been on the receiving end of all of the arguments the plaintiff made in Adams. And we have fought – not always successfully – for decisions that apply the law rigorously and aren’t swayed by sympathy. We are pleased that the Adams court did just that.

We sometimes sit around trading stories about the dumbest lawsuits we have ever seen. Our personal favorite is a class action that the Drug and Device Law Spouse defended years ago seeking damages against a national shipping company because items sent by “Second Day Air” did not always go in an airplane.  The packages arrived as promised, but the plaintiffs were shocked, shocked to learn that items sent from San Francisco to Palo Alto were carried in an ordinary (and Earth-bound) truck.  There is also the one about the guy who sued his dry cleaner for $67 million after the cleaner lost his pants.  It was reported that the cleaner showed up in court and tendered the trousers—cleaned and pressed.  The plaintiff was unimpressed.

Many cite the famous McDonald’s coffee spill case of the 1990s as a dumb and frivolous lawsuit, but at least that plaintiff suffered a serious injury—third degree burns that required skin grafts and an extended hospital stay. It was uncontested that the coffee drinker had standing to sue, regardless of what you think about the ultimate allocation of fault.

We cannot say the same for the plaintiff in a class action that an MDL judge in New Jersey dismissed last year for lack of standing, which the Third Circuit has now affirmed. In In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Liability Litigation, No. 17-2980, 2018 WL 4225028 (3d Cir. Sept. 6, 2018), the plaintiff used the defendants’ talcum powder, which worked exactly as it was supposed to without any ill effect.  She did not allege any defect in the product; she did not allege any injury or disease; she did not allege any increased risk of injury or disease; and did not allege any fear of developing any injury or disease in the future. Id. at *2.  She also allegedly used up the product. Id. In other words, there was no durable good or remaining product that she claimed she could not use.  Whatever she purchased, she used it until it was gone. Id.

What a frivolous lawsuit that no intelligent and scrupulous lawyer ever should have filed, right? Well, not exactly.  The district court’s order dismissing the case and the Third Circuit’s opinion affirming that result are clearly correct.  And, “frivolous” is probably a fair description.  Be that as it may, this class action was not a random misfire conceived in the minds of attorneys who didn’t know any better.  This class action was a deliberate and calculated attempt to test the limits of Article III standing and to stretch even further the wrongly decided opinion on standing in Cottrell v. Alcon Laboratories, the Third Circuit opinion that we ranked as the fourth worst drug and device decision of 2017.  That was the opinion where the Third Circuit held that purchasers of eye drops had standing to sue, even when the product labeling was indisputably accurate and the product worked exactly as expected.  How then did the eye drop purchasers suffer any compensable injury?  The bottle dispensed drops that were too big, allegedly resulting in the users paying more than they should have.  We are being charitable in our description of Cottrell.  In fact, the allegations of injury there were too speculative to support standing, as other another Circuit has found and as we have explained here, here, and here.

But at least the plaintiffs in Cottrell attempted to plead an economic injury.  The plaintiff in the J&J Talcum Powder case wanted to take Cottrell one step further by establishing standing to sue while affirmatively pleading no injury at all.  She and her lawyers lost.  The plaintiff in J&J alleged that she suffered an economic injury because, had she been informed that using baby powder could lead to an increased risk of ovarian cancer, she would not have purchased the powder in the first place. Id. at *2.  In other words, she had buyer’s remorse and sincerely wished she had not purchased the product after she consumed it with no harm or worry. Id. at *1.

Those facts did not allege an economic injury. As the Third Circuit explained, there are generally three ways to plead an economic injury.  A plaintiff can allege an “alternate product theory” by alleging that, but for the defendant’s conduct, he or she would have purchased an alternative, less expensive product.  A plaintiff can also allege a “premium price theory,” under which he or she claims that wrongful advertising of a product as “superior” induced the plaintiff to pay an unfair premium.  Finally, a plaintiff can allege that he or she was deprived of the “benefit of the bargain” and did not get what he or she paid for.

The plaintiff’s allegations missed all of these theories. She did not allege that any cheaper alternative existed, and she did not identify any unlawful “premium” paid for her powder. Id. at *2-*3.  As for the “benefit of the bargain,” she alleged only that she was promised that the baby powder was “safe,” when it allegedly was “unsafe” because of an increased risk of ovarian cancer. Id. at *3.

Let’s keep one thing straight. We do not believe there is any reliable scientific evidence that talcum powder can cause ovarian cancer, and we reported on a California court finding exactly that here.  But even taking the plaintiff’s allegations as true, conclusory allegations of purchasing an “unsafe” product did not establish an economic injury sufficient to support Article III standing.  Distinguishing Cottrell, the Third Circuit held that “a plaintiff must do more than offer conclusory assertions of economic injury in order to establish standing.  She must alleged facts that would permit a factfinder to value the purported injury at something more than zero dollars without resorting to mere conjecture.” Id. at *4.

