Here’s a guest post, authored by Clem Trischler and Jason M. Reefer of Pietragallo Gordon.  It’s about ultimately winning a fentanyl patch trial where the plaintiff pursued a res ipsa or “malfunction theory” case.  It’s a counterpoint to the horrible case out of Illinois that we ranked as our #1 worst case last year.  We don’t really want to talk about that much, so without further mucking around, here’s the guest post:

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

Litigation involving fentanyl pain patches isn’t the most frequently discussed topic on the Drug and Device Law Blog, but it’s certainly had its moments.  For example, the Blog lamented the Eastern District of Pennsylvania’s “generic reasoning” in the aftermath of Mensing, where the federal court refused to rule on the validity of failure-to-warn claims in the context of fraudulent joinder.  Even worse, Bexis described DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011), a case involving the name-brand Duragesic® patch, as “ooee gooey.”  In DiCosolo, an Illinois appellate court allowed the plaintiff to proceed on a “malfunction theory,” even though, inter alia:  (1) the allegedly defective product was lost by the plaintiff and, therefore, unavailable for inspection; (2) there was no observable malfunction; and (3) the plaintiff did not rule out other secondary causes for the decedent’s death . Factor in an improper and inflammatory closing by plaintiff’s counsel and an $18 million verdict, and you have the “worst drug/device product liability decision of 2011.”

Mylan, which manufacturers a generic fentanyl patch, recently found itself in a similar situation in Mardegan v. Mylan (S.D. Fla.).  The Blog last discussed this case here, where the Court allowed the plaintiff to re-plead several iterations of a failure-to-warn claim to comport with the learned intermediary doctrine.  But those were the days before Mensing (the motion was filed in December 2010, but not ruled upon until August 2011), so those claims went by the wayside at summary judgment, and the plaintiff proceeded (for all intents and purposes) only on a manufacturing defect theory.

Mardegan, much like DiCosolo, was fairly typical as far as fentanyl litigation is concerned.  Someone with a variety of health issues died while using (and misusing) a galaxy of medications, including multiple central nervous system (“CNS”) depressants.  Fentanyl is a potent analgesic, often prescribed for patients with debilitating, constant pain that cannot be controlled by other narcotics.  The fact that fentanyl is even prescribed suggests that the patient is probably dealing with serious health issues and likely taking a combination of drugs, which must be carefully monitored.

The decedent in Mardegan was no different, suffering from a long list of medical and personal issues.  Making matters worse, the evidence at trial established that the decedent lied to her physician to obtain fentanyl patches in the first place, was using more medication than was prescribed, and was using medications that weren’t prescribed for her.  The medical examiner attributed the decedent’s death to “drug toxicity, including fentanyl.”

Undeterred, the decedent’s father hired a lawyer and brought a lawsuit against Mylan, alleging that unspecified defects in the patch caused it to deliver fentanyl at an excessive rate.  But the allegedly defective patch in Mardegan was discarded by the police and therefore unavailable for inspection.  And unlike DiCosolo, the plaintiff in Mardegan had no evidence of a recall or a self-serving, eleventh-hour affidavit from the plaintiff suggesting a problem with the patch.

Without evidence of any problem with the product itself, the plaintiff in Mardegan retreated to the “last refuge of a plaintiff without a case,” namely the “malfunction theory,” to prove a manufacturing defect.  The malfunction theory is similar to res ipsa loquitur in the negligence context and allows a plaintiff to use the circumstantial evidence of a product malfunction to infer the existence of a defect.  In Florida, this is commonly referred to as the “Cassisi inference,” named after a decision out of the Florida District Court of Appeal.  See Cassisi v. Maytag Co., 396 So.2d 1140 (Fla. 1st DCA 1981).

The plaintiff’s predictable argument went something like this:

1. Mylan’s labeling states that the mean maximal concentration of fentanyl delivered from a 50 mcg/hr patch in a living subject’s blood stream is expected to be 1.4 ± 0.5 ng/ml;

2. Accordingly, a patient’s serum fentanyl concentration should not exceed 1.4 ± 0.5 ng/ml if the 50 mcg/hr patch is functioning properly;

3. The decedent died while wearing a 50 mcg/hr patch;

4. The decedent’s postmortem blood fentanyl level, drawn over 30 hours after death, was measured at 8.5 ng/ml;

5. The patch, therefore, malfunctioned.

Thus, the plaintiff’s case rested entirely on a purported “elevated” fentanyl level, measured in a postmortem blood sample collected over thirty hours after the decedent was found dead.  When you boil this theory down, it amounts to nothing more than the circular (and flawed) premise that the product is defective because it malfunctioned, and it malfunctioned because it is defective.

While there may be some appeal to its simplicity, the plaintiff’s malfunction theory was invalid both legally and factually (from a defense perspective).  The Court saw it differently, and allowed the case to go to a jury. Let’s start with the legal arguments, since this is a legal blog.

First, the malfunction theory has no place in the context of a complex pharmaceutical product liability action, where the sole evidence of malfunction – ergo, defect – depends upon an interpretation of postmortem toxicological testing well beyond the common knowledge of jurors.  Res ipsa loquitur and, by extension, the malfunction theory, find their roots in the law school favorite Byrne v. Boadle, 159 Eng. Rep. 299 (Ex. 1863), where a barrel of flour fell from a second story window and injured a pedestrian.  It doesn’t take a rocket scientist (i.e. an expert witness) to conclude that when a barrel inexplicably crushes a passerby, someone was negligent.  To wit, Cassisi involved a self-igniting dryer that burnt down a house, Cassisi, 396 So.2d at 1250, 1252, while the foundational case upon which the Cassini malfunction doctrine rests, dealt with a machine that “erratically” retracted and amputated the plaintiff’s fingers.  Greco v. Bucciconi Engineering Co., 283 F. Supp. 978, 980 (W.D. Pa. 1967).  Any layperson understands that a household appliance does not spontaneously combust but for a defect, or that a machine does not suddenly and inexplicably retract unless it malfunctions.  In those scenarios, “the jury’s knowledge from common experience” allows for an inference of a defect.  Liberty Mutual Insurance Co. v. Sears, Roebuck & Co., 35 Conn. 687, 406 A.2d 1254 (1979) (cited in Cassisi, 396 So.2d at 1150) (emphasis supplied).

Cases involving complex pharmaceutical products, which carry inherent risks, are inapposite.  A lay juror is simply not equipped to evaluate the performance of a fentanyl patch, based solely on an interpretation of postmortem toxicological testing.  Put differently, an average person cannot look at a fentanyl level in a toxicology report and jump to the conclusion that there was a problem with a fentanyl patch.  The simple fact that expert testimony is required to interpret and explain the relevance of a postmortem blood fentanyl level underscores the inapplicability of the malfunction theory.  Cf. Anderson v. Gordon, 334 So.2d 107, 109 (Fla. 3rd DCA 1976) (“[Res ipsa loquitur] may not be applied where expert medical evidence is required to show not only what was done, but how and why it occurred since the question is then outside the realm of the layman’s experience.”).  No matter, ruled the Court, since the plaintiff’s expert testified at deposition that a defect in the product was the “most probable” cause of the decedent’s death.

Next Mylan argued that the plaintiff failed to meet the second Cassisi element, namely his burden of demonstrating that direct evidence of a defect is unavailable due to the nature of the occurrence or malfunction.  As recognized by Cassisi itself, an inference of a defect is proper in “those cases in which the product was so badly damaged by a malfunction as to render impossible the plaintiff’s ability to point with specificity the exact one of several potentially dangerous conditions which caused the accident.”  Cassisi, 396 So.2d at 1149.  The rationale of the malfunction doctrine is that a plaintiff should not be put out of court because the defect itself prevents plaintiff from proving the existence of a defect.

But unlike an exploding tire or a self-igniting machine, the fentanyl patch used by the decedent did not self-destruct due to a purported defect.  It was available for inspection for months after the decedent’s death, and presumably could have been tested for residual fentanyl content to determine whether it did, in fact, deliver more fentanyl than it should have.  The plaintiff, however, allowed the product to be destroyed as part of the police department’s standard protocol relating to evidence retention, then showed up in court and asked for an inference of defect because the product was unavailable.  The Court obliged, thereby creating a perverse incentive for a plaintiff to lose the allegedly defective product and gain the benefit of a Cassisi inference – a policy that Bexis railed against in his discussion of DiCosolo, the ooey gooey).

Mylan still had one more bullet in the chamber to take down the monstrous malfunction doctrine:  the plaintiff’s failure to rule out reasonable secondary causes for the decedent’s death.  Even the plaintiff’s expert testified at his deposition that there were no less than four explanations for the death separate and apart from a defective patch, and he could not rule out any of them.  Given controlling Eleventh Circuit case law requiring the exclusion of secondary causes, see Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1302 (11th Cir. 2011), this appeared to be a recipe for a defense win.

Not so fast, said the Court.  Even though the plaintiff could not rule out secondary causes, the Court held that it was enough to reach the jury because his expert testified that the “most probable” scenario was a defective patch.  Putting aside the fact that, as a pathologist, the expert was in no way qualified to render an opinion regarding transdermal drug delivery systems, the Court’s decision erroneously shifted the burden to Mylan to disprove the plaintiff’s theory of defect.  But in Florida, even when the malfunction theory is applicable, it remains a plaintiff’s burden to prove a defect.  See West v. Caterpillar Tractor Co., 336 So.2d 80, 87 (F1a. 1976). A manufacturer is not an insurer, and the Court’s ruling improperly blurred this important distinction.

Against this wave of bad law (or, as it were, bad interpretations of the law), Mylan had to win the case the old fashioned way – on the facts.  To do so, Mylan was able to demonstrate to the jury that their fentanyl patch could not and did not do what the plaintiff claimed it did – deliver fentanyl faster than its chemically controlled rate.  The “could not” part was rather straightforward; Mylan’s corporate representatives, including the inventor of the product, explained that the patch’s design features chemical rate control that ensures predictable delivery of fentanyl consistent with the pharmacokinetic information in Mylan’s label.

Plaintiff’s counsel countered, “But then how do you account for the decedent’s 8.5 ng/ml postmortem fentanyl level?”  The answer is simple: postmortem redistribution (“PMR”).  PMR, as a toxicological principle, has been recognized for over two decades and is a generally accepted phenomenon.  See Pounder, D.J., and Jones, G.R., “Post-Mortem Drug Redistribution – A Toxicological Nightmare,” Forensic Science International 1990; 45:253-63.  In laymen’s terms, what happens with PMR is that certain chemicals (such as fentanyl) are stored in adipose tissue (such as fat) during lifetime, but will “redistribute” after death to aqueous tissues (such as blood) due to natural changes that occur when life ends.  Why is this important in pharmaceutical litigation?  Because PMR renders wholly speculative and inherently unreliable any attempt to infer a defect in a drug delivery system based on a postmortem blood sample.  See, e.g. Andresen, et al., “Fentanyl: Toxic or Therapeutic? Postmortem and Antemortem Blood Concentrations After Transdermal Fentanyl Application,” Journal of Analytical Toxicology, 2012;36:182-94.

Courts have become increasingly aware of PMR, see, e.g. Battle v. Gold Kist, Inc., No. 3:06-cv-782-J-32TEM, 2008 WL 4097717 at *8 (M.D. Fla. Sept. 2, 2008) (discussing the “highly problematic validity of post-mortem blood testing” due to PMR), and are growing skeptical of expert opinions that fail to properly account for its impact.  In fact, PMR was the final nail in the coffin of the Digitek MDL, as discussed here. See also, In re Digitek Products Liab. Litig., ___ F. Supp. 2d ___, 2011 WL 5282595 (S.D.W. Va. Nov. 3, 2011).

While the plaintiff in Mardegan was able to get around the law, he could not escape science.  The jury returned a unanimous verdict for Mylan after just twenty minutes of deliberation, expressly finding that the Mylan patch is not defective.  There’s nothing “ooee gooey” about that.