We were in western Tennessee last week for an argument.   We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession of mallard ducks down a red carpet to the lobby fountain, where the ducks climb steps and jump in.   There they spend the next six hours, splashing and snacking, ‘til, at 5 pm, with just as much ceremony, they march back to the elevator and are returned to their rooftop habitat.   They are rotated back to a duck farm after three months, where they live out their lives as wild ducks while new recruits take the next three-month shift at the hotel. It is altogether delightful, and the hotel capitalizes with “all things duck” – duck-shaped butter served with morning toast, duck-shaped soap at the sink, duck-shaped chocolates on the pillows. (And no duck served in any hotel restaurant!)  It all fits together perfectly.

Unlike today’s case, a duck out of water from both jurisdictional and substantive perspectives. In Jones v. Medtronic, Inc., 2019 U.S. Dist. LEXIS 137304 (D. Ariz. Aug. 14, 2019), the plaintiff underwent three spinal fusion surgeries using the defendants’ intervertebral body fusion devices, their spinal fixation system, and their Infuse bone graft material The plaintiffs’ spine failed to fuse. She filed suit, asserting the usual product liability claims and alleging that the defendants’ bone graft material was not supposed to be used with the particular fusion devices used in her surgeries but was designed only for use with another fusion device. She alleged that the fusion devices used in her surgeries were known to “migrate, subside, and [be] expulsed,” which prevented them from containing the bone graft material long enough for spinal fusion to occur.   Jones, 2019 U.S. Dist. LEXIS 137304 at *3. The defendants moved to dismiss the complaint pursuant to Rules 12(b)(2) (lack of personal jurisdiction) and 12(b)(6).

Motion to Dismiss for Lack of Personal Jurisdiction

In their 12(b)(2) motion, the three defendants argued that the plaintiff had not made a prima facie showing that the court had either general or specific personal jurisdiction over them. As an initial matter, the court found that one of the defendants had waived its objections to personal jurisdiction because it had not raised the issue when it filed a motion to dismiss an earlier version of the complaint. With respect to the remaining defendants, the court found that it did not have general personal jurisdiction because the defendants were not incorporated in Arizona and did not have their headquarters or principal places of business in Arizona. With respect to specific personal jurisdiction, the court explained that, under Bauman, the plaintiff was required to make a sufficient showing that the defendants purposefully directed their activities toward Arizona or “performed [acts] that resulted in it availing [themselves] of the laws of Arizona.” Id. at *10.   The court explained that the plaintiff had not adequately alleged that the defendants maintained manufacturing facilities in Arizona or that her claims arose out of or were related to the defendants’ forum-related activities.   The plaintiff’s fusion surgeries were not performed in Arizona, and the court emphasized that “the plaintiff’s status as a resident of Arizona is insufficient to confer personal jurisdiction” over the defendants. Id.  As such, the court held, it did not have personal jurisdiction over either defendant.   This left one defendant, and the court addressed the 12(b)(6) motion with respect to that defendant.

Motion to Dismiss for Failure to State a Claim

Manufacturing Defect: The plaintiff alleged that the fusion devices had a manufacturing defect because they “had a tendency to migrate, subside, and be expulsed from the implant site.” Id. at *11. The court explained that, under Arizona law, a manufacturing defect is a “flaw[] as a result of something that went wrong in the manufacturing process.” Id. at *12 (citations omitted). The court held that the plaintiff’s “conclusory allegations” were “insufficient to state a plausible” manufacturing defect claim. Id.

Design Defect: The plaintiff alleged that the spinal fixation system had design defects that prevented the plaintiff’s spine from fusing. Because the plaintiff’s design defect claim did not “clearly identify whether [it was] based in negligence or strict liability,” id. at *15-16, the court considered both possibilities, and held that the plaintiff’s pleadings did not satisfy either standard.  The facts asserted in the complaint did not “support [a] claim that the . . . spinal fixation system fail[ed] to meet the purpose for which it was designed,” as a negligent design claim would require, according to the court.  Nor did the complaint adequately allege that the spinal fixation system “was unreasonably dangerous and failed to perform in a reasonably safe manner” or that its benefits did not outweigh its risks, alternate tests of a strict liability – design defect claim. Id. at *17. As such, the court held, the plaintiff had not pled a plausible design defect claim sounding in either negligence or strict liability

Failure to Warn: Because the fusion devices were Class III medical devices, any warnings claims were subject to express preemption under Riegel. The court explained that, “in order to avoid preemption, a plaintiff has to sue for conduct that violates a federal requirement . . . but cannot sue only because the conduct violates that federal requirement ([to avoid] implied [Buckman] preemption).” Id. at *19. Here, the plaintiff alleged that, because the (allegedly) “correct” fusion device failed to include certain warnings required by FDA, she was implanted with the “wrong” fusion device. Problem was, the defendants asked the judge to take judicial notice of the 2009 label, presumably in effect for the plaintiff’s 2010 surgery, which contained the specific warning the plaintiff alleged was missing.   The plaintiff admitted that she hadn’t been able to find that label – she only had labels from 2002 and 2015. You know what the court held here. (We would have had fun briefing the “warnings causation” argument if, in fact, plaintiff had been allowed to proceed with a claim that a warning was allegedly missing from a product that was never implanted in her.)

