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We commented last week that we were not surprised by the numerous post-BMS personal jurisdiction decisions we were seeing. Lots of courts and parties around the country were watching and waiting for this one. So, let’s add some more. This time from another of plaintiffs’ favorite “magnet jurisdictions” – Missouri. Historically, product liability plaintiffs bringing pharmaceutical and medical device cases have flocked to Missouri (the City of St. Louis in particular) among other notoriously plaintiff-friendly venues as litigation tourists. They would file multi-plaintiff complaints against drug and device companies not located in Missouri, including at least 1 Missouri plaintiff – to tie the case to the state — and at least 1 plaintiff from defendant’s home state – to destroy diversity.

So, when defendants would remove these multi-plaintiff complaints, which we always do, we would have to argue misjoinder and simultaneously move to dismiss all of the out of state plaintiffs for lack of personal jurisdiction. Previously, pre-BMS, the Eastern District of Missouri was rather hostile to such removals. Swiftly remanding case after case for lack of subject matter jurisdiction, opting to completely skip the personal jurisdiction issue altogether. Apparently, BMS is changing that – which frankly, we expected. But now we have some decisions.

The complaints in Siegfried v. Boehringer Ingelheim Pharm., Inc., 2017 WL 2778107 (E.D. Mo. Jun. 27, 2017) and Jordan v. Bayer Corp., 2017 U.S. Dist. LEXIS 109206 (E.D. Mo. Jul. 14, 2017) look pretty much as described above. Each case had 94 plaintiffs, of which only a handful were residents of Missouri (8 in Siegfried and 7 in Jordan). The remaining plaintiffs were from different states all over the country, including the states where defendants are citizens. Siegfried at *1; Jordan at *1-2. At least 1 to get personal jurisdiction and at least 1 to defeat diversity.

As do most courts when faced with competing issues of subject matter and personal jurisdiction, these courts cited Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999) for the proposition that the court has discretion to determine which to consider first. Siegfried at *2; Jordan at *5. While federalism usually tips the scales toward deciding subject matter jurisdiction first, where personal jurisdiction “turns on federal constitutional issues” and/or “judicial economy” concerns, personal jurisdiction can be prioritized. Jordan at *5. Put even more simply, post-BMS, “[p]ersonal jurisdiction is now the more straightforward inquiry.” Siegfried, at *3. That’s because BMS is “dispositive of the specific personal jurisdiction issue” regarding out-of-state plaintiffs suing an out-of-state defendant. Jordan at *9. Specific personal jurisdiction is lacking.   Therefore, reasoned the Siegfried court

Remanding this case for lack of complete diversity, only to have the case removed again later once the non-Missouri plaintiffs are dismissed, would be a waste of judicial resources.

Siegfried at *2. After BMS, neither the Eastern District of Missouri nor the original Missouri state court can exercise personal jurisdiction over the non-residents, so why remand the case to reach the same conclusion. Siegfried at *5. It would be an unnecessary extra step.

Applying a “straightforward” BMS analysis, both courts dismissed all of the out of state plaintiffs with no connection to Missouri. Siegfried at *5 (“nonresident plaintiffs did not ingest the drug in the forum, nor do they claim to have suffered resulting injuries in the forum. The personal injuries of the non-Missouri plaintiffs have no connection with Missouri. They did not arise out of, or relate to, defendants’ activities in Missouri.”); Jordan at *10-11 (“the non-Missouri plaintiffs do not allege that they acquired the [] device from a Missouri source or that they were injured or treated in Missouri . . . . And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum.”). Because the dismissal of the non-Missouri plaintiffs negated any challenge to complete diversity, the motions to remand in both cases were denied. Siegfried at *5; Jordan at *11. Yet another post-BMS victory.

 

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The warranty is “express.”

Before you say, “Well, duh,” this sometimes actually does matter. Here’s how.

Most complaints in product liability actions involving prescription medical products that include express warranty counts do so as one of a bunch of different causes of action, all pleaded seriatim (“one after another,” in non-lawyer speak).  Believe it or not, lawyers get tired of repeating themselves – especially those (like our adversaries) who don’t bill by the hour.  Thus, in complaints, we usually see each cause of action in multi-count complaints begin with a paragraph “incorporating by reference” facts that were pleaded earlier in the document.

That can be fatal to express warranty claims – because the warranty must be “express” – whereas other claims, such as failure to warn, can be maintained on the basis of allegedly omitted facts.  Thus, incorporation by reference (or pleaded facts) that only incorporates allegations of omitted facts isn’t enough to plead express warranty.  This is one more way to make express warranty claims go bye-bye (see our TwIqbal cheat sheet for others), and it appears that, increasingly, plaintiffs have been called out for this failing.

The only appellate prescription medical product case that we’ve seen on this point is Rite Aid Corp. v. Levy-Gray, 876 A.2d 115 (Md. App. 2005), aff’d on other grounds, 894 A.2d 563 (Md. 2006).  In Levy-Gray, an omission by the defendant pharmacist of a statement in the manufacturer’s labeling didn’t cut it as a basis for express warranty:

[I]n order to have an express warranty there must be an affirmative statement of fact by the seller about the goods.  A claim that there is a warranty by omission is at odds with the UCC definition of an express warranty.  Here, the manufacturer’s package insert . . . contained, inter alia, the following statement:  [statement omitted]  The omission of this statement, which was relevant to the negligence claim asserted by Plaintiff, and is of some relevance to the medical causation issues, is not relevant to the creation of an express warranty.

Id. at 126 (citation omitted) (emphasis added).

Several federal district courts have made the same point.  The issue arose in the Testosterone MDL, where the “plaintiffs have pointed to no statement that constitutes an express warranty.”  In re Testosterone Replacement Therapy Products Liability Litigation, 2014 WL 7365872, at *8 (N.D. Ill. Dec. 23, 2014).  “[P]laintiffs must plead more than misstatements and omissions to state a claim for breach of express warranty.”  Rather, plaintiff “must point to a specific affirmation or promise.”  Id.  In Young v. Bristol-Myers Squibb Co., 2017 WL 706320 (N.D. Miss. Feb. 22, 2017), the court raised the issue sua sponte (meaning “on its own”), pointing out:

[T]he Court notes that, while not raised by the defendants, [plaintiff’s] breach of express warranty claim must fail to the extent it is based on alleged omissions in [the drug’s] prescribing information. An omission is neither an affirmation of fact nor a promise.

Id. at *15 n.10 (citation omitted).

Non-express “express” warranty claims also failed in House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017), because allegations of omissions were insufficient:

[Plaintiff] cannot base her express warranty claim on allegations that the Prescribing Information fails to include the “true risks” of the drugs and does not contain “adequate information[.]”  An express warranty is created by an “affirmation of fact or promise,” not an omission.

Id. at *6 (citations omitted).  In Vakil v. Merck & Co., 2016 WL 7175638 (D.N.J. Dec. 7, 2016), the court disposed of a warranty claim under Virginia law (significant because Virginia doesn’t have strict liability) observing that “during oral argument” plaintiff “indicated that his theory was more akin to an omission. Therefore, summary judgment is granted to Defendants as to the breach of express warranty claim.”  Id. at *5.

