Gather round brothers and sisters, and hear the word of the Texas Court of Appeals. Today’s sermon addresses the intersection of religion and regulation.  Take out your hymnal, and turn to Hawkins v. State, 2018 Tex. App. LEXIS 7863 (Texas Ct. App., 14th Dist. Sept. 27, 2018).  Consider the case of Mr. Hawkins, hereinafter referred to as “the defendant,” but who self-identified as a bishop of the Genesis II Church of Health and Healing.  A primary teaching of said church was the amazing curative power of “MMS,” which variously stands for Miracle Mineral Solution, Master Mineral Solution, or  Miracle Mineral Supplement. (We think of MMS as an abbreviation either for the more prosaic Multimedia Messaging Service or the sillier Make Me Smile.  But who are we to depart from church doctrine?).  MMS is a sodium chloride product typically used as a disinfectant.  It is an industrial bleaching agent.  The defendant held monthly seminars and taught his flock how to mix and consumer MMS.  And what bounty shall this marvelous MMS elixir deliver?  Why, nothing less than a cure for cancer, HIV, heart disease, autism, and Ebola.  So sayeth the defendant.


The state of Texas heard this preaching and, lo, announced that it was Bad.  The state filed an action under the Deceptive Trade Practices Act (DTPA). The main prayer for relief was to enjoin the defendant and his followers to refrain from promoting MMS.  Justice in Texas was swift.  The state’s prayer was answered.  The MMS folly was put asunder.  The injunction was issued.  Thusly were poor innocents spared the fate of dousing their innards with bleach and tumbling into the fiery pit of disease and despair.


But the defendant gnashed his teeth against this ruling, and filed an appeal.  Alas, his teeth must still be gnashing, because the Court of Appeals decreed that the trial court’s ruling was Right and Good.


As a preliminary matter, the trial court quickly disposed of a raft of frivolous arguments, such as that the court had no jurisdiction over a sovereign church, that the government lawyers were unauthorized to practice law, that a church cannot be a dba, and that there was no contract between church and state.  For anyone who clerked and had to attend to tax objector appeals, this litany of beefs will seem familiar.  Sometimes the hardest part for a court or opponent is first to figure out exactly what the argument is, then restate it cogently, then bash it with solid precedent (which is much preferable to the jawbone of an ass, though we have occasionally encountered or even employed that weapon, too, in our almost two score of legal practice).


The actual substantive argument by the defendant is the most interesting: that “no one has the right to prevent a church or its believers from teaching its belief and offering its sacraments if the sacraments do not consist of controlled or illegal substances.”  Ah, at last we arrive at the type of lofty issue we might have encountered in Con Law class.  But the religious freedom claim here is framed exceedingly weakly.  The state brought the DTPA action on the grounds that the defendant had engaged in false, misleading, and deceptive ads and practices by promising benefits of MMS that it in fact lacks, by failing to disclose the utter lack of scientific research supporting such claims, and, worst, by failing to disclose the health risks of MMS.  Religious freedom is not a freedom to poison fellow citizens.  That much is clear.   We’d also say that religious freedom is not a freedom to lie to one’s fellow citizens, but even with the passing of Christopher Hitchens we’d expect some debate on that proposition.  But more to the point, religious freedom does not call off neutral application of the state’s police powers.


Whereupon the Hawkins court consulted a Higher Authority – the federal Food and Drug Administration.  In 2010, the FDA issued a safety alert about MMS, warning that it was an industrial bleach used for stripping textiles, and that consumption of MMS could lead to nausea, vomiting, diarrhea, and severe hydration.  At least one person suffered a life-threatening reaction after drinking MMS.  That’s the FDA warning against physical harm, not taking sides in some religious schism.


What’s the church’s position? According to at least some MMS labels, reactions such as nausea and vomiting were “evidence that MMS is working.”  Indeed, MMS seems to work in mysterious ways.  Some of the most damning evidence resides on the defendant’s website.  Those who adhered to the ways of MMS would know how to fix 95% of mankind’s maladies.  The church claimed to be “superior to health insurance.”  (Okay, our mind might be open about that one.). Learn about MMS, and you can call yourself a Reverend.  Dispense MMS to 50 unlucky people, and you can call yourself Doctor.


But the defendant probably should not call himself Lawyer.  For all of his arguments fell on deaf ears.  Hawkins was not a case of religious discrimination.  The police power of the state had not been exercised arbitrarily or capriciously.  Render unto Caesar, etc.  Little wonder that the appellate court wasted little ink in affirming the trial court’s ruling and offering an easy Amen.


