Sometimes Almost is Enough to Make Us Smile

            It’s a beautiful day in the Philadelphia area.  The humidity is down, the sun is out, the breeze is delightful.  If we were morning radio jocks, we’d be telling you to drop your briefcases and laptops and pick up your Frisbees, suntan lotion and beach chairs and head for the nearest park, lake or beach.  And so we hope that at least some of you are reading this on a portable device from one of those locations (or even reading it tomorrow when the heat gets dialed back up to sauna-like levels).   On a day like this, we don’t need much more to make us smile. And that’s why we are choosing to view the case of Doughtery v. C.R. Bard, Inc., 2012 U.S. Dist. LEXIS 100374 (E.D Pa. Jul. 18, 2012) as the glass half-full.  Actually, it is probably more like three-quarters full.  So, on this atypically pleasant day in July in the Mid-Atlantic, we envision enjoying an almost full glass of our favorite ice-cold summertime beverage (we’re envisioning an Arnold Palmer since we’re writing this before noon, but the choice is yours).

            The reason Doughtery, is an “almost” for us, is that, like so many cases that look at Pennsylvania medical device/prescription drug product liability law, it strips plaintiff of “almost” all of her claims.  For instance, we don’t think any of our readers would be surprised to learn that plaintiff will be permitted to plead a negligent failure to warn claim.  In fact, this is often the only claim left standing at the motion to dismiss stage under Pennsylvania law.  See post on Kee v. Zimmer, Inc., 2012 U.S. Dist. LEXIS 68862 (E.D. Pa. May 17, 2012).  We say permitted because plaintiff is being given a chance to amend her complaint to see if she can plead facts sufficient to withstand TwIqbal scrutiny.  Doughtery, 2012 U.S. Dist. LEXIS 100374 at *5.  Plaintiff actually included a proposed second amended complaint with her response to the motion to dismiss, but because it still included several claims that the court was dismissing with prejudice, plaintiff was sent back to the drawing board. 

            Nor do we think it comes as any surprise that plaintiff’s breach of implied warranty for fitness for a particular purpose claim and claim under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law were dismissed with prejudice.  Id. at *4, 31-33.  But where this case doesn’t quite reach the point of overflowing our cup is in its discussion of strict liability.  We’ve reported on numerous cases – too many to count – that hold that Pennsylvania’s across-the-board application of Restatement §401A, comment k to drugs and medical devices bars strict liability claims.  See here , here , here, and here.  In fact, some of the cases discussed in these posts are cited in Doughtery recognizing that many courts have read Pennsylvania law “broadly to preclude all strict liability claims.”  Id. at *14.  What Doughtery, however, further recognizes is that that those courts didn’t specifically address a strict liability manufacturing defect claim and therefore weren’t controlling on that issue.  Id.   To our dismay, the court also cited to Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) to support the argument that Pennsylvania law recognizes strict liability in drug and device cases for something “more than a failure to warn.”  Doughtery, at *14.  We’ve made our feelings about Schiff well known here.  

            To be honest, we’ve contemplated that strict liability manufacturing defect was a door left open in Pennsylvania.  It is just so rarely pursued by plaintiffs, that it is a really tiny door.  Picture Alice standing before the 15 inch door to Wonderland and pondering how she was going to get through.  Except plaintiff’s don’t often get a magic vial that says “Drink Me” that grants them easy access to a manufacturing defect claim.  Hence, when strict liability failure to warn and design defect claims are tossed out in Pennsylvania, that usually does away with strict liability in its entirety.  Plaintiff Doughtery having expressed the desire to attempt to squeeze through that little door, the court decided Pennsylvania law permitted that opportunity.  The court’s reasoning was twofold:  (1) nothing in the lead Pennsylvania cases “unambiguously precludes all strict-liability claims against a [drug/device] manufacturer, id. at *16-17 (see discussion of cases in footnote 9); and (2) “the fact that the Pennsylvania Supreme Court decided to apply a negligence standard to failure-to-warn claims does not necessarily mean that the court would similarly adopt a negligence standard for manufacturing-defect claims.” Id. at *20.  As to point two, the court noted that the concern behind applying strict liability to drugs/medical devices in the context of failure to warn and design defect is that

if a manufacturer could not count on limiting its liability to risks that were known or knowable at the time of manufacture or distribution, it would be discouraged from developing new and improved products for fear that later significant advances in scientific knowledge would increase its liability.