We also looked outside the drug/device sphere, and were surprised by the relative paucity of precedent.  Either plaintiffs aren’t pleading omissions in express warranty claims or defendants are letting them get away with it.  There’s one citable appellate decision, and it’s almost 30 years old.  Sidco Products Marketing, Inc. v. Gulf Oil Corp., 858 F.2d 1095, 1099 (5th Cir. 1988) (“Omissions, however, are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.”) (applying Texas law).  Young cited Sidco.  So did the next two cases – coincidentally, both from Missouri:

Plaintiffs repeatedly allege that the press releases and advertisements all failed to disclose the defect, so, to the extent their express warranty claims are based on advertisements and promotional materials, these claims are based on omissions. A breach of express warranty claim, however, cannot be premised on an omission.

In re General Motors Corp. Anti-Lock Brake Products Liability Litigation, 966 F. Supp. 1525, 1531 (E.D. Mo. 1997), aff’d on other grounds, 172 F.3d 623 (8th Cir. 1999)

Plaintiff, therefore, bases liability not on what the documents provide, but on what they do not provide.  The law is clear that [plaintiff] may not recover under this theory because omissions are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.

Cambridge Engineering, Inc. v. Robertshaw Controls Co., 966 F. Supp. 1509, 1524 (E.D. Mo. 1997) (quoting Sidco).

Likewise, defendants in tobacco product liability cases have not allowed plaintiffs to pass off “warranty by omission” as an “express warranty.”  Witherspoon v. Philip Morris, Inc., 964 F. Supp. 455, 465 (D.D.C. 1997).  Omissions of this and that are “at odds with the definition of express warranty.  Plaintiff has not pleaded an express promise on the part of Defendant.”  Id.  Accord Hughes v. Tobacco Institute, 2000 WL 34004261, at *10 (E.D. Tex. May 5, 2000) (“nondisclosure . . . does not create an express warranty”), aff’d on other grounds, 278 F.3d 417 (5th Cir. 2001).

Another appellate decision actually exists, but it’s non-citable:

Essentially, [plaintiff] bases his claim not upon an express affirmation of fact or description of the goods, but instead, upon the omission of language such as simulated or imitation.  [Plaintiff] has presented no authority that an omission of fact can create an express warranty.

Pocino v. Jostens, Inc., 2006 WL 1163785, at *5 (Cal. App. May 3, 2006).

Finally, we found one other case, on point, not citing anything beyond the relevant UCC section, but reaching the same result:  “[A] failure to include information in the specification sheet is the exact opposite of an express warranty.”  “[O]missions . . . are simply insufficient to support a breach of warranty.”  Cannon Technologies, Inc. v. Sensus Metering Systems, Inc., 734 F. Supp.2d 753, 769-70 (D. Minn. 2010).

Express warranty claims deserve attention in prescription medical product liability litigation.  Some courts allow such claims to escape preemption.  Others give express warranty claims a longer (or at least different) statute of limitations.  Such claims should not be allowed to persist when there is no basis for them, so any express warranty claim based on omissions should be challenged at the first opportunity.

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We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and oh-so-creative imagining of the backstory of “the Witches of Oz” – Galinda (later, without the first “a,” the “Good Witch of the North”) and Elphaba, the viridescent lass who, in Baum’s classics, grew up to achieve infamy as the “Wicked Witch of the West” – beginning with their days as schoolgirls and reluctant roommates.  We are eternally charmed by the subtle scarecrow-Toto-Dorothy references woven throughout (we notice at least one new one every time we see the show) and we never tire of the score (“Defying Gravity,” “For Good”).  We also don’t think it puts too fine a point on it to appreciate the resonance of a character whose life is shaped by a childhood in which she never “fit” and to be gratified by her unlikely happy ending.

 

And in this manner (wait ‘til you see this tie-in), the lesson diverges from unhappy ending of the plaintiff’s expert metallurgist in today’s case, whose conclusions were excluded, in part, because they did not “fit” the facts of the case and the issues the expert had considered. In its (regrettably) unpublished and (not regrettably) short decision in Redd v. DePuy Orthopedics, Inc., 2017 WL 2859536 (8th Cir. June 6 2017), which features an appearance by our beloved “sham affidavit doctrine,” the United States Court of Appeals for the Eighth Circuit reviewed the Eastern District of Missouri’s decision excluding the plaintiff’s expert’s “defect” and “causation” testimony and granting summary judgment for the defendant.

 

In Redd, the plaintiff – five feet tall, 302 pounds, and taking immunosuppressant drugs – received a total hip replacement using the defendant’s artificial hip.  Four years later, the hip stem fractured.  When it was removed, “doctors learned that it had not properly grown into the bone at the top of [the plaintiff’s] hip,” 2017 WL 2859536 at *1.  Plaintiff’s doctors were aware of this risk, heightened by the plaintiff’s marked obesity and her medications.  The plaintiff was implanted with a second hip stem, which similarly fractured less than two years later.

 

The plaintiff filed suit, asserting the usual negligence, strict liability, and manufacturing defect claims. She retained her metallurgy expert to opine about the cause of the hip stems’ fractures.  The expert “had done research in fatigue fracture initiation in metal objects but not in metal objects implanted in the human body.  His analysis considered metallurgical factors but not any biomechanical factors (such as a hip stem’s failure to grow into the hip bone . . .).” Id. He also “did not review any records related to the manufacturing process . . . .” Id. He opined that the fracture of the plaintiff’s hip stem was caused by the improper “phase” of the metal along with the “grain size” of the metal alloy (metallurgical terms of art, we assume).  He “acknowledged that environmental factors could have also contributed to the failure of the hip implant, but said that any small variation in the biomechanical forces would have been secondary in nature to the hip stem’s . . . state” in causing the failure. Id. (internal punctuation omitted).

 

The defendant moved for exclusion of the expert’s testimony and for summary judgment. In response, the plaintiff submitted an affidavit in which the expert testified, for the first time, that the “phase” of the metal in the hip stem violated the defendant’s own specifications, and that “environmental factors would be secondary in the cause of the fracture when the material is inherently defective to begin with.” Id. (internal punctuation omitted).  The defendant moved to strike the affidavit on the grounds that it impermissibly supplemented or changed the expert’s opinion after the close of discovery.

 

Throw a little Daubert on this expert, and his opinions melt away.

 

The district court held that the expert, while qualified to testify about metallurgy, lacked a scientific or factual basis for his “manufacturing defect” or “causation” testimony. The court further found that the expert had failed to consider the issue of the forces that were exerted on the implant inside the plaintiff’s body.  Finally, the court granted the defendant’s motion to strike the expert’s affidavit, noting that statements in the affidavit contradicted the expert’s earlier testimony and “a party cannot change testimony,” by submitting an affidavit, “just to avoid summary judgment or a Daubert motion.” Id. at *2.  (This is the “sham affidavit doctrine,” which we have used with glee and success in our own appeals.)  With the expert’s “defect” and “causation” testimony excluded, the plaintiff could not meet her burden of proving those claims, and the court granted summary judgment for the defendant.

