Off-label Promotion in California – Same Facts, Same Law, Different Results

            This post is solely on behalf of the Dechert half of the Blog.  The Reed Smith half is involved in these cases and they ain’t saying a word (not out loud, anyway).

            As litigators, we are all too familiar with the adage “you win some, you lose some.”  Unless and until an issue is decided by the Supreme Court (and all too often not even then), the law is subject to interpretation by judges, who after all are just people with their own outlooks and biases.  Hence, we often report on cases with very similar facts but very different results –often leaving us scratching our heads.  And that’s what happened in two recent California cases involving the same spinal fusion product.  Both plaintiffs alleged unlawful off-label promotion.  One court found the claims preempted, the other did not.  Go ahead, scratch away – we can’t figure out the difference either – other than one court got it wrong.

            You can guess which we think that was.

            First, we’ve said it before and we’ll say it again:  Off-label promotion is not a tort.  Courts have so held repeatedly, here’s just a sampler.  So while in some instances off-label promotion is not permitted by the FDA, “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 349 n.4 (2001).  This statute (21 U.S.C. §337(a)) is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at 352.  The California exemptions from §337(a) − see 21 C.F.R. §808.55 − have nothing to do with these cases or this device. 

            That brings us to the court that got it right:  Coleman v. Medtronic, 2012 WL 2335532 (Cal. Super. Jun. 13, 2012).  Under Riegel, that court had previously tossed plaintiff’s claims but  allowed plaintiff to continue to try and state a non-preempted claim by allowing leave to amend on two occasions. Plaintiff there focused on a “warning” claim alleging off-label promotion.  On motion to dismiss #2, the court took a second look at permitting the warning/off-label claim based mostly on dicta from a case in Minnesota.  Moving away from the dicta and looking at the totality of implied preemption law, the Coleman court concluded, properly, that plaintiff’s off-label promotion claims were “impliedly preempted because they would involve imposing a state requirement that is different from or in addition to the federal requirement and therefore preempted.”  Coleman, 2012 WL 2335532. 

The next court, in Cabana v. Stryker Biotech, LLC, slip op., (Cal. Super. Aug. 20, 2012), didn’t agree.  Before tackling the unfortunate preemption ruling, we should point out how little’s left of that case.  In response to defendant’s motion for summary judgment, plaintiff gave up strict liability manufacturing, design defect and failure to warn claims and her implied warranty claims.  Slip op. at 4.  That's 90%+ of most product liability cases.  All that’s left is general negligence, express warranty (which invariably vanishes the moment a plaintiff has to put up or shut up about what the warranty actually was) and fraud.  Plaintiff definitely has only a small playing field left. 

As to preemption – hey wait, we thought this was summary judgment − where are the actual facts?  For some reason, the court focused almost exclusively on mere allegations in the complaint, slip op. at 2-4, and not on whether plaintiff had any evidence to support those allegations, particularly as they concern off-label promotion.  Summary judgment, however, is supposed to pierce the pleadings; bare allegations are not sufficient:

Plaintiffs cannot simply incant the magic words that Defendants violated FDA regulations in order to avoid preemption.  Moreover, the nonmovant may not defeat a properly focused motion for summary judgment by relying on mere allegations without introducing definite and competent evidence.

Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 313 (D.P.R. 2011), citing, Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir. 1994); Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 282 (E.D.N.Y. 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1158 (D. Minn. 2009), aff’d 623 F.3d 1200 (8th Cir. 2010).  We could cite a lot more, but we think the point’s been made.

Too bad for the defense in Cabana, though; that plaintiff skated.

Reading Cabana as a whole, the court seems to hold that all a plaintiff needs to do is allege a violation of federal law – in this case off-label promotion – and that’s enough to create a triable issue of fact.  We call this a “magic words” approach.  Even though we don’t like all of the recent Cornett case (see last week’s post here), the New Jersey Supreme Court at least required facts to go forward.  Off-label promotion cases must not:

• be nothing more than a private action to enforce FDA statutes and regulations;
• be nothing more than a challenge to the approval of the device or label;
• require proof of fraud on the FDA; or
• involve off-label promotional activities that are legal under FDA guidelines.

Cornett v. Johnson & Johnson, ___ N.J. ___, ___ A.3d ___, 2012 WL 3210943, at *14 (N.J. Aug. 9, 2012).  The Cornett court sent the plaintiff back with an admonition to come up with the right evidence, otherwise “defendants may move for summary judgment, and the trial court should not hesitate to grant such relief.”  Id.

Not so in Cabana.  That court didn’t care what the state law cause of action was – if the complaint alleged the magic words -- “violation of federal law” – preemption simply disappears.  Ignoring the state-law side of “parallel” was the only way the court distinguished a wealth of cases strongly in favor of preemption.  For instance, as to Riegel v. Medtronic, 552 U.S. 312 (2008), which established express preemption, the court said:

Here . . . plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements.  In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.  Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here. 

