The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

This post is from the non-Reed Smith side of the blog.

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

 

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district court allowed a claim alleging that the defendants failed to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Marvin v. Zydus Pharmaceuticals (USA) Inc., 203 F. Supp. 3d 985, 986 (W.D. Wis. 2016) (citing 21 C.F.R. §§ 208.1, 208.24(b)).

A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the district court in Wisconsin concluded that this very federal-sounding claim was actually based on an “independent” state duty to warn.  Go figure.

That cheesy conclusion spilled over last week into an amiodarone case in Illinois, which again alleged that the defendants failed to provide medication guides. And again the district court concluded that federal law did not impliedly preempt the plaintiffs’ state law tort claims based on a failure to warn.  The case is Hernandez v. Wyeth-Ayerst Laboratories, Inc., No. 15 C 11176, 2017 U.S. Dist. LEXIS 58743 (N.D. Ill. Apr. 18, 2017), and if anything, these plaintiffs were even more forward about co-opting federal regulations that the plaintiffs were in Marvin.

The Hernandez plaintiffs alleged two violations of the FDCA:  First, that the defendants violated the FDCA by promoting amiodarone off label as a first-line anti-arrhythmic medication; and second, that the defendants failed to provide medications guides. Id. at *3.  The generic drug manufacturer defendants justifiable argued that these claims were preempted under PLIVA v. Mensing and Buckman v. Plaintiffs’ Legal Committee, but the district court rejected both arguments.

The district court’s discussion of Mensing is a bit confused.  Applying the often-misunderstood “parallel claim” exception to express preemption, the court held that because the plaintiffs were alleging a violation of federal regulations, their claim was “parallel” to federal law and thus was not preempted. Id. at **8-10.  The problem with this is that Mensing did not apply express preemption.  It was an implied preemption case, and the district court had no business applying “parallel claim” analysis to implied preemption, where a “parallel claim” exception does not exist.  The district court even concluded that the plaintiffs’ claim was “not expressly preempted.” Id. at *9.  That is fine as far as it goes.  But we would be surprised if the generic defendants argued express preemption.  And even if they did, disposing of express preemption does not dispose of implied preemption.  They are different things.

What cases did the district court cite? One was the Seventh Circuit’s opinion in Bausch v. Stryker Corp., for which we have expressed our vigorous disagreement multiple times (including here and here), and another was a district court case called Garross v. Medtronic.  Both addressed express preemption as applied to pre-market approved medical devices.  Apples versus oranges.  Or if staying with our cheese theme, cheddar versus Limburger.

The district court’s treatment of Buckman fares no better.  According to the court, the “plaintiff alleges that [the generic manufacturer defendant] violated its duty to warn under Illinois law because it violated the FDCA’s requirement to provide distributors with medication guides.” Hernandez, at *9 (emphasis in original).  Did you catch that?  The plaintiff was suing because the defendant alleged violated the FDCA.  The court even put “because” in italics.  This is a recipe for implied preemption under Buckman, and it runs directly into section 337(a) of the FDCA, which gives the government exclusive power to enforce the Act.  We have often observed that plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging that are suing for a violation of the FDCA, but not because the defendant violated the FDCA.

These plaintiffs were not even close. The district court acknowledged they were suing because the defendants violated the FDCA, but it somehow found that Buckman did not apply.  Recall that Buckman held that claims were preempted where “federal enactments [were] a critical element” in the plaintiffs’ case. Buckman, 531 U.S. 341, 352 (2001).  That seems to describe the Hernandez plaintiffs’ case to a tee.  The district court also did not discuss, or even acknowledge, section 337(a), which prohibits private causes of action to enforce the FDCA.  The district court again cited Bausch, and it observed that the generic defendant did not cite an express preemption provision.  It did not otherwise explain how these plaintiffs could so overtly purport to enforce the FDCA through a state law failure-to-warn lawsuit.