Id. at *21 (citation and quotation marks omitted).   The court then reasoned that that concern is not an issue for alleged manufacturing defects.  Id. at *23 (strict liability creates proper incentives for manufacturers to adhere to good quality control practices). 

Having decided that Pennsylvania law does not bar a strict liability manufacturing defect claim, the court’s ruling on breach of implied warranty of merchantability should come as no surprise.  The Doughtery court, like many others, took the position that “the theories of strict liability and breach of the implied warranty of merchantability are parallel theories of recovery, one in contract and the other in tort.”  Id. at *29 (citation and quotation marks omitted).  As such, “comment k precludes implied-warranty claims against manufacturers of prescription drugs and devices to the same extent that it precludes strict-liability claims against such manufacturers.”  Id. at *28-29.  If strict liability manufacturing defect claims survive, so too do implied warranty claims based on manufacturing defects – or so says Doughtery.  Id. at *30. 

What’s left?  Negligence, strict liability manufacturing defect, breach of implied warranty of merchantability but only to the extent based on a manufacturing defect, and breach of express warranty.  And we have a plaintiff who has submitted at least three complaints to the court and hasn’t gotten it right yet.   So, to return to where we started, enjoying a sunny day on the East Coast, we leave you with the court’s words of caution to plaintiff and her counsel:

I caution Doughtery that she must allege sufficient facts to support an inference that an express warranty was created, including the specific source of the alleged warranty (e.g., a publication or package insert) and the specific statements made, something that she has not done in either her first amended complaint or her proposed second amended complaint.

Id. at *37, n.15.  And:

The infirmities in Doughtery's first two complaints were due, at least in part, to her counsel's apparent unfamiliarity with the applicable law. I caution Doughtery and her counsel to carefully review the relevant law before drafting and filing her second amended complaint. I am unlikely to allow a third amended complaint should her second amended complaint fail to plead adequate factual allegations or legally proper claims for relief.

Id. at *38.  We like to think of these as the prologue to Doughtery part II -- at which point our cup could well be filled to the brim.

Guest Post - Not Ooey Gooey This Time Around

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.

Of Treating Physicians And Manufacturing Defects

The new case, Williams v. Mast Biosurgery USA Inc., ___ F.3d ___, 2011 WL 2566426 (11th Cir. June 30, 2011), raises two fascinating issues, but we only offer our opinions about one of them. The facts in Williams are unfortunate, as is true with most of the cases we handle.


The plaintiff, a young lady, was being evaluated for possible infertility.  Her treating gynecologist (doctor #1) found an ovarian cyst and drained it.  During that procedure, he also found “significant dense adhesions that had resulted from a prior surgery some years before,” 2011 WL 2566426, at *1 – surgery that, oddly in our view, was not further described or discussed.

More on that later.

More significant surgery, to remove these adhesions, soon followed.  To prevent adhesions from recurring, doctor #1 inserted the medical device in question, a “bioresorbable” (that is, designed to break down and gradually be destroyed by the body’s biological processes) barrier manufactured by the defendant.

Anyway, since we’re describing a product liability suit, things necessarily went awry.  Within a month after this surgery, the plaintiff returned, in bad shape.  A colonoscopy (performed by doctor #2 in a different medical specialty) revealed “several stiff, hard and brittle pieces of plastic” perforating the plaintiff’s colon.  Id.  This required a second surgery – by a doctor #3 – which “cleaned out” the material and a significant accompanying infection.  Doctor #3 “suspected” the material was from the barrier that had been implanted in the second surgery.

A pathologist (doctor #4), also examined the material.  He echoed doctor #3's suspicions, but his testimony turned out to be incomptently based solely on a product label he had been given.

