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It’s MLB playoff season and once again the Milwaukee Brewers are at the top of the field. They, along with the Philadelphia Phillies and the Chicago Cubs, have all secured a home-field advantage in the playoffs. That means those teams have the tactical edge of getting the final at-bat in each inning and overall. They also play on their own field, usually in front of their own fans–where they feel more comfortable. Simply put, historically, home teams win more. So, it’s not surprising that in litigation too, everyone wants home-field advantage. Plaintiffs want to stay in state court with sympathetic juries, while defendants prefer the cool neutrality of federal court. And yet, time and again, plaintiffs try to thwart federal jurisdiction by naming local pharmacies or hospitals as defendants to defeat diversity.

The plaintiff in today’s case did just that. But the court was having none of it. First, the decision finds the pharmacy was fraudulently joined because Illinois does not recognize either failure to warn (with a limited exception) or strict liability claims against pharmacies. Second, when faced with dismissal of the non-diverse defendant, plaintiff tried to pull a jurisdictional bait-and-switch: seeking leave to amend her complaint to add another non-diverse entity as a defendant. An entity she knew about at the time of filing her complaint but didn’t sue until the case had made its way to federal court and she was facing denial of her motion to remand.  Baseball is a game, litigation is not. The court did not entertain plaintiff’s gamesmanship. 

In In re Depo-Provera Products Liability Litigation, 2025 U.S. Dist. LEXIS 186000 (N.D. Fla. Sep. 22, 2025), the court was presented with an individual plaintiff’s motion to remand her case which she brought against the manufacturer of the drug and the local pharmacy where she filled the prescription. The removal argued that the pharmacy was fraudulently joined.  

Plaintiff’s first argument in favor of remand was that removal was improper under the forum defendant rule which provides that a case cannot be removed if any properly served and joined defendant is citizen of the state where the action is brought.  But since a fraudulently joined defendant cannot be “properly” joined, fraudulent joinder is an exception to the forum defendant rule.  Id. at *7-8.

Plaintiff next argued that joinder of the pharmacy was not fraudulent because she had a valid failure to warn claim. But the law is clear: “Illinois pharmacies have no duty to warn patients/consumers or doctors of the adverse effects of the prescription drugs they dispense, absent one narrow circumstance.” Id. at *9. The underlying rationale is that it is the doctor who knows the patient best and should be making prescription and treatment decisions, not the pharmacist.  The narrow exception to the rule, absent here, is when the pharmacy knows a customer is susceptible to adverse consequences of the drug—such as a known allergy or known contraindication. But the courts have made clear that pharmacists have no duty to investigate or learn about such conditions, only that if known they should act in accordance with that knowledge.  Id. at *9-10.  Here, not only did plaintiff plead no facts showing the pharmacy had specialized knowledge, the complaint alleged that plaintiff returned to her physician to administer the injectable drug. “Given these facts, there is no question that interjecting a duty to warn on the part of [the pharmacy] in this case could interfere with the prescribed treatment and disrupt the physician-patient relationship.”  Id. at *14.

Plaintiff next argued that her strict liability design defect claim was also viable against the pharmacy because Illinois law imposes liability on every entity in the distributive chain. To which the court responded:

After a thorough review of the case law on this issue, the [court] is convinced that Illinois law does not recognize a claim for strict liability design defect against a dispensing pharmacy for a prescription drug. . . . Indeed, under Illinois law, there is a decades-long recognition of the need to shield healthcare providers who ‘pledge[] to protect human life and health,’ in part by implementing a public policy that ‘dictates against the imposition of strict liability’ in order to avoid a diminution in those protections.   

Id. at *16-17 (citations omitted).

In other words, public policy dictates a “special standard” for prescription drugs that necessitates an exception to the general rule that would impose strict liability in the marketing chain. Id. at *18.  The policy exception has routinely been extended to pharmacies recognizing that holding a pharmacy strict liability for injuries allegedly caused by ingestion of the drugs it dispenses “would impose on the retail druggist the obligation to test, at its own expense, new drugs” and in turn the “costs to society which needs and values the pharmaceutical products sold by druggists, would be unduly high.” Id. at *19.

Accordingly, because Illinois would not recognize either a failure to warn or a strict liability action against the pharmacy, it was dismissed.  Thereby establishing complete diversity and proper federal jurisdiction. But plaintiff tried one more trick—moving to amend her complaint to add another non-diverse defendant, Planned Parenthood, at which plaintiff also received the drug and related treatment. 

Federal courts, under 28 U.S.C. § 1447(e), have the discretion to deny joinder of non-diverse defendants after removal. And thank goodness they do. Otherwise, we’d be watching a nonstop circus of plaintiffs dropping non-diverse defendants into complaints like surprise party guests. Adding non-diverse parties post-removal to manufacture a remand is forum shopping dressed up as due diligence.  The court’s discretion under § 1447(e) is guided by four factors: plaintiff’s motive, the timeliness of the request to amend, whether denying amendment will significantly injure the plaintiff, and any other “relevant equitable considerations.” Id. at *20-21.   

As to both motive and timeliness, pharmacies/health care providers aren’t exactly covert operatives. They don’t sneak under the radar. If you’re filing a product liability lawsuit about a prescription drug, you know where you filled the prescription. You were there.  In fact, in this case, plaintiff’s original complaint contains allegations about Planned Parenthood’s role in providing the drug to her, but she did not seek to name it as a defendant until 5 months after filing, 3 months after removal, and 1 month after defendant’s motion to dismiss.  Id. at *23.  Suspicious timing indeed.

Nor is plaintiff at risk of being significantly injured if amendment is denied. The statute of limitations has not run.  While perhaps not the most convenient, plaintiff could separately pursue her claims against Planned Parenthood in a parallel state court action. Id. at *24. The court found no other relevant equitable factors worthy of consideration and therefore denied the motion to amend. 

The decision is great on both Illinois pharmacy law and fraudulent joinder.  Now, let’s go Phils!

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As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects.  A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,” “consumer alert,” or “public service health announcement” to disguise their solicitation, “display[ing] the logo of a federal or state government agency in a manner that suggests affiliation with the sponsorship of that agency,” and calling something a “recall” although that “product that has not been recalled by a government agency.”  Recht v. Morrisey, 32 F.4th 398, 406 (4th Cir. 2022) (affirming constitutionality of state legislation prohibiting these practices).