 

On appeal, the Eighth Circuit affirmed all of the district court’s holdings. First, it held that the expert’s affidavit, invoking, inter alia, manufacturing specifications he earlier testified that he had not been provided, “arguably crossed the line between clarifying prior testimony and changing prior testimony,” id. (citation omitted); thus, the district court had not abused its discretion in excluding the affidavit from consideration.  The court also rejected the plaintiff’s argument that the district court had erred when it required the expert to exclude biomechanical causes of the plaintiff’s fracture.  The court emphasized that, while “an expert need not rule out all possible causes of an injury, [he] nonetheless should adequately account for obvious alternative explanations.” Id. at *3 (internal punctuation and citation omitted).  In this case, the expert failed to consider the obvious alternative cause of the plaintiff’s fracture; namely “the failure of the hip stem to grow into [the plaintiff’s] hip bone and properly distribute her weight,” id, and gave no consideration to the biomechanical forces applied to the hip stem.  As such, the court concluded, the district court had acted within its discretion in excluding the expert’s testimony on causation and defect.

 

Short, tidy, and correct on all counts. Keep ‘em coming.  As for us, we are off to see the Wizard (again).

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The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks.  That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court.  Another reason could be that the California Supreme Court’s opinion reaching for personal jurisdiction in BMS was so clearly swimming against the Supreme Court’s recent current that its reversal was widely anticipated and thus gained notoriety even faster than usual.  That last part is speculation, but still, we have not heard so much about personal jurisdiction since poor Mr. Burnham traveled from New Jersey to California to visit his kids. See Burnham v. Superior Court, 495 U.S. 604 (1990).

So what will we see following BMS?  We saw last week that some plaintiffs will try to stretch even the most tenuous forum contacts into specific jurisdiction, and some courts may go along with that.  We expect that most will not.  Take for example a recent opinion from the New Jersey Appellate Division, Dutch Run-Mays Draft, LCC v. Wolf Block, LLP, __ A.3d __, 2017 WL 2854420 (N.J. App. Div. July 5, 2017).  In Dutch Run, a Florida real estate developer sued a dissolved Pennsylvania law firm in New Jersey state court, and it argued that the law firm’s compliance with New Jersey’s business registration statute created personal jurisdiction “by consent.”  The New Jersey courts rejected that position.  Sure, the plaintiff was able to identify New Jersey contacts—business registration, a New Jersey registered agent, two New Jersey offices, the residency of some partners on the law firm’s dissolution committee, and three lawsuits that the law firm filed in New Jersey’s courts.

The problem for the plaintiff was that its claims had nothing to do with these New Jersey contacts. As the court put it, “[T]he negligence forming plaintiff’s cause of action did not arise from defendant’s contacts with New Jersey.  Plaintiff cannot show any relationship between the underlying matter and the business or attorneys in New Jersey.” Id. at *5.  Thus, no specific personal jurisdiction.  This is a faithful application of BMS, which requires a causal link between the defendant’s forum contacts and the plaintiff’s alleged injury.

Equally as important, the court held that the law firm’s registration in New Jersey did not imply “consent” to general personal jurisdiction under Daimler AG v. Bauman:

Plaintiff suggests Daimler’s holding is narrowed by its facts, specifically that Daimler was not registered as a foreign entity and had no registered agent or offices in California.

This limited view ignores Daimler’s definitive due process analysis. . . .  We now join the many courts that have circumscribed the view of general jurisdiction post-Daimler. . . .  In light of Daimler, we reject the application of [Allied-Signal, Inc. v. Purex Indus., Inc. 242 N.J. Super. 362 (App. Div. 1990)] as allowing general jurisdiction solely based on the fiction of implied consent by a foreign corporation’s compliance with New Jersey’s business registration statute. . . .  Importantly, the exercise of general jurisdiction requires satisfaction of the “continuous and systematic contacts” to comply with due process. Mere registration to conduct some business is insufficient.

Dutch Run, at *7 (emphasis added, citations omitted).  The court also rejected the plaintiff’s request for “jurisdictional discovery” because “[w]e remain unconvinced that permitting further discovery would have altered our conclusion.” Id. at *8.

Speaking of discovery, we also commend to you the order rejecting “jurisdictional discovery” in In re Baltimore City Asbestos Litigation (Smith v. Automotive Prods. Co.), Memorandum Opinion & Order, No. 24X13000333 (Baltimore City Circuit Ct. June 7, 2017).  In Smith, a Pennsylvania plaintiff sued multiple Pennsylvania defendants in Pennsylvania.  But after some defendants won summary judgment, the plaintiff tried to re-file his lawsuit in Maryland, which has a longer statute of limitations.  Slip op. at 2.

The Maryland court initially reserved ruling on personal jurisdiction and allowed limited “jurisdictional discovery.” This made neither side happy, resulting in dueling motions for reconsideration:  The defendants asked again for dismissal, and the plaintiffs wanted broader discovery.

The defendants won. Citing BMS, the court ruled that it lacked specific personal jurisdiction over the defendants because

this suit is unrelated to any alleged contact the Defendants may have had with the State of Maryland. Further the Defendants in this suit have conducted virtually no business in the State of Maryland and, therefore, have not purposefully availed themselves of the privilege of conducting activities in the State.  Therefore, this Court lacks specific jurisdiction over the Defendants in this suit.

Slip op. at 5. The court similarly lacked general personal jurisdiction over the defendants because they were not “at home” in Maryland, where “the only relevant inquiry is whether the defendant is either incorporated or has its principle place of business in the forum state.”  Slip op. at 6 (citing Daimler AG v. Bauman).  Like the New Jersey court in Dutch Run, the Maryland court rejected “jurisdictional discovery” because “[i]t is clear that further discovery will not uncover facts demonstrating the existence of general jurisdiction over any of the moving Defendants.  All of the Defendants are incorporated outside of Maryland.  The Defendants’ principal places of business are all in Europe.”  Slip op. at 6.

We bring you these two cases not only because they are timely, but because they confront tactics that we expect to see post-BMS—assertions of jurisdiction “by consent” and requests for “jurisdictional discovery.”  Our view on jurisdiction by consent is clear:  We don’t think it holds up; and as the New Jersey court found, a majority of courts have ruled that business registration alone does not form consent to jurisdiction.

As for discovery, these courts were correct to reject discovery where the facts already showed that jurisdiction was lacking. To this, we can add only that courts contemplating “jurisdictional discovery” should be reticent, very reticent.  As is commonly true with phased discovery, defining the phases can be challenging, leading to substantial overlap between discovery on jurisdictional facts versus discovery on all other facts.  It is a slippery slope toward full-blown discovery, in a case where the plaintiff has not yet established the court’s jurisdiction.  Look at what the plaintiff did in Smith v. Automotive Products, discussed above—the court gave them jurisdictional discovery, and their response was to ask for more.  We are not surprised.  Of course, this all assumes that a court has the power to allow discovery against a defendant contesting jurisdiction in the first place.  We don’t know the answer to that question, but the yet-to-be established nature of the court’s prerogative is another reason to tread lightly.

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We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients.  By and large, those associates do an excellent job.  On those rare occasions when we find ourselves grousing about the quality of research, it usually has something to do with reliance on overly-specific computer searches.  Sometimes it seems as if the lawyers punch a search term into Lexis or Westlaw that would capture only cases that are precisely on point.  The problem with that approach is the possibility of missing cases that support general principles, or offer other oblique ammunition for one’s position.  Today’s case, Canale v. Colgate-Palmolive Co., 2017 U.S. Dist. LEXIS 97506 (S.D.N.Y. June 23, 2017), is an example of that kind of helpful, albeit indirect, authority.  The plaintiffs in Canale filed a class action attacking the defendant for allegedly overstating the whitening power of its toothpaste.  The toothpaste contained hydrogen peroxide, and its advertising bragged of deep whitening – more than three shades.  The plaintiffs asserted that the hydrogen peroxide was not strong enough and was not in contact with tooth enamel long enough to achieve the promised results.  The causes of action were based on breach of warranty and violations of New York’s General Business Law sections 349 and 350, which outlaw deceptive practices and false advertising.