It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue.  This time the case was U.S. ex rel. D’Agostino v. EV3, Inc., 2015 U.S. Dist. LEXIS 173025 (D.Mass. Dec. 30, 2015), and, again, the motion to amend was denied.  The reasons for the denial were futility and undue delay.  The reasons for those reasons are fairly interesting.

But first, permit us to vent about qui tam cases.  That “ex rel” in the caption of today’s case tells you that it is a qui tam case.  The D’Agostino case was brought by a former employee of one of the defendants.  Some might call him a whistle-blower.  Some, as we shall see, might not.  He was a medical device sales rep and he alleged that the defendants violated the federal False Claims Act and the False Claims Acts of twenty-six states and the District of Columbia.  A False Claims qui tam action is brought on behalf of the government.  It is a relic from the Civil War era and arose to address sellers of war goods who were cheating the government.   A do-gooder who knew about the cheating would file an action and get moneys returned to the treasury, with the do-gooder taking a cut.  Everybody wins, right?  By the way, the do-gooder is not actually called a do-gooder; instead, the term “relator” is used.  After the relator files a qui tam action, the government then decides whether it wants to intervene in the case.

In D’Agostino, the governments  did not intervene.  By the light of any sentient onlooker, that decision not to intervene suggests that the case is not especially strong.  It also appears that some of the whistle-blowing was no big deal, because some of the allegations were already matters of public disclosure.  That is not at all atypical of these cases.  While the qui tam plaintiffs bar likes to brag about how it is doing a public service, more often the cases are merely opportunistic lunges for bounties.  That qui tam plaintiffs bar is also indignant that not every state has seen fit to pass its own False Claims Act.  Multiple false claims acts multiply bounties without actually increasing any worthwhile enforcement.  And we have not yet even gotten to the bit about how the allegations of false claims are specious because there is no actual false claim.

Continue Reading D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era.  To be very brief, Jurisfiction is the fictional police force for BookWorld, one of Fforde’s fictional universes.  Tuesday is a Jurisfiction agent (sometimes rather more than that).

“Jurisfiction,” unfortunately, is also something we see in our line of work, sometimes making us wonder whether the likes of Emperor Zhark, the Red Queen, and Pinky Perkins may have aliases who serve in the all-too-real judicial branches here in the States.  Jurisfiction is shorthand for a decision that gets a legal issue totally bollixed  – perhaps applying the UltraWord to the issue – allowing the user to control the plot, garbling it, and ultimately making all precedent useless.

We recently ran across a shining example of jurisfiction in the discussion of FDA warning letters found in Mihok v. Medtronic, Inc., ___ F. Supp.3d ___, 2015 WL 4722847 (D. Conn. Aug. 10, 2015).  Here’s what Mihok held on that subject:

The Complaint is rooted in FDA Warning Letters which state that [defendant] failed to comply with the CGMP regulations. . . .  While perhaps not dispositive on the issue, the FDA’s conclusions and interpretations of its own regulations are likely to receive a considerable degree of deference.  See, e.g., Conroy v. Dannon Co., Inc., No. 12 CV 6901(VB), 2013 WL 4799164, at *6 (S.D.N.Y. May 9, 2013) (stating that the FDA’s interpretations of its own regulations promulgated under title 21 “are ‘controlling unless plainly erroneous or inconsistent with the regulations’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment”) (citing and quoting PLIVA, Inc. v. Mensing, ––– U.S. ––––, ––––, 131 S.Ct. 2567, 2575, 180 L.Ed.2d 580 (2011)); Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622, 632 (4th Cir. 1993) (finding district court abused its discretion in refusing to consider regulatory agency’s assessment of defendant’s compliance with agency regulations and noting that the district “court should welcome [the agency’s] appraisal of [the defendant’s] compliance with regulations, given its concern for deference to agency interpretations of its own regulations”). Indeed, it is precisely when a court is called upon to interpret the regulations, i.e., when they are ambiguous, and where their application to facts raises complex issues, that the court is most likely to defer to the FDA’s prior determinations.  See Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013) (noting that “an agency’s informal interpretation of its own ambiguous regulation is [typically] controlling” but declining to give “deference to two warning letters that the FDA sent” because neither party to the case “contended that the FDA regulations . . . [w]ere ambiguous, and the Court d[id] not find that they [we]re”); James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015) (“The FDA is allowed great deference in the interpretations of its own regulations…. The more complex the issue, the more scope is likely to be given for the FDA to draw the interpretations.”).