Having used the product, and having failed to allege any injury or even an increased risk or fear of injury, the plaintiff did not have the facts. So what did she offer instead?  A promise of “models for calculating damages and restitution that are linked to her theory or relief and are based on the evidence in the case.” Id. at *6.  Aha, the experts will take care of it all in “models.”  Forgive us for being skeptical, but also give the Third Circuit credit for insisting that a plaintiff still must allege facts:

[E]ven at the pleading stage, a plaintiff must set forth sufficient factual allegations that, if proven true, would permit a factfinder to determine that she suffered at least some economic injury.  . . .

[Plaintiff] fails to allege even that the Baby Powder provided her with an economic benefit worth one penny less than what she paid. We must, therefore, conclude that she received the benefit of her bargain and has suffered no economic injury.

Id. at *7.  The Third Circuit also ruled that an alleged increased risk to others did not count because the plaintiff’s “references to Baby Powder being unsafe to others are not relevant to determining whether [she] has standing herself.” Id. at *8 (emphasis in original).

The Third Circuit found the plaintiff lacked standing to sue for restitution and injunctive relief for similar reasons: Her restitution claim rested on mere conjecture, and her claim for injunctive relief made no sense because she was not at risk of suffering an economic injury.  We don’t blame the plaintiffs’ lawyers for trying to stretch Cottrell beyond the breaking point, but in the end they did not succeed.  The Third Circuit summed it up this way:  “[Plaintiff’s] wish to be reimbursed for a functional product that she has already consumed without incident does not itself constitute an economic injury within the meaning of Article III.”  Amen.

This isn’t the first time we’ve written about the Hyde case in the Bard IVC Filters MDL.  Back in July we reported on some pretrial rulings in that bellwether case.  Get ready for more.  The decision on tap for today, Hyde v. C.R. Bard, Inc., 2018 WL 4215028 (D. Arizona Sept. 4, 2018), is sort of a man-bites-dog item, as it involves a motion in limine by the plaintiffs to exclude warnings information.  Generally, we on the defense side are the ones arguing to keep prejudicial information out, so the posture of Hyde is interesting.  Just in case you haven’t committed the facts of Hyde to memory, here’s a refresher:  Mrs. Hyde received an IVC filter implant in 2011.  Three years later, she learned that the filter had tilted, perforated the IVC wall, and fractured.  The plaintiffs brought a lawsuit sounding in various theories.

[Interlude for discovery.  Interlude for motion practice.]

Applying Wisconsin law, the Court granted summary judgment on the failure to warn claims. (As we reported back in July, the plaintiffs proffered no evidence that a different warning would have inspired the doctor to employ a different device or do anything differently.)  That ruling left claims for strict liability design defect, negligent design, negligence per se, loss of consortium, and punitive damages.  In advance of trial, the plaintiffs filed a motion to exclude the device’s instructions for use (“IFU”) and certain guidelines published by the Society of Interventional Radiologists (“SIR”).  Usually, plaintiffs love to trot out the IFU and point out offending lacunae. What’s different here?

The plaintiffs argued that because the failure to warn claims had been dismissed, the instructions and warnings set forth in the IFU were no longer relevant to any issue in the case and should therefore be excluded.  Similarly, the plaintiffs argued that the SIR guidelines, which evinced the knowledge of IVC filter complications in the medical community, were no longer relevant in the wake of dismissal of the failure to warn claims.  According to the plaintiffs, design defect must be tested against consumer expectations, and the IFU and SIR guidelines play no role with respect to such consumer expectations.   Plainly, the plaintiffs wanted the IFU and SIR guidelines out.  The defendants wanted them in.   We’re guessing the IFU warnings must be quite clear and that the SIR guidelines must be quite helpful for the defense.

Luckily for the defendants, Wisconsin law was quite clear and quite helpful for them.  In 2011, the same year as the plaintiff’s implant, the Wisconsin legislature enacted tort reform that included adoption of  section 2 of the Restatement (Third) of Torts (1998).  (We wrote about the cheesehead tort reform here.)  Section 2 employs a risk-utility balancing test and consideration of a broad range of factors, including the instructions and warnings accompanying the product.  Consumer expectations are in that broad range of factors, but no longer make up the whole ballgame. They definitely are not a basis for excluding information otherwise relevant to safety.

Under post-2011 Wisconsin law, a jury must consider not only whether there was a reasonable alternative design, but also whether a failure to adopt that design rendered the filter “not reasonably safe.”  Can the IFU and the SIR guidelines help a jury answer that question?  Almost certainly, yes.  The SIR guidelines lay out the acceptable rates of risk in IVC filters. Thus, they are relevant to the jury’s determination of whether the filter was reasonably safe.  The IFU tells physicians about risks of the filters and how to mitigate them.  That information, too, is relevant in determining whether the filter was reasonably safe.  The defendants are free to argue to a jury that the warnings provided with the filter “disclosed the risks of complications, that the medical community was aware of those risks and found them to be acceptable, and that the omission of an alternative design therefore did not render the filter ‘not reasonably safe.’”

