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Growing up down in Georgia, Bexis used the phrase “a whole lotta nuthin’” frequently when encountering things (like the 1970s Underground Atlanta tourist trap) or people (like Lester Maddox, who governed the same way he rode bicycles) that didn’t impress him much.  That’s the phrase that came to mind when we read In re E. I. du Pont de Nemours & Co. C-8 Personal Injury Litigation, ___ F.4th ___, 2023 WL 8183812 (6th Cir. Nov. 27, 2023).  Indeed, the opening sentence of the du Pont opinion was:  “Seldom is so ambitious a case filed on so slight a basis.”  Id. at 81.  And yes, du Pont was an appeal from yet another bizarrely pro-plaintiff MDL decision.

Continue Reading A Whole Lotta Nuthin’
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A few years ago, we detailed the efforts of the plaintiffs’ bar to tweak the Restatement of Torts to decrease the chance that a suit for damages would be defeated because the plaintiff engaged in a criminal act.  The Restatement (Second) from 1979 called this the Wrongful Acts Doctrine, but the concept has a long history that has resulted in many names for determining when there is or is not a bar to recovery based on the plaintiff’s criminal conduct.  We tend to lump this all under in pari delicto because lawyers like to use Latin phrases even if they do not always know what the actual Latin means.  In the context of torts related to personal injury, where many states apply some version of comparative or contributory negligence to allow a jury to assign fault by percentage, it is not hard to see why swinging too far in either direction might be a problem.  Even curmudgeonly defense lawyers like us can see why barring the recovery of a plaintiff who can otherwise make out a claim simply because she was engaging in some arguably criminal conduct at the time of the defendant’s tortious action or the resulting injury would be wrong.  At the same time, a plaintiff who was injured because he was intentionally committing a felony should be barred from recovery.  And we mean a complete bar up front, not just a piece of the puzzle at trial after the defendant is forced to choose between spending a bunch of money to work up and try the case and paying the felonious plaintiff to go away.

We do not know why, but a perusal of our “in pari delicto” topic shows we have already posted on decisions addressing this issue four times in the last two years.  We could have a morbid interest tort cases with some overlay of criminality, much like a Netflix viewer whose recommendations are filled with documentaries on serial killers, or there could be an actual uptick in blogworthy cases relating to whether criminal conduct by the plaintiff bars recovery.  It has been said that “there is no honor among thieves.”  We could add that “some plaintiff lawyers have no shame when it comes to finding someone with deep pockets to blame.”  Rhyming aside, this purported principle (perhaps, a “new saw”) played out all the way to the Pennsylvania Supreme Court in DiNardo v. Kohler, — A.3d –, 2023 WL 8102948 (Pa. Nov. 22, 2023).  We do not make light of the underlying facts of DiNardo, which include four murders committed by the plaintiff—his mother sued on his behalf, but we will refer to him as the plaintiff—while under the psychiatric care of the physician defendant.  The plaintiff confessed, pleaded guilty to four first degree homicides, and was sued for wrongful death by the families of the murder victims.  Then plaintiff sued his psychiatrist and three levels of her employers in an attempt to shift liability based on alleged malpractice in his care.  Because DiNardo was decided under the Pennsylvania equivalent of 12(b)(6), we have few facts outside of plaintiff’s allegations.  As a result, we do not know what happened with the wrongful death cases or whether there was any support for his allegations about the defendants.  In brief, the allegations were that the psychiatrist cleared him to be released from an involuntary commitment, later reduced his antipsychotic medications, and ultimately advised him to stop the medications during a session that occurred a day after the first murder and a day before the other three.  In paraphrase, the core allegation was that the psychiatrist should have known plaintiff was homicidal and prevented him from committing homicides by keeping him involuntarily committed and/or maintaining him at his highest doses of antipsychotics.  As for Plaintiff’s alleged harm, we will get to that.

