More New Stuff

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will want to read (and cite) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Ali involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.

Ali involves several preemption issues, and is also good on TwIqbal and the Virginia Consumer Protection Act.  On preemption, as usual the battleground was the so-called “parallel claim” exception.  2012 WL 3692396, at *7.  Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.”  Id.  Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice).  Id.

Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect.  Again they faced TwIqbal.  “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff's injuries.”  Id. at *8.  The manufacturing defect claim required:  (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite[] the relevant FDA manufacturing standards that were allegedly violated,” id., and (2) “sufficient facts to support the inference that the defendant's federal violations resulted in the defect that caused the plaintiff's injuries.”  Id. at *9 (citations and quotation marks omitted).  The Ali complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation.  Id. at *10.  As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court.  Id.  Nor do allegations that are nothing more than “simple recitations of regulatory language” enough.  Id. at *11.  Plaintiff can’t get away with copying sections of the Code of Federal Regulations.  That the plaintiff was injured does not mean that an FDCA violation occurred:

[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . .  Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.

2012 WL 3692396, at *11 (citations omitted).

The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful.  The court essentially held “so what?”  Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body.  Id. at *12.  That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question.  Id.

To get around TwIqbal, the plaintiffs in Ali trotted out Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009), the case we love to hate. The judge in Ali hated Hofts almost as much as we do:

This Court respectfully disagrees with the Hofts court’s application of the Rule 8 pleading standard. . . .  This Court finds the Hofts court unusually lax in its application of the standard.  In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings.  Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [TwIqbal].  Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff's claim rests.  In Hofts, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff's allegations that the defendant violated federal requirements.  This Court declines to adopt that approach in the context of this case.

This Court also respectfully disagrees with the Hofts court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements.  Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . .  This Court agrees with the majority of federal courts in holding, post-Riegel, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.

2012 WL 3692396, at *13

The plaintiffs in Ali made a premature demand for discovery before meeting their Rule 8 pleading requirements.  The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in TwIqbal] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant's liability.”  Id. at *14.

Ali also followed the majority rule on preemption of express warranty claims.  If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted.  Id. at *15.  The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.”  Id. at *16.  The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed.  Id.

We’ve also collected cases holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes.  Ali is another such case:

By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).

Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA.  Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device.  Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law.  The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.

2012 WL 3692396, at *19.  Gotta love it.  Ali is the greatest.

Prescription Drugs in Texas − You Can’t Get There from Here

We’re somewhat less enamored with Romero v. Wyeth, C.A. No. 1:03-cv-13467, slip op. (E.D. Tex. Aug. 31, 2012), sent to us by Janelle Davis of Thompson & Knight, although we must admit Romero does have its moments.

Romero evaluates a variety of claims purportedly arising under Texas law, in the wake of the big win in Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012).  On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud).  The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:

“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . .  [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . .  Because [plaintiff] cites no other authority [besides the lower court decision reversed in Centocor] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here.  Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].

Romero, slip op. at 5.

That’s the good part of Romero. The parts responsible for our “you can’t get there from here” comment then follow.  For one thing the court allows a naked failure to test claim to continue.  Abundant precedent, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action.  The Texas Supreme Court dealt with such a claim in American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:

The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.

The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.

Id. at 439.  Then there’s the Fifth Circuit.  In Dow Agrosciences LLC v. Bates, 332 F.3d 323, (5th Cir. 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Id. at 333.  And again, in Skotak v. Tenneco Resins, Inc., 953 F.2d 909 (5th Cir. 1992):

[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . .  [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury.  [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.

Id. at 912 n.5 (affirming summary judgment).

Oh well, so much for appellate precedent.  Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, Romero concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed.  Slip op. at 7-8.  It may be our favorite legal proposition, and it sure applies here - a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action.

“[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law).  We’re sure there’s plenty more where that comes from.

Romero also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis.  Slip op. at 11-12.  It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the Erie federalism point) and in Centocor the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:

The learned-intermediary doctrine is not an affirmative defense. . . .  While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof.  Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case - that the product warning was inadequate.

___ S.W.3d ___, 2012 WL 2052783, at *20.  With comment k, the analysis is the same, only it involves design rather than warning claims.  Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in Romero.  Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, Romero does not cite a single Texas prescription medical product case for its contrary proposition.

There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think Romero can get there from here under what Texas law really is rather than what plaintiffs might want it to be.

We Think That’s About Right

Finally, from our home turf here in Pennsylvania, we offer the decision in Boeynaems v. LA Fitness International, LLC, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today.  This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests.  The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:

[T]he Court mandates cost allocation as fair and appropriate.  The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.

Id. at *11.  The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:

If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment.  Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.

Id.

We think that’s just about right.  If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case.  If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense.  So as Ron Weasley might say, “put your Galleons where your gob is.”

Preemption Amongst the Palmettos

There have been two recent state supreme court decisions concerning PMA medical device preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  One of them, Cornett v. Johnson & Johnson, ___ A.3d ___, 2012 WL 321094 (N.J. Aug. 9, 2012), will be the subject of Monday’s post, as our Dechert colleagues are from New Jersey and wanted to write about that one.


The other one, Weston v. Kim’s Dollar Store, ___ S.E.2d ___, 2012 WL 3205150 (S.C. Aug. 8, 2012), comes from South Carolina and involves one of the more unusual PMA products − non-corrective, UV light protective contact lenses.  That’s right − some decorative, colored contact lenses are PMA approved (due to UV protection), and thus protected by Riegel preemption.

The plaintiff in Weston didn’t seem to believe it either.  Almost all of her argument in the intermediate appellate court, and some of her argument in the high court, was devoted to claiming that the product was really “cosmetic” and thus didn’t deserve to be subject to pre-market approval.  Weston, 2012 WL 3205150, at *2-3.  The court wisely refused to let state-court plaintiffs attack whether a product should be subject to FDA PMA requirement:

There is no dispute that the lenses [plaintiff] purchased were UV lenses.  [Defendant] received a letter from the FDA approving PMA supplement . . ., which “requested approval for incorporating an ultra-violet absorber” into [the relevant] lenses.  Additionally, the FDA approved a supplemental PMA in 1999. . . .  Thus, because of the presence of the UV-absorbing component, we find that these lenses were subject to device-specific FDA requirements.  The record establishes as a matter of law that these lenses are covered by PMAs . . . therefore, express preemption is triggered.

