California Court of Appeal, The People v. Johnson & Johnson, Docket No. D077945

Antitrust

 

Trade Regulation

 

Unfair Competition

 

Misleading Statements

 

False Advertising

 

Design Defect and Failure-to-Warn Theories of Liability

 

The FDA Did Not Create a Safe Harbor

 

Statute of Limitations

 

Tolling Agreement

 

Consumer Law

 

Drugs & Biotech

 

Health Law

 

California Law

 

 

 

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon) appeal an adverse judgment following a bench trial. The trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically-implantable transvaginal pelvic mesh products. The court found Ethicon committed 153,351 violations of the Unfair Competition Law (UCL) (Bus. & Prof. Code, § 17200 et seq.) and 121,844 violations of the False Advertising Law (FAL) (§ 17500 et seq.), and it imposed a $1,250 civil penalty for each violation.

(Further undesignated statutory references are to the Business and Professions Code.)

 

(…) In 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification alerting health care providers about complications from pelvic mesh implants used to treat SUI and POP.

 

(…) In 2012, the FDA ordered Ethicon to conduct post-market surveillance studies for one of its SUI devices (TVT-Secur) and three of its POP devices (Prolift, Prolift-M, and Prosima). Instead of conducting these post-market surveillance studies, Ethicon stopped selling the products commercially. Ethicon also changed the indication for its fourth POP device (Gynemesh PS) from a transvaginal indication to an abdominal-only indication. Ethicon continued selling its other SUI devices (TVT, TVT-Obturator, TVT-Abbrevo, and TVT-Exact) up to and throughout the present lawsuit.

 

Ethicon’s competitors continued to sell pelvic mesh products for transvaginal repair of POP, even after Ethicon stopped selling most of its POP devices. However, in April 2019, the FDA concluded there was not a reasonable assurance of safety and effectiveness for any commercially- available pelvic mesh products intended for transvaginal repair of POP. Therefore, the FDA ordered all remaining manufacturers of surgical mesh intended for transvaginal repair of POP to stop selling and distributing such products.

 

Ethicon’s Communications About Its Pelvic Mesh Products 

During the relevant timeframe, Ethicon disseminated three categories of communications giving rise to the violations at issue here: (1) Instructions for Use (IFUs); (2) marketing communications directed to California doctors; and (3) marketing communications directed to California patients.

 

(…) In 2016, the Attorney General filed an enforcement action against Ethicon on behalf of the People of the State of California. The operative complaint alleged Ethicon violated the UCL and FAL by disseminating deceptive advertisements relating to its pelvic mesh products.

 

(…) The UCL has a four-year statute of limitations (§ 17208) and the FAL has a three-year statute of limitations (Code Civ. Proc., § 338, subd. (h)). However, the parties executed a tolling agreement, effective October 17, 2012. Thus, the earliest date Ethicon could be held liable for UCL violations was October 17, 2008, and the earliest date it could be held liable for FAL violations was October 17, 2009. 

 

Governing Laws

 

 

Unfair Competition Law

 

The Unfair Competition Law, or UCL, forbids unfair competition, which is defined as “any unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising and any act prohibited by” the False Advertising Law.  (§ 17200.)  The UCL’s “ ‘purpose is to protect both consumers and competitors by promoting fair competition in commercial markets for goods and services.’ ”  (Abbott Laboratories v. Superior Court (2020) 9 Cal.5th 642, 651 (Abbott Labs).)“ ‘In service of that purpose, the Legislature framed the UCL’s substantive provisions in “ ‘broad, sweeping language’ ” ’ [citation] to reach ‘anything that can properly be called a business practice and that at the same time is forbidden by law’ [citation].  ‘By proscribing “any unlawful” business practice, “section 17200 ‘borrows’ violations of other laws and treats them as unlawful practices” that the unfair competition law makes independently actionable.’ ”  (Abbott Labs, supra, 9 Cal.5th at pp. 651–652.)  “However, the law does more than just borrow.  The statutory language referring to ‘any unlawful, unfair or fraudulent’ practice makes clear that a practice may be deemed unfair even if not specifically proscribed by some other law.  ‘Because ... section 17200 is written in the disjunctive, it establishes three varieties of unfair competition—acts or practices which are unlawful, or unfair, or fraudulent.’ ”  (Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co. (1999) 20 Cal.4th 163, 180 (Cel-Tech).)