What can this case possibly have to say for drug litigation?  To begin with, the toothpaste’s peroxide content meant that it was both a cosmetic and an over-the-counter (OTC) drug.  A product qualifying as both a cosmetic and drug is subject to the stricter requirements applicable to drugs.  Either way, such a product enjoys the preemption protections in the Food, Drug and Cosmetics Act,  21 U.S.C. sections 379r and 379s.  The FDCA forbids state law (including jury verdicts) or regulations that would impose a requirement on cosmetics or OTC drugs that are “different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable” via the FDCA.  Thus, the defendant filed a motion to dismiss the case in its entirety, and preemption was one of the grounds. The plaintiffs ultimately evaded preemption because the court found no FDA requirement regarding the tooth whitening claim, so there was nothing federal that the state laws against deceptive advertising  contradicted.

Okay, you’re still probably wondering why a drug defense hack would care about this case.  If an associate failed to find this case in her research, who cares?

There are two preemption points in Canale that are valuable:

1. The plaintiffs’ opposition to the defendant’s motion rested solely on implied preemption cases.  That is, the plaintiffs argued that there was no impossibility preemption.  That is, the plaintiffs had completely missed the point.  The defendant was not arguing impossibility preemption.  Rather, the defendant argued that Congress had expressly manifested an intent to preempt state law.  The plaintiffs had confused express preemption with implied preemption, but the Canale court kept the distinction straight.  So should you.

2.  The plaintiffs, predictably, argued that there was a presumption against preemption.  But, consistent with point 1 above, the Canale court held that “where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  It is nice to have in your pocket such a clear statement on this issue from SDNY.

Still, as we mentioned, the preemption argument did not carry the day for the defendant.  So was this a win for the plaintiffs?  Not at all.  The issue of whether or not the advertising for the whitening toothpaste was deceptive had already been addressed to the Federal Trade Commission.  The issue was pending. The FTC had at least as much expertise as the court in deciding whether the hydrogen peroxide in the toothpaste had sufficient whitening power (let’s face it, the FTC has more expertise), the FTC is specifically tasked with discretion to police allegedly deceptive labeling, there was a risk of inconsistent rulings, and the FTC had gotten the issue first.  Consequently, the Canale court – after observing that “primary jurisdiction” is something of a misnomer because it isn’t , strictly speaking, jurisdictional – decided to stay the litigation to allow the FTC to do its job and determine whether the toothpaste advertising really was deceptive.

Staying a class action is definitely a good result for the defendant.  Despite the setback on the preemption front, we bet the Canale result put smiles on the faces of the defendant and its lawyers – nice, big, shiny smiles.

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

Usually when we are talking about Michigan, it’s to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.” M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b).  Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it’s somewhat rare to get to post on a Michigan law case that isn’t focused on the statute or preemption, but we found one – Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff’s surgeon in plaintiff’s hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in “Class I/Clean wounds.” Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19.   In addition, the product’s labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to “high concentrations of digestive enzymes.” Id. at *17.

Against this background, plaintiff filed suit alleging that defendant’s product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant’s insufficient testing led it to market the product as a “biologic mesh,” when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff’s injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff’s treating surgeon who performed the surgery removing the mesh. Plaintiff opted not to have Dr. Rosen prepare a full Rule 26 expert report, the consequences of which were that he would be limited to testifying as a treating physician and so only permitted to testify as to those opinions that were formed “for purposes of, and within the scope of, his care and treatment of [plaintiff].” Id. at *2. Most of Dr. Rosen’s opinions were not.

For example, Dr. Rosen’s opinion that the mesh was unsafe for use in Class I wound was excluded as not being related to his care and treatment of the plaintiff. That may have been an opinion he held at the time he treated plaintiff, but it was not formed for the purpose of or within the scope of his care and treatment of plaintiff. Id. at *23. He had no reason to form a safety opinion to care for and treat plaintiff and he didn’t include any such opinion in his medical records or in any discussion with plaintiff or any of his colleagues. Id. Moreover, Dr. Rosen did not report plaintiff’s case to the FDA as an adverse event. Id. Dr. Rosen’s opinions on the sufficiency of the testing and adequacy of the warning suffered the same fate – to even be considered potentially admissible Dr. Rosen needed to prepare a proper Rule 26 expert report “setting forth the scientific or experiential basis” of his theories. Id. at *25.

But that wasn’t the only fatal flaw for Dr. Rosen’s opinions. His opinions were also unsupported. Unlike his litigation opinion that defendant’s biologic mesh was unsafe for Class I wounds, Dr. Rosen had opined in numerous peer-reviewed articles that defendant’s product was acceptable in that precise situation. Id. at *23-24. The blatant contradiction was another ground for exclusion. Id. at *25. These same peer-reviewed publications also discussed the need for further study of the biologic mesh for treating Class II and III wounds, but nowhere suggested that further testing was needed regarding treatment of Class I wounds such as plaintiffs. So, Dr. Rosen’s opinions on adequate testing were also unsupported. Id. at *26.

As to the adequacy of the warning, plaintiff argued that the product’s labeling should have included a warning to remove the mesh in the event of a seroma (what plaintiff had) or an infection. Id. Dr. Rosen, however, could only opine that “there should be more information” about the types of cases for which the mesh should be used. Id.  That was not enough to clear plaintiff’s hurdle of proving as a matter of law that defendant had a duty to warn. Id. Moreover, as noted above, the label did warn about weakening and breakdown – the very side effects plaintiff suffered. Id.

Finally, Dr. Rosen also offered an opinion on causation. He testified that he saw the mesh “sitting on a bed of pus,” removed it, and concluded that the mesh caused the infection because the infection cleared up after removal. Id. at *29. The court didn’t question that Dr. Rosen knew an infection when he saw it.  But “the ability to diagnose medical conditions is not remotely the same … as the ability to deduce … in a scientifically reliable manner, the causes of those medical conditions.” Id. (citation omitted). Bottom line – nowhere in his opinion did Dr. Rosen rule out the other potential causes of plaintiff’s infection and failure to heal; such as his diabetes, obesity, blood pressure, and use of immunosuppressants. Id. *29-30.

But Dr. Rosen wasn’t the only problem with plaintiff’s case. Plaintiff’s failure to warn claim also failed for lack of causation. First, the learned intermediary doctrine applies to a medical device. Id. at *21-22. So any duty to warn ran to plaintiff’s surgeon. Second, there was no evidence that plaintiff’s surgeon read the product’s labeling. Id. at *29.   He had not met with the defendant’s representative, had not read the instructions for use, and had not read any of the literature about the product. Under this circumstance, no additional or different warning would have made a difference because the doctor wouldn’t have seen it. No failure to warn.

Defendant also had no duty to conduct a randomized prospective clinical trial before marketing the product. There was no evidence that such a clinical trial was the standard of care for 510k mesh products at the time defendant’s product was approved. Id. at *27.