Weston, 2012 WL 3205150, at *3.

The plaintiff in Weston also complained that the defendant “knew its [contact] lenses were frequently sold without a prescription and by unauthorized sellers, yet . . . failed to take steps to ensure customers received lenses by prescription only.”  Id. at *1.  Interesting claim − one we don’t see every day.  However, in the context of this PMA device, the plaintiff offered no evidence of any FDA requirement that obligated a device manufacturer to police its supply chain to ensure that the “prescription-only” sales limitation was enforced.  “Any claim that imposes requirements different from or additional to those set forth in the PMA is expressly preempted.”  Id. at *4.

The court in Weston did hold that a manufacturing-based claim (conceded by the defendant to be unpreempted) should survive, along with any “any claim that parallels applicable federal requirements.”  Id.  Unfortunately, that was as far as the court thought it could go − “due to the lack of specificity in Petitioner's complaint and the trial court's order granting summary judgment, we regret we cannot be more specific in delineating which claims survive the partial grant of summary judgment.”  Id.

That is unfortunate.  The original order granting summary judgment on preemption grounds was entered way back in 2006 − well before Riegel.  See Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C.C.P. Nov. 28, 2006).  We sure hope it doesn’t take the plaintiff another six years to litigate whether she has any viable parallel claims beyond the one conceded by the defendant (not that we think there are any).

Summer Reading

August means vacation time in the law business.  Still, vacation does not mean (to some of us, anyway) forgetting about drugs and devices altogether.  With that in mind, here are a couple of items of interest for summer reading − one’s fairly long; the other fairly short.

The long one that we recommend reading is a recent law review article by friend-of-the-blog Professor Ralph Hall, entitled “Rethinking Lohr: Does 'SE' Mean Safe & Effective, Substantially Equivalent, or Both?” 13 Minn. J. L. Sci. & Tech. 737 (2012).  In brief, the article examines recent statutory and regulatory modifications to the “510k clearance process” that have occurred since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and concludes that it’s high time to re-examine Lohr’s restrictions on the use of preemption in non-PMA medical device litigation:

This article questions whether litigants and courts have ignored major statutory and regulatory changes in the FDA’s authority over medical devices and have too simplistically followed the Supreme Court’s decision in Medtronic, Inc. v. Lohr.  We believe that this is exactly the situation and that the precedential value of Lohr is highly questionable.

13 Minn. J. L. Sci. & Tech. at 739 (footnote omitted).  Professor Hall concludes, after reviewing the evolution of the 510k system in detail, that unlike the 1982 device clearance in Lohr, the FDA now (and has for some time) predicates device clearances on “safety and effectiveness” criteria:

Today, the FDA makes safety and effectiveness determinations for 510(k) medical devices in determining the classification of the new device, compared to the predicate device, and whether the new device is substantially equivalent or not substantially equivalent.

13 Minn. J. L. Sci. & Tech. at 789.

While much of Professor Hall’s article explores express preemption, we were gratified to see a discussion of the Mensing “impossibility” approach to implied preemption as applied to medical devices under the FDA’s regulations governing medical device alterations. 13 Minn. J. L. Sci. & Tech. at 768-769.  We’ve had exactly the same thoughts ourselves.

Since most medical devices are not PMA approved, and preemption is the strongest legal defense there is, if you defend these sorts of products, we think you’ll find Professor Hall’s article most illuminating.

That’s the long one.  Our other recommendation requires a lot less reading and (perhaps) more thinking.  The other day, four life sciences industry groups sent a public letter (thanks to Fulbright and Jaworski for the link) to the Centers for Medicare and Medicaid Services asking that CMS hurry up and finalize its reporting regulations for the Physician Payments Sunshine Act.

Huh?  Do you even know what that is?

You should, because it will affect your clients, and might well affect how you prepare and try your cases.

As the recent letter explains, as part of the Affordable Healthcare Act − which the Supreme Court recently upheld in large part − the health care industry is now required to report “payments to teaching hospitals, physicians, and physician ownership and investment interests.”  Exactly what should be reported and how is now being sorted out.  Read the letter for details.

Then think a bit.

These reports of “payments” will be public.  Various financial ties between physicians − the plaintiffs’ prescribers/treaters, and both sides’ (but mostly our) experts − will soon be “transparent,” that is, generally available.  Expect more learned intermediary rule challenges to physician “independence” due to financial ties − something we’ve discussed here.

Think about how this new statute is going to impact your cases; what juries will think about this type of information.  There’s nothing in the legislation addressing (that is to say, precluding) admissibility of reported data in civil litigation.

Then also think about how to level the playing field.

There’s no reason not to seek discovery from plaintiffs’ experts to determine if they’ve received similar emoluments from plaintiff-side groups.  It gets back to the level playing field we’ve argued for, particularly in the context if informal physician interviews.  If this kind of information is discoverable/admissible as to our side, it should be equally discoverable/admissible as to entities on the other side of the “v.”

Happy reading.  There will be a quiz after Labor Day.

Plaintiff’s Second Bite at the Apple Leaves a Sour Taste in Our Mouth

            Back in December we blogged about a medical device case that was dismissed for failure to state a claim – it involved a voluntarily recalled heart pump (which is a Class III medical device that received premarket approval).  At that time, the court found plaintiff’s claims preempted by Buckman v. Plaintiff's Legal Commmittee, 531 U.S. 341 (2001) (fraud-on-the-FDA preempted) and Riegel v. Medtronic, Inc., 522 U.S. 312 (2008) (§360k of Medical Device Amendments expressly preempts claims against manufacturers of Class III medical devices).  However, the court afforded plaintiff an opportunity to amend her complaint to see if she could state a parallel state law claim of the type found not preempted by Hughes v. Boston Scientific Corp., 631 F.3d 762 (5^th Cir. 2011).  Guess what – according to the court, she did. 