If there was ever going to be a case with a bar to civil suit from the plaintiff’s own criminal acts, then this one would probably be it.  Yet the Pennsylvania Supreme Court accepted a discretionary review after the Superior Court expanded the trial court’s partial dismissal to a complete dismissal.  Less than two years ago, the Pennsylvania Supreme Court had decided another, to us, clear application of in pari delicto in a case called Albert v. Sheeley’s Drug Store, 265 A.3d 442 (Pa. 2021).  In that case, the plaintiff’s decedent alleged overdosed on a scheduled medication that was diverted by his friend, who obtained them by picking up a prescription written for his mother.  Both the decedent and his friend clearly committed felonies in connection with acquiring and possessing the scheduled medication, but the plaintiff sued the dispensing pharmacy over the overdose death for allegedly not following an instruction not to let the decedent’s friend pick up prescriptions.  The wrongful death claim in Albert was held barred.  With that recent background, one might assume that DiNardo would be a slam dunk at every level.  The trial court, however, had allowed claims for compensatory damages to proceed, while barring claims for indemnity in the wrongful death cases.  2023 WL 8102948 , *3.  Its reasoning seemed to hinge on whether the harms plaintiff allegedly suffered were, according to his allegations, caused by his criminal conduct.  By contrast, the Superior Court saw that each of plaintiff’s alleged harms—pain and suffering from committing murder, getting sued, seeing the impact on his family’s business, and going to prison for life—were because he had committed murder.  Id.

We will detour for a minute to address an elephant or two in the room.  First, even without in pari delicto or the wrongful acts doctrine, these do not seem like compensable injuries.  There is no alleged physical injury to plaintiff.  Even under a negligent infliction of emotional distress theory, there needs to be a physical impact and/or the plaintiff’s presence within a zone of danger.  Nope.  Second, the plaintiff’s guilty plea, presumably to receive a life sentence instead of the death penalty, runs directly contrary to the asserted claims and damages.  Even without claim or issue preclusion—translating a criminal conviction on a plea deal to non-mutual offensive collateral estoppel in a civil case is complicated—the plaintiff gained an advantage by admitting to a Pennsylvania court that he committed the four murders with the requisite intent.  Taking a contrary position in another Pennsylvania court should not be permitted.  Pennsylvania civil complaints are required to be verified by the plaintiff or an authorized agent, not merely signed by a lawyer, so taking a contrary position in a complaint is no less impermissible.

Back to what DiNardo actually addressed.  The question on appeal was:

Does the “no felony conviction recovery” rule preclude the award of any civil damages or relief where, as here, [Appellant] alleges that [DiNardo] would not benefit or profit from his own criminal acts, but rather would be compensated for alleged medical malpractice relating to the crimes for which he pleaded guilty?

Id. at *4.  The court embarked on a lengthy recounting of the parties’ positions and an even more lengthy dive into the jurisprudence since 1725 on the subject of bars to recovery based on criminal conduct by the plaintiff.  This included a discussion of the “no felony conviction rule” versus in pari delicto and other variants.  We will not recap, except to highlight the conclusion:

In short, our case law, while somewhat limited, firmly establishes that, under both the no felony conviction recovery rule and the in pari delicto doctrine, persons convicted of serious crimes must bear the losses stemming from their criminal acts, and, as a matter of public policy, will not be permitted to shift responsibility for these losses to others. Stated another way, injuries that flow from volitional criminal conduct cannot provide a basis for a recovery in tort.

Id. at *11.  DiNardo was far from the first time that a healthcare provider had been sued over the impacts of a patient’s criminal conduct.  Such claims had been rejected by courts in at least six other states (id.) and sound public policy supported that “injuries arising from volitional criminal conduct should not provide a basis for a recovery in tort” by the criminal.  Id. at *12.  Among the public policy reasons was that, to hold otherwise, could have “detrimental effects on the practice of psychiatric medicine.”  Id.  We can go a step further:  it would be hard to get mental health practitioners willing to treat serious mental illness if near boundless, and likely uninsurable, liability could result from their patient’s criminal acts.

After “reaffirming” the bar against actions for “damages sustained as a direct result of [the plaintiff’s] volitional participation in, and conviction for, serious criminal acts” and “losses which flowed from such acts,” the court identified three issues it was not resolving.  Id. at *13.  First, it did not address a conviction based on “less than intentional,” including a conviction for “guilty but mentally ill.”  Second, it did not address what happens without a conviction.  Third, it did not address “less serious crimes” than first-degree murder.  Of course, the same court in Albert had barred a suit where the plaintiff’s decedent was not convicted and his felony of possessing a controlled substance without a prescription (and perhaps conspiracy to obtain same) was less serious than first-degree murder.