As to deference, Defendants cite a non-binding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), for the proposition that “a warning letter from the FDA is not considered a final agency action,” and contend that, as a result, “Plaintiffs’ allegations … raise legal questions as to the potential effects of various actions by a federal agency … [which] should be decided in a federal forum.”  The Second Circuit has not taken a position on whether an FDA Warning Letter is considered a final agency action.  Even if it is not, such letters may still be entitled to deference.  See Cmty. Health Ctr. v. Wilson-Coker, 311 F.3d 132, 138 (2d Cir. 2002) (“[E]ven relatively informal [agency] interpretations, such as letters from regional administrators, warrant respectful consideration” where the statute at issue is complex and the regulatory agency possesses “considerable expertise”) (citations and quotations omitted).  Regardless, they may serve as evidence of regulatory violations.  Gelber v. Stryker Corp., 788 F. Supp.2d 145, 155–56 (S.D.N.Y. 2011) (finding plaintiffs who provided FDA Warning Letters as evidence of violations of FDA regulations stated claims for manufacturing defects).

Mihok, 2015 WL 4722847, at *5-6 (citations not omitted, for once).  Under this analysis, there being no undecided FDA-related issue, Mihok was remanded to state court.

Continue Reading Warning Letters and Jurisfiction

Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.

We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease (“IBD”). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims.   For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change.

We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.

The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings. Continue Reading Deeper Dive on New Jersey Accutane Summary Judgment Decision

Today’s post comes from the non-Dechert side of the DDL blog.

This week is the anniversary of the beginning of Facebook.  The question of whether Zuckerberg et al. could successfully “monetize” that platform has apparently been answered.  There are almost as many ads and push notifications as there are things that we actually care about, such as pictures and updates from friends and family.  Even worse than the ads are the political rants, stalker high school classmates, and suggestions to join stupid games.   After a nephew invited us to play Farmville for the fifth time, we unfriended him.  It was an easy call, especially since most of his entries involved home-made backyard mixed martial arts films and his f-bomb quotient would have made the makers of Scarface and Midnight Run blush.   Why isn’t there a “Dislike” button we can click?

But today we will “Like” a pair of decisions out of the Southern District of Texas.  The cases are Jackson v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9286 (S.D. Tex. Jan. 27, 2015), and Garza v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9292 (S.D. Tex. Jan. 27, 2015). The cases involve the same judge, the same defendants, and the same claim that ingestion of Reglan/metoclopramide caused tardive dyskinesia.  They were issued on the same date.  Both opinions are short, well-reasoned, and follow settled Fifth Circuit law.

Continue Reading S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim

Some states have statutes that we find very helpful.  Louisiana has the Louisiana Product Liability Act, with its strong exclusivity clause; New Jersey’s PLA provides some very helpful presumptions, including a presumption of adequacy for FDA-compliant drug labeling.  We have often cited the Texas statute that creates a presumption that pharmaceutical manufacturers and sellers are not liable for allegedly inadequate warnings if the labeling was approved, unless the plaintiffs can rebut the presumption in specific ways.  Michigan has a good statute too, which we will get to in a moment.

We like these statutes because they are one step closer to the high-regulation, low-litigation model of product liability that we favor.  We say that not just because we represent drug companies and medical device manufacturers, but also because it is the best approach for the consistent and effective regulation of medical products. Regular readers are familiar with the conundrum created when drug and medical device labeling is regulated through civil litigation.  As we recently wrote in connection with primary jurisdiction, when the FDA determines what drug labeling should and should not say, it applies its expertise to a balanced view of the product’s risks and benefits. When regulating that same labeling through civil litigation, the jury sees only the one plaintiff who has experienced an alleged injury.  It is a skewed and incomplete depiction of the product’s true risk profile and, by extension, the adequacy of the labeling that accompanies it.  A balanced view ensures that life-saving and life-improving products will remain available to patients in need and that doctors will have the information regarding risks and benefits necessary to make informed treatment decisions.

Because we feel this way, we lament the fact that state product liability statutes often deal with drugs, but not medical devices.  Texas and Michigan are both that way, and we don’t know why that should be.  All drugs have risks and cannot be made one-hundred percent risk free.  Same with medical devices.  That’s why a doctor’s prescription is required.  Drugs are regulated by federal law administered by the FDA.  So are medical devices.  Drugs are accompanied by approved written information stating their indications and setting forth their risks in a regimented way.  Medical devices?  Check.  Ditto the common law.  Courts overwhelmingly apply both the learned intermediary rule and comment k in the same fashion to drugs and medical devices.  The same policy considerations apply, and urge the application of those laws in medical device cases when we have the opportunities.  If bills were introduced to expressly extend those states’ laws to medical devices, we would vote for them.