 

 

False Advertising Law

 

The False Advertising Law, or FAL, “broadly prohibits false or misleading advertising, declaring that it is unlawful for any person or business to make or distribute any statement to induce the public to enter into a transaction ‘which is untrue or misleading, and which is known, or which by the exercise of reasonable care should be known, to be untrue or misleading.’ ”  (Nationwide Biweekly Administration, Inc. v. Superior Court (2020) 9 Cal.5th 279, 306 (Nationwide), quoting § 17500.)  The FAL is “‘designed to protect consumers from false or deceptive advertising.’”  (Id. at p. 305; see Kwikset Corp. v. Superior Court (2011) 51 Cal.4th 310, 331 [“The UCL and false advertising law are both intended to preserve fair competition and protect consumers from market distortions.”].)  “Like the choice of the term ‘unfair’ in the UCL, the governing substantive standard of the FAL—prohibiting advertising that is ‘untrue or misleading’ [citation]—is set forth in broad and open-ended language that is intended to permit a court of equity to reach any novel or creative scheme of false or misleading advertising that a deceptive business may devise.”  (Nationwide, supra, 9 Cal.5th at p. 308.)  “The FAL prohibits ‘“not only advertising which is false, but also advertising which, although true, is either actually misleading or which has a capacity, likelihood or tendency to deceive or confuse the public.”  [Citation.]  Thus, to state a claim under either the UCL or the false advertising law, based on false advertising or promotional practices, “it is necessary only to show that ‘members of the public are likely to be deceived.’”’ ”  (Ibid.)

 

 

(…) The remedies and penalties provided for in the UCL and FAL generally are cumulative to each other and to remedies and penalties available under other laws.  (§§ 17205, 17534.5.)  Thus, conduct that violates both the UCL and FAL can result in separate penalties of up to $2,500 for each UCL violation and for each FAL violation.  (See People v. Toomey (1984) 157 Cal.App.3d 1, 22 [the UCL and FAL “allow for cumulative remedies, indicating a legislative intent to allow ... double fines”]. (p. 21).

 

 

1

 

Target Audience Standard

i

 

“To prevail on a claim under the fraudulent prong of the Unfair Competition Law ‘based on false advertising or promotional practices,’ the plaintiff must ‘ “show that ‘members of the public are likely to be deceived.’ ” ’  [Citations.]  An advertisement or promotional practice is likely to deceive if it includes assertions that are (1) untrue, or (2) ‘ “true [, but are] either actually misleading or which [have the] capacity, likelihood or tendency to deceive or confuse the public.” ’ ”  (Shaeffer v. Califia Farms, LLC (2020) 44 Cal.App.5th 1125, 1135 (Shaeffer).)  The FAL “substantively overlaps” with the fraudulent prong of the UCL and the “burden under these provisions is the same:  To prevail on a claim under the false advertising law, the plaintiff must show that ‘ “ ‘members of the public are likely to be deceived ....’ ” ’ ”  (Id. at p. 1136; see also Chapman v. Skype Inc. (2013) 220 Cal.App.4th 217, 226 [for claims under “ ‘the UCL or the false advertising law, based on false advertising or promotional practices, “it is necessary only to show that ‘members of the public are likely to be deceived’ ” ’ ”] (Chapman).

 

 

In assessing the likelihood of deception, the challenged advertisement or practice is typically viewed “through the eyes of the ‘reasonable consumer’—that is, the ‘ordinary consumer acting reasonably under the circumstances....’ ”  (Shaeffer, supra,44 Cal.App.5th at p. 1135.)

 

 

However, “ ‘where the advertising or practice is targeted to a particular group or type of consumers, either more sophisticated or less sophisticated than the ordinary consumer, the question whether it is misleading to the public will be viewed from the vantage point of members of the targeted group, not others to whom it is not primarily directed.’ ”  (In re Vioxx Class Cases (2009) 180 Cal.App.4th 116, 130 (Vioxx), quoting Lavie v. Procter & Gamble Co. (2003) 105 Cal.App.4th 496, 509–510 (Lavie).)

