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A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been the neighborhood fox, known to all for years (we live right next to Valley Forge National Park).  The conversation went back and forth for a while, eventually including descriptions of larger size, different coloration, and much longer legs than the fox’s.  We remained unconvinced.  Eventually, our neighborhood e-mail chain came alive with close-up photos of what was undeniably a coyote, taken a scant hundred yards away in a neighbor’s back yard.   Because we are law nerds, it occurred to us that coyotes are just like causation:  an expert can assert a causal link, and assert it again, but, ultimately, there has to be evidence to support the assertion.

As the court agreed in today’s case, a nice (albeit unreported) affirmance of a HUMIRA summary judgment victory out of Maryland’s Court of Special Appeals. In Larson v. Abbott Labs., Inc., 2018 WL 3479236 (Md. Ct. Spec. App. July 19, 2018), the plaintiff, a highly-educated space engineer who had been diagnosed as HIV-positive years before, alleged that the defendant’s psoriasis medication caused him to become sufficiently immunocompromised that he contracted progressive multifocal leukoencephaly (PML).  PML is an often-fatal viral brain disease that left the plaintiff physically disabled and cognitively impaired, and unable to care for himself.  PML is caused by a virus that that is present in the bodies of most adults in the United States but that generally remains inactive except in severely immunocompromised people. HUMIRA’s prescribing information warned that medications of its class had the potential to affect defenses against infection, and that the safety and efficacy of the medication in immunosuppressed patients had not been evaluated.  The warnings did not specifically mention HIV patients.

The plaintiff had been diagnosed as HIV-positive five years before he took HUMIRA. During that time, he treated his plaque psoriasis with home remedies.  When it worsened, he asked his treater about treatment with HUMIRA.  She sought information from the defendant, then referred the plaintiff to a physician who concluded from the information that, because the plaintiff’s HIV was well controlled and that he was not severely immunocompromised (and because a tuberculosis skin test came back negative), he was an appropriate candidate for the medication.  What was unknown to the doctor – and apparently to the plaintiff – was that recent lab results revealed progression of his HIV disease.   (The plaintiff’s infectious disease specialist had attempted to contact him with the results, but he hadn’t responded by the time he began his HUMIRA treatment.) Within three months after beginning his treatment, he began exhibiting headaches and extreme fatigue.  His condition worsened, and he was diagnosed with PML shortly thereafter.

The plaintiff filed suit, asserting the usual product liability claims. His primary causation expert was a “highly-regarded infections disease specialist with significant experience” treating HIV-positive patients. Larson, 2018 WL 3479236 at *7.  The defendant moved to exclude the expert’s opinion.  The trial court granted the motion, and, because the plaintiff was left without expert causation testimony, the court granted summary judgment for the defendant.  The plaintiff appealed.

The plaintiff presented several questions for the appellate court’s determination, including questions related to the trial court’s holdings about the adequacy of the product’s warnings. The appellate court found that it needed to consider only one question – whether the trial court erred in barring the testimony of the plaintiff’s general and specific causation experts and granting summary judgment – because a negative answer to that question obviated the need to consider any of the others.  In the process, the court rejected the plaintiff’s argument that the it needed to address the adequacy of the warnings whether or not the plaintiff could establish medical causation.  As the court explained,

Generally, the “proximate causation element” in a failure to warn case against a pharmaceutical manufacturer is established by proof that the allegedly inadequate warning was a substantial contributing factor to the plaintiff’s injury. . . . In certain product liability cases, however, such as the case before us, the parties disagree over whether sufficient evidence exists to show that the product, itself, can cause the specific injury alleged and, therefore, whether the manufacturer had a duty to provide different or additional warning to prevent the injury. . . . . What is often termed “general causation” is present “when a substance is capable of causing a given disease. . . . General causation, therefore, relates to the element of duty — i.e., whether the risk of the type of injury the plaintiff suffered was reasonably foreseeable, and therefore, whether the manufacturer had a duty to warn the prescribing physician in the first place. . . . Evidence demonstrating [medical] causation . . . must exist independent of whether the manufacturer’s allegedly defective warning label was a proximate cause of the injury. In other words, evidence of general and specific causation was necessary in this case to establish [the defendant’s] duty to warn . . . .

