Today’s post is another guest post from friend of the Blog Kevin Hara, of Reed Smith, who channels our resident movie critic in this wide-ranging discussion of pleading and procedural weirdness.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

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If ever one wanted to feature a case where the plaintiffs and their attorneys fumbled and stumbled around like Keystone cops, it would be Paulsen v. Abbott Laboratories, 2018 U.S. Dist. LEXIS 50256 (N.D. Ill. March 27, 2018), involving the prescription drug Lupron, used to treat endometriosis.  The case really reminded me of the madcap, masterful ensemble movie, “It’s A Mad, Mad, Mad, Mad World” (hereinafter, “Mad World”) (yes, it’s a bit dated in some ways, but it still merits watching if you haven’t) with a veritable Who’s Who of 1950s-1960s Hollywood comedy royalty, including Edie Adams, Sid Caesar, Milton Berle, Ethel Merman, Jonathan Winters, Terry Thomas, Mickey Rooney, Phil Silvers, and Buddy Hackett.  Not to mention two time Oscar Winner Spencer Tracy and Jimmy Durante, who literally kicks the bucket as his character passes away and starts the mayhem.  Even if one does not consider the film a classic, its cultural relevance is beyond debate, as in addition to the headliners, the supporting cast included Peter Falk, Eddie “Rochester” Anderson, the 3 Stooges, and the great Arnold Stang.  Moreover, it bears mention that the renowned director of Mad World, was Stanley Kramer, more recognized for his social dramas, including Guess Who’s Coming to Dinner, The Defiant Ones, and Judgment at Nuremberg.  With such an accumulation of talent, it comes as no surprise that Mad World received six Academy Award and two Golden Globe nominations, and is categorized by many as an all-time classic in American movie history.  The plot is full of twists and turns, but beautifully elevated, with stellar writing and acting to match: 5 strangers witness an accident, and simultaneously learn about a large sum of money hidden in a park, buried beneath a large “W,” with Durante’s last gasp.  At first, they agreed to equal shares of the $350,000, but soon each plots to recover the loot on his own, and everyone begins a mad dash with assorted partners in crime (spouses, friends, relatives, etc.) to be the first to reach the cash.  In so doing, each of five groups tries to undermine the others, and they all encounter setbacks from being locked in the basement of a hardware store, stranded on a highway with a child’s bicycle, sinking in a river, a drunken airplane pilot, and more.  (For those of you from younger generations who are Googling the names or the movie above, you might be more familiar with a newer iteration of a similar story in the movie Rat Race, starring Whoopi Goldberg, Dean Cain, John Cleese, Cuba Gooding, Jr., Cathy and Kathy Bates, among others.)

If you have not seen the movie, you certainly should, but one iconic scene essentially captures the film, a sequence in which Winters demolishes an entire gas station, mostly by hand, in several hilarious, frenetic minutes. The movie ends with all of the misguided, money hungry adventurers in the hospital with multiple injuries, but none of the treasure.  In a last, desperate (and shameless) grab for the bounty, the hapless male contingent is catapulted, one by one, from the ladder of a fire engine attempting to rescue them, as the terrified crowd below watches and the entire haul slowly floats to the now delighted onlookers.  In short, grasping for money, at the expense of ethics, morality, and intelligent planning gets you nowhere.

Procedural History

Much like the film, Paulsen has misdeeds galore, with seeming chaos at every turn, thanks to its beginning as a multi-plaintiff, misjoined complaint with a California resident, and a Georgia resident (Ms. Paulsen) bringing an action in the Eastern District of New York in April 2010. See Cardenas v. Abbott Labs., 2011 U.S. Dist. LEXIS 116879 (N.D. Ill. March 7, 2011).  Plaintiffs alleged injuries as a result of injections of the drug, and asserted negligence, strict liability, failure to warn, breach of warranty and fraud causes of action against various defendants.  In homage to the movie, it is fitting to provide aliases for the defendants using the names of the actors in the movie – because it is the plaintiff’s shenanigans that are the focus here – not the defendants’ titles and actions. Therefore, in that regard, the defendants are now dubbed Abbott Laboratories (hereinafter “Sid”), Takeda Pharmaceuticals of North America, Inc., (“Ethel”),Takeda Chemical Industries, Inc., (“Milton”) and TAP Pharmaceutical Products, Inc. (“Jonathan”) (collectively, “Defendants”). Id. at *3.  The Defendants filed a motion to dismiss, objecting to venue, so plaintiffs amended their complaint, adding New York and New Jersey plaintiffs.  Didn’t matter.  The case was transferred to the Southern District of New York. Id. Defendants again filed a motion to dismiss, and the Southern District of New York transferred the action to the Northern District of Illinois in 2011, addressing issues of venue and personal jurisdiction, and dismissing defendant “Milton” because it was not served with the complaint. Id. (but more on that later). Id. Finally, the Illinois federal court considered a substantive (Rule 12 (b)(6)) motion to dismiss, and found that plaintiffs provided “nothing but the fact that [they] received Lupron injections ‘on several occasions.’” Id. at *12-13.  For example, the complaint failed to indicate “whether Plaintiffs [were] women, nor [did] it establish whether Lupron was prescribed to Plaintiffs” for on- or for off-label use.  All these omitted facts were, obviously, “particularly within Plaintiffs’ control.” Id. Therefore, the court dismissed the complaint, with leave to amend to allow plaintiffs to put “some minimal amount of flesh” on their bare-bones allegations. Id. at *13-14.