Cabana, slip op. at 4-5 (citations omitted).  That’s almost a textbook definition of a purely federal cause of action barred under Buckman and §337(a).  Heck, even Riegel involved off-label use.  552 U.S. at 320 (physician use was contraindicated by the labeling).  Likewise, the court dismissed California appellate law, McGuan v. Endovascular Technologies, Inc., 182 Cal.App.4^th 974 (Cal. App. 2010), as inapplicable, because in McGuan the plaintiff’s state law claims focused on “defects in the design, testing, and manufacture of the . . . [d]evice, the failure to warn . . ., and the fraudulent concealment of the dangers and defects of the product.”  Slip op at 5.  Oh really?  That looks no different than plaintiff’s failure to warn and fraud claims in Cabana.   If the point was to distinguish Cabana from McGuan by saying that plaintiff Cabana is bringing a claim for violation of a federal regulation, not a state law tort claim -- well, we direct your attention back to square one:  the United States, not private litigants, enforces the FDCA and FDA regulations.  Hmmm….  What should we use to make the point this time?  How about something recent?

Even if a plaintiff does properly plead facts demonstrating the defendant’s failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA.  Only the federal government may file suits against manufacturers that do not comply with federal regulations.  Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under §360k, §337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations.  As a result, Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.

Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19 (W.D. Pa. March 14, 2012).

The Cabana court was also unpersuaded by defendant’s argument that this was not a parallel violation claim because plaintiff has no evidence that any of the off-label promotion she alleges in her complaint actually violated a federal regulation. A “parallel” claim can’t be “parallel” to nothing.  We discussed this issue last week in our post on Cornett.  While Cabana cites to Cornett, at least Cornett (1) recognized the safe harbor provisions adopted by the FDA regarding off-label promotion, and (2) demanded real evidence of the purported promotion (Cornett was a legitimate pleadings-based case).  Now Cornett didn’t get it exactly either (as we alluded above), because it overlooks the fact that just because off-label promotion may fall outside the safe harbor doesn’t mean it’s tortious off-label promotion.  It’s only potentially “illegal,” and that’s up to the FDA, and the FDA only, to determine.  Cabana misses this point too.

Finally, we are left wondering how plaintiff’s off-label promotion allegations in Cabana support a failure to warn claim.  In the end, if plaintiff is basing her claim solely on allegations that defendant promoted its device for off-label purposes – then we’re in Buckman-land.  Rather, plaintiff must base her cause of action on some other recognized legal claim.  But promotion and warnings are two different things.  By definition, a failure to warn claim requires two things: a warning and causation.

As to the warning, either the risk of an off-label use is the same as that of the labeled use or it isn’t.  If it is, then the label already warns about it, and if it doesn’t, well the plaintiff is asking for something “different from or in addition to” the FDA-approved labeling.  That’s preempted.  If the risk of the off-label use isn’t shared with the labeled use, then … well, it’s the same result, isn’t it − only worse.  This sort of claim creates the potential of a finding that state law would require the defendant to add a warning uniquely related to off-label promotion.  That’s way “different from or in addition to” the approved label. 

Then there’s causation − that whatever the “known” risk (California is a state-of-the-art state) the defendant allegedly failed to warn about  was unknown to the physician using the product, that the physician actually received and relied on the allegedly inadequate information, etc….  There’s none of that in Cabana.  These additional tort requirements (required under Buckman) have nothing to do with if or how the product was supposedly promoted for off-label use.  Promotion allegations, in the end, can’t save a failure to warn claim, negligent or otherwise.  Only the FDA can require a warning about an off-label use.

All in all, we are once again wondering how two courts in the same state, governed by the same law could come to two so disparate conclusions.  While the plaintiff skirted preemption in Cabana, she still hasn’t provided the slightest indication that she actually has facts that could prove her claims – those few that remain.  On that note, we are also very familiar with the adage:  lose the battle, but win the war.   We understand from other reports on this case, there is more discovery to be done and another opportunity to have the judge in Cabana to get it right.  Here’s hoping we can report on a favorable overall outcome in Cabana in the months to come.

Read! Read! Read!

“Read!  Read!  Read!”  That’s what our late-great civil procedure professor, Bob Carter, would always shout as he led the class through another close reading of the language in a key opinion.  He was a stickler for reading the whole thing.  (He was funny too, like when he told us the story of a panhandler who failed to convince a lawyer passing by that he too had once been a lawyer, at least until he shouted to the lawyer as he walked away, “Pennoyer v. Neeeeeffffffff!!!”)  But Professor Carter was right.  You’d better read the whole thing.  He didn’t shout “Parse!  Parse!  Parse!” or “Assume!  Assume!  Assume!”  That sure doesn’t work.

And that, along with preemption, is why the plaintiff lost in Hairston v. South Beach Beverage Co., 2012 U.S. Dist. LEXIS 74729 (C.D. Cal. May 18, 2012.)  The plaintiff claimed that the labeling of a drink that he purchased had misled him.  So he brought claims under three different California statutes and the federal Magnuson Moss Warranty Act, arguing that the defendant had misrepresented its drink by (1) calling it “all natural,” (2) using fruit names to describe its flavors when it didn’t contain fruit juice, and (3) stating that it contained certain vitamins, but the vitamins were synthetic. 

The court disposed of the last two claims under California law first.  They’re preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”).  Id. at *8-9.  As we’ve posted before,

the Nutrition Labeling and Education Act (“NLEA”), which amended the FDCA, contains an express preemption provision:

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement . . .  of this title.

