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.

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 discussed personal jurisdiction a lot on the Blog lately, and not so lately, and for good reason. The Supreme Court’s reining in of both general and specific jurisdiction provides additional ways for defendants to win cases – particularly where the other side isn’t paying enough attention to the now more difficult legal environment.  The recent decision in Wagner v. Terumo Medical Corp., 2018 WL 6075951 (S.D. Cal. Nov. 21, 2018), is an example of what we mean.

The factual key to Wagner was that the plaintiff sued the wrong entity.  The named defendant didn’t start making the medical device in question until after the plaintiff’s implantation surgery.  Plaintiff’s failure to research the ownership history of the product at issue proved fatal in the current, less forgiving personal jurisdiction environment.

First, the plaintiff tried general jurisdiction, relying on the largely discredited theory that registering to do business/designating an agent for service of process constituted “consent” to general jurisdiction. That doesn’t work in California:

Plaintiff’s reliance on California Corporations Code Section 2100 to support general personal jurisdiction is misplaced. Although [defendant’s] status as a registered foreign corporation in California is relevant to the personal jurisdiction inquiry, . . .  California does not require corporations to consent to general personal jurisdiction in that state when they designate an agent for service of process or register to do business. . . .  The designation of an agent for service of process and qualification to do business in California alone are insufficient to permit general jurisdiction.  As such, Section 2100 does not provide a basis for general personal jurisdiction.

Wagner, 2018 WL 6075951, at *5 (citations and quotation marks omitted).

The general jurisdiction argument was pretty poor, but since the plaintiff in Wagner was a California resident, one would expect plaintiff to have a better time of it with specific personal jurisdiction.  Not this time, though.  The specific jurisdiction test is one part “purposeful direction” of activities to the forum and one part that the case “arises out of or is related to” those aforesaid activities.  Wagner assumed the first prong.  In California (at least when its supreme court wasn’t trying to expand the mass tort industry), the second half of that test requires “but for” causation:

The second prong requires Plaintiff’s claim to be one which arises out of or relates to the defendant’s forum-related activities. . . .  [T]he second prong of the specific jurisdiction test [i]s a “but for” test.  Under the “but for” test, a lawsuit arises out of a defendant’s contacts with the forum state if a direct nexus exists between those contacts and the cause of action.

Id. at *6 (citations and quotation marks omitted). On this test, plaintiff’s failure to do the necessary homework lost the case. “Given that, at the point of plaintiff’s alleged injury, it had not yet acquired the rights to that [relevant] line of products, Plaintiff fails to show a causal nexus between [defendant’s] activities in the forum and her injury.” Id. (footnote omitted).

Thus, unless plaintiff is able to find some jurisdictional basis in “successor liability,” she is out of court.  Id. at *6 n.9.  Maybe plaintiff can.  California’s “product line exception” is a notoriously lax form of successor liability (Pennsylvania has a version of that, too).  But our general point remains the same.  Personal jurisdiction is no longer a “gimme” for plaintiffs, and defendants need to be familiar with all its ins and outs, because we can win cases that way.  Conversely, plaintiffs need to exercise considerably more care in where they file cases.  Thus, here on the Blog, we are devoting ourselves to exploring those ins and outs.

It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083, slip op. (Cal. Super. Oct. 1, 2018).

One problem that that current breast implant litigants face that their more numerous predecessors did not is preemption.  All that earlier litigation caused the FDA to upclassify breast implants to Class III, pre-market approved devices, and PMA means preemption.

In California, that also means the filing of half-baked, failure-to-report claims that no self-respecting plaintiff would otherwise bring, as a way to allege something that gets around preemption.  Trouble is, these breast implant plaintiffs can’t even allege that the defendant didn’t report any adverse incidents.  Even what plaintiff did allege was notably speculative:

Plaintiff now has alleged, however, that if [defendant] had reported additional adverse incidents subsequent to 2000, and if the FDA had made such incidents public, and if Plaintiff’s doctors had been aware of such reports, Plaintiff’s doctors might have provided an earlier diagnosis leading to earlier surgery to remove the implants and Plaintiff’s damages . . . might have been lessened.

Slip op. at 5. That’s a lot of “what ifs” piled on top of “what ifs,” but this plaintiff couldn’t even get to that.

There weren’t any unreported adverse events.