Plaintiffs filed an amended complaint in October 2011, and discovery commenced, but with Paulsen the only remaining plaintiff, in August 2013 her counsel moved to withdraw. See Paulsen, 2018 U.S. Dist. LEXIS 50256, at *8.  The judge granted the motion, allowing plaintiff 30 days to file an appearance.  That didn’t happen either.  The action was dismissed for lack of prosecution in October 2013 after plaintiff failed to appear. Id.

Plaintiff’s Second Action

Undeterred, plaintiff filed a new complaint on May 11, 2015, alleging claims for negligence, strict product liability, failure to warn, breach of warranty, and fraud against “Sid”, “Ethel”, “Milton” and “Jonathan”. Id. at *9.  Plaintiff alleged that she had been injected with Lupron twice for on-label treatments, and had suffered various injuries, all of which occurred in Georgia. Id. at * 3-4.  Defendants moved to dismiss, claiming that the lawsuit was untimely and seeking application of the six-month limitation in Georgia’s savings statute [Ga. Code Ann. § 9-2-61(a)], while plaintiff maintained that Illinois’s one-year period governed the issue, 735 ILCS 5/13-217.6. Id. at *10.  After determining that the only Illinois citizen, Sid, was a real party in interest (a dispositive issue, because if not, Georgia’s statute controlled time-barring the case), the judge denied the motions to dismiss without prejudice. Id. at *10-11.

Dismissal of Milton and Jonathan

Defendants resubmitted their motions to dismiss in April 2017, arguing that Milton and Jonathan were not properly served, an interesting issue that itself could be the subject of its own post. Id. at *17-18.  Suffice it to say that the court ruled that service on Jonathan’s surviving corporation (because Jonathan no longer existed at the time the case was originally filed in 2010) was improper because in essence, “[p]laintiff cannot effectively serve one corporation by serving a completely different corporation.” Id. at *19, 25.

As to Milton, the court did not reach the service issue because plaintiff voluntarily dismissed Milton on July 9, 2011, − but refiled the action, again, on May 11, 2015, well outside the one-year limitation of Illinois’s savings statute. Id. at *26-27.  Thus, the court dismissed the claims against Milton with prejudice. Id. at *27.

Rule 12(b)(6) Motion

At long last, the court turned to the Rule 12(b)(6) motion to dismiss for failure to state any cognizable claims, pursuant to TwIqbal.  By now, it should hardly surprise anyone (even plaintiff herself, one would think) that the claims were almost all poorly pled, and most were dismissed.  For example there was “nothing in the complaint that connect[ed] Ethel to Jonathan and its alleged responsibility for Lupron-related activities beyond their shared parent company.” Id. at *30.  The familiar catchall of “Defendants” failed to state a plausible claim against Ethel and was “therefore insufficient to satisfy Rule 8’s pleading the claims,” resulting in the court’s dismissal of all claims without prejudice. Id.

Merits of Plaintiff’s Causes of Action

Turning to the merits, court next conducted a choice of law analysis, using Illinois’s “most significant relationship test” to determine whether Illinois or Georgia law applied. The court ultimately decided that Georgia law would apply, largely because plaintiff resided in, and suffered her alleged injuries in that state, which had the strongest interest in the litigation. Id. at *35-37.