The judge similarly dispatched “adulteration” and “misbranding” claims.   The “adulteration” claim was based on the substitution of one fusion device for the other, which, the court observed, was effected by the surgeon, not the defendants. The misbranding claim made little enough sense that we won’t belabor it except to note that the court held that the claim “[flew] in the face of logic.” Id. at *23.

In sum, the complaint was a “hot mess,” in the words of some new Tennessee friends we made this week, and it mercifully and properly was dismissed.   We really like this decision, especially the judicial eye rolling evident throughout. We’ll keep you posted on similar victories. Meanwhile, if you are going to be in western Tennessee, email us and we’ll point you in the direction of the ducks!




On our office bulletin board, we keep a post-it listing the states we have not yet visited.   We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We’ve been to Utah lots of times, and were annoyed at this development. And St. George is not easy to reach. The local airport is temporarily closed, and the closest major airport is in Las Vegas, 130 miles away. So we flew to Las Vegas and gritted our teeth for the drive. We needn’t have.   The drive is entirely on I-15, passing through Nevada and a tiny corner of Arizona before hitting Utah. It traverses the spectacular Virgin River Gorge – you should Google it – and was altogether a lovely surprise. The takeaway (spoiler alert – this is the clumsy transition to today’s case): “not new” doesn’t necessarily mean “not good.”

We warned you. Today’s case, actually from a few months ago, treads familiar ground: medical device preemption under Riegel, and Buckman preemption. But it is very good. In White v. Medtronic, Inc., 2019 WL 1339613 (E.D. Mich. Feb. 20, 2019), the plaintiff alleged that his now-deceased wife was injured by the defendant’s bone graft device, a Class III medical device.. The plaintiff alleged that the device was implanted in an “off-label” manner and asserted the usual litany of product liability claims. The defendant moved to dismiss, arguing that the plaintiff’s claims were preempted by the MDA.

The court explained that, under Riegel, the MDA expressly preempts any state law claims related to a Class III medical device (a device subject to premarket approval, or “PMA”) that impose a requirement that is “different from or in addition to” those imposed by the MDA. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). Under Riegel’s two-pronged test, a state claim is preempted by the MDA when: 1) the federal government has established requirements applicable to the device in question; and 2) the state law claims, rather than asserting claims that parallel the federal requirements, seek to impose requirements that relate to safety and effectiveness and are different from, or in addition to, the federal requirements. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). In addition, under Buckman, only the federal government can enforce the MDA and the FDCA, so claims are impliedly preempted to the extent that they are based on violations of either statute.

The first prong of the Riegel test was easily satisfied, as there was no dispute that the FDA had established requirements that applied to the defendant’s device. As such, the “critical question” was whether the state-law claims “invoke[d] requirements beyond those established by the federal government.” Id. at *3. “The short answer,” according to the court, was “they do.” Id.

Claims Grounded in Negligence and Failure to Warn

The plaintiff based a number of his claims on allegations that the defendant had failed to warn of risks associated with the bone graft device, including risks of implanting the device in the allegedly off-label manner in which it was implanted in the plaintiff’s wife.   But the plaintiff did not allege that the defendant failed to provide any of the warnings required by the FDA through the PMA process; rather, the claims were “premised on the theory that Defendants had a duty to provide warnings different from or in addition to” those FDA required. Id. at *4 (emphasis in original). As such, the MDA expressly preempted the warnings claims. Moreover, with respect to the negligence claims, the court held, “No negligence claims can be maintained as to [Class III] devices that complied with the FDA requirements because success on those claims requires a showing that the FDA requirements themselves were deficient. These claims cannot be presented to a jury because, if successful, they would be inconsistent with the federal requirements.” Id. (citation omitted).   This is true even if the claims come “in the guise of a general tort suit addressing only safety issues related to off-label uses,” id. at *5, because “off-label usage of medical devices is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering in the practice of medicine.” Id. (internal punctuation and citation omitted). Moreover, the claims related to off-label promotion didn’t “pass muster as parallel state torts” claims, because there is “no Michigan law duty to refrain from off-label promotion of a medical device.” Rather, “off-label promotion exists only as a creation of the FDCA scheme.” Id.   In addition, the court held, the plaintiff’s claims related to off-label use and failure to report adverse events were impliedly preempted under Buckman as impermissible attempts to enforce violations of the FDCA.