Moreover, the IFU and SIR guidelines are relevant to the plaintiffs’ punitive damages claims.  The plaintiffs will surely try to persuade the jury that the defendants acted with “malice.”  But what the defendants, via the IFU,  told physicians about the device’s risks is relevant to whether the defendants acted with “intentional disregard for patient safety.”   The SIR guidelines are relevant to the defendants’ “awareness of filter complication rates and the extent of harm posed by filter complications, and can also inform the jury of risk levels found acceptable by interventional radiologists – a relevant fact for deciding whether Defendants ‘acted with a disregard for patient safety.”

We began this post by remarking how odd it seemed that it was the defense that wanted warnings information in, and the plaintiffs that wanted it out.  It also seems a bit odd to us that it is the plaintiffs who are insisting on a strict line of demarcation between different tort theories (failure to warn vs. design defect), and the defense who treat the line as kind of fuzzy.  But we’ve seen something like this before.  You needn’t strain your memory too much to recall how in the Bartlett case the plaintiff tried to evade preemption by arguing that the case was only about design defect and that failure to warn was out of bounds.  The defense demonstrated that there were aspects of the design defect claim that were implicated by preemption principles.  The result was a resounding defense SCOTUS victory that many of us are trading heavily on today and expect to do so for a good long while.

“Thinking out of the box” has become a hackneyed phrase, but sometimes it is perfectly accurate.

 

 

One of our primary goals is to bring you the latest and greatest news in the drug and device litigation world. But sometimes we don’t learn of a case at the time it’s decided. So, then we need to move on to another of our guiding principles – if it’s good for the defense, we talk about it. So, while today we happen to have come upon a case that was decided in 2017, it dovetails with our recent post Taking Out the Laundry With TwIqbal where we talked about plaintiffs’ attempts to bluff their way to a valid parallel violation claim. And that’s exactly what the plaintiff in Rand v. Smith & Nephew, Inc., 2017 WL 8229320 (C.D. Cal. Apr. 5, 2017) tried to do. Plaintiff put together a “laundry list” of allegations that the defendant’s device violated with no hint of what exactly the defendant did that was in violation. In our prior post we commented that “most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.” Fortunately, Rand can be added to that list.

The device at issue in Rand is a hip resurfacing prosthesis that underwent pre-market approval from the FDA. That’s why we are talking about parallel violation claims. Following a nice Riegel analysis, the court looked at plaintiff’s allegations for each cause of action.

Strict liability: Under California law, this is a claim for a design, manufacturing and warning defect. Because the FDA reviews “device design, manufacturing processes, and device labeling” as part of the PMA, “the MDA preempts state-law claims against these three aspects of PMA-compliant devices.” Id. at *4. So, plaintiff made 2 laundry lists – one of “various federal regulations” and another of defendant’s alleged misconducts. Double the nonsense.

First, plaintiff included regulations that go to the adequacy of defendant’s PMA application. “But FDA’s approval demonstrates the agency’s reasonable assurance of [the device’s] safety and effectiveness based on the application.” Id. So any claim premised on those regulations is preempted. Second, the court moved on to TwIqbal finding some allegations so poorly pleaded that it is “impossible to determine whether they add to federal requirements and hare hence preempted.” Id. Finally, some allegations were completely conclusory.

Plaintiff’s second list wasn’t much better. Not only did it include conclusory allegations – basically just speculation – but plaintiff also included alleged misconduct that was irrelevant. For example, plaintiff alleged wrongdoing regarding device components used in off-label combinations but plaintiff was implanted with such a combination. In other words, plaintiff was tossing pasta at the wall and just hoping something stuck. That’s not good enough under TwIqbal.

The only allegation that made the cut was failure to report adverse events. Id. This is California, so it’s to be expected.

Negligence: This largely mirrors plaintiff’s strict liability claim and suffers the same fate. The only new “misconduct” included in the negligence count was about defendant’s withdrawal of the device for “demographics groups” to which plaintiff didn’t belong. Irrelevant. Id. at *5. And, plaintiff surmised that defendant’s breach proximately caused his injury but provided no support for that allegation. Id. The entire negligence claim was dismissed.

Breach of express warranty: Again, most of plaintiff’s allegations are insufficient:

Without more details, the statements that [defendant’s] devices are of merchantable quality, safe, effective, and fit and proper for its intended use are no more than an affirmation merely of the value of the goods or a statement purporting to be merely the seller’s opinion or commendation of the goods. Such unspecific statements do not create a warranty.

Id. (citation and quotation marks omitted). The court did find that a press release cited by plaintiff created an express warranty but plaintiff failed to allege how the press release violated any PMA requirement. Without that, the claim was dismissed without prejudice.

Breach of implied warranty: This claim was preempted:

Both types of implied warranties involve an assertion that the goods are fit for then intended purpose. Implied warranty of merchantability further imposes labeling requirement and requires that the goods conform to the statements on the label. But these conditions are precisely what a PMA entails. Thus, unless the defendant violates these conditions under the PMA, § 360k(a) expressly preempts this claim.