Imagine then our disappointment when we read Miller v. Mylan, Inc., No. 12-2502, 2013 U.S. App. LEXIS 1077 (6th Cir. Jan. 21, 2014), where the Sixth Circuit actually narrowed the application of Michigan’s statute (we told you we would get back to Michigan’s statute) and expanded the role of litigation in regulating a drug.  In Miller, the patient used an analgesic skin patch and sadly died, which resulted in a lawsuit against the product’s manufacturer.  The manufacturer moved to dismiss the complaint under Michigan’s statute, which states that

a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with [FDA’s] approval at the time the drug left the control of the manufacturer or seller.

Id. at *3 (quoting Mich. Comp. Laws § 600.2946(5)).  The manufacturer argued that it was entitled to the statute’s protection, and the district court agreed and dismissed the complaint.  This was the correct result.  The Michigan statute does not “immunize” drug manufacturers like they are diplomats who freely ignore parking laws.  It cuts off civil liability if the manufacturer fully complies with the federal regulatory regime set up to ensure the safety and efficacy of prescription drugs.  That’s what we were talking about before—high regulation, low litigation.

The case went off the rails in the Sixth Circuit, where two judges took a look at the product and decided that maybe it was not a drug after all.  Maybe it was a “combination product,” which is an FDA term of art.  And if that’s the case, then a Michigan statute “that immunizes manufacturers of ‘drugs’ from suit” would not apply.  Id. at **1-2.  Oddly, the plaintiffs made this argument neither in the district court nor in the Court of Appeals, and the term “combination product” did not appear in the parties’ briefs until after the Sixth Circuit sua sponte requested supplemental briefs on whether the product was a “combination product” and whether the statute would apply to such a product.  Appellate clerks have a term for this:  It’s called a “rescue mission,” which is when an appellate court really wants to reverse a judgment and does its own research to re-craft the appellant’s argument to enable that result.

We feel sympathy for the decedent too, but the Sixth Circuit’s mission took Michigan law in the wrong direction.  To be clear, the analgesic skin patch was a drug.  How do we know that?  Well, the plaintiff (the decedent’s successor) alleged it was a drug in her initial complaint, and when given the opportunity to amend her complaint she again alleged it was a drug.  Id. at *17.  The manufacturer said the product was a drug; the FDA regulated the product as a drug; and the district court based its ruling on the fact that the product was a drug.  The analgesic patch achieved its primary intended purpose through metabolization of its active ingredient, which is what “drugs” do.  (Compare, for example, a combination product such as antibiotic-coated surgical mesh, which fights infection and mechanically repairs a body structure.)  When everyone agreed that the analgesic patch was a drug, including the relevant federal regulator, we scratch our heads wondering what piqued the interest of these two Circuit Judges.  They should have deferred to the FDA’s determination; and even if the court thought that the FDA’s treatment of the product was somehow ambiguous, it should have deferred to the FDA’s primary jurisdiction and allowed the FDA the first opportunity to take a clear position.

The Sixth Circuit therefore took a clear state statutory provision with bright-line rules that, if anything, should be expanded to include other FDA-regulated products and made them less clear and more narrow.  As we’ve said time and time again (and so has the Sixth Circuit when it’s not determined to rescue a plaintiff), it’s not the role of a federal court sitting in diversity to expand liability under state law where the state courts have not done so.

The concurring opinion adds insult to injury by stating that rather than deferring to the FDA’s regulatory determination, a product’s identity as a drug is a factual issue subject to discovery.  The manufacturer had requested judicial notice of FDA documents to establish that the analgesic patch was a drug, which was a perfectly appropriate request to make.  The concurring opinion took exception with that, noting that the only document it reviewed as relevant “is not central to plaintiff’s claim” and “seems central to the defense.”  Id. at *13 (emphasis in original).  According to the concurring judge, such a document should be introduced in support of a motion for summary judgment, which “would of course be made after plaintiff had an opportunity for discovery about all the exchanges between [the manufacturer] and the FDA with regard to the patch.”  Id. at **13-14.

For one thing, we do not see how it matters whether a request for judicial notice aids the plaintiffs or the defense.  More importantly, the principal benefit of statutes that defer to regulatory systems and expertise, such as Michigan’s, is that drug manufacturers who comply with the rules do not have to endure civil litigation, including and especially expensive discovery.  The concurring opinion stood this point on its head by reading the statute to permit, or even require, more litigation to get to a result.  This is exactly the sort of case that should have been determined on the pleadings, and the district court had it right in the first instance under Michigan law.