            We have not hidden our dislike for Hughes (here) and we are not overly fond of Bass v. Stryker Corp., 669 F.3d 501 (5^th Cir. 2012) (here) – and therefore, are not particularly enamored of the Fifth Circuit’s track record on PMA preemption.  Both of those decisions push open wider the door the Supreme Court left slightly ajar in Riegel – allowing a state law claim “premised on a violation of FDA regulations” as “parallel” to rather than in addition to federal requirements.  Riegel, 552 U.S. at 330.  Both of those cases involved allegations of failure to comply with “generally applicable” FDA regulations – incident-reporting regulations in Hughes  and quality-control regulations in Bass.  And, so for her second bite at the apple, plaintiff in Bush v. Thoratec Corp., 2012 U.S. Dist. LEXIS 89685 (E.D. La. June 27, 2012), found her own “generally-applicable” regulation and alleged it as the basis for her state law failure to warn claim. 

            Now, on a positive note, we have to acknowledge a fairly thorough analysis by the court of whether there is a parallel state law claim.  Unfortunately, we don’t agree with the result.  Under Louisiana law, a manufacturer has a post-sale duty to warn “of a characteristic of the product that may cause damage and the danger of such characteristic.”  La. Rev. Stat. §9:2800.57(C).  So plaintiff needed to find a “federal hook on which to hang the parallel state law failure-to-warn claim.”  Bush, 2012 U.S. Dist. LEXIS 89685 at *14.  Her “hook” was 21 U.S.C. §7.49 – “guidelines” for medical device recall notices (remember, we said the product was voluntarily recalled).  Guidelines?  Can “guidelines” really be the basis for a claim of violation of federal law?  Aren’t guidelines by definition not “requirements”?  Don’t guidelines offer non-specific guidance without establishing any hard and fast rules?  No definitions?  No parameters?  So, how exactly do you violate a “guideline”?  And, who’s to say a jury’s interpretation of a guideline wouldn’t be more stringent than the FDA’s interpretation – making the claim no longer parallel?  These were the types of questions/arguments raised by the defendant in Bush.  We don’t find the court’s answers particularly satisfying.

            First, a quick look at some of the language in the recall notice guidelines.  Section 7.49 says a recall notice “should be commensurate with the hazard of the product being recalled.” Boy, that’s loaded with subjectivity.  The content “guidelines” provide:  a recall notice should be “brief and to the point;” “clearly identify the product;” “explain concisely the reason for the recall and the hazard involved;” and “provide specific instructions on what should be done with . . . recalled products.”  Bush at *15.  And, the recall guidelines themselves provide that §7.49 “recognize[s] the voluntary nature of recall by providing guidance.”  Id. at *21 (emphasis in original). 

            Defendant posed several arguments why the guidelines could not form the basis for a parallel violation claim:

• The guidelines are vague, imprecise and do not “define the parameters of what constitute specific instructions in a recall notice” and therefore “there is no specific requirement to be violated, and any requirement imposed by state tort law would necessarily be a preempted additional requirement inconsistent with federal regulation.”  Id. at *17-18 (quotation marks omitted).  The court even agreed that §7.49’s guidelines are “more general than” the reporting requirements or quality-control standards allegedly violated in Hughes and Bass.  Id. at *18.  But apparently not general enough.

• The guidelines are not mandatory and “therefore, a state tort claim enforcing those standards would be different from or in addition to federal requirements.”  Id. at 21.  How do you violate something that is voluntary?

• The content allegedly missing from the recall notice “goes beyond the § 7.49 guidelines, rendering Plaintiff's state claim not genuinely equivalent or parallel to the corresponding federal violation.”  Id. at *22.  Again, we’re not sure what §7.49 really requires, so any finding that the notice was deficient strikes us as an additional federal requirement.

Despite these, in our opinion, valid arguments, the court summed up the issue this way:

Thus, Louisiana law requires a manufacturer to give post-sale “adequate warning” of a potentially dangerous and damaging characteristic of a product . . . Federal law dictates that recall notices should be “commensurate with the hazard of the product being recalled,” and should be drafted in accordance with “guidelines” to include “the reason for the recall and the hazard involved” and “specific instructions on what should be done with respect to the recalled products.” Putting the two together, Plaintiff argues that Defendant violated § 7.49 by failing to include sufficiently specific instructions or a more emphatic description of the risks to the [medical device], and that the violation of that federal requirement is remediable through a state failure-to-warn claim.

Id. at *16.  And the court found that that was enough to get by a motion to dismiss.  Where we take some solace is in the court’s recognition that while plaintiff has done enough for now, defendant’s arguments might hold more water at the summary judgment stage.  See id. at *23-24 (“the meaning of § 7.49 may be more thoroughly explored in a motion for summary judgment, and it is entirely possible that Plaintiff's claim will be defeated at that stage.).  So, we’ll be on the lookout for our second bite at the apple and hoping for a sweeter result. 

Another Personal Injury Class Action Goes Down in Flames

The thing about personal injury claims is that they’re personal. Each case has distinctive details, such as why the plaintiff used the product, what she relied on, what harm resulted, and what caused the harm.  That’s why personal injury claims are not fit for class treatment.  They are almost never certified.

In fact, nowadays, they are not only rejected; they are rejected hard.  That’s what happened in Haggard v. Endogastric Solutions, Inc., 2012 U.S. Dist. LEXIS 89767 (W.D. Pa. June 28, 2012).  The defendant manufactures a device (EsophyX) that is inserted without an incision to treat GERD.  The plaintiff had it inserted, choosing it over a competitor’s surgically implanted device (Nissen).  When the device didn’t work, his doctor couldn’t completely remove it, and the plaintiff claimed that this eliminated certain other treatment options that had been available to him.  He reluctantly tried the competitor’s Nissen device, but his symptoms got worse.  Plaintiff then filed his class action, claiming that the defendant had misrepresented that the insertion procedure was reversible, when in fact it was only “revisable” (apparently something less than reversible).  Id. at *1-3.

If this sounds like a situation rife with unique personal facts, that’s because it is.  And so plaintiff’s attempt to put a class together failed miserably.