Id. at *6 (citation omitted). Since plaintiff used the device for the purpose the FDA approved – no breach of implied warranty claim.

Fraudulent concealment: Here again plaintiff attempts to rely on a failure to report adverse events to state his claim. But essential to a fraud claim is that defendant had a duty to disclose the concealed fact to plaintiff. Id. We think this negates failure to report as a basis for strict liability as well and we’ve made our views on that clear many times. Here, plaintiff didn’t allege that federal regulations require defendant to report adverse events to plaintiff – nor can he because that’s not the law. That means that this would be an “additional requirement” which is preempted. Id..

The claim also failed for no allegation of intentional concealment by defendant and for not satisfying Rule 9(b)’s heightened pleading requirement for fraud. Id.

It may not be the latest and greatest, but it adds to the wealth of decisions tossing plaintiffs’ multi-paragraph list of violations which are a lot more bark than bite.

In the early days of the Blog, in 2009, when Bexis and Mark Herrmann were operating in relative obscurity, we posed the question whether it was ethical to remove to federal court a case that may well be non-removable and hope that opposing counsel is “asleep at the switch”:

“Heck, I’ll remove it anyway.  Opposing counsel may be asleep at the switch and not file a motion to remand within 30 days.  If plaintiff doesn’t timely move to remand, the objection to removal is waived, and my case can be tried to judgment in federal court.”

Is that ethical?

We received one response, which we discussed, that an:

attorneys’ first obligation should be to the integrity of the legal system, and not to their clients’ interests.  Even so, I’m not sure I’d say ‘no’ to either question, given that a yes answer means that incompetent attorneys who don’t realize they are violating the rules would have an advantage over competent attorneys.

With that the issue dropped off the radar.

That question returned to our minds when we researched our recent post on removal before service.  We came up with case after case holding that the so-called “forum defendant” rule was waivable, not jurisdictional, and thus that failure to move for remand in a case that featured complete diversity of the parties – but a defendant located in the forum state – was waiver so that the case stayed in federal court.  That means if a defendant is savvy enough to remove before service in accordance with the express terms of 28 U.S.C. §1441(b)(2), and opposing counsel is, as we said before, “asleep at the switch,” the removal succeeds regardless of a court’s substantive views on removal before service.

For example, in one of our removal before service cases, Selective Insurance Co. v. Target Corp., 2013 WL 12205696 (N.D. Ill. Dec. 13, 2013), the court held:

Plaintiff asserts §1441(b) (2) − the “forum defendant rule” − as a basis for remand, arguing that because defendant . . . is an Illinois citizen, removal was improper.  This rule is statutory, not jurisdictional, and thus may be waived or forfeited.

Id. at 1 (citing Hurley v. Motor Coach Industries, Inc., 222 F.3d 377, 379 (7th Cir. 2000)).  The cited Hurley decision held just that:

We must decide, therefore, whether the forum defendant rule is jurisdictional, in the sense we have been using the term, or if it is of a lesser status.  That question has been bouncing around the federal courts of appeals for more than 75 years, yet oddly enough it remains unresolved in this circuit.  The overwhelming weight of authority, however, is on the “nonjurisdictional” side of the debate.

Id. at 379. Hurley cited the following “overwhelming” precedent supporting the waivability of the forum defendant rule.  Snapper, Inc. v. Redan, 171 F.3d 1249, 1258 (11th Cir. 1999); Korea Exchange Bank v. Trackwise Sales Corp., 66 F.3d 46, 50 (3d Cir. 1995); In re Shell Oil Co., 932 F.2d 1518, 1522 (5th Cir. 1991); Farm Construction Services, Inc. v. Fudge, 831 F.2d 18, 21-22 (1st Cir. 1987); Woodward v. D. H. Overmyer Co., 428 F.2d 880, 882 (2d Cir. 1970); Handley-Mack Co. v. Godchaux Sugar Co., 2 F.2d 435, 437 (6th Cir. 1924), with only Hurt v. Dow Chemical Co., 963 F.2d 1142, 1145-46 (8th Cir. 1992), going the other way.

Another pre-service removal case reached the same conclusion.  The court in Almutairi v. Johns Hopkins Health System Corp., 2016 WL 97835 (D. Md. Jan. 8, 2016), stated:

I am unaware of any specific guidance from the Supreme Court or the Fourth Circuit concerning whether a motion to remand based on the “forum defendant rule” constitutes a procedural or a jurisdictional challenge to removal.  See Councell v. Homer Laughlin China Co., 823 F. Supp. 2d 370, 378 (N.D.W. Va. 2011) (recognizing that the Fourth Circuit “has yet to rule on this question…”).  However, “[o]f the ten circuits that have spoken on the issue, nine have found that removal by a forum defendant is a procedural defect, and thus waivable.”  Id.