In our day job, we generally rely on final decisions of FDA about things like drug approvals, device clearances, and rules and guidances.  We also rely on the general integrity of the FDA’s processes.  Even when there are things we do not like on the merits, like observations in form 483s or warnings letters—each is not a final determination of anything according to FDA—we often look to the process itself, which can include a number of steps after the offending statement or action is final.

We also find ourselves calling to the Congressional charge of FDA to protect public health and its various powers of enforcement as counters to the plaintiff charges that FDA’s actions or actions do not amount to condoning our client’s conduct.  Even when we read reports like IOM’s panning aspects of FDA, we still find ourselves looking at the process for the product in our case, with (we hope) thorough evaluation of evidence, layers of review, and consistency in reasoning.

The underlying facts in Ivy Sports Medicine, LLC v. Sebelius, No. 11-cv-1006 (RLW), 2013 U.S. Dist. LEXIS 51763 (D.D.C. April 10, 2013), test even our somewhat slanted view of things.  The case came up on dueling summary judgment motions on an Administrative Procedures Act (APA) review of an FDA decision on a medical device.  We have posted on cases in a similar posture before and noted the tension we, as a drug and device products defense lawyers, feel when FDA screws up.  In Ivy, the court is asked to decide whether FDA has inherent authority to correct what it considered a massive screw-up and whether it behaved rationally—as opposed to arbitrarily and capriciously—in its correction.  In other words, as a big-boned Colorado kid would demand respect for his authority in any situation, is FDA’s inherent authority to be respected when it takes unusual steps to correct a prior abuse of its authority?

Continue Reading Respecting FDA’s (Inherent) Authority

A couple of weeks ago we praised a primary jurisdiction case
out of California. It was a food case, but we wondered whether primary
jurisdiction could be a more active, robust line of defense in drug and device
cases now that Wyeth v. Levine has curtailed the preemption defense.  Just last week we showered praise upon a Minnesota judge for showing the door to a
forum-shopping plaintiff.  Now we have the privilege of reporting on a
Minnesota case that applied the primary jurisdiction doctrine to put the brakes
on a product liability case.  Again, it is a food case, but this is the
time of the year when we often end up with unexpected food gifts.  And the
next time we get disappointed by such a gift or turn it down will be the
first.  Yes, that even goes for fruitcake.


In Taradejna v. General Mills, Inc., 2012 U.S. Dist. LEXIS
174264 (D. Minn. Dec. 10, 2012), the plaintiff brought a class action alleging
violations under the Minnesota Prevention of Consumer Fraud Act, the Minnesota
Unlawful Trade Practices Act, and the Minnesota Uniform Deceptive Trade
Practices Act, related to the alleged mislabeling of Yoplait Greek yogurt
products.  The plaintiff contended that “Yoplait Greek yogurt is neither
yogurt nor Greek.”  Taradejna, 2012 U.S. Dist. LEXIS 174264 at *3. 
(We are reminded of that European History class we took, where one could be
assured of at least a B on the final exam by beginning the essay with
this:  “The Holy Roman Empire was neither Holy nor Roman nor an
empire.”  To this day, we do not know what that means, but we still
declaim it whenever we want to show off the benefits of a liberal arts
education.  It’s like referring to Proust without ever having read a word
he wrote.  We also remember the Linda Richman character from the old Saturday Night Live “Coffee Talk” skits, who would pose similar topics for her audience.  For example, “Rhode Island is neither a road nor an island.  Discuss.”)


How can yogurt lie?  The plaintiff has a story to
tell.  According to that story, the defendants were unprepared for the
popularity of Greek yogurt.  So far so good.  We confess that we feel
ambushed by Greek yogurt – ambushed by luscious goodness.  Be that as it may, the
unexpected huge demand for Greek yogurt prompted the defendants to use Milk Protein
Concentrate (MPC). A blend of dry dairy products, MPC is sold in a powdered
form.  We do not know whether that is good or bad.  We do not know
whether that MPC is somehow anti-Greek.  But we do know this much: 
the labeling of Yoplait Greek yogurt discloses MPC as an ingredient.  It
is not as if that MPC is being smuggled in via a dairy Trojan Horse. 


Nevertheless, the plaintiff argued that the inclusion of MPC makes the
Yoplait Greek yogurt an impostor.  In 1981, the FDA promulgated standards
of “identity” for yogurt.  21 C.F.R. § 131.200.   As
part of yogurt identity (admit it – you never expected a legal blog to discuss
“yogurt identity”  did you?), the FDA proposed to limit “other optional
ingredients” that could be included in yogurt.  47 Fed. Reg. 41519 (Sept.
21, 1982). The FDA drafted a provision limiting the use of “other optional
ingredients” in yogurt to certain milk-derived ingredients (e.g., concentrated
skim milk, nonfat dry milk, buttermilk, whey), sweeteners, flavorings, color
additives, and stabilizers. 21 C.F.R. §131.200 (d)(1)-(5).  Surely you
noticed that the FDA’s list of “other optional ingredients” does not include
MPC. Bad news for our defendant yogurt-slingers, right?