Id., at *9-10. And so the court proceeded to determine whether the trial court had erred in excluding the plaintiff’s causation experts. The plaintiff’s causation theory was that “the immunosuppressant effect of HUMIRA permitted the ‘unmasking’ of [the virus that causes PML], despite the fact that” the plaintiff was not as immunosuppressed as HIV-positive patients who develop PML” even in light of his most recent lab results.  Id.  Maryland is a Frye state.  Under that standard, as the court explained, an expert’s opinion is admissible only if the basis of the opinion is “shown to be generally accepted as reliable within the expert’s particular scientific field.” Id. at *12 (internal punctuation and citations omitted). The standard applies equally to new scientific techniques and to accepted methods applied to support novel theories.

With respect to plaintiff’s main causation expert, the trial court had held that his causation conclusions “[had] not been sufficiently tested and proven to qualify as reliable forensic conclusions rather than scientific hypothesis.” Id. at *13.   The expert’s primary contention was that, “in addition to general HIV disease progression, some additional functional immune deficit must be present for PML to occur,” and that HUMIRA caused that deficit in the plaintiff. Id.   The trial court held that the expert had not considered other potential contributing factors, and that he could not provide a sufficient factual basis for his opinion that HUMIRA was “the missing link.” Id. at *14.

The appellate court stated that, “to constitute a sufficient basis for his general causation opinion, Dr. Jacobson needed to provide support for his contention that” the class of drugs was “known to be associated with an increased risk of PML” at the time the plaintiff took the drug. Id. The plaintiff contended that this support was to be found in the expert’s reference to the drug’s black-box warning about opportunistic pathogens coupled with “well-documented reports of PML occurring in patients who had received” this class of drugs.” Id. But, the court pointed out, the expert did not discuss the “well-documented reports of PML” or explain how the reports helped form the basis of his opinion.   The plaintiff also asserted that the expert relied on “peer reviewed studies, reviews of other biologicals, and FDA Adverse Event Reporting data,” but, the court found, he did not explain how the existence of case reports demonstrated a causal connection, and, the one article he cited related to a drug with a different mechanism of action than HUMIRA’s.

The court echoed the trial court’s holding that there “is sound scientific reasoning to suggest that [the drug’s immunosuppressive effect] could be a factor, but it falls short of showing with any degree of reliability that it is a factor, much less a substantial contributing cause” of the plaintiff’s PML. Id. at *15 (emphasis in original).   The court also reviewed the depositions of the plaintiff’s other experts, and held that, although they “believed that [the plaintiff’s] use of HUMIRA likely contributed to his immunological decline, none could provide a sufficient factual basis for that conclusion. . . . Indeed, [one] conceded that a scientifically reliable causal association” had not been established, id., and another stated “more unequivocally that he believed that [the plaintiff’s increased immunosuppression]” occurred “independent of HUMIRA, representing progression of his HIV disease.”  The same expert discussed an article establishing “the theoretical possibility” that the class of drugs was associated with PML, but explained that “it [didn’t] necessarily establish causation . . . .” Id.

The court commented that it agreed with the trial court that “it may well be that additional research will confirm some or all of [the expert’s] hypotheses. What is determinative in this case, however, is that those causal theories have not been established now nor were they established” when the plaintiff took the drug.  The court also acknowledged that there were ethical obstacles to conducting controlled studies on HIV-positive individuals, and that, because PML is a rare disease, “the amount of epidemiological data that could be useful is limited.”  But this didn’t excuse the experts’ theoretical causation opinions.  The court concluded, “We hold that [the plaintiff’s] experts’ opinions were not grounded on an adequate supply of data, and, therefore, the circuit court properly excluded their testimony.” Id. at *16,

We love a good expert exclusion. BTW, the coyote pictures are really cool.  E-mail us, and we will send them to you.

 

 

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.

Today’s date is rich in literary history.  It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors’ mastery and our pedestrian scribblings.  Perhaps the biggest laugh-out-loud moment a book ever gave us was from Lolita, when the Humbert character travels a long way to visit a family that has at least one member he is especially, um, interested in, only to be greeted at the train station by the patriarch, who shared “the news that his house had just burned down – possibly, owing to the synchronous conflagration that had been raging all night in my veins.”

Today is also the birthday of Henry Fielding, the great British novelist of the 18th century.  In high school we were forced to read Joseph Andrews and Tom Jones, and we grumbled about it, especially upon getting a peek at the girth of Tom Jones (we mean the book).  But the joy, wisdom, and energy of Fielding’s words, often propelling the most ribald adventures, converted our dread into a wholly unforced pleasure, indeed. There is a sentence in Tom Jones that stopped us abruptly in our tracks. Fielding on many occasions spoke directly to the reader, and at one point he explained his intention to “fill my pages with humour till mankind learn the good nature to laugh only at the follies of others and the humility to grieve at their own.”  Has any writer ever articulated a more noble goal?