The defendants also argued statute of limitations and that the plaintiffs did not sufficiently plead their claims, but the former argument failed, and latter resulted only in leave to amend. For our part, summer is approaching, and we still have not tried Wisconsin cheese curd.  Maybe we will soon have the good fortune of attending a Midwestern county fair, where we are told cheese curd runs in abundance.  Or maybe we’ll just go to Chicago and have a hot dog.

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand Ole Opry, and country greats from the 1970’s and 1980’s occupy a significant and permanent place in our soul.  So we were moved by a new video making the rounds of social media today. Entitled “Forever Country,” it is features 30 Country Music Association Award winners – both modern and legendary – in a beautiful montage celebrating 50 years of the CMA awards. You can see it here. There is also some pretty cool irony in the choice of “Take Me Home, Country Roads” as the song that opens the video and winds its way throughout. In 1975, John Denver was nominated as Country Music Association Entertainer of the Year. The previous year’s winner, Charlie Rich, was a bit “in his cups,” as they say, when he read the nominations. As he announced Denver as the winner, he struck a match and lit the card on fire in protest, because he did not think Denver was truly “country.” Happy to debate that when we have coffee, but we (unashamedly) love John Denver, as our office neighbors will attest. We are happy that Denver’s signature song was used in this celebration of country music. If it wins him some new fans, better late than never.

Also better late than never to report on today’s case, which just appeared online though it was decided 2 ½ years ago. In Peterson v. Wright Medical Technology, 2014 U.S. Dist. LEXIS 189473 (C.D. Ill. Feb. 13, 2014), the United States District Court for the Central District of Illinois considered the defendant’s motion for summary judgment on the plaintiff’s failure-to-warn claim in a hip implant case. The plaintiff, who was obese, received a new modular artificial hip to address his “significant end stage osteoarthritis” caused by an earlier accident. At the time of the plaintiff’s hip implant, his surgeon “had been an orthopedic surgeon for 31 years and had seen many evolutions of hip implants. He had read several journal articles about modular implants, including the [subject implant].” He had also read the Instructions for Use (“IFU”) included with the implant. He “knew that a patient’s weight and activity level could have an effect on the ultimate outcome of the surgery but had no reason to believe that Plaintiff was not an appropriate candidate for the implantation of this device.” The surgeon explained all of these risks to the plaintiff and required him to attend a two-hour teaching session before obtaining his informed consent.  Peterson, 2014 U.S. Dist. LEXIS 189743 at *3-4.

Two years after the plaintiff’s surgery, the titanium modular neck of his artificial hip broke into two pieces. In his complaint, the plaintiff asserted the usual strict liability and negligence claims, along with a punitive damages claim that was later dropped. The defendant moved for summary judgment on the plaintiff’s warnings claims sounding in both strict liability and negligence.

Continue Reading Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies.  We are not talking about the injectables favored by 1970s East German Olympians or 1980s NFL draft flops.  And certainly not the supplements advertised on late night television as more targeted enhancers.  (McConnell says that he heard they work as well as a Tarantino remake of a Kurosawa re-envisioning of a Shakespeare tragedy, whatever that means.)  No, we are talking about protein powder, which people who lift weights often shake up with water or milk to chug after a workout.  If you have ever cleaned the “shaker bottle” used by a high school athlete after his/her workouts, then you would know that the real problem with these powders is how much remains as a putrid clump in the bottle.  If you have not had that pleasure, then you probably know that they sell protein powder in tubs ranging from large to ridiculously large at a variety of retailers.  If you have glanced at the options among the protein powders on the retail shelves, then you may have noticed that they tout the number of grams of protein per serving and maybe something about the source of the protein.  If you are the plaintiff in Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2015 U.S. Dist. LEXIS 77509 (N.D. Ill. June 16, 2015), and you paid $20 for a container of this stuff, then you bring a purported class action for purchasers of the same product in ten different states.  You also lose.

