In medical device product liability cases to which preemption by reason of FDA pre-market approval (“PMA”) applies, courts have consistently misinterpreted the Supreme Court’s dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) − finding the plaintiff’s “parallel” violation claims waived by failure to assert in the court of appeals – as somehow endorsing such claims.  Of course, only those PMA plaintiffs able to take advantage of prior FDA enforcement actions (usually, but not exclusively, warning letters or recalls) really have any basis to raise so-called “parallel” claims, but that certainly won’t stop other plaintiffs desperate to avoid preemption.

Lacking factual basis to make a valid parallel claim, such plaintiffs frequently try to bluff their way through by burying their opponents in garbage.  Typically, this ploy takes the form of a “laundry list” of allegations that the defendant’s device violated just about every FDA good manufacturing practice (“GMP” or “CGMP” in the cases) in the title 21 of Code of Federal Regulations, and for good measure, sometimes other regulations as well.  These allegations often go on for several pages in a complaint, with no hint of what exactly the defendant did that was in violation, and even less about how any of these purported violations caused any injury to this particular plaintiff.

Fortunately, most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.  “To plead a parallel claim successfully, a plaintiff’s allegations must meet the plausibility standard articulated by the Supreme Court in Iqbal and Twombly.”  Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *13 (E.D. Pa. March 31, 2015), aff’d, 885 F.3d 760 (3d Cir. 2018).  “[M]ore is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations.”  Swisher. v. Stryker Corp., 2014 WL 1153716, at *2 (W.D. Okla. March 14, 2014).  “Plaintiff must do more than simply allege the existence of the regulation, and then state that Defendants violated it.” Grant v. Corin Grp. PLC, 2016 WL 4447523, at *6 (S.D. Cal. Jan. 15, 2016).

One of the first cases to encounter, and to dispatch, this kind of abusive pleading was Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009).  Since the complaint in Ilarraza “goes on to list eleven federal regulations alleged to have been violated,” id. at 583, the opinion needed over two  pages just to explain the regulations that plaintiff claimed that the defendant violated.  Id. at 586-88.  However, “no regulation relied upon refers specifically to the medical device at issue here.”  Id. at 588.  TwIqbal therefore barred the claims:

[W]here, as here, a plaintiff relies on nothing more that CGMP’s in support of a parallel cause of action, preemption bars the claim. . . .  Plaintiff’s claim cannot withstand the pleading requirements [that] . . . require dismissal of complaints that do nothing more than engage ion a “formulaic recitation of the elements of a cause of action.  Where, as here, the plaintiff has done nothing more that recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed.

*          *          *          *

Here, Plaintiff fails to set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.

Id. at 588, 589 (Twombly citations omitted).

Another early pleading case is In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), in which MDL plaintiffs, after Riegel was decided, loaded up their master complaint with lots of alleged regulatory violations.  Id. at 1153-54.  Dismissing the complaint, the court held:

Plaintiffs’ failure to allege in detail the federal requirement(s) purportedly violated by Medtronic also raises the specter of Twombly. . . .  Hence, their assertion that the [device] did not comply with the CGMPs/QSR is insufficient, without more, to save their claims. Under Twombly, Plaintiffs were required to provide enough factual detail in the Complaint to alert [defendant] of the “grounds” upon which their manufacturing-defect claim rests. Merely alleging that [defendant] failed to comply with the CGMPs/QSR . . . is insufficient without some factual detail about why that violates federal standards.

Id. at 1158 (citations and quotation marks omitted).  The Eighth Circuit affirmed, holding, in pertinent part, that “Plaintiffs simply failed to adequately plead that [defendant] violated a federal requirement specific to the FDA’s PMA approval of this Class III device.”  In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1207 (8th Cir. 2010).

But TwIqbal has defeated “laundry list” pleadings much more recently.  In Canary v. Medtronic, Inc., 2017 WL 1382298 (E.D. Mich. April 18, 2017), plaintiffs’ complaint recited “over the course of nine pages and nearly thirty paragraphs . . . a plethora of CGMPs and other regulatory provisions to which Defendant allegedly was subject.”  Id. at *8.  Nonetheless, the court TwIqballed the complaint.

