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

Looking back on the blog, the last time we posted about the Pelvic Mesh MDL was this summer when we lauded a remand judge for not allowing plaintiffs to expand their expert reports to include opinions already excluded by the MDL judge. At that time we commented briefly on the uncertainty that accompanies remand. That decision was a positive post-remand development. Today’s decision is the flip side. Remand gone awry and unfortunately, affirmed by the Eleventh Circuit.

The decision is captioned Eghnayem v. Boston Scientific Corporation, 2017 U.S. App. LEXIS 20432 (11th Cir. Oct. 19, 2017) and is actually a consolidation of four plaintiffs’ cases. The cases all involve Florida residents and were consolidated and remanded from the MDL in the Southern District of West Virginia to the Southern District of Florida. Id. at *3. The remand court proceeded to try the 4 cases together over defendant’s objection. After almost identical multi-million dollar verdicts were entered for each plaintiff, defendant appealed.

The primary grounds on appeal were the improper consolidation of the cases for trial and the exclusion of evidence of FDA clearance. The Eleventh Circuit said both decisions by the district court were not an abuse of discretion. Interestingly while the court found limiting instructions were sufficient to overcome the prejudice of the multi-plaintiff trial, it also found that limiting instructions would not have cured the prejudice that would have resulted if the FDA clearance had been admitted into evidence. That’s a bit of plaintiffs getting to have their cake and eat it too.

We posit there is only one reason for consolidating trials of more than one plaintiff in a tort case not involving a common accident – to prejudice defendants. Plaintiffs argue consolidation saves time, but is there any proof to back that up? It certainly creates a host of appellate issues that clearly take more time. Plaintiffs in Eghnayem offered testimony from 25 witnesses at trial. Largely, testimony of individual plaintiffs and their individual physicians which have no relevance to the claims of the other plaintiffs. Id. at *7. Testimony that confuses juries with different plaintiff-specific facts and frankly invites juries to reach improper conclusions, such as all these people wouldn’t be suing unless something was wrong.

Defendant, of course, raised all these prejudicial concerns which the trial court and the appellate court believed could be swept away by “expressly instruct[ing the jury] to consider each plaintiff’s claims separately.” Id. at *12. How exactly a juror is supposed to do that is unknown and feels almost impossible. But the appellate court went even further and presumed that “even had the cases not been consolidated, the plaintiffs would likely have been able to submit evidence of other patients with similar injuries.” Id. at *15. Evidence of adverse events or clinical trial events may be admissible as to notice – but in a severely more limited way than when 4 distinct claims and injuries are litigated fully to the same jurors.

For example, one plaintiff had “graphic images” showing her removed mesh and the tissue that was removed along with it. The Eleventh Circuit concluded that sometimes graphic evidence is particularly helpful. Id. at *17-18. And it might well be – for that particular plaintiff. But to conclude that those images would have been admissible as to the other 3 plaintiffs borders on inconceivable.

What about evidence that post-dated some of the plaintiffs’ implantations. Where drug or device usage occurred at varying times, one of the many problems of consolidation is that defendants are deprived of the state of the art defense and exposed to improper admission of subsequent remedial measures. The result is a “perfect” plaintiff’s case being tried, with all plaintiffs able to rely on all evidence relevant to anybody, regardless of differences in time and place. The Eleventh Circuit agreed with defendant that post-implant evidence couldn’t go to notice in those cases, but it may be relevant for some other reason and therefore, limiting instructions over exclusion was the proper course. Id. at *19. But it is a course that wouldn’t be necessary if the cases were tried individually.

Finally, defendants argued that the similarity in the damage awards – almost identical – is evidence that the jury was confused; unable to distinguish between and among the plaintiffs. Given plaintiffs with “different medical histories, and different treating doctors; . . . prescribed the [mesh] at different times for different conditions; and claimed to suffer different injuries, after different lengths of exposure, resulting in different treatment courses,” id. at *6-7, the uniform result isn’t a mystery, it’s juror confusion leading to a formulaic verdict. The appellate court, however, found that “similar” injuries resulting in “similar” verdicts wasn’t unreasonable. Id. at *14. But that’s just buying into the flawed premise that these claims were similar enough to try together in the first place. With that as the starting place, it is no wonder the Eleventh Circuit found no abuse of discretion.

This case highlights several of the key reasons drug and device defendants fight against consolidated trials. If you want a more in depth discussion of the topic, including cites to rulings that agree with us, check out our post here.