Continue Reading Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

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

It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two.  It is a tried and true metaphor, like its modern English counterpart — between a rock and a hard place.  But it is particularly fitting in products cases dealing with pre-market approved medical devices.  So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:

Continue Reading The Scylla and Charybdis of PMA Preemption

We’ve blogged several times about the nearly unanimously accepted proposition that FDA regulatory status – that is, the bare fact that a drug or medical device is used off-label – is not a medical risk, benefit, or alternative about which physicians must tell patients under the law of informed consent.  Bexis in particular is emphatic on this point because he played a big part in creating that law in the Bone Screw litigation.

Recently, in a case we didn’t blog about – because we didn’t want to tip off the other side – a Maryland intermediate appellate decision had gone the other way. We’re now pleased to inform everyone, however, that the Maryland Court of Appeals (that state’s highest court) has reversed that bad decision on precisely the grounds we hoped it would (yes, Bexis was in touch with the appellant physician’s counsel in that case). Here’s the money quote:

Information pertaining to an “off-label” use provides the patient with no information about the treatment itself.  As the Pennsylvania court recognized in Southard [a case Bexis briefed], “‘[t]he mere fact that the FDA has not cleared a product for a particular use does not mean that the product is not in fact suitable for that purpose; it simply means that the FDA has not cleared it.’” Southard, 781 A.2d at 107.  Because it provides no information regarding the medical treatment, it cannot, therefore, be considered material information to an informed consent discussion.  We note, finally, with respect to this issue, that the FDA-approval status does not provide any information regarding the materiality of the risks of the administration of [the drug]; it does not inform the fact-finder of the likelihood or severity of any risk.

Shannon v. Fusco, 2014 Md. Lexis 275 (Md. April 24, 2014) (citation and footnote omitted) (emphasis added).

This post is not from the Dechert side of our tripartite blog.

We are particularly pleased with the result in Drager v. PLIVA USA, Inc., ___ F.3d ___, 2014 WL 292700 (4th Cir. Jan. 28, 2014), a generic preemption case that – like so many – involves metoclopramide/Reglan.  Drager is the first appellate court post-Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to get it 100% right on the tempest in a teapot plaintiffs have attempted to create regarding the “consumer expectation” approach to design defect.  In Bartlett the Court construed New Hampshire law, and New Hampshire follows the majority rule “risk/utility” approach to design defect.  Plaintiffs in Bartlett succeeded in the lower courts in converting New Hampshire strict liability into a form of absolute liability by claiming that they didn’t need any alternative design to assert a design defect. The Supreme Court had none of that and properly rejected plaintiffs’ construction of New Hampshire law.  133 S. Ct. at 2473-74.  Ever cautious, the Court “save[d] for another day” whether a “true absolute-liability state-law system” (which no state has actually adopted) could escape preemption. Id. at 2474 n.1.

Plaintiffs desperate to escape preemption have tried nitpicking Bartlett to death.  They have sought to extend the Court’s hesitation to address legal theories not actually presented to include the minority “consumer expectation” approach to design defect.  A couple of decisions have thereby been induced to – not reject preemption – but at least suggest that this issue could be open after Bartlett.  See Bell v. Pfizer, 716 F.3d 1087, 1096 (8th Cir. 2013) (remanding issue for consideration by district court) (applying Arkansas law), Fullington v. Pfizer, Inc., 720 F.3d 739, 747 (8th Cir. 2013) (same).  Other appellate courts have dodged the issue in one way or another.  Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 397 (6th Cir. 2013) (Tennessee would not apply consumer expectation test to drugs).

In our prior “bullseye” post we praised In re Fosamax Products Liability Litigation, ___ F. Supp.2d___, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013), for getting this issue right.  Risk/utility vs. consumer expectation in the context of preemption under Bartlett simply doesn’t matter.  The result in either case (should a plaintiff win), would be liability predicated on a defendant’s failure to do the impossible:  alter a drug’s (or medical device’s) design without FDA pre-approval.  Impossibility preemption doesn’t give a damn about the theory, it looks at whether the common-law outcome can be squared with the defendant’s federal obligations.