However, we recognize that attorney advertising is First Amendment protected commercial speech.  E.g., Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).  It is also big business – as discussed in the recent ATRA publication, “Legal Services Advertising in the United States”:

Trial lawyers and aggregators increasingly spend large sums of money on advertising to recruit new clients for class action lawsuits.  In 2024, it is estimated that more than $2.5 billion were spent on more than 26.9 million ads for legal services or soliciting legal claims across the United States. When compared with the same time period in 2020, spending on these ads increased more than 32%.

Id. at Introduction & Background (unnumbered page 2).  Our current Secretary of HHS certainly knows this, as he formerly worked at Morgan & Morgan, which is by far the most prolific plaintiff lawyer advertiser of all.  Id. at p.8 (M&M spent almost 4 times as much on advertising as any other p-side firm).

Marketing of prescription medical products is also widespread.  As the Supreme Court held in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (our post here) – “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”  Id. at 557.  Sorrell held a state statute that attacked pharmaceutical marketing unconstitutional as a content-based speech restriction.  That statute “disfavor[ed] marketing, that is, speech with a particular content.  More than that, the statute disfavor[ed] specific speakers, namely pharmaceutical manufacturers.”  Id. at 564.  That pharmaceutical marketing was also “commercial speech” didn’t matter where the government attempted suppress it on a “viewpoint”-related basis:

[The statute] imposes more than an incidental burden on protected expression.  Both on its face and in its practical operation, [the] law imposes a burden based on the content of speech and the identity of the speaker.  While the burdened speech results from an economic motive, so too does a great deal of vital expression.  [The] law does not simply have an effect on speech, but is directed at certain content and is aimed at particular speakers.

Id. at 567 (citations omitted).

The FDA recently sent out a flood of vague, nearly identical form “warning letters” that attacked a particular type of pharmaceutical marketing – direct-to-consumer (“DTC”) advertising – as supposedly “misleading” without identifying any particular advertisement run by the recipient or any particular “misleading” attribute of any such advertisement.  This is a dramatic change from FDA practice, with warning letters previously being directed at specific ads, specific allegations of violations, and proposing specific remedial action.  Moreover, the accompanying  FDA “news release” does not does not read like any regulatory document that we’ve ever seen, but rather like a plaintiffs’ lawyers diatribe, calling DTC advertising that has been legal (and not tortious) for decades as a “pipeline of deception” and vaguely attacking “deceptive practices” and “increasingly lax” FDA enforcement in order to “hold the pharmaceutical industry accountable.”  That’s not even-handed regulation; that’s a p-side closing argument  Id.  And there’s more.  The FDA even threatens high-tech surveillance of pharmaceutical advertising:

Going forward, the agency will aggressively deploy its available enforcement tools.  The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.

Id.

This blunderbuss approach is every bit the sort of viewpoint-based attack on pharmaceutical advertising, and in particular on DTC advertising, that was held unconstitutional in Sorrell.  The same sort of intent to suppress pharmaceutical free speech that was present in Sorrell (“preventing [drug] detailers − and only detailers − from communicating . . . in an effective and informative manner,” 564 U.S. at 564), practically oozes from every pore of the FDA’s broad and vague attack.  Indeed, this action is probably more violative than Sorrell of the First Amendment, since its broad and vague threats of enforcement and surveillance smack of both a prior restraint and a blatant attempt to chill pharmaceutical free speech (except for plaintiffs’ lawyers) generally.

So both lawyer advertising and pharmaceutical advertising are big business.  The current HHS regime – now run by a plaintiff’s lawyer – plainly seeks to tilt the playing field so that plaintiffs’ lawyers have free reign, while suppressing speech from the other side.  That would have the effect of making the media even more dependent on lawyer money for its revenue than it is now.  We don’t think that’s fair, or constitutional.  As we said over eight years ago:

The bottom line is this:  Lawyer advertising holds no preferred position among types of commercial speech.  Indeed, there are no “types” of commercial speech – it’s all the same constitutionally.  So when attorneys on the other side advocate bans on truthful manufacturer speech, because supposedly even truthful off-label information is a threat to the public health, they should remember that the same thing can be said about truthful attorney advertising.

We’re quite willing to apply the same standards to both sides.

We’ve detailed the FDA’s very checkered history when it comes to the First Amendment and suppression of manufacturers’ truthful scientific speech.  We fully expect to see another round, and assuming current precedent holds, to see the FDA take it on the chin once again.

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The title of today’s post is from a quote by Justice Holmes in a dissenting opinion, Abrams v. United States, 250 U.S. 616, 630 (1919).  Abrams involved a conviction under the Espionage Act based on the publication of leaflets that were distributed in New York during World War I. Among other things, the leaflets denounced President Wilson as a hypocrite and a coward, and lamented the “hypocrisy of the plutocratic gang in Washington and vicinity.” Id. at 620.  In his dissent (joined by Justice Brandeis), Justice Holmes espoused the power of free speech in connection with our country’s experiment with its Constitution. Or, as Justice Holmes more eloquently put it: “It is an experiment. All life is an experiment. Every year if not every day we have to wager our salvation upon some prophecy based upon imperfect knowledge. While that experiment is part of our system[,] I think that we should be eternally vigilant against attempts to check the expression of opinions that we loathe and believe to be fraught with death . . . .” Id. at 630.

Continue Reading The Best Test of Truth Is the Power of the Thought to Get Itself Accepted in the Competition of the Market
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This is from the non-RS side of the Blog.

We admit that the use of “everything” in our title may be excessive.  The order in In re Rantidine [sic] Cases, JCCP 5150 (Cal. Super. Ct. Sept. 15, 2025) (“Cali Ranitidine”), slip op. here, did not cause climate change, poverty, hunger, air pollution, earthquakes, military conflicts, or any number of things that rational people typically want to avoid.  It did not eliminate free speech, silly internet cat videos, pie, your favorite sports team, beautiful alpine sunsets, or many other things our readers might list as “good things.”  In terms of helping to perpetuate a flawed litigation, throwing California product liability law into disarray, mucking up procedural norms, and misspelling “bellwether” and “Ranitidine,” though, it made a big mess.