After determining that plaintiff sufficiently alleged that Sid played a role in manufacturing Lupron beyond its ownership of Jonathan, the court declined to dismiss strict products liability and failure to warn claims against Sid. Id. at *40.  However, it ruled that plaintiff’s allegations that Sid failed to adequately test the product before approval, did not advise “Plaintiffs and their physicians,” and misrepresented “the dangers associated with the use of Lupron,” failed to allege either that Sid owed or breached a duty to plaintiff. Id. at *45.  The allegations could not support plaintiff’s negligence claims against that defendant. Id. Nor could plaintiff state a claim for express warranty through statements that Defendants “expressly represented” that Lupron was “safe and efficacious,” “safe and fit for its intended use,” or “of merchantable quality.” Id. at *46-47.  In dismissing plaintiff’s claim, the court observed that “Plaintiff [did] not identify any specific warranty that Sid made to her … “nor [did] she identify the content of any statement by Abbot.” Id. at *47.  Similarly, plaintiff’s breach of implied warranty claim failed because she could not establish privity – as the complaint stated only that she used Lupron, and was devoid of allegations “that she purchased it.” Id. at * 49.

Further – and utterly unsurprisingly by this point − plaintiff’s fraudulent misrepresentation claim was not pled with the heightened particularity required by Rule 9(b), “[t]he who, what, when, where, and how: the first paragraph of any newspaper story.” Id. at *50 (citation omitted).  Rather, the complaint merely claimed that Defendants generally misrepresented the product’s safety in its labeling, marketing, and advertising over several decades. Id. However, plaintiff failed to articulate “who made these statements (other than Defendants, without specifying which Defendant made which statement), where and when these statements were made (other than to say sometime in the 1990s-2000 in Georgia and elsewhere), or how exactly Lupron’s safety was misrepresented.” Id. at *51.  Finally, her negligent misrepresentation claim was also doomed absent “allegations pointing to [defendant’s] statements on which Plaintiff relied” prior to her Lupron injection. Id.  Therefore, the court concluded that plaintiff’s negligent misrepresentation claim could not proceed “under Rule 8’s pleading standard,” and it too, was dismissed. Id. at *52-53.

In a nutshell, plaintiff ran afoul of every tenet of basic pleading 101 by repeatedly offering only threadbare allegations without specific facts; generalized and conclusory allegations leveled only at “Defendants;” and rote recitations of the elements of a claim without the facts to support it. However, to our chagrin, and much more to that of the Defendants, the court dismissed all of plaintiff’s claims, except for strict product liability and failure to warn, with leave to amend, despite seven years of failed pleadings. Id. at *54.  At least, the court issued plaintiff a none too subtle warning, stating it was “cognizant of the long procedural history,” and conditioning its leave for plaintiff to file an “amended complaint consistent with this opinion, if Plaintiff believes that she can overcome the deficiencies identified above for the dismissed claims.” Id. at *55 (emphasis added).

Given Plaintiff’s history of inartful pleading, repeated procedural errors, and other tactical blunders, one can expect, and hope, that like the buffoons in “Mad World,” when this case finally does end, plaintiff and her attorneys will wind up empty-handed.

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

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.

 

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week.  As much as sixteen inches of snow fell in some suburbs, and thousands of people, some of whom had just regained electric power after the last storm, were knocked into the dark and cold when tree limbs felled by heavy snow took power lines with them.  For the second time in as many storms, we found ourselves in a pocket on the low end of predicted accumulations.  We only got about six inches of snow, and it started melting quickly when temperatures rose in the evening.  And, again, our end of the street did not lose power.  (Assuming cooperation from the technology gods, this no longer affects us, as we happily parted with some retirement savings a few years ago in favor of a whole-house generator, after a four-day outage during which we tested long-held friendships by descending with the Drug and Device Law Menagerie in tow.)  The only “blip” was a scary near-miss.  We were out walking the Drug and Device Law Little Rescue Dogs at the height of the storm when a huge tree limb crashed down on a spot where we had stood ten seconds earlier.  Reminds us not to sweat the small stuff – this could have been tragic.

But save for that significant footnote, it was all pretty good.   And our assessment of today’s decision is similar.  In In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 1109554 (D. Ariz. Mar. 1, 2018), the court ruled on a number of motions in limine in advance of a mid-March trial.  The plaintiff alleged that she was injured when defendant’s filter, inserted in her inferior vena cava (“IVC”) to capture blood clots, migrated and fractured.  The filter that was implanted in the plaintiff, a Class II device, was granted 510(k) clearance by the FDA because of its “substantial equivalence” to an earlier filter model the defendant had marketed.  And that is the source of the most interesting rulings.