Plaintiff first tried to certify a class that consisted of everyone who had used the defendant’s device.  The court rejected this class for a bunch of reasons, many of which are obvious.  It failed the “typicality” requirement.  The class rep had “marked” differences with the other putative class members as to the information received and relied upon, as well as the harm suffered, particularly given that plaintiff admitted that, unlike with him, the device worked for most of the class members:

Evidence of record indicates there would be numerous, inevitable questions regarding the information received by individual patients - from their physicians or other sources - and their reliance on particular representations. . . . More importantly for purposes of a typicality analysis, Plaintiff’s theory of harm because he was informed as to and relied on representations of its “reversibility” in electing a surgical procedure is harm of a fundamentally different nature - i.e., it is different in kind - from the inchoate harm, if any, of being subject to misrepresentations in the abstract.

Id. at *14, *17. 

That’s enough to doom this case.  But the court went on to say that under Dukes the class would have failed “commonality” for these same reasons.  Id. at *13-14 n.5.  It would have failed "adequacy" of representation because plaintiff’s counsel had a conflict representing class members who had successful surgeries and those who did not.  Id. at *19 n. 10.  It couldn’t be certified under FRCP 23(b)(2) because that subsection is reserved for claims primarily seeking injunctive or declaratory relief, yet plaintiff was primarily seeking “monetary relief.”  Id. at *20. 

There’s more.  The class failed FRCP 23(b)(3)’s predominance requirement because, as we said, personal injury claims are personal.  Individual, not class-wide, issues predominated: 

In this case, reliance on Defendant’s alleged misrepresentations in electing to undergo the . . .  procedure is central; it is the lynchpin of damages. . . . But the evidence of record indicates that (1) putative class members received information regarding the procedure primarily from their physicians, which information likely varied for reasons related to both the physicians themselves and the individual patient’s medical circumstances; (2) the amount and content of information received by a patient directly from Defendant’s marketing or other materials likely differed from Plaintiff’s and as between putative class members as well; and (3) individual decisions to undergo the procedure were likely influenced by and premised on varying individual considerations.  In addition, it is not immediately apparent that prospective EsophyX patients would ordinarily place substantial emphasis on reversibility in view of the fact that the procedure was offered as a less intrusive alternative to the Nissen procedure, so that in the infrequent event EsophyX was unsuccessful, progression to the Nissen - rather than attempted reversal - would be, as it was for Plaintiff, the recommended course. . . . The resultant injury/harm is also, of course, central to this case and it too raises a multitude of individual, as opposed to, common issues.

Id. at *23-25.  That’s a lot of differences. 

It also failed FRCP 23(b)(3)’s “superiority” requirement:

[I]n light of the extent to which determinations would need to be made on an individual basis, adjudicating the claims as a class would be unlikely to reduce litigation or preserve judicial resources.  To the contrary, individual questions of information received, reliance, and actual injury would require extensive individual assessments and significant trial time would likely have to be devoted to their resolution.

Id. at *27-28.  In other words, this case had no business being a class action.

Plaintiff didn’t give up, though.  He tried to hide all these individual differences and certify an alternative class that included only patients who relied on the defendant’s alleged misrepresentation that insertion of the device was reversible.  This was a “non-starter.”  Id. at *7. 

Individual differences can’t simply be swept away to create a class action.  They were still there, and they were still a problem.  This sleight of hand only shifted the determination of these individualized issues from a merits analysis to a class membership analysis, making the class itself “untenable because it is not objectively, reasonably ascertainable”:

The determination of class membership under Plaintiff’s alternative definition would require this Court to adjudicate on a person-by-person basis whether each proposed class member relied on Defendant’s representations.  That is, class membership would not be ascertainable without the imposition of serious administrative burdens incongruous with the efficiencies expected in a class action.

Id. at *11. 

Frankly, this “alternative” class wasn’t really a class at all.  Three people do not a class make.  The defendant pointed out that, despite two years of lawyer advertising, plaintiff had only been able to identify two other individuals as potential members of this alternative class.  Id. at *12.  And so plaintiff’s alternative class failed numerosity at well. 

This was what kids nowadays call an Epic Fail.  They are “personal” injury claims, not “class” injury claims, and courts keep rejecting plaintiffs’ attempts to say otherwise.  Who knows? Maybe plaintiffs will eventually stop filing them.

Odd Facts Should Not Make Bad Law

When we saw the first one we thought, that’s odd, but it’s mostly a malpractice claim pretty far from our sweet spot.  When we saw the second one, we thought, maybe we should blog about this now….  But the result was mostly unfavorable, and other, more significant things were happening.  But now that we’ve seen a third one, well we think we finally have to comment.  We don’t want the odd facts that the plaintiff pleaded (we have some difficulty believing their truth) in Schiff v. Hurwitz to mess up Pennsylvania law − any worse than it already is, that is.

First, some legal propositions:

Proposition one − No separate duty to test theory exists under Pennsylvania product liability law − period.  The relevant cases, all in our duty to test cheat sheet, are:  Lance v. Wyeth, 4 A.3d 160, 168-69 (Pa. Super. 2010), appeal granted, 15 A.3d 429 (Pa. 2011); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005) (per curiam); Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 570 (E.D. Pa. 2011); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 318 n.32 (E.D. Pa. 2007); Stitt v. Philip Morris, Inc., 245 F. Supp.2d 686, 694 (W.D. Pa. 2002).

Proposition two − The Food, Drug & Cosmetic Act (“FDCA”) does not give private persons a right of action to enforce it.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir. 1994); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990); Green v. Dolsky, 685 A.2d 110, 115 (Pa. 1996); 21 U.S.C. §337(a).

Proposition three − Strict liability does not lie against the maker of a prescription medical product under Pennsylvania law − not for any type of defect (except possibly manufacturing).  Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996); Baldino v. Castagna, 478 A.2d 807, 810 (1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 & n.8 (Pa. 1971), Lance, 4 A.3d at 164-65; Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006); Sykes, 484 F. Supp.2d at 318 & n.31; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2001).

