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Patora v. Vi-Jon, LLC, 2023 U.S. Dist. LEXIS 153421 (S.D.N.Y. Aug. 30, 2023), is a typical express preemption decision resulting in dismissal of a typical consumer protection-based purely economic loss class action against an over the counter (OTC) product.  The plaintiffs, suing on behalf of a putative class, alleged that they purchased an OTC laxative product that contained a bacterial contaminant.  The defendant had recalled the product. The plaintiffs asserted that they became ill as a result of the bacteria, but their claim was not for personal injury, it was for the money they paid for the laxative.  According to the plaintiffs, the laxative label was deficient because it did not list the bacteria as an ingredient, nor did it warn of the possibility of bacterial contamination.  The plaintiffs contended that they, naturally, would not have purchased the product if they knew of the bacterial contamination.  The product was worthless. The plaintiffs wanted their money back.  The complaint set forth causes of action for deceptive acts or practices and false advertising under New York General Business Law.


The defendant filed a motion under Fed. R. Civ. P. 12(b)(6) to dismiss the complaint because the claims were expressly preempted by the Food, Drug and Cosmetic Act, 21 U.S.C. section 301 et seq. (FDCA).  The FDCA contains an express preemption provision for state laws governing OTC drugs, including laxatives.  Under that express preemption provision, no state can enforce any OTC labeling requirement not “identical” to what the FDA requires.  In essence, the plaintiffs were attempting to turn what amounted to manufacturing defect allegations (if the bacteria was in the laxative, it got in by mistake) into a warning claim more amenable to class action status by claiming that a possible contaminant should have been listed as an “ingredient” in the OTC product’s labeling.  We’re tempted to call the claim clever, but it actually isn’t.  We’ve seen it before and it has failed before.  

The FDA promulgated regulations define a drug active “ingredient” as a substance “intended” to furnish pharmacological activity or other direct effect in the diagnosis, mitigation, treatment, or prevention of disease.  A contaminant does not come close to fitting the bill. An inactive ingredient is any other “component,” which, in turn, is “intended” for use in the manufacture of a drug product. Intention, then, is at the heart of the matter.  Some people say that divining anyone’s intention is impossible.  Perhaps you’ve heard something like that with respect to some recent indictments of rather famous figures.  But juries make determinations about intention every day.  Sometimes judges do, too,  Sometimes it is really easy.  That was the case in Patora.  No one suggested that the alleged bacteria was intended to be in the laxative.  Therefore, the bacteria is not an active or inactive ingredient, and federal law does not require that the bacteria appear on the ingredients list.  The plaintiffs’ insistence that the bacteria be listed as an ingredient is not only not “identical” to federal regulations, it is directly contrary to them.
Moreover, to the extent that the plaintiffs’ claim is more about absence of warning as opposed to absence of an ingredient listing, the claim still runs counter to federal law.  OTC products are required to contain warnings included in an applicable OTC monograph.  Not all OTC products are included in a monograph, but the laxative product in question was listed in a 2023 monograph.  That monograph set forth nine specific warnings.  The Patora court read the monograph and concluded that “neither the general OTC requirements for warning labels nor the 2023 monograph laxative-specific requirements for warning labels mandate a warning related to the potential inclusion of any bacteria” – let alone the specific one in this case.  


Since the FDCA does not mandate the disclosure that the plaintiffs were demanding, the plaintiffs’ claims were expressly preempted. The Patora court quoted another case saying that the plaintiffs’ claims are “exactly what the FDCA does not permit.”  Given the obvious express preemption of these contaminant-as-ingredient claims, and given the build-up of precedent on precisely this point, by now these claims by plaintiffs are utterly frivolous.  

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As we’ve discussed before, the United States Supreme Court, in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), sent the presumption against preemption, in express preemption cases anyway, into the dustbin of history.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125 (citations and quotation marks omitted).

Continue Reading On the Erstwhile Presumption Against Preemption, the Third Circuit Sticks Out Like a Sore Thumb
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We observed oral argument the other day in a case that could have a significant impact on potential liability under California tort law for pharma companies and all other innovators.  In Gilead v. Superior Court, No. A165558 (Cal. Ct. App. First Dist.), a panel of the California Court of Appeal is considering whether a prescription drug manufacturer can be liable in tort not for a product defect, but for negligence in failing to develop a different, allegedly safer product sooner than it actually did.  This is an important case, since a decision in favor of the plaintiffs would create a new “duty to innovate” under which a drug manufacturer could be liable for failing to develop a different drug that, in 20/20 hindsight, might have been better for some patients.  No court has allowed this. 

At issue are life-saving antiretroviral drugs used to treat patients with HIV, and we have written on similar cases involving the same drugs and legal theories before.  See, e.g., here and here.  The defendant in Gilead has developed multiple drugs used to treat or prevent infection with the AIDS virus, including several containing tenofovir disoproxil fumarate (“TDF”) as an active ingredient.  That is the group of drugs that the plaintiffs allegedly used and that allegedly caused harmful side effects.  Keep that in mind.  These plaintiffs are claiming that they used a product and suffered physical harm as a result—i.e., unambiguously product liability claims.

The problem for these plaintiffs is that there is no evidence of a product defect in TDF drugs.  As a result, they are not claiming a defect in design; they are not claiming that the drug warnings were inadequate; they are not claiming that TDF drugs should be withdrawn from the market; and they agree that TDF drugs have benefited and continue to benefit thousands of patients. 

So the plaintiffs pivoted.  The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later.  Plaintiffs now claim that TAF has a better safety profile compared to TDF and that the defendant unreasonably (i.e., negligently) paused TAF’s development, thus depriving them of a drug that they say might have avoided their injuries. 

That is how we got to oral argument in the California Court of Appeal.  The trial court denied the company’s motion for summary judgment and ruled that the plaintiffs could pursue a negligence claim based on the purported delay in developing TAF drugs.  On the company’s interlocutory appeal (via a discretionary writ petition), highly skilled advocates for both sides argued their positions to a curious and prepared three-judge panel for more than an hour. 