Defendants’ Motion to Exclude Evidence of Complications Associated with Predicate Device

Earlier, the plaintiff had moved to exclude evidence of the 510(k) clearance process, a motion that the defendants “vigorously opposed.” In re Bard IVC Filters, 2018 WL 1109554 at *1.  The court agreed with the defendants, “noting that the FDA grants 510(k) clearance only where the device is as safe and effective as a predicate device and does not raise different questions of safety and efficacy than the predicate device.” Id. (internal punctuation and citations omitted).  As such, compliance with the 510(K) clearance process was “certainly probative under Georgia law on the issues of reasonableness of the design, manufacture, and warnings of the [cleared filter]” as well as issues related to the plaintiff’s punitive damages claim. Id. Georgia law, hmmmm…. The Fourth Circuit’s Cisson misstep, going 180° the other way, was also Georgia law, as we discussed here.  Needless to say, we like this one better.

But having fought for admission of evidence of the 510(k) clearance process, the defendants were faced with the plaintiff’s intention to introduce evidence of complications with the predicate device. The defendant moved to exclude this evidence, arguing that the complications were not “substantially similar” to the issues the plaintiff experienced with her device.  The defendant argued that, ‘[b]ased on clinical experience with the [predicate] filter, [it] made several significant changes to the [new] filter.” Id. Because the plaintiff received the new filter, which had been “changed significantly” from the predicate device, the defendants argued that problems with the predicate device  had no relevance to the plaintiff’s case.

The court denied the motion, noting that the defendant had “avowed to the FDA that the design, material, components, fundamental technology, . . . and intended use featured with the [new filter] are substantially equivalent to those featured with the predecessor [filter].” Id. The defendants further asserted that “one of [the] goals in developing the [new] filter was to reduce the number of incidents of filter fracture and migration that [it] had observed with the [predecessor].” Id. The court concluded, “Given these facts, . . . [the defendant’s] knowledge of problems with the [predecessor filter] is relevant to central issues in this case” – whether the defendant properly designed the new filter to correct the problems, whether it failed to properly warn about the problems, and whether its conduct justified an award of punitive damages. Id. at *2.

This ruling presents a quandary. We have spent many years defending manufacturers of Class 2 medical devices and advocating for admission of evidence of 510(k) clearance. We can appreciate the tension and the difficulty of drawing appropriate evidentiary lines.  But evidentiary lines and regulatory requirements are different.  This is a variant of the same fallacy underlying the 510(k) admissibility point discussed above.  FDA regulatory requirements and admission of evidence in civil litigation are two different things, created for different purposes, and often don’t mix well.

That is true here. For one thing, there is more to 510(k) than just substantial equivalence (“SE”).  The entire relevant part of the FDCA allows for an SE finding where the device being considered:

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by [FDA] that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

FDCA §513(i)(1)(A) (emphasis added), So a substantial equivalence finding by the FDA does not mean that the predicate device is technologically the same – or necessarily even close – as long as it “does not different questions of safety and effectiveness.”  That’s a lot different from the “substantially similar” standard generally used for admission of other occurrence evidence.

Admission of evidence of 510(k) clearance should not automatically open the floodgates to evidence of problems a plaintiff didn’t’ experience with a device she didn’t receive. The other occurrence could well arise from a “different technological characteristic.”  That would require a deeper dive into the regulatory pedigree of the device than occurred here.  We are thinking about this issue for a future post. Meanwhile, here are some highlights of the court’s less complicated rulings:

Defendants’ Motion to Exclude FDA Warning Letter

The defendants moved to exclude an FDA warning letter because: 1) it was an “informal advisory statement” by FDA; 2) it was issued more than seven years after the plaintiff received her IVC filter; and 3) the specific topics in it were not related to the filter the plaintiff received or to any issue in the case. Id. at *3.  The plaintiff countered that the letter was evidence to counter the defendant’s assertion that the FDA had never expressed concern about the defendant’s filters or taken any action against the defendant.   The court held that several sections of the warning letter lacked probative value because they addressed topics that were not at issue in the litigation.   Others addressed a generation of filter that was developed after the filter the plaintiff received.  The court granted the motion in limine with respect to those topics, but reserved for trial the question of the admissibility of topics related to the defendant’s handling and reporting of filter failures.  The court did conclude that, if the letter should become relevant at trial, it would be admissible under the public records exception to the hearsay rule.  Whatever happens later, the defendant’s first point about warning letters being “informal” and “advisory” was spot on.  We examined that issue in great detail here and here.