Proposition four − Strict liability does not lie against health care providers in Pennsylvania.  Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 537-38 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1991); Kelly v. St. Mary Hospital, 694 A.2d 355, 358 (Pa. Super. 1997); Podrat v. Codman-Shurtleff, Inc., 558 A.2d 895, 897 (Pa. Super. 1989); Makripodis v. Richardson-Merrell, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Flynn v. Langfitt, 710 F. Supp. 150, 152 (E.D. Pa. 1989); Eby v. Milton S. Hershey Medical Center, 31 Pa. D. & C.4th 121, 125 (Pa. C.P. 1996).

Proposition five − Strict liability cannot be reimported into prescription medical products/health care services under the guise of a consumer fraud claim brought under the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”), because the act is inapplicable to medically-related activities.  Walter v. Magee-Women’s Hospital, 876 A.2d 400, 407-08 (Pa. Super. 2005), aff’d, 906 A.2d 1194 (Pa. 2006); Foflygen v. Zemel, 615 A.2d 1345, 1354 (Pa. Super. 1992); Gatten v. Merzi, 579 A.2d 974, 976 (Pa. Super. 1990), Kee v. Zimmer, Inc., 2012 WL 1758618, at *4 (E.D. Pa. May 17, 2012); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 557 (E.D. Pa. 2010); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *5-6 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2005) (applying Pennsylvania law); Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 538-39 (Pa. C.P. 2003); Crossen v. Peretz, 2002 WL 34576549 (Pa. C.P. Oct. 17, 2002); Luke v. American Home Products Corp., 1998 WL 1781624, at *8 (Pa. C.P. Nov. 18, 1998); see Beyers v. Richmond, 937 A.2d 1082, 1088 (Pa. 2007) (favorably citing and applying medical professional UTPCPL precedent to hold that lawyers were also not within the scope of the UTPCPL).

Proposition six − Hospitals have no common-law obligation to obtain informed consent to medical procedures from patients.  Valles v. Albert Einstein Medical Center, 805 A.2d 1232, 1239 (Pa. 2002); Watkins v. Hospital of the University of Pa., 737 A.2d 263, 268-69 (Pa. Super. 1999); Friter v. Iolab Corp., 607 A.2d 1111, 1114 (Pa. Super. 1992).

Proposition seven − In Pennsylvania the informed consent doctrine is not unlimited.  It extends only to the risks and benefits of surgery, specifically not including any obligation to explain the FDA regulatory status of prescription medical products to patients.  Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001).  Nor does the informed consent doctrine require disclosure of a physician’s financial interests.  Duttry v. Patterson, 771 A.2d 1255, 1259 n.2 (Pa. 2001); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 659 (E.D. Pa. 1995).

Proposition eight − and probably the most important for present purposes − federal judges exercising diversity jurisdiction have no business “predicting” novel expansions of state-law liability.  They follow, and do not lead, state courts.  Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975); Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002) Camden County Board of Chosen Freeholders v. Beretta, 273 F.3d 536, 541 (3d Cir. 2001); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).

Second, we’ll take a look at the facts in Schiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012) (hospital institutional review board’s (“IRB) motion) (“Schiff III”); Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) (medical device manufacturer’s motion) (“Schiff II”); and Schiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012) (doctor’s motion) (“Schiff I”), as they’re pleaded. That’s all we have to go on since all three Schiff opinions decide Rule 12 motions to dismiss.  Maybe these weird allegations will become less beguiling when the pleadings can be pierced.  Here's hoping, anyway.

The plaintiff’s allegations in Schiff − which we have a hard time believing − are that the defendant medical device manufacturer sold a Class II device (that means no preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) called “Invasix” that the FDA had cleared for marketing and labeling for certain uses.  The plaintiff, however, allegedly did not use the device for any of those labeled uses.  Instead, the plaintiff alleges that she was provided the device in the context of some sort of underground, non-FDA authorized clinical trial of a new use.  This underground trial purportedly was conducted like a clinical trial, in that her surgeon was an “investigator” and the trial was carried out under the auspices of the defendant hospital IRB.  In accordance with the usual trappings of a clinical trial, the plaintiff signed a written agreement under which she was to receive money for participating in the trial and any medical expenses from adverse events suffered in what amounted to a medical experiment would be paid for.  Plaintiff alleged that the manufacturer defendant, in order to avoid the FDA's clinical trial requirements, falsely represented (it's not clear to whom) that the new use had no safety issues.  The plaintiff further claims that she was not informed of any safety risks by anyone − in particular that the defendant surgeon’s informed consent discussion omitted mention that she didn’t fit within the trial’s protocol and didn’t mention any safety risks.  Then, of course (since this is a product liability action), plaintiff suffered injury from those risks.  Plaintiff also claimed she wasn’t informed that the defendant surgeon “was a paid investigator.”  Schiff I, 2012 WL 1355613, at *1-2; Schiff II, 2012 WL 1828035, at *1-2; Schiff III, 2012 WL 1971320, at *1-2.  We’ve seen a lot of claims in several decades of practice, but we've never encountered allegations of an under-the-table or off-the-books clinical trial before.  That's the source of our skepticism about whether the pleaded facts in Schiff are true, or even could be true.  But there’s always a first time….

On these purported facts, the plaintiff in Schiff alleged (at least) the following general theories:  (1) against the treating surgeon:  UTPCPL violations; (2) Against the manufacturer (Invasix): negligence, strict liability, breach of warranty, and misrepresentation; (3) against the hospital IRB:  UTPCPL violations and intentional infliction of emotional distress.  Plaintiff may well assert other claims − these are just what was discussed in the Schiff set of opinions.

Third, and the whole point of this post, here is why we’re bothered by what’s been going on in Schiff.

From our perspective, it appears that these weird FDA/clinical investigation allegations have mesmerized the court, at least as far as the pleadings are concerned.  By that we mean that these allegations have induced a federal judge into permitting causes of action − for strict liability, for negligence, and under the UTPCPL − that have at best never been recognized under Pennsylvania law, and at worst are flatly rejected by controlling precedent.

It’s no isolated occasion. Precedentially unconstrained rulings typify the three Schiff opinions.

