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.