Plaintiffs’ Motion to Exclude References to IVC Filters as “Lifesaving” Devices.

The plaintiff sought to preclude the defendants from “putting on a ‘filters save lives’ defense” or from describing the filters as “lifesaving” or “life-extending.” Id. at *4.  The court denied the motion, holding that, under Georgia’s risk-utility analysis, “evidence concerning the benefits of IVC filters is directly relevant. . . .”

Plaintiffs’ Motion to Exclude “Standard of Care” Evidence

The plaintiffs sought to exclude the defendants from presenting evidence that IVC filters are “within the standard of care for medical treatment of pulmonary embolisms.” Id. at 5 (citations omitted).   The court denied the motion, agreeing with the defendants that “evidence regarding the use and benefits of IVC filters, and when they are called for, will be relevant to the jury’s risk-utility analysis, as well as evaluation of the failure to warn claims and [the surgeon’s] decision to implant” the defendant’s filter in the plaintiff. Id. In response to the plaintiffs’ concern that the jury could be confused about the standard of care to apply, the court conceded that “the standard of care for . . . design and marketing of IVC filters is entirely different from the medical standard of care for when filters should be used to treat patients.” Id. As such, the court held, the parties should refer to the “medical standard of care” when referring to the standard for implanting the filters, and should seek a clarifying instruction if warranted.

Plaintiffs’ Motions: “Nonparty at Fault” and “Intervening Cause”

Under Georgia law, a defendant may identify a “non-party at fault” and present evidence of that party’s fault to the jury. The jury may then include the non-party in its apportionment of fault and damages.  In this case, the defendant identified a diagnostic radiologist as the only “nonparty at fault,” alleging that the radiologist’s failure to report the condition of the filter to the plaintiff’s physicians was a cause of the plaintiff’s injuries.  While this was the only non-party whose fault the defendants intended to prove to the jury, the defendants argued that they should be permitted to introduce other doctors’ conduct, under a separate legal doctrine, as “intervening causes” of the plaintiff’s injuries, breaking the chain of causation between the defendant and the plaintiff and relieving the defendant of liability under Georgia law.  The plaintiffs moved to exclude evidence that  doctors not identified as “nonparties at fault” were “intervening causes” of the plaintiff’s injuries.  The court denied the motion, holding “. . . [A]lthough Defendants will be precluded from arguing that [other doctors] were negligent or at fault for purposes of apportioning liability, the Court cannot say that they should be precluded from asserting the fault of these nonparties as an intervening cause” of the plaintiff’s injuries.  The court emphasized that it would be careful to instruct the jury about the distinction between the two doctrines.

Plaintiffs’ Motion to Exclude Statements from Professional Associations

The plaintiffs sought to exclude evidence of statements of professional associations, trade groups, societies of physicians, and the like, arguing that the statements were hearsay, and, introduced through non-experts, would “evade Daubert scrutiny and would violate Rule 403.”  The court reserved its rulings for trial, holding that it could not grant the motion because the plaintiffs did not identify particular statements.  But it held that, on the present record, it could not conclude that the probative value of certain statements was outweighed by the potential for prejudice or that testimony about the absence of certain statements constituted inadmissible hearsay.  We see an analogy to how the federal rules treat learned treatises for hearsay purposes.

All in all, a pretty good day, with the exception of the quandary created by the rulings related to the admissibility of 510(k) evidence. That one isn’t as black and white as the ruling that was made.  We will keep you posted.

 

In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.

Georgia

The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.

Tennessee

Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.

Texas

“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.

Sometimes it takes a lot of words to say something.  The Iliad.  War and Peace.  SCOTUS’s Obergfell decision.  But sometimes, in just a few words, it is possible to create an image, or stir a memory, or underscore a point.  Call me Ishmael.  I have a dream.  A rose by any other name would smell as sweet.  And, apropos of sweet-smelling roses, today’s very short Georgia Supreme Court decision makes the point that expert opinions are expert opinions even when clothed as fact testimony, and must be excluded from evidence unless they meet the relevant admissibility standards. Yugueros v. Robles, 2016 WL 6407314 (Ga. Oct. 31, 2016), is not a drug or device decision.  It is a medical malpractice case, but its holding is relevant for anyone who deals with opposing experts.  Which we do, regularly and painfully.  (You can see a recent post on a similar issue here.)