Well, because we are in FDA-land, nothing is as clear as one
would like.  In response to comments and objections, the language
regarding “other optional ingredients” was stayed,
and the limitation, while published, was not put into effect. We are in yogurt
limbo.  But the key to the plaintiff’s claim in the Taradejna case is that
because MPC is not an ingredient expressly listed or described within the
applicable standards of identity for yogurt, use of this ingredient is not
permitted in yogurt.  Okay, says the defendant, we see your FDA paralytic
reticence, and we raise you a belated FDA answer to a public question at a 2004
milk seminar: “May whey protein concentrate (WPC) and/or milk protein
concentrate (MPC) be used as ingredients in yogurt to increase the nonfat solids
content? Yes, 21 C.F.R. 131.200(d), which would have precluded WPC or MPC use,
was one of several provisions of the standard of identity for yogurt that were
stayed in 1982.”


Still with us, or have you decided to put the lid on this
yogurt stuff and get yourself a proper breakfast, like waffles?  (Mmmmm …


Now let’s turn to the FDA’s issuance of a Proposed Rule in
2009 (mind you, this yogurt saga started in 1981).  The rule would allow
for certain modifications to the standards of identity for yogurt, including
“the use of reconstituted milk and whey protein concentrate as standard dairy
ingredients.” 72 Fed. Reg. 2443 (Jan. 15, 2009). The FDA observed that while
the published standards do not permit the use of certain ingredients such as
preservatives or a reconstituted dairy ingredient as a basic ingredient,
“because of the stayed provisions, FDA has not taken enforcement action against
the use of these ingredients in yogurt.…” 74 Fed. Reg. at 2224.  The FDA
explained that, as of 2009, it has not held a public hearing to resolve these
issues “due to the competing priorities and limited resources.” Id. at
2444.  It was apparently a very busy 28 years.  (True that – think
about all the stuff that happened between 1981 and 2009.  The Soviet Union
collapsed.  Then there were all those disasters:  Chernobyl, the
Challenger explosion, Tiananmen Square, O.J., Katrina, the Wyeth v. Levine decision, Ishtar).


In the 2009 Proposed Rule, the FDA advocated incorporation
of “technological flexibility into standards so long as the basic nature and
essential characteristics of the food are not adversely affected.” 
Therefore, the FDA proposed to permit the optional use of any safe and suitable
milk-derived ingredient as an optional dairy ingredient in the manufacture of
yogurt to increase the nonfat solids content of the food above the minimum
required 8.25 percent, provided the ratio of protein to total nonfat solids of
the food and the protein efficiency ratio of protein present in the food are
not decreased as a result of the use of such ingredients.  That Proposed
Rule remains a Proposed Rule.  The Taradejna court points out, perhaps ruefully,
that “[i]t appears that no public hearing has yet been held on the 2009
Proposed Rule.”  2012 U.S. Dist. LEXIS 174264 at *10.   As we
said, the FDA has been busy.


The plaintiff, an Illinois resident, filed the complaint in
March 2012, in Minnesota state court. The defendants removed the case to federal court.  The plaintiff alleged that in March 2012,
he “purchased a serving of Yoplait Greek yogurt, which brandished the label
developed and approved by Defendants” at a Chicago grocery store. (So, as in
the Minnesota case discussed last week, we have another carpet-bagging
plaintiff in pursuit of snowdrifts and hospitable jurisprudence.)  The
plaintiff alleged that while MPC was listed as an ingredient on the label, the
label was “inadequate to disclose the fact that what Plaintiff was going to
purchase and ultimately eat, was not actually ‘yogurt’ as marked.”  Id. at


The defendant interposed a number of defenses.  The one
that worked was primary jurisdiction.  Primary jurisdiction “applies where
a claim is originally cognizable in the courts, and comes into play whenever
enforcement of the claim “requires the resolution of issues which, under a
regulatory scheme, have been placed within the special competence of an
administrative body.” Id. at * 14-15.  Agency expertise is the most common
reason that courts apply the doctrine of primary jurisdiction. “In addition,
courts apply the doctrine to promote uniformity and consistency within the
particular field of regulation.”  Id. at 15.  When the primary
jurisdiction doctrine applies, the “district court has discretion either to
stay the case and retain jurisdiction or, if the parties would not be unfairly
disadvantaged, to dismiss the case without prejudice.”  Id.