Let’s dispel the haze, shall we?

We will assume for purposes of this argument − although the Pennsylvania Supreme Court has never spoken on the subject − that under some circumstances, Pennsylvania would allow a negligence per se-type cause of action for at least some violations of the FDCA.

But not these.

Why?

Start with legal Propositions 1 and 2 − Pennsylvania recognizes no duty to test, and there exists no private FDCA cause of action.  A clinical trial, whether FDA approved or not, is simply a very formal a method of testing a product for safety and effectiveness.  Pennsylvania courts have said over and over again, that unless a product is otherwise defective, it doesn’t matter whether it was properly tested, or indeed tested at all.  If one assumes the rather fantastic allegations in Schiff that a surreptitious clinical trial of an experimental use was being conducted, that’s just an elaborate attack on the testing (or lack of same) of the product.

But plaintiff's argument that the purported clinical trial should have been conducted under FDA auspices is simply an claim that the defendants violated the FDCA.  As a private individual seeking damages, plaintiff simply can’t do that − not unless the claim resembles a recognized, pre-existing tort.  That’s been looked at over and over again in medical device preemption cases (we’re not arguing preemption here because it’s a class II device), and the lack of an FDCA private right of action restricts plaintiffs to FDCA-related claims that “parallel” state law.  We’ve done lots of posts on parallel claims, and most of our medical device preemption scorecard is devoted to what is or isn’t a “parallel” claim, so we won’t delve deeply into that here.

Since a duty to test doesn’t exist under Pennsylvania law, the FDCA violation claims in Schiff can’t possibly be parallel to any recognized Pennslyvania product liability claim.  The defendant manufacturer might have violated the FDCA from here to kingdom come (or at least to Israel, where it’s based) but that’s for the FDA to sort out.  As we’ve recently posted, private plaintiffs simply don’t have standing to raise FDCA violations that don’t also amount to traditional common-law claims − and the underground clinical trial allegations here aren't even in the vicinity.

So the FDCA regulatory haze in Schiff is just that − a smokescreen of basically irrelevant allegations that do nothing but confuse and obfuscate the plaintiff’s common-law causes of action − or lack of same.

One of those other causes of action would seem to be informed consent.  If, as plaintiff Schiff claims, she was not told the underlying medical risks and benefits of the surgery in question, then that would support a traditional informed consent action against the surgeon.  Moreover, if the procedure in question was really “experimental” − in the sense that its risks and benefits were unknown − then the law requires patients to be told this fact.  See Proposition 7.  However, as the Pennsylvania Supreme Court has pointed out “the doctrine of informed consent is a limited one.”  Valles, 805 A.2d at 1240 (quoting Duttry, 771 A.2d at 1258).  Informed consent obligations are owed only by doctors, not by hospitals, and certainly not by manufacturers.  See Proposition 6.  The learned intermediary rule, at the heart of most of the cases in Proposition 3, limits a manufacturer’s informational obligations to warning the treating physicians.  If those choose not to pass along information, that’s both their prerogative and their responsibility.

Thus, the apparent holding in Schiff III, 2012 WL 1971320, at *3, that some sort of “negligence” based warning claim (exactly what is never articulated) exists against the hospital IRB is simply contrary to Pennsylvania law governing the informed consent obligations of hospitals.  The only negligence theory (we'll put aside that "informed consent" in Pennsylvania sounds in battery, not negligence) that might even arguably exist to impose liability on a hospital for inadequate patient information would be under Friter, supra − that a hospital voluntarily agreeing to participate in an FDA-regulated clinical trial voluntarily assumes, and must perform reasonably, the informed consent obligations stated in FDA regulations.  But the allegations in Schiff are antithetical to any Friter-based cause of action, since plaintiff asserts that the defendants sought to circumvent FDA clinical trial regulations, not follow them.  Again, we’re left with a bare allegation that the hospital (and its IRB) should have complied with the FDCA, which must fail since it’s not “parallel” to any liability Pennsylvania law has ever recognized against a hospital.

Could there be a claim against the hospital in Schiff?  It’s hard to tell, and we don’t have a lot of experience in this area, but IRBs are supposed to supervise clinical trials.  To the extent plaintiff claims that she fell outside of the alleged study’s alleged protocol, well, at least compliance with protocol sounds like something that’s within the scope of an IRB’s supervisory duty.  So maybe.

The departures from established Pennsylvania law are even worse in Schiff II, with its holding that the alleged FDCA violations somehow provide an informational claim that can bypass the learned intermediary rule, see 2012 WL 1828035 at *6 (“defendant was negligent for failing to follow FDA regulations regarding investigative devices and failing to properly test the . . . device”).  We've already dealt with the non-existent "duty to test."  As for the rest, let’s be blunt.  Once a physician/patient relationship is in place, for forty years Pennsylvania has not recognized any exception to the learned intermediary rule, not for pharmacists, not for contraceptives, and certainly not for clinical trials.  Once again, there is no “parallel” direct-to-patient warning duty in Pennsylvania.  It’s a bare FDCA violation claim that the plaintiff in Schiff has no standing to pursue.

What could conceivably be pursued, buried beneath all the FDA-related dross in the Schiff complaint, is a claim that the manufacturer withheld information about safety and effectiveness (or the lack of data supporting same) from the prescribing surgeon.  That would state a claim under Pennsylvania law, but Schiff II wanders so far afield from anything recognizable as a Pennsylvania cause of action, that its hard to tell if a normal claim is even being alleged.  Also, the plaintiff in Schiff asserts a breach of contract claim, that the manufacturer agreed to pay for certain things, and then didn’t.  That could also be a viable claim, assuming the accuracy of the pleading (which is questionable).

Likewise, Schiff II purports to tease some sort of “strict liability” claim from the plaintiff’s FDCA-related allegations:

Plaintiff argues that, because the strict liability claim is based on more than a failure to warn theory, the claim is permitted to go forward.  Plaintiff argues that the “risk of thermal injury rendered the device unsafe, defective and dangerous as well as [defendant manufacturer’s] failure to consider the factors set forth in the FDA Guidance Document on RF medical devices” also permits for recovery for strict liability.  At the Motion to Dismiss phase, this Court finds that plaintiff has adequately pled a claim for strict liability.