The court next dismissed the “all natural” claims under California law, adopting Professor Carter’s wisdom.  “Read! Read! Read!”  The label didn’t say “all natural” and stop there.  It also said “with vitamins.”  To the extent that plaintiff argued that this actually meant “with all natural vitamins,” the label also included an ingredients list.  And that list was explicit on what was in the drink, including the vitamins: 

[T]o the extent there is any ambiguity [to the “all natural” and “with vitamins” language], it is clarified by the detailed information contained in the ingredient list, which explains the exact contents of [the drink]  [R]easonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations on the packaging.

Id. at *14-14 (citations omitted).  Goodbye “all natural” claim under California state law.

We would have preferred it if the court had summarily dismissed the “all natural” claim on the basis of preemption.  The explicit preemption language of the NLEA is broad enough to encompass this claim, even if the FDA’s labeling regulations do not yet explicitly address the term “all natural.”  We’ve addressed this before.  But we’re also glad that this gave the court an opportunity to hold the plaintiff accountable for trying to parse the label to create a claim.  That’s not how lawsuits should work.

Finally, the court dismissed the federal claim under the Magnuson Moss Warranty Act.  Id. at *16-19.  We’ve already blogged on how the FDCA bars claims under other federal statutes (such as the Lanham Act) when it comes to food labeling.  This is true, too, for claims under the Magnuson Moss Warranty Act, which itself has a clause that says that its warranty protections give way to other federal legislation, such as the FDCA.  Id. at *17. 

Professor Carter was right then, and he’s right now.  If the plaintiff has just Read! Read! Read! he would have seen what the defendant was telling him all along, and this lawsuit wouldn’t have been necessary.  But then again it was fun to reminisce about Professor Carter.  Maybe a future decision will give us another opportunity to quote him.  He said lots of funny stuff. 

Is That a Pomegranate You Have There?

It’s Memorial Day weekend, and it’s time for barbeques.  While many of us will choose an alcoholic drink to enjoy during the festivities, there may be non-alcoholic drinks involved too.  Maybe a nice juice drink.  That usually means grape, apple or cranberry juice, or some combination of them.  Lately some people are even choosing pomegranate juice.  Yeah, we know, but some people are drinking it.  But when those people pick their pomegranate juice, do they always know what they’re getting? 

That’s what the plaintiff complained about in Pom Wonderful LLC, v. Coca-Cola Co., 2012 U.S. App. LEXIS 9921 (9^th Cir. May 17, 2012).  The plaintiff claimed that the defendant misled consumers with the naming and labeling of its juice product, “Pomegranate Blueberry” a/k/a “Pomegranate Blueberry Flavored Blend of 5 Juices,” because the drink actually contained only 0.3% pomegranate juice and 0.2% blueberry juice, with the vast majority of the juice being apple and grape.  Id. at *2-3. 

Now, this was a business dispute.  The plaintiff was a rival juice distributor.  But it has broader implications because it addresses what can happen when two federal statutes clash. 

The plaintiff brought its claim under the Lanham Act, which broadly prohibits false advertising and authorizes a lawsuit by anyone who believes that s/he will likely be damaged by the false advertising.  Id. at *7 (citing 15 U.S.C. § 1125(a).  The FDCA, as we know, broadly regulates food and beverage labeling.  But, while the Lanham Act authorizes private plaintiff lawsuits, the FDCA does not.  It is solely enforced by the FDA.  Id. 

The plaintiff’s Lanham Act allegations at issue in the appeal were that (i) the name “Pomegranate Blueberry” misrepresented the actual contents of the drink, and (ii) the phrase “Flavored Blend of 5 Juices” was misleadingly smaller and less conspicuous than the name “Pomegranate Blueberry.”  

But FDA regulations and the FDCA itself address naming beverages, the words and statements that must or may be included in labeling, and their prominence and conspicuousness.  Id. at *11-14 (citing 21 U.S.C. §§343(f), (i); 21 C.F.R §§102.33 (c), (d)).  That’s a conflict between plaintiff’s claims under the Lanham Act and the FDCA. 

So which applies?  The court noted that courts should “try to give as much effect to both statutes as possible.”  Id. at *8 (citing Schering--Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009)).  But when it comes to the FDCA, courts have focused on the fact that Congress entrusted the FDA with enforcement, not private plaintiffs.  Under that reasoning, courts have held that the FDCA limits all sorts of Lanham Act claims:

A plaintiff may not, for example, sue under the Lanham Act to enforce the FDCA or its regulations because allowing such a suit would undermine Congress’s decision to limit enforcement of the FDCA to the federal government.  Nor may a plaintiff maintain a Lanham Act claim that would require a court originally to interpret ambiguous FDA regulations, because rendering such an interpretation would usurp the FDA’s interpretive authority.  Where the FDA has not concluded that particular conduct violates the FDCA, we have even held that a Lanham Act claim may not be pursued if the claim would require litigating whether that conduct violates the FDCA.

Id. at *8-9 (citations omitted). 

Not surprisingly, then, the court held “that the FDCA and its regulations bar pursuit of both the name and labeling aspects of [plaintiff’s] Lanham Act claim.”  Id. at *11.  The Court reasoned, properly, that Congress and the FDA have already spoken to such naming and labeling and that the FDA, not litigants and the courts, should impose any further restrictions or, if it so finds, declare defendant’s label misleading:

Congress and the FDA have . . .  considered and spoken to what content a label must bear, and the relative sizes in which the label must bear it, so as not to deceive.  . . . [T]he FDA has not (so far as we can tell) required that all words in a juice blend’s name appear on the label in the same size or that words hew to some other standard that [plaintiff] might have us impose.  If the FDA thought such a regulation were necessary . . .  it could have said so.  If the FDA believes that more should be done to prevent deception, or that [defendant’s] label misleads consumers, it can act.