There was one other significant issue on appeal. The district court excluded all evidence of the device’s 510k FDA clearance. This isn’t the first mesh case to reach this conclusion. See our post on the issue here discussing a post-remand case that made a better call by allowing the evidence albeit with a strong limiting instruction. While not perfect, that decision is certainly better than the Eleventh Circuit finding that 510k clearance “has no relevance to the state law claims.” Id. at *22. Or its decision that admitting the evidence would have been unnecessarily time-consuming and led to jury confusion on core issues. Id. at *23. We would disagree with those conclusions anyway but find them particular hard to swallow where the same court concluded that a multi-plaintiff trial wasn’t unduly prejudicial or confusing. We are in fact confused as to how a jury instruction regarding what the 510k process is and is not would not be curative, but a limiting instruction that the jury “may not even consider the fact that there’s more than one case being brought” alleviates the myriad of prejudices a multi-plaintiff trial visits upon defendants.

Implied Preemption.  Off-label promotion. TwIqbal.  They make up a core of our posts, yet we never seem to tire of them.  Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant.  Today’s case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant’s sublingual spray prescription painkiller drug, which she had started the day before.  Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing.  Calling it “negligent marketing” does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted.  The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff’s decedent, as opposed to the approved indication for breakthrough pain with cancer.  While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway.  These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink (here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption.  Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted.  As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis.  It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection.  Instead, it assumed that the off-label promotion alleged violated the FDCA’s prohibition on misbranding.  2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff’s claim was so squarely focused on alleged violations of the FDCA.  Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA.  The Markland plaintiff, however, labeled the defendant’s alleged conduct as violating the FDCA, “federal law,” and “requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain.” Id. at *9.  “Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant’s] alleged off-label promotion of [the drug]” and “the very concepts of off-label use and off-label marketing are born out of the FDCA.” Id.   This was well phrased, as was the later statement that “it is only because of the existence of the FDCA’s restrictions on off-label marketing that Mr. Markland claims [defendant’s] actions were improper or otherwise violated a duty.” Id.

This is the recipe for implied preemption under Buckman.  It also means there is no negligence claim under Florida law, “which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations.” Id. at 10 (citing negligence per se cases).  Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as “critical element[s],” which should prevent such piggybacking.  So, plaintiff’s case was done and could not be revived by amending the complaint.  In other words, there was no need for a second and third strike before judgment could be entered.  This was so despite the Court’s expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11.  This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

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

We understand that illnesses and injuries can be emotional; sometime extremely emotional and rightfully so. We understand that some treatments can add to the stress. We certainly understand that when a treatment results in complications or does not turn out as hoped, an already tense situation can become intense. We don’t deny the “personal” side of personal injury cases. But drug and device products liability cases are not infliction of emotional distress cases. Which is what the court found in Ripple v. Davol, Inc., 2017 U.S. Dist. LEXIS 82867 (S.D. Fla. May 31, 2017).

Plaintiff brought most of the standard products liability causes of action – negligence, strict liability, failure to warn, breach of implied warranty, negligent misrepresentation, and fraud – but also included claims for both intentional and negligent infliction of emotional distress.  Id. at *2. The court dismissed the warranty claim for lack of privity, id. at *10-11, and misrepresentation and fraud for failure to satisfy the heightened pleading requirement. Id. at *11-13.

On infliction of emotional distress, the court explained that under either an intentional or negligence standard, plaintiff has to allege “conduct so outrageous in character, and so extreme in degree, as to go beyond all possible bounds of decency, and to be regarded as atrocious, and utterly intolerable in a civilized community.” Id. at *7 (citations omitted). Just read that again and let it sink in. We think it is immediately apparent that such a claim does not belong in a drug or medical device case. We are talking about products that had to be approved by the FDA before being sold and the levels of testing, analysis, monitoring, and reporting that goes along with that. Satisfying all the FDA requirements and then marketing a medical device that can only be obtained via a licensed surgeon who must also implant the device is hardly an atrocity that would offend the bounds of decency.

Plaintiff’s only response was that her infliction of emotional distress claims were based on defendant’s failure to properly test or properly design the device. Id. at *8. The opinion contains citations to the type of conduct that does rise to the “utterly intolerable” level and the horrors described even briefly in the parentheticals make it abundantly clear that failure to test/design doesn’t even come close. Id. at *8-9.

