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

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

Today’s case gives us a lesson and a laugh.  The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes.  The laugh comes from watching plaintiff lawyers invoke preemption [!] to keep frail claims alive.  The case is Small v. Amgen, Inc., et al., Case No. 2:12-cv-476 (M.D. Florida Sept. 25, 2015).  You can read the slip opinion here.  The plaintiff claimed that Enbrel, which she was taking to treat her rheumatoid arthritis, eventually caused her to suffer from a diverticulitis infection.  Before we get to the matters at hand in this opinion, we learn that the court had earlier dismissed claims for negligence per se and negligent failure to test or inspect.  That’s a nice start.  [These earlier decisions in the Small case were mentioned here and here.]  Now the defendants moved for summary judgment on the remaining claims, arguing that they were barred by the learned intermediary doctrine.

The Small case looks like it should be a big problem for the plaintiff, since the Enbrel package insert identified infections as a primary risk.  The defendants also distributed an FDA-approved medication guide that warned patients of the risk of serious infection.  Moreover, before starting her Enbrel treatment, the plaintiff was given a consent form that warned of “life-threatening infections.”  The plaintiff attempted to vault past these inconvenient facts by pointing out that there were no warnings that Enbrel could cause “asymptomatic serious infections,” and that the defendants failed to school doctors and patients “on how to mitigate and manage the risks associates with the use of Enbrel.”  None of that should matter, because the treating doctor was very knowledgeable and testified that any of this new information would not have changed her mind about prescribing Enbrel. Under the learned intermediary rule (Florida is not one of those screwy states that abrogated the learned intermediary rule or cobbled together a silly exception), the failure to warn claims should fail.


Continue Reading M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

This is from the non-Dechert side of the blog.

We do not write too often about tobacco decisions. While FDA has added a Center for Tobacco Products and there are still lots of cases against tobacco manufacturers, we are more likely to talk about some consumer protection or preemption issue from a food case than any issue from a tobacco case.  Rather than discussing the reasons why we typically ignore the tobacco cases in our nearly never-ending search for bloggable cases, we will say what interested us in Berger v. Philip Morris USA, Inc., No. 3:09-cv-141567 (M.D. Fla. Apr. 23, 2015).  First, the decision is a grant of a post-trial motion for partial judgment after essentially the same motion was denied without prejudice at the end of the plaintiff’s case.  For readers who have not gone through this particular emotional roller coaster, it can be analogized to watching your playoff basketball or hockey team be up three games to two, fail to clinch the series in game six, and then take game seven.  You were sure that your team would lose game seven after the earlier missed opportunity.  Then, your relief at the ultimate win is somewhat tempered by the thought that you could have avoided significant progress toward an ulcer. Still, this is much better than taking the loss.  Ask any Caps fan.  Second, it involved a verdict of more than $20 million going away.  And, third, it involved the issue of the plaintiff’s reliance on representations by the defendant—representations that the court had no trouble characterizing in the most damning ways.  Going back to the basic principles of tort law—Palsgraf, anyone?—even decades of an industry-wide “disinformation campaign” does not create liability unless it can be tied to the plaintiff’s use of the product.


Continue Reading Fraud In The Smoke Will Not Do

A pharmacy case from Florida caught our eye this week.  We still have fresh in our minds the survey that Bexis posted a few days ago of state laws limiting the liability of non-manufacturing sellers of prescription medical products.  It was an impressive collection, as Bexis-prepared surveys tend to be, and it covered the potential liability (or lack thereof) of distributors, suppliers, pharmacies, etc.  You know, anyone in the chain who did not manufacture the drug or device and who typically would have no role in developing the product or its warnings. It comes up a lot for us in the context of removal jurisdiction, where plaintiffs fraudulently join local or non-diverse defendants in an attempt to prevent removal to federal court.  The plaintiffs never—and we mean never—actually pursue claims against the local defendants, and we routinely resist their motions to remand cases to state court with arguments that there are no viable claims against mere pass-through sellers of pharmaceutical products and medical devices.

In this regard, the result in Oleckna v. Daytona Discount Pharmacy, No. 5D13-3057, 2015 WL 477841 (Fla. Dist. Ct. App. Feb. 6, 2015), is not helpful because it allows negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written.  In Oleckna, the patient was being treated for stress, and his doctor prescribed Xanax and narcotic pain medication over a period of two years.  Id. at *1.  The patient, sadly, died allegedly “due to combined drug intoxication” of the prescribed medications, and his estate sued the physician who wrote the prescriptions and a pharmacy who filled many of them—allegedly more than 30 prescriptions.  Id. 


Continue Reading Florida Court Races to Questionable Conclusion on Pharmacy Liability

This post strays from our usual posts in a few respects.  First, it is about a Florida state intermediate appellate court opinion in a slip and fall case.  You will not find us posting on many of those.  Second, while we do post on discovery issues, it is usually about the scope of discovery that can be pursued against drug and device manufacturers.  This is about discovery on the plaintiff, which is less common (but not unique).  Third, and most significantly, this is about social media, specifically something called “Facebook.”  We understand that many, many people who are young, social or both—we (in the singular form of that pronoun sometimes utilized in our posts) are neither—spend quite a bit of time with their Facebooking.  Indeed, this Facebook thing is so popular that it has taken on several verb forms.  Based on our research, but not personal experience, many spend large parts of their waking time updating their “friends” (as the term is used broadly) on details of their life, reviewing posts/updates from others, and adding value to society by “liking” or commenting on what others have posted.  Sometimes, these Facebookers post photographs of themselves doing all sorts of things, including things that rational people might not memorialize through digital photography, let alone share with others through a medium where everything pretty much lasts forever.  Some of these photo-posting Facebookerists happen to be plaintiffs in civil litigation.  Hence, this post.

Continue Reading A Day In The Real Life Of A Facebooking Plaintiff