A number of courts have rejected this “laundry list” approach to pleading a parallel claim arising from a manufacturer’s alleged violation of FDA regulations or CGMPs. . . .  [T]he allegations that follow Plaintiff’s lengthy recitation of purportedly relevant CGMPs and regulatory duties are too vague and conclusory to satisfy the Twombly/Iqbal standard of plausibility. . . .  [T]he allegations put forward by Plaintiff here in support of her product liability claims lack the factual content necessary to permit the plausible inferences (i) that Defendant violated one or more FDA regulations . . . and (ii) that Plaintiff was injured as a result of these violations.

Id. (citations omitted).

A similar result was reached in McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016).  Five unrelated plaintiffs tried to gin up a parallel claim with a long list of purported regulatory violations, filing a single complaint that “simply include[d] a laundry list of over twenty-five federal ‘requirements,’” to which were appended “over twenty alleged breaches” – all “without giving any indication as to what federal requirement was violated by each alleged breach.”  Id. at 820-21.  TwIqbal barred that hot mess:

Most importantly . . . Plaintiffs have failed to allege any identifiable causal connection between the alleged [violations] and Plaintiffs’ resulting injuries. . . . The Complaint then baldly alleges that all identified . . . breaches caused Plaintiffs’ damages. . ., [but] [g]iven the lack of allegations that in any way link [defendant’s] failure to follow procedures . . . with . . . any of Plaintiffs’’ [] devices . . ., we can only conclude that Plaintiffs’ claims are based entirely on speculation.  Indeed, we are unable to discern any plausible and non-speculative causal connection between any of [defendant’s] alleged . . . failings and . . . Plaintiffs’ [] devices.  Accordingly, we conclude that the negligent risk management claim, as currently pled, does not set forth a plausible claim for relief.

172 F. Supp.3d at 821 (citations and quotation marks omitted).  A similar string of regulatory violation allegations got the bum’s rush in Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011), because, “[t]o the extent these vague and conclusory allegations are not impliedly preempted . . ., plaintiffs have failed to set forth facts to plausibly allege how defendants violated these provisions or how [injured plaintiff’s] injury is linked to any such violation.”  Id. at 164-65.

Likewise, in Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671 (S.D.W. Va. 2015), plaintiffs’ allegations of “wholesale noncompliance with the requirements of . . . a series of statutory provisions” failed TwIqbal.  Id. at 698.

[P]laintiffs do not allege how any of the defendant’s promotional activities violated federal law because they neither identify any specific conduct on the part of the defendant . . . nor any substantive federal regulation, restriction, or standard . . . actually made applicable to any of the defendant’s devices.  On such allegations, the defendant (and this Court) are left to guess as to the manner in which the defendant was negligent under state law.  More is required of a valid parallel claim.

Id. (citations omitted).  A similar “list[] without any supporting factual allegations eight provisions of the FDCA and corresponding federal regulations which Plaintiff’s allegedly violated” was TwIqballed in Gavin v. Medtronic, Inc., 2013 WL 3791612, at *16 (E.D. La. July 19, 2013), since “Plaintiff has failed to identify violations of federal regulations and provide allegations connecting those violations to Plaintiff’s specific injury.”  Id. at *17.

Parallel violation claims fail where “plaintiff cites generally applicable CGMPs and contends the [PMA device] violated them, without alleging specific facts to support his assertions.”  Gale v. Smith & Nephew, Inc., 2013 WL 9874422, at *3 (S.D.N.Y. Sept. 13, 2013).  In Shuker, the court denied plaintiff’s attempt to amend the complaint, due to woefully insufficient pleading:

In Count II of their Second Amended Complaint, Plaintiffs allege Defendants were negligent in that they breached their duty “to comply with the [FDCA] and the regulations promulgated pursuant to the Act” by violating a host of statutory and regulatory provisions.  Although defendants devote twenty pages − approximately one-third of the Second Amended Complaint − to cataloging these alleged violations, they offer no legal support for, or explanation of, most of the theories they seek to advance. . . .  As a result, the Court is left to parse a lengthy laundry list of FDCA provisions and FDA regulations.