In Yugueros, the appellant performed extensive cosmetic surgery on the appellee’s decedent (his wife).  Subsequently, Mrs. Robles went to the emergency room suffering from severe abdominal pain.  After an abdominal x-ray, which the E.R. doctor determined to be “unremarkable,” Mrs. Robles was discharged.  A radiologist who later saw the abdominal film could not rule out the presence of free air in the abdomen, which “could be a normal post-operative condition or could indicate a more serious issue.” Yugueros, 2016 WL 6407314 at *1.  The radiologist recommended a CT scan and posted his opinion in Mrs. Robles’s electronic medical record.

Continue Reading Expert Testimony in Sheep’s Clothing is Still Expert Testimony, Says Georgia Supreme Court

Usually, when res judicata comes up in our cases, we are trying to fend it off. Luckily, non-mutual offensive res judicata is rarely recognized, so plaintiffs usually fail when trying to preclude the drug or device manufacturer from putting up a full defense based on a prior ruling or verdict in a different case. Occasionally, in serial product liability litigation, we find a plaintiff trying to sue over the same injury twice, but that rarely requires motions, let alone motions based on res judicata. Today, however, we are discussing a Georgia state court case where a drug company’s settlement with Georgia and other governmental entities in a longstanding federal case precluded eight Georgians from suing the same company on behalf of Georgia. Were we to channel a fellow blogger, we might draw some parallel to “The Walking Dead,” which is filmed in Georgia and had been based in Georgia until season 5 (when the gang headed up to Virginia). We might say something about how related cases that pop up after an adjudication on the merits are like “walkers” and have to be disposed of accordingly. We might inject some spoilers by mentioning which main character got shot in the most recent episode and which main character is rumored to die in the next episode. We might even connect these events to an earlier failure to resolve an earlier dispute more definitively. Instead, we will just stick to the case.

Jordan v. State, No. A15A1733, 2016 Ga. App. LEXIS 176 (Ga. App. Mar. 23, 2016), does not have the drug manufacturer as a party to the appeal because it was the State of Georgia that filed and won the motion to dismiss below (although treated as a motion for summary judgment on appeal). This procedural quirk flows from the nature of qui tam litigation. In 2004, a relator named Starr filed a suit in the Eastern District of Pennsylvania against her former employer claiming that its marketing of a prescription anti-psychotic for off-label uses created liability under various statutes, including the federal False Claims Act for reimbursement by various governmental entities. (Some of this background is presented in Jordan, but some details are added from public information.) Over time, other relators filed similar cases, the United States intervened, and Starr’s complaint was amended to include claims under the later-enacted Georgia False Medicaid Claims Act (GFMCA) and various similar state statutes. In late 2013, there was a massive settlement of criminal and civil cases between the manufacturer, the United States, and a number of states—including Georgia—resulting in, among other things, payment of millions of dollars to Georgia and a dismissal with prejudice of the Starr case.

Continue Reading Some Good Georgian Res Judicata

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation. The three decisions are: Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background. These three are not mass tort cases. They are examples of what happens when there is indiscriminate plaintiff-side advertising. People call up these 800 numbers because they had “mesh” implanted. They don’t have the targeted product but – what the hey? – it’s mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike. So we’ll concentrate on the Goodson opinion – if for no other reason than alphabetical order.

Continue Reading New Jersey Mesh Summary Judgment Hat Trick

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

It has been over 2 months since we lasted posted about an InFuse decision.  What’s been happening (outside the DDL Blog world) since that last post.  The Cuban flag was raised at its embassy in Washington DC officially restoring full diplomatic relations between the two countries for the first time since 1961.  At almost the same time, the Confederate flag was removed from the South Carolina Capitol ending 54 years of it being on display.   The Boy Scouts of America ended its ban on gay adult leaders and the first two women graduated from the Army Ranger School.  And the last time Labor Day gas prices were this low, George W. Bush was in his first term as president (under $2 in New Jersey).

There is nothing quite so historical or monumental about the latest InFuse decision.  It doesn’t break new ground or celebrate the demise of old prejudices.  But it is a good, strong, solid opinion and another nail in the coffin for off-label promotion claims.

The case is Latimer v. Medtronic, Inc., No. 2014-CV-245871, slip op.,  (Ga. Sup. Ct. Sept. 4, 2015).  The allegations are essentially the same as we’ve seen in other InFuse cases – because my doctor chose to use the device off-label, preemption should fly out the window.  But as this court recognized, slip op. at 11-12, almost every court in the country that has considered that argument has found it significantly lacking.  Time to add Georgia to the list.  The decision includes a nice recitation of PMA preemption law, id. at 8-11, which serves as the court’s foundation for its ultimate conclusion that with the exception of affirmative fraud claims (which weren’t adequately pleaded), none of plaintiff’s other claims pass through the narrow gap between express and implied preemption.  Id. at 11.