The defense emphasized at the outset that no court has ever recognized a duty to develop a product more quickly.  One judge quickly challenged counsel on whether the duty here is the ordinary duty to exercise reasonable care to avoid foreseeable injury to others.  Another asked whether this was merely “old world negligence.”  Thus began argument on the origin and limits of tort duties in California.  Yes, the California Civil Code codifies a duty to avoid harm to others, but that does not mean everyone has a duty to avoid everything.  In other words, you can’t just say there is a “duty” and call it a day.  You have to ask what is the duty and what does the duty require?

Counsel argued that the answers depend on public policy, and compelling policy factors weigh against creating this new duty “not to delay development of a safer alternative drug.”  To begin with, the new duty would undermine decades of California product liability law, which centers on proof of a product defect.  Recall that these are unambiguously product liability claims, yet the plaintiffs here are seeking compensation without claiming that the product they used was defective. 

Moreover, a new “duty to innovate” would wreak havoc on product development, not only for prescription drug manufacturers, but throughout the biotech industry and beyond.  Companies make decisions on product development every day, including whether and where to allocate finite resources.  Imagine the chilling effect on innovation if companies had to make those decisions at the risk of being second guessed by juries 20 years down the road.  Finally, the plaintiffs’ proposed duty is unnecessary because product liability law already protects consumers.  The defendant here is not claiming “immunity.”  It was and remains subject to liability under established product liability law, provided the plaintiffs could plead and prove a claim. 

In the end, counsel urged that imposing undue liability would discourage drug development.  In Brown v. Superior Court, 44 Cal. 3d 1049 (1988), the California Supreme Court rejected strict product liability for prescription drugs partly because public policy favors the development and marketing of beneficial new drugs.  That public policy applies here.  By subjecting development decisions to hindsight scrutiny, years after the fact, the plaintiffs’ proposed duty would diminish a manufacturers’ incentive to develop superior products, presumably because any new, “better” product would open the door to claims that it should have been developed earlier and replaced its predecessor sooner.  That is especially true considering that tort inquiries are skewed, i.e., they are decided with reference to one plaintiff, which discloses only the risk side without consideration of the benefits. 

The plaintiffs argued out of the blocks that their negligence claim alleging a failure of reasonable care can and should proceed separate and apart from a product defect claim.  One judge asked whether TDF could be “defective” because there was a better alternative, apparently trying to reconcile the plaintiffs’ allegations with established product liability law.  Plaintiffs, however, did not bite.  Counsel argued that proof of a product defect in TDF would be a specific analysis under California law, but the plaintiffs’ claims have nothing to do with TDF.  As plaintiffs who took the TDF medicines, their claims are about the defendant’s failure to develop more quickly and market faster the later drug, TAF.  (Query how the plaintiffs’ claims could have nothing to do with a defect in TDF, the drug they ingested and that allegedly caused them harm.  But we will come back to that.) 

The duty, according to plaintiffs, is the general duty under the California Civil Code to take reasonable care to avoid causing injury to foreseeable product users.  In the plaintiffs’ view, the defendant has turned duty on its head:  Instead of asking whether the court should create a new duty, the court should accept the Civil Code as the source of a duty of reasonable care and then ask whether public policy should create an exception.  On this point, plaintiffs argued that the California Supreme Court has held that negligence and strict products liability are two separate things. 

One judge expressed surprise that, if plaintiffs’ view is the law, why courts don’t see more cases seeking liability based on product development decisions, using off-road vehicles as an example.  That prompted the plaintiffs to observe that most products are covered by strict products liability.  Prescription drugs are the exception under Brown v. Superior Court, which plaintiffs have to find a way around.  This to us was a significant point, since it basically admits that plaintiffs are trying to evade the limitations that California product liability law places on pharmaceutical design defect claims and the underlying public policy recognized by decades of California precedent. 

Two judges asked whether that means plaintiffs were proposing a duty to innovate, which plaintiffs promptly denied.  This part frankly was confusing, since plaintiffs argued that the defendant had “already innovated” TAF.  But what does that mean?  Sure, the defendant had TAF in development, but there are different stages of innovation, so at what point does the law impose an obligation to bring a product to market, or else face the prospect of tort liability at some undetermined point in the future? 

One judge asked that very question, noting that manufacturers would need to know if and when the law imposes that obligation.  Plaintiffs did not really have an answer, but reverted to their argument that the defendant’s breach of duty was deciding to “delay” development of TAF and that reasonableness is the standard.  Plaintiff closed by noting again, in response to a question, that this is not a product liability case.  The Court of Appeal might accept that, but of course we do not:  The plaintiffs’ core allegation is that they used a product and were harmed as a result.  This is a product liability case. 

On rebuttal, the defense reiterated that plaintiffs are claiming a duty to innovate and that, yes, manufacturers need to know whether and when the law imposes a duty to bring a product to market.  The defense also emphasized the consequences of creating a new duty.  Product development questions are not for juries to decide in hindsight 20 years after the fact.  The California Supreme Court protected incentives to develop and market new and beneficial drugs in Brown v. Superior Court, and the Court of Appeal should not create new duty that would undermine those incentives. 

We have a few observations after reflecting on this oral argument.  First, we agree with the defense that the Court of Appeal can and should confront and decide the core issues of duty presented by this petition.  There was some argument regarding waiver and preservation of issues (which we spared you in our recap).  But, in the end, the advocacy on both sides was top rate, and the panel was engaged.  No court will be better equipped to decide these issues anytime soon. 

Second, no matter the outcome, a petition for review to the California Supreme Court is certain.  The Court of Appeal clearly understands this too, as the panel expressly noted that it was not taking the matter under submission.  That is highly unusually under California procedure.  Because the statutory clock for filing an opinion in California starts ticking upon submission, the Court of Appeal has basically granted itself an unlimited extension of time.  The Presiding Justice said that the Court might request more briefing, or it might take the matter under submission on a later date.  Either way, the Court admonished the parties to “not call us, we’ll call you.”  They know their opinion will be subject to scrutiny and will take their time. 

Third, we could hazard a prediction of the outcome, but could not do so with any certainty.  The panel clearly understood from the beginning that the plaintiffs were asserting a negligence liability theory separate and apart from products liability (“old world negligence”), but the judges also explored the policy considerations more and more as the arguments progressed. 