Almutairi, 2016 WL 97835, at *5.  In addition to the cases previously cited by Hurley, Almutiari added:  Lively v. Wild Oats Markets, Inc., 456 F.3d 933, 939-40 (9th Cir. 2006), Handelsman v. Bedford Village Assocs. Ltd. Partnership, 213 F.3d 48, 50 n.2 (2d Cir. 2000), Blackburn v. United Parcel Service, Inc., 179 F.3d 81, 90 n.3 (3d Cir. 1999), and Pacheco de Perez v. AT & T Co., 139 F.3d 1368, 1372 n.4 (11th Cir. 1998).

So at least in the context of removal before service, we now unhesitatingly answer our question from 2009 in the affirmative.  By all means remove before service, even in the face of adverse precedent in some district courts.  At best, the plaintiff will miss the issue entirely and will waive any reliance on the forum defendant rule (which is waivable everywhere but in the Eighth Circuit).  At worst, (1) the case is randomly assigned to a federal who has already ruled adversely, and (2) the plaintiff seeks remand in a timely fashion.  In that situation, as our recent removal-before-service posts demonstrate, the defense side has both the upper hand in the argument, and significant appellate support.  See, e.g., Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., ___ F.3d ___, 2018 WL 3999885, at *4-5 (3d Cir. Aug. 22, 2018); Novak v. Bank of N.Y. Mellon Trust Co., 783 F.3d 910, 912, 914 (1st Cir. 2015); La Russo v. St. George’s University School, 747 F.3d 90, 97 (2d Cir. 2014).  A combination of persuasive argument and recent arguments might get a fair-minded judge to change his/her mind.  Even the worst possible result – remand accompanied by an order to pay counsel fees – isn’t all bad, since the sanctions order would be immediately appealable.

But we want to make one thing perfectly clear.  Pre-service removal involves only statutory language relating to diverse “forum defendants.”  There is nothing in the statute, or in the case law, that allows the presence of a non-diverse defendant to be avoided by pre-service removal.  Pre-service removal does not make non-diverse cases diverse.  Any counsel who screws up this fundamental distinction deserves whatever sanctions a court hands out.

 

You haven’t heard of Blue Car syndrome?  Remember the last time you went car shopping. You found a particular make and model (a “blue car”) and then, like magic, you see that same “blue car” 10 times in the next week. It’s in the parking lot of your gym. It pulls up next to you in traffic. It’s even parked down the block from your house. The blue cars didn’t just suddenly appear. So what happened? It’s sometimes called the Baader-Meinhof phenomenon or frequency illusion. It occurs when something you’ve just noticed, like a new car, suddenly crops up everywhere. You really are seeing more blue cars, but not because there are more blue cars, but because you are now noticing them more.

That might not strictly speaking be true for us and pre-service removal — we’re pretty sure we’d notice whenever the issue came up – but it certainly feels like out of nowhere pre-service removal became a hot topic last month. No sooner did we update our research on the issue, then the Third Circuit makes a favorable ruling allowing pre-service removal. Just five days after that decision, the Northern District of Illinois does the same thing.

In Cheatham v. Abbott Laboratories Inc., — F. Supp. 3d –, 2018 WL 4095093 (N.D. Ill. Aug. 28, 2018), plaintiff, a citizen of Louisiana sued Abbott, a citizen of Illinois and Delaware, in state court in Illinois. Before the complaint was served on defendant, it removed the case to federal court and plaintiff promptly moved for remand arguing the forum defendant rule. Id. at *1-2. As with any pre-service removal case, the dispute turned on the interpretation of the “properly joined and served” language of 28 U.S.C. §1441(b)(2). If a “properly joined and served” defendant “is a citizen of the State in which [the] action is brought,” removal is not permitted. Id.

Defendant’s argument: Under the plain meaning of the statute, as defendant was not served at the time of removal, the forum defendant rule does not apply. Cheatham, at *3-4.

Plaintiff’s argument: Allowing pre-service removal undermines the purpose of the forum defendant rule to preserve the plaintiff’s choice of forum where there is no prejudice to an out-of-state party. Id. at *2-3.

That’s the debate: purpose v. plain meaning. And that is the split among the courts to have decided the issue. Although, as our recent update points out, plain meaning has been gaining ground in the recent circuit court decisions on the issue. The Cheatham decision does a nice job of setting out both arguments with citations to cases going both ways before ultimately concluding that “the statutory text must control. Courts must give effect to the clear meaning of statutes as written.” Id. at *5 (citations omitted).

Courts that have applied the “purpose” interpretation believe that it is necessary to look beyond the language of the statute to be “faithful to Congressional intent.” Id. at *3. Those courts seem to be particularly concerned by “snap removals” – where a defendant learns of the filing of a lawsuit from monitoring the docket and then immediately removes the case. In the age of online filing, docket monitoring is not new or uncommon. Plaintiff called it both improper and strategic gamesmanship. Id. at *2. But just because something is strategically advantageous to one side doesn’t make it improper. Nor does it make it gamesmanship in the sense that it is a dubious tactic.

