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

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else.  The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff.  Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.”  Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.

Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug.  Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015).  Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability.  Id. at *13.  We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”

Continue Reading The Elephant in the Room in Alabama