2015 WL 1475368, at *13 (factual citations omitted).  The allegations failed because “Plaintiffs have not pleaded facts supporting a plausible inference that Defendants engaged in” the claimed violations, pleaded “conclusory allegation[s]” that were “entirely speculative,” and “provide[d] no explanation of any such deviation[s].”  Id. at *14, 16.

The same result occurred in Paturzo v. Boston Scientific Corp., 2017 WL 8220600 (C.D. Cal. April 21, 2017), where bald allegations of multiple regulatory violations could not save a supposed “parallel” claim from dismissal:

Although Plaintiffs list several federal regulations that Defendants purportedly violated, they fail to allege any facts relating the [device failure] to Defendants’ manufacturing processes and, specifically, the FDA’s requirements for manufacturing. Plaintiffs’ allegations of Defendants’ failure to establish or maintain certain quality control procedures are simply regurgitations of the text of the federal regulations.  Alone, they amount to no more than an allegation that Defendants violated federal standards.

Id. at *5.  The court could “draw no reasonable inference that the [device failure] was the result of a manufacturing defect, let alone that the manufacturing defect arises from Defendants’ failure to comply with FDA requirements. Id. Accord Chester v. Boston Scientific Corp., 2017 WL 751424, at *9 (D.N.J. Feb. 27, 2017) (complaint “provides a laundry list of FDA regulations with which Defendants were obligated to comply” but “is missing . . . any plausible pleading of if, how, or when Defendants violated any of the listed regulations”).

See also Skinner v. St. Jude Medical, Inc., 2016 WL 4054931, at *3 (W.D. La. July 27, 2016) (“it is difficult to discern whether any of [plaintiffs’] claims are parallel claims because the amended complaint contains little more than a laundry list of bare, conclusory allegations”); Nevolas v. Boston Scientific Corp., 2016 WL 1532259, at *3-4 (W.D. Okla. April 15, 2016) (5 paragraphs of violation allegations insufficient; “more is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations) (quoting Swisher, supra); Ward v. St. Jude Medical, Inc., 2016 WL 1208789, at *2 (S.D. Fla. March 28, 2016) (“Although the amended complaint alleges that the defendants violated various federal statues, it does not present device-specific premarket violations linked to the plaintiffs’ alleged harm.”); Ellis v. Smith & Nephew, Inc., 2016 WL 7319397, at *4-5 (D.S.C. Feb. 16, 2016) (list of 12 alleged violations “failed to allege how the violations of these federal requirements would give rise to liability under state law for [plaintiff’s] injuries”); Grant, 2016 WL 4447523, at *6 (complaint “is utterly devoid of factual allegations concerning what manufacturing procedures Defendants allegedly violated”); Nevolas v. Boston Scientific Corp., 2016 WL 347721, at *3 (W.D. Okla. Jan. 28, 2016) (complaint “simply makes numerous conclusory allegations, devoid of any factual support, that defendant violated in unspecified ways various federal regulations and federal manufacturing requirements”); Thibodeau v. Cochlear Ltd., 2014 WL 3700868, at *4 (D. Ariz. July 25, 2014) (“negligence claims cannot simply put forth a laundry list of PMA or federal law provisions Defendants failed to follow without some factual allegations in support”); Williamston v. Medtronic, Inc., 2014 WL 2042004, at *7 (W.D. La. May 15, 2014) (footnote omitted) (“[t]he simple listing of various federal regulations is insufficient to successfully plead a state law claim predicated on the violation of federal requirements”); McPhee v. DePuy Orthopedics, Inc., 2013 WL 5462762, at *5 (W.D. Pa. Sept. 30, 2013) (“Plaintiffs merely list the CFR provisions and assert that Defendant was negligent in violating the listed provisions”); Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *6-7 (D.N.J. Jan. 15, 2013) (list of regulations “fail[s] to assert the facts necessary, or indeed, any facts at all, to establish a claim that would parallel a violation of federal law” and “fail[s] to allege any ‘cognizable link’ between [the] alleged federal violations and [plaintiff’s] injury”); Cohen v. Guidant Corp., 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (complaint was “flawed . . . because it lists boilerplate FDA regulations without linking any of those regulations to a defect in [plaintiff’s] specific pacemaker that was caused by Defendants violating FDA regulations”); Cenac v. Hubbell, 2010 WL 11537934, at *2-3 (E.D. La. April 16, 2010) (list of four regulatory violations in complaint TwIqballed “because it provides no facts with respect to how [defendant] violated federal regulations”).

In Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016), plaintiffs tried to cobble together a failure-to-report claim from an allegation that defendant violated no less than fourteen FDA regulations. Id. at *5 (listing regulations).  This “laundry list” failed because “[a] general allegation that Defendant failed to report adverse events to the FDA is not sufficient to demonstrate causation.”  Id. at *6 (citations omitted).  Plaintiffs’ “acts present only conclusory allegations that Defendant failed to report adverse events without specific instances of actual adverse events.”  Id.  For a comprehensive rundown (as of September, 2016) of causation issues in failure-to-report cases, see this prior post.

A fortiori, the minimalist approach the pleading FDCA violations also fails.  Plaintiffs “cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).  “[B]road references to federal regulations in pleadings are insufficient.”  Gross, 858 F. Supp.2d 466, 494 (W.D. Pa. 2012).

Although Plaintiff acknowledges that [defendant] must comply with the specific regulations that apply to the . . . PMA device, he does not outline what these regulations are or how [defendant] allegedly violated same.  Because Plaintiff pled his negligence claim in a very general manner, he has failed to state a claim for negligence that survives preemption.

Id. at 497 (citation omitted).  In Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), the plaintiff alleged generally that the defendant violated the FDA’s CGMPs, citing generally, “21 C.F.R. §820.1 et. seq.”  But “[p]laintiff fail[ed] to explain how Defendants violated the CGMPs.”  Id. at *4.  That attempt resulted in dismissal because:

Plaintiff has failed to identify a single parallel federal statute or regulation related to any of her claims.  Therefore, the Court concludes that, as a matter of law, the MDA expressly preempts Plaintiff’s claims.

Id. (footnote omitted). See also Ali v. Allergan USA, Inc., 2012 WL 3692396, at *7 (E.D. Va. Aug. 23, 2012) (plaintiff’s “Complaint offers a series of conclusory allegations that that [defendant] violated federal law in the manufacture and marketing of the [device].  However, without factual enhancement, these statements are insufficient to plead plausible federal violations”); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1302 (D. Colo. 2008) (“nowhere does plaintiff’s complaint provide any factual detail to substantiate that crucial allegation”).

Thus, although on first glance a complaint’s multi-paragraph list of FDA regulations that the defendant allegedly violated may look imposing, chances are that the plaintiff has failed either to plead facts sufficient to establish any violation as to the particular device or to allege how the purported violations caused a product defect that actually caused the injuries being alleged.  In either instance, the plaintiff’s “parallel” claim preemption dodge should properly be TwIqballed.

It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest Pharmaceuticals opinion in 2015, which we covered here.  Since then, we have covered the topic at some length in connection with orders coming out of the Eliquis MDL in New York, which you can revisit here, here, here, and here.  These posts report on a series of orders in which the district judge dismissed multiple cases because federal law impliedly preempted the plaintiffs’ claims.

A district judge has now issued a similar dismissal ruling in a prescription drug case in the Northern District of Alabama, McGee v. Boehringer Ingelheim Pharm., Inc., No. 4:15-cv-2082, 2018 WL 1399237 (N.D. Ala. Mar. 20, 2018).  Here is the gist of it.  We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA’s pre-approval through the Changed Being Effected (or “CBE”) process.  Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply.  Then came PLIVA v. Mensing, which held that federal law impliedly preempted state-law failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval.  Because generic manufacturers cannot change their labeling to comply with state law without violating federal law, state law claims must give way.