In the Taradejna case, the underlying issue was whether MPC
is a proper, permitted ingredient in yogurt. The court reasoned that
“resolution of this question falls squarely within the competence and expertise
of the FDA.”  Id. at *16.   Issues of food labeling are
sufficiently complex that they “are best left to FDA for consideration prior to
judicial review.” Id.  And here, just as with last week’s case, the
Minnesota judge delivers some prose that is precise and delicious:  “The
current standard of identity for yogurt, the stayed 1982 limitations, the
Agency’s subsequent public statements about the standard, and the 2009 Proposed
Rule do not constitute a model of clarity.”  Id. at *16-17.  
The FDA is in the best position to resolve any ambiguity about the standard of
identity for yogurt – a matter requiring scientific and nutritional expertise.
Moreover, “given that the FDA has issued its 2009 Proposed Rule on the standard
of identity for yogurt, it would be imprudent for the Court, at this juncture,
to substitute its judgment for that of the Agency’s while revision of the
standard of identity is pending.”  Id. at *17. 

And then of course
there is that concern for uniformity and expertise.  Either it’s all Greek
to America, or it isn’t.  Or something like that.  And here’s a
non-surprise:  “several recently-filed yogurt lawsuits throughout the
country involve the same or similar issues as found in the instant suit. The
increasing volume of this litigation creates the potential for inconsistent
judicial rulings.”   Id.  Accordingly, the court dismissed the
case without prejudice and directed the parties to initiate the proper
proceedings with the FDA. 

Call it a blow against an overly litigious culture. 


As we said a couple of weeks ago, FDA expertise and the need
for uniformity also exist in the drug and device arena.  If primary jurisdiction applies in Taradejna, imagine how much stronger the primary jurisdiction argument would be where the FDA has actually done more on a subject than one proposed rule in 30 years.  Moreover, now that we know
that FDA-created confusion can also be a factor in favor of applying primary
jurisdiction, we are rubbing our hands together and getting ready to fire up
some motions. 


   *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *


One week ago, the post was entitled “Good News and BadNews.”  Some bad news is especially tough to endure.  Some bad news
is beyond our capacity to understand.  Some bad news is beyond our capacity
to discuss without fury or despair. 


For most schools in this area, Winter break starts in the
middle or end of this week.  The commuter trains have been full of little
kids, some on field trips and some accompanying their parents to the holiday displays
in Philadelphia.  We have been laying down our newspaper, closing our eyes, and
listening to the laughter of the children.  It is much needed music. 





There was much gnashing of teeth among members of the defense bar in the wake of Wyeth v. Levine‘s curtailment of FDA preemption.  It felt like a missed opportunity.   But some of our more persistent and creative colleagues insisted that a lot of the facts and factors we typically seized upon to argue for preemption – extensive FDA regulation, the need for expertise and uniformity — might still be helpful in setting up other defenses.  What other defenses, you ask?  Primary jurisdiction is the first one that comes to mind.

Last week supplied a short and adorable example in Astiana v. The Hain Celestial Group, Inc., 2012 U.S. Dist. LEXIS 165368 (N.D. Cal. Nov. 19, 2012).  The plaintiffs contended that the defendants’ use of the word “natural” on their cosmetic products was false and misleading.  The plaintiffs asserted causes of action under California law for common law fraud, unlawful, unfair, and fraudulent business practices in violation of California’s Unfair Competition Law, false advertising, and violation of California’s Consumer Legal Remedies Act.  That’s a familiar face, isn’t it?

Of course, we normally talk about the “D” in FDA – drugs.  Sometimes, when we hunger for adventure, we chew on a case involving the “F” – food.  There is no C-word in FDA, but there is in the FDCA, the Food, Drug, and Cosmetic Act.   We do not often discuss cosmetics cases, but since the theme of today’s post is putting lipstick on the Wyeth v. Levine pig, maybe it is appropriate that the Astiana case concerns cosmetics.

No matter the subject matter, we have all seen Astiana-type assertions before.  Look here, for example.  Come to think of it, we had the feeling that we have seen similar allegations before with a plaintiff named Astiana.  It is not as if it is a common name. After a little Googling, we confirmed our suspicion.  It turns out that Astiana has gone around suing various companies in California courts for adorning their product labels with the word “natural.” Naturally, we wondered how the same person can be constantly fooled in exactly the same way. It is like that old gag where it is reported that every day a man gets run over by a bus.  A wag then exclaims how awful it must be to be that unfortunate man.  Well, here it apparently really is the same person. In one case, Astiana complained about the use of the word “natural” on an ice cream container.  In its defense, the manufacturer pointed out, perhaps reluctantly, that ice cream does not exist at all in nature.