That’s where Drager comes in.  It’s the first court of appeals to face this false distinction head on and identify this non-issue for what it is.  Plaintiff in Drager (which was named Gross in the district court) claimed that Maryland follows the “consumer expectation” test, 2014 WL 292700, at *5, and maybe it does.  That doesn’t matter a hill of beans (is “immaterial,” id.), though, where the issue is impossibility preemption:

The Court in Bartlett did not determine that the New Hampshire law was preempted because it applied the risk-utility approach. Instead, it concluded that there was no action that the defendant could take under that approach to increase the safety of its product without violating the restrictions of the FDCA.  We have no trouble concluding that the same is true under either the risk-utility or the consumer-expectations approach in Maryland.  [Defendant] cannot be required to stop selling its product, but at the same time it is prohibited from making any changes to the product itself or the accompanying warnings.  Regardless of the way in which Maryland assesses the unreasonableness of a product’s risks, if [defendant’s drug] is unreasonably unsafe, there is no apparent action that [defendant] can take in compliance with FDCA restrictions to avoid strict liability.

Drager, 2014 WL 292700, at *5 (emphasis added).  That’s precisely the point – and the only point. If the result of a verdict is that, to avoid liability under state law, the defendant would have to violate FDA regulations requiring Agency pre-approval of any alteration of the product’s design, then state law is preempted as “impossible” to enforce in the face of supreme federal law.

And once again, we point out that this is true whether the product in question is a generic drug, an innovator drug, a PMA medical device, a §510k medical device, or a vaccine.  In every instance FDA pre-approval (and often an entirely new start-to-finish approval process) is required before the product’s design can be altered.  There is no “changes being effected” way around FDA pre-approval for design changes.

There’s other stuff in Drager too, but to us it’s not as important as the court’s dispatching of the consumer expectations/risk-utility distinction without a difference.  Specifically:

  • It was not an abuse of discretion for the court to refuse a motion to amend that was never properly made.   Drager, 2014 WL 292700, at *2. The judge can’t be blamed where the plaintiff failed to follow basic rules of civil procedure
  • “[C]ourts may not avoid preempting a state law by imposing liability on a generic manufacturer for choosing to continue selling its product.”  Id. at *3 (sure, that’s the same as Bartlett, but it’s a quotable quote).
  •  “[A] generic may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability.  Therefore, if a generic drug manufacturer cannot satisfy a state law duty except by taking one of these four actions, that law is preempted and of no effect.”  Id.  Another quotable quote.
  • There’s no separate claim for negligent failure to test.  “Divorced from the context of an eventual sale to the consumer, [defendant] could not owe any duty to that consumer to perform any testing or inspection on its product, and there could therefore be no cause of action for negligence.”  Id. at *4.  Thus, Drager goes on our duty to test cheat sheet.
  • “Maryland law does not recognize causes of action for breach of implied warranties of merchantability or fitness for a particular purpose when the goods at issue are pharmaceuticals.”  Id. at *6.  Nice to have that said so clearly.
  • Where a defendant cannot change its product’s formulation or warnings, warranty claims amount to a choice of liability or stop selling the product, and are therefore preempted.  Id.
  • “[T]he content of generic drug manufacturers’ product descriptions and other assertions is mandated by federal law,” therefore express warranty claims are preempted.  Id.
  • It is “frivolous” to argue that fraud and negligent misrepresentation clams based on “promotional and warning materials” are preempted, since these claims “are premised on the content of statements made by the defendant to the plaintiff.”  Id. at 7.  Hear that?  Frivolous.

In a pair of cases, the Maryland Court of Appeals (the state’s highest court) rumbled through more than $1 billion in verdicts in a gasoline spill case, reducing them to nothing (although one plaintiff managed a new trial on one issue unrelated to this post).  See Exxon Mobil Corp. v. Albright, ___ A.3d ___, 2013 WL 673738 (Md. Feb. 26, 2013); Exxon Mobil Corp. v. Ford, ___ A.3d ___, 2013 WL 673710 (Md. Feb. 26, 2013).  While a lot of the analysis in these opinions is devoted to property damage issues (purportedly from groundwater contamination) that we don’t see much in our drug/device sandbox, they also dealt with a couple of issues that are near and dear to our hearts – medical monitoring and fraud on the FDA.