In McGee, the district court joined others in recognizing that even an innovator manufacturer cannot use the CBE process unless there is “newly acquired evidence” of a causal association between a risk and the drug.  In that event, the innovators cannot change their drug labeling without the FDA’s pre-approval and implied preemption applies.  Id. at **3-4.  “So, if a plaintiff can allege the existence of newly-acquired information that supports a labeling change under the CBE regulation, and if the manufacturer subsequently fails to show by ‘clear evidence’ that the FDA would not have approved a change to the label, then a failure-to-warn claim will survive the manufacturer’s preemption defense.” Id. at *4.

In other words, before we even get to Wyeth v. Levine’s “clear evidence standard,” the plaintiff has to plead facts establishing that the manufacturer had newly acquired information and that the new information provides reasonable evidence of a causal association between the alleged risk and the drug.

The plaintiff in McGee failed.  He alleged that the product manufacturer failed to warn adequately regarding the risk of diabetic ketoacidosis, or “DKA.” McGee, 2018 WL 1399237, at *1.  But the complaint was ambiguous on what the manufacturer knew about that condition and when the manufacturer knew it. Id. It all came down to timing.  The plaintiff alleged that there were reports of DKA before the FDA approved the defendant’s drug, but reports that pre-date drug approval obviously are not “newly acquired” information.  In addition, any allegation that the manufacturer should have alerted the FDA about the DKA risk before approval is a fraud-on-the-FDA claim preempted under Buckman. Id. at *4.

The plaintiff also alleged that the FDA issued a warning with reference to adverse events after the plaintiff allegedly experienced DKA, but “common sense dictates that any information [the manufacturer] obtained after January 17, 2015, when Mr. McGee suffered DKA, is irrelevant to Mr. McGee’s claims because [the manufacturer] could not have used that information to change its label and prevent Mr. McGee’s injury.” Id.

In theory, the plaintiff could have stated a claim with reference to information newly acquired after approval but before he used the product.  “But Mr. McGee lumps together claims and facts from before, during, and after this brief time period” and “[w]ithout clarification, the court cannot tell when Mr. McGee alleges [the manufacturer] had what information.” Id.  Alas, the court granted leave to amend.  But the district court in the Eliquis cases gave the plaintiffs additional chances to plead too, and they were unable to come up with the facts.

The plaintiff in McGee may have similar difficulty.  We know from Eliquis that dumbing down the complaint and making the allegations more vague will not work, and the district court in McGee has already faulted this plaintiff for his imprecise pleadings in any event.  The court had particular distaste for allegations that were “nothing but a useless set of legal conclusions.” Id. at *5.  The court continued:

Worse, the complaint spews these legal conclusion with few supporting facts that would assist [the defendant] in understanding what the company did wrong. This type of “shotgun” pleading fails to plead a cognizable cause of action.  If Mr. McGee chooses to file an amended complaint, he must eliminate the unnecessary and unhelpful “shotgun” assertions and claims.

Id. (citations omitted). These are pretty strong words, but nothing beyond what any court should expect under Rule 8 and TwIqbal.  The takeaway is that the “newly acquired evidence” argument is well-grounded in the law and supported now by substantial precedent.  Moreover, plaintiffs will not always have the facts to get around it.

At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting.  When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post.  A short per curiam decision noted how awful plaintiffs’ complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant’s motion to dismiss.  We were feeling sleuthy, however, so we tracked down the district court’s decision from a year ago.  It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.

Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant.  The plaintiffs claimed that a surgeon used defendant’s product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending.  So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen.  Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth.  We did a little looking and saw that PureGen is an “osteoprogenitor cell allograft” derived from donated adult stem cells.  We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway.  In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen “had never been approved by FDA for use in the spine.”  Defendants moved to dismiss.

We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part.  After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman.  The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury.  (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.)  The design defect claim was identical (and similarly off-target from ORC 2307.75).  The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status.  The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not.  A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced “representations made by defendants concerning the product and/or with applicable federal requirements.”

The court’s analysis of these claims was clear and quotable:

Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations.  However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.

Well-reasoned. And dispositive.  And now affirmed on appeal.