Plaintiff paid dearly for failing to serve a Rule 26 expert report for their sole medical expert, although it appears that even with a report very little of what their expert was offered to opine on would have been admissible under Daubert anyway. And with no causal nexus between the doctor and the warning, plaintiff’s failure to warn claim was dubious regardless of whether the expert testimony was admissible or not. While any one of these things would have sunk the case, we’re glad the court explored them all. The opinion is loaded with good precedent.

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One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box warning was not only inadequate but so poor as to be worthy of punitive damages.  Id. at *7.  Fortunately the Missouri Supreme Court granted a transfer (on January 5, 2017, according to Westlaw) and (we hope) will restore sanity on at least some of the issues in Barron.  However, the mere fact that a boxed warning – the strongest FDCA warning there is – could be utterly disregarded as in Barron got us thinking.

How have courts treated boxed warnings in other inadequate warning cases?

Initially, we’re not dealing in this post with claims that, in order to be adequate, a defendant’s labeling should have included a boxed warning. We’ve dealt with that kind of claim elsewhere, and our position is that, since the FDA must pre-approve all boxed warnings, all “should have added” claims are preempted.  This post deals with prescription medical products that already have boxed warnings.  Preemption becomes an issue in existing black box cases only if the plaintiff claims that the black box should have been changed – since (as discussed in the posts linked to previously) changes to black box warnings require prior FDA approval.

Looking back through our posts, we see we’ve described one decision, Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013), reaching such a result. Hain recognized that “[a] ‘black box’ warning is the strongest warning required by the FDA.”  Id. at 6 (citing 21 C.F.R. §201.57(c)(1).  Regardless of what might be the case with other, similar products:

[B]y mandating each manufacturer include the strongest type of warning possible to warn of [the risk at issue], the FDA ensured each prescriber’s attention would be focused on the risk. . . .  [A] boxed warning required by the FDA existed in the package insert at the time [plaintiff] ingested [the drug].  Courts have previously held prescription warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.

Id. at 7.

In In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333 (N.D. Ala. 2012), the primary authority cited in Hain, the court determined that under the law of any state in the country, an on-point black box warning was adequate as a matter of law.  Such a warning was “the highest level warning possible, prominently displayed at the beginning of a drug’s official prescribing information.”  881 F. Supp.2d at 1339.  There could be no doubt that such a warning “was sufficient to alert to the possibility of the harm actually suffered.” Id. at 1340.  Plaintiff’s quibbles about when the drug should be used failed because they sought to tell physicians how to practice medicine.  “[T]he decision as to use [of] a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.  Id.

Unlike the majority of cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from [the drug], but for failing to tell physicians when to prescribe it. . . .  [Even] the plaintiffs recognize that a black box warning is “the most serious warning in the FDA’s arsenal”. . . .  For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law.

Id. at 1342-43 (citation omitted).  Accord In re Chantix (Varenicline) Products Liability Litigation, 889 F. Supp.2d 1272, 1304 (N.D. Ala. 2012) (“the court finds that [the] black box warning is adequate as a matter of law”).

Similarly, in Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah 2016), the court held that a boxed warning of a usually fatal condition was adequate to warn physicians of that risk as a matter of law:

[I]t is undisputed that as a condition of [the drug’s] re-approval . . . the FDA required that the prescribing information contain a “black box” warning about [the risk] which is the strongest warning  required or permitted by FDA.  The black box warning, as the most serious warning available, can be reasonably expected to catch the attention of the consumer. . . .  [T]he intensity of the warning matched the magnitude of the risk.  The black box warning . . . was not qualified or minimized in any way because the magnitude of the risk − death or severe disability − was of the highest possible degree.

Id. at 1343-44 (footnotes omitted).  Accord Amos v. Biogen Idec, Inc., ___ F. Supp.3d ___, 2017 WL 1316968, at *5 (W.D.N.Y. April 10, 2017) (adequacy as a matter of law; the drug’s “label contained this information in a black box warning, the strongest warning available”); Gentile v. Biogen Idec, Inc., 33 Mass. L. Rptr. 607, 2016 WL 4168942, at *6 (Mass. Super. July 28, 2016) (“[t]he black box warning in effect when [the prescriber] first prescribed [the drug] to [plaintiff’s decedent] explicitly warned against the precise risk . . . that [she] ultimately suffered, and fully disclosed the serious consequences of that disease”).

In Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010), the product’s black box warning “advised physicians of the specific risks at issue in the instant case,” thus the court found “no evidence that [defendant] breached its duty to exercise reasonable care to inform [the prescriber] and others similarly situated of the risks associated with” taking the drug in question, even though the prescriber testified that he did not remember the warning correctly.  Id. at *10.  In Whiteside v. Johnson & Johnson, 2015 WL 11120989 (Mag. N.D. Tex. Mar. 13, 2015), adopted, 2015 WL 11120990 (N.D. Tex. July 8, 2015), the court dismissed the action with prejudice when the plaintiff abandoned ship in the face of the defendant’s summary judgment motion.  The court noted that the “Plaintiff’s prescription postdat[ing] . . . Defendants’ addition of an adequate ‘black box’ warning about the risks associated with the drug in question . . . would be fatal to Plaintiff’s claims.”  Id. at *1 n.1. See also Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *2-3 (N.D. Tex. Nov. 15, 2007) (black box warning held adequate as a matter of law; Texas presumption unrebutted); Clark v. Hoffman-La Roche, Inc., 2006 WL 1374516, at *7 (N.J. Super. May 2, 2006) (boxed warning “satisfied [defendant’s] burden under either New Jersey or Utah law to provide an adequate warning with respect to the risks” at issue); cf. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832, at *34 (W.D. La. Sept. 2, 2014) (characterizing post-prescription boxed warning as “hav[ing] full and adequate warnings”).

In a couple hours of looking we found more than a half-dozen cases where boxed warnings were held adequate as a matter of law.  Thus any court “unaware of any court holding that such a [boxed] warning is per se adequate as a matter of law,” Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *6 (N.D. Ohio Sept. 30, 2016), either didn’t look very hard, or wasn’t willing to accept what it found.

In our view, the bottom line with boxed warnings is: one, the presence of a boxed warning concerning the relevant risk of a prescription medical product demonstrates that the risk is adequately warned about and sufficiently emphasized, making the warning adequate as a matter of law; and in any event two, since the FDA controls the content of black box warnings, any allegations that existing boxed warnings are inadequate are necessarily preempted.

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Maybe we should not be surprised when courts within California reach to find personal jurisdiction over out-of-state corporations even when non-Californians sue. That is what BMS v. Superior Court was all about.  Right?  Well, it happened again last week in Dubose v. Bristol-Myers Squibb Co., No. 17-cv-00244, 2017 WL 2775034 (N.D. Cal. June 27, 2017), and it has us scratching our heads.

This is not an obscure issue. We know from Bauman that a company is subject to general personal jurisdiction only where it is “at home,” which means state of incorporation or principal place of business.  (You can view our post-Bauman personal jurisdiction cheat sheet here.)  And the Supreme Court famously held just two week ago in BMS that California’s courts cannot exercise specific personal jurisdiction over an out-of-state defendant unless there is “an affiliation between the forum and the underlying controversy, principally, [an] activity or an occurrence that takes place in the forum State.” Bristol-Myers Squibb v. Superior Court, 137 S. Ct. 1773, 1781 (2017).  That means there must be a causal link between the defendant’s forum contacts and the alleged injury to the plaintiff.  Contacts with other people—even people taking the same drug—do not count.