A Tough Medical Monitoring Standard

First, we’re sorry to report, Albright (the lead opinion) did recognize a cause of action for medical monitoring by presently uninjured plaintiffs.  2013 WL
673738, at *26, 31.  That being said, we’re pleased to report that the court attached rigorous requirements to the monitoring cause of action – a “proven necessary medical costs” requirement as tough as any state we’ve seen.

What do we mean?  Well, first, medical monitoring is a “remedy”; thus plaintiffs must first prove some underlying cause of action.  Albright, 2013 WL 673738, at *26-27.  Second, medical monitoring costs must be both “necessary and reasonable.”  Id. at *27 (emphasis original).  “Necessity for medical monitoring . . . must be reasonably certain, rather than merely possible.”  Id. Third, a plaintiff must “experience[] direct and hence discrete exposure.”  Id. at *28 (emphasis original).  Fourth, the condition for which monitoring is allegedly needed must be “related specifically and tangibly to that exposure.”  Id.  Fifth and finally, the risk must be “a direct and proximate result of th[at] exposure.”  Id. (emphasis original).

The court in Albright was determined that medical monitoring not become an excuse for crappy, unsupported claims:

[W]e are wary of damages for speculative claims resting on tenuous proof of risk of disease attributable to the type of exposure. . . . [W]e believe that . . . recovery for a latent disease due to toxic exposure involves necessarily somewhat nebulous forecasts of a potential risk to develop a disease in the
future. . . .  Requiring quantifiable and reliable proof, however, will assist courts in determining whether causation and significant risk are present in a plaintiff’s prima facie case.

Id. at *28 (emphasis original).  The medical monitoring standards that the court adopted are expressly intended to “inhibit[] damages awards for speculative, and thus unreliable, opinions as to a plaintiff’s potential risk of developing a future disease.”  Id. at *29.

Continue Reading Maryland Allows Medical Monitoring (Sort Of); Rejects Fraud On The FDA

Having been in this business (defending pharmaceutical product liability) for a long time now, we’ve learned that what happens to prescribing doctors often comes back to haunt our clients. Nowhere is that better illustrated than with the thankfully discredited theory of regulatory informed consent, which since we’ve already discussed it, here, we won’t go into again in any depth.

You can stop cheering now.

That theory – that the docs had to tell their patients about off-label use – was ginned up for the sole purpose of inducing prescribers to turn around and point the finger at our clients for supposedly encouraging the off-label use in the first place.

We ended up learning more about the law of informed consent than we had ever hoped (or feared) was possible. But Herrmann won that issue when it first arose in the Ohio state court system, and Bexis got cited by the U.S. Supreme Court, so it sort of evened out.

From that experience, and others, we’ve learned to keep up, at least generally, on what’s happening in medical malpractice litigation. If some new theory comes along, and the plaintiffs start hammering the docs with it, sooner or later the plaintiffs (and maybe the docs) are going to turn around and try out their new favorite toy on us.

Just what we need.

And that’s exactly what happened last week in Gourdine v. Crews, ___ A.2d ___, 2008 WL 4068177 (Md. Sept. 4, 2008) (PDF copy here). Thankfully the Court of Appeals of Maryland (which we’ll call the “Supreme Court” from now on because it’s less confusing to everyone not steeped in Maryland terminology) was having none of the new, expansive theory that the plaintiffs were peddling. If plaintiffs had gotten their way, pharmaceutical companies would have been liable, not just to the people who use their drugs, but potentially to anybody.

Here’s what went down in Gourdine. Defendant pharma company made a drug (or possibly a biologic) used by diabetics to maintain steady blood sugar levels. The drug – allegedly accompanied by defective warnings – was used by a patient who wasn’t the plaintiff. While driving a car, the patient lost consciousness, allegedly from low blood sugar. There was an accident, and in that accident the plaintiff’s decedent (who, again for simplicity’s sake, we’ll call “plaintiff”), who was the driver of the other car, was killed. Who gets sued? Why the deep-pocket pharma company, of course.

Now, the lower courts – admittedly in response to defense arguments – had taken the easy way out. They relied on the learned intermediary rule to hold that, because the defendant drug company had no duty to warn the patient directly, there obviously could be no broader duty to warn the public at large. See Gourdine v. Crews, 935 A.2d 1146, 1150 (Md. App. 2007), affirming, 2006 WL 5277412 (Md. Cir. June 28, 2006).