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

“He who knows others is wise; he who knows himself is enlightened.” — Lao Tzu

This may not be exactly what the court in Moore v. C.R. Bard, Inc., 2016 U.S. Dist. LEXIS 156923 (E.D. Tenn. Nov. 14, 2016) had in mind when it authored its recent opinion dismissing the complaint in this case, but the decision brought these ancient philosophical words to our mind. Of course, if we are talking about self-knowledge advice, we might be more partial to Ann Lander’s “Know yourself. Don’t accept your dog’s admiration as conclusive evidence that you are wonderful.” But, we trust you get the point. You better know yourself first before you start worrying about what you don’t know about others.

Plaintiffs tend to put the cart before the horse on this issue. When faced with a motion to dismiss for failure to state a claim, plaintiffs focus intently on what they claim they don’t know yet or can’t possibly know – but never seem interested in all of the things that they should know before filing a lawsuit. That’s a big part of where plaintiffs fell short in Moore.

During surgery to repair a hernia, two mesh products were implanted in plaintiff – one Bard product and one Ethicon product. Id. at *2-3. Plaintiff alleged that both products were made of polypropylene; that both defendants failed to adequately warn about the risks of their products; and that following surgery plaintiff’s condition worsened which he alleges is due to one or both of the mesh products. Id. at *3-4. And, that is all plaintiff alleged.

Continue Reading Excellent TwIqbal Decision — Plaintiffs Need to Look for Some Enlightenment

Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean:  the spider-like creatures with small centers, from which long, bent legs emanate in all directions.  That is sort of what IVC filters look like, although any resemblance ends there.  Manufactured from thin flexible metal, IVC filters can be implanted in the big vein that returns deoxygenated blood to your heart—the vena cava—to trap clots (or anything else) and prevent them from traveling to your heart and lungs, where they can cause serious mischief.  They are potentially life-saving devices.  They last came to our attention the other day when we received a robotic phone call asking us if we knew anyone with an IVC filter who might want to sue.  Ye gods.

An order granting a motion to dismiss in an IVC filter case crossed our desks this week, and its discipline and thoroughness caught our eye. The case is Dunson v. Cordis Corp., No. 16-06-03076, 2016 U.S. Dist. LEXIS 94873 (N.D. Cal. July 20, 2016).  The complaint in Dunson included the claims of six different plaintiffs whose claims appear to be unrelated, except that they have the same lawyers and were treated with similar filters made by the same manufacturer. Id. at **3-4.  They all alleged complications from filter implantation, and they alleged the full range of product liability claims.  Only the express warranty claim survived, and here is why:

Strict liability for design defect:  Guess what.  The plaintiffs sued in California, and California does not permit strict liability design defect claims in prescription medical device cases.  Plaintiffs tried to get around this by asserting in their opposition, for the first time, that some of them had their filters implanted in Arizona and Pennsylvania and that those states’ laws therefore should apply. Id. at **9-12.  This position raises so many questions:  If they were treated outside California, do they also reside outside California?  If so, why are Pennsylvania and Arizona residents suing a Florida corporation with an Ohio headquarters in California’s courts?  If they are from out of state, why did they conceal those facts and wait until opposing a motion to dismiss to admit them?  The answers are that these are forum-shopping plaintiffs who are importing their claims along with hundreds of others into California for no legitimate purpose.  Their choice-of-law argument did not work this time around.  The district court still dismissed their design defect claim, and it admonished the out-of-state plaintiffs to allege facts in their amended complaint to support their choice of law. Id. at **12-13.  The court was “skeptical.”