So the plaintiff tried to make them up.

The entire questionable “causal chain” wasn’t based on any known, but unreported, events at all, but rather on allegations about how studies were conducted:

[I]t is premised on [defendant’s] failure to report adverse incidents that were not detected because of how [defendant] conducted the studies rather than on a failure to report adverse incidents that actually occurred.

Id.  Even for a liberal jurisdiction, that was just too much.  There must be something that actually wasn’t reported.

Because Plaintiff has failed to allege facts showing that [defendant] failed to report actual adverse events that in fact occurred, the failure to warn (failure to report adverse events) claim is preempted because plaintiff has failed to allege how [defendant’s] actions in conducting these studies violated federal law.

Id.

While the Mize court “adopted the reasoning” of Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017) – a case we discussed hereMize was really a step into fantasy beyond even Ebrahimi.  As pleaded, Ebrahimi at least involved allegations that (vaguely) alleged that events weren’t reported.  Mize didn’t.  She seems to have been alleging that the defendant was obligated to conduct studies in a way that maximized the number of reportable adverse events.  That “duty” is, of course, contrary to tort policy and medical ethics, both of which seek to reduce, not increase, product injuries.

The plaintiff in Mize also tried to allege a “manufacturing defect,” but that didn’t fare any better.  Lacking any direct evidence, plaintiff tried to rely on “allegations that supported . . . [a] 1998 Consent Decree.” Slip op. at 3.  But plaintiff’s implant wasn’t manufactured until at least two years after that decree, and the decree itself was “evidence of a promised change in practices,” so the decree could not be evidence of any defect in the device implanted in the plaintiff.  Id.  Again, simple logic seems beyond the plaintiff in Mize.

Finally, the Blog wishes to express its appreciation to Dustin Rawlin, of Tucker Ellis, and his team of, Peter Choate, Monee Hanna and Allison Burke, who not only won the case, but were thoughtful enough to send it along to us.  Keep up the good work.

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.

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of the devices’ 510(k) regulatory pathway.  Most or all of these orders rely on the Supreme Court’s 1996 opinion in Medtronic, Inc. v. Lohr, where the Court held that federal law did not preempt certain medical device warnings claims involving 510(k) devices.  In so holding, the Court distinguished the pre-1990 510(k) clearance process from the more involved and “rigorous” premarket approval (“PMA”) process and observed that the old 510(k) process was “focused on equivalence, not safety.”  518 U.S. 470, 493 (1996).

The Supreme Court did not hold that 510(k) clearance has no bearing on safety and efficacy, but the language quoted above provides a foothold for those inclined to marginalize the FDA’s role.  Indeed, we believe the Supreme Court’s view of the 510(k) process was already outdated in 1996.  As we have explained multiple times (including here), the 510(k) clearance process is keyed directly to safety and efficacy, and the Supreme Court has been retreating from Medtronic v. Lohr almost since the day the opinion was filed.

A district judge in Los Angeles recently provided what we think is the correct perspective. The case is Otero v. Zeltiq Aesthetics, Inc., No. CV 17-3994, 2018 WL 3012942 (C.D. Cal. June 11, 2018), and it is not a preemption case, or even a product liability case.  Instead, patients sued the manufacturer of a non-invasive fat-reducing system under California’s permissive consumer fraud statutes, claiming that the company made partial statements that were misleading and failed to disclose material information about the product. Id. at **1-2.

What were the misleading partial statements and omitted facts? The plaintiffs alleged that the manufacturer stated (truthfully) that the product was “FDA-cleared” and “FDA-cleared as safe and effective.” Id. at *1.  And the manufacturer failed to explain the difference between “FDA clearance” on the one hand and “FDA approval” on the other.  That’s the omission.

We have unending sympathy for individuals who fight weight gain and for whom the condescending admonition to exercise more and eat less is not helpful. Be that as it may, these claims have no arguable merit, and the district court correctly dismissed them.  With regard to the alleged “partial” representation that the device was “FDA cleared,” the district court ruled that “Plaintiffs fail to explain how that true representation—on its own—could cause reasonable consumers to erroneously believe that the system received FDA approval.” Id. at *2.  The court continued:

Plaintiffs simply point out that under California law, true statements may mislead reasonable consumers if other relevant information is omitted. Although that is an accurate legal proposition, it does not establish that “FDA-Cleared” gives rise to viable [California statutory] claims, especially because the “mere possibility” that some consumers acting unreasonably will conflate FDA-clearance and FDA-approval is insufficient.