Somehow – the opinion does not describe the circumstances – these plastic pieces were never analyzed “to determine their identity or composition” before they were (we guess, the opinion is less than clear) thrown away.  Id.

Oops.  It's always a bad idea to lose the product in a product liability case.

This failure to retain the offending pieces was the first problem with the plaintiff’s case, which led directly to the second problem – the plaintiff did not retain any experts, instead attempting to make a case solely through the four treating physicians’ testimony.

The lack of any expert led to the court’s first interesting conundrum – to what extent the plaintiff’s treating physicians provided “lay” or “expert” opinion testimony. This distinction is important because expert testimony is subject to Daubert standards.  The trial court found that major parts of these physicians’ testimony was excludable as incompetent expert testimony.  The holes in the plaintiff’s case left by those exclusions defeated causation (but not in the way we were expecting), resulting in summary judgment.

The plaintiff appealed.

The distinction between “lay” and “expert” treating physician testimony is important, and there aren’t that many appellate cases discussing it in a prescription medical product context (Williams didn’t cite any).  But this isn’t a subject we’re opining about ourselves, because depending on how things work out we might find ourselves on either side of this issue in any given case.  Sometimes it’s the defense that likes the “lay” opinion testimony of the plaintiff’s treating physicians – sometimes (as in Williams) it’s the plaintiff.  So we’re not taking sides; just describing the court’s resolution of this interesting issue.

As a gross generalization, the “lay opinions” that a treating physician can testify about are those s/he acquired from things observed/done in the course of treating the particular patient.  Anything further – resulting from the application of the treating physician's medical knowledge to a broader set of facts – is “expert” testimony that must withstand the rigors of Daubert.  As the Eleventh Circuit stated the issue in Williams:

Much of the testimony proffered by treating physicians is an account of their experience in the course of providing care to their patients.  Often, however, their proffered testimony can go beyond that sphere and purport to provide explanations of scientific and technical information not grounded in their own observations and technical experience.  When such a situation presents itself, the trial court must determine whether testimony not grounded in the physician's own experience meets the standard for admission as expert testimony.

2011 WL 2566426, at *4.

There are also procedural differences in how lay opinion testimony, as opposed to expert testimony, is discoverable under the rules.  Neither the district court nor the Court of Appeals based their rulings on failure to follow the proper discovery rules.  Id. at *3 n.1.

In Williams the plaintiff argued that the testimony of all four physicians (the original gynecologist who drained the cyst and found the adhesions; the implanting surgeon, the explanting surgeon, and the pathologist) should have been admitted in full as “lay” testimony.”

The Court of Appeals disagreed, and affirmed the district court (the abuse of discretion review standard undoubtedly helped, too).  Critical parts of the treaters' testimony relating to the (now missing and never definitively identified) pieces of plastic crossed the line and were actually expert opinions.

By the way, the plaintiff did not dispute the trial court’s Daubert-based expert evidence exclusions on the appeal – so the lay/expert distinction was the whole ball of wax.  Williams, 2011 WL 2566426, at *5 n.5.

The court “focus[ed] on the physician statements that the foreign substance removed from [plaintiff’s] abdominal cavity was [the product in question].”  2011 WL 2566426, at *4.  Indisputably, foreign objects – pieces of plastic – were removed from the plaintiff. That alone, however, did not establish a defect in the defendant's product.

But not for the reason we expected.

Whenever we're in a missing product case, as defense attorneys we go first to product identification, because it’s pretty basic that unless the plaintiff can prove that the defendant’s product (as opposed to something else) that hurt him/her, that provides an easy, early end to the case.  So we were surprised that the earlier surgery was never the subject of any significant discussion.  Perhaps those pieces of plastic – never analyzed in any way – were accidentally (or intentionally, but the medical records would probably show that) left over from the first surgery.  Something made out of plastic could have broken the first time around.  Those pieces could have been benignly sitting there for years until disturbed by the later surgery to remove the adhesions.  A surgeon, not not expecting to find anything of the sort and intent on doing his job, could have moved things around without seeing small pieces of plastic and produced a perforation of the colon .