If plaintiff’s allegations were sufficient, “any manufacturer who is liable for strict products liability or negligence is also liable for the infliction of emotional distress upon those damaged by the product.” Id. at *9. An infliction of emotional distress claim cannot be solely premised on ordinary products liability and negligence. It must involve a degree of “physical contact” or “severely threatening behavior.” Id. at *10. Neither of which is present in this case or in any drug/device case (at least that we can think of). With no supporting case law and no supporting facts, the court dismissed the claims with prejudice.

We don’t see a lot of infliction of emotional distress claims in this arena, probably for the very reasons discussed in Ripple. But the court’s explanation for why these claims are not viable is among the best we’ve seen.

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not certifiable.  Anyway, continuing in the tradition of unusual, pro-plaintiff results from the Florida Supreme Court (but not necessarily the district courts of appeals), we have two more to discuss.

First, since we blogged about the preemption result in Charles v. Southern Baptist Hospital, Inc., 178 So.3d 102 (Fla. App. 2015), we feel we ought to warn you that the favorable preemption decision was reversed late last month by the Florida Supreme Court.  Charles v. Southern Baptist Hospital, Inc., ___ So.3d ___, 2017 WL 411333 (Fla. Jan. 31, 2017).  Basically, the court held that the provisions of the federal Patient Safety and Quality Improvement Act (“PSQI”), didn’t preempt (expressly or impliedly) an unusual Florida constitutional provision (called “Amendment 7”) granting patients (read:  plaintiff lawyers) access to “adverse medical incidents” – even though these incidents were compiled and provided to PSQI evaluation committees in accordance with the statute.  Anything that had been initially created for any other purpose couldn’t qualify as protected “patient safety work product” under the PSQI.  2017 WL 411333, at *8.  The statute provided:

Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.

42 U.S.C. §299b-22(a)-(b).  Tort litigation was not mentioned in subsection (c), but the court in Charles grabbed a “rule of construction” from elsewhere in the statute, and used that to create an exception to confidentiality that Congress has not seen fit to create in subsection (c).  Charles has a lot of mumbo-jumbo about not reading statutes in “isolation” and giving “every portion” meaning, 2017 WL 411333, at *4-5, but none of that can hide that the decision ignored the “notwithstanding any other provision” language and used something other than “subsection (c)’ to create a huge hole in confidentiality that Congress did not authorize.

That’s one.

In In re Amendments To Florida Evidence Code, ___ So.3d ___, 2017 WL 633770 (Fla. Feb. 16, 2017), the same court showed the same lack of respect for the state legislature that Charles had shown to the United States Congress.  In 2013, the legislature passed a statute to replace the prior Frye-based analysis of expert testimony with that of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  2017 WL 633770, at *2-3.  In re Amendments refused to amend the Florida Rules of Evidence to comply with this legislative directive.  This result followed a narrow 16-14 vote to that effect by a rules committee (no doubt packed, like Pennsylvania’s, with plaintiff-side members).  Id. at *1.

The reason for refusing to follow the Legislature’s directive was as bizarre as Engle – that Daubert may well be unconstitutional:

[T]he Committee and commenters who support the recommendation raised what we consider “grave constitutional concerns.”  Those concerns include undermining the right to a jury trial and denying access to the courts.  While the Court does not address the constitutionality of a statute or proposed rule within the context of a rules case, the fact that there may be “grave concerns about the constitutionality of the amendment” has been a basis previously for the Court not adopting an amendment to the Evidence Code. . . .  [W]e decline to adopt the Daubert Amendment to the extent that it is procedural, due to the constitutional concerns raised, which must be left for a proper case or controversy.

In re Amendments, 2017 WL 633770, at *3.  The court cited no precedent at all for this jaw-dropping proposition.  Daubert – a United States Supreme Court decision – has been around, now, since 1993.  The Federal Rules of Evidence (Rule 702) have been amended to conform to Daubert.  As the dissent points out, no court anywhere has ever declared Daubert unconstitutional before:

[T]he United States Supreme Court decided Daubert in 1993, and the standard has been routinely applied in federal courts ever since.  The clear majority of state jurisdictions also adhere to the Daubert standard.  In fact, there are 36 states that have rejected Frye in favor of Daubert to some extent.  Has the entire federal court system for the last 23 years as well as 36 states denied parties’ rights to a jury trial and access to courts?  Do only Florida and a few other states have a constitutionally sound standard for the admissibility of expert testimony?  Of course not.