Plaintiff claims that the language on the front—a cylinder or truncated ovoid container does not really have a front, but we will let that slide—of the product he bought from his drug store was misleading because it said “Whey Protein Powder” and “26 grams of high-quality protein,” when each serving actually contains 21.8 grams of whey protein and 4.2 grams of other proteins plaintiff did not consider as high quality as the stuff left over from making cheese.  Id. at **5-6.  Based on this, plaintiff alleged violations of the ten consumer fraud acts, unjust enrichment and express warranty.  The defendant moved to dismiss on several grounds, including on preemption based on the FDCA and National Labeling and Education Act, which is why we saw the case. As we have said before, the NLEA has an express preemption provision for any state requirements for food labeling—protein powder is food—that are not identical to its own.  And the NLEA does have requirements on how protein content is to be discussed in labeling—by giving the “total protein contained in each serving size or other unit of measure.”  Id. at *9.  The regulations even say how total protein can be calculated, which appears to reject the plaintiff’s idea that the non-whey protein in the product he bought should not really count.  Plaintiff wanted the product’s labeling to “differentiate between whey protein and protein from amino acids” and that “would not be identical to the labeling requirements imposed by federal law.”  Id. at *11.  That is pretty straightforward express preemption, but there was a cherry and whipped cream on top of this frothy vanilla shake.  First, in adopting the protein labeling regulations, the FDA had considered and rejected the comment that labeling should specify how much of the protein in a food product was “high quality.”  Id. at **11-12.  Second, the same court had already rejected similar arguments in the context of labeling for fiber content and been affirmed by the Seventh Circuit.  Among the previously rejected arguments was that preemption of food labeling claims under the NLEA can apply to complaints only about the content of the Nutrition Facts portion of the food product’s labeling.  Id. at **14-16.  So, plaintiff could not base his consumer fraud claims on the disclosure of the amount of whey protein in the product.

Fighting off its lactic acid build up, the court proceeded to address the non-preemption grounds for dismissal.  Because the NLEA does provide for the possibility that the names of food products can be misleading by focusing on only one of its ingredients, there was a possibility of claim under the Illinois consumer fraud statute if the product’s name was misleading in the context of the entire labeling.  Plaintiff contended that the name “Whey Protein Powder” was misleading because the product was not all whey protein.  His problem, aside from being so litigious that he sued over allegedly overpaying for a $20 container of protein powder that had only 83% of its protein derived from his preferred source, was that the product’s name on the label was followed by “Vanilla” and “Naturally & Artificially Flavored Drink Mix.”  It also lacked any descriptor like “only whey” or “100% whey” or “absolutely, exclusively whey” or “way, way whey.”  Thus, it was “clear to any consumer upon first glance that the Product is not pure whey protein, and thus the label does not create a likelihood of deception or have the capacity to deceive based on the identifying name of ‘whey protein powder.’”  Id. at *19.  This meant the product name was not misleading as a matter of law and the non-preempted consumer fraud claim was dismissed.  The express warranty claim was pressed aside because “26 grams of high-quality protein per serving” was considered “puffing” and not a potentially actionable express warranty.  Id. at *22.  The unjust enrichment claim fared no better because it was premised on dismissed consumer fraud claims.  Id. at *23.

The one down-side to the decision is that the dismissal of all of these claims was without prejudice.  While we know that plaintiffs tend to get at least to their third set (i.e., the second amended complaint) before a dismissal under 12(b)(6) will be with prejudice, we doubt that any amount of stretching of the facts or law here will allow plaintiff to re-frame his allegations in a way to avoid preemption and state claims under state law.  Maybe he can get those noted trainers Hans and Franz to pump—clap—him up before he tries.

This post comes from the Cozen O’Connor side of the blog only.

City of Chicago v. Purdue Pharma L.P., 2015 U.S. Dist. Lexis 60587 (N.D. Ill. May 8, 2015), deals with an effort by the City of Chicago to recover payments it made to drug companies on opioid prescriptions for City employees (and retirees) covered by HMO, PPO and worker’s compensation plans. Id. at *9-11.  Chicago claimed that it should get its money back because the drug companies misrepresented that the opioids were effective for more than short-term treatment of cancer pain.  The City lost—at least for the time being.