In any event, Williams did not turn on pure product identification.  One piece of admissible lay opinion testimony was doctor #1’s statement that he didn’t put anything in the patient other than the product.  2011 WL 2566426, at *6.  Nobody raised the possibility of leftovers from the prior surgery.

Instead, what doomed the plaintiff’s case was a total lack of evidence about whether and how the observed pieces of plastic established a failure of the defendant's product to act in an intended fashion:

[O]ne other piece of testimony merits our consideration.  [Doctor #1] provided the only direct testimony that [the barrier device] had failed to perform as intended and thus was defective.  We agree with the district court that such a conclusion requires some knowledge of how [the device] should have performed, a question outside the ken of a lay witness because it must be premised on scientific or other specialized knowledge.

2011 WL 2566426, at *6.  Such testimony crossed the line.  An opinion about how a bioresorbable product was supposed to perform, how long it ordinarily took to break down, and what the break down products should have been, was “based on a hypothesis, not the experience of treating the patient.”  Id. at *4.

The procedural takeaway from Williams is that experience with a product generally – beyond the individual plaintiff’s treatment – could not be admitted as the lay opinion testimony of a treating physician.  Rather, it is expert testimony that was admissible, or not, only subject to the strictures of Daubert.

There was no such Daubert-admissible expert testimony in Williams.  As a matter of substantive Georgia law, that meant, because plaintiff could not prove how the product was supposed to perform, there was no evidence that it had failed to perform as expected.

On this second point – what is necessary to establish a manufacturing defect – we have no problem stating that we fully agree with the ruling in Williams.  The entire concept of a manufacturing defect is based upon the product not meeting intended performance/specifications, and the plaintiff in Williams, by failing to offer any evidence of proper performance/specifications, flunked out.

In manufacturing defect cases, res ipsa loquitur a/k/a “malfunction theory” a/k/a “circumstantial evidence” is always the last refuge of a plaintiff without a case, and that’s precisely where the Williams plaintiff sought to hide out – thankfully unsuccessfully.  The intended behavior of a bioresorbable product during its first month in the body was not something that a lay juror could understand without the assistance of admissible expert testimony.  This situation was not obvious like a “loud rattling noise” in a brand new car.  Williams, 2011 WL 2566426, at *6 (distinguishing McDonald v. Mazda Motors, Inc., 603 S.E.2d 456 (Ga. App. 2004)).  Nor was it equivalent to pieces of an implantable medical device that reveal a “clear break.”  2011 WL 2566426, at *7 (distinguishing Williams v. American Medical Systems, 548 S.E.2d 371 (Ga. App. 2001)).

In short, Williams was hardly an “unremarkable” broken product case:

[T]he issue of whether there was a defect concerned a bioresorbable plastic product with which even the treating physicians, let alone the lay jurors, had little to no experience.  Under these circumstances, where those who had observed the patient and her condition could not assess accurately what they had observed and its significance, we do not believe that Georgia law would have permitted [plaintiff] to proceed to a jury without testimony about the nature of the product, its properties or its expected functioning when implanted in the human body.

2011 WL 2566426, at *7.  The mere fact that some foreign body injured the plaintiff did not establish that this particular product had a manufacturing defect at the time it left the manufacturer’s hands.  The plaintiff offered no evidence to exclude product mishandling, negligent implantation, contraindicated use, or “other potential causes” of the purported malfunction.  Id. at *8.

We would add that there was also no evidence that the foreign bodies even came from the product at all.  They could just as well have been artifacts from the prior surgery that – until disturbed by later surgery – had not been causing any trouble.

Bottom line in Williams was that the plaintiff failed to prove any case of manufacturing defect.  Beyond that, both sides need to be cognizant of applicable evidentiary limitations whenever relying upon lay opinion testimony of treating physicians.  This time the plaintiff stepped in it.  Next time, the shoe could be on the other foot.