This plaintiff started like other InFuse plaintiffs by arguing that express preemption should not apply because his surgeon used the device off-label.  Plaintiffs wield “off-label use” like vaudevillian magicians used “abracadabra.”  Instead of pulling a rabbit out of a hat, plaintiffs try to make preemption disappear.  But the courts have seen the smoke, the mirrors, and the strings – and they’re simply not buying it.  Use doesn’t matter.  PMA federal regulations are applicable to the device, not the use.  Id. at 13.  Plaintiffs’ parlor tricks don’t improve when they switch to “off-label promotion.”  “[N]othing in §360k(a) suggests that the preemption analysis somehow depends on how the device is being promoted to be used.”  Id. at 14 (citations omitted).  So, regardless of off-label use and promotion, preemption still applies.

Failing to avoid preemption all together, plaintiff’s next argument was to claim that he was asserting a parallel claim for prohibited off-label promotion.  The court by-passed the question of whether off-label promotion is in fact prohibited, ruling instead that even if it was – a claim based on it would be impliedly preempted.  Id. at 15.  There is no state law cause of action prohibiting off-label promotion. Off-label use is completely a “creature of the FDCA.”  Therefore, “any claim based on off-label promotion would be in substance a claim for violating the FDCA.”  Id. (citations omitted).  That’s a Buckman no-no.

Having put aside any notion that off-label use/promotion somehow changes the equation, the court turned to applying the preemption analysis to plaintiff’s specific claims.  First the court pooled together all of plaintiff’s failure to warn claims.  Regardless of how they are “labeled” (negligence, strict liability, statutory fraud), “to the extent each claim rests on a contention that Medtronic failed to inform Plaintiff or his surgeon about risk allegedly associated with the use of the Infuse device, each is at bottom, a failure to warn claim.”  Id. at 15.  And since each is a claim that Medtronic should have provided warnings different from or in addition to those required by the FDA, each is preempted.

The court didn’t pull any punches.  Even though the failure to warn claims were preempted, the court went on to find that they would also have failed as a matter of Georgia law.  Having looked at the labeling and other medical information available from the FDA at the time of plaintiff’s surgery, the court concluded that “Medtronic had no duty to warn Plaintiff’s surgeon, because where a product is vended to a particular group or profession, the manufacturer is not required to warn against the risks generally known to such group or profession.”  Id. at 22.

Plaintiff tried to save his failure to warn claims by alleging failure to report adverse events to the FDA.  The argument is that since that is a federal requirement, a failure to warn claim based on it is a non-preempted parallel claim.  First, plaintiff didn’t plead that claim in his complaint.  But even if he had, “there is not duty under Georgia law to report adverse events to the FDA.”  Id. at 17.  For a state law claim to parallel a federal requirement, the state law claim must exist.  This one does not.  But the court didn’t stop there.  It held that a failure to report claim would also be impliedly preempted as nothing more than a prohibited private right of action to enforce FDA reporting requirements.  Id. at 18.  Another Buckman no-no.  And, the court found that the failure to report claim would fail because plaintiff did not allege a causal connection between the purported failure to report and his injuries.  Id. at 18n.5.  Express preemption, implied preemption, and no causation – a trifecta.

Moving next to design defect, it’s hard to argue that a claim that a product should have been designed in a manner different than that approved by the FDA is not expressly preempted.  It is.  Id. at 18-19.  More importantly, applying Bartlett the court also found the claim impliedly preempted.

To the extent Plaintiff contends that Georgia law required Medtronic to change Infuse’s design or labeling without FDA approval, his claims are impliedly preempted, because federal law affirmatively prohibits manufacturers from changing the design or labeling of PMA-approved devices without obtaining prior or ultimate FDA approval. Any claim predicated on the contention that Medtronic was as a matter of state law required to adopt a different design or label fails, because under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted.

 

Id. at 19 (quotation marks and citations omitted).