Befitting the bizarreness of Cali Ranitidine, we will start with the third of these.  Here are a few things that we did not think were in dispute about civil litigation, regardless of whether you are talking about an individual federal case, a federal MDL, a California JCCP, or some other variant.  Pleadings come first.  A complaint will number the counts asserted against the defendants, attempting to break them up by the particular legally cognizable causes of action asserted and how they apply to the different parties (e.g., count 1 against defendant X, count 2 against defendant Y, count 3 against both).  The defendants can answer, move to dismiss, or move for a more definite statement.  A motion to dismiss might argue, for instance, that count 1 lacks sufficient factual allegations of each element of the recognized cause of action or that there is no such cause of action recognized under applicable law.  It could also argue that count 1 is preempted because the state requirements inherent in liability under that count would conflict with federal requirements.  As we have said many times, when dealing with a challenge to whether a particular count states a valid claim and an argument that the claim would be preempted, a court has to evaluate the state law claim first, both on whether it exists and whether the allegations in the complaint support it.  Regardless of how many rounds of amendment it might take, what counts are live should be sorted out before discovery starts.  Among other things, the claims and defenses help to define the scope of discovery.  Importantly, down the road, the defendants can move for summary judgment by arguing that plaintiffs failed to adduce enough admissible evidence to carry their burden to establish a prima facie case as to each live count.  The defendants can also seek summary judgment based on having evidence to carry their own burden on a defense, such as preemption.

Part of why following this basic sequence matters is that the court’s consideration of summary judgment should not result in 1) an amendment of the complaint to add something new (although it could delete claims or parts of claims where plaintiffs caved or lost), 2) the recognition of a novel cause of action that is not in the live complaint at the time of the summary judgment ruling, 3) an expansion of claims one way or another beyond what was at issue in fact and expert discovery and any motions thereon, and/or 4) a court finding plaintiff failed to offer evidence to carry her burden on any claim that survives summary judgment.  We recognize how tortured some of these may seem, but Cali Ranitidine violated each of these truisms.

We will not recap all posts on the larger litigation.  The bottom line is that plaintiffs lost just about everything that mattered in the MDL, including on preemption and the exclusion of their general causation experts.  An appeal is pending to the Eleventh Circuit, and defendants keep winning trials in Illinois state court.  In general, there have been years of sturm and drang, starting with questionable lab “findings” and a cautious FDA, but there never was science supporting cancer from ranitidine use or liability for selling a drug that did not cause cancer.  The national holdout has been the California JCCP, in part because the assigned judge has changed over time and in part because California is California.

This brings us to the decision in Cali Ranitidine, which resulted from a few rounds of briefing on a branded manufacturer’s summary judgment motion in a now former “bellweather [sic] trial” case that the court concluded should apply across the board.  Frankly, the issue should have been very narrow and pretty easy.  Defendant moved on the plaintiff’s manufacturing defect claim—count and allegations in the live Third Amended Master Complaint unspecified in Cali Ranitidine—after getting rid of all design defect claims as preempted.  Of course, this was not a count asserting liability under an avowed “inherent defect,” “magic defect,” or “gobbledygook defect.”  It was purportedly a “manufacturing defect” claim because everyone knows California, like most other jurisdictions, breaks up product liability into design defect, manufacturing defect, and warnings defect.  See, e.g., Ramos v. Brenntag Specialties, Inc., 372 P.3d 200, 204 (Cal. 2016) (“California law recognizes three types of product defects for which a product supplier may be liable: manufacturing defects, design defects, and warning defects.”).

Last April, the JCCP held exactly that in connection with preempting all design defect claims; in our prior words:  “And because ‘strict products liability’ is limited to the three traditional categories (design defect, manufacturing defect, and failure to warn), any ‘non-standard’ design defect claim would also fail.”  Because California follows comment k under § 402A of the Restatement (Second) of Torts for prescription drugs, vaccines, and devices, the liability is not strictly “strict,” but there are still three basic subspecies.  California does not recognize a duty to test, res ipsa for product liability, or some other possible variants.  (Don’t get us started on Conte and the innovator liability nonsense.)  In the multiple attempts at Master Complaints, the plaintiffs had asserted numbered counts under each of the three big subspecies against the defendants, no matter what other mud they threw at the wall.  That was the focus of prior motions practice under the California equivalent of 12(b)(6).

Cali Ranitidine was supposed to address plaintiffs’ fourth attempt to offer a manufacturing defect claim that would be recognized by California law, not preempted, and supported by evidence adduced in discovery.  We mention evidence because this was a decision on a summary judgment motion, although it may be the only summary judgment decision from an MDL, JCCP, etc., we have seen that does not identify the summary judgment standard or purport to apply it.  That plaintiff had the burden to come forward with evidence sufficient to carry his burden on each element of the cause of action at issue is nowhere to be found.  Instead, the only mention of burden is defendant’s burden to establish preemption, which was punted to another day.  Slip op. at 20-21.  What the Cali Ranitidine court did, completely out of place for the advanced stage of the litigation and procedural posture of the motion, was to engage in a theoretical analysis of whether plaintiffs could pursue, presumably in a fifth master complaint that would potentially reopen discovery, a novel claim for something between California’s design defect claim—preempted across the board—and California’s manufacturing defect claim—which the plaintiffs acknowledged they could not support.  Id. at 3-4.  In adopting a new “hybrid theory” that plaintiffs would have a chance to support, the court did not evaluate the applicable count in the live complaint, any of its allegations, whether it conformed to prior court orders, or whether there was sufficient evidence in the record to support the count.  You know, what a court is supposed to do when entertaining a motion for summary judgment, even if it lapses back to the standards for a motion to dismiss.  Years after the JCCP was formed in January 2021, the court’s frolic and detour into novelty was without procedural precedent.