When Congress completely re-wrote 28 U.S.C. §1441(b) in 2011 it left the “properly joined and served” language intact. If you want to talk about Congressional intent, the buck stops in 2011. In fact, the Cheatham court, like others applying the plain meaning of the statute, acknowledge that “Congress will rewrite the statute if it feels that removal where an in-forum defendant has not yet been served constitutes an abuse of the judicial system.” Id. at *5. Having left that provision in place, the forum defendant rule does not apply where the forum defendant has not been served at the time of removal.   Defendant learned of the action “before it became a forum defendant that was both properly joined and properly served,” id., and promptly removed it. There was no bending of the rules required. Diligence isn’t gamesmanship.

And, we actually don’t think pre-service removal is not a frequency “illusion” – it’s real and going in defendants’ favor.

Today’s guest post is by frequent contributor Dick Dean of the Tucker Ellis firm.  This time, Dick is sharing some insights on Wyeth v. Levine, 555 U.S. 555 (2009), which we consider the single worst prescription medical product decision since we started blogging.  Not surprisingly, Dick shares our views of Levine.  We agree with him.  Further, if Levine had been decided the way Dick advocates, all of the subsequent preemption focus on “independent”action, “major” changes and “newly acquired” information could have been avoided, and a more rational system turning on the substance of the conflict would have ensued.

As always, our guest bloggers are 100% responsible for the contents of their posts, deserving of all the credit (and any blame) for what they have written.

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Cases involving the “purposes and objectives” obstacle part of the implied preemption doctrine are rare.  The recent decision in Fontana v. Apple, Inc., ___ F. Supp. 3d ___, No. 2:18-cv-00019, 2018 WL 3689044 (M.D. Tenn. August 3, 2018), is a reminder of the efficacy of this powerful, but little used, defense.  Plaintiff brought a personal injury action claiming he developed cancer from the use of a cell phone.  In the 1990s these claims were addressed by extensive Daubert practice.  But this claim was dismissed at the pleadings stage because it interfered with the FCC’s ability to carry out its mission of setting radio frequency emission levels established by the Telecommunications Act of 1996.  It was specifically based on “purposes and objectives” obstacle preemption.  That is good for the cell phone industry but does it “speak” to us in the pharmaceutical defense world?  Indeed it does.  Fontana relied heavily on Farina v. Nokia Inc. 625 F.3d 97 (3rd Cir. 2010) [ed. note: blogged about here], finding a similar claim obstacle preempted, and Robbins v. New Cingular Wireless PCS, LLC, 854 F.3d 315 (6th Cir.2017) (barring an attempt to prohibit the building of a cell tower based on health reasons finding obstacle preemption).  The rationale of Fontana, Farina and Robbins is straightforward:

The reason why state law conflicts with federal law in these balancing situations is plain.  When Congress charges an agency with balancing competing objectives, it intends the agency to use its reasoned judgment to weigh the relevant considerations and determine how best to prioritize between these objectives.  Allowing state law to impose a different standard permits a re-balancing of those considerations.  A state-law standard that is more protective of one objective may result in a standard that is less protective of others.

Farina, 625 F.3d at 123 quoted by Fontana, 2018 WL3689044 at *2.

Allowing juries to impose liability on cell phone companies for claims like [plaintiff’s] would conflict with the FCC’s regulations.  A jury determination that cell phones in compliance with the FCC’s SAR guidelines were still unreasonably dangerous would, in essence, permit a jury to second guess the FCC’s conclusion on how to balance its objectives.

Farina, at 125-6 quoted by Fontana at *3.

Of course, the parallel to FDA determinations about efficacy and safety of drugs and the sufficiency of labels is striking.  The FDA engages in a classic weighing process as to whether a drug can come on the market and what its label should say.  Its processes are far more detailed than those of the FCC which played out in these three cases.  But jury second guessing of pharmaceutical labels is permitted by the Supreme Court in Wyeth v Levine, 555 U.S. 555 (2009), where the Court rejected preemption because of the manufacturer’s ability to submit a change in the label.  But that leaves the second issue in Wyeth—who should decide adequacy.  The three-Justice dissent (Alito, Roberts and Scalia) fully adopted the “purposes and objectives” argument—that the FDA should make these decisions and not be second-guessed by juries as to labeling decisions.

It should first be noted that even given Wyeth, there are areas within the pharmaceutical area where “purposes and objectives” preemption has been applied.  That is exactly what happened in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 353 (2001) (finding state law fraud on the FDA claims to be impliedly preempted).  It also happened in Zogenix v. Patrick, No. 14-11689, 2014 WL 1454696 (D. Mass. Apr. 15, 2014) [ed. note: blogged about here], where Massachusetts state rules made it impossible to market an opioid approved by the FDA.  These rules were struck down since they interfered with the FDA’s ability to carry out its mission of regulating drugs.  Specific reliance was placed on the purposes and objectives portion of implied preemption.