The court also ruled that plaintiff’s breach of express and implied warranty claims were preempted.  Plaintiff’s claim was based on allegations that Medtronic had breached warranties that the device was safe.  “To prevail on this claim, a jury would need to find that Infuse was not safe and effective as labeled” which would conflict with the FDA’s PMA determination that the device was safe and effective.  Id. at 20.  That conflict means that the state would be imposing different or additional requirements (express preemption) and that the claims “interfere with FDA’s regulation of Class III medical devices” (implied preemption).  Id. at 20-21.

Finally, the court dismissed plaintiff’s claims under the Georgia Fair Business Practices Act and Uniform Deceptive Trade Practices Act.  The claims survived preemption only to the extent they were predicated on “alleged affirmative misrepresentations rather than purported omissions.”  Id. at 16.  Fraud by omission requires a state law “disclosure requirement” that would be different from or additional to the requirements of federal law.  Id.  But these claims failed to clear several other obstacles — such as the fact that both statutes have safe harbors that exempt actions or conduct authorized or in compliance with federal law.  Id. at 22.  Since the FDA granted premarket approval and authorized the sale of the device – plaintiff is outside the scope of either act.  Moreover, the Fair Business Practices Act applies only to consumer products, which a prescription medical device is not and the Uniform Deceptive Trade Practices Act only provides injunctive relief not damages.  Id. at 22-23.  To top it all off, these fraud claims were not pleaded with the requisite specificity. The complaint is missing the who, what and when for any alleged misrepresentation.  And it might even be missing the misrepresentation.  Plaintiff alleged that doctors were paid to promote off-label use.  But “off-label marketing . . . is itself not inherently fraudulent.”  Id. at 24.  Off-label does not mean false.  

This case might not be as newsworthy as say today’s trending news such as the NFL switching from Roman to Arabic numerals for Super Bowl 50, or that 5 NYPD police officers tackled and cuffed former tennis star James Blake after he was misidentified, or that Donald Trump has soared to 32% in the polls.  Then again, if those are the headlines – we’ll stick with off-label use.

Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right.

A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations. You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves.

Continue Reading Georgia Court Takes a Holistic Approach to Pleading

Not quite a year ago we praised a decision out of the Northern District of Georgia for dispatching a plaintiff’s expert after applying Daubert and dispatching an entire case after applying logic.  The case was called Brown v. Roche Laboratories, Inc., 2013 U.S. Dist. LEXIS (N.D. Ga. June 6, 2013), and it was another of those sad SJS/TEN cases.  The plaintiff expert’s causation opinion was based on a temporal association and not much else.  Moreover, as we reported with a surfeit of accuracy and eloquence, “the learned intermediary rule precluded the claim, inasmuch as the doctor knew of the risk and made a considered decision to prescribe the drug in spite of the risk.  No expert in the world could solve that problem for the plaintiff.”

It’s seldom a good idea to reread something you wrote a while ago.  You plop down in the chair, don the Kmart reading glasses, and take another look at your precious prose.  Within seconds, disappointment and embarrassment plop down beside you.  Our review of the Brown blogpost was mixed.  We think we were right, but we also think we were unduly prolix.  We took eight paragraphs to summarize an uncomplicated opinion.

And now the Eleventh Circuit has issued an opinion affirming the lower court’s ruling, affirming our own take on the case, and affirming our hunch that our verbosity was unnecessary.  In an unpublished opinion that barely makes it onto the fourth page, the court affirmed summary judgment without even reaching the Daubert issue.  Brown v. Roche Laboratories, Inc., 2014 U.S. App. LEXIS 9946 (11th Cir. May 20, 2014).  The plaintiff could not prove that the failure to warn physicians to test and substitute an alternative antibiotic for penicillin-sensitive patients was the proximate cause of the plaintiff’s skin condition.  Under Georgia law, “if a manufacturer of a prescription drug warns a patient’s physician of any risk or hazards of the drug and, despite the known risk of harm, the physician administers the drug, the manufacturer is insulated from liability for injuries by the patient.”  The doctor who prescribed the medicine testified that he knew the plaintiff was sensitive to penicillin and that there was a possible cross-reactivity, yet he went ahead with the prescription.  That “reasoned decision … severed any causal link between the alleged ineffectiveness of the warning label” and the alleged injury.

Perhaps we have already been too loquacious in rendering this sound, straightforward result.   Sometimes it is hard to resist the impulse to be a singer of tales.  And we will let that stand as the first clue about where this writer will be on vacation by the time you read this – just in case anybody wants to play the game of Where in the World is Stevie Mac.  Further hint: think of a country a long ways away and with a pretty long coastline.  Further further hint:  think of a country that wasn’t a country when Bush 41 was in office.