Continue Reading California Federal Court Dismisses Inferior Complaint

In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee.  Downtown Memphis had not yet undergone “gentrification,” so a short walk in any direction from the Federal Building had to be undertaken with some caution.  In addition to barbecue and blues, a federal litigant’s visit to Memphis held the prospect of appearing before any one of an interesting assemblage of district judges.  Judge Odell Horton had taken senior status after a long stint as chief judge of the district; he was a Carter appointee and exceedingly nice to everyone.  He was also the first African American federal judge in Tennessee since Reconstruction.  Judge Julia Smith Gibbons had taken over as the chief judge after starting on the federal bench at 33—a Reagan appointee—and everyone knew she would be heading up to the Sixth Circuit at some point.  Judge Jerome Turner was another Reagan appointee, who we recall mostly for taking his clerks to lunch regularly and for an untimely death a few years later.  Judge Bernice Donald assumed the bench while we were there, having been tapped to jump up from the bankruptcy court by the first President Clinton.  (The actor/Senator who was in Die Hard 2: Die Harder showed up for the swearing in ceremony.)  Judge McCalla had been appointed by the first President Bush and clerked (for Judge Bailey Brown, before he went up to the Sixth Circuit) in the same chambers some years earlier.  He had the military bearing you would expect from his pre-law background as an office in Vietnam and a well-deserved reputation for being “by the book” and “no nonsense.”  (The softer side that attorneys appearing before him missed was evident when he was with his family, including the puppy we helped train while housesitting.)

Twenty years later, we discuss Judge McCalla’s decision in Fleming v. Janssen Pharms., Inc., No. 2:15-cv-02799-JPM-dkv, 2016 WL 3180299 (W.D. Tenn. June 6, 2016), which follows the memorable Yates decision authored by Judge Gibbons, who did, indeed, head up to the Sixth Circuit.  Hence why we recounted the iudicis personae of the Western District from our relative youth. Fleming involves asserted state law claims in connection with plaintiff’s alleged kidney injuries from a branded prescription diabetes drug.  Defendants moved to dismiss on various grounds, which we will discuss in the order of importance to us.

First, of course, was the argument that plaintiff’s design defect claim was preempted as pleaded. This angle of attack is noteworthy because winning any kind of preemption for a branded prescription drug at the motion to dismiss phase is rare and because the progression from Bartlett to Yates (decided on summary judgment) to such motions being viable was something we forecast/urged. As discussed more later, plaintiff had pretty barebones design defect allegations that suggested that all drugs within this class of anti-diabetic agents was too risky and that there were “several safer alternative products”—not alternative designs for this product. Id. at *1.  In response to defendant’s argument for impossibility preemption, plaintiff contended that its claim was based on a “duty to design the drug differently before FDA approval,” which could have been characterized as “never start selling theory.” Id. at *5.  “The Sixth Circuit, however, found this type of argument to be ‘too attenuated’ and ‘speculat[ive]’ because it requires several assumptions as to FDA approval and a patient’s selections of and medical reaction to the alternative design.” Id. (quoting Yates, 808 F.3d 281, 199-300).  While a case with the same drug in the Eleventh Circuit had rejected Yates impossibility preemption while granting a motion to dismiss, the analysis in Fleming was straightforward.  “The Court finds that Plaintiffs’ design defect claims are preempted by federal law because preemption can apply to both generic and branded drugs and because it would have been impossible for Defendants to comply with both state and federal law.” Id. Like we said, this is a “by the book” judge.  Other judges taking a similar approach could provide the advantage of getting obviously preempted design defect claims out early, narrowing the scope of fact and expert discovery.

Continue Reading Dismissing Drug Design Defect Based on Preemption

In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly descriptor of ethnically ambiguous looking people, whose roots have been mashed together to form something not readily identifiable by traditional visual stereotypes. (At least it seemed friendly when we heard it applied to our own offspring.) Personally, we think it is a nice concept and the less that categorizing people to determine their rights, opportunities, and expectations happens, the better. For a number of aspects of product liability law, however, the decision on whether to proceed categorically or case-by-case is still hotly contested. This is particularly true for comment k to the Restatement (Second) of Torts, § 402A, which forms the meat of the decision in Segovia v. Bristol-Myers Squibb Co., CV. No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).

Segovia involves a fatal hemorrhagic stroke with an anticoagulant prescribed and used for atrial fibrillation. We are not sure what was different from the first complaint, but the second try made vague allegations about misrepresentations to FDA and others that it was “tested and found to be safe and effective for its indicated uses” and that FDA and others had not been told of the drug’s “defects” in support of allegations of strict liability and negligent failure to warn and design defect theories. While it seems like this complaint asserted claims based on non-existent duties and clearly preempted claims, the only issues addressed by the court on the motion to dismiss were whether Hawaii law took comment k to preclude design defect claims for all prescription drugs categorically and whether any fraud-based claims had been pleaded with sufficient particularity.