 

 

A fraudulent or deceptive omission is actionable if it is “contrary to a representation actually made by the defendant, or an omission of a fact the defendant was obliged to disclose.”  (Daugherty v. American Honda Motor Co., Inc. (2006) 144 Cal.App.4th 824, 835; see Collins v. eMachines, Inc. (2011) 202 Cal.App.4th 249, 255 (Collins) [“fraud or deceit encompasses the suppression of a fact by one who is bound to disclose it, or the suppression of a fact that is contrary to a representation that was made”].)  In other words, omissions-based claims can be pure-omissions claims or partial-misrepresentation claims.

 

 

In assessing whether an omission is fraudulent or deceptive, courts typically consider whether the omission satisfies one or more of the four factors set forth in LiMandri v. Judkins (1997) 52 Cal.App.4th 326, 336.  As this court explained in LiMandri:  “There are ‘four circumstances in which nondisclosure or concealment may constitute actionable fraud:  (1) when the defendant is in a fiduciary relationship with the plaintiff; (2) when the defendant had exclusive knowledge of material facts not known to the plaintiff; (3) when the defendant actively conceals a material fact from the plaintiff; and (4) when the defendant makes partial representations but also suppresses some material facts.’ ” (LiMandri, at p. 336; see Collins, supra, 202 Cal.App.4th at p. 255 [applying the LiMandri factors to determine whether a failure to disclose constituted actionable fraud or deceit].

As previously noted, the governing standard in a false advertising case is whether “ ‘ “ ‘members of the public are likely to be deceived.’ ” ’ ”  (Nationwide, supra, 9 Cal.5th at p. 308.)  If the challenged advertisement is likely to deceive, it is actionable “without individualized proof of deception, reliance and injury.”  (Massachusetts Mutual Life Ins. Co. v. Superior Court (2002) 97 Cal.App.4th 1282, 1288; see Prata v. Superior Court (2001) 91 Cal.App.4th 1128, 1137 [“The Legislature considered [the UCL’s] purpose so important that it authorized courts to order restitution without individualized proof of deception, reliance and injury if necessary to prevent the use or employment of an unfair practice.”], italics omitted.)

 

 

(…) Similarly, in Hrymoc v. Ethicon, Inc. (N.J. Super. Ct. App. Div. 2021) 467 N.J. Super. 42 (Hrymoc), certification granted October 19, 2021, 085547, a patient suffered severe medical complications after receiving a Prolift implant.  She sued Ethicon under New Jersey’s products liability law and a jury returned a verdict in her favor on design defect and failure-to-warn theories of liability.  (Id. at pp. 199–200.)

 

 

(…) The Kaiser, Hrymoc, Hammons, and Carlino decisions arose in other jurisdictions and the plaintiffs’ claims in those cases were predicated on legal theories and trial records different than those presented here.  However, each decision reveals a similar narrative:  Ethicon disseminated IFUs that were likely to deceive doctors because the IFUs falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences of those complications.  The statement of decision and the appellate record in the present case tell precisely the same story.  Viewing the evidence in the light most favorable to the People, as the prevailing party, we conclude there was substantial evidence to support the trial court’s factual finding that Ethicon’s IFUs were likely to deceive doctors.

 

 

Substantial Evidence Supported the Findings Regarding Ethicon’s Written Marketing Communications, But Not its Oral Marketing Communications

 

However, unlike the trial court, we conclude the uniform nature of Ethicon’s sales representatives training does not, standing alone, give rise to a reasonable inference that every single one of Ethicon’s thousands of oral communications with doctors included false or misleading statements.  The mere fact a sales representative may have been trained in a particular way—even in a manner that promoted the disclosure of misleading information—reveals little, if anything, about the content of any particular conversation that may have occurred many months or years later.  Further, there is no evidence—at least none of which we are aware of—suggesting Ethicon’s sales representatives read or recited a uniform script, Ethicon’s IFUs, or Ethicon’s printed marketing materials during their oral communications with doctors.

 

 

We hasten to add that there is nothing inherently less problematic about a false or deceptive statement that is spoken aloud, as opposed to one that has been memorialized in writing.  In an appropriate case, where the content and deceptive nature of the oral statement is established, the speaker may be held liable for violating the UCL or FAL.  (See People v. Dollar Rent-A-Car Systems, Inc. (1989) 211 Cal.App.3d 119, 128–129 [the FAL’s prohibition against false or misleading advertising “extends to the use of false or misleading oral statements”].)  We merely conclude there was insufficient evidence in this case regarding the substance of Ethicon’s oral marketing communications; thus, there was insufficient evidence that these communications were likely to deceive their target audiences.