The FDCA governs the labeling of cosmetics, but does not say much beyond a general prohibition on labels that are “false and misleading in any particular.”  21 U.S.C. section 362.  The FDA has issued no policy, informal or otherwise, regarding use of the term “natural” in cosmetics.  Not surprisingly, the plaintiffs argued that the court did not need to await any guidance from the FDA, because courts routinely decide what is misleading.

But in the wonderful Pom Wonderful case (which we blogged about several times, including here), the occasionally wonderful Ninth Circuit held that courts should not decide such issues when such a decision would “undermin[e], through private litigation, the FDA’s considered judgments. ” Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170, 1178 (9th Cir. 2012).  Last week, we griped about a not-so-wonderful lower court decision that failed to apply Pom Wonderful with appropriate vigor.  But Astiana is a much better decision.  It is, not to put too fine a point on it, simply wonderful.  All it has to do is flutter its fattened eyelashes at us and we swoon.  It had us at Hello.  Actually, it had us at the all caps “DISMISSES” near the end.  Astiana is like a makeup call for last week’s Pom Wonderful not-quite-progeny.

The Astiana court read Pom Wonderful to stand for the proposition that courts should not butt in where Congress had entrusted the task of guarding against deception to the FDA.  According to the Astiana court, Pom Wonderful was not about preemption.  Rather, it was about primary jurisdiction.   The doctrine of primary jurisdiction applies when there is (1) a need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration. Astiana, 2012 U.S. Dist. LEXIS 165368 at *6.

The Astiana court concluded that all of those factors applied to the issue of whether a cosmetics label was false or misleading.  It did not matter that the FDA has so far been silent as to what the word “natural” means in the context of cosmetics. Every once in a while the FDA drops hints as to what it takes to call a food “natural,” but the FDA has never done so for cosmetics. Moreover, cosmetics are regulated separately from food, and cosmetics, unlike foods, “are by their nature artificial and/or synthetic.” Id. at *8.   Why is the FDA so coy about the meaning of the word “natural”?   Is it playing hard to get?  Is it just busy washing its hair?  Whatever the reason for the FDA’s reticence on what a “natural” cosmetic is, the court declined to fill in the vacuum.   The court believed that imposing its judgment on whether “natural” was misleading would undercut the FDA’s judgments and authority.   Id. at *9, citing Pom Wonderful.  And then the court gives us that same feeling that Chris Matthews says candidate Obama gave him in 2008 when it “DISMISSES the complaint.”   Id.  But the dismissal is without prejudice.  Darn it.  Sometimes we have to wonder whether the Astiana case loves us as much as we love it.

What animated Pom Wonderful and Astiana was deference to the FDA.   Naturally, we wonder why such deference is not equally warranted with respect to drugs and medical devices. Surely, drugs and devices require as much expertise and uniformity as fruit juice, ice cream or eyeliner.

We’ve blogged a lot about implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and in particular how the FDCA expressly bars private enforcement of purported violations of the Act.  That’s good – very good indeed – as far as it goes.  But what’s the point as a practical matter?

We think the point is how preemption protects Congress’ additional decision in the FDCA to grant the FDA almost unlimited discretion to prosecute, resolve, or excuse violations as the Agency sees fit.  Basically, the FDA’s exclusive enforcement authority reinforces those parts of the FDCA that confer upon the FDA the ability to select which violations of the FDCA to prosecute and which to settle administratively.  As the Court observed in Buckman, FDA has “complete discretion” in deciding “how and when [its enforcement tools] should be exercised” and must exercise that discretion “to achieve a somewhat delicate balance of statutory objectives.”  531 U.S. at 348.  Preemption and prosecutorial discretion go hand in hand.

The Supreme Court looked at this interplay some years earlier in Heckler v. Chaney, 470 U.S. 821 (1985), in which death row inmates tried to throw a monkey wrench into their sentences by seeking to force the FDA to prevent the use of certain drugs use in executions.  The FDA had exercised prosecutorial discretion to refuse to enforce the statute in this manner.  The Supreme Court affirmed the FDA’s right to determine for itself how to enforce the Act:

[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise.  Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all.  An agency generally cannot act against each technical violation of the statute it is charged with enforcing.  The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.

Id. at 831-32.

Continue Reading Don’t Forget FDA Prosecutorial Discretion