The power of the reasoning in Fontana, Farina and Robbins merits a review the of Wyeth analysis of “purposes and objectives” preemption.  The Wyeth majority’s rejection of the “purposes and objectives” claim is thin and wanting.  It is an afterthought to an opinion that deals primarily with impossibility preemption given the provisions of the “changes being effected” provision.  It is at odds with prior Supreme Court precedent on “purposes and objectives” in Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000) (finding obstacle preemption based on a general rule of the Department of Transportation favoring a “mix of seat restraints), and with subsequent precedent in Arizona v. United States, 567 U.S. 387 (2012) (an immigration case).  In Wyeth, the Court first noted that Congress had long recognized a role for state law causes of action under the FDCA.  Id. at 574–75.  But the fact that some state actions may be “complementary” does not mean that others may not be at cross purposes. Second, the court coupled the “complementary” argument with the fact that there was no express preemption provision in the FDCA.  Id.  But the Supreme Court itself has consistently held that the lack of finding of express preemption does not bar implied preemption.  See Geier, 529 U.S. at 869; Buckman, 531 U.S. at 352.  Third, it refused to consider the “new” FDA legal position on preemption.  An agency position is certainly not conclusive to whether there is “purposes and objectives” preemption, since the position of the United States on this issue is a changing one dependent on the politics of the administration in power. Moreover, implied preemption is not dependent on the FDA advancing that position.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (where implied preemption was found over agency objection).  But the major failure was that the Wyeth majority did not compare the entire federal regulatory scheme to the state jury system on the issue of who should decide adequacy; it demanded a specific regulation at odds with the jury system.  Wyeth, 555 U.S. at 580.  It distinguished Geier finding there was a “specific rule” in conflict with state tort lawsuits, but that rule was only that the Department of Transportation allowed a “mix” of restraint systems.  The generality of that “rule” does not begin to compare with the detailed federal regulations on drug approval and labeling decisions.  Simply put, the majority in Wyeth used an incorrect legal test to determine whether there was “purposes and objectives” preemption.

Wyeth, however impaired, is still the law.  But precedents do get changed.  And the Supreme Court’s treatment of this issue after Wyeth helps to demonstrate that Wyeth was wrong in its “purposes and objectives” analysis.   In Arizona v. United States the Supreme Court confronted a preemption challenge to a number of Arizona statutes involving immigration.  One such statute, section 6 of Arizona S.B. 1070, provided that a state officer could arrest someone if the officer had probable cause to believe that a person was “removable” from the country.  The United States argued that this statute was an obstacle to the “removal” system created by federal statutes and regulations.  Section 5 of the state legislation made it a misdemeanor for an unauthorized alien to apply for work in Arizona.  The government argued that was at odds with federal legislation making a specific choice not to impose criminal liability for this conduct.  The Supreme Court agreed that these statutes did create an obstacle to the full “purposes and objectives” of Congress.  567 U.S. at 406–07, 410.  It looked at what was provided for by each regulatory scheme and determined whether there was a conflict between them.

Presuming that Judge Gorsuch would follow the Scalia position in Wyeth—that has three Justices supporting that position.  Justice Thomas does not generally agree with “purposes and objectives” preemption.  But U.S. v. Arizona may be viewed by new Justices as a basis to reevaluate the Wyeth position of “purposes and objectives” preemption.  Justice counting aside, the reasoning of this part of Wyeth makes no sense.

That said, a note of caution is in order.  Cases where this defense is advanced in the pharmaceutical area should be carefully chosen with careful consideration given to the facts and the judges involved.  Enough bad law has already been made in this area.  In the short term, fact patterns like Zogenix where the state tries to intrude into the regulatory area cry out for this defense.  Using it now in a typical failure to warn claim is not likely to succeed.  But Wyeth’s reasoning is subject to challenge.  As other industries get the “cell phone” treatment on “purposes and objectives” preemption, this disparity will increase the focus on that reasoning.

Recently Rudy Giuliani was broiled for saying that the truth isn’t the truth.  Denying a tautology won’t typically earn one high marks for logic.  Add in the callback to Pontius Pilate’s “What is truth” question, and it sounds like bad epistemology in service of bad morality.  But we’re not here to talk politics.  Nor are we here to try to answer Pilate’s question.  Maybe the Drug and Device Law Daughter, who is just starting her second year at Harvard Divinity School, can field such questions.  We cannot.

As a former prosecutor of mail frauds and wire frauds and as a current defender of companies accused of consumer fraud, the question we have faced is usually more along the lines of “what is a lie.” It is not merely the opposite side of the street, though it surely is in the same neighborhood.  Liars are everywhere.  They overstate their income when applying for a loan.  They understate their income when reporting to the IRS.  They use sucker lists to lure retirees into investing in nonexistent oil wells.   They loot companies via creative accounting.  They tell us our table will be ready in “just a few minutes.”  They tell us our flight is “On Time.”  They check the box saying they have read and they accept the terms and conditions.  They pretend not to want the last slice of pizza.