Id. So can a true statement ever support a claim?  Under some circumstances not presented here, it appears that one could, although that would be truly exceptional case.  Can a true statement support a claim where it is merely possible that a consumer will unreasonably misconstrue it?  This court ruled that it cannot.

There is more. The plaintiffs also argued that adding the words “safe and effective” to “FDA-cleared” was misleading because that claim can only be made in connection with FDA approval, citing Medtronic v. Lohr.  (See, we were going to get back to Medtronic v. Lohr eventually, and here we are).  In the part of the order that we like the most, the district court convincingly debunked the myth that “safe and effective” is unique to the PMA process:

It appears that this argument relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which allegedly establishes that “‘[t]he § 510(k) notification process is by no means comparable to the PMA process’ and in no way warrants that the device is safe and effective.”  [quoting Plaintiffs’ brief.]  Although Medtronic observed that obtaining Section 510(k) clearance is not as onerous as the “rigorous” PMA process, the Supreme Court did not find that the former has no bearing on a device’s safety and effectiveness. In fact, Medtronic acknowledged that “the FDA may well examine § 510(k) applications . . . with a concern for the safety and effectiveness of the device . . .”  The Supreme Court later clarified “the FDA simultaneously maintains the exhaustive MPA and the more limited § 510(k) process in order to ensure . . . that the medical devices are reasonably safe and effective.

Id. at *3 (first emphasis added, second in original).  In other words, the plaintiffs (and others before them) were relying on a snippet to misread Medtronic and overstate its holding.  The district court went on to state that the FDA’s regulations connect 510(k) clearance to safety and effectiveness, too:

Indeed, the FDA regulations provide that if the agency has found that a device is substantially equivalent to—but has “technological characteristics” that are different from—a predicate device, then that means the agency has concluded that “[t]he data submitted . . . contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.”

Id. (emphasis in original).  Finally, the district court noted that compliance with general and special controls, which Class II medical devices must do, further provides “reasonable assurance of the safety and effectiveness of the device.” Id. There was no deceptive, no misleading statement.  Only true representations of a medical device’s regulatory pathway.  That is not the basis for a consumer fraud claim.

Nor is it consumer fraud when a manufacturer does not explain the difference between FDA clearance and FDA approval. The district court ruled that a manufacturer’s duty to consumers is limited to warranty obligations, absent an affirmative misrepresentation or a “safety issue.” Id. at *4.  We are not sure this is an accurate statement of a medical device manufacturer’s duty to consumers, especially considering the presence of prescribing physicians (i.e., the learned intermediaries) for many devices.  We also can’t imagine a situation where a medical device manufacturer would be under a legal obligation to explain FDA regulations to consumers.  But even taking the rule at face value, the plaintiffs alleged no safety risk. Id. at *5.  Maybe they were unsatisfied with the results (i.e., effectiveness) and wanted their money back.  Whatever their beef was, it was not about safety.

The plaintiffs walked away with their core claims dismissed without leave to amend. The district court gave them another chance to plead that they actually observed other statements that they claimed were misleading, based on counsel’s representations at argument that their clients might have seen them. Id. at **5-6.  We don’t know.  It seems to us that if those facts existed, the plaintiffs would already have pleaded them.  The takeaway for us is the reality that the 510(k) process does tie into safety and efficacy.  Don’t let anyone tell you otherwise.

Today’s guest post by Reed Smith associate Jennifer Eppensteiner concerns an interesting First Amendment development.  Everybody knows how California’s wildly overwrought Proposition 65 has turned that state’s products, from beer to bacon, into billboards for remote and scientifically suspect cancer warnings.  Well, how about a ruling that requiring scientifically unsound warnings on products is compelled false speech in violation of the First Amendment?  As always our guest posters deserve 100% of the credit (and any blame) for their posts.

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It is probably a safe bet to say that many of the blog’s readers settle in to enjoy these posts with a cup (or, on anticipated longer days after long nights, carafe) of coffee.  Readers in California may soon be drinking coffees with warning labels – no, not of the Jackie Chiles Java World “Caution: Hot!” variety – but a cancer warning, courtesy of Proposition 65 (“Prop 65”).  Coffee consumers are a passionate bunch, so the recent Los Angeles Superior Court proposed ruling to this effect has been widely publicized.  Readers may not be familiar, however, with another recent Prop 65 ruling, one with an arguably better outcome for product manufacturers.  That’s why I’m here today.

The outcomes in drug and medical device litigation often turn on the label. Regardless of how detailed a warning is, in what font and size it’s printed, and whether it comes in a bold, black box, plaintiffs always insist that the warnings were insufficient.  They sometimes base their position on nothing more than attorney argument, and often they cite isolated information that is against the great weight of authority, such as an anecdotal case report or an outlier study with small sample sizes and inconclusive results.

Thankfully, the Eastern District of California recently recognized that requiring a manufacturer to include a cancer warning based on the questionable finding of a single organization, when all other regulatory and governmental bodies had found the opposite, would violate the manufacturer’s First Amendment rights by forcing it to say something that was false, and with which it disagreed. Nat’l Assoc. of Wheat Growers v. Zeise, et al., Civ. No. 2:17-2401, 2018 WL 1071168, at *7 (E.D. Cal. Feb. 26, 2018).  Before the court was a motion for preliminary injunction, requesting the court do two things:  (1) stop the State of California from identifying glyphosate on a list of cancer-causing products; and (2) enjoin the warning requirement of Prop 65 from being enforced against Plaintiffs with regards to glyphosate.  Id. at *1.

Before we get into the court’s reasoning, some background on Prop 65. Officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, Prop 65 purports to protect California’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals.  Under Prop 65, the Governor of California is required to publish a list of chemicals “known to the State” to cause cancer, as determined by certain outside entities.  Id.  Prop 65 also prohibits any person in the course of doing business from knowingly and intentionally exposing anyone to the listed chemicals without a prior “clear and reasonable” warning.  Id.  The prohibition, and corresponding warning requirement, takes effect 12 months after the chemical has been listed.  Id.  Private persons are authorized to file suit to enforce Prop 65, adding to the overwarning problem.

Glyphosate is a widely-used herbicide used to control weeds in various settings.  Id. at *1, n.1.  Glyphosate can even be used on coffee plantations.  But I digress.  Plaintiffs or their members sell glyphosate-based herbicides, use glyphosate in their cultivation of crops that are incorporated into food products sold in California, or process such crops into food products sold in California.  Id.  In 2015, the International Agency for Research on Cancer (“IARC”) of the World Health Organization (“WHO”) classified glyphosate as “probably carcinogenic” to humans based on evidence that it increased cancer rates in animal studies and limited evidence that it could cause cancer in humans.  Id. at *2.  In this case, the IARC is the outlier.  Several other organizations, including the United States Environmental Protection Agency (“EPA”) and other agencies within WHO found no evidence that glyphosate causes cancer.  Id.  Still, relying on the IARC’s “probably carcinogenic” classification, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Intent to List Glyphosate in November 2015 and subsequently began listing glyphosate as a chemical known to state of California to cause cancer in July 2017.  Id.  The warning requirement would therefore take effect in July 2018.  Id.

After finding that Plaintiffs’ First Amendment claim was ripe for the court’s consideration, the court turned to the issue of injunctive relief. Injunctive relief, “an extraordinary and drastic remedy,” requires that the moving party establish several familiar elements:  (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities in tips in its favor, and (4) an injunction is in the public interest.  Id.

Regarding the likelihood of success on the merits, the court first distinguished between the State’s listing of glyphosate as a chemical “known to” cause cancer and the subsequent warning requirement.  The former is government speech; the latter is commercial speech.  Id. at *5.  This distinction is significant because the “[t]he Free Speech Clause restricts government regulation of private speech; it does not regulate government speech.”  Id. (citing Pleasant Grove City v. Summum, 555 U.S. 460, 467 (2009).  So, while Plaintiffs could not demonstrate likelihood of success on the merits with regards to the listing of glyphosate, a different analysis was required for the warning requirement itself, which would have the effect of compelling commercial speech – the labeling of a product.  Id.

Commercial speakers receive protection of the First Amendment, subject to some limitations.  The government may require commercial speakers to disclose “purely factual and uncontroversial information” about commercial products or services, as long as the “disclosure requirements are reasonably related” to a substantial government interest and are neither “unjustified [n]or unduly burdensome.”  Id. (citing In Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985)).  As explained above, only the IARC found that the evidence warranted branding glyphosate as “probably carcinogenic.”  On the other hand, the court noted that

…the EPA has reviewed studies regarding the carcinogenicity of glyphosate multiple times and has determined each time that there was no or insufficient evidence that glyphosate causes cancer, most recently in September 2016. Several international agencies have likewise concluded that there is insufficient evidence that glyphosate causes cancer, including the European Commission’s Health and Consumer Protection Directorate–General, multiple divisions of the World Health Organization besides the IARC, and Germany’s lead consumer health and safety regulator.

Id. at *7.  Based on the great preponderance of scientific opinion, the court reasoned that it was “inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization … when apparently all other regulatory and governmental bodies have found the opposite, including the EPA.”  Id.  Accordingly, the court found that “here, given the heavy weight of evidence in the record that glyphosate is not in fact known to cause cancer, the required warning is factually inaccurate and controversial.”  Id.

After finding that the required warning would be false and misleading, the court found the scales tipped in Plaintiffs’ favor on the issues of irreparable harm, balancing of the equities, and public interest factors.  The court granted Plaintiffs’ request for a preliminary injunction enjoining the warning requirement of Prop 65.  Jackie Chiles would agree that requiring such a warning would be an infringement on Plaintiffs’ constitutional rights.  That’s outrageous, egregious, preposterous!

Remember, as well, that the First Amendment equally applies to tort litigation.  The blog has discussed the product liability implications of New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964), several times.  This is another such instance.  To the extent that, as in Nat’l Assoc. of Wheat Growers v. Zeise, the First Amendment prevents the government from forcing a product manufacturer to “speak” falsely based on the results of an outlier study, it equally precludes private plaintiffs from seeking damages for a manufacturer’s failure to include the same false information on a product warning.

Where might that come in useful?

Today’s case isn’t about prescription drugs, but rather illegal drugs. More specifically, whether a user of illegal drugs can recover in a civil action against someone who failed to prevent the user from obtaining the drugs. While this is outside our usual field of focus, we have posted about the in pari delicto doctrine before and believe the decision could be analogously useful to drug companies in at least some types of opioid litigation and therefore worthy of notice.

You won’t find that fancy Latin phrase in Hollywood v. Superior Court, 2018 Cal. App. LEXIS 190 (Cal. App. Ct. Mar. 8, 2018), but that is what the case is about. Plaintiff voluntarily checked himself in to a rehabilitation facility and then proceeded to smuggle in heroin and overdose. Id. at *2-3. He then brought a negligence action against the rehab facility alleging it failed to take reasonable steps to make sure residents could not get illegal drugs. Id. at *3-4. So the question is whether plaintiff’s own misconduct bars his right to recovery in tort for his injuries – in pari delicto or “wrongful conduct” rule. The case also discusses whether the claim is barred on statutory grounds.

The court examined defendant’s statutory defense first. The statute at issue is the Drug Dealer Liability Act (DDLA) which is based on the Model Drug Dealers Liability Act which has been adopted in some version in more than 20 states. Id. at *8. The primary goal of the DDLA is to provide a civil remedy for damages to those who are injured as the result of someone else’s use of illegal drugs – parents, employers, insurers. Id. at *9. Such parties are entitled to both economic and non-economic damages and can recover from both the person who actually sold the illegal drugs to the user and anyone “who knowingly participated in the marketing of illegal controlled substances.” Id. at *12. In other words, the DDLA imposes a broad market share liability “in order to deter drug traffickers with potentially high civil damages awards.” Id. at *11.

The DDLA also allows an illegal drug user to bring a more limited claim, if certain conditions regarding cooperation with law enforcement and non-use of illegal drugs are met. The claim can be brought only against the direct supplier/manufacturer/importer of the actual drugs used and only economic damages can be recovered. Id. at *12-13. The DDLA goes on to state: “An individual user of an illegal controlled substance may not bring an action for damages caused by the use of an illegal controlled substance, except as otherwise provided in this section.” Id. at *13. In Hollywood, the rehab facility argued that that sentence precluded plaintiff from bringing his negligence claim against it as it was not the supplier of the drugs that caused his injury. Now all of this should sound like preemption to our DDL blog readers, but because we are talking about co-equal state law (state statute and state common law), the question is framed as whether the enactment of the statute displaced the existing common law. Id. at *8n.7. And yes, California’s general rule is a presumption against displacement. Id. at *15-16.

First, in construing the sentence limiting the claims a drug user can bring, the court noted that the DDLA defines “individual user” as “the individual whose use of a specified illegal controlled substance is the basis for an action under this division.” Id. at *15. Therefore, the DDLA did not need to repeat “under this division” when talking about the claims an individual user could bring because it was already limited by definition to claims under the act. Id. Second, the court found no legislative intent to “supplant common law” as to the circumstances of when a drug user could pursue claims against a third-party. Since the primary goal of the DDLA was to expand the class of potentially liable parties, the court was unwilling to interpret the act to restrict or bar other common law remedies.

Application of that common law to plaintiff’s claim, however, found it was lacking any legal support. In its analysis of the “wrongful conduct” doctrine, the court examined the development of the law in relation to liability for furnishing alcohol. After some back and forth in the courts, the California legislature enacted a statute to limit the liability of those who serve alcohol finding the consumption of alcohol should be the proximate cause of injuries to the intoxicated person or injuries caused be the intoxicated person, with exceptions for serving minors. Id. at *19-21. Similar laws exist protecting hosts who furnish alcohol. Id. at *22. Some plaintiffs have argued that because these laws confer immunity on those who serve/furnish alcohol, “persons less directly responsible for the intoxicated state of another may be liable under nonstatutory theories.” Id. We had to quote it because we couldn’t think of another way to state such a ridiculous concept. Fortunately, California courts have found it just as ridiculous. In this case, the court concluded that the rehab facility took reasonable steps such as a search upon arrival and periodic room checks to prevent residents from using illegal drugs. It was not required to take extraordinary measures. Such a claim is not supported under the law, nor would public policy favor burdening the very facilities who are trying to help addicts with potential liability for “their residents’ foreseeable but unpreventable predilection to obtain and ingest drugs.” Id. at *28.

The Hollywood court could not find a single case “suggesting that liability could be predicated on the mere failure to undertake affirmative efforts to stop the user from ingesting drugs.” Id. at *25. In other words, there is no viable “general failure to thwart drug use” claim.  Id.  The same logic should apply to claims against manufacturers of prescription opioid drugs for failure to monitor distributors and retail sellers.

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the trip), we left behind record cold and treacherous ice in Philadelphia, so we had no climatic complaints.  We were slightly apprehensive, however, because we were sailing on the very ship that had been in the news a few weeks earlier for a norovirus outbreak that sickened a couple hundred passengers.  But we convinced ourselves that the adverse publicity surrounding the recent outbreak would ensure that pre-sailing sanitation and onboard precautions were at an all-time high.  And we were correct:  the entrance to every venue on the ship was blocked by crew members bearing giant bottles of hand sanitizer, application of which was required for passage.  Even at the 24-hour soft-serve frozen yogurt machine (if we were assured this would be operational at all times, we could happily exist without dining rooms), the crew member manning the controls would not hand over a cone to anyone who did not sanitize first.  It apparently worked:  we came through unscathed and heard of no reports of illness on the ship.  (We also had a blast — played round after round of trivia, “clear kayaked” off the coast of Cozumel, drank many glasses of wine, and spent hours and hours motionless except for turning the pages of our book.)  Bottom line was that the cruise line did all that it was supposed to do to protect its passengers.  Beyond that, people had to be smart and careful, because the ship’s duty only extended so far.

Today’s case also involves questions of duty and of whether the defendant’s duty extended as far as the plaintiff said it did.   In Liu v. Janssen Research & Development, LLC, No. B269318, 2018 WL 272219 (Cal. Ct. App. Jan. 3, 2018), an unpublished decision from the California Court of Appeal, the plaintiff’s son and decedent died after briefly participating in a clinical trial for a long-acting injectable form of the defendant’s antipsychotic medication.  The decedent had begun treatment for mental illness nine years earlier, and had been taking another antipsychotic medication for five of those years.  His treating psychiatrist was the doctor selected to be the principal physician/investigator for the defendant’s clinical trial, and it was she who invited the decedent to participate in the study.