Id. at *13-14 (citations omitted).

The Court finished by explaining that it is not the place of litigation to displace the expertise of the FDA:

[W]e must respect the FDA’s apparent decision not to impose the requirements urged by [plaintiff].  And we must keep in mind that we lack the FDA’s expertise in guarding against deception in the context of juice beverage labeling. In the circumstances here, “the appropriate forum for [plaintiff’s] complaints is the [FDA].”

Id. at *16. 

That is a nice way to finish.  So enjoy your Memorial Day weekend and, if you want, your Pomegranate Blueberry juice.  But know that there might be a lot of apple and grape in that drink.  Maybe a beer or mojito  is simpler.

The Pain Pump Litigation Pumps Out another Good Decision

To us, sometimes plaintiffs’ lawyers sound like Cary Grant.  You know, “Duty, Duty, Duty.”  (By the way, “Judy, Judy, Judy” is a famous misquote.  Cary Grant never once said it in a movie.  But he did say it here – at the 0:50 and 1:30 marks.)  Plaintiffs’ lawyers are often looking for new duties and how companies failed to satisfy them.  When a traditional duty, such as failure to warn of a risk, doesn’t work, new alleged duties seem to crop up.  Susan Burnett of Bowman & Brooke kindly sent us a recent pain pump decision that’s a good example of this – Todd v. Stryker Corp., 2012 U.S. Dist. LEXIS 60953 (E.D. Cal. May 1, 2012).  And the court was having none of it.

In Todd, the traditional claim that the defendant company failed to warn of a risk of which it knew or should have known didn’t work.  The state of the science at the time that the pain pump was used in the plaintiff didn’t support the risk.  There had only been a tiny number of adverse events, a discussion of them at a medical conference, and a fairly weak set of medical literature.  Id. at *13-15 & *20-12.  And, worse for plaintiff, the company seemed to react responsibly to that information, conducting investigations of its files and the medical literature, reporting events to the FDA and seeking advice from outside experts.  Id. at *15-16.

So what’s a plaintiff to do?  Well . . . create a new duty.  While the FDA had cleared the pain pump’s 510(k) application and thereby allowed it to be marketed, it had denied another 510(k) application (apparently more than once) that sought to market it for the particular indication for which the pain pump was used in plaintiff.  Aha!  While maybe there was insufficient scientific evidence of an actual risk, the company should have warned doctors about this regulatory history.  Then maybe doctors would have some basis to speculate about a risk.

This is just what it sounds like: an attempt to sidestep the science.  But in a failure to warn case the science is not something to be worked around.  It defines the very duty that the defendant is supposed to satisfy.  Regulatory history adds nothing.  There’s a reason that labels include sections for indications, warnings, precautions, and adverse events, and not for regulatory history.  As the Todd court put it, regulatory history is simply not a risk about which a warning should be given:

There is no duty to warn the patient’s physician of a prescription product’s regulatory history, because the history is not a "dangerous propensity" about which an adequate warning must be given . . . . .

Id. at *9-10. 

That makes sense.  As we all know, the FDA denies clearance of 510(k) applications for many reasons.  Maybe the FDA decided that there was no substantially equivalent predicate device on the market, or that additional information was needed to clear the new indication. 

Putting regulatory history in a label would simply invite doctors to speculate on what it means.  That’s the opposite of what labels are for.  Doctors are experts in medicine, not regulation.  And, so, labels are places for scientific and medical information, not regulatory dockets.  (For this reason, the rule in informed-consent cases is that doctors need only inform patients of a drug's benefits and risks, not regulatory status.  See our post on this here.)  If the particular regulatory history in which plaintiff was interested was the result of science that supported the presence of a risk (which apparently was not the case), the science, not the regulatory history, should have been put in the label.  The court properly rejected this new duty. 

Plaintiff didn’t abandon regulatory history so easily, though.  She also argued that the mere fact that the FDA denied clearance for the indication signaled the need to warn of a risk.  But this thinking has the same deficiency as plaintiff’s “regulatory history” argument.  The FDA denies clearance for many reasons.  The denial isn’t what matters.  It’s the science.  And, the science didn’t support the risk. 

Undaunted, the plaintiff tried yet another new duty, one that we've seen tried before: the duty to test.  We already deconstructed here plaintiffs’ past attempts to create a claim out of the amorphous and open-ended concept of duty to test.  We even created a cheat sheet of plaintiffs’ many failed attempts.  Suffice it to say that the Todd court wasn’t buying it either.  It found, as have many other courts, that there is no such thing as an independent tort for failure to test:

When the warnings accompanying a prescription product adequately inform the prescribing physician of dangers inherent in its use, the manufacturer's alleged failure to test that product cannot, by itself, either cause injury or be a source of liability for the manufacturer.

Id. at *10.

Now, the Todd plaintiff’s claims had other, more ordinary deficiencies, including a proximate cause problem because the treating doctor decided to use the pain pump and medication on the basis of his own training and judgment, not any alleged influence by the company.  Todd, 2012 U.S. Dist. LEXIS 60953, at *23-25.  But what makes Todd most interesting, at least to us, was the court’s treatment of plaintiff’s less ordinary claims – the new duties, duties, duties.  The court wasn’t having any of it.

A 100% Naturally Bad Preemption Decision

            Sometimes a decision bounces around a bit before it lands on our plates.  But when we finally spot it and read it, we realize it might be worth a quick chew.  It may be a tasty little tidbit like a particularly good Twiqbal decision outside the drug/device arena.  A savory morsel on a regulatory scheme and preemption involving an agency other than the FDA.  And, sometimes it can be a sour bite – the type that makes your lips pucker and want to spit it out.  That’s precisely what we’d like to do with almost all of a recent decision by the Central District of California – spit it out and throw it away.  Since we can’t do that – we decided we’d blog about it. 

            If our above metaphors weren’t obvious enough, we’re talking about a food case – Briseno v. ConAgra Foods, Inc., 2011 U.S. Dist. LEXIS 154750 (C.D. Cal. Nov. 23, 2011).  And, I guess we can start with the good news – the case was dismissed without prejudice under Rule 9(b) for failure to plead fraud with particularity.  Id. at *29-41.  While we applaud the court for getting it right on the deficiency of the pleadings – they left the door wide open for this suit to spring back to life.  That’s the sour part. 

            The case is about oil – not the black gold kind – the kind we pour on salads and use to fry chicken.  Wesson Oil to be exact.  Do you remember the Florence Henderson TV commercials from the 1970s – “Your chicken has a certain Wessonality” and 1980s – “with every bite you know you’re frying right.”    Who wouldn’t buy cooking oil from Mrs. Brady (wait a minute, didn’t Alice do all the cooking?).  In fact, some form of Wesson cooking oil has been on the market since the 1860s.  So, who can possibly have a problem with it?  Answer:  a group of plaintiffs who filed a nationwide putative class action alleging that Wesson’s labeling of the product as “100% Natural” is false and misleading because the manufacturer “uses plants grown from genetically modified organism seeds.”  Briseno, at *4.  We direct your attention back to the 1980s Mrs. Brady ad – Wesson’s label has said 100% Natural since at least then – 25 years ago.  So what’s the problem?  And, if this is a food labeling issue – why isn’t it preempted?  Like we said, we’re making the lemon face.

            Plaintiffs alleged causes of action for violations of California’s false advertising law (“FAL”), unfair competition law (“UCL”), Consumer Legal Remedies Act (“CLRA”), and breach of express warranty.  In addition to restitution, plaintiffs sought 1) “a permanent injunction enjoining ConAgra from continuing to harm [plaintiffs]” and 2) “an order requiring ConAgra to adopt and enforce a policy that requires appropriate disclosure of genetically modified ingredients and/or removal of misleading natural claims.”  Id. at 5-6.  We mention these two requests because somehow the court found #2 was preempted but #1 was not.  If the alleged harm is that the FDA-approved label says “100% Natural” and doesn’t identify genetically modified ingredients, then isn’t an injunction to stop that harm a court-ordered revision of the label?  In other words, a state law requirement that ConAgra label its product differently than what is required by the FDA?  We fail to see how the requested injunctive relief is different from an order requiring removal of “natural” claims.  They both have the same effect – a change of the label contrary to the requirements of the FDA.  So shouldn’t both be preempted?

            To try to understand the court’s reasoning, let’s start where it did – the Nutrition Labeling and Education Act (“NLEA”) which contains an express preemption provision:

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement . . .  of this title.

21 U.S.C. § 343-1(a)(5).  We think this is the equivalent of “Check, please.”  This meal is over – case preempted.  But even if there remain a few notches on the belt that can be loosened to allow for another course, we don’t think the analysis leads to the conclusion the court reached here.

 

            The Briseno court cites other cases where plaintiffs claimed to have been misled by a manufacturer’s use of the term “all natural” (usually dealing with the inclusion of high fructose corn syrup) and those claims were held to be not preempted.  We’d probably disagree with the reasoning of those decisions as well.  What we found more interesting was the court’s attempt to distinguish this case from others where plaintiffs were asking the court to require a manufacturer to change a label that was permissible by the FDA.  For example, they dismiss the holding in Dvora v. General Mills, Inc., 2011 U.S. Dist. LEXIS 55513 (C.D. Cal. May 16, 2011) as inapplicable.  There plaintiffs alleged that the manufacturer’s advertising of “Total Blueberry Pomegranate” cereal was false and misleading.  In finding the claims preempted, that court said:

Defendant persuasively argues that Plaintiff's lawsuit seeks to impose requirements that are not identical to th[e] regulatory scheme. First, Plaintiff apparently seeks to forbid General Mills from labeling its product “Total Blueberry Pomegranate,” even though such descriptions of “characterizing flavor” are expressly authorized by federal law. Second, Plaintiff appears to demand that General Mills affirmatively state on the package that the cereal “does not actually contain blueberries or pomegranates,” even though FDA regulations would not require this. Third, Plaintiff objects to the depiction of brown colored “clusters” that (according to Plaintiff) allegedly “resemble blueberries and/or pomegranate seeds,” even though FDA regulations would have permitted General Mills to depict even fresh blueberries and pomegranates on its box.

Dvora, at *4.  That’s different from the Wesson Oil case how?  The FDA regulations don’t prohibit pictures of blueberries on the cereal box just like they don’t prohibit defendant from putting “100% Natural” on its bottle.  If the lawsuit “seeks to impose requirements that are not identical to the regulatory scheme” – the claims are preempted.  The regulatory scheme here seems to have allowed a claim of “100% Natural” for at least 25 years. A court order that requires that claim be removed is most certainly “not identical.”  Indeed, the Briseno court itself found:

Congress and the FDA have thoroughly regulated the manner in which ingredients must be listed on packages, including specifying how oil products must be labeled. See, e.g., 21 U.S.C. § 343(i)(2); 21 CFR § 101.4(b)(14).  Entering an order of the type Briseno seeks would impose a requirement that is not identical to federal law, and his prayer for such relief is thus preempted.

Briseno, at *26-27 (emphasis added).  Again, we are left perplexed by the court’s ability to use this analysis to reach different conclusions on two claims that seek the same relief – a change in the label.   

The court seemed to be singularly focused on the fact that despite the “considerable interest to consumers and industry,” FDA has not sought to define terms like “natural” in the food context (FDA invokes the “limited resources” defense).  Id. at *16.  But that doesn’t change the fact that Congress has empowered FDA – not the judiciary – with controlling the labeling content of food.  So, we also support ConAgra’s second argument, that if not preempted, the case should be dismissed or stayed under the doctrine of primary jurisdiction.

[P]rimary jurisdiction is properly invoked when a claim is cognizable in federal court but requires resolution of an issue of first impression, or of a particularly complicated issue that Congress has committed to a regulatory agency.

Id. at *28 (citation omitted).  Essentially, the doctrine provides that courts may decide that for the sake of “better informed and uniform legal rulings,” initial decision-making responsibility should be performed by an agency with “specialized knowledge, expertise, and central position within a regulatory regime.”  Id. at *27.  If the agency entrusted to decide these issues has yet to resolve the question, why should the courts? 

            This is something we like to call “judicial triumphalism” – the use of tort litigation for social purposes to induce courts to step in and make decisions on issues that are more competently addressed by other branches of government – here the FDA.  If people want to attack the use of genetically modified food, they should be going to Congress and the FDA and courts should be stepping aside, rather than be used as a platform for the advancement of social causes.  If you haven’t already guessed, the court was not persuaded by the primary jurisdiction argument either. One of the court’s reasons was because FDA has not shown an indication that will “provide guidance on the use of the term ‘natural’ in the immediate future.”  Id. at *29.  Well, maybe if the champions of this cause were properly blocked from using the courthouse to fight their battle, they would re-direct their efforts where they belong – at the FDA.

            FYI – plaintiffs did file an amended class action complaint and defendant has filed another motion to dismiss set to be heard next month – so stay tuned, we haven’t reached the final course. Although we aren’t optimistic that what’s coming will be any easier to swallow.

A Pro-defense Decision – Good for the Digestion

            As an openly defense-oriented blog, most of our posts deal with cases in which plaintiffs could not make out their claims.  They didn’t have sufficient evidence of a design defect.  They couldn’t prove proximate causation.  That type of thing.  But, what if plaintiff’s claim is that the defendant can’t prove its claim about its product?  Well, in California, you can’t do that. 

            That was the issue addressed by the court in Stanley v. Bayer Healthcare LLC, 2012 U.S. Dist. LEXIS 47895 (S.D. Cal. Apr. 3, 2012).  Plaintiff’s doctor recommended she take probiotics to help relieve the diarrhea she had been experiencing as a result of her diverticulitis.  Based on her pharmacist’s recommendation, plaintiff purchased Phillips’ Colon Health Probiotic Caps (“PCH”), which contained the following statement: “Helps Defend against Occasional DIARRHEA.”  She used the product for about a week without any relief.  She filed a consumer fraud class action complaint one week later.  Id. at *2-4.  Seems to be curious timing, but we’ll refrain from further comment on that.  Because, despite the quick filing of the suit, plaintiff had almost a year to develop her allegations and theories – without success.

            Attempting to state a claim under California’s Consumer Legal Remedies Act (“CLRA”) and Unfair Competition Law (“UCL”), plaintiff alleged that defendant’s statements about the digestive and health benefits of PCH were false and misleading because defendant had “a complete lack of scientific or clinical data to support its claims,” and defendant “fail[ed] to provide the consumer with a single bit of information that would support its claims about the benefits of the [PCH],” and defendant’s claims “are not substantiated by the vast majority of generally accepted scientific literature.”  Id. at *5.   Putting aside whether plaintiff could prove any of those allegations, she had a bigger problem – California doesn’t recognize a private cause of action for failure to substantiate an advertising claim:

Private individuals may not bring an action demanding substantiation for advertising claims. Instead, pursuant to Cal. Bus. & Prof. Code § 17508, only prosecuting authorities may require an advertiser to substantiate its advertising claims.

Id. at *9 (citations omitted).  See National Council Against Health Fraud, Inc. v. King Bio Pharmaceuticals, Inc., 107 Cal. App. 4th 1336, 1344 (2003) (“[p]rosecuting authorities, but not private plaintiffs, have the administrative power to request advertisers to substantiate advertising claims before bringing actions for false advertisement ....”).