In re Amendments, 2017 WL 633770, at *6 (dissenting opinion).  The dissent cited two cases directly rejecting this sort of constitutional challenge to Daubert. Id. (citing Junk v. Terminix International Co., 628 F.3d 439, 450 (8th Cir. 2010), and E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 558 (Tex. 1995)).  That’s two more cases than the majority cited.  It’s also probably the tip of the iceberg.  The relevant West keynote for Junk is #24, and for Robinson is #8.  According to Westlaw, these two keynotes, between them, have been cited by 97 other cases.

We agree with the dissent in In re Amendments – the proposition that, after a quarter century, Daubert is unconstitutional is absurd.

Not only absurd, but utterly unsupported by precedent.

Fish rot from the head, and there is currently something very rotten in the State of Florida.

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude come from Germany or Florida.  Callers describe News of the Weird headlines, and Carolla and guests try to guess whether the events happened in Germany or Florida.  You can listen to this segment from the old Loveline radio show.

Here are some examples of “Germany or Florida” clues:

  1. Man ate his dog.
  2. Carjacker forced to flee after realizing he could not drive a stick-shift.
  3. Trio shoots at imaginary foe, thereby attracting police to their homegrown meth lab.
  4. Naked swimmer hospitalized after angler hooks his penis.
  5. Man dies after blowing up condom machine.
  6. Sister assaults twin over sexy toy.
  7. Government creates blatant ex post facto law depriving tobacco companies of basic tort defenses.

Okay, you probably know about that last one.  The answers to the others are below.  By the way, Carolla is not alone in identifying The Sunshine State as also being The Sublimely Strange State.  30 Rock had a running gag about Florida craziness.  See examples here.  Also, Seth Meyers on the Late Show runs a “Fake or Florida” bit that can, at best, be charitably labeled as being derivative of Carolla’s gag.  On last Sunday’s Last Week Tonight, John Oliver reported a story about a Florida man who planned to bomb Target stores up and down the east coast, with  the idea of buying up Target stock on the cheap afterwards.  After pointing out how the story involved home-made explosives, a big box store, and a terrible get-rich-quick scheme, Oliver noted that if the story also had a snake on meth, we would have full-on Florida Bingo.

Even before we earned our law license, we were aware that there is something … different … about Florida’s legal system.  In our law school library, you could pull the 12 So. 2d volume off the shelf and it would automatically open up to the Lason v. State case, in which the Florida Supreme Court upheld the conviction of a 76 year old man for “abominable and detestable crimes against nature.”  Some law school libraries have needed to insert photocopies of the Lason case after the original pages were worn out completely.  Good times.

Last week there was a mini-eruption of Florida case law, and we will cover some of those opinions this week.  It is not quite Shark Week for our blog, but it is close.  Today’s case, Wolicki-Gables v. Doctors Same Day Surgery, Ltd., 2017 WL 603316 (Fla. DCA 2d Feb. 15, 2017), is unusual.  The case is ostensibly about spoliation, but it is really about preemption and the dreaded parallel claim exception.  Luckily, the case comes out the right way.  But getting there was like doing a couple of laps on Mr. Toad’s Wild Ride. (You didn’t think you were getting out of this blogpost without at least one Disney World reference, did you?)

Mrs. Wolicki-Gables claimed a physical injury from a failed pain pump system.  She and her husband initially sued the manufacturer of the pain pump, alleging causes of action for strict liability and negligence.  The case was filed in state court, but was then removed to federal court.  The pain pump system had received pre-market approval from the FDA.  Because of that fact, and because of the Supreme Court’s decision in Riegel, the federal court held that the Wolicki-Gables’ product liability claims against the manufacturer were preempted by federal law.  The Eleventh Circuit affirmed the summary judgment in favor of the manufacturer.

Continue Reading Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.

Continue Reading Heeding Presumption Only Goes So Far In Post-Sale Warning Case

In his poem “To Summer,” Blake begs the season to “curb thy fierce steeds, allay the heat/That flames from their large nostrils!”  That is typical Blake; he takes our favorite time of the year and turns it into a satanic beast.  We’d prefer to consider the delightful aromas that Summer brings to our nostrils: beach, fresh cut grass, BBQ, citronella, funnel cakes, empty courtrooms, etc.  Plus, if we believe the Seals and Crofts song “Summer Breeze,” the scent of jasmine is out there.  Summer is redolent of youth and hope.