2012 WL 1828035, at *5.  We've read this quote several times, and it’s still so vague and garbled that we can’t even figure out what kind of strict liability (design, warning, manufacturing?) is at issue.  Schiff II doesn't mention design.  It doesn't mention manufacturing.  But it nevertheless states that there's something "more than a failure to warn."  But the only thing mentioned aside from an inherent risk (which can only be warned about - see Viguers, supra, for the proposition that inherent risks aren't design defects), is the purported FDCA violation.

We do know this − Propositions 3 and 4.  Strict liability does not exist in Pennsylvania in the context of medical procedures involving prescription medical products.  That’s been the law, without exception (where the bar to strict liability has been asserted; we know a couple of cases where it wasn't) in Pennsylvania since Incollingo in 1971.  The absence of strict liability has been reaffirmed regularly by appellate courts applying Pennsylvania law.  Indeed, the most significant pending controversy in prescription medical product liability litigation in Pennsylvania is whether a negligence claim exists for design defect.  Even the very pro-plaintiff Lance decision (now before the Pennsylvania Supreme Court) agreed that no strict liability claim of any sort exists.  The fight in Lance is solely over negligence.

And then there’s fraud/UTPCPL.  As the abundant precedent cited in support of Proposition 5 holds, the Pennsylvania consumer fraud statute doesn’t apply to medical procedures of any sort or in product liability actions involving prescription medical products that physicians use in such procedures.  But in all three Schiff decisions allow novel UTPCPL or fraud causes of action to proceed against persons against whom that such claims have never before been allowed − and once again, the bizarre FDCA violation claims are at the heart of the allegations. In Schiff I:

Here, [plaintiff] avers that confusion and deceptive conduct surrounded the affiliation, connection, and association [defendant surgeon] had with the [defendant manufacturer] and the “BodyTite Procedure” as well as Plaintiff’s lack of knowledge of the clinical trial involving the Invasix device.  Furthermore . . . [the surgeon] allegedly failed to warn [plaintiff] of the potential dangers of the Invasix Device and, critically, allegedly misrepresented that the FDA approved, or was at least involved in the clinical trial, of the Invasix Device.

2012 WL 1355613, at *4 (emphasis added).  The “critical” UTPCPL allegations − indeed the only facts actually cited − all have to do with the purported non-FDA clinical trial.

In Schiff II, instead of the UTPCPL, plaintiff alleged, and the opinion allowed, a “misrepresentation” claim where “some of the alleged misrepresentations were made regarding the classification of the device.”  2012 WL 1828035, at *7.  There's the FDA again.  Once again, however, this claim is completely incompatible with controlling Pennsylvania law − our supreme court’s unanimous Southard decision cited in Proposition 7 above.  There the court held:

[T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results.  The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.

781 A.2d at 107 (emphasis added).

Not material....

Need not be disclosed to the patient....

It's safe to say that, as a matter of controlling Pennsylvania law, the supposed FDA “classification” of a regulated product “does not constitute a material risk” and “need not [be] disclose[d].”  It’s hard to get clearer than Southard that "misrepresentations . . . regarding the classification of the device" are immaterial and cannot possibly be the subject of any viable fraud claim, since such information doesn't have to be disclosed in the first place.

In Schiff III, once again, the UTPCPL allegations deemed most important are those involving the purported FDCA violations:

The Complaint further avers that [the IRB] engaged in unfair trade practices because the FDA had not given prior approval for [these] devices in . . . plastic surgery procedures.  These facts, in addition to others in the Complaint, are sufficient to state a claim for unfair trade practices and negligence.

2012 WL 1971320, at *4.

But yet these FDCA violation allegation have no analogy in any legal claim recognized in Pennsylvania, given Proposition 5 − that the UTPCPL simply doesn’t apply to medical providers.  Here, in a slightly different guise, we have the same bare FDCA regulatory violation (that private plaintiffs can’t pursue, Proposition 2) being passed off as something else, this time the violation of another statute.  Plaintiff can’t do that either − it’s been tried.  As the Third Circuit has held:

[Plaintiff’s] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations.  Jurisdiction for the regulation of OTC drug marketing is vested jointly and exhaustively in the FDA and the FTC. . . . and what the FD & C Act and the FTC Act do not create directly, the Lanham Act [a federal statute] does not create indirectly.

Sandoz Pharmaceuticals, 902 F.2d at 231 (cited in Proposition 2).  In this respect, the UTPCPL as alleged in Schiff is no different than the Lanham Act claim alleged in Sandoz − both try to create forbidden private FDCA violation claims “indirectly” under cover of another statute.

So as we see it the FDCA-related allegations in the Schiff litigation about the purported surreptitious conduct of a clinical trial are both, (1) irrelevant, since there’s no FDCA-based cause of action paralleling any recognized claim under Pennsylvania law, and (2) immaterial, since the Pennsylvania Supreme Court has already held that FDA regulatory status is not information that need be disclosed to patients at all.

More fundamentally we believe that the repeated allowance of novel and often already-rejected supposed “Pennsylvania law” causes of action in Schiff needs to stop.  That’s Proposition 8.  Schiff is merely diversity-jurisdiction-based state-law litigation.  The Supreme Court and the Third Circuit have repeatedly and vehemently held that federal courts just cannot do what’s been going on in Schiff − allowing novel theories of liability that state courts have not recognized.

[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.

Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, 423 U.S. at 4 (1975).

 Unlike our role in interpreting federal law, we may not act as a judicial pioneer in a diversity case. 

Sheridan , 609 F.3d at 253.

As a federal court sitting in diversity, we are charged with predicting how another court – in this case, the [relevant state] Supreme Court – would rule on the record presented to us. . . .  [I]n reaching our conclusion we have exercised restraint in accordance with the well-established principle that “where two competing yet sensible interpretations” of state law exist, “we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the state] decides differently.”  To hold here, as [plaintiff] urges. . . would undoubtedly subject manufacturers and dealers to greater liability. . . .  Given the muddled state of [state] law on this point, we must decline [plaintiff’s] invitation.