Faced with this clear statement of the law, plaintiff acknowledged that a claim based on lack of substantiation wasn’t actionable, but then responded to defendant’s motion for summary judgment on this ground by arguing that defendant failed to substantiate its claims.  Stanley, 2012 U.S. Dist. LEXIS 47895, at *12.  Huh?  If you are shaking your head in confusion, so are we and apparently so was the court:

Plaintiff argues at length both in her motion for class certification and in opposition to the summary judgment motion that Defendant's claims regarding the general digestive and immune system health benefits of PCH are actually false because they lack proper scientific substantiation. However, the alleged lack of substantiation does not render claims false and misleading under the UCL or CLRA.

Id. at *12.  Plaintiff’s expert evidence suffered from the same fatal flaw – none of plaintiff’s experts opined that defendant’s statements about the product’s benefits were “actually false, or explain[ed] how those statements might mislead a reasonable consumer.”  Id. at *15-16.  Rather, they focused on an alleged lack of substantiation – for which there is no private cause of action.

 

            Apparently waking up to the reality of having targeted a non-actionable claim, at the time of the class certification and summary judgment hearing, plaintiff argued for the first time that she could maintain her action under the “unlawful conduct” arm of the UCL.   The alleged unlawful conduct was defendant’s failure “to properly substantiate its claims pursuant to standards set by the FDCA.”  Id. at *19.  The court had several reasons for discounting plaintiff’s “unlawful conduct” argument, including that it raised issues regarding preemption that would have required briefing and that it was still essentially a lack of substantiation claim.  Id.  But the court examined the underlying evidence anyway, which didn’t further plaintiff’s cause. 

            Under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), manufacturers of dietary supplements, which PCH is, are allowed to make certain “structure/function claims” without pre-approval by the FDA.  Id. at *21.  Structure/function claims are statements that

describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize[] the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.

Id.  (quotation marks omitted).  A dietary supplement manufacturer must provide notice to the FDA within 30 days of first use of a structure/function claim, and must include a disclaimer on the label stating that “the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease.”  Id. (citations and quotation marks omitted).

            Plaintiff’s experts, therefore, attempted to opine that the statements on the PCH labeling were health claims – which require more rigorous substantiation -- not structure/function claims.  However, plaintiff’s experts had to admit that they didn’t know how the FDA defines a health claim.  To which the court had this to say:

Plaintiff cannot create a genuine issue of material fact regarding whether Defendant met the level of substantiation required under federal law by presenting opinions from experts who are not aware of the relevant regulatory standards.

Id. at *23.  We certainly like the sound of that.

            Plaintiff tried a few other avenues to attempt to save her claim, but they proved to be as full of potholes as the lack of substantiation claim:

• The product didn’t work for me – OK, but “nothing on the PCH box, internal packaging, or advertisement represents to consumers that the product is intended to relieve diarrhea. The fact PCH did not relieve Plaintiff's diarrhea does not mean a reasonable consumer would be mislead into believing it would work as Plaintiff suggests. The Plaintiff has failed to produce any evidence that the product does not work for the purposes for which it is advertised - to promote overall digestive health and to defend against occasional diarrhea and other gastrointestinal issues.”  Id. at *24.

• They didn’t tell me I had to take it continuously – But the packaging said:  “Daily Probiotic Supplement” and the label directs that PCH is “to be taken Daily or Everyday to support digestive health.”  So, “what additional material fact [did] Defendant [have] an affirmative duty to disclose?”  The court agreed that plaintiff left that question unanswered.  Id. at *27-28. 

• A different size bottle of PCH that I didn’t buy contained a statement that I didn’t rely on about scientific studies that I allege is misleading – The court’s conclusion is self-explanatory:  “There is no evidence Plaintiff . . .ever saw the [statement].  Thus, the statement cannot form the basis of Plaintiff's false advertising claim.”  Id. at *30. 

So, no private cause of action for lack of substantiation plus no evidence to prove any statement was false or misleading equals no class action.   Toss in the good expert sound bites and this case certainly sits well in our stomachs. 

Foreseeability Gets Its Wings Clipped In California

Late last night we received this message from a correspondent (who will remain anonymous since we lack permission):

Hopefully the groundwork for getting Conte thrown-out has been laid.  Only a matter of time.  And with any luck we’ll have an opportunity some day soon.

Getting a message like that makes us sit up a little straighter.  So we took a look at the attached case, O’Neil v. Crane Co., S177401, slip op. (Cal. Jan. 12, 2011), and we can see what she’s talking about.

As readers may recall from our original rants about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), we think that decision is just flat wrong.  The California Supreme Court’s unanimous decision in O’Neil only reinforces that view.

O’Neil involved asbestos.  The plaintiff worked on an aircraft carrier.  Decades before the plaintiff was aboard ship, one class of defendants made the carrier’s propulsion system.  Those defendants supplied products that had no asbestos at all, but were manufactured to specifications that required addition of asbestos insulation from other sources.  Slip op. at 2. They were sued because it was “foreseeable” that asbestos would be used in conjunction with their products.

A second group of defendants made the asbestos-containing gaskets that were components of the ship’s engines.  These gaskets wore out and were replaced by similar products made by others well before plaintiff was aboard ship.  Id.  They were sued because it was “foreseeable” that their products would wear out and be replaced by other asbestos-containing products.

In neither case did plaintiff allege that he was exposed to asbestos from any products actually sold by the defendants.  Slip op. at 6.

