Not long ago we published a blogpost, “New California Ranitidine Litigation Order Makes A Huge Mess Of Everything” about a California trial court decision that created, out of whole cloth, what it called a “hybrid theory” of strict liability that jumbled together elements of the long-established – and long separate – concepts of design and manufacturing defect, while sprinkling in the negligence concept of intent.  See In re Rantidine Cases, 2025 WL 2796831 (Cal. Super. Sept. 15, 2025).  As a result, the court allowed a “manufacturing” defect that was uniform across all units of the product, because it construed plaintiffs’ attack on the defendants’ manufacturing processes as a manufacturing defect.

In this post we will attempt to describe just how far out of bounds this “hybrid theory” really is.

First, the California Supreme Court has stated over and over again that there are three, and only three, theories of strict liability.  The seminal Barker case recognized the three categories of manufacturing, design, and warning defects:

[T]he defect or defectiveness concept . . . rang[es] from products that cause injury because they deviate from the manufacturer’s intended result, to products which, though “perfectly” manufactured, are unsafe because of the absence of a safety device, and including products that are dangerous because they lack adequate warnings or instructions.

Barker v. Lull Engineering Co., 573 P.2d 443, 453 (Cal. 1978) (parentheticals with examples of each omitted).  Thus, “California law recognizes three types of product defects for which a product supplier may be liable: manufacturing defects, design defects, and warning defects.” Ramos v. Brenntag Specialties, Inc., 372 P.3d 200, 204 (Cal. 2016).  In Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996), a case involving prescription drugs, the court likewise stated:  “Strict liability has been invoked for three types of defects − manufacturing defects, design defects, and ‘warning defects,’ i.e., inadequate warnings or failures to warn.”  Id. at 1350 (quoting Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549, 553 (Cal. 1991)).  Accord Webb v. Special Electric Co., 370 P.3d 1022, 1029 (Cal. 2016) (“The law has long recognized three types of product defects: manufacturing defects, design defects, and ‘warning defects.’”); O’Neil v. Crane Co., 266 P.3d 987, 994 (Cal. 2012) (same); Finn v. G. D. Searle & Co., 677 P.2d 1147, 1168 (Cal. 1984) (“failure to warn” is “a category of defect separate from manufacturing or design defects”).  Thus, the trial court’s decision to create a new, hybrid form of product defect runs contrary to an unbroken string of a half dozen California Supreme Court decisions over the last forty years.  When it comes to product defects, California follows the doctrine stated in Monty Python & the Holy Grail:

Then shalt thou count to three, no more, no less.  Three shall be the number thou shalt count, and the number of the counting shall be three.  Four shalt thou not count, neither count thou two, excepting that thou then proceed to three.

(Emphasis added).

Second, the essential difference between the definitions of “design” and “manufacturing” defects was concisely stated in Barker:

[W]hen a product comes off the assembly line in a substandard condition it has incurred a manufacturing defect.  A design defect, by contrast, cannot be identified simply by comparing the injury-producing product with the manufacturer’s plans or with other units of the same product line, since by definition the plans and all such units will reflect the same design.

573 P.2d at 454.  Thus, in California, no “hybrid” defect theory exists, based on a method of product manufacture.

The plaintiff in Gall v. Smith & Nephew, Inc., 286 Cal. Rptr.3d 108 (Cal. App. 2021), tried precisely that – like the plaintiffs Ranitidine (we refuse to use the typoed caption of that JCCP) – after failing to establish a manufacturing defect under California law against a manufacturer of a prescription medical product:

A defective product differs either from what the manufacturer intended or from the standard items in the manufacturer’s same product line. . . .  [Plaintiff] did not show his implant came from the factory in substandard condition.  The evidence was to the contrary. . . .  

[Plaintiff] points to a[n] . . . inspection report by the Food and Drug Administration that criticized [defendant] for lacking validation of supplier processes.  The trial court accurately characterized this report as showing merely that [defendant’s] quality control process did not satisfy the regulatory authorities.  No evidence shows any defective product entered the stream of commerce.

[Plaintiff] cites no product defect precedent for substituting a process defect for a product defect.

Id. at 114 (citations omitted) (emphasis original).  That appellate rejection of any sort of “process defect,” should have been the end of it – but Ranitidine didn’t even cite Gall, which is controlling precedent.

A similar process-type defect masquerading in “manufacturing defect” garb failed in In re Coordinated Latex Glove Litigation, 121 Cal. Rptr.2d 301, 310 (Cal. App. 2014), review denied (Cal. Oct. 2, 2002) (“we reject [plaintiff’s] effort to revive a direct design defect theory under a consumer expectations rubric”).  That plaintiff attacked the defendant’s glove manufacturing process generally for not controlling “protein levels,” and sought to call that a “manufacturing defect.”  But the appellate court was not fooled.  “In general, a manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from some other ostensibly identical units of the same product line.”  Latex Glove, 121 Cal. Rptr.2d at 309 (quoting Barker, 573 P.2d at 454) (emphasis original).  “[T]he testing, improvement, research and development efforts, targets and goals of the manufacturer” were not “manufacturing defects” because “[t]he products did not differ from the manufacturer’s intended result, nor did they have materially significant differences among identical units.”  Id. at 316.

Focus is on whether the particular product involved in the incident was manufactured in conformity with the manufacturer’s design.  Here, we are unable to separate out the raw material, . . . from the forming and processing of it. . . .  , The [products] in this case were processed exactly as [defendant] intended that they should be, in light of the state of its scientific and manufacturing knowledge at the time. . . .  [T]hat simultaneously manufactured [units] were subject to different standards at different production lines . . . does not require that some items must be deemed defective under a manufacturing defect approach.  Rather, such arguments actually deal with design defect evidence.

Id. at 315 (emphasis added).  Judgment n.o.v. was therefore proper against the purported “manufacturing” defect claim based on design defect evidence – specifically evidence (no different from the allegations in Ranitidine) that the defendant’s manufacturing processes failed to control for a chemical inherent in their product.  Id. at 316.

Third, this distinction between a unit-specific manufacturing defect and the “all” units design defect unsuccessfully alleged in Gall and Latex Glove is particularly significant in California prescription medical product liability litigation, since the California Supreme Court abolished design-related claims against prescription medical products in Brown v. Superior Court, 751 P.2d 470, 480 (Cal. 1988).  “We decline to hold, therefore, that a drug manufacturer’s liability for injuries caused by the defective design of a prescription drug should be measured by the [strict liability] standard set forth in Barker.” Id. at 480.  Cf. Carlin, 920 P.3d at 1352 (allowing a nominally “strict liability” warning claim in prescription medical product liability litigation, limited to “known or reasonably scientifically knowable risks”).

In the decades since Brown, plaintiffs have repeatedly attempted to disguise generally applicable attacks on the characteristics of prescription drugs, medical devices, and biologics as “manufacturing defects” – but until Ranitidine they universally failed.  The result in Ranitidine flies in the face of a truly impressive amount of accumulated California precedent.

“A manufacturing defect is one which results from an error in the production process.  The product comes off the assembly line in a substandard condition,” whereas a design defect “is common to all the products of a certain line.”  Finn, 677 P.2d at 1163.  In addition to the directly on point Gall and Latex Glove “process” cases, Garrett v. Homeric Osteonics Corp., 153 Cal. Rptr.3d 693, 706 (Cal. App. 2013), review denied (Cal. June 12, 2013), stated in a medical device case:

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.

Id. at 706 (citations omitted).

Another Los Angeles County decision, Rizi v. Merck & Co., 2022 WL 18396233 at *15 (Cal. Super. Oct. 20, 2022), reached the same conclusion in sustaining a demurrer against  a disguised design defect claim brought as a “manufacturing defect” in vaccine litigation.

Here, [defendant] argues that Plaintiff fails to allege that his [vaccine] doses deviated from the intended design.  Instead, Plaintiff contends, the Complaint alleges that [the vaccine] contains dangerous and undisclosed toxins by design, which states a cause of action for design, not manufacturing.

In Opposition, Plaintiff notes that the Complaint alleges that the “[the] vaccines injected into Plaintiff were defective and unreasonably dangerous because they failed to comply with manufacturing specifications required by the governing manufacturing protocols and also required by the regulatory agencies, included but not limited to the FDA, by among other things, containing ingredients and toxins that were not disclosed in the FDA-approved specifications and/or otherwise not disclosed in the package insert.

Plaintiff argues that Mize v. Mentor Worldwide [citation omitted] stands for the proposition that a plaintiff states a cause of action for defective manufacturing where a medical device does not comply with the design as approved by the reviewing agency.

However, the Mize Court specifically noted that plaintiff alleged defendant “sold contaminated implants”. . . .  Here, on the other hand, Plaintiff does not allege that his particular doses were contaminated, only that [defendant’s] design deviated from that which was presented to the FDA.

This sounds in design defect rather than manufacturing defect.

Id. at *5-6 (citations omitted).

Fourth, federal courts applying California law likewise recognize that:

[A] plaintiff must first show that the product as delivered departed from the governing specifications.  A manufacturing defect occurs when the product differs from the manufacturer’s intended result or from other ostensibly identical units from the same product line.  If a product meets the design specifications applicable at the time of manufacture, there is no manufacturing defect.

Carson v. Depuy Spine, Inc., 365 F. App’x 812, 814 (9th Cir. 2010) (applying California law) (citations and quotation marks omitted).  Thus, “defects in design are of a wholly different character than those occurring in the manufacturing process.”  In re Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices, & Products Liability Litigation, 754 F. Supp.3d 1145, 1181 (C.D. Cal. 2010).  “[I]f Plaintiffs maintain that the . . . Defect is common to all [defendant’s] models . . ., they are by definition alleging a design defect; Plaintiffs in a class action may not simultaneously maintain that their [products] contain only a manufacturing defect.”  Buniatyan v. Volkswagen Group of America, Inc., 2016 WL 6916824, at *5 (C.D. Cal. April 25, 2016).

Just since 2013, more than a score of California federal district courts have drawn the same distinctions between allowable manufacturing defect claims and either Brown– or preemption-barred design defect claims in prescription medical product liability litigation.  For example, in Hannan v. Boston Scientific Corp., 2020 WL 2128841 (N.D. Cal. May 5, 2020), the “plaintiffs allege[d] . . . improper or incorrect manufacturing processes that result[ed] in the products . . . deviating from its intended design.”  Id. at *5.  The purportedly “incorrect manufacturing processes” included “use of raw materials not intended for use in human medical implants and heat sealing/treatment.”  Id.  Those allegations, which implicated “processes” rather than individual units, got the heave-ho:

Despite casting this allegation as a manufacturing defect, the allegations are indicative of a flaw in the design of an entire line of products rather than one product differing from other ostensibly identical units.  In other words, plaintiffs’ manufacturing defect claim essentially advances a design defect theory. . . .  Brown precludes such a theory.

Id. (citations omitted).  See also:

• Fussy v. RTI Surgical, 2025 WL 2244586, at *4 (Mag. E.D. Cal. Aug. 6, 2025), (“a manufacturing defect claim must identify/explain how the product either deviated from the manufacturer’s intended result/design or how the product deviated from other seemingly identical models”; claim dismissed), adopted, 2025 WL 2644322 (E.D. Cal. Sept. 15, 2025).
• Adams v. Abbott Laboratories, 2025 WL 895086, at *3 (Mag. E.D. Cal. March 21, 2025) (“A manufacturing defect claim is predicated on a theory that a suitable design is in place, but that the manufacturing process has in some way deviated from that design”; claim dismissed), adopted, 2025 WL 2658765 (E.D. Cal. Sept. 15, 2025).
• Ruiz v. Medtronic, Inc., 2025 WL 278029, at *3 (E.D. Cal. Jan. 23, 2025) (“Plaintiff acknowledges she must explain how the . . . tool deviated from the manufacturer’s intended design but does not cite to any allegations in the complaint that describe the manufacturing defect”; claim dismissed).
• Kinnee v. TEI Biosciences, Inc., 2023 WL 8191097, at *10 (S.D. Cal. Nov. 27, 2023) (“the FAC fails to discuss how any [device] units ultimately differed from Defendants’ designs”; claim dismissed).
• Crawford v. Zimmer Biomet Holdings, Inc., 2023 WL 2189425, at *6 (E.D. Cal. Feb. 23, 2023) (“the problem is that the FAC does not explain how the [device] actually differed from [defendant’s] design or manufacturing standards.  Without an explanation of how the [device] actually differed, the effect is simply to allege the insufficient legal conclusion”; claim dismissed).
• Garcia v. Sanofi Pasteur Inc., 617 F. Supp.3d 1169, 1173 (E.D. Cal. July 28, 2022) (“There are no facts alleged that suggest − either directly or circumstantially − that the vaccine administered to Plaintiff deviated from the manufacturer’s intended result or from other ostensibly identical units of the same product line; that it was produced in a substandard condition; or that it differed from the manufacturer’s intended result or from other ostensibly identical units of the same product line”; claim dismissed) (citation and quotation marks omitted) (emphasis original).
• Holcomb v. Pfizer, Inc., 2022 WL 17670003, at *6 (E.D. Cal. Dec. 14, 2022) (“The Court agrees with Defendant that Plaintiff’s complaint contains no allegations regarding how the doses of [the drug] he consumed differed in any way from others that Defendant produced”; claim dismissed).
• Rathkey v. Zimmer, Inc., 2022 WL 18359146, at *3 (C.D. Cal. Oct. 28, 2022) (“because the Proposed TAC does not allege with specificity how the implanted products deviated from the intended result, design, or ostensibly identical models, the complaint fails to state a claim”).
• Oregon v. Boston Scientific Corp., 2022 WL 1607960, at *5-6 (E.D. Cal. May 20, 2022) (“plaintiff’s allegations in fact suggest a design defect claim, not a manufacturing defect claim; plaintiff “has failed to allege how the particular product implanted in her is different from all the other products like it.  Accordingly, the court will grant defendant’s motion to dismiss”).
• Colbath v. Merck & Co., 2022 WL 935195, at *5 (S.D. Cal. March 29, 2022) (“Plaintiff does not explain how the two [vaccine] doses he received deviated from Defendants’ intended design. . . . Because Plaintiff alleges that all [vaccine] doses contain undisclosed DNA fragments and dangerous toxins, it appears he is actually alleging that the design of [the vaccine] is defective.”; claim dismissed).
• Zetz v. Boston Scientific Corp., 398 F. Supp.3d 700, 709 (E.D. Cal. 2019) (“allegations that the Product degraded and fragmented and failed to perform as designed and intended after being implanted into [plaintiff] do not demonstrate, let alone plead, a manufacturing defect”; claim dismissed).
• Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1160 (E.D. Cal. 2019) (“Because the FAC fails to identify or explain how the [drug] either deviated from the manufacturer’s intended result/design or how [it] deviated from other seemingly identical “units” . . ., no plausible claim is stated and dismissal is appropriate”).
• Garcia v. Boston Scientific Corp., 2019 WL 2598716, at *3 (E.D. Cal. June 25, 2019) (“Plaintiff’s assertions are similarly phrased to describe problems of design rather than ones related to the physical manufacture of the Product.”; claim dismissed).
• Sivilli v. Wright Medical Technology, Inc., 2019 WL 3803808, at *2-3 (S.D. Cal. Aug. 13, 2019) (“Plaintiff’s allegations fail to allege how the specific [device] in Plaintiff has a manufacturing defect.  Plaintiff’s entire complaint reads like a design defect claim.”; claim dismissed) (citation and quotation marks omitted).
• Broge v. ALN International, Inc., 2019 WL 2088420, at *3 (N.D. Cal. May 13, 2019) (“The Court previously dismissed this claim because Plaintiff had failed to allege facts from which it could be inferred that the [device] was suitably designed, and that her unit deviated from such design.  Plaintiff still has not alleged facts indicating that the [device] was suitably designed.  To the contrary, she alleges facts giving rise to a reasonable inference that the [device] was not suitably designed and that the medical issues she suffered were due to the design rather than her particular unit’s deviation from the design.”; claim dismissed).
• Patton v. Forest Laboratories, LLC, 2017 WL 10439658, at *7 (C.D. Cal. Nov. 1, 2017) (“the Court does not see how Plaintiffs could possibly allege a viable manufacturing defect claim when the whole premise of their lawsuit is that all [the drugs] (rather than a specific batch that [plaintiff] was prescribed) is unreasonably dangerous”; claim dismissed).
• Jager v. Davol Inc., 2017 WL 696081, at *4-5 (C.D. Cal. Feb. 8, 2017) (“To adequately plead a manufacturing defect claim, a plaintiff must demonstrate that the product caused a plaintiff’s injury because it deviated from the manufacturer’s intended result or from other ostensibly identical units of the same product line.”; “Plaintiffs have only deleted references to a design defect, without including any additional information as to how the [device] at issue was different from any other seemingly identical models.”  They only allege “that the [device]  had a ‘propensity to break and perforate organs,’” which “only suggests that the design . . . was the problem . . . but does not explain what aspect of manufacture made the particular product defective; claim dismissed) (emphasis original).
• Dunson v. Cordis Corp., 2016 WL 3913666, at *6 (N.D. Cal. July 20, 2016) (“Because plaintiffs do not identify how their [devices] differ from the manufacturer’s intended result or from other ostensibly identical units of the same product line, their strict liability – manufacturing defect claim fails.”) (citation and quotation marks omitted).
• G.M. v. Sanofi Pasteur, Inc., 2016 WL 7638186, at *3 (C.D. Cal. March 22, 2016) (“plaintiff’s allegations . . . do not ‘identify’ or ‘explain’ how the product deviated from other seemingly identical product models,” which failed “to adequately state a manufacturing defect claim [and] require[d] the dismissal of her manufacturing defect claims.”).
• Schwartz v. Wright Medical Technology, Inc., 2014 WL 11320637, at *4 (C.D. Cal. Sept. 11, 2014) (“Plaintiff has failed to adequately allege a claim for strict products liability under a manufacturing defect theory. . . .  Plaintiff misconstrues the word ‘result’ as used in Barker.  Plaintiff argues that she suffered certain injuries as a result of the [device] and that Defendants did not intend such injuries.  While undoubtedly true, this is not the result at issue.  The correct analysis focuses on the “result” of the manufacturing process – whether the product came off the production line defective in some way.”; claim dismissed).
• Dilley v. C.R. Bard, Inc., 2014 WL 2115233, at *3 (C.D. Cal. May 21, 2014) (“[Plaintiff] has failed to augment his allegations in any way that establishes what manufacturing defect the [devices] allegedly suffered from.”; “[Plaintiff] must identify how the particular [devices] he received deviated from Defendants’ intended design.  A general study does little to advance this pleading requirement.”).
• Baker v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 6698653, at *4 (N.D. Cal. Dec. 19, 2013) (“Plaintiff argues that because she suffered from certain injuries which she alleges were caused by [the drug], in hindsight, [the drug] then clearly deviated from the Defendant’s intended result.  However, the SAC contains no allegations of how the deviation occurred or whether her [drug] was manufactured defectively.  Plaintiff has thus provided only insufficient legal conclusions that [the drug] had a manufacturing defect.”; claim dismissed).

There is literally no California law – let alone law in the Brown-governed prescription medical product liability litigation space – that would allow the sort of universal manufacturing “process” defect that the trial court made up from whole cloth in Ranitidine.  An unbroken string of six California Supreme Court cases since 1984 have all recognized three, and only three, strict liability theories.  The concept of a “process” defect has been expressly rejected in Gall and Latex Glove.  Finally, more federal decisions than any of us has fingers and toes to count have examined and exposed the fallacies of Ranitidine’s “bad results could not have been intended” excuse for concocting a novel defect theory out of whole cloth and pro-plaintiff cost shifting.

One can only hope that an interlocutory appeal saves all the litigants (and the already strained California judicial system) the time and effort of litigating an entire JCCP on a theory that has never existed under California law.