The Supreme Court, which had only recently addressed the rule (Rite Aid Corp. v. Levy-Gray, 894 A.2d 563, 579 (Md. 2006) (“we adopted the ‘learned intermediary’ doctrine”)), found some problems with dismissing the case on this rationale. There was a factual problem. The learned intermediary rule only applies to prescription drugs. Both prescription and OTC (“over the counter,” meaning no prescription required) versions of this particular drug existed. And of course there was a factual dispute as to which version the patient had been using. See 2008 WL 4068177, at *1 nn. 5-6. There was also a legal hurdle – the plaintiff had conceded that there was no duty to warn the patient directly, and essentially didn’t care how the information would be transmitted to the product-using driver. See Id. at *1 n.2. Therefore, the dispositive question, as most of the Supreme Court saw it, wasn’t the learned intermediary rule at all, but rather the general scope of the duty to warn in product liability. Id. at *10. Cf. Id. at *19-21 (concurring opinion would affirm dismissal of the claims under the learned intermediary rule).

Oh goodie. We don’t see many pure no-duty-at-all cases in our line of work.

The plaintiff made two arguments: First, she claimed that, because it was “foreseeable” that a user of a diabetes drug could lose consciousness while driving if improperly warned about a risk of low blood sugar, she had a claim in negligence. Second, she argued that because she was injured by somebody else’s use of the product, she had a claim for “bystander” product liability.

The Supreme Court thankfully disagreed with both these arguments. We say “thankfully” because, if either of them were adopted, prescription drug makers would be exposed to a whole new wave of liability to various and sundry non-product users. Plaintiff was arguing for liability to “members of the motoring public,” 2008 WL 4068177, at *6, and in every subsequent case a duty would allegedly be owed to some similarly broad and amorphous group of non-users.

As to foreseeability, the court held: (1) that negligence and strict liability weren’t all that different and shared “duty” as an essential element, id. at *9-10; and (2) that the scope of duty in both negligence and strict liability actions was narrower than mere foreseeability. Id. at *11-12. That’s good because, with 20-20 hindsight, essentially anything can be described as “foreseeable.” Rather, “[d]uty requires a close or direct effect of the tortfeasor’s conduct on the injured party.” Id. at *12. Duty was constrained by “policy” considerations:

As a practical matter, legal responsibility must be limited to those causes which are so closely connected with the result and of such significance that the law is justified in imposing liability. Some boundary must be set to liability for the consequences of any act, upon the basis of some social idea of justice or policy.

Id. (citation and quotation marks omitted).

This is where the medical malpractice cases come in. All over the country, plaintiffs have for years been trying to tag doctors with professional duties to persons who aren’t their patients. They had tried that in Maryland and lost, in a case called Dehn v. Edgecombe, 865 A.2d 603 (Md. 2005). A doctor who performed a failed vasectomy wasn’t liable as a matter of law to the pregnant wife of the patient. Of course the claimed injury was “foreseeable,” but that wasn’t enough. “Policy” intervened. The court in Dehn refused to extend malpractice liability beyond the physician/patient relationship to essentially anybody with whom a plaintiff might have sex. 865 A.2d at 615.

The same policy rationale can be applied to preclude a drug manufacturer from being liable to anybody whom a user of its drug might injure due to some behavior linked to the effects of the drug. And that’s basically why the court in Gourdine refused to impose liability:

In the case sub judice [a fancy way of saying “this case”], there was no direct connection between [the defendant drug manufacturer’s] warnings, or the alleged lack thereof, and [plaintiff’s] injury. In fact, there was no contact between [the defendant] and [plaintiff] whatsoever. To impose the requested duty. . .would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by [the patient] after her ingestion of the drugs. Essentially, [defendant] would owe a duty to the world, an indeterminate class of people, for which we have resisted the establishment of duties of care.

2008 WL 4068177, at *14 (citation and quotation marks omitted).

So from us here at Drug and Device Law, here’s a heart-felt thanks to our colleagues in the medical malpractice defense bar for being at the point of the spear on this issue. There’s more linking our respective clients than just the learned intermediary rule.

Getting back to Gourdine, the court next addressed the “bystander” issue, something we’re accustomed to thinking of as more of a strict liability than a negligence concept. The court didn’t, though. It concluded that bystander liability, as well, was a matter of “foreseeability” limited by policy. The court found a meaningful policy limitation in the fact that, in all prior bystander cases, the product itself had directly caused the injury. 2008 WL 4068177, at *14. With prescription drugs, however, the claimed “bystander” neither took the drug nor read any drug warnings. Id. at *14-15. All the plaintiff could come back with was more non-patient malpractice cases – from jurisdictions that used pure foreseeability to determine duty. Id. at *15. After Dehn, those cases were inapposite. Id.