Travelers Indemnity, 594 F.3d 238, 253 (3d Cir. 2010) (quoting Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)).

[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.  Instead, a federal court follows the precedents of the state’s highest court and predicts how that court would decide the issue presented.

City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002).

In a diversity case . . . federal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . . Our role is to apply the current law of the jurisdiction, and leave it undisturbed.

Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) (quoting City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993)).

At bottom, Schiff doesn’t strike us as that hard or complicated of a case.  There’s a question of whether the defendant adequately warned the prescribing surgeon of the risk (or perhaps of it's unknown nature) that the plaintiff encountered.  If not, did the surgeon already know the risk from his own clinical experience or elsewhere?   Did the surgeon adequately pass along the relevant risks to the plaintiff as part of his informed consent discussion?  If some sort of experimental surgery was involved, was plaintiff adequately informed by the surgeon that the relevant risks could not be accurately estimated on the basis of what was known?  And if there was some sort of protocol-based investigation going on (whether FDA-authorized or not), did the defendant surgeon follow the protocol and inform the patient that she was being enrolled in such a study − and did the defendant IRB adequately ensure that study protocols were being followed?  That’s it.  That sounds like what Schiff was (or should be) about.  The rest, all the regulatory brouhaha, is a smokescreen at best and an invitation to error at worst.  Right now, it unfortunately appears that the invitation is being accepted.  We hope that changes.

Not A WIn, Not A Loss

The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss.  Like Gaul, the decision contains three parts, and we have comments as to each.


Very briefly, the case involves a total hip implant constructed from titanium.  After being implanted for over three years, it broke.

Design Defect

The first part of the opinion denied summary judgment on design defect claims.  The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”).  Mims, 2012 WL 1681810, at *2.  Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.

The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough.  Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:

One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.

Id. at *2.

Frankly, we don’t mind that particular ruling too much.  We could even see using this quote in one of our cases.

The real problem in Mims was that the defendant hadn’t separately moved to exclude the plaintiffs’ expert under Daubert.  The court latched onto that and refused to “consider the reliability” of the expert testimony on summary judgment.  Id. at *3.  This procedural two-step is worrisome in that it allows an expert opinion that may well be inadmissible to defeat summary judgment.  The general rule has been that only admissible evidence counts on summary judgment, and the court’s wielding of a procedural fine-toothed comb undercuts that rule.  One take-away from Mims is to make sure to file Daubert motions separately and in advance of summary judgment, depending of course on the pre-trial schedule in any given case.

Another more unusual suggestion:  We’ve had some success using preemption against this type of claim, see Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2-3 (Pa. C.P. Philadelphia Co. June 9, 1999) (claim that implant should not have been made from stainless steel held preempted), but it depends on the classification regulation.  We’ll explain.  There’s usually no preemption in Class II metallic implants like hip implants under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), but there can be − if there’s a “device-specific” regulation, and the plaintiff’s particular claim is “different from or in addition to” something in that regulation under 21 U.S.C. §360k(a).

There are device-specific regulations for essentially all medical devices − but unfortunately they’re usually one-paragraph long and thus don’t cover many aspects of the device.  These are the FDA’s identification and classification regulations.  However, they do frequently say something about the metallic composition of implants. There are several hip implant I&C regs, see 21 C.F.R. §§888.3300-3350, and we don’t know which one applies specifically to Mims.  Most of them mention only “cobalt-chromium-molybdenum,” which was the plaintiff’s proposed design alternative in Mims, so the preemption argument wouldn’t fly.

However, if §888.3310 were applicable to this implant, or if some plaintiff’s expert offered the same opinion against the manufacturer of a §888.3310 implant, there’s a decent preemption argument.  That’s because this section states, as to composition, that such devices are “made of alloys, such as cobalt-chromium-molybdenum and titanium alloys.”  Emphasis added.  In this device-specific regulation, the FDA has expressly stated that “titanium alloys” are okay.  Thus, our preemption argument in such a situation would be that since a device specific regulation specifies “titanium” as acceptable composition, a common-law claim that titanium construction alone is a defect would be preempted even under Lohr.

Warning Defect

The second part of the Mims opinion also denied summary judgment as to the plaintiffs’ warning claim.  2012 WL 1681810, at *4.  The defendant moved based solely on the warning’s adequacy.  That’s hard to do unless the relevant part of the warning is really detailed.  The description of the warnings in Mims suggests otherwise in that case.

We find it much easier to win summary judgment in warning cases on causation − that the prescriber already knew the allegedly omitted information or that the information wouldn’t have changed what the prescriber did or the warnings.  Supporting facts would also include the prescriber continuing to utilize the device, with no change in procedure, after the plaintiff’s injury.

The lesson from Mims is that warning summary judgment motions ideally should have a double-barreled approach of both adequacy and causation.

The court in Mims seemed to assume, without any evidence (at least none was cited) that a different warning might have led to a different outcome.  Maybe the issue simply wasn’t raised in the Mims motion, but again the court’s willingness to rely on less than admissible evidence is troubling, since summary judgment can be sought on the grounds that the plaintiff has no evidence on an essential element where the plaintiff bears the burden of proof.

Punitive Damages

The final third of the Mims opinion dismissed punitive damages claims as a matter of law because the defendant demonstrated that the implant complied with FDA regulations:

[T]he Court concludes that the Plaintiffs would not be able to establish by clear and convincing evidence culpable tortious conduct that would authorize the imposition of punitive damages. Moreover, punitive damages are typically not appropriate where the manufacturer has complied with regulatory standards.

Mims, 2012 WL 1681810, at *5 (citing Stone Man, Inc. v. Green, 263 Ga. 470 (1993); Welch v. General Motors Corp., 949 F.Supp. 843 (N.D.Ga.1996)).

This part of Mims almost makes up for the rest of it.  Preclusion of punitive damages by regulatory compliance is something we’ve advocated before, here.  We prominently mentioned the Stone Man decision that the court followed in Mims.  So we take this opportunity to applaud the third part of Mims.

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:

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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.