The City claimed that the drug companies had mounted a coordinated campaign to use key opinion leaders to write, speak and create guidelines on long-term opioid therapy, use professional and patient advocacy groups as marketing tools, develop and support medical journal articles on long-term opioid therapy, misuse CME programs to market such long-term therapy, and more.  In this campaign, according to the City, the drug companies overstated the effectiveness of opioids, downplayed the effectiveness of alternatives, and hid or understated risks such as addiction.  Id. at *4-9.  The City made common law fraud, conspiracy and unjust enrichment claims, and claims under certain Chicago municipal codes that, among other things, incorporated the Illinois Consumer Fraud and Deceptive Businesses Practices Act. E.g., Chicago Municipal Code § 2-25-90.  Chicago asked for its money back and, as is often the case, hired private counsel to help them get it.  Read here for our take a number of years ago on efforts by municipalities to recover these and other types of costs.

Continue Reading Another Municipality Tries to Recover Its Costs for Pharmaceuticals

It was big news that there will be a six hour return of The X-Files, a show that dazzled us from 1993 to 2002.  The “myth-arc” episodes about an alien invasion, black oil, and the disappearance of Special Agent Mulder’s sister were overwrought and confusing, but the standalone entries were television at its creepy best.  The bullpen of X-Files writers was stellar, including, among others, Darin Morgan and Vince Gilligan.  You probably have heard of Gilligan, since he later went on to helm a program now carved on the medium’s Mt. Rushmore, Breaking Bad.  (Gilligan’s current show, Better Call Saul, is also quite good.  And the ‘hero’ is a lawyer!)  Morgan is less well-known, but he penned some of the most admired X-Files episodes, which married humor to mystery in ways not matched since.  If you want to treat yourself to three hours of splendid viewing, fire up Netflix and take in these four all-time great X-Files episodes, the first two by Morgan and the latter two by Gilligan:

Continue Reading Illinois Appellate Court Misapplication of Bartlett Preemption: The Monster Case of the Week

Today’s case under discussion, Robison v. Orthotic & Prosthetic Lab, Inc., 2015 Ill. App. LEXIS 68 (Ill. App. Ct. Feb. 4, 2015), makes us think of Jim Carrey, George Costanza, and Bruce Willis.  You might already have heard of the Robison case.  Only a week old, this product liability case, involving a claim that a prosthesis failed, has quickly garnered notoriety.  The Illinois appellate court threw out a settlement because the plaintiff attorney extracted that settlement without bothering to disclose that his client had died.

Why do we think of those three particular cultural icons?  To begin, let’s lay out the procedural posture of the Robison case.  The defendant appealed from an order enforcing a settlement agreement in the product liability action.  The defendant argued that the settlement agreement was invalid because the attorneys who purportedly represented the plaintiff during settlement negotiations lacked the authority to negotiate a settlement inasmuch as the plaintiff had died and a proper representative of the estate had not been substituted as the party plaintiff.  (The substitution process begins with the quaintly named “suggestion of death” that many jurisdictions, including our home jurisdiction here in the Commonwealth of Pennsylvania, require.)  The defendant also contended that the settlement agreement was invalid because the attorneys who purportedly represented the plaintiff during settlement negotiations failed to disclose the material fact that the plaintiff had died eight months prior to the commencement of the negotiations.  Got it?

Continue Reading The Death of a Client is a Material Fact That Must Be Disclosed in Settlement Negotiations