As to the first question, the court did not look to our relatively recent discussions on this issue, but generally looked to older cases to find the public policy rationale for taking a case-by-case approach for prescription drugs—which was essentially determinative on a motion to dismiss. But we are getting ahead of ourselves. The first step was determining what Hawaii case law already said about comment k and only two cases were discussed. Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded that summary judgment based on comment k was inappropriate where there was evidence that the “pacemaker was demonstrably capable of being made safe for its intended use.” Forsyth v. Eli Lilly & Co., 1998 WL 35152135, **3-4 (D. Haw. Jan. 5, 1998), involved a prescription drug, but did not decide the issue of categorical or case-by-case because a genuine issue as to the adequacy of warnings was sufficient to preclude summary judgment. Rather than view these cases are leaving the issue open, the Segovia court found “neither Larsen nor Forsythe create a blanket rule of design defect immunity for pharmaceutical manufacturers, and the Court declines to extend comment k in a fashion that the Hawaii courts themselves have thus far declined to do.” 2016 U.S. Dist. LEXIS 52405, *11. We think this misconstrues comment k, which does not provide “immunity,” and what it means to conclude that all prescription drugs are “unavoidably unsafe.”

Continue Reading Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud

In drug and device litigation, product identification can be a significant issue. Many of us have poured over medical records and worked through question modules at depositions to determine whether the plaintiff actually used our client’s drug or device. Undermining product identification can be one of the quickest ways to end a lawsuit. But it doesn’t get much quicker than it happened in Weddle v. Smith & Nephew, Inc., 2016 U.S. Dist. 48512 (N.D. Ill. Apr. 11, 2016). There, the plaintiff couldn’t (at least so far) get passed the pleadings.

In a variant of the old “when in doubt, pick C” approach to standardized tests, in Weddle, plaintiff went with, “when in doubt, pick them all.” Plaintiff had a Trident Hindfoot Fusion Nail system (“Trident), manufactured by Smith & Nephew, Inc., implanted in her foot. Id. at * 1-2. But other products, including nails and cement manufactured by Howmedica Osteonics Corp. and screws manufactured by DePuy Synthes Sales, Inc., were also implanted. After pain and other problems that required several more surgeries, plaintiff sued everybody. Id. at * 2. She alleged that Smith’s Trident, and/or Howmedica’s nails and cement, and/or DePuy’s screws caused her problems. Id. at * 8. In other words, she picked everybody. But, much like using your #2 pencil to fill in all the circles on a standardized test answer sheet, it didn’t work. The Court dismissed her complaint for failure to state a plausible claim. Id. at *20.

Continue Reading Court Dismisses Medical Device Claims That Named Many Defendants But Picked None Of Them

This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.

Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim.  2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015).  The court was clear on why.  While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff.  In other words, plaintiff did not allege facts to suggest proximate causation.  The court was explicit:

As to Defendant’s second argument regarding causation, while Plaintiff alleges the specific defect in Defendants’ product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.

Id. at *16-17.  Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation.  Plaintiff needed to allege “facts as to his own prescribing physician.”  Id. at *17.

Continue Reading How Easy Is It to Allege Proximate Causation in a Medical Device Case

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

Smith & Nephew, Inc. continues to push the plaintiffs out of court in a hip implant case pending in federal court in New Jersey.  Earlier this year, Smith & Nephew won its motion to dismiss plaintiffs’ first complaint because it contained almost no facts and plaintiffs’ counsel opposed the motion with nothing more than a tardy letter attaching medical records, correspondence and no legal authority.  See Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  We blogged about it here.

The court gave plaintiffs another chance, however, and plaintiffs took it.  Things didn’t get any better.  To quote Bugs Bunny’s sign from the classic Gashouse Gorillas episode: “Was this trip really necessary?”  (See the 5:00 mark.)  It wasn’t.

Continue Reading The District of New Jersey Holds That You Can’t “Discover” Your Way to a Parallel Violation Claim