Applying the above rule to the DiNardo complaint and the facts of plaintiff’s conviction that the complaint had omitted, plaintiff had clearly been convicted of, and admitted to, “volitional participation in . . . serious criminal acts.”  Id. at *14.  In addition, every claimed “damage” or “loss” in the complaint “flow[ed] from the murders to which DiNardo pleaded guilty.”  Id.  Semantics over whether the relief sought in the suit would be “damages” or “benefits” to him were unavailing, well, semantics.

Whether DiNardo will make it more difficult for a plaintiff to sue over injuries sustained by taking a prescription drug that was obtained through the commission of a felony remains to be seen.  On its face, the bar for applying a bar has not moved much.  What has been emphasized, however, is the need for courts to look beyond creatively drafted complaints and omissions of allegations about the plaintiff’s own criminal conduct to dismiss barred claims up front.

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We generally keep our distance from medical cannabis/marijuana.  We’re not one of those blogs.  But if legal holdings of interest to us happens to involve cannabis, we will comment.  Thus, we bring you Schmidt v. Schmidt, Kirifides & Rassias, PC, ___ A.3d ___, 2023 WL 7502499 (Pa. Commw. Nov. 14, 2023), holding that the cost of legal, physician-prescribed medical marijuana is legitimate medical expense reimbursable through the Pennsylvania Worker’s Compensation system, notwithstanding such products’ complete lack of FDA approval.

The claimant had switched to a type of prescription medical marijuana (cannabinoid (“CBD”) oil) and away from the opioid drugs he had previously been taking for a work-related injury.  Id. at *1-2.  However, the employer “refused to reimburse Claimant’s out-of-pocket CBD oil expenses on the basis that CBD oil is not a pharmaceutical drug.”  Id. at *2.  The administrative law judge found that this treatment with medical marijuana was medically appropriate, and the fact that it was available over-the-counter did not exclude it from coverage.  Id. at *3-4.

However, the board that oversees Pennsylvania’s workers’ compensation program reversed, holding that FDA warning letters concerning this product precluded reimbursement:

Based on the stated position and recent actions of the FDA, an insurer or employer cannot be required to pay for cannabis or cannabis-derived products . . . .  Therefore, Employer’s failure to reimburse Claimant . . . is not a violation of the Act. . . .  Finding a violation here is concomitant to compelling an employer to violate federal law.

Schmidt, 2023 WL 7502499, at *5 (citation and quotation marks omitted).

On further appeal, the Pennsylvania Commonwealth Court (an intermediate appellate court with jurisdiction over, inter alia, administrative appeals) reversed.  That the medication was purchased OTC did not matter.  Rather,  the “Claimant need only show that CBD oil is a medicine or supply.”  Id. at *12 (citation omitted).  These terms were not limited to prescription-only products:

[T]he term “medical supplies” is defined as “[a]ny item that is essential for treating illness or injury.”  Here, [claimant’s physician] prescribed CBD oil to Claimant to treat his pain.  The CBD oil has benefitted Claimant’s well-being by reducing his pain, eliminating his need to increase the use of highly addictive opioid medications, and forestalling expensive and risky surgery. Accordingly, CBD oil fits within the definitions of “medicines” and “supplies.”

Schmidt, 2023 WL 7502499, at *14 (citations and footnote omitted).  Further, resolution of issues like OTC status was within the scope of independent “utilization review” (“UR”)  − a statutory “remedy” that the employer had failed to seek.  Id. at *15.  Finally, given the Worker’s Compensation Act’s “humanitarian objectives,” if the act was to be construed to bar reimbursement of OTC products, that would require legislative action.  Id. at *20.