Sometimes we get the sense that the sense of smell does not get its due.  We are taught that seeing is believing.  McCartney sang, “Listen, do you want to know a secret?”  Morrison insisted, “C’mon, c’mon, c’mon and touch me, babe.”  It took us a moment to think of any olfactory songs, but there are more than you might suspect.  Primus inter pares, of course, is Nirvana’s “Smells Like Teen Spirit.”  A mellow Mac Davis asked his fans to “Stop and Smell the Roses.”  Lynyrd Skynyrd rocked out to “That Smell.”  Todd Rundgren might have been floating in that ocean of cash he got from producing Bat Out of Hell when he wrote “The Smell of Money.”  And what was the reason for the great guitarist Buddy Guy’s fixation on all things nosey?  His huge catalog of classics includes “I Smell Trouble,” “I Smell a Rat,” and “Smell the Funk.”  Does all that Chicago blues stinkiness have anything to do with the fact that the name “Chicago” comes from an Indian word for a malodorous onion?   [Meanwhile, expect the Abnormal Use blog to issue a challenge about which roster of legal geeks can come up with more smelly songs.  Hey, Dedman, we’re waiting.]

A lawyer friend of ours who was born without a sense of smell reports that she considers it a blessing.  She reasons that when people mention smells, they (like Buddy Guy) are usually not happy about it.  There is more fetor than perfume in the air.  But, clearly, not everyone agrees with this opinion.

Today’s case, Bunin v. Matrixx Initiatives, Inc., 2016 WL 3090777 (Fla. 4th DCA June 1, 2016),  was brought by a plaintiff who alleged that she had lost her sense of smell from using a nasal spray. Loss of the sense of smell is called anosmia.  She brought her case in Florida state court in 2009, and brought in an expert to testify that the nasal spray was what caused the plaintiff’s anosmia.  The issue was whether that expert’s opinions would be tested by Florida’s old expert standard, which existed when the case was filed, or the new test, patterned after the federal Daubert test, which had been enacted by the Florida legislature in section 90.702 of the Florida statutes in 2012 — after the case had been filed.  In other words, the issue was whether Florida’s adoption of the Daubert test would have retroactive effect.   Retroactivity mattered in this case, because the trial court held that the plaintiff expert’s opinions would have been admissible under the old test (the court referred to a “pure opinion” rule, which sounds loosey-goosey), but not under the new Daubert test.

The appellate court held that the test for retroactivity is “well-settled.” Procedural or remedial statutes are to be applied retrospectively and are to be applied to pending cases.  More specifically, a statute “that merely ‘relates to the admission of evidence’ is generally considered procedural.”  Applying this rule, “Section 90.702 of the Florida Evidence Code indisputably applies retrospectively.”  That makes sense.  After all, no matter what the expert test is under any state law, if the case is in federal court, the Daubert test (and Fed. R. Evid. 702) will apply.  That is because the standard for admitting expert evidence is procedural.  If it were substantive, we’d be talking about Erie.

Once the appellate court decided that Florida’s version of Daubert applied, it wasted little time in affirming the trial court’s exclusion of the plaintiff expert.  There was no abuse of discretion.  Without the expert causation opinion, the case was not viable.  Accordingly, it was dismissed.

We’d say that the Florida Bunin opinion passes the smell test.

Last November we blogged about “specialized” preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a metal-on-metal hip replacement. What made the Mink case unusual was that the plaintiff had been a clinical trial participant. Thus, in addition to the usual product liability personal injury claims, the plaintiff also challenged the early termination from the clinical trial, calling it a breach of contract. The hip replacement system had made it through the FDA’s rigorous Pre-Market Approval (PMA) process, and the court dismissed the plaintiff’s claims because, as summarized in our deathless prose, “participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.”

The plaintiff was afforded an opportunity to amend the complaint, and did so by adding much specificity as to how the medical device allegedly deviated from manufacturing and regulatory requirements. The claims at issue were: (1) negligence, (2) strict liability, (3) breach of contract, and (4) misrepresentation. But the result was no different: the court still dismissed the claims. Check that; the result was different. This time the dismissal was with prejudice. That decision is Mink v. Smith & Nephew, Inc., 2016 U.S. Dist. LEXIS 32519 (S.D. Fla. March 11, 2016), and some of the court’s prose, as well as its reasoning, is pretty deathless, too.