So a second expression of thanks is due. The malpractice bar plowed this furrow first, too – even though they didn’t know it at the time.

Because the plaintiffs were asserting novel theories of liability, there were other interesting issues floating around in Gourdine. There was a preemption question, which the Supreme Court didn’t reach. See 2008 WL 4068177, at *1 n.4. But for that reason, you’ll find the trial court decision in Gourdine on our drug preemption scorecard.

Another really interesting issue the court did discuss was the attempted assertion of a negligence per se claim based on alleged violations of the Food, Drug and Cosmetic Act (“FDCA”). We’ve blogged before on the many reasons we believe that FDCA-based negligence per se claims are bogus, and we’re pleased (and relieved) to report that the Maryland Supreme Court agrees with us, at least on some points.

One of the limitations on negligence per se is the requirement that the supposedly violated statute establish a “specific” duty. That’s because there’s no good reason to set aside the ordinary negligence standard for something that’s just as vague as the common-law concept of “reasonable care.” A related limitation is that the statute in question, to qualify for negligence per se, must evince an intent to protect some particular class of persons – not the general public as a whole. 2008 WL 4068177, at *17.

In Gourdine, since the plaintiff was asserting a warning based claim, she relied upon the following FDCA provisions and FDA regulations: 21 U.S.C. §331(a)-(b) (prohibiting “adulteration” and “misbranding”); 21 U.S.C. §352(a) (imposing “false or misleading in any particular” standard for misbranding); 21 C.F.R. §201.56(b) (“labeling shall be informative and accurate” and not “false or misleading in any particular”); 21 C.F.R. §201.57(f)(2) (specifying contents of labeling); 21 C.F.R. §202.1(e)(5)(ii)-(iii) (extending “false or misleading” standard to advertising; adding “fair balance” requirement).

When we look at that list, we sit up and take notice. The adulteration/misbranding sections have been the most commonly invoked basis for FDCA-based negligence per se.

Not in Maryland. The court held that none of these sections could support negligence per se because they were too general to constitute obligations owed to any group other than the general public:

These statutes and regulations, however, are framed to protect the public in general, and, as we have heretofore stated, a statutory obligation which runs to everyone in general and no one in particular cannot impose a duty between two parties.

2008 WL 4068177, at *18 (citation and quotation marks omitted).

So we can move Maryland into our list of jurisdictions hostile to FDCA-based negligence per se. If we win preemption in Levine, this could be pretty important in dealing with any “parallel violation” claims that escape preemption.

Finally, the plaintiff asserted a fraud claim. The court blew out that cause of action as well. Gourdine imposed a tight limitation on fraud claims that required direct dealings between the plaintiff and the defendant:

Clearly, in order to sustain a cause of action based on fraud or deceit, the defendant must have made a false representation to the person defrauded. . . . In the case sub judice, [the defendant drug manufacturer] did not owe a duty to [plaintiff]; moreover, [plaintiff] was not a party to the alleged misrepresentations made by [defendant] to [the patient]. As a result, the Circuit Court did not err in entering summary judgment.

2008 WL 4068177, at *19 (footnote omitted) (emphasis original). The omitted footnote rejected an argument that Maryland law should follow Restatement (Second) of Torts §310-311 and allow indirect fraud.

While there’s a bit of “the bold face giveth and the fine print taketh away” quality to this part of Gourdine, our clients now have an argument that, in a real learned intermediary case where there are no direct-to-patient communications, fraud claims will not lie.

So Gourdine is one of those cases that we want to describe as a “big win” until we ask ourselves why?

It’s only “big” in the sense that our side prevented the adoption of an utterly unprecedented and wildly expansive theory of liability. While the decision puts a roadblock in the way of the other side’s never-ending quest to hold everybody liable to anybody for everything, after Gourdine our clients are essentially no better off than where they started – they’re just not a whole lot worse off. Our side has enough to worry about with liability to people who actually use its products. Opening up liability to the general public would amount to imposing national health insurance by contingent fee.

So while we’re grateful for the ruling in Gourdine – and, in particular, that the bottom line was unanimous – at the end of the day, we have to say that the opposite result simply would be too awful to contemplate.