In O’Neil the court unanimously held that “foreseeability” did not trump the other policies animating product liability – and did so for both strict liability and negligence.

As to strict liability the court stated:

We have never held that strict liability extends to harm from entirely distinct products. . . . Instead, we have consistently adhered to the Greenman formulation requiring proof that the plaintiff suffered injury caused by a defect in the defendant’s own product.

Slip op. at 10.

There is no duty to warn in California about defects in another supplier’s product, even though the defendant also failed to warn about similar risks in its own product:

[Defendants] gave no warning about the dangers of asbestos . . . in their products.  However, [plaintiff] never encountered these original parts. His exposure to asbestos came from replacement gaskets and packing and external insulation added to defendants’ products long after their installation. . . .  There is no dispute that these [other] products were made by other manufacturers.  No case law supports the idea that a manufacturer, after selling a completed product to a purchaser, remains under a duty to warn the purchaser of potentially defective additional pieces of equipment that the purchaser may or may not use to complement the product bought from the manufacturer.

Slip op. at 15 (citation, quotation marks, and footnote omitted).  Substitute a prescribing physician for the navy in O’Neil and you’ve got Conte.

Imposition of warning duties relating solely to other manufacturers’ products goes “too far”:

An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far.  There is no precedent in California law for such a broad expansion of a product manufacturer’s duty.

Slip op. at 25-26.

Where the exposure comes solely from subsequent exposure to other manufacturer’s products, there is no warning liability based on “foreseeability.”  “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.”  Slip op. at 27.  “[T]he foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a nondefective product, or one whose arguably defective product does not actually cause harm.”  Id. at 28.

We reaffirm that a product manufacturer generally may not be held strictly liable for harm caused by another manufacturer’s product.  The only exceptions to this rule arise when the defendant bears some direct responsibility for the harm, either because the defendant’s own product contributed substantially to the harm, or because the defendant participated substantially in creating a harmful combined use of the products.

Id. (citations omitted).

Public policy requires that product liability be limited to the manufacturers of products that actually cause harm.

• “[A] manufacturer cannot be expected to exert pressure on other manufacturers to make their products safe.” Slip op. at 30.
• Non-manufacturers “will not be able to share the costs of ensuring product safety with these other manufacturers.”  Id.
• “It is also unfair to require manufacturers of nondefective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.”  Id.
• “[I]mpos[ing] on manufacturers the responsibility and costs of becoming experts in other manufacturers’ products . . . would impose an excessive and unrealistic burden.”  Id. (citation omitted).

Now, Conte involved a “negligent misrepresentation” claim rather than strict liability, but that won't save it from O'Neil.  See 85 Cal. Rptr.3d at 310 (“this is a case involving legal principles of negligent misrepresentation, and not a products liability action”), 310 n.7 (“negligent misrepresentation will subsume intentional fraud”).

O’Neil goes on to reach the same result – holding that there is no equivalent non-manufacturer liability claim in negligence.  The California Supreme Court directly addresses “foreseeability” and its limits, applying the public policy factors that Conte refused to address.  “[I]n strict liability as in negligence, foreseeability alone is not sufficient to create an independent tort duty.” O'Neil, slip op. at 29 (citation and quotation marks omitted) (emphasis added).  “Duty” in negligence “is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.”  Id. at 30-31.

The plaintiff in O'Neil argued foreseeability uber alles.  The court did not agree:

[F]oreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.

Slip op. at 31 (citations and quotation marks omitted).  Rather, “when the consequences of a negligent act must be limited to avoid an intolerable burden on society, policy considerations may dictate a cause of action should not be sanctioned no matter how foreseeable the risk.  Id. (citation and quotation marks omitted).

These “policy considerations” (the same Rowland v. Christian factors that Conte ignored, 85 Cal. Rptr.3d at 814) mandate no liability where product-related claims are being made against non-manufacturers.

• The connection between defendants’ conduct and [plaintiff’s] injury is extremely remote because defendants did not manufacture, sell, or supply any . . . product that may have caused his [injury].”  O’Neil, slip op. at 32.
• Plaintiff’s injury is “attenuated,” as it occurred decades after the allegedly negligent conduct  Id.
• “[L]ittle moral blame can attach to a failure to warn about dangerous aspects of other manufacturers’ products.”  Id.
• “There is no reason to think a product manufacturer will be able to exert any control over the safety of . . . products made by other companies.”  Id.
• “Manufacturers may also have scant ability to influence their customers’ choices about other products.”  Id.
• “[R]ecognizing a duty of care would clearly impose a significant burden on defendants and all other companies that could potentially be held liable for injuries caused by products they neither made nor sold.”  Id. at 33.
• “[R]ecognition of such a duty could lead to an overabundance of potentially conflicting product warnings.”  Id.
• “[I]t is doubtful that manufacturers could insure against the “unknowable risks and hazards” of other manufacturers’ products used decades later.  Id.

For all these reasons, the court in O’Neil unanimously held that, regardless of foreseeability, there should be no negligence liability against the manufacturer of one product for injuries caused by similar products manufactured by other companies:

[E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law. [S]ocial policy must at some point intervene to delimit liability even for foreseeable injury. The same policy considerations that militate against imposing strict liability in this situation apply with equal force in the context of negligence.

Slip op. at 33 (citations and quotation marks omitted).

We hope, as did our anonymous correspondent, that O’Neil spells the beginning of the end for Conte.