That is what makes the order in Dubose so confounding.  In Dubose, a South Carolina plaintiff sued a New York pharmaceutical manufacturer in the Northern District of California alleging product liability claims arising from her use of a prescription drug in South Carolina.  This is Bauman and BMS all over again, right?  Well, the district court saw it differently because the plaintiff alleged that the defendant conducted clinical trials within California, which became “part of an unbroken chain of events leading to Plaintiff’s alleged injury.” Dubose, at *3.  The district court therefore found specific personal jurisdiction based on those clinical trials, and it distinguished BMS v. Superior Court on the basis that there were no California contacts alleged in that case sufficient to support jurisdiction.

Having found jurisdiction, the district court then promptly transferred the case to South Carolina, where it should have been filed in the first place. But even though the case ultimately came to the correct result—sending a litigation tourist packing—we question the court’s order finding jurisdiction for several reasons.  First, we cannot distinguish BMS as easily as the district court did.  The alleged California contacts in Dubose were clinical trials.  But what are clinical trials?  They are physicians prescribing drugs to patients.  Sure, the prescriptions are written under approved protocols and data is collected.  But a patient being treated in a clinical trial does not look all that different from a patient being treated outside a clinical trial.  The Supreme Court held in BMS that “the mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug] in California . . . does not allow the State to assert specific jurisdiction.”  137 S. Ct. at 1871.  The clinical trial participants referenced in Dubose were similarly “prescribed, obtained, and ingested” the drug within California.

Second, the district court in Dubose came to its conclusion because the clinical trials purportedly were in the “but for” causation chain leading to the alleged injury.  But were they?  Pharmaceutical companies typically run clinical trials at centers throughout the world.  Were the data from the California clinical trials really a “but for” cause of a patient ingesting a drug in South Carolina at some later point in time?  Put another way, if the California clinical trials never occurred, would the product really not have come to market?  We don’t know, but our point is that the causal chain leading from a specific, geographically defined subset of clinical trials to an alleged injury seems tenuous at best.

Third, the district court’s order seems to hold that any forum contact is sufficient to support specific personal jurisdiction, so long as it can be related to the plaintiff in any way.  But recall that specific personal jurisdiction is grounded in due process, which asks whether it is fundamentally fair to hold a defendant to answer in a forum where it is not at home.  At some point, the affiliation between the forum contact and the claim can be so attenuated that it can no longer be said that one “arose from” the other.  That is what we think is going on in Dubose.

If specific personal jurisdiction exists in every state where a multi-center clinical trial occurred, then any plaintiff who used the drug conceivably could sue the manufacturer in any of those states—no matter where the manufacturer is based and no matter where the plaintiff resides or used the drug. In the one example the district court cited, that would translate to specific personal jurisdiction in 44 states. Dubose, at *3 (citing M.M. ex rel. Meyers v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. Ct. App. 2016)).  That is not “specific” personal jurisdiction.  That more resembles the concept of universal jurisdiction that the Supreme Court condemned in Bauman.

It could not be more unlike the disciplined contours of specific jurisdiction set forth in BMS.  The proliferation of jurisdiction to a multiplicity of states allowed the litigation tourism problem to arise in the first place.  It is also what led the Supreme Court to reel in personal jurisdiction.  Moreover, while the district court observed that “it is not clear what the alternative would be,” we would say the alternative is that Plaintiffs can sue a defendant where the defendant is at home or in states where they reside or where they ingested the product and experienced alleged injuries.  The Supreme Court made this clear in BMS too, where it rejected the plaintiffs’ “parade of horribles” and held that its “straightforward application of settled principles of personal jurisdiction” left plaintiffs ample alternatives, whether suing alone or in combination with others.

The case is in South Carolina now, so we doubt this order will undergo appellate review. That’s unfortunate.  Another thing is that the district court in Dubose relied most heavily on the M.M. ex rel. Meyers order to support its finding of jurisdiction.  But M.M. is currently in the U.S. Supreme Court on a petition for certiorari.  In light of BMS, we would not be surprised if the Supreme Court granted cert., vacated the order, and remanded for further proceedings.  That would leave Dubose as even more of an outlier.

 

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Finally, some good news out of California – at least when personal jurisdiction isn’t the issue.

Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803 (Cal. App. June 30, 2017), and the result, particularly on the design side, was much more to our liking.

Indeed, there may well not have been post-BMS personal jurisdiction in Trejo either, since the plaintiffs were Hondurans injured in Honduras.  It’s not clear from the opinion where the drug at issue – an over-the-counter (“OTC”) ibuprofen-based pain relief medication – was purchased.  Somewhere in the United States, we gather, and it was then sent as a “care package” to the purchaser’s Honduran relatives.  Trejo, 2017 WL 2825803, at *2.

The drug was eventually taken, in Honduras, by someone other than its intended user, and that person, the eventual plaintiff, subsequently suffered Stevens-Johnson Syndrome (“SJS”), a nasty condition that we’ve encountered frequently on this blog.  This particular exercise in litigation tourism was quite initially successful.  A jury awarded over $50 million (including $15 million in punitive damages), finding for plaintiff on negligent failure to warn, negligent design, and strict liability design defect under the so-called “consumer expectation” test and the risk-benefit test.  The defendant “won” (if you could call it that) on strict liability warning defect and design defect under the “risk/utility” test. Id. at *5.  California not only allows plaintiffs two bites at the warning apple on separate negligence and strict liability theories, but three bites at the design apple under separate negligence, strict liability/consumer expectation design defect, and strict liability/risk/utility design defect theories.  No wonder plaintiffs flock to the state.

On appeal, however, the plaintiff in Trejo lost it all.

The design defect rulings are the most significant for the rest of us.

First, Trejo becomes the fourth appellate court to hold that the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), applies generally, and it not limited to generic drugs – the others being Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016) (airplanes); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir., 2015) (branded drugs), and In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015) (branded drugs). Trejo joins Sikkelee and Yates in applying Mensing/Bartlett to design defects.  And Trejo is the first appellate decision to apply Mensing/Bartlett specifically to OTC drugs.

This is a good direction for the law to be moving. No appellate court has held that Mensing/Bartlett is limited to design defects in generic drugs.

Here’s what the unanimous Second District Cal. App. panel in Trejo had to say about preemption:

While the FDCA contains an express preemption provision concerning OTC drugs (21 U.S.C. §379r) – with a great big exception that exempts “product liability” claims from preemption – express and implied preemption operate independently.  Thus the savings clause for “product liability” doesn’t preclude implied preemption where product liability claims are in conflict with federal law.  Trejo, 2017 WL 2825803, at *23 (“[t]he savings clause does not foreclose the possibility that conflict preemption may arise from federal sources other than . . . §379r”).

Plaintiff’s design defect claim was that the defendant shouldn’t have used ibuprofen at all, but rather dexibuprofen, an isomer of the drug in question, “even though the FDA has not approved dexibuprofen for sale in the United States.” Id. at *5.  That’s right – plaintiff articulated a blatant stop-selling claim of the sort Bartlett had held preempted, and the Court of Appeal called “barnyard expletive” on plaintiff’s tortured argument otherwise:

[Plaintiff] asserts that he did not argue that defendants “should have withdrawn [the drug] from the marketplace, or should have never sold it in the first place.”  This argument is merely a matter of semantics. No matter how plaintiff words his argument, the claim that defendants failed to sell dexibuprofen instead of ibuprofen requires the claim that defendants should have withdrawn [the drug] from the market because defendants could not have changed the active ingredient of [the drug] without undergoing an entirely new FDA drug application process.