The decedent underwent a screening EKG, which revealed several abnormalities, and a blood test, which revealed slightly elevated liver enzymes. The treater concluded that the results were not clinically significant, and “based on [the decedent’s] otherwise normal physical examination and denial of a family history of cardiac disease,” she admitted him to the study. Liu, 2018 WL 272219 at *1.

Three days later, after a second blood test, the decedent was injected with a non-therapeutic one-milligram dose of the study drug to test for adverse reactions. A second EKG was performed within two hours.  The next day, the results of this EKG and the pre-injection blood test were analyzed, and they indicated worsened cardiac function and much higher liver enzymes than four days earlier.  The decedent was admitted to an acute-care hospital, where he was diagnosed with cardiomyopathy, pneumonia, failing liver function, and altered mental state.  He died two days later.

The plaintiff sued a host of study defendants, including the treater and the drug manufacturer, for negligence, product liability, and negligent failure to warn. After much motion practice, the case proceeded to trial on only the negligence claims and against only the drug manufacturer.  The defendant moved in limine to exclude the plaintiff’s cardiology and pharmacology experts’ opinions that the one-milligram test dose contributed to the decedent’s death, but the trial court admitted the testimony.

At the close of evidence, the trial judge granted a partial directed verdict, finding that the physician/investigator (the treater) was not the agent of the defendant for purposes of finding the defendant vicariously liable for her medical negligence. This left two issues for the jury to consider: 1) whether the defendant manufacturer had an independent duty to intervene in the decedent’s medical care, even if the medical issues “preexisted, or were unrelated to, the study itself,” id. at *5; and 2) the defendant’s duty to monitor the administration of the study drug, including the issue of whether the one-milligram test administration caused the decedent’s death.  The jury found that the defendant was negligent and that its negligence was a substantial factor in causing the decedent’s death, assessing the defendant’s fault at 70% and awarding $5.6 million in damages.

On appeal, the Court of Appeal considered whether the defendant had a duty to intervene in the decedent’s treatment for his preexisting heart disease, and whether there was sufficient evidence that the single one-milligram test dosage was a substantial factor in causing the decedent’s death. With respect to the first question, the court held, “We agree as a matter of law that defendant, as the drug manufacturer/sponsor of a clinical trial, undertook a general duty not to harm the study participants as part of the clinical trial protocols. Administration of the [test dose] fell within the scope of this duty, and we will discuss the sufficiency of the evidence to support liability under this duty of care . . . . But the significant legal question . . . is whether the general duty not to harm study participants encompassed a duty to diagnose or treat [the decedent’s] preexisting, life-threatening heart disease and to intervene in the medical care and decisions precipitated by [the decedent’s] abnormal test results.  . . . [W]e conclude that it did not.”  Id. at *6.

The court’s holding turned on the question of foreseeability. It explained that the general duty FDA regulations impose on study sponsors – to ensure compliance with study protocols and the participants’ safety – is intended to “protect participants generally from foreseeable harm caused by the drug studies themselves, including participants’ adverse reactions to study medications.” Id. at *7.   But it cited state law decisions standing for the proposition that “it is not foreseeable to a study sponsor that study physicians with the primary responsibility for participants’ health and safety will fail to recognize, diagnose, and properly treat preexisting, life-threatening conditions that first manifest during drug studies,” as did the decedent’s heart and other conditions. Id. (citations omitted).  Simply put, “it is not reasonably foreseeable to a drug study sponsor that the response by study physicians . . .  would fall below the standard of care for a medical practitioner.” Id. at *8.

That left the question of medical causation. As noted, the jury’s verdict was based on the testimony of the plaintiff’s cardiology and pharmacology experts. Both experts testified on direct examination that the test dose was a substantial factor in causing the decedent’s death.  But, while the pharmacologist testified that the drug could cause heart arrhythmias, she admitted that there was no evidence that the decedent died from an arrhythmia.  And, while the cardiologist “unequivocally concluded the administration of any amount of the test drug . . . was sufficient to push the decedent ‘over the edge,’ [he] did not provide a reasoned explanation that illuminated for the jury how or why such a low dose of [the drug] could have had such a substantial effect on [the decedent’s] life-threatening heart disease.” Id. As such,  the appeals court found that, “at best, [both] causation experts opined as to a theory that might have contributed to [the decedent’s] death, [they] did not provide the necessary factual basis to qualify that theory as substantial evidence.” Id. at *12.