FDA non-approval of medical marijuana likewise made no difference.  “FDA approval of a treatment is not a requirement under the Act.”  Id. at *21  “[W]hether a treatment is FDA approved for a particular purpose should be raised within the framework of the  UR process.”  Id. at *15.  Having legalized medical marijuana, Pennsylvania was under no obligation to follow FDA limitations on what was medically reimbursable.  “[T]hat some firms marketing CBD products may violate federal law . . . does not make Claimant’s use or Employer’s reimbursement for CBD oil illegal.”  Id. at *17.  Nor did marijuana’s continued illegality under federal law make employer reimbursement somehow “illegal.”  All the employer was required to do was pay money for medical treatment found “reasonable and necessary” under Pennsylvania’s workers’ compensation scheme:

Since the employer is not prescribing marijuana, but rather reimbursing the claimant for his lawful use thereof, the employer is not in violation of federal law. . . .  Because the employer would not be in violation of federal law by reimbursing the claimant for his lawful medical marijuana use, and the [administrative judge] concluded that the medical marijuana use was causally related to the work injury, the employer is required to reimburse the claimant for his out-of-pocket costs under the [Workers’ Compensation] Act.

Schmidt, 2023 WL 7502499, at *18 (citations and quotation marks omitted).  FDA non-approval did not matter where a cannabis product “is lawfully sold over the counter in Pennsylvania and all over the United States.”  Id. (citation and quotation marks omitted).

We’ve stated numerous times that state law, not FDA regulatory status, governs the legality of off-label use.  Schmidt is interesting to us because it goes one step beyond – medical marijuana, including CBD oil, has no FDA approval for any use.  With well over half the states having legalized medical use of cannabis, continuing federal inaction on this issue risks the FDA being left behind.

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So says the Fifth Circuit in Torrey v. Infectious Diseases Society of America, — F.4th –, 2023 WL 7890067 (5th Cir. Nov. 16, 2023).  Which joins the Second and Third Circuits in protecting scientific free speech.  Cases we discussed here and here and which support our firm belief that scientific articles are “core” speech that is fully protected under the First Amendment. 

Torrey in not a products liability case.  Plaintiffs, individuals who allege they suffer from persistent Lyme disease symptoms, brought a misrepresentation claim against the Infectious Diseases Society of American (“IDSA”) regarding guidelines IDSA published in a peer-reviewed medical journal.  Plaintiffs claim the guidelines cast doubt on how chronic Lyme disease should be treated or even whether the condition exists.  Plaintiffs allege this led to insurance companies denying coverage for chronic Lyme disease.  Id. at *1. 

Why are we interested?  Because this is not so far off from the attacks on scientific speech that we see in products liability litigation.  Attacks on methodology used.  Attacks on potential conflicts of interest due to corporate funding.  The types of attacks that should be resolved by the scientific community, not litigation.  So, we laud decisions regardless of context that support our view that nobody should be able to use litigation to sue the other side of an ongoing scientific debate into silence.

The district court in Torrey dismissed the misrepresentation claim because “medical opinions” are “not factual representations.”  Id. at *2.  The fact that other studies exist that reach different conclusions does not make the IDSA guidelines factual misrepresentations.  On appeal, the Fifth Circuit reviewed the decision de novo. 

First, the court found that plaintiffs did not challenge the premise that “merely publishing a medical opinion,” cannot give rise to liability for misrepresentation.  Id. at *3.  Rather, plaintiffs claimed that the district court failed to read the guidelines “in context.”  Plaintiffs suggested that the test should be “the perception” of the guidelines as applied by the medical community but cited no authority for that proposition.  The court in fact looked at the guidelines as a whole, finding they are explanations of medical research and knowledge citing to other published studies and clinical trials.  As opposed to plaintiffs who targeted “isolated portions” of the guidelines.  Id.

Second, plaintiffs argued that the guidelines “explain away” contradictory studies.  But that is part of the scientific process – examining and refuting contradictory evidence.  Scientific literature does “not become actionable factual representations merely because [it] disapprove[s] of studies Plaintiffs prefer.”  Id.  A difference of opinion is jut that and nothing more.

Third, plaintiffs argued that the guidelines disclaimer contradicts its opening sentence.  The opening sentence states that the guidelines are for use by health care providers who treat Lyme disease.  The disclaimer essentially says the guidelines are just that—guidelines.  They “cannot always account for individual variation among patients” and ultimate treatment decisions should be made by the treating physician.  Id. at *4.  As the court noted, it is hardly contradictory both to offer general guidance and to recognize that final treatment decisions should be left to the judgment of the treating doctor; the person who best knows the individual patient.

Finally, plaintiffs focused on two statements in the guidelines which the court quickly concluded were medical opinions:

In this context (a scientific debate over treatment options for persistent Lyme symptoms), to say that evidence is not “convincing” or that some treatment is “not recommended” is plainly to express a medical opinion. Just because Plaintiffs disagree with those opinions does not mean that IDSA is somehow liable because their doctors or insurance providers found the opinions persuasive.

Id.

With absolutely no compelling argument from plaintiffs, the Fifth Circuit joined the others in holding that scientific discourse and journal articles are protected by the First Amendment.  Ring another bell for freedom of speech.

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In prescription medical product liability litigation, both sides invest a lot in their expert witnesses.  In addition to spending time, money, and effort, we work out our legal theories with our experts, and share with them our views of the facts, both good facts and bad facts.  Thus, when the other side inveigles one of ours to switch sides – usually with the promise of a lot more money for a lot more testimony – the result can be a lot of collateral litigation.

We’ve blogged a couple of times before about turncoat experts, so the recent decision in Hawkins v. DePuy Orthopaedics, Inc., 2023 WL 7292164 (D.D.C. Nov. 6, 2023), attracted our interest.  Then we discovered that Hawkins was only the most recent of several decisions barring testimony by the same turncoat expert – one Stephen Li – due to his prior employment with the same defendant concerning product liability litigation involving the same product (and other similar products, as well).  See also King v. DePuy Orthopaedics, Inc., 2023 WL 5624710 (D. Ariz. Aug. 31, 2023); Cannon v. DePuy Orthopaedics, Inc., 2023 WL 7477903 (N.D. Ga. Aug. 16, 2023); McCoy v. DePuy Orthopaedics, Inc., 2023 WL 4551081 (S.D. Cal. July 14, 2023); but see Winkelmeyer v. DePuy Orthopaedics, Inc., 2023 WL 2974480 (W.D. Mo. Apr. 17, 2023).  We note that a couple of other decisions (both precluding Dr. Li from testifying) apparently exist, but because they are either oral or under seal, we have not seen and do not discuss them.  The plaintiffs in those cases were named Sheehy and England.

Continue Reading Wrecked on a Li Shore – The Saga of a Turncoat Expert
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We hope our loyal readers had a wonderful Thanksgiving. As you reflect on what you’re thankful for this year, we would like to suggest one more item for your list: Discounted registration to ACI’s Drug and Medical Device Litigation Conference, coming up on December 5-6. As we mentioned, the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. If you use the code D10-999-DDLB24 when you register, you’ll save 10 percent off your conference registration.

Several of your bloggers will be in attendance – look for Bexis in his usual front row seat – and we are looking forward to interesting presentations from the always-exceptional faculty of in-house counsel, top defense firms, and experienced jurists.

If you want to register, you can do so here. We look forward to seeing you in New York!

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We’ve written about Lone Pine orders many times before.  (Here and here, for example.) In brief, a Lone Pine order (so-called because that is the name of the seminal New Jersey case) requires plaintiffs to furnish medical evidence, usually in the form of an expert affidavit, showing that the plaintiff suffered from the alleged injury and/or that such injury was caused by the product in question.  Drug and device defendants frequently ask for Lone Pine orders in aggregated litigation, with the goal of getting rid of the junky part of the case inventory.  And by “part,” we are usually talking about more than half of the cases.  It’s no surprise that plaintiff lawyers hate Lone Pine orders.  Compliance puts a hurt on plaintiff lawyer pocketbooks and leverage.  Sadly, some benighted judges steer clear of Lone Pine orders, for reasons that are unclear or specious.  Many defense hacks will tell you that the best shot at getting a Lone Pine style order is to call it something else.  It’s as if the name itself is poison.  But things change once a defendant settles a big chunk of cases.  At that point, many judges will enter a Lone Pine-ish order as a form of “docket control.”  The order cuts off the tail, makes the settlement viable, and rewards the defendant for playing ball.  One cannot help but wonder why, if the order makes sense near the end of the litigation, it doesn’t make even more sense much earlier, when it could have done some real good and avoided undue litigation expense. 

In today’s case, Warman v. Livanova Deutschland, GMBH, 2023 WL 7383158 (Ohio Ct. App. Nov. 8, 2023), Lone Pine takes root in Ohio.  Warman is a one-off case, rather than the usual aggregated mass tort extortion festival, but the court’s use of a Lone Pine order is still a breath of fresh (pine aroma) air.  The plaintiff sued a device manufacturer and a hospital, alleging that he had been exposed to harmful bacteria from a heater-cooler device employed during his heart surgery. The plaintiff claimed that he developed a serious infection after exposure to the bacteria. His lawsuit bounced around among various courts and then ended up in the Hamilton County Court of Common Pleas.  Then the plaintiff lobbed a bunch of discovery requests at the defendants.  They balked.  The defendants demanded that, before revving up the discovery sadness machine, the plaintiff should come across with some proof that he had actually developed a post-operative infection and that it had some causal connection to bacteria emitted by the heater-cooler device. The trial court considered this request (the fact that it did not reject it outright was already a small victory), and paid attention to the defendants’ point that the plaintiff side should have whatever medical records needed to establish the existence of a post-operative infection. 

The plaintiff lawyer objected to the Lone Pine order, but assured the court that “I’ve got all kinds of medical records that he’s got an infection.  Do you want me to have a doctor produce a report that my client got an infection as a result of the surgery?  I can do that.”  Good, said the court, go ahead and do that.  The court gave the plaintiff 60 days to show evidence of an infection.  Those 60 days came and went and the plaintiff “had not produced an expert statement or other evidence of any post-operative infection.”  Then the trial court issued an order making further discovery contingent on production of the expert report.  The court set a status conference approximately 90 days in the future and warned the plaintiff that the plaintiff needed to produce an expert report by the status conference “or the cases will be dismissed.” 

Now picture calendar pages flipping by.  Now picture the courtroom on the date of the status conference.  Now picture an empty chair at the plaintiff counsel table.  The plaintiff lawyer did not show up and had not filed an expert report. The plaintiff lawyer had not lived up to his promise.  But the court did.  It dismissed the case.  A couple of hours later, the plaintiff lawyer filed an expert disclosure identifying an expert who would testify that the plaintiff’s exposure to the heater-cooler device during the operation placed him “at risk” for an infection.  The expert did not discuss whether the plaintiff had actually developed an infection or even whether he had suffered any unexplained negative symptoms after his surgery.  Armed with this rather unimpressive expert disclosure (truly too little too late), the plaintiff appealed dismissal of his case, arguing “that the trial court unfairly truncated discovery.”

The appellate court affirmed the dismissal. The appellate court viewed the Lone Pine order as essentially “a discovery order.” Such discovery orders are largely entrusted to the trial court’s discretion, and it was impossible to say here that the Lone Pine features of the discovery order constituted an abuse of discretion.  The court distinguished away a bad Ohio Lone Pine precedent, pointing out that the plaintiff in Warman did not argue that “he was denied access to any specific tests, documents, or other information from defendants that would have enabled his expert to substantiate whether he had an infection.”  Rather, compliance with the order was entirely in the plaintiff’s control and did not depend on any of the discovery plaintiff had requested, nor did the plaintiff ever seek to compel the discovery.  It was telling that the plaintiff lawyer utterly failed to tell how specific information in the possession of the defendants would have supplemented medical records and shown that an infection occurred: “His inability to do so suggests that the problem with filing a motion to compel was not just that it may have been met with skepticism or hostility; it was that the motion would have lacked specificity and substance.”  Further, the tardy plaintiff expert disclosure was vague and inadequate. The expert said that the infections at issue are hard to diagnose and can incubate for five to seven years.  Okay.  But the disclosure was authored more than seven years after the surgery. How can the existence of an infection still be a jump ball?  The plaintiff expert never explained how any additional information “would illuminate a diagnosis that could not be reached from the medical records alone.” 

The appellate court decided that the trial court’s stay of discovery was an appropriate exercise of discretion.  The stay was “justified by a weightier interest than efficiency.”  Rather than “rushing [the plaintiff] out the door, the court’s order guarded against a potentially frivolous claim that, although sufficiently pleaded to survive a motion to dismiss, apparently lacked basic evidentiary support.”  The defendants were not hiding any information.  The plaintiff simply did not have a case.  Because the plaintiff failed to substantiate that he had ever had the claimed infection, dismissal was appropriate. 

We offer congratulations and we offer thanks (we can read a calendar) to defense counsel, Joe Winebrenner at Faegre Drinker, for winning the appeal in this important and excellent case.

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It’s a short week, so we are going to do a short post about a short decision on a product that lasted a long time. 

An inferior vena cava (“IVC”) filter was implanted in plaintiff in 2004.  Some years later she experienced a complication, not identified in the decision, which led her to file a products liability suit against the manufacturer in June 2022 – over 18 years later.  In re Cook Medical, Inc., 2023 U.S. Dist. LEXIS 205990, at *1 (S.D. Ind. Sep. 27, 2023).  Plaintiff is a resident of Texas and had her 2004 surgery in Texas, so the court applied Texas law which has a 15-year statue of repose. 

A statute of repose sets a definitive date beyond which an action cannot be filed.  It does not matter that plaintiff’s cause of action has not yet accrued.  A statute of repose is triggered by an event like the sale of the product and establishes a bright line cutoff that extinguishes liability.  For that reason, statutes of repose are considered defense friendly.  But they typically require a significant period of time to pass.  The standard is around 10-15 years from sale or manufacturer. (Note Montana’s is only 3 years). 

And while they are usually hard and fast rules, some statutes of repose, like Texas’s, have exceptions.  Texas law provides that the 15-year statute of repose does not apply if the product is accompanied by an express warranty “that the product has a useful safe life of longer than 15 years.”  Id. at *2.  In this case, plaintiff tried to rely on language in the IVC filter’s Patient Guide that said the product was safe effective as a temporary or permanent device.  Id. at *3.  However, the Patient Guide also lists possible adverse effects such as migration of the device or perforation of the vena cava.  Read together, the Patient Guide did “not guarantee the [filter] would conform to a particular standard for the duration of [plaintiff’s] life.”  Id. at *4.  Any “warranty” that the product could remain permanently implanted was qualified by the identification of possible adverse events.  Since the manufacturer did not warrant the IVC filter had a “useful safe life” of more than 15 years, this exception did not apply.  While this may seem case-specific, it is hard to imagine any manufacturer of an implantable medical device warranting the life span of its product given all of the variables of the human body, a person’s healing capacity, a person’s compliance with medical advice, etc. 

Plaintiff next argued she qualified for the “latent disease” exception.  This exception provides that if a plaintiff is exposed to a product before the end of 15 years, that exposure caused plaintiff’s disease, but the symptoms of the disease did not manifest in a reasonably noticeable way until after 15 years had passed, the statute of repose does not apply.  Notice the word “disease.”  Plaintiff tried to argue that “disease” should be broadly interpreted to include “medical device failures.”  Id. at *5.  Not only did plaintiff have no case law to support her interpretation, but the statute also establishing the exception does not mention medical devices or the types of injuries that arise from them.  The plain language of the statue applies to “diseases resulting from exposure to a product.”  Id.  Think asbestos, lead, Agent Orange.  Not a medical device that works as intended for more than 15 years. 

Defendants’ motion for judgment on the pleadings was granted in its entirety.

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In stark contrast to the “MDL treatment” that the Valsartan plaintiffs received earlier this year, the decision in Post v. Amerisourcebergen Corp., 2023 WL 5602084 (N.D.W. Va. Aug. 29, 2023), was more mainstream.  Class certification was denied for a variety of good reasons.

Unlike the result, the Post class action allegations, were relatively unusual.  The members of the class were all patients of the same physician.  Plaintiffs alleged that “defendants” “unlawfully made payments to [the physician] to induce him to misdiagnose” them so that they were eligible for the product at issue.  Id. at *1 We’re not 100% sure, but only one of these “defendants” apparently was the product’s manufacturer.  Plaintiffs sought “the return of every payment made from every source” for this treatment – essentially, they wanted after-the-fact (Post-hoc?) free medical care.  Id.  In addition, they demanded various damages for “invasion of privacy” and “negligence,” as well as punitive damages.  Id.

And they wanted this all as a class action.

The Post reaction?  No way.

Continue Reading Post-Out Sticky Notes
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Several of your Reed Smith bloggers are making plans to be in New York on December 5 – 6 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

The good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DDLB24 when you register. You’ll save 10 percent off your conference registration.

If you want to register, you can do so here. We look forward to seeing you in New York!

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