Trejo, 2017 WL 2825803, at *21 n.20 (emphasis added).

The Bartlett “independence principle” also required preemption.  It was impossible for the defendant to do what plaintiff contended state law required (materially change the drug’s design) immediately because material design changes to OTC (and all) drugs (and medical devices) require the prior review by and approval of the FDA.  “[F]ederal law prohibited the manufacturer from taking the remedial action required to avoid liability under [state] law.”  Trejo, 2017 WL 2825803, at *25 (quoting Bartlett, 133 S. Ct. at 2476).  That ruling applied to all drugs:

Consistent with our conclusion that the savings clause . . . does not prevent the applicability of ordinary preemption principles in the nonprescription drug context, we agree . . . that Bartlett’s holding is not limited to prescription drugs.

Trejo, 2017 WL 2825803, at *25 (emphasis added).  The FDCA did not permit the defendant to substitute freely one active ingredient for another.  “Dexibuprofen therefore would be a new drug, requiring a new drug application.”  Id.

[F]ederal law prohibited defendants from changing the design of [the drug] by selling dexibuprofen without prior FDA approval.  Defendants accordingly could not have avoided design defect liability without violating federal law.  “FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product.”

Id. (quoting and following Yates, 808 F.3d at 298).

Preemption applied because the defendant could not have acted “unilaterally” to make the design change purportedly required by state product liability law – whether design defect is measured by consumer expectation or risk/utility:

Thus, under federal law [citations omitted] defendants could not unilaterally change the chemical composition of [the drug] from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of [the drug].  Nor could they be required to stop selling [the drug] in order to avoid state liability.  Plaintiff’s design defect claim accordingly is preempted.

Id. at *26 (Bartlett citations omitted) (after quoting from a half-dozen cases listed in our post-Levine drug preemption cheat sheet).

Moreover, after trying the case as a straight-forward “you should have designed the product differently” claim, plaintiff could not attempt to convert it to some kind of quasi-warning-based case.  Plaintiff had a real warning claim (which we’ll get to) and couldn’t convert one possible design related factor (presence of warnings) into the whole design ball of wax to avoid preemption after having tried a different case to the jury.  Id.

But there’s more on design first.

Second, as we mentioned, California allows plaintiffs generally to prosecute design defect claims on either a consumer expectation or risk/utility theory of liability.  Not anymore in prescription medical product cases after Trejo.  Trejo also held, quite apart from preemption, that the consumer expectation theory was inapplicable to complicated products such as OTC drugs – and thus, we would argue, a fortiori would be inapplicable to prescription medical products.

The consumer expectation test is only appropriate for products that “everyday experience” allows consumers generally to have safety expectations about:

[T]he consumer expectations test is reserved for cases in which the everyday experience of the product’s users permits a conclusion that the product’s design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design.

Trejo, 2017 WL 2825803, at *27 (quoting Soule v. General Motors Corp., 882 P.2d 298, 308 (Cal. 1994)) (emphasis original).  OTC drugs – let alone prescription products – aren’t that.  Plaintiff tried the case with expert witnesses, which is a no-no under the consumer expectation theory.  That plaintiff did so demonstrated the theory’s inapplicability.

The circumstances of [the drug’s] failure involve technical details and expert testimony regarding the effect of the product upon an individual plaintiff’s health, and the ultimate question of whether [the drug] was defectively designed calls for a careful assessment of feasibility, practicality, risk, and benefit.

Id. at *30 (citations and quotation marks omitted).  SJS was an “unusual reaction” to the drug, thus “expert testimony was required to explain plaintiff’s theory.”  Id.  “Accordingly, we conclude that the consumer expectation test should not have been applied.”  Id.

In light of this complexity, plaintiff’s excuse for consumer expectations fell in the same barnyard as his argument against stop selling preemption.  Simply testifying that “I didn’t expect to get hurt” didn’t cut it:

Plaintiff here contends that the consumer expectation test applies because the ordinary consumer does not expect to contract SJS/TEN from taking OTC [ibuprofen].  However, it could be said that any injury from the intended or foreseeable use of a product is not expected by the ordinary consumer.  If this were the end of the inquiry, the consumer expectation test always would apply and every product would be found to have a design defect.

Trejo, 2017 WL 2825803, at *29 (emphasis added).  A consumer cannot, by playing dumb, bootstrap himself into a consumer expectation claim.  “[T]he consumer expectation test does not apply merely because the consumer states that he or she did not expect to be injured by the product.”  Id. Admittedly, we haven’t seen that many California plaintiffs audacious (or desperate) enough to utilize consumer expectation theories against FDA-approved products; nonetheless we’re beyond pleased now to have explicit appellate authority precluding this theory of liability against our clients.

After Trejo, it becomes a lot harder for any plaintiff to pursue a design defect claim against a prescription medical product in California.  If the design considerations that go into OTC drugs are too complex and involved to allow use of the consumer expectation theory of liability, than that theory is even less available to more sophisticated prescription products whose risks and benefits are so esoteric that the FDA has concluded that they should be dispensed only after evaluation by medical doctors.  Likewise, the Mensing/Bartlett preemption rationale against design defects is equally applicable to all FDA regulated products.  Can a branded drug manufacturer change its product’s active ingredient – or any other aspect of the product that materially affects product safety?   No.  And neither can a medical device manufacturer.  Effectively, all design defect claims that could make a difference in a product liability action (that materially affect “safety”) require prior FDA review, and thus should be preempted under Trejo and the Mensing/Bartlett independence principle.

That’s still not all.  We still have Trejo’s disposition of the warning-related aspects of the verdict to discuss.

Third, the Court of Appeal unanimously held that the jury’s verdict for the defendant on strict liability warning defect was fatally inconsistent with its verdict for plaintiff on negligent failure to warn.  Trejo, 2017 WL 2825803, at *8-14.  From a national perspective, this result is less important than the design defect aspects we just finished with, because disposition of the warning claim has to do with the interaction of California’s peculiar warning-based legal doctrines, which still attempt to maintain a difference between negligence and strict liability in the warning context.  Most other states treat them interchangeably.

It’s still important in Trejo, however.  $50 million is $50 million.

Briefly – because the whole thing reeks of hair-splitting to us – “both the strict liability and negligence theories were premised on a single alleged defect.”  Id. at *8.  “[U]nder either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury.”  Id. at *6.  However, “strict liability, which was developed to ease a claimant’s burden of proof, requires proof of fewer elements than negligence.”  Id.  Thus, negligence requires “an additional element, namely, that the defect in the product was due to negligence of the defendant.”  Id.  Where (as here) the claimed defect under both theories is the same, that means that strict liability simply eliminates an necessary element, so that “a positive verdict on the latter [negligence, is] difficult to explain if strict liability cannot be found.”  Id.