Judgment for the plaintiff reversed. And though the decision is unpublished and can’t be cited, it reinforces the reality that duties are not unlimited and drug companies aren’t responsible for medical care and aren’t liable for everything that happens to everyone who takes their drugs.  We like this decision and wish it were published – we’ll keep our eyes open for one that is.  And now, we’d gladly use a gallon of hand sanitizer for one more stroll around the deck with a frozen yogurt cone.

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s.

Guess what?  In a development that we weren’t entirely surprised to see happen, the California Supreme Court recognized not only innovator liability, but innovator liability in perpetuity, later during the same day that our 2017 “worst of” post was published, which coincidentally was the first day of winter.  Winter is not just coming, it’s now here.  California’s tort climate just became much colder for our pharmaceutical clients.

So we’re publishing this addendum to this week’s “worst of” post.  This year there will be two number one worst of the worsts.  Given everything else that’s happened in 2017, we suppose that is appropriate.

  1. T.H. v. Novartis, 2017 WL 6521684, slip op. (Cal. Dec. 22, 2017).  Innovator liability, which effectively shifts 100% of potential liability for drug injuries to the 10% of the drug market that branded drugs represent, received the nod of all seven justices in this 4-3 decision. Y et, remarkably, the majority took the view that “the burden on brand-name drug manufacturers” to warn “those who are prescribed the generic version of the drug is zero.”  That attitude, an insouciance towards any policy supporting prescription drugs (Brown cited not at all by the majority, and only once, parenthetically, by the somewhat less restrained concurrence) was apparent throughout.  The result is pharmaceutical companies being disfavored, even compared to asbestos manufacturers. The same dismissively pro-plaintiff attitude that recently caused the same court to invite all mass tort plaintiffs to sue in California (2016-1) rears its ugly head again.  T.H. defined negligence “duty” broadly and vaguely – “each person has a duty to use ordinary care and is liable for injuries caused by his failure to exercise reasonable care in the circumstances” – so that it could characterize even this vast expansion of liability to non-manufacturers as some sort of “exception” to the a general rule that allegations of negligence make anyone liable to everyone for anything.  But then T.H. inconsistently discounted a mountain of contrary federal precedent because federal courts aren’t supposed to predict novel expansion of state-law liability.  At least Sindell, bad as it was, was honest about its unprecedented result.  T.H. is not the first time we’ve seen an opinion putting the “duty” rabbit in the hat like this to support a novel liability theory; Lance (2014-2) did the same to allow a stop-selling “negligence” theory.  Lance has preemption problems, and T.H. might, too, at least on the case-specific off-label use facts.  The majority appears to believe that off-label risk warnings can be added “unilaterally,” which they can’t.  Somewhere, Justice Traynor, who conceived of product liability as ensuring the liability followed profit from product sales and ability to control product quality, must be spinning in his grave.  Innovator liability violates both principles, and also lets off the hook the party that profited from the product and directly controlled its risk.  Almost as bad – and even more extreme – is the second holding that innovator liability is effectively perpetual.  Bookending California’s expansive “product line” form of successor liability, T.H. creates “product line” predecessor liability; so that even sale of all rights to the product before (here, six years before) the relevant product sale does not extinguish liability.  It must have been a clear day, since the majority was able to foresee forever.  On this issue T.H. was 4-3 (with the vote of a randomly selected “assigned” justice being the difference), with the dissenters rightly focusing on:  (1) lack of control over a successor’s warnings; (2) overwarning of scientifically questionable risks; (3) insufficient deterrence of the actual product manufacturers; (4) “destabilization” of the pharmaceutical industry by perpetual, unlimited liability; (5) liability spillover to other products; (6) an unrealistic attitude towards corporate transactions; (7) relative lack of moral blame; and (8) unavailability of insurance for risks of competing products and the resultant increase in the price of branded drugs.  Although T.H. is a bit less blunt in expressing the motivations for its novel liability holding than Weeks (2014-1), the California court’s underlying intent to use common-law liability to hold branded drugs hostage to federal action eliminating generic preemption is found in both in the majority’s footnote 2 and the first paragraph of the concurrence.  We trashed T.H. here, and will undoubtedly be doing that again.