It almost does not matter that the new “hybrid theory” was nonsensical and clearly fell within the court’s prior preemption ruling.  Id. at 12.  Creating a new cause of action simply because the established ones failed is bad.  The court’s reasoning might be worse.  We all know that the gist of a manufacturing defect claim is that the plaintiff’s particular product failed to meet the design specifications for the product and that the failure caused an injury.  Plaintiffs in the JCCP admitted that they could never meet that standard for any case, so they wanted to establish a novel manufacturing defect claim based on the circular argument that every pill the defendant every produced was defective because the defendant failed to prevent those pills from having some uncertain amount of NDMA beyond the uncertain amount they would have had anyway.  Legally speaking, that is nonsense, but it sounds most like the “non-standard” design defect claim the court had previously held preempted.  In its selective tour of California product liability law over time to end up with the idea that having too much of a purported carcinogen in every pill ever made by the defendants could lead to non-preempted liability under an expanded understanding of design defect, the court made more mistakes than we can address here.  We are not even counting simple sloppiness, such as the spelling and punctuation errors.  Nor factual errors, such as asserting that FDA recalled all ranitidine products.

Fundamentally, the court misunderstood what the design of a product, particularly a drug, is by engrafting a concept of “intent” that matches better with absolute liability (which California expressly does not have) and certainly has nothing to do with strict liability (which looks solely to product “condition,” as opposed to manufacturer “conduct”).  The tautology goes that no manufacturer intends for its drug, as manufactured, to have excessive levels of a carcinogen, so the entire manufacturing process could be seen as defective if it produced identically “excessive” levels of carcinogen in every pill released.  Id. at 13.  The court got here by concluding a deviation from design specifications was one way to establish a manufacturing defect and deviating from the amorphous concept of the “intent” of the manufacturer for a product was another.  Id. at 14.  This is quite silly because intent and design are different.  Suppose that Drug Company X intends that its new drug will effectively treat medical condition A without excessive risks.  That is not a design.  The design of a drug includes the active drug ingredient and the rest of what gets pressed into the finished product.  Hopes and dreams are not part of it.

Similarly, the intent of a widget—effectively performing its appointed widgetty task without undue risk of breakage from stress or fatigue, for instance—is not the same as its design.  A manufacturing defect claim means the plaintiff’s particular product does not match the design, typically reduced to specifications and release criteria in the real world, not that the manufacturer failed to eliminate all risks or excessive risks whether from a contaminant, degradation product, or something else.  Plaintiffs here did not have evidence of an actual specification that each pill was supposed to have no more than X% or Y ppm of NDMA and they were all released despite exceeding that specification.  They certainly did not have admissible evidence that the amount by which the pills purportedly exceeded the non-existent specification was sufficient to cause cancer in any human and that it had done so for a specific plaintiff.

As we said, California follows comment k for prescription drugs.  The court said it would apply comment k to OTC drugs too.  Id. at 15.  Comment k’s discussion of unavoidably unsafe products is certainly contrary to the court’s rationale.

The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Section 2 of the Restatement (Third), which California appellate courts have cited with authority, says a product “contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product.”  It also limits strict liability to design, manufacturing, and warnings.  California’s pattern instruction 1200 is similarly limited.  Its notes include the following case quote, the second sentence of which negates Cali Ranitidine’s expansive interpretation of “design” in this context:

“A product has a manufacturing defect if it differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line. In other words, a product has a manufacturing defect if the product as manufactured does not conform to the manufacturer’s design.” (Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 190 [153 Cal.Rptr.3d 693].)

Similarly, California’s pattern instruction 1202 states, “A product contains a manufacturing defect if the product differs from the manufacturer’s design or specifications or from other typical units of the same product line.”  This is not supportive of the hopes and dreams expansion.  We are sure that the defendant presented all of this authority and much more in arguing against the late expansion of California product liability law.

Instead of granting summary judgment, as it was required to do even if it had let plaintiffs shift to a novel hybrid theory that was not in a live complaint, Cali Ranitidine made up a roadmap of proof.  The statements in the decision that should have led to summary judgment on manufacturing defect were legion.  For instance:

  • “The evidence on this motion does not show that BI’s manufacturing of any pills deviated from its intended processes.”  Id. at 3
  • “No evidence shows a meaningful distinction between the pills the plaintiffs ingested or the batch they came from and all the other BI manufactured pills.”  Id.
  • That “a safer FDA-approved method [of manufacturing] . . . is not clear from the record on this motion.”  Id. at 19.
  • Plaintiffs’ evidence of excess NDMA compared to other manufacturing processes was contradicted, not supported, by the work of their dubious lab, and none of their other evidence “meet[s] the evidentiary standard at this point.”  Id.
  • Plaintiffs failed to cite “any evidence showing that the alleged ‘delta’ [of purportedly excessive NDMA] was a substantial factor in causing cancer.”  Id. at 20.

Instead of summary judgment (or summary adjudication), plaintiffs got an opportunity “to marshal the evidence required under this Order,” which defendants could challenge in future, including on preemption.  Id. at 20-21.  While this may have some superficial appeal, it is the burden of the plaintiff facing a summary judgment motion to marshal evidence supporting a challenge claim/count, put it in the record, and show how it adds up to a prima facie case.  Plaintiffs had plenty of chances to do that here.  They were also the ones who argued a new theory at the hearing on the manufacturer’s summary judgment motion, apparently abandoning the briefed position and failing to support the new theory with evidence.  Id. at 1.  They submitted two extra briefs and had a second hearing, again failing to put evidence in the record to support the theory they espoused (that was not even supported by the live complaint).  Id. 

Lest there be any doubt, California Rule 3.1350(e)(3) requires the party opposing a motion for summary judgment or summary adjudication to file its “evidence in opposition” at the time it responds.  Whatever evidence plaintiffs filed, it did not support the traditional claim for manufacturing defect or the hybrid claim they ultimately convinced the court to adopt.  As such, that should have been the end of the claim for manufacturing defect, however framed.  We still think the end result will be that hybrid manufacturing defect claims fail across the JCCP.  It will just take more time and effort—and perhaps an appeal—to get there.

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Don’t stop us if you’ve heard this before, because you have. (Here and here, for example). Wilson v. Coopersurgical, Inc.,  (S.D. Illinois Sept. 9, 2025), is yet another case from the Filshie Clip litigation illustrating the power of premarket approval (PMA) preemption.  The defendant won dismissal on summary judgment after the case had survived initial motions to dismiss.  Indeed, this favorable summary judgment decision was a complete reversal of a bad 2023 preemption decision on the pleadings in the same case, which we blogged about here, and which we named the #6 worst case of 2023. This to-be-published decision is also significant in that it overcame the Seventh Circuit’s Bausch decision, which had distorted the parallel requirement exception to federal preemption. 

Filshie Clips are a form of contraception – tubal ligation, to be more specific. They are titanium clips with silicone linings.  Doctors implant them in a woman’s fallopian tube.  The Filshie Clip is a Class III medical device. That means it had to go through the rigorous PMA process, which it did in 1996. And that means that Filshie Clips enjoy express federal preemption of any claim seeking to impose “any requirement” that is “different from, or in addition to, any requirement” under the federal regulations. 

The claim in Wilson was the usual one: that the Filshie Clip had migrated and caused certain adverse health effects. The plaintiff claimed that such migration of Filshie Clips occurred 25% of the time in the overall patient population, that the defendants knew it, but did not warn her. The plaintiff also alleged that the defendants had failed to report adverse event complaints accurately to the Food and Drug Administration (FDA). Interestingly, the plaintiff’s doctor knew of the risk of migration, but apparently did not tell her. Also interestingly, the warnings and precautions section in the instructions accompanying the Filshie Clips discussed the importance of patient counselling and explicitly mentioned the risk of clip migration and expulsion. 

But, as with any failure to warn case, a plaintiff lawyer can always dream up an allegedly better warning. It is a vast waste of time and judicial resources.  Federal preemption should avoid or eliminate such waste. That is what happened in Wilson, though a bit later than we’d like. 

The plaintiff filed a 93 page complaint with a litany of multiple, redundant, and unnecessary claims. Here, those claims included strict product liability design defect, strict product liability failure to warn, negligence, gross negligence, and punitive damages. The defendants argued that the plaintiff’s claims were both implied and expressly preempted. The Wilson court agreed with the defense argument and dismissed the case. 

Implied preemption occurs under the Buckman Supreme Court case when plaintiffs seek to use state law to police statements that a defendant was required to make to the FDA under federal law.  The plaintiff’s design defect claims were expressly preempted because the design was FDA compliant.  

As is typical, the failure to warn claims demanded more detailed warnings. But to ask for warnings on a PMA device that are more detailed than what the FDA requires is foreclosed by express preemption.  The failure to report claims were both expressly and impliedly preempted.  The Wilson case rejected a prior adverse federal district court reporting precedent (Laverty) in light of the Norabuena appellate Illinois decision. The federal court in Laverty held that Illinois law imposed a parallel requirement of adverse event reporting, and therefore did not hold the claims preempted.  By contrast, the Norabuena court held that “there is no Illinois requirement that parallels” any federal adverse event reporting obligation. Illinois appellate decisions are entitled to great weight on Illinois law issues.  The federal court in Laverty had gotten Illinois law wrong.  If there was no Illinois requirement, there was no parallel requirement, and the implications of the wretched Bausch case were avoided.

Reporting claims are expressly preempted for imposing obligations different than those imposed by the FDA.  They are also impliedly preempted because, absent any recognized state-law claim, they improperly seek to enforce federal regulations.  

A variety of other claims, all based on alleged reporting violations, were similarly preempted. Here is how the Wilson court summed up disposition of those various and sundry claims:

“Plaintiff’s claims of negligence and gross negligence must suffer the same fate as her claims of strict liability. Those claims are largely based on the same allegations and theories of liability. And, as to the strict liability claims, the Court has already found the PMA for the Filshie Clip has never been suspended or withdrawn by the FDA, the design of the Filshie Clip has always conformed to the design approved by the FDA in the PMA process, the FDA determination that the Filshie Clip is safe and effective with a reported .13% migration rate remains intact as a matter of federal law, the FDA approved updated instructions for use of the Filshie Clip with the same migration rate of .13%, the record does not indicate the design of the Filshie Clip has deviated from the design approved by the FDA, the Filshie Clip inspections for use ‘w[ere] approved … by the FDA and adhere[] to the FDA-approved language,’ and Plaintiff did not raise a state requirement that parallels the federal FDA reporting requirements because ‘there is no [such] Illinois requirement.’”  

Preemption made all the substantive claims go away, which also eliminated the claim for punitive damages and eliminated the need for the court to address causation. 

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2024 was a big year for blood and tissue shield statute decisions across the country (from  Florida, California, North Carolina, Illinois, and Ohio). And it looks like we added Oregon to the tally this year, but we let Kentucky and Nelson v. Aziyo Biologics, Inc., 2025 WL 2045167 (E.D. Ken. Jul. 15, 2025) slip by us. So, on this first full day of Fall, we bring you a case from mid-summer–with a twist.

As our prior posts discuss, human tissue implant manufacturers typically can limit their liability under state blood and tissue shield statutes.  But what about intermediaries?  The organizations that harvest the donor tissue—organ procurement organizations (OPOs)?  Nelson says yes, relying on a state anatomical gift statute.

Plaintiff received a surgical implant made from human tissue and alleged that the tissue was contaminated with tuberculosis which he then contracted.  In addition to suing the manufacturer of the implant, plaintiff brought negligence, warranty and fraud claims against the OPOs who harvested the tissue.  The basis for plaintiff’s claim was that the  OPOs did not act in good faith by not screening the tissue for tuberculosis.  Plaintiff relied on the fact that the donor was Mexican-born and that statistical evidence shows higher tuberculosis rates in Mexican-born individuals; therefore defendants were on notice to screen. 

The OPO defendants moved for summary judgment on the grounds that they were immune from civil liability under Kentucky’s Anatomical Gift Act.  The Act provides that:

A person that acts in accordance with [the Act] or with the applicable anatomical gift law of another state, or attempts in good faith to do so, is not liable for the act in a civil action, criminal prosecution, or administrative proceeding.

KRS § 311.1943(1).

Which led the court to find that the plaintiff was putting the cart before the horse.  You never get to the question of good faith if defendants acted in accordance with the Act.  Which they did.  The Act requires OPOs to conduct “reasonable examination to ensure the medical suitability of the body or part for its intended purpose.” KRS §311.1935(3). What is reasonable is a question answered by federal regulations.  OPOs are federally regulated to screen and test donors for certain infectious diseases.  Tuberculosis is not one of them. See Nelson, at *2. 

Because the plaintiff could not point to any provision of the Act (or of federal regulations) that defendants violated, the court never had to get to the good faith inquiry. Defendants acted in accordance with the Act and therefore are entitled to immunity.  OPOs provide an invaluable service; immunity ensures they can continue their critical life-saving role.

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In what we view as a game-changing submission, on September 3, Lawyers for Civil Justice filed a 20-page analysis of no fewer than nine third-party litigation funding (“TPLF”) contracts that, one way or another, have become public.  This analysis rips away the veil of secrecy that has surrounded TPLF, analyzes why and how specific TPLF contract provisions distort litigation in numerous ways, and demonstrates why nothing less than full TPLF disclosure is necessary to prevent abuses and to level the litigation playing field.  It’s titled, “An Examination of TPLF Contracts Reveals Common Control Mechanisms that Can Affect the Litigation Process and Influence Substantive Outcomes − Transparency Doesn’t Impose a Burden; It Lifts a Veil (yes, Bexis’ fingerprints can be found on the LCJ submission).

We highly recommend that anyone interested in TPLF transparency read the entire piece, but here are the main points in bullet form:

  • The boilerplate disclaimers of control over litigation decisions found in most TPLF contracts are belied both by other provisions that enable such control and by the actions of funders exercising that control.
  • TPLF contracts give the funders the right to stop funding plaintiffs at their sole discretion, thereby giving them effective control over the litigation.
  • TPLF contracts give funders veto power over any settlement.
  • TPLF contracts often invert and/or distort the attorney-client relationship, with counsel selected by and taking orders from the funder, not the funded plaintiff that counsel purports to represent.
  • TPLF contracts often obligate the funded plaintiff to follow the funder’s chosen counsel, not the other way around, with the funder controlling when, or if, counsel can be replaced.
  • TPLF contracts often require plaintiffs to seek only monetary recoveries, ignoring injunctive and other non-monetary relief, and some even penalize plaintiffs by forcing them to pay funders the “monetary value” of non-monetary relief.  Such skewed demands lead to skewed judicial outcomes.
  • TPLF contracts can create “zombie litigation” where a funder refuses to settle, even though all of the actual parties – both plaintiffs and defendants – desire to do so.
  • TPLF contracts swear plaintiffs to secrecy, forbidding plaintiffs from disclosing even the fact of funding absent a court disclosure order.
  • TPLF contracts vaguely demanding “reasonable” cooperation from plaintiffs convert tactical and strategic disagreement into “breaches” of contract, for which plaintiffs may lose all control of the litigation, often as determined by arbitration controlled by funders.
  • TPLF contracts often require counsel to report any “breaches” by their nominal clients to funders.
  • TPLF contracts often alter plaintiff’s counsel’s compensation, and contain inducements over and above ordinary contingent fees.
  • TPLF funders further exercise control over counsel by hiring them for “portfolios” of cases.
  • TPLF contracts often require plaintiffs to provide funders secretly with confidential litigation documents, without regard to court confidentiality orders.
  • TPLF contracts often insulate funders from paying for sanctions, even when the sanctionable conduct occurred at the funders’ behest.
  • TPLF contracts are opaque, and likely to mislead judges viewing them ex parte, with boilerplate disclaimers of control being illusory in light of numerous other provisions providing funders with effective control over all aspects of litigation.

All of these bullet points from the LCJ submission are supported by specific citations – often multiple citations – to particular provisions in actual TPLF contracts that LCJ has collected in one place for the first time.  That alone is significant, since TPLF agreements are notoriously closely held and not generally available for critical evaluation.

The LCJ submission also contains citations to pertinent case law – much of which has been decided just in the past couple of years – that attorneys fighting for TPLF disclosure in individual cases will find highly useful.  See:  In re Fresh Acquisitions, LLC, 2025 WL 2231870 (Bankr. N.D. Tex. Aug. 5, 2025); Valjakka v. Netflix, 2025 WL 2263684 (N.D. Cal. July 10, 2025); MSP Recovery Claims Series, LLC v. Sanofi-Aventis U.S., LLC, 2024 WL 4100379 (D.N.J. Sept. 6, 2024); In re Pork Antitrust Litigation, 2024 WL 5118901 (Mag. D. Minn. Feb. 9, 2024), aff’d, 2024 WL 2819438 (D. Minn. June 3, 2024); In re: Valsartan NDMA Contamination Litigation, 405 F. Supp.3d 612 (D.N.J. 2019).

As the LCJ submission demonstrates, a simple, uniform rule of civil procedure mandating disclosure of the actual TPLF agreements to all parties is the only way to ensure that third-party funders are not secretly distorting litigation to serve their own ends, at the expense of everyone else, even (and often especially) the very plaintiffs that they fund.  Moreover, a blanket disclosure rule – as has proven to be the case with insurance disclosure – will be self-executing, without the need for incessant collateral litigation that the current “wild, wild west” approach to TPLF disclosure generates.

The LCJ submission conclusively establishes what we on the receiving end of third-party funded litigation instinctively knew all along − that (even more than the insurance agreements on our side of the “v.”) TPLF affects, or could affect, multiple facets of the litigation process, and thus has importance far beyond its relevance (or not) to the limited “claims or defenses” in a particular action.

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The saga over the illegality defense in Kansas appears to have run its course, and as in previous chapters, the defense has prevailed.  The Tenth Circuit has ruled that the defense of illegality exists under Kansas law and that it applies to product liability claims.  As we reported here and here, this is the first case applying illegality (aka in pari delicto) as a defense to product liability claims under Kansas law, and the Tenth Circuit ruling is the first appellate opinion to so hold.

To recap, the decedent in Messerli v. AW Distributing, Inc., No. 23-3241, 2025 WL 2525275 (10th Cir. Sept. 3, 2025) (to be published), sadly passed away allegedly as a result of inhaling intoxicating fumes (or “huffing”) from computer dusters, those cans of compressed air you use to blow away dust.  As we wrote here, a federal district court in Kansas granted a motion to dismiss on the basis that the decedent had engaged in illegal conduct, which supported a complete defense.  That was because Kansas’s illegality defense bars claims arising from a plaintiff’s illegal conduct, and huffing is a crime in Kansas under laws against “the unlawful abuse of toxic vapors.”

The Tenth Circuit affirmed, noting at the outset that Kansas has outlawed toxic vapor abuse for good reason, citing the addictive and dangerous nature of certain inhalants and the multiple emergency room visits associated with them. 

In coming to its conclusion, the Tenth Circuit’s reasoning was threefold.  First, the court held that the illegality defense exists under Kansas common law that that the Kansas Product Liability Act did not abrogate it.  The KPLA merges all product liability theories into a single product liability claim, but where the Act is silent, common law fills in the gaps.  The KPLA did not expressly abrogate the illegality defense, and multiple recent Kansas cases confirm that the illegality defense is still available under the common law in tort actions.  The same is true in multiple other states.

Second, Kansas’s adoption of comparative negligence in 1974 did not overrule the illegality defense, either.  On this point, the plaintiff argued that the decedent’s illegal acts should not bar recovery completely, but should reduce the recovery by an amount to be determined by a jury.  The Tenth Circuit, however, rejected this argument on the basis that Kansas courts have continued to apply the illegality defense since the legislature adopted comparative fault.  Moreover, and we think more importantly, comparative fault and illegality are horses of a different color.  Unlike comparative fault, the illegality defense does not aim to apportion fault, but instead prevents injured parties from benefiting from their own illegal behavior.  This is a policy choice.  The Restatement (Second) of Torts recognized that “the public policy behind this rule is that a court should not lend its aid to a [person] who founds [a] cause of action upon an immoral or illegal act.”  Messerli, at *7.  And the Tenth Circuit agreed with other courts holding that plaintiffs should not be compensated for injuries that “involve a substantial violation of law.”  Id. 

Third, the Tenth Circuit affirmed the district court’s Erie determination that the Kansas Supreme Court would apply the illegality defense in product liability cases.  The Kansas Supreme Court has long endorsed a preference that juries allocate fault based on “comparative degrees of causation.”  Id. at *8.  The illegality defense, however, is different because

the policy argument behind the illegality defense is not based on allocating fault, but on the principle that the courts should refuse to allow a plaintiff to benefit from his own illegal act.  The degree of the injured party’s culpability is not at issue.  We are concerned only with whether we should aid a plaintiff who violated the law. 

Id.  The key is that Kansas common law, like the law other states, has always applied the illegality defense for reasons separate and independent from contributory negligence and comparative fault.  As a result, the defense applies to tort claims generally and likewise to product liability claims under the KPLA. 

From there it was a short path to affirming the dismissal.  The complaint alleged that the decedent huffed dusters and that toxic vapor intoxication caused his death.  Because the complaint squarely alleged that illegal acts allegedly caused the death, the illegality defense barred the plaintiff’s claims. 

The Tenth Circuit’s opinion is useful not only because it is the first of its kind, but also because of the clarity of its reasoning.  A plaintiff’s product misuse is one thing; a plaintiff’s attempt to base a civil action on his or her own illegal conduct is quite another.  File this opinion away for future use. 

Thanks to Scott Kaiser, Stephen Nichols, and Holly Pauling Smith at Shook Hardy for bringing this opinion to our attention and for attaining this result.

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The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.

Every time we see a case that does that—upholds preemption on summary judgment—we wonder why the court didn’t uphold preemption at the pleading stage, on a motion to dismiss.

As the Supreme Court recognized in Riegel v. Medtronic, Inc., 552 U.S. 312, 330  (2008), when Congress enacted 21 U.S.C. § 360k(a) as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, it did not just intend to protect manufacturers of Class III, premarket approved (“PMA”) devices from litigation judgments–it hoped to protect manufacturers against the costs of discovery as well.  In other words, federal preemption is most effective in carrying out congressional intent when it is enforced at the outset of the case, not after years of expensive litigation.

So we checked the Gregory docket. 

Three years ago, in 2022, the defendant filed a preemption motion to dismiss, and (sensibly) asked the court to stay discovery until that pleading-stage motion was decided.  The Court denied the stay and ordered discovery to proceed. And then, basically, the Court just sat on the motion to dismiss until case events and the passage of time rendered it moot: 

  • After more than a year had passed without a decision on the motion to dismiss, discovery closed. 
  • Then two years passed, and defendant filed its summary judgment motion. 
  • Then three years passed. 
  • Finally, the Court granted the motion for summary judgment, which brings us to the opinion that is the subject of our present post.  After it does so, the clerk administratively closes the motion to dismiss in the process of closing the case, meaning that first motion to dismiss was never heard and never decided. 

So much for the prohibition against plaintiffs “unlocking the doors” to discovery with an inadequately-pled or legally-barred claim. 

We are frustrated just recounting these facts, because we do not think this is anyone’s idea of the swift and efficient administration of justice.  Sadly, we have been in this situation ourselves, with preemption motions pending unheard as the months and years click by.

This situation also reminded us of the pair of preemption motion to dismiss denial/preemption summary judgment grant opinions we wrote about in this post. 

Setting our frustrations aside, we now turn to the opinion at hand, which would have been a perfectly acceptable preemption decision had it been issued three years earlier on motion to dismiss.

The plaintiff in Gregory had been implanted with a urinary control device, a Class III medical device approved by the FDA through the PMA process.  This is a product liability case, so of course alleged device failures and a revision surgery were involved.  The plaintiff asserted the usual assortment of claims—strict liability, negligence, breach of express and implied warranties—and he threw in a few extras, like a New York General Business Law claim alleging deceptive representations related to the device.

As you would expect, the court’s analysis centered on the express preemption provision, 21 U.S.C. § 360k(a), which prohibits states from imposing requirements “different from, or in addition to” federal requirements applicable to medical devices, and Riegel.  The court reiterated that state law claims are preempted unless they are “parallel” to federal requirements—i.e., premised on a state law claim that involves a parallel federal duty, rather than a state law claim that would impose additional or different obligations beyond the federal requirements in effect for the device.

Strict Liability, Negligence, Strict and Negligent Infliction of Emotional Distress

Plaintiff’s claims for strict products liability and negligence were found to be preempted, as were the related claims for negligent or intentional infliction of emotional distress.

Although “Plaintiff [did] assert, albeit in conclusory fashion, that Defendant’s manufacturing process violated federal requirements…. Plaintiff does not explain how Defendant’s manufacturing process violated federal law.”  Moreover, “to survive MDA preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely ‘on res ipsa loquitor’.”

Given that plaintiff never identified any particular manufacturing-related PMA violation on summary judgment, you can bet his complaint never articulated what that alleged violation was either.  So, good on the court for recognizing that conclusory assertions of noncompliance are insufficient, but that was a light bulb that should have gone off three years earlier. 

Implied Warranty

The court likewise dismissed the implied warranty claim, because the FDA had granted premarket approval and plaintiffs cannot used implied warranty to demand a different, allegedly safer design.  As the court acknowledged,

“[t]o do so would impose different and additional requirements to federal law. And again, Plaintiff’s allegations in support of this claim are scant. Plaintiff has not identified a particular defect in the device or a particular FDA requirement Defendant allegedly violated.” 

Really?  Bet that was true at the pleading stage as well. 

Express Warranty

The express warranty claim was preempted to the extent it was based on FDA-approved representations and, in any event, there was no evidence the defendant made any express warranty to plaintiff, either directly or through his physician, anyway.  (And also, promises the plaintiff’s doctor allegedly made about the device’s longevity were not attributable to the defendant manufacturer, as the doctor was not the manufacturer’s agent.)

Deceptive Business Practices

Plaintiffs’ New York deceptive business practices claim was also preempted to the extent it challenged FDA-approved promotional materials. The court further found that, even if the claim were not preempted, plaintiff failed to provide evidence of any materially misleading statement by the defendant regarding the device’s expected lifespan.

So, there you have it.  The decision in Gregory reaffirms the formidable barrier that federal preemption poses to state law claims involving PMA-approved Class III medical devices. Plaintiffs must plead and prove specific violations of federal law to avoid preemption; generalized allegations of defect or malfunction are insufficient. 

Eventually.

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Some litigations are gifts that keep on giving. A big chunk of DDL work product consists of commentary on a couple of mass torts. Maybe it is a version of the 80-20 rule, or how a huge percentage of crimes are committed by a relatively small group of career criminal recidivists. For a while, Aredia-Zometa cases consistently supplied grist for our mill. The pelvic mesh gave us a lot of rulings (mostly lousy) by the MDL courts, and a lot of rulings (mostly good) by the remand courts. More recently, it looks like the Bair Hugger MDL will never stop issuing interesting decisions. Early on, those decisions were not so good.  But lately, the courts (often the remand courts, so that pattern in itself is noteworthy) have been reassuringly sane. 

One of the most basic elements of product liability is product identification. The very name “product liability”suggests as much. The plaintiff had to be injured by the defendant’s product.  That fundamental requirement was lacking in Prichard v. 3M Co., 2025 WL 2586388 (N.D. Ga. Aug. 19, 2025), a decision in a case remanded from the Bair Hugger MDL.  

Recall that the Bair Hugger is a medical device used to regulate patient body temperature during surgery. Recall, also, that plaintiffs claimed infections due to contaminants from the device.  The Prichard complaint was a dreaded MDL short-form complaint, which is often a vehicle for sloppiness or outright fraud. Prichard’s complaint was ridiculously overpleaded (originally 19 separate causes of action) in typical MDL style. But none of those causes of action can survive absent product identification. There simply cannot be, say, causation, without product identification.  

MDL courts are too often too lax about requiring product identification.  That is why MDL’s have grown to a point where they constitute a gargantuan percentage of the civil docket.  Rather than police bloated inventories by insisting on some proof of product identification (and injury and causation), some MDL judges devote all their time to dreaming up ways to force settlement.  But once a remand court is facing the prospect of trial, that court becomes less interested in social engineering and more interested in not wasting judicial resources and jury time on garbage cases.  At that point, courts pay more attention to such niceties as product identification. 

Prichard reminds us of a bank robbery case in which the teller identified the FBI case agent as the crook. (That actually happened to one of our colleagues.  We had a jolly time taping trial transcript pages on his door.) In Prichard, the plaintiff’s medical records listed only a serial number identifying the device used during surgery. When the hospital was subpoenaed, it turned out that the number identified a device that wasn’t a Bair Hugger at all. 

Did the plaintiff realize he was mistaken and try to get his lawsuit right?  He did not.  Rather, the plaintiff’s convenient testimony, first appearing in his fact sheet, was that some unidentified nurse gave him something she called a “Bair Hugger” during surgical prep.  Unfortunately for plaintiff, that “evidence” (how many times have plaintiffs tried to fill in an essential evidentiary gap with a purported oral statement made by an unidentified employee?) did not prevent summary judgment, because it was blatant hearsay. Remember that inadmissible hearsay cannot defeat summary judgment.  The plaintiff had not attempted to identify the nurse, nor did he, personally, know what a Bair Hugger looked like.  

Beyond that, evidence that the hospital had purchased several of the defendant’s products more than a 15 years before the plaintiff’s surgery was not enough, given the positive identification of a different product in his medical records.  The hearsay and the sometime use of the product by the hospital might have been enough to survive lax MDL plaintiff vetting, but it could not prevent summary judgment in the remand court.  

Moreover, that one of the defendant’s heating devices was used during surgical prep did not mean that it was used during the surgery itself, where the claimed injury took place.  

The plaintiff attempted to exploit the defendant’s answer to the complaint, which admitted that the plaintiff’s “medical records indicate that the Bair Hugger may have been used in this procedure.”  That was then and this is now.  Allowing for a possibility means little, especially when there was “now evidence to the contrary, which cannot be supplanted by the parties’ earlier speculation.”  (Still, this sort of thing lends credence to the Roy Cohn school of litigation: deny everything.) 

By now, most of you can guess what the plaintiff’s last ditch argument against summary judgment was: more discovery, please. But discovery was closed, and that actually mattered to this court. In any event, a plaintiff cannot oppose summary judgment with “vague assertions” about what additional discovery might reveal. The court granted the defendant summary judgment, and denied the plaintiff’s request for further amendment of the complaint. 

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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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