Exactly that happened in Trejo, and it cost plaintiff $50 million.  It wasn’t the first time, either.  A previous decision, Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 262-64 (Cal. App. 1999), was directly on point, forthrightly holding that “[a]s a practical matter then, the difference in the two concepts [negligence and strict liability] is so small as to make no difference.”  Id. at 263.  The jury’s finding for the defendant on the “easier” warning defect claim was necessarily inconsistent with its finding for plaintiff on the “harder to prove” negligent warning claim.  Trejo, 2017 WL 2825803, at *14 (“The jury’s special verdict on negligent failure to warn is fatally inconsistent with its verdict on strict liability failure to warn and must be reversed.”).

Who knows what would have happened if this plaintiff had not insisted on more than one bite at the apple?  That’s what we’ll find out on retrial.  We have no idea when that might be however, since further appellate review in Trejo is certainly possible.  In this respect, we are reminded that Bartlett, like Trejo, was also an SJS case.

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New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up.  You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots aren’t allowed to vote, but maybe it’s the other 49 states that have it wrong. Then again, New Mexico did give us the McDonald’s hot coffee case, which ranks right up there with poor Mrs. Palsgraf’s conked noggin among significant injuries in the history of American tort law.  If you don’t remember the facts of Palsgraf v. Long Island R.R., please enjoy this Lego version.  We’ve heard rumors (we haven’t bothered to scour the New Mexico statutes) that New Mexico law frowns on letting ladies pump their own gas, and one can apparently get in trouble with the authorities there by dancing either around or under a sombrero.  And let’s not forget that tv-dom’s number one lawyer is no longer Perry Mason, Ally McBeal, or any of the denizens of the McKenzie Brackman law firm in LA – no, it’s Saul Goodman of Albuquerque.  We first met Saul on Breaking Bad.  Saul had his charms, but it is hard to imagine a sleazier lawyer. Now he is the protagonist (?) in one of the best current shows, Better Call Saul.  If you haven’t yet taken a look at the show, do yourself a favor and give it a try.  The writing, the acting, the camera work — s’all good, man.
It’s good to know that idiots can’t vote in New Mexico.  Can they bring lawsuits?  Ponder that question.  Don’t ponder too long.
Today’s lesson centers on the recent case of Inge v. McClelland, ___ F. Supp. 3d ___, 2017 WL 2829696, 2017 U.S. Dist. LEXIS 98386 (D.N.M. June 26, 2017). The plaintiffs alleged that the defendant pharmacy wrongly sold them opioids, and that the result was that the plaintiffs got addicted and suffered all the terrible sequelae of said addiction.  The plaintiffs lost their jobs and lost custody of their children. The legal theories included federal RICO, various New Mexico common law torts, as well as violation of New Mexico’s Unfair Practices Act.  The factual assertions are rather arresting: the pharmacy dispensed thousands of opioid pills at potency levels given to end-stage cancer patients – which these plaintiffs most certainly and obviously were not.
Pretty strong case, right?
Oops, we left something out.  You see, the plaintiffs had conspired with a nurse practitioner to write up fraudulent prescriptions.  The plan was to find a pharmacist with flexible professional ethics or an exceedingly limited attention span. The plaintiffs would then procure the pills and split them with the nurse practitioner.  It’s not clear whether getting addicted and descending into a hellish fog was part of the plan, but that’s what happened.  Somehow the plaintiffs were able eventually to rouse themselves from their opioid torpor and file this lawsuit.
The defendant moved to dismiss the case because the claims were barred by the wrongful conduct rule and its corollary, the in pari delicto doctrine.  Anytime we can hearken back to our high school Latin days, we will.  In pari delicto is short for the phrase “in pari delicto melior est conditio possidentis,” which means, roughly, “in equal fault, better is the condition of the possessor.”  Great Caesar’s ghost, what does that mean?  Well, all is made crystal clear in a post that Bexis wrote nearly ten years ago setting forth the in pari delicto rule and supplying a list of cases from several jurisdictions.  (We wondered whether it was high time to update that list, but then Bexis told us that a reasonably current list of in pari delicto cases resides in his book.  Tell your librarian to get that book!)  The rule is based on a public policy to preclude anyone who injures him or herself in the course of criminal activity from recovering in tort for those injuries.  Put another way, perhaps more appetizing for those of you who delight in legal jargon, criminal conduct is an intervening act that cuts off liability.  In drug cases, that criminal activity usually involves plaintiffs who obtain prescription drugs under false pretenses. The drugs obtained are almost always some form of narcotics, as was so in the Inge case.

New Mexico law has a version of the wrongful conduct rule, and it operates as a complete bar to a plaintiff’s case.  Acquisition of narcotics through fraudulent prescriptions is a violation of both federal and state law.  So is narcotics trafficking, which the plaintiffs admitted to when they said they were going to split the pills with the nurse practitioner.  Most versions of the in pari delicto rule limit application to instances where the harm suffered is one that the violated criminal law was intended to avoid. In Inge, the alleged injury – addiction – was precisely the harm at which the criminal laws were aimed.

This case is a laydown, isn’t it?

Yes, it is.  But that’s not to say that the plaintiffs in Inge offered no resistance.  The plaintiffs argued that merely presenting false prescriptions was not, in itself, illegal.  Even assuming there is any force to that argument, the plaintiffs admitted that the scheme was to share the drugs with the prescribing nurse practitioner.  That is straight-up illegal.  (We prosecuted drug cases long ago.  We harbored no love for the crazy-long federal mandatory minimum sentences, but it was hard to shed a tear for the drug-dealers.  We wouldn’t have felt any sympathy for the Inge plaintiffs, and, based on the facts set forth in the court’s opinion, we would not even have considered a plea agreement that did not lock in some jail time.)  The Inge plaintiffs also argued that their conduct was less culpable than the defendant pharmacist, since nothing would have come to fruition without the defendant’s alleged agreement to fill obviously bogus prescriptions.  They also offered the inevitable argument that the defendant’s misconduct, as a licensed pharmacist, was worse than the misconduct of [supply your own epithet for drug-abusers and/or drug-dealers].  The court did not buy these arguments.  It is not as if the pharmacist forced the plaintiffs to concoct and follow through on this opioid abuse and distribution scheme. Moreover, however serious the pharmacist’s alleged breach of professional ethics was, it did not make the plaintiffs’ illegal conduct somehow legal.

Interestingly, the Inge plaintiffs also argued that, rather than operate as a full-blown bar to their action, the in pari delicto rule should come into play as an element of comparative fault that the jury could consider.  In support of this argument, the plaintiffs cited a case from West Virginia, which allowed a case very like the Inge case to proceed.  West Virginia, of course, has a significant opioid problem.  See Talbot, “The Addicts Next Door,”  The New Yorker (June 5/12, 2017).  You could quarrel with the West Virginia decision, and you could quarrel with the public policy view underlying such decision, but none of that mattered to the Inge court, because it wasn’t the law of New Mexico.
As a final, and somewhat comical point, the court dismissed the unfair practices claim along with all the others, because whatever else you might say about the defendant pharmacist, he did not make any misleading, false, or deceptive statement in dispensing the pills to the plaintiffs.  Nope, they got exactly what they asked for — and then they got into trouble.  But what they didn’t get was an opportunity to recover damages, including treble RICO damages, in a frivolous lawsuit.

Naturally, anytime you hear of a drug dealer case in New Mexico, you probably think of Breaking Bad.  This time, it’s more like Breaking Stupid.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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