What makes something a lie that leads to liability?    Even putting aside the difficult issue of discerning a defendant’s intention to prevaricate, how does the law tackle claims that someone did wrong by uttering something at odds with the truth?  The police are not the truth police, and civic dockets could not bear the strain if every lie led to a lawsuit.  So the law has introduced concepts of materiality and detrimental reliance.  A lie is actionable only if it made a difference. It had to have fooled someone who is not a fool.  It had to have caused harm.

One summer, between our junior and senior years in college, we worked in the New Jersey legislature.  It was the summer of the FBI’s Abscam investigation (see American Hustle).  A couple of politicians, including a U.S. Senator, six members of the House of Representatives, a New Jersey State Senator, and the Mayor of Camden, did perp walks on their way to corruption convictions.   But the legislators and staffers we worked with were a competent and honorable group.  One of them focused on consumer fraud matters.  He told us that anytime a state investigator wanted to ring up some citations, all that was required was a visit to a nearby supermarket.  Weigh some packaged meat, compare to the stated weight, and – voila! – there would almost certainly be a discrepancy.  Evaporation and the passage of time produced a lie.   Thankfully, a rule of reason prevailed.   Nobody was really deceived or hurt.   Let’s be grownups about this.   There are plenty of real frauds to pursue.  It wasn’t cynicism; it was realism, aided by a set of reasonable priorities.

Years later, we found ourselves in Southern California.   It’s hard to say why it’s so, but it quickly became clear to us that folks on the west coast were a lot less tolerant of puffery or even the slightest deviation from their idea of truth and purity.  Is it a state of innocence?  Does life under perpetually sunny skies foster a heightened sense of entitlement?  Look at the lawsuits alleging that a company incorrectly called its product organic or natural.  They are not all filed in California, but it seems that most of them are.  Even so, most of those lawsuits don’t get much traction in the courts, because a regulatory agency had made a determination  of what could and could not be put on a product label.  In such cases, courts don’t need to engage in science, or semantics, or epistemology.  It turns out that sometimes Pontius Pilate’s question is preempted.

Today’s case originated in Southern California: Welk v. Nutraceutical Corp., 2018 U.S. Dist. LEXIS 135595, 2018 WL 3818033 (S.D. Cal. Aug. 10, 2018).  The plaintiff had purchased liquid vitamin B12 and complained that the packaging overstated its contents.  The claim centered on test results from a “reputable supplement analysis center located in California” showing that, once opened, the liquid vitamin B12 “undergoes degradation at an unknown rate.”  After only 11 days, a sample of the product weakened from 255 ug/ml to 213 ug/ml.  The plaintiff contended that the amount of B12 eventually “becomes negligible and ineffective.” Thus, the bottle’s label was “untrue, false, and misleading.”  The complaint included various actions for misrepresentation, and did so on behalf of a purported class of consumers.

Tell the truth: this claim does not exist unless it is a class action, right?  And what does that tell you?

Stepping back for a moment, doesn’t this claim remind you of the statement on cereal boxes about how the contents may have settled? When you are a child, this statement might possibly have arrived as unpleasant news.  Open a box of Cap’n Crunch, and one is greeted by almost as much air as nuggets of cavity-inducing goodness. But as adults, we read this statement with calm resignation.  Perhaps that is because we, too, our bodies and our minds, have settled over time.

The defendant in Welk moved to dismiss the claim for various reasons.  The best of those reasons was that the claim was preempted by the Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act.  There is an express preemption provision barring state law food labeling requirements that are “Not identical” to federal regulations.  The FDA regulates the labeling of the “quantitative amount” of nutrient supplements such as vitamin B12, and decrees application of a specific testing methodology.  The defendant’s labeling complied with the FDA’s labeling and testing methodology.

How does the plaintiff endeavor to evade preemption?  The plaintiff argued that the defendant improperly failed to disclose the fact of degradation.  But that assertion of degradation rests upon a testing methodology that is certainly not “identical” to the one mandated by the FDA.  Accordingly, the court, in a very short, very to-the-point decision, held that the plaintiff’s misrepresentation claims were preempted and must be dismissed.  Was the vitamin label a lie?  Not really.  As with many of the cases we encounter, the alleged lie was one of omission.  Tell me more, says the plaintiff.  One can always think of more.   How to decide?  There’s a scientific test.  Who decides?  The FDA.

We cannot count ourselves surprised by the result in Welk.  It is consistent with several others we have seen in food and nutraceautical cases.   But we do count ourselves as envious.  Most of our cases involve drugs and medical devices.  (No surprise there; take a look at the title of this blog.  Please don’t accuse us of false advertising because today’s case involves neither a drug or device.  We’re about to tie it together, okay?  Okay.  Here goes.). The preemption language for medical devices is there, but it’s been unduly watered down by a couple of courts.  The logic for preemption of drug labeling is there, but it, too, was overly cabined in some regrettable judicial decisions that are starting to collapse from their contradictions. (Many of those decisions indulged in a presumption against preemption – a presumption that has since been discredited.) Imagine if food preemption rules applied to all the products regulated by the FDA. Think of the logic, consistency, clarity, and efficiency.  We could use a little more of that in the DDL world.

That is no lie.