Fourth, in our biased view, the defense has the better argument on the merits.  The plaintiffs are simply asking for too much.  If their claims really are unrelated to TDF drugs and instead focus only on the company’s purported delay in developing the allegedly safer TAF drugs, then it is difficult to see any limit to “failure to innovate” liability.  Taken to its logical conclusion, any person who might have benefitted from a product not yet on the market could claim that the manufacturer should have set different priorities or moved faster, including patients who received no treatment at all.  Would, for example, the advent of an effective anti-Alzheimer’s drug create claims for the millions currently afflicted by that condition?  That really would take the “product” out of product liability.  We also believe it is obvious that product development decisions should not be subject to 20/20 hindsight and that the Supreme Court’s endorsement of drug innovation in Brown v. Superior Court rings very loudly here.  Finally, the defense hack in us sees no one benefitting from this other than litigants and their lawyers.  A new duty to innovate will not result in more beneficial drugs coming to market, and it would likely have the opposite effect by penalizing companies that chose one development pathway other another, as all manufacturers do. 

We will keep you posted. 

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Today’s case, Ganz v. Grifols Therapeutics LLC, 2023 WL 5437356 (S.D. Fla. 2023), involves a biologic but also speaks to drugs and medical devices. The mixed decision dismisses design-defect and failure-to warn claims but allows manufacturing-defect and failure-to-recall claims to proceed. Although we’ll briefly summarize those rulings, the decision is more interesting for noting three issues that it does not resolve—issues involving preemption, pleading standards, and common-law duties.

The Ganz plaintiff alleges that her husband died after experiencing hypersensitivity to a biologic approved by the FDA. She asserted negligence, design-defect, failure-to-warn, and manufacturing-defect claims against the manufacturer and its holding company.

The court dismissed all claims aginst the holding company for lack of personal jurisdiction. It held that the plaintiff failed to carry her burden of establishing general or specific jurisdiction over the holding company because she offered no evidence to rebut an affidavit stating that the holding company was neither incorporated nor headquartered in the forum state and had not engaged in any claim-related conduct in the state. In short, the court applied the uncontroversial principle that conclusory allegations in a complaint are insufficient to overcome evidence tending to disprove jurisdiction. 2023 WL 5437356 at *4­.

As for the claims asserted against the manufacturer, some were dismissed while others were not.

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), because “[i]t would be impossible for [the manufacturer] to comply with both its state duty to change the composition of [the biologic] and its duty under 21 C.F.R. § 601.12(b)(2) not to make such a change without first obtaining FDA approval.” 2023 WL 5437356 at *7­.

Note, however, the caveat. The court dismissed the design-defect claim “as pleaded.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law. So understood, the claim rests on the contention that the manufacturer had a state-law duty to change the biologic’s composition notwithstanding the federal duty to leave the composition unchanged. Bartlett clearly forecloses such a clam.

But what if the plaintiff had instead pleaded a so-called “pre-approval design defect claim” premised on a supposed state-law duty to “have come up with a safer design prior to seeking FDA approval”? 2023 WL 5437356 at *7­. Would such a claim be preempted? Courts are divided. As we discussed here, the Sixth Circuit held such claims preempted in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), while as we discussed here, the Seventh Circuit reached the contrary conclusion in Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020). Yates was number one on our 2015 top-ten list; Kaiser was number three on our 2020 ten-worst list. That circuit split notwithstanding, the Ganz court “decline[d] to address” the issue, finding that the plaintiff had not pleaded a “pre-approval” design-defect claim in the complaint but had instead articulated it for the first time in opposition to the manufacturer’s motion to dismiss. 2023 WL 5437356 at *7­. Similarly, because the manufacturer had not raised it until its opening brief, the court refused to consider the manufacturer’s contention that “Florida products liability law does not permit a pre-approval design defect claim.” Id. at *7 n.6. The court directed the parties to brief the issue thoroughly if the plaintiff files an amended complaint purporting to assert such a claim.

Ganz dismissed the plaintiff’s failure-to-warn claim, but not on preemption grounds. Despite “reject[ing]” the plaintiff’s contention that Wyeth v. Levine, 555 U.S. 555 (2009), “broadly eliminates any preemption defense for a brand-name manufacturer of drugs,” the court concluded that the plaintiff’s failure-to-warn claim was not preempted because, in the court’s view, she adequately alleged the existence of “newly acquired” information that would have permitted the manufacturer to unilaterally change its label without prior FDA approval under the changes-being-effected regulation. 2023 WL 5437356 at *8. According to the court, the plaintiff adequately pleaded the existence of newly acquired information sufficient to justify a labeling change when she alleged that the manufacturer had recalled some lots of the biologic after receiving reports of increased rates of hypersensitivity. While there may be some facial plausibility to the court’s finding, it is hard to reconcile with the court’s simultaneous recognition that, “[i]n conducting a review of the safety of [the biologic] following [the manufacturer’s] voluntary withdrawal of certain lots, the FDA concluded … that the risk of hypersensitivity was adequately described in [the biologic’s] labeling.” Id. at *9. Regardless of that inconsistency, the court dismissed the failure to warn claim on Twombly grounds, holding that the plaintiff failed to plead any facts plausibly suggesting that the biologic’s label—which mentioned the risk of hypersensitivity seventeen times—was in fact inadequate. Id. at *10.

It is worth noting that although Ganz dismissed the failure-to-warn claim on pleading grounds, it sidestepped an interesting pleading issue—namely, whether a plaintiff must plead around preemption to avoid dismissal. On the facts of Ganz, the question would have been whether the plaintiff was required to plead facts plausibly suggesting the existence of newly acquired information that would have allowed the manufacturer to unilaterally change its label without prior FDA approval. Finding that the plaintiff had pleaded sufficient facts in any event, the court did not need to determine whether such facts were required to avoid dismissal on preemption grounds. But the pleading issue is a recurring one in medical-product litigation. Hoping to evade preemption for as long as possible, plaintiffs often argue that preemption is an affirmative defense, that plaintiffs are not required to plead around affirmative defenses, and that claims therefore cannot be dismissed on preemption grounds at the pleading stage. When confronted with such an argument, defense counsel should point to the many cases granting motions to dismiss on preemption grounds and remind courts that plaintiffs are frequently required to plead around affirmative defenses, such as the statute of limitations, to avoid dismissal.

Ganz allowed two claims to proceed:  a manufacturing-defect claim and a failure-to-recall claim.

As happens all too often, the court let the manufacturing-defect claim slide on very thin factual allegations. Although the complaint identified no purported manufacturing defect, the court thought the allegations of a manufacturing defect sufficiently plausible given that the FDA had evaluated the manufacturer’s manufacturing processes when trying to identify the cause of the increased rate of hypersensitive reactions. 2023 WL 5437356 at *12. The court did not offer, and we cannot think of, a reason why one could plausibly infer the existence of a manufacturing defect from the mere fact that the FDA had evaluated the manufacturer’s manufacturing processes.

Finally, the court held that the plaintiff had adequately stated a failure-to-recall claim, rejecting the manufacturer’s contention that the complaint failed to allege facts sufficient to adequately plead causation. But here again the court failed to address an interesting issue—whether there even is a common-law duty to recall a defective product. The court did not reach the question because the manufacturer did not raise it in its opening brief. But as we have noted here, here, and here, courts and the Restatement hold that there is no such duty.

Because it granted the plaintiff leave to amend, the Ganz court might yet have an opportunity to address the questions that it put to the side. Stay tuned.

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Tripolskiy v. Boston Sci. Corp., 2023 U.S. Dist. LEXIS 146689 (C.D. Cal. Aug. 18, 2023), is a case that has much to recommend it. The opinion is clear. It is short.  It is from the district where we once prosecuted criminals amidst the palm trees and smog.  Most important, Tripolskiy is a premarket approval preemption win involving a recalled device. 

The plaintiff sued the manufacturer of an implantable cardioverter defibrillator (ICD) because the battery depleted more quickly than it should have. He was not factually wrong about that. Indeed, the ICD  had been subject to multiple recalls because of the accelerated battery depletion. The plaintiff’s battery started beeping after four years, but the battery life had been represented to be over eight years. 

The manufacturer had mailed recall notices to field representatives and implanting surgeons, but the plaintiff alleged that the defendant had failed to furnish adequate notice to his physician.  The plaintiff filed his complaint in state court, but the defendant removed the case to federal court. Then the defendant got the case dismissed on the grounds of express preemption.  But the dismissal was without prejudice and the plaintiff was allowed to file a first amended complaint. That amended complaint included causes of action for negligence, strict liability, breach of warranty, concealment, misrepresentation, intentional infliction of emotional distress, etc. 

Again, the defendant moved to dismiss. 

 The ICD was a class III medical device, meaning it had gone through the FDA’s “rigorous” premarket approval (PMA) process and meaning that any legal claim seeking to impose any requirement “different from, or in addition to” FDA regulations was expressly preempted. Inevitably, the plaintiff tried to salvage his claim by invoking the dreaded and disdained (at least by us) parallel claim exception. (Aside from the “all deliberate speed” language in Brown v. Board, it’s hard to think of SCOTUS language that has visited more mischief on the law than the Riegel parallel claim ditty.)

The court in Tripolskiy did not buy the plaintiff’s parallel claim argument. Mind you, the court managed to worry us for a bit by reminding us that “[t]he Ninth Circuit is particularly hostile to motions to dismiss under Rule 12(b)(6).” But the SCOTUS requirement under TwIqbal of plausibility and concrete, non-vague factual allegations carried the day, at least for now. 

At the defendant’s request, the court took judicial notice of PMA materials, the recall notice, and the defendant’s public device lookup information from its website. The PMA materials on the FDA website were the sorts of things that courts will pretty much always judicially notice. The defendant’s website was a different matter, or at least it could have been.  The plaintiff did not dispute the judicial notice of the website. In any event, the website was considered as it related to notice, not the truth of the contents. 

The problem with the plaintiff’s amended complaint was that its recitation of FDA regulations was conclusory.  For example, references to failed process controls is so broad and vague as to be meaningless. The plaintiff listed FDA regulations without identifying how exactly the defendant violated them. Importantly, neither a device malfunction nor FDA recalls, by themselves, “create a presumption that FDA requirements have been violated.”  

Did we mention that the plaintiff was acting as his own attorney? As is too often the case, the court in Tripolskiy extended undue mercy to the pro se plaintiff, and permitted him to try again. It was not yet clear to the court that the allegation of other facts could not possibly cure the deficiency. 

Really?  Whither finality?

Still, Tripolskiy is potentially useful to the defense side re judicial notice and the effect of product recalls, so we should be grateful for that. 
*********************

In life, finality is not always welcome. 

Over the past year the DDL bloggers have lost loved ones, including a father and a sister, among others. There has been entirely too much death.  It hurts. The law matters a lot to us, but it is nothing compared to the departures of family and friends. 

Last week saw the sudden, untimely death of a lovely man, Mike Henningsen, who had the wisdom to marry into our family. He was kind and generous. He solved problems.  He had a ready grin and a hearty, authentic laugh. He always brought the fun. 

Mike shared our Bruce Springsteen fandom. A couple of years ago, he called to tell us he had tickets for a Springsteen concert in Glendale, Arizona. Good tickets. A five hour plane ride later, we were together in the pit, twenty feet from the Boss, and singing along to “Rosalita.” “I ain’t here on business baby/I’m only here for fun.”  Good times. 

On his current tour, Springsteen has been ending his concerts with “I’ll See You in My Dreams.”  We’d rather see Mike in his 1985 Targa, or at a game, or at the dining room table.  But for now, we’ll have to content ourselves with seeing Mike in our memories and dreams. 

“When all our summers have come to an end

I’ll see you in my dreams 

We’ll meet and live and laugh again

I’ll see you in my dreams 

Yeah, up around the river bend

For death is not the end

And I’ll see you in my dreams.”

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Not too long ago we discussed post-remand Pennsylvania Supreme Court filings in the Mallory personal jurisdiction matter. After reviewing both sides’ filings, we observed: “[U]nless the Pennsylvania Supreme Court in Mallory were to act contrary to the positions of both sides, the DCC issue will be decided promptly, on this appeal.”

Well, that’s exactly what happened. On August 29, the Pennsylvania high court entered this order:

AND NOW, this 29th day of August, 2023, Norfolk Southern Railway Company’s Application to Set a Briefing Schedule on Remand from the U.S. Supreme Court or, Alternatively, to Exercise King’s Bench or Extraordinary Jurisdiction is DENIED. Pursuant to Mallory v. Norfolk Southern Railway Company, 143 S.Ct. 2028 (filed Jun. 27, 2023), the judgment of the Court of Common Pleas of Philadelphia County is REVERSED, and the case is REMANDED to that court for further proceedings.

So no relief will be forthcoming on registration-based general jurisdiction from this quarter. We expect Pennsylvania courts, and particularly the unfortunate jury pools in Philadelphia and Allegheny Counties, to be burdened with large amounts of litigation having nothing whatever to do with the Commonwealth.

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Plaintiff in Gurule v. Boston Scientific Corp., 2023 Cal. Super. LEXIS 49321 (Cal. Super. Jul. 18, 2023), tried to pull off a little magic through misdirection, but couldn’t fool the court.  Plaintiff tried to distract the court from the complete lack of sufficient allegations to satisfy even notice pleading requirements by alleging an elaborate conspiracy among the manufacturer, the prescribing surgeon, and apparently a group of urologists at USC.  The “conspiracy” was based on the surgeons doing things like attending manufacturer sponsored events, consulting for the manufacturer, and receiving grants and sponsorships.  Essentially, all the things doctors and medical device manufacturers do – collaborate on product development and education.  Comes as little surprise that that was not enough to keep the case alive.

Plaintiff underwent surgery to implant a penile prosthesis and alleges that he has suffered complications since the surgery.  The device is a Class III, Pre-Market Approved prescription medical device.  Which means plaintiff had to allege claims that were not expressly preempted by Riegel v. Medtronic, Inc., 552, U.S. 312 (2008).  Something they did not do for failure to warn.  Plaintiff’s only failure to warn allegations were that defendant needed to include warnings that were different from or in addition to those approved by the FDA.  While plaintiff stated that he was asserting a parallel claim – saying it and doing it are two different things.  Gurule, at *17-18.  The court also found that plaintiff’s allegations “hinge[] entirely on FDA and PMA violations.”  Id. at *18.  Since they were based on the FDCA rather than California state law, the claims were also impliedly preempted. 

But that was not the only problem with plaintiff’s failure to warn claim.  California adheres to the learned intermediary doctrine and plaintiff failed to allege that his physician was not adequately warned.  Id. at *20.  And while a failure to report adverse events to the FDA is not preempted in California, plaintiff failed to include any of the necessary allegations to sustain such a claim – that any adverse events were not reported; that the FDA would have made them public; or that his surgeon relied on the FDA database.      Id.

None of plaintiff’s remaining claims fared any better.  His manufacturing defect claim was dismissed as entirely conclusory.  No defect, no malfunction, no causation.  Id. at *21-22.  Negligent misrepresentation was done in by the learned intermediary doctrine because defendant’s duty ran to the implanting surgeon, not plaintiff.  Id. at *23.  Plaintiff’s breach of express warranty claim was unsupported by any allegations that defendant made any representations to plaintiff’s surgeon that formed the basis of the bargain.  Id. at *25.  Finally, California’s Unfair Competition Law provides only a derivative claim.  With no other viable claim, plaintiff’s UCL claim also failed. Id. at *24.       

If plaintiff is going to try to pull a rabbit out of a hat, they better have more up their sleeve than a quasi-conspiracy.

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When we last commented on the Alliance for Hippocratic Medicine v. FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.”

In continuing the stay, the Fifth Circuit recently clipped the district court’s decision (which purported to take mifepristone off the market altogether) still further, but in our opinion, still not enough.  While we’re tempted to launch into another diatribe about:  (1) the absurdity of what amounts to the issuance of a merits decision on drug regulation – not on the basis of the huge amount of science the FDA considered – but solely in the allegations of a complaint filed by an anti-choice political group, and (2) the bizarre concurrence by a judge some consider “the worst Trump Judge in America,” we’ve decided to stick (for now) to the implications of Alliance for Hippocratic Medicine v. FDA, ___ F.4th ___, 2023 WL 5266026 (5th Cir. Aug. 16, 2023) (Hippo III), which are significant enough.

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products.  That’s why Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), is so important.  It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions.  It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation.  E.g., Estee Lauder, Inc. v. FDA, 727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whether a state requirement can safely be ignored”), aff’d, 67 F.3d 1268 (7th Cir. 1995), vacated on other grounds, 518 U.S. 1030 (1996).

Thus, for what we do, the most disturbing aspect of Hippo III is the extraordinarily low bar it sets for “standing” to challenge the validity of FDA actions.  If that bar is not re-raised, any medical crank in the country can try to overturn FDA product approvals.  Just think about how antivax nuts could attempt to attack COVID-19 (or any other) vaccine if the “substantial risk” of “future injury,” Hippo III, 2023 WL 5266026, at *6, necessary for standing to file suit amounts to only a ”fairly likely” possibility that “one of them” might suffer one of four purported “injuries.”

  • They “must participate in the medical treatment that facilitates” something they don’t like.
  • “[T]reating [allegedly adversely affected] patients imposes mental and emotional strain above what is ordinarily experienced in an emergency-room setting.”
  • “[P]roviding emergency treatment forces the Doctors to divert time and resources away from their ordinary patients, hampering their normal practice.”
  • “[P]atients [allegedly injured by the FDA-approved product] involve more risk of complication than the average patient, and so expose the Doctors to heightened risk of liability and increased insurance costs.”

Id. at *7-8.

Remember, the product in Hippo III is an FDA-approved prescription medical product.  There is a reason that a physician’s prescription is required for this kind of product – by definition, it comes with sufficient risks that medical supervision is necessary to approve its use.  If mifepristone’s approval is subject to attacks on this flimsy sort of purported injury, then so is practically any other FDA-approved prescription product.  The complaint is full of exaggerations of the purported risks of mifepristone that the procedural posture of Hippo III forces the court to accept as “true,” but those exaggerations are false.  To take one of a myriad of publicly available examples:

Data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

Comparatively, the risk of death by penicillin − a common antibiotic used to treat bacterial infections like pneumonia − is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions.  Risk of death by taking Viagra − used to treat erectile dysfunction − is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

CNN, “How safe is the abortion pill compared with other common drugs” (april 21, 2023)

Neither penicillin nor Viagra is subject to mass tort litigation (although plaintiffs tried with the latter).  Plaintiffs – or purportedly “public interest” medical groups acting at their behest – are certainly capable of making the same sort of allegations found in against any targeted FDA-approved prescription medical product.  If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened.  Every mass tort could well be accompanied by a “second front” of belated collateral attacks on the FDA’s regulatory approvals, REMS, conditions of use, and who knows what other FDA actions.

On what level of risk?  Well, the rate of “severe conditions” stated in Hippo III as the basis for allowing standing ranged between 0.02% (two in ten thousand) and 0.06% (six in ten thousand).  2023 WL 5266026, at *8.  The majority of prescription drugs have significantly higher risks, indeed many come with boxed warnings. Moreover, the Hippo III plaintiffs also contend that “they are injured by treating women who experience less urgent medical side-effects.”  Id. at *8 n.2.  If the supine standing analysis in Hippo III is indeed the law – rather than “a ticket for one train only” invented by three Republican judges for anti-choice political reasons, then the barriers that have traditionally existed to collateral attack of FDA (and other administrative) decisions no longer exist.  Linda Greenhouse, “Thinking About the Supreme Court After Bush v. Gore,” 35 Ind. L. Rev. 435, 436 (2002).

Yet bad as it is, the risk analysis in Hippo III is the most testable of the purported standing criteria.  Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.  2023 WL 5266026, at *11.  If this is the law, the law is an ass – and we can look forward to vastly increased litigation involving administrative agencies of all sorts.

Hippo III does the same damage to the concept of legally “cognizable injury.”

[T]hreatened injuries must also be legally cognizable.  The injuries here are.  To begin, economic harm − like damage to one’s business interest − is a quintessential Article III injury.  The Doctors therefore sustain a concrete injury when they are forced to divert time and resources away from their regular patients.  And by the same token, the Doctors sustain a concrete injury when mifepristone patients expose them to greater liability and increased insurance costs.

2023 WL 5266026, at *14 (citations omitted).  The conclusion simply does not follow.  Can plaintiffs sue over anything that might threaten to increase their insurance premiums?  If that’s true then everybody can sue over increased flooding from climate change.

But it’s not true – the law is not an ass.  Before Hippo III, the idea that increased insurance premiums as damage from use of prescription medical products has been considered nutty and well beyond the scope of private litigation.  In fact, somebody actually tried and drew back a nub.  See Enriquez v. Johnson & Johnson, 2021 WL 5272370, at *3 (N.J. Super. App. Div. Nov. 12, 2021) (no negligence claim because pharmaceutical company “owed no duty of care” not to increase plaintiffs’ insurance premiums; “The nature of the risk to consumers of health insurance is too far removed [from defendants’ conduct], and any risk too attenuated, to find as a matter of fairness that a duty should extend to such outer limits.”).

Thus, quite apart from any political views on the abortion issue itself, we strongly oppose the dumbed-down standing requirements that Hippo III appears to have authorized.  This result threatens the integrity of the system of federal prescription medical product regulation that has served this country well for nearly a century.  It also threatens our client’s ability to rely on the FDA’s expert decision-making in prescription medical product liability litigation.  Hippo III is anti-law, anti-science, anti-government, and anti-common sense.

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Thirteen years litigating the same case is a looooong time.  Absurdly long.  Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments.  Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones and instant messages.  Long enough for new judges to be appointed by multiple presidential administrations, while erstwhile stalwarts of the bench take senior status or retire.  Circle of life.  You get the picture.

Perhaps the biggest downside of litigation lasting so long is cost.  Litigation is ridiculously expensive, and spending more than a decade litigating one case must really, really add up.  But apparently there can be an upside to a slow pace too:  With that much time, new evidence can materialize that improves the liability picture. 

We saw that happen in the Zofran litigation.  Zofran initially was approved as an anti-nausea medication for chemotherapy patients.  As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. 

Litigation began over alleged birth defects in 2015 and whether the manufacturer should have added warnings about that issue.  Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects.  Eventually, in 2021, it allowed a label change—but not one the plaintiff wanted.  Instead, the new label merely stated that current data precluded an assessment of teratogenic risk.  See Perham v. GlaxoSmithKline LLC (In re Zofran Ondansetron Prods. Liab. Litig.), 57 F.4th 327 (1st Cir. 2023). 

In Zofran, the passage of time helped crystalize the FDA’s regulatory stance about the proposed birth defect warning.  Events that took place years after the lawsuit started led the court to eventually agree that there was “clear evidence” the manufacturer had “fully informed the FDA of the justifications for the warning . . . and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”  Id. at 341.  With clear evidence the FDA would not allow the warning the plaintiff said should have been given, the entire MDL was deemed preempted, pursuant to Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019)and Wyeth v. Levine, 555 U.S. 555 (2009).  A good result, but a long time coming.

The same dynamic that resulted in a win in Zofran now has resulted in a win in a False Claims Act case, United States ex rel. Krahling v. Merck & Co., 2023 U.S. Dist. LEXIS 135853 (E.D. Pa. July 27, 2023). 

In Khraling, two qui tam relators contended that false claims were submitted to the federal Center for Disease Control and Prevention (CDC), which purchases mumps vaccines for its “Vaccines for Children” program.  Mumps is a once-prevalent childhood disease that can cause meningitis, encephalitis, sudden onset deafness, and even death. 

Starting with the initial mumps vaccine approval in 1967, the FDA extensively regulated the vaccines’ labeling.  This oversight included a mid-1990’s review of labeling—driven by the National Childhood Vaccine Injury Act, 42 U.S.C. § § 300aa-1-34—regarding the potency of the mumps portion of the MMR-II vaccine (a vaccine for measles, mumps, and rubella).  The Khraling relators nevertheless filed their false claim lawsuit in 2010 alleging that the manufacturer misled the CDC about the potency of its mumps vaccines. 

“Years of discovery” then followed.  Nine, to be exact.  Years of summary judgment practice followed that.  Over three, apparently.  With the case reassigned to a new judge in the middle.

So, after all that, was there evidence the federal government was misled about the potency of the mumps vaccines it purchased?  No, of course not.  Not only had the FDA evaluated the mumps potency issue before the lawsuit was filed, Khraling, 2023 U.S. Dist. LEXIS 135853 at *45, the government’s post-filing conduct also confirmed it was not misled.

First, the filing of the qui tam action led the government to investigate the claims and, after it did so, the DOJ declined to intervene in the case, suggesting it did not see a problem with the vaccine purchases.  Second, even after the court authorized the relators’ expert (Dr. Kessler) to submit his opinions and evidence about the mumps vaccine potency issue to the FDA and CDC, the CDC continued to purchase the mumps vaccines, and the FDA did not take any action either.  In other words, the government’s (lack of) response to the relators’ false claims allegations meant that the information just wasn’t material to the CDC’s decision to buy the vaccine.  Id. at *58.  No materiality means no false claims, and thus thirteen years of litigation ends with summary judgment in the defendants’ favor. Another good result, but again, a long time coming.

The Krahling opinion provides a good reminder that the regulatory history for an on-market pharmaceutical, device, or vaccine is not static.  With a bit of time (preferably not too much), regulatory events might even develop, post-litigation, in a way that strengthens your factual position and preemption arguments.

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Here is another guest post by Reed Smith‘s Kevin Hara examining the exclusion of a couple of slapdash expert witnesses, and the resultant grant of summary judgment. Since it is summer time, it is only fitting that he does so using baseball analogies. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.

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Baseball has always held a special place in American society, and while it is no longer revered to the same degree as it once was, few things are more evocative of summer and tradition than this remarkable sport.  This guest blogger is admittedly biased, having spent the majority of his formative years in one of baseball’s true havens, St. Louis, Missouri, home of the team who wears the Birds on the Bat—the Cardinals.  Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention, a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams.  Remarkably, the Cardinals have not finished last in the National League in more than a century, since 1918, around the time World War I ended.  At its essence, success in baseball depends on preventing your opponent from scoring runs, relying on pitching and defense, and plating runs of your own based on your offense.  With the exception of this season, the Cardinals have generally excelled at the fundamentals, one of the reasons for their long-standing success. 

However, there is a truly spectacular story unfolding this year, as a phenomenal once-in-a-lifetime athlete, Shohei Ohtani of the Los Angeles Angels is in uncharted territory—as a dominant starting pitcher and nearly unstoppable hitter who just achieved the unparalleled feat of pitching a complete game shutout in the first game of a doubleheader and hitting two gargantuan home runs in the second.  Oh(tani), and in subsequent game he hit another home run.  He is, at the same time, a force in both run prevention and run creation, which combines, for this Cardinals fan, Albert Pujols and Bob Gibson.

This combination brings us to today’s case, MacSwan v. Merck & Co., 2023 U.S. Dist. LEXIS 103532 (W.D.N.Y. June 14, 2023).  While MacSwan may not be as sublime as the season Ohtani is enjoying, it is a best-of-both-worlds scenario, because the defendant successfully moved to exclude Plaintiff’s experts on causation and moved for summary judgment on Plaintiff’s failure to warn and breach of implied warranty claims, effectively playing both solid defense and winning offense in one fell swoop.  Incidentally, Fosamax litigation (a different MDL) has yielded some monumental decisions, including one of the worst cases of 2017 and the Supreme Court’s subsequent reversal.

Plaintiff ingested Fosamax, an oral bisphosphonate used to prevent and treat osteoporosis, and alleged it caused her to suffer osteonecrosis of the jaw (“ONJ”).  Id. at *1-2.  The court exercised its “gatekeeping” function under Rule 702 to assess whether the methodology underlying Plaintiff’s proffered expert testimony was “scientifically valid” and whether it could “be [properly] applied to the facts in issue.”  Id. at *3 (internal quotation marks and citations omitted).  Plaintiff had two experts, Dr. Morhaim, on causation and Dr. Merchant, a supposed treater.  Like Dr. Seuss, I’ll refer to them as M1 and M2, respectively.  Neither passed Rule 702 muster.  Id.

M1 was a periodontist with expertise in “oral implantology,” with a “full-time periodontal and implant practice,” and two decades as an expert legal consultant.  Id. at *6.  He opined Plaintiff’s “adverse dental condition was BRONJ, [ONJ associated with bisphosphonate use] and was directly due to her taking the oral medications Fosamax and Atelvia.”  Id. at *7.  M1 had read literature “pertaining to bisphosphonates,” and worked with patients taking such medications, requiring him to “understand and explain” the products’ risks and benefits—qualifying him to “opine generally regarding the diagnosis and treatment of ONJ.”  Id. at *8-10.  In addition to his general expertise, he sought to “offer general and specific causation opinions that Fosamax caused Plaintiff’s injuries.”  Id. 

However, M1 was the medical equivalent of a pinch hitter.  He “never treated or examined Plaintiff; . . .neither reviewed all of Plaintiff’s relevant medical and dental records, nor cite[d] to specific scientific studies or data to support his opinion.”  Id. at *7-8. (emphasis added).  In other words, M1’s opinion did not rest on sound methodology, leading the court to reject it:

[M1] testified in deposition that he had read relevant scientific literature during his career, including various articles mailed to his home, however, he could not cite any particular article and his report references no scientific literature or clinical data. This is not the level of scientific rigor that would be expected in his profession.

Id. at *12 (internal citations, brackets and quotation marks omitted).  His “informal discussions with colleagues and his diagnosis of ONJ in five patients taking bisphosphonates,” failed to provide a reliable basis for general causation because his experience was “confined” to those cases and entailed “diagnosing” the condition, not “ascertaining its causation.”  Id. at *12-13.  As the court aptly stated, his experience with any nexus between Fosamax and ONJ was “extremely limited.”  Id. at *13.  Plaintiff took a big swing and a miss on general causation for her first strike.

M1’s specific causation opinion was similarly suspect.  For instance, he reviewed only “some of Plaintiff’s medical records,” and did not review Plaintiff’s pre-2010 dental records, which documented she was already missing a number of teeth.  Id. at *13, 17.  Likewise, his conclusion that Plaintiff’s ONJ was “directly related to her bisphosphonate use” hinged on his theory that the “effects of Fosamax were present” in Plaintiff’s body for nearly 2 decades based on its lengthy half-life—an assertion for which he “fail[ed] to cite a source.”  Id. at *13.  M1 further admitted not knowing whether Fosamax remained pharmacologically active even if it remained buried in the bone for a prolonged period.  Id.  The court was unable to determine whether this half-life hypothesis was “based on sufficient facts or data.”  Id. at *14 (citation omitted).  M1’s reliance on his selective review of Plaintiff’s treatment records further undermined the reliability of his opinion that Plaintiff even had BRONJ, as did his failure to properly exclude potential alternative causes—such as a partial denture and smoking—which he admitted could cause dental infections.  Id.  at *17-18.  Nor did M1 adequately account for the effects of Atelvia, another oral bisphosphonate Plaintiff ingested, despite acknowledging it carried similar risks of ONJ.  Id. at *21.  He inexcusably saw “no reason to [rule out alternative causes],” based on his conclusory testimony that “if the patient is on [Fosamax] and there is clinical evidence of BRONJ, then it’s related and caused by that medication being in the patient’s system”—a BRONJ diagnosis “by definition.”  Id. at *19. (internal quotation marks and punctuation omitted).  This is quintessential ipse dixit testimony that falls far short of Rule 702 standards, and the court agreed, excluding all M1’s causation opinions because they lacked the requisite reliability, and allowing him to offer such opinions would be “highly prejudicial.”  Id. at *22-23.  After another swing and a miss on causation, Plaintiff was now down two strikes.

Plaintiff attempted to have her treating infectious disease specialist M2 offer an opinion based on his treatment that plaintiff had osteomyelitis and that her CT scan showed ONJ, but like M1 (in addition to not being disclosed under Rule 26), that opinion was riddled with unreliability.  For instance, ONJ is not an infectious disease, and M2 had neither researched nor lectured regarding oral bisphosphonates, and had no training as a dentist or oral surgeon.  Id. at *23.  Nor did he review Plaintiff’s medical or dental records or speak to Plaintiff’s dentists.  That’s a lot of “nots,” but the worst was that M2 was “unaware of when, how long, and what dosage” of Fosamax Plaintiff ingested.  Id. at *24.  M2 admitted Plaintiff was diagnosed with BRONJ prior to his examination, and he examined Plaintiff only twice.  Id. at *25.  Therefore, the court limited any testimony to his treatment of Plaintiff on those occasions, including review of CT scans and lab records and his observations of such information.  Id. at *27.  However, recognizing treating physicians attempting to offer causation opinions are subject to Rule 26, the court prohibited M2 from so opining—“including any opinion in Plaintiff’s medical records that she had BRONJ” which would “impermissibly allow him to serve as a conduit for another witness’s testimony.”  Id. at *28 (emphasis added).  This was Plaintiff’s third strike on causation, and in baseball terms, she—and any expert causation testimony—was now out.

Next, it was the defendant’s turn to step to the plate, moving for summary judgment.

Although there were disputed facts regarding the timing and duration of Plaintiff’s Fosamax use, they were not material to Plaintiff’s claims regarding the adequacy of the warning label, the alleged failure to warn Plaintiff’s prescribing physician, or breach of the implied warranty of merchantability.  Id. at *41-42.  Plaintiff asserted negligence and strict liability failure to warn claims, which are analyzed identically under New York law, under the standard of what a reasonable manufacturer knew or should have known.  Id. at *42.  To prevail on a failure to warn claim, Plaintiff had to prove that the defendant’s warning to the prescribing physician was inadequate and that such inadequacy caused her alleged injuries.  Id. at *43.

Plaintiff started taking Fosamax in 2001, and he argued Defendant’s failure to update its warning label to include information about the risk of ONJ until 2005 was actionable.  Id. at *45.  Putting aside that defendant could not unilaterally alter its label using the FDA’s Changes Being Effected regulation, based on the court’s exclusion of M1’s and M2’s testimony, Plaintiff could offer “no admissible expert testimony regarding a causal association between Fosamax and ONJ” prior to 2005.  Id. at *48-49.  Nor could Plaintiff fill that void by relying on expert testimony from other cases.  Id. at *49.  Expert testimony was necessary to address complex issues including the “causal relationship between Fosamax and ONJ” before 2005.  Id. at *50.  Absent such evidence, Plaintiff could not show any warning inadequacy in the Fosamax label, negating an essential element of her failure to warn claim.  Id.  So medical causation was absent.

However, even if the pre-2005 Fosamax label’s warning were inadequate, Plaintiff still “must demonstrate that had a different, more accurate warning been given, her physician would not have prescribed the drug in the same manner.”  Id. (internal quotation marks, punctuation and citations omitted).  Plaintiff failed to produce evidence that her prescribing dentist would have changed or discontinued her Fosamax if the drug had carried a different warning.  Id. at *50-51.  Rather, Plaintiff admitted her treater continued to prescribe Fosamax after the 2005 ONJ warning label update, and in 2007 her dentist knew about the “association between oral bisphosphonates and ONJ, but he also did not advise Plaintiff to cease taking them.”  Id. at *51.  As such, the failure of Plaintiff’s physicians to change their prescribing behavior, despite knowledge of the purported risks of ONJ meant Plaintiff could not prove any warning inadequacy proximately caused her alleged injuries.  Id.  Accordingly, the court granted summary judgment because there was no triable issue of fact “as to the adequacy of Defendant’s pre- or post-2005 warnings and whether Plaintiff’s treatment providers altered their prescribing decisions if a different [warning] was provided.”  Id. at *52.  Warning causation failed as well.

Plaintiff’s breach of implied warranty claim required her to establish “the product was not minimally safe for its expected purpose—without regard to the feasibility of alternative designs or the manufacturer’s reasonableness” in marketing the product.”  Id. at *53 (internal quotation marks and punctuation omitted).  Plaintiff produced no evidence that Fosamax was not “minimally safe,” as M1 admitted the risk of Plaintiff developing ONJ was “very low,” and that Fosamax’s benefits exceeded its risks.  Id. at *54.  The court granted summary judgment on Plaintiff’s implied warranty because she failed to show Fosamax was not “minimally safe.”  Id. at * 55.

In addition to pitching a shut out by successfully moving to exclude Plaintiff’s expert testimony on general and specific causation, Defendant successfully went to bat and hit a game-winning summary judgment home run.  As the Cardinals’ long-time Hall of Fame broadcaster Jack Buck used to declare at the end of every triumph, “That’s a winner!”

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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