Other Preempted Claims

The plaintiff asserted breaches of express and implied warranties and violations of Michigan’s consumer protection statute. Like the warnings claims, the court held that these claims were preempted because the duties the claims sought to enforce “relate[d] to, and [were] potentially inconsistent with, the federal regulatory scheme.” Id. at *7. In addition, Michigan’s consumer protection statute contains a safe harbor for conduct regulated under state or federal statutory authority, which “of course [included] the FDCA and the MDA.” Id.   Finally, the court held that the plaintiff’s design and manufacturing defect claims were preempted because “PMA constitutes approval of the product’s design, testing, intended use, and manufacturing methods,” so permitting the claims to go forward would “in essence, impose [requirements] different from or in addition to that already approved by the FDA.” Id. (citations omitted).

Other Bases for Dismissal

The court went on to dismiss the plaintiff’s fraud claims for failure to satisfy Rule 9(b) and also as “fraud on the FDA claims” preempted under Buckman. In an interesting twist, the court added that the fraud claims – in essence, that the defendant made false statements about the safety of off-label use of the device or concealed information about the device to induce doctors to use the device – were not tied specifically to the plaintiff’s late wife or to her doctors. Instead, they “attempted to advance a ‘fraud on the market’ theory, with the ‘market’ being the medical community at large” that had “no place in a products liability case. . . .” Finally, the court held that, in any event, the plaintiff’s claims were time-barred.

We like this no-doubt-about-it defense victory.   We’ll keep you posted on similar decisions, and on our continuing  adventures as we cross states off of our post-it.

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

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (S.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More

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.

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

Yesterday we brought you the latest InFuse federal appellate court win.  Today we tee up the latest state appellate court win – David v. Medtronic, Inc., 2015 WL 3645254 (Cal. Ct. App. Jun. 12, 2015).

In this InFuse case, 37 plaintiffs filed a single complaint in California state court against Medtronic (manufacturer of the InFuse device); Wyeth (developer of the protein used with the device); and Dr. Gary K. Michaelson whom plaintiffs alleged “invented, in part” the cage component of the device.  Id. at *1-2.  Neither Medtronic nor Wyeth is a California corporation.  Dr. Michaelson, however, is a resident of Los Angeles.  Id.  Only one of the plaintiffs is a California resident.

Medtronic filed motions both to sever each plaintiff’s case and to dismiss all but the California plaintiff on the grounds of forum non conveniens.  The trial court granted both motions and the appellate court upheld those decisions.

As to severance, both courts found that plaintiffs had not satisfied the standards for permissive joinder – a right to relief “arising out of the same transaction, occurrence, or series of transactions or occurrences.”  Id. at *3.  After providing examples of how this standard is properly met, the court distinguished

Here, the only common factor is that plaintiffs each had Infuse, or the Infuse protein, implanted in them. Plaintiffs do not allege, for example, that they each had the same class of spinal surgery, based at least in part on the same representation, and that the Infuse failed in each of them in the same way. On the contrary, they had different surgeries, performed by different surgeons, with different knowledge and exposure to different representations by Medtronic. This is not sufficient.

Once severed, the trial court then ruled that for the non-California plaintiffs, alternative forums existed (their home states) and that public and private factors weighed in favor of the litigation proceeding in those alternative forums.  Id. at *4.  On appeal, plaintiffs only challenged the first finding – whether alternative forums existed.  Their argument was that “all defendants, including nominal ones, must be subject to jurisdiction in an alternative forum in order for it to be available.”  And, that since Dr. Michaelson was not subject to jurisdiction in plaintiffs’ home states, viable alternative forums did not exist.  No one disputed that Dr. Michaelson was at best a nominal defendant (most certainly named to defeat diversity jurisdiction) – so the question was whether there is a nominal defendant exception to the “all defendants” alternative forum rule.  As a question of first impression in California, the court looked to federal precedent holding that a plaintiff cannot be allowed to avoid transfer “merely by including as a defendant a party who cannot be sued in the transferee court, but is of no real importance to the outcome of the case.”  Id. at *5.

Finding the federal rulings persuasive, the court had to decide what to do with plaintiffs’ claims against Dr. Michaelson – which although tenuous, did not warrant dismissal based on the current motions.  Rather than allow the “peripherally liable” party either to dictate litigation in an inconvenient forum or to escape liability completely, the court decided a second severance was in order.  Plaintiffs’ claims against Medtronic were severed and dismissed on forum non conveniens grounds and the claims against Dr. Michaelson were allowed to proceed in California.  When plaintiffs cried duplication – the court reminded them they were free to dismiss their claims against Dr. Michaelson if they so chose.

This is a significant decision for defendants faced with a complaint that tries to use both misjoinder and fraudulent joinder to keep cases in plaintiff-friendly jurisdictions.  We like to see that courts are onto the ruse.

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

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases.  Think of it like taking a shot on goal.  The shot deflects off the goalie’s stick and goes wide – that’s express preemption.  The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements.  You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion.  Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot.  Wrong. No free shot.  No empty net.  All the obstacles remain in place.  Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series.  Go Capitals!).

Continue Reading InFuse State Court Appellate Win

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

We’ve been reporting on individual InFuse cases that have been chopped down by defendant swinging a preemption axe of sorts.  One by one, the cases have toppled. Occasionally, a branch or two hangs on, but they’re often too weak or flimsy to survive for long.  But yesterday, the Western District of Tennessee took a bulldozer to 141 InFuse cases.  The decision strikes a decisive blow to plaintiffs’ off-label promotion theories, while reinforcing the predominance of preemption in PMA medical device cases.

The decision was entered in Hafer v. Medtronic, Inc., No. 2:13-cv-02340-JTF-dkv, slip op. (W.D. Tenn. Apr. 13, 2015), but applies to the entire group of InFuse cases that were consolidated before a single judge in that jurisdiction.  The allegations are essentially the same as we’ve seen in other InFuse cases, discussed here.   Namely, that plaintiffs’ surgeons opted use the InFuse device, a multi-component spinal fusion medical device, in an off-label manner.  In so doing, say plaintiffs, they were not implanted with a PMA approved device and so preemption should not apply.

Continue Reading Breaking News: 141 InFuse Plaintiffs Have Their Cases Clipped by Preemption

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

The InFuse litigation has certainly given us quite a lot to talk about – and almost all of it positive.  It has been a treasure trove for defendants on off-label marketing and promotion claims.  We’ve collected this bounty of riches here.  While each case has its own nuances, they are all really slight variations on a theme – the almost unanimous rejection of plaintiffs’ attempts to use off-label marketing to thread the preemption needle.  While the reasoning varies from court to court, the over-arching message is the same – off-label marketing does not change the preemption analysis.  The InFuse device, regardless of how it was used by a particular surgeon in a particular surgery, is a PMA-approved, Class III device and therefore covered by both Riegel express preemption and Buckman implied preemption.  Very little slips through the small space between the two.

If you want a more complete history of the InFuse litigation, we point you to our collection referenced above.   For even casual readers of our blog, we think you’ve probably seen some of our writings on the topic and so we aren’t going to wade back through the details.  Today’s post is more of an update.  Here are the latest four InFuse victories.

Truthful v. Untruthful Promotion

First up is Byrnes v. John Small, 2015 U.S. Dist. LEXIS 33555 (M.D. Fla. Mar. 18, 2015). This case is fairly typical for InFuse. Failure to warn and design defect claims are preempted, id. at *13-14, *17-19.  We will point out that this is another court that understands that the FDA approves devices, not “specific uses” of devices.  Id. at *18.  More importantly, Byrnes is also another outright rejection of our least favorite InFuse case, Ramirez, and points out the poor logic of that ruling.  Id. at *18-19.

Continue Reading Let’s Talk InFuse

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

Most of our reports on the InFuse litigation have been positive — credits rather than debits.  Last week, we had to move to the other side of the ledger and report on case that in our belief was definitely lacking.  But that one case was hardly enough to unbalance the account.  And just a few days later, three new decisions came down pushing the InFuse Litigation even further into the pink.

For a full accounting, you can examine our InFuse posts here.  We won’t reiterate all that has come before, but overall plaintiffs have met with very limited success in their attempts to use allegations of off-label promotion and/or use to get around the dual protection afforded by PMA express preemption (Riegel) and implied preemption (Buckman).  As today’s post demonstrates, the overwhelming defense wins are not going unnoticed by either federal or state court judges.

These latest InFuse wins come from the Western District of Michigan – the companion cases of Wright v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7681 (W.D. Mich. Jan. 23, 2015) and Thorn v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7687 (W.D. Mich. Jan. 23, 2015) – and Florida state court – Buccelli v. Mayer, No. 2014-CA-001667 NC, slip op. (Fla. Cir. Ct. Jan. 27, 2015).

Continue Reading InFuse Litigation Still In the Pink