Any time you find yourself drawing an analogy to asbestos lawsuits, you know you’re in trouble.   We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation.  Almost always those procedures would make it easier for plaintiffs to ‘prove’ little things like product identification, and would abridge defendants’ rights to seek certain discovery or file motions.  If the symbol for the legal system is a scale, the symbol for the asbestos docket should be a meat-grinder.  We had the experience earlier in our career of representing a tertiary asbestos defendant that really and truly had nothing to do with any harm inflicted on any asbestos plaintiff.  It should never have been sued.  But after the actual asbestos manufacturers went bankrupt, enterprising plaintiff lawyers sued any and every entity in sight so as to keep the asbestos gravy train rolling.  Instead of winding down to extinction or at least to something with narrowly circumscribed limits, asbestos litigation entered second and third waves of opportunistic litigation. It is like what Hannah Arendt said about totalitarian regimes, how they constantly need to find new enemies and scapegoats.  Asbestos litigation became a bizarre, parallel legal system, more characterized by (bad) social engineering than coherent rules and procedures.  Our encounter with the asbestos maw was relatively brief.  We represented a company that made components for automobile brakes.  Mind you, the company did not use or touch asbestos at all.  After the products entirely left our clients’ hands, somebody else would add the asbestos.  When we pointed out that fact to the plaintiff lawyers, they still insisted that we must pay a nuisance exit fee.  When we sought to file a motion with the court, we were advised that the asbestos docket permitted no such motions until the eve of trial.   Good system, huh?

We do not know a whole lot of the facts behind the New England Compounding Pharmacy MDL, but the first opinion we have seen from it (there will doubtless be many more) gave us an ugly asbestos flashback.  The MDL stems from allegations that the New England Compounding Center (NECC) produced a contaminated medicine that caused people to suffer from fungal meningitis.  NECC recalled the medicine.  It then surrendered its pharmacy license, ceased production of all medical products, and filed for bankruptcy.  The plaintiffs steering committee filed actions against NECC, naturally enough, and also filed actions against affiliated entities and individuals.  The plaintiffs also filed complaints against not-so-affiliated entities and persons, including hospitals, clinics, and doctors.  This is where we started thinking about asbestos cases.  If there must be a remedy for every wrong, does that mean the remedy can be collected from someone who did nothing wrong?   The NECC opinion we are looking at today, In re New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL No. 13-02419-RWZ (D. Mass. Jan. 13, 2015), provides an interesting snapshot.  This particular opinion relates to actions where plaintiffs alleged that Illinois medical providers played a role in administering the contaminated NECC medicine, thereby causing injuries.  The claims were for medical negligence, violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, failure to warn, strict product liability, and punitive damages.  

The good news for the defendants was that the court dismissed the strict liability claim, because that theory could apply only if the defendants were predominantly providing a product rather than a service.  The court, quite sensibly, concluded that the medical providers were predominantly providing a service rather than a product.  But the rest of the opinion was bad news for the defendants.  The defendants made an argument that rings true to our admittedly biased ears: that physicians have no duty to regulate pharmacies and drug manufacturers.  But the court concluded that the master complaint passed muster because it alleged that the defendants had a duty to exercise reasonable care to ensure that the drugs they administered  to patients were procured from drug companies that complied with pharmaceutical laws, made safe and effective drugs, and utilized proper quality control, safety, and sterility measures.  Wow.  The plaintiffs also alleged that physicians must take care that the drugs administered were not contaminated, and must inform plaintiffs of the sources of drugs (especially if there was “an unaccredited, mass producing, out of state, compounding pharmacy, unregulated by the FDA … and the dangers associated therewith”).  That is a fairly breathtaking litany of duties for doctors.  The complaint also alleged that the defendants “deceptively concealed” information about the source of the medicine and failed to inform patients that they were being administered “an unsafe, unreasonably dangerous drug compounded by NECC.”    Those allegations were deemed enough to make out claims for negligence, consumer fraud, and failure to warn.  Moreover, because the complaint said that the defendants went beyond mere inadvertence and, instead, demonstrated such utter disregard for the rights of others as to amount to “complete neglect for the safety of patients,” and that the defendants “willfully and knowingly failed to abide by consumer safety regulations and withheld important safety information from patients,” the claims for punitive damages could go forward.

The court did cite TwIqbal, but certainly did not appear to apply the standard with any rigor.  As a result, the plaintiffs have gotten away with very vague, very broad allegations that rip large holes in the duty envelope.  It will be interesting to see what sort of proof the plaintiffs have that the doctors actually knew what was going on at the compounder.  Are these defendants now on the hook because they really were negligent, or merely because they were next?