Continue Reading Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

Today is Veteran’s Day.  This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement.  It is a federal holiday, but most of us go about our usual business. Too bad. The holiday was originally designed for parades and gratitude.   Veteran’s Day was Monday-ized between 1968-75, but right-minded people with a sense of history insisted that it be restored to traditional, date-specific status.  Veteran’s Day is celebrated on November 11 because that is the anniversary of the World War I armistice.  In 1918, the guns went silent on the eleventh hour of the eleventh day of the eleventh month.  The meaning of that date is more important than creating yet another three day weekend to encourage folks to travel and spend.  Odds are that you know of someone in your own family history who served this country in time of war.  Maybe there is a legend about a great-great grandfather who huddled in Flanders’ fields in the Great War.  Or a Marine who hit the beach at Iwo Jima.  Or a soldier who flew helicopters in Da Nang but never wanted to talk about it.  Or a college roommate who is grateful his time over in the sandbox was relatively short.  Or a friend in the reserves who just last month was called to Afghanistan to help move some hardware home.  Maybe you had a big lump in the throat when you shook hands good-bye.

Thanksgiving is three weeks away, but today is also a day for thanks.

President George H.W. Bush is a veteran.  He was a navy aviator in World War II.  On September 2, 1944 Bush piloted a Grumman TBM Avenger plane that attacked Japanese installations on Chichijima.  Bush’s aircraft was hit by flak and his engine caught on fire. Nevertheless, Bush finished the mission and released bombs over his target, scoring several damaging hits. With his engine ablaze, Bush flew several miles away from the island, where he and one other crew member bailed out.  The other man’s parachute did not open. Bush waited for four hours in a raft,  until he was rescued by the lifeguard submarine USS Finback.  According to Bush, while he floated in the Pacific, not knowing for sure whether he would make it, he thought about many things, including the Bill of Rights.  Some ridiculed that story, but are we really so cynical as to discount the possibility that someone contemplating  what they were fighting for might think it right and even a little noble to be on the side that favors freedom of speech?  Thanks to that Greatest Generation, and thanks to all the great generations that followed who served to preserve our freedoms, including the freedoms of defense hack lawyers like us to scribble our silly blogs.

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Today’s case actually has something to do with freedom of speech.  It is an off-label/first amendment speech with a twist – the plaintiff doctor sued a writer for criticizing his off-label use of a drug.  The action was brought under both the Lanham Act and Florida common law.  The issue was whether the speech in question was the type of commercial speech that might be susceptible to such claims (with all the requisite balancing) or whether it was noncommercial speech that was immune from attack.  In Tobinick v. Novella, 2015 U.S. Dist. LEXIS 150083 (S.D. Florida Sept. 30, 2015), the court decided that the speech at issue was not actionable under the Lanham Act because it is not commercial speech, and that the Florida unfair competition claims failed as well because they rely on a similar theory of liability.

Continue Reading Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

It’s not often that we get to blog about a new area of federal preemption, but we do so today.  This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product liability litigation to the extent that it affects our client’s customers – hospitals and prescribing physicians.

We’re talking about a statute called the “Patient Safety and Quality Improvement Act” (“PSQIA”).  It was passed as part of HIPAA amendments in 2005 to create reporting systems for medical errors, so that such errors could be analyzed and the analysis used to prevent future medical errors.  That’s all well and good, but we know how plaintiffs’ lawyers are anytime anything adverse has to be reported – and, more importantly, so did Congress.  Just as FDA adverse event reporting is protected, 21 U.S.C. §360i(b)(3) (reports inadmissible); 21 C.F.R. §20.63(f)(2) (discovery of reports preempted), so too is peer review reporting under the PSQIA.

This information – data generated by reporting and analysis of medical errors – is called “patient safety work product” (“PSWP”).  The PSQIA provides that it is privileged and confidential:

(a) Privilege

Notwithstanding any other provision of Federal, State, or local law . . ., patient safety work product shall be privileged and shall not be. . . .

(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding. . .;

(3) subject to disclosure pursuant to section . . . the Freedom of Information Act[] or any other similar Federal, State, or local law;

(4) admitted as evidence in any Federal, State, or local governmental civil proceeding . . . .

(b) Confidentiality of patient safety work product

Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.

42 U.S.C. §299b-22(a-b).  Just about every state has some form of peer review privilege, and now PSQIA provides a uniform federal overlay to those
state-created protections.

Continue Reading Federal Preemption and Peer Review – A New Frontier