 

 

Substantial Evidence Supported the Finding that Ethicon’s Marketing Was Likely to Deceive Patients.

 

 

Overview of the Safe Harbor Defense  

 

Under the safe harbor defense, “specific legislation may limit the judiciary’s power to declare conduct unfair under the UCL.  If the Legislature has permitted certain conduct or considered a situation and concluded no action should lie, courts may not override that determination. When specific legislation provides a ‘safe harbor,’ plaintiffs may not use the general unfair competition law to assault that harbor.”  (Cel-Tech, supra, 20 Cal.4th at p. 182.)  Stated another way, the Attorney General or another UCL plaintiff may “not ‘plead around’ an ‘absolute bar to relief’ simply ‘by recasting the cause of action as one for unfair competition.’ ”  (Ibid.)

 

 

The FDA Did Not Create a Safe Harbor for Communications Related to the POP Products

 

The FDA’s limited review of the draft Prolift and Prolift+M IFUs—a review undertaken as part of the section 510(k) clearance process—did not create a safe harbor.  “To forestall an action under the unfair competition law, another provision or executive action, per our stated assumptions must actually ‘bar’  the action or clearly permit the conduct.”  (Cel-Tech, supra, 20 Cal.4th at p. 183; Klein v. Chevron U.S.A., Inc. (2012) 202 Cal.App.4th 1342, 1379 [“to qualify for the ‘safe harbor’ rule, the defendant must show that a statute ‘explicitly prohibits liability for the defendant’s acts or omissions’ [citation] or ‘expressly precludes an action based on the conduct’ ”].)The FDA’s conduct during the clearance process did not clearly sanction or approve the final IFUs for non-510(k) purposes.  “ ‘The 510(k) process is focused on equivalence, not safety.’  ...  These determinations simply compare a post–1976 device to a pre–1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device.’ ”  (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 493; accord Kaiser, supra, 947 F.3d at p. 1018 [in products liability case, trial court properly excluded evidence that FDA cleared Prolift because the section 510(k) clearance process and FDA safety review serve different purposes].)

 

 

(…) The court found its calculation was likely an undercount because, for certain gaps of time, Ethicon did not have internal company data necessary for the Attorney General’s forensic accountant to calculate the number of deceptive IFUs and marketing communications that Ethicon disseminated.  These gaps of time were omitted from the violations count (fn. 16).

 

 

 

 

(California Court of Appeal, April 11, 2022, The People v. Johnson & Johnson, Docket No. D077945, Certified for Publication)

T.H. v. Novartis Pharmaceuticals Corporation, S233898

Misrepresentation (California law): Duty of care: Warning: Product warning: Failure to warn: Strict liability: Negligence: Sophisticated user & intermediary defenses: Tort:

Under our state’s law, there is no per se requirement in negligent misrepresentation actions that the misrepresentation be made by the product

manufacturer. Consider Hanberry v. Hearst Corp. (1969) 276 Cal.App.2d 680, where the plaintiff alleged that defective shoes caused her injuries. (Id. at p. 682.) The Court of Appeal allowed the negligent misrepresentation claims to go forward against a nonmanufacturer — the publisher of Good Housekeeping magazine, which had given the shoes its renowned seal of approval. (Id. at p. 683.) This seal appeared not only in the pages of its own magazine, but was used by the shoe manufacturer in its advertising as well as on the product and its packaging. (Ibid.) The court acknowledged that the defendant publisher was neither the seller nor the manufacturer of the shoes, but nonetheless recognized a duty of care because of the allegations that the publisher “held itself out as a disinterested third party which had examined the shoes, found them satisfactory, and gave its endorsement”; and the plaintiff reasonably relied on the endorsement and “purchased the shoes because of it.” (Id. at pp. 686, 683.) As to the plaintiff’s claim under strict liability, however, the court affirmed the trial court’s dismissal — declining to extend strict liability “to a general endorser who makes no representation it has examined or tested each item marketed.” (Id. at p. 688; see also Conte, 168 Cal.App.4th at pp. 101-102 [similarly distinguishing between strict liability and negligent misrepresentation theories].)

Novartis suggests that we recