Photo of Michelle Yeary

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

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

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That’s because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff’s claims are being dismissed again. Plaintiff’s negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff’s warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator (“ICD”) and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device’s battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won’t walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff’s manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate “the manufacturing and inspection history” of the device which in turn proved that the device “passed all quality control inspections, and complied with the FDA-imposed requirements.” Id. at *4. Defendant also established that they learned that a subset of the ICD’s were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device’s capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant’s end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn’t mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff’s theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a “prohibited-unless-expressly-authorized” theory, she’s walking herself away from a parallel violation claim. “If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily ‘in addition to’ federal requirements.” Id.  That means plaintiff’s attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff’s expert neglects to explain how the capacitors could function without it. It’s a technical argument about electrodes (and that’s not this blogger’s area of expertise) but the more general takeaway is that you can’t argue a design that is non-functional. “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect.” Id. at *7 (citation omitted).

Plaintiff’s next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. “Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a “reasonable assurance” of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That’s why they go through the heightened scrutiny and a risk/benefit analysis for approval. “If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted.” Id. The MDA and Riegel would be “dead letters.” Id.

Plaintiff’s final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that’s an irrelevant fact. “For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device’s manufacture.” Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff’s warranty claims. First, they were barred by the terms of defendant’s limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA’s conclusions. Juries can’t be allowed to “substitute their own cost-benefit analysis in place of that applied by the experts at the FDA.” Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we’ve always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

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

Today is a follow-up post on Bell v. Boehringer Ingelheim Pharms, No. 17-1153, 2018 U.S. Dist. LEXIS 90337 (W.D. PA. May 31, 2018). When we last blogged about this case back in February, the court had tossed out everything except negligence and fraud/misrepresentation claims on well-settled Pennsylvania law that prescription drug cases sound only in negligence. The court then dismissed the remaining claims for failure to satisfy TwIqbal pleading standards. Plaintiffs were afforded an opportunity to amend and re-plead the claims recognized under state law. They did. And once again, they don’t get by TwIqbal.

So, what’s missing this time around? The court starts out by noting that despite being dismissed for factual insufficiency, plaintiff made few factual revisions in the amended complaint. Id. at *4. So few that the court was able to essentially adopt its factual recitation from the first decision. Id. That’s an underwhelming start and things don’t improve for the plaintiff as the court examines each claim in turn.

Starting with plaintiff’s catch-all negligence claim, the court found “[t]he amended complaint contains a boilerplate laundry-list of alleged negligence that is virtually identical to the negligence claim in the original complaint.” Id. at *12. Since plaintiff just re-packaged his conclusory allegations from the original complaint, the amended complaint once again fails to state “any facts about how defendants breached their duty or how defendants’ conduct caused [plaintiff’s] injury.” Id. at *13. At the heart of plaintiff’s negligence claim was his allegation that defendants should have changed their label to warn about the risk of kidney injury following FDA approval. But for that claim to survive, plaintiff would have had to have pleaded what new information became available to warrant a change, what the changed warning should have said, and how any alleged breach was the cause of plaintiff’s injury. Id. at *13-14. Absent all those pieces, plaintiff’s negligence claim was dismissed.

Negligent misrepresentation was even easier to dismiss because it was an exact duplicate of the original complaint. Id. at *14. We’ve all heard the expression that the definition of insanity is doing the same thing over and over and expecting a different result. Well, same allegations equal same result. Dismissal.

Next up was plaintiff’s negligent design claim. This claim was previously dismissed for failure to plead the availability of a safer, alternative design as required by Pennsylvania law. So, plaintiff argued he satisfied that requirement in the amended complaint by pointing to other available products. But different products are just that different products – not alternative ways to design the product at issue. Saying plaintiff could have taken a different product doesn’t do anything to establish how the design of defendant’s product was defective or how it could have been designed differently. Id. at *15. Another dismissal.

Last, plaintiff based his fraud claims on allegations that defendants concealed information about the risks of the drug from the FDA, the public, plaintiff, and plaintiff’s physicians. But fraud claims don’t just have to satisfy TwIqbal, they are held to the more rigorous Rule 9(b) standard. Generality won’t suffice. Id. at *16. And plaintiff’s claim was just that, too general. The amended complaint contained no allegations about what information was concealed. It was missing the “who, what, when, where and how” of defendants’ alleged fraud, i.e., the “first paragraph of any newspaper story.” Id. at *17. So, fraud was dismissed as well.

Despite the complete lack of factual support for any of plaintiff’s claims, he once again asked for a chance to re-plead. The court, somewhat reluctantly, granted the request but made it clear that any final attempt by plaintiff to fix these pleading deficiencies would have to be a significant improvement. Specifically, plaintiff has

to clearly articulate the legal theory he is pursuing and to allege sufficient facts to make each element of the claim plausible. He must also eliminate his overbroad, conclusory “shotgun” allegations so that defendants are given adequate notice of what [plaintiff] claims they did wrong.

Id. at *18-19. Given plaintiff’s track record, this seems like a fairly high hurdle to clear. Stay tuned to see if plaintiff tees it up for strike three.

 

It’s been a few years since we talked about the conundrum facing pharmacies if they suspect prescriptions are medically unnecessary or improper. Back in 2015, two cases were decided within days of each other that allowed claims to go forward suggesting that a pharmacy could be potentially liable for both filling suspect prescriptions (see here) and for not filling suspect prescriptions (see here). Hence “damned if you do (question a prescription) and damned if you don’t.” We obviously have issues with both decisions as our prior posts explain. We don’t like the creation of new, ill-defined duties and we don’t like anything that creeps around in learned intermediary territory. But this is also a state-by-state issue and we have found other states not willing to make the leap to find that pharmacies have a duty to monitor patients or warn about excessive prescriptions. See Hernandez v. Walgreen Company, 2015 Ill. App. LEXIS 986 (Ill. App. Ct. Dec. 28, 2015). So, there is no bright line regarding what a pharmacy should do and it certainly seems at a minimum that pharmacies in different states are going to have to follow different rules – interesting when you consider the vast majority of prescriptions are filled by large national chains.

While the overarching question remains unanswered, a recent Seventh Circuit decision took a closer look at the substance of a “damned if you don’t” case that made it all the way to trial and found that most of it shouldn’t have survived summary judgment.

In Mimms v. CVS Pharmacy, Inc., — F.3d —, 2018 WL 2126720, *1 (7th Cir. May 9, 2018), plaintiff was a pain management physician who prescribed, among other things, opioids. On several occasions, CVS pharmacy employees informed customers that they would not fill Dr. Mimms’s prescriptions leading Dr. Mimms to sue CVS for alleged defamation. Id.   By the time the case went to trial it was based on four statements allegedly made by CVS employees:

  • “CVS doesn’t fill Dr. Mimms’[s] prescriptions or prescriptions for any other pill mills.”
  • “Dr. Mimms went to jail.”
  • “Dr. Mimms has been … or will be arrested.”
  • “Dr. Mimms is under DEA investigation.”

Id. Defendant moved for summary judgement on all four statements which was denied. Id. Defendant moved for judgment as a matter of law as to the first three statements at the conclusion of plaintiff’s case at trial. That too was denied and a verdict was entered in favor of plaintiff. Id.

Under Indiana law, to prove defamation, plaintiff had to establish that the speakers acted with actual malice. That is that they either knew their statements were false or had serious doubt as to their truth. Id. The district court found that plaintiff had met its burden regarding knowledge of falsity by showing that “CVS’s corporate office had concluded an investigation of Mimms and had not stopped stores from filling his patients’ prescriptions.” Id. In other words, the court imputed the knowledge of the principal to its agent which it is not permitted to do. Id. at *2 (citing New York Times v. Sullivan, 376 U.S. 254, 287 (1964)). Plaintiff had to prove that the employees themselves knew their statements were false or had serious doubts about their truth, which he did not do. Plaintiff pointed to emails from corporate officers to store supervisors asking supervisors to remind employees that company policy is not to make derogatory statements when refusing to fill prescriptions. Id. But there was no evidence that the email was sent to any of the speakers and more importantly it contained no information that would have informed speakers about the truth or falsity of their statements. So, plaintiff had no evidence from which a reasonable juror could conclude that the first three statements were made with actual malice. The court granted judgement as a matter of law as to those statements.

There was, however, some evidence that created a genuine dispute as to whether the speaker of the fourth statement – plaintiff was under DEA investigation – doubted its veracity. Id. So, while that statement would have survived summary judgment, the court found that CVS is entitled to a new trial based on erroneous trial rulings. At trial CVS was not allowed to offer evidence that Dr. Mimms’s former clinic had been subpoenaed for records of his prescriptions. That evidence CVS argued went to whether the statement was in fact true – a complete defense to defamation. Id. at *3. Even though Mimms had left the clinic at the time the subpoena was issued, “the fact that the DEA was seeking records for Mimms’s patients shortly after he left the practice supports CVS’s claim that Mimms was under investigation.” Id. CVS was also prohibited from introducing a transcript from a criminal trial in which a Health and Human Services agent testified that he investigated Mimms with a DEA agent. The Seventh Circuit found that the unduly prejudicial portions of the transcript could be redacted. It also concluded that the district court unnecessarily relieved plaintiff of his stipulation not to assert a hearsay objection to the transcript at trial. CVS relied on that agreement in deciding not to seek live testimony of the agent. Id. Finally, CVS was prohibited from offering evidence that Mimms’s professional reputation was already tarnished. While prejudicial, of course, the state of plaintiff’s reputation in a defamation action is critical to the issue of damages. Not allowing the evidence was an abuse of discretion. Add it all up and CVS is entitled to a new trial – one that feels like it should be drastically different than the first one.

 

This DDL blogger happens to have a relatively new teenager in the house. And said teen has been working on an assignment related to the novel by Lois Lowry, “The Giver.” If you are unfamiliar with the book or the more recent movie adaptation (and if you only know the movie, we recommend the book as the former doesn’t dig deep enough into the source material’s thought-provoking ideas), it is about a seemingly utopian society without war, poverty, pain, or suffering. This state of perfection is achieved through sameness. Everyone dresses the same, speaks the same, acts the same. The goal is to eliminate all conflict and for no one to feel uncomfortable. And to achieve this, free will and freedom of choice are non-existent.

The book’s themes have made for some very interesting dinner table debates about the benefits and drawbacks of sameness. While we’ve managed to identify the obvious benefits, we also always find the benefit comes at a price that we are typically not willing to pay. Sacrificing the ability to feel love to also not have to endure feeling pain. Sacrificing human life so that there is no hunger. So, in this DDL household, sameness has come under considerable attack and it is no surprise that individuality is being championed by the teen (and parent too, with some limitations).

And as we transition from home life to work life, we couldn’t help but acknowledge the parallel as we again find ourselves the advocates of individuality over sameness. This time it’s about a flawed class rather than a dystopian society.

In Andre v. Alere, 2018 U.S. Dist. LEXIS 69045, *3 (S.D. Cal. Apr. 24, 2018), putative class representatives allege that defendants’ marketing of its INRatio products was deceptive and misleading and that defendants are therefore liable under various state’s consumer protection laws. The INRatio products are handheld devices used to monitor blood clotting time in people taking warfarin. Class certification was originally denied back in December as to both a nationwide class and as to alleged state-specific sub-classes. Id. at *4-5. Plaintiffs sought reconsideration as to the six sub-class states (Colorado, Florida, Georgia, Maryland, New York, and Pennsylvania). They allege that based on new facts they can satisfy Federal Rule of Civil Procedure 23(b)(3)’s predominance requirement as to the learned intermediary doctrine, statute of limitations, and damages. The court disagreed.

For a class to be certified, Rule 23(b)(3) requires that “the question of law or fact common to class members predominate over any questions affecting only individual members.” And the court’s analysis is a “rigorous” one that can extend beyond the pleadings. Id. at *6.

Plaintiffs, for the first time in their reply brief, argued that the learned intermediary doctrine did not apply to their claims for several reasons. First, they alleged it does not apply because they are alleging a design defect claim not a failure to warn claim. But, that argument didn’t align with the allegations of their complaint which were about omissions and representations – i.e. failure to warn. Id. at *14. Nor did plaintiffs’ cite any authority for learned intermediary not applying to design defect claims. Id. Next plaintiff argued that the learned intermediary doctrine doesn’t apply where only economic injuries are sought. But again, they offered no legal support for their contention. Id. Finally, plaintiffs argued that because the INRatio product is user-operated, the doctrine doesn’t apply. On this point, it appears plaintiffs and defendants submitted competing examples of how prescribed medical devices that involve some patient operation are treated and concluded plaintiff’s argument was not persuasive. Id. at *15. Regardless of whether the patient has to be the one to use the device daily, it still had to be prescribed by his/her physician warranting application of the learned intermediary doctrine.

So, since the learned intermediary doctrine is applicable, Plaintiffs had to argue that it is subject to “common proof.” They did this by alleging that defendants “failed to warn any physicians.” Id. at *7-8 (emphasis added). But, as defendants argued, the inadequacy of the warning is only part of the equation. Plaintiffs must also show that “the inadequate or lack of warnings were the proximate cause of Plaintiffs’ injuries.” Id. at *8. The court cites at least one case from each of the six states at issue to support the proximate cause arm of the learned intermediary rule. Id. at *10-11. What all of those cases have in common is the conclusion that “proximate cause determination will ultimately lead to individual inquiries into each doctor’s experience with the product.” Id. at *12. Inquiries such as the extent of the physician’s knowledge of the risks and side effects and the source of that knowledge; and whether the physician stands by his/her prescribing decision; and the physician’s individualized medical decision based both on his/her knowledge of the product and of the patient. Id. at *12-13. While warning adequacy might be subject to common proof, individuality predominates on the issue of specific, proximate causation. Also, plaintiffs couldn’t point to a single case where class certification was granted involving the learned intermediary doctrine.

Class certification was also denied due to the lack of predominance as to damages and the statute of limitations. Again, individuality can’t be ignored.

On damages, plaintiffs put forth a full-refund model under California law and argued that it satisfied predominance and that a state-by-state analysis was not necessary. Id. at *16-17. The court, however, found that the cases plaintiffs relied on were not that black and white. See id. at *17-19 (analyzing plaintiff’s cases).      It was not enough to summarily conclude that predominance was satisfied as to all because it was satisfied as to some. The required “rigorous analysis”

is not satisfied by merely arguing that courts in some of the six states allow for a full refund model. Plaintiffs have failed to specifically demonstrate that each of the six sub-class states’ consumer protection statute and claims for implied breach of warranty in four sub-class states are connected to their theory of damages or that these state law causes of action damages provide for a full refund recovery.

Id. at *21. Plaintiffs had to show sameness among the six states, which it failed to do.

As to statute of limitations, plaintiffs argued that because each of the six states recognizes equitable tolling and/or the discovery rule, “then necessarily common proof will prevail over individualized questions” because no plaintiff knew until the product was recalled that the product was defective. Id. at *22-23. But plaintiffs ignore that both equitable tolling and the discovery rule require consideration of whether the plaintiff acted with due diligence – an individualized inquiry. Id. at *23. The court gives an example from the complaint of one of the putative class representative’s experiences with the device that should have alerted him to an issue before recall and points out that plaintiffs have not addressed how equitable tolling or the discovery rule would apply in that situation. Id. at *24. Since it cannot be determined if the statute would be tolled for all plaintiffs from the date of recall, individual issues predominate over common ones.

In “The Giver” sameness is a metaphor for the lack of truth and diversity. The destroyer of creativity, free will, joy, happiness, and love. The things that make life worth living. In DDL world individuality may not be the meaning of life, but it’s enough to ward off class actions which certainly makes us happy.

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

It may be post Mardi Gras season, but we don’t think there is ever a bad time to embrace the motto – “Laissez les bons temps rouler.” Quite literally – “Let the good times roll.” However, don’t try this with your high school French teacher, because after her gasp of horror, she will tell you that the grammatically correct way to get a party started in France is “Prenons du bons temps.” Of course, the Louisiana version is really Cajun French as opposed to France French and with both having so many good things to offer it’s really a matter of preference in a given moment. Like deciding if you’re in the mood for bouillabaisse or crawfish etouffee; a beignet or a croissant; a Hurricane or a Cabernet Franc.

Now that we’ve got you thinking about what’s for dinner, we can narrow our Louisiana focus to just the Louisiana Products Liability Act (“LPLA”) – hoping to whet your legal appetite now. In the case of Pierre v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 67773 (E.D. Lous. April 23, 2018), plaintiff alleged she was injured as a result of defendant’s self-fixating mesh that was used in plaintiff’s abdominal surgery. Plaintiff alleges she suffered an infection and pain following her surgery. Id. at *2. We are jumping to the end of the decision to immediately lop off several of plaintiff’s claims. The court dismissed claims for breach of warranty of fitness for ordinary use, negligence, breach of implied warranty, negligent misrepresentation, and negligent design all on the grounds that they exceed the scope of the LPLA and the LPLA “sets forth the exclusive theories of liability for manufacturers for damage caused by their products.” Id. at *15.

So, what claims does the LPLA allow? Manufacturing defect, design defect, failure to warn, and express warranty. Id. at *5. And on defendant’s motion to dismiss, only half those claims survived. The first claim to survive, unusual for a drug/device case, is for manufacturing defect. That’s because here plaintiff had a specific allegation that the mesh used in her surgery was improperly sterilized which led to her development of an infection. Because plaintiff is challenging a deviation from the standard procedures for this product, she’s stated a claim for a manufacturing defect. But the court was clear that what plaintiff could not do is attack the defendant’s sterilization process generally, only this particular alleged deviation. Id. at *7-8.

Next plaintiff alleged two design defects. First plaintiff alleged that the mesh was defective in that it was made of polyester, a weaker material than used in other mesh products, and that the weaker material required a different method of being secured which ultimately led to causing plaintiff more pain than she would have suffered with a different method of attachment. Id. at *8-9. Since plaintiff alleged a design defect, alleged that that defect was the cause of one of her injuries (pain), and that alternative designs existed, she passed TwIqbal on this claim. Her second design claim, however, did not meet that standard. Plaintiff alleged that the design of the mesh caused her infection by lowering her pH. But missing from this claim is any suggestion of “the existence of a feasible alternative design that would prevent the alleged injury.” Id. at *10.

There was no splitting the baby on plaintiff’s failure to warn claim. It was dismissed in its entirety. As to the alleged failure to warn about infection, plaintiff relies exclusively on a single marketing document. However, plaintiff failed to allege any facts “to plausibly suggest that [plaintiff’s] surgeon relied, or any competent surgeon would rely, on this marketing document when deciding whether to perform surgery.” Id. at *11. A pretty demanding standard when you infer, and we think the court was so implying, that no competent surgeon relies on marketing material to make medical decisions. Moreover, the court pointed out several ways in which the marketing document cites to other documents, most importantly to the “Instructions for Use” of the mesh demonstrating that “Defendants did not rely solely, if at all, on the marketing document to warn users of the risks.” Id. at *12. Not to mention that the risk of infection is a “common surgical complication” most likely already known to plaintiff’s surgeon. Id.

Plaintiff’s second failure to warn claim was based on a failure to warn that the mesh might contract after surgery causing pain. Id. Here plaintiff failed to allege any facts about what warning was provided to plaintiff’s surgeon relying only on a boilerplate statement that defendant didn’t warn. Id. But such an “allegation is too broad to state a claim because it does not identify (1) which aspects of the product warranted a warning and (2) what injuries resulted from the failure to warn.” Id. at *13. Too vague to withstand dismissal.

So too was plaintiff’s breach of express warranty claim. Plaintiff only alleged that defendant warranted the product was safe and fit for its intended use, merchantable, adequately tested, and did not have dangerous side effects. Id. at *14. But a claim that a product is “safe” or “effective” is only a “general opinion” or “general praise,” insufficient to form the basis for an express warranty under the LPLA.

Of the 6 claims brought that were permissible under the LPLA, only 2 survived the motion to dismiss. Not a complete win, but good enough to put in the “good times” category. And if you don’t want to get embroiled in the French debate, we recommend following the lead of Shirley & Lee from 1956 or The Cars from 1978 and just let the good times roll (in English).

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly a revelation. But we will say that the opinion entered by the magistrate in Harper v. Janssen Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 58298 (M.D. Ala. Apr. 4, 2018) is strong and well-reasoned. A good addition to any learned intermediary library.

Plaintiff is the mother of a boy who was diagnosed with autism at the age of 4. From the age of around 5 or 6 until he was 10, plaintiff’s son was prescribed Risperdal among other medications. During that time he began gaining weight and experienced high prolactin levels. At the age of 16, plaintiff’s son was diagnosed with gynecomastia, an abnormal development of breasts in males. Id. at *5-8. Plaintiff filed suit alleging claims for failure to warn under common law and under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”), negligence, wanton misconduct, breach of implied warranty of merchantability, fraud, and negligent misrepresentation. Id. at *5.

At the core of all of plaintiff’s claims is an allegation that the manufacturer failed to provide accurate or complete information about the risk of gynecomastia with the use of Risperdal. So, there are two key areas of inquiry – what information did the manufacturer provide and what did the prescribing physician know. Starting with the Risperdal label, throughout the time plaintiff’s son was taking Risperdal, elevated prolactin levels and gynecomastia were included in the precautions section of the label. Further, at all relevant times, the label included a warning that “safety and effectiveness in children have not been established.” Id. at *9-10. Plaintiff focuses on studies done by the manufacturer that allegedly show that Risperdal had a greater risk of increasing prolactin levels than other anti-psychotic drugs in the same class and argue that this information was available to defendant at the time plaintiff’s son was prescribed the drug and it should have been part of the warning. Id. at *12-14.

Moving on to the prescribers – the first doctor to prescribe Risperdal to plaintiff’s son testified that at the time he prescribed he knew that safety and effectiveness had not been established for children, that he took that into consideration when prescribing, and that it was his practice to discuss with the parents of child patients that this was an off-label use. Id. at *15. He was also aware that the label called for periodic re-evaluations if the drug was used long-term and again it was his practice to do so and that he only continued patients on medications if he felt the benefits outweighed the risks. Id. at *16. And, the prescriber was aware that Risperdal was associated with weight gain and was also aware that prolactin-elevating compounds could lead to gynecomastia. He took both into account when prescribing Risperdal. Id. at *16-17. The second prescriber was likewise aware that Risperdal was not approved as safe and effective for use in children and would have considered that at the time he prescribed to plaintiff’s son. Id. at *19.

Before jumping into its legal analysis, the court made a few astute observations about the intersection between science and the law and in particular the uncertainty of medicine that are uncommon in legal opinions and so we decided to provide for you directly here:

To a significant degree, this case epitomizes the limitations of medical science, the law, and their interaction. The course of human history has seen profound improvements in our understanding of health, disease, and other afflictions. Recent advances in diagnosis and treatment of medical conditions, both physical and mental, are often little short of miraculous. Despite these advances, our understanding of maladies and their safe and effective treatment remains incomplete and imperfect. This is especially and poignantly true with respect to the broad category of mental health conditions. Doctors and the pharmaceutical industry have developed any number of powerful medicines for treatment of many of those conditions, with varying levels of effectiveness. All these medicines carry the burden of potential side effects for some or all users. Determining the origin of adverse conditions associated with certain drugs is often difficult.

Measuring the breadth and fixing the limits of legal liability for adverse drug reaction requires development and application of legal principles in an area of great medical uncertainty and conflicting economic and societal goals. Through federal and state legislation, administrative regulation and approvals, and the common law, we establish standards for patients, doctors, and pharmaceutical companies to govern their affairs. Legal concepts of proof and causation are often not readily applied where scientific knowledge is incomplete and uncertain. The twin aims of providing appropriate compensation to individuals injured by others while encouraging doctors and drug companies to advance the field of medicine frequently conflict, as in this case.

Id. at *21-22. We’ve blogged on occasion about the pitfalls of the law getting too far ahead of science and how making the two fields meet can be quite tricky – nice to see it in an opinion.

So, faced with a label that warned of the risk, and prescribers who knew and considered the risk, and imperfect scientific knowledge – what was left for the judge was to enter summary judgment. Plaintiff argued that while the Risperdal label contained some warnings, those warnings were incomplete or misleading about the extent of the risk (the studies noted above). However, the label was “not intended to be a risk profile for adolescents.” Id. at *28. The label explicitly stated the drug’s safety and effectiveness had not been established for pediatric patients and also went on to include both increased prolactin and gynecomastia in the precautions. More importantly, as noted above, the prescribers were aware of the risks. “The prescribing decisions of [plaintiff’s son’s] health care providers were made after weighing the risks and benefits of the medication. Critical to a plaintiff avoiding the learned-intermediary doctrine is a demonstration that the manufacturer failed to warn the physician of a risk not otherwise known to the physician.” Id. at *30 (citation and quotation marks omitted).

Further, as to the studies showing increased risk upon which plaintiff relies, plaintiff’s initial prescriber testified “that until a study is completed and the data analyzed, it is not available to him to rely upon in making his prescribing decision.” Id. at *29. Great support from the prescriber for keeping out science that post-dates prescription and usage of the drug. If the studies weren’t published until after the doctor stopped prescribing, they couldn’t factor into his prescribing decision and they shouldn’t factor into the court’s failure to warn analysis.  Putting all this together, the court concluded both that the defendant provided adequate warnings and that the “prescribing physicians knew use of Risperdal in children was an “off-label” use, independently knew of the risks associated with the medication or researched them prior to prescribing the medication, and chose to prescribe it anyway.” Id. at *31. Learned intermediary doctrine bars any failure to warn claim.

Plaintiff’s remaining claims fell away quickly as well. Wanton disregard requires a showing of recklessness or conscious disregard for the safety of others. Again plaintiff’s pointed to the label and argued it wasn’t enough. “The fact that the warnings could have been broader or stronger does not equate to reckless disregard or an indifference toward safety.” Id. at *33.  The label contained a warning of the very risk at issue, therefore, defendant was not indifferent to safety. Breach of implied warranty failed because (a) Alabama doesn’t recognize it for inherently dangerous products and (b) the drug served its purpose of treating mental health. Id. at *35-36. Finally, plaintiff’s fraud and misrepresentation claims fail because even if you assume all facts in the favor of plaintiff, she hasn’t established reliance by her son’s treaters or causation where the treaters knew of the risk and prescribed anyway. Id. at *38.

Learned intermediary may not be a hot new topic, but this testimony and the analysis by the court is pretty top-notch.

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

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.

 

Today’s case isn’t about prescription drugs, but rather illegal drugs. More specifically, whether a user of illegal drugs can recover in a civil action against someone who failed to prevent the user from obtaining the drugs. While this is outside our usual field of focus, we have posted about the in pari delicto doctrine before and believe the decision could be analogously useful to drug companies in at least some types of opioid litigation and therefore worthy of notice.

You won’t find that fancy Latin phrase in Hollywood v. Superior Court, 2018 Cal. App. LEXIS 190 (Cal. App. Ct. Mar. 8, 2018), but that is what the case is about. Plaintiff voluntarily checked himself in to a rehabilitation facility and then proceeded to smuggle in heroin and overdose. Id. at *2-3. He then brought a negligence action against the rehab facility alleging it failed to take reasonable steps to make sure residents could not get illegal drugs. Id. at *3-4. So the question is whether plaintiff’s own misconduct bars his right to recovery in tort for his injuries – in pari delicto or “wrongful conduct” rule. The case also discusses whether the claim is barred on statutory grounds.

The court examined defendant’s statutory defense first. The statute at issue is the Drug Dealer Liability Act (DDLA) which is based on the Model Drug Dealers Liability Act which has been adopted in some version in more than 20 states. Id. at *8. The primary goal of the DDLA is to provide a civil remedy for damages to those who are injured as the result of someone else’s use of illegal drugs – parents, employers, insurers. Id. at *9. Such parties are entitled to both economic and non-economic damages and can recover from both the person who actually sold the illegal drugs to the user and anyone “who knowingly participated in the marketing of illegal controlled substances.” Id. at *12. In other words, the DDLA imposes a broad market share liability “in order to deter drug traffickers with potentially high civil damages awards.” Id. at *11.

The DDLA also allows an illegal drug user to bring a more limited claim, if certain conditions regarding cooperation with law enforcement and non-use of illegal drugs are met. The claim can be brought only against the direct supplier/manufacturer/importer of the actual drugs used and only economic damages can be recovered. Id. at *12-13. The DDLA goes on to state: “An individual user of an illegal controlled substance may not bring an action for damages caused by the use of an illegal controlled substance, except as otherwise provided in this section.” Id. at *13. In Hollywood, the rehab facility argued that that sentence precluded plaintiff from bringing his negligence claim against it as it was not the supplier of the drugs that caused his injury. Now all of this should sound like preemption to our DDL blog readers, but because we are talking about co-equal state law (state statute and state common law), the question is framed as whether the enactment of the statute displaced the existing common law. Id. at *8n.7. And yes, California’s general rule is a presumption against displacement. Id. at *15-16.

First, in construing the sentence limiting the claims a drug user can bring, the court noted that the DDLA defines “individual user” as “the individual whose use of a specified illegal controlled substance is the basis for an action under this division.” Id. at *15. Therefore, the DDLA did not need to repeat “under this division” when talking about the claims an individual user could bring because it was already limited by definition to claims under the act. Id. Second, the court found no legislative intent to “supplant common law” as to the circumstances of when a drug user could pursue claims against a third-party. Since the primary goal of the DDLA was to expand the class of potentially liable parties, the court was unwilling to interpret the act to restrict or bar other common law remedies.

Application of that common law to plaintiff’s claim, however, found it was lacking any legal support. In its analysis of the “wrongful conduct” doctrine, the court examined the development of the law in relation to liability for furnishing alcohol. After some back and forth in the courts, the California legislature enacted a statute to limit the liability of those who serve alcohol finding the consumption of alcohol should be the proximate cause of injuries to the intoxicated person or injuries caused be the intoxicated person, with exceptions for serving minors. Id. at *19-21. Similar laws exist protecting hosts who furnish alcohol. Id. at *22. Some plaintiffs have argued that because these laws confer immunity on those who serve/furnish alcohol, “persons less directly responsible for the intoxicated state of another may be liable under nonstatutory theories.” Id. We had to quote it because we couldn’t think of another way to state such a ridiculous concept. Fortunately, California courts have found it just as ridiculous. In this case, the court concluded that the rehab facility took reasonable steps such as a search upon arrival and periodic room checks to prevent residents from using illegal drugs. It was not required to take extraordinary measures. Such a claim is not supported under the law, nor would public policy favor burdening the very facilities who are trying to help addicts with potential liability for “their residents’ foreseeable but unpreventable predilection to obtain and ingest drugs.” Id. at *28.

The Hollywood court could not find a single case “suggesting that liability could be predicated on the mere failure to undertake affirmative efforts to stop the user from ingesting drugs.” Id. at *25. In other words, there is no viable “general failure to thwart drug use” claim.  Id.  The same logic should apply to claims against manufacturers of prescription opioid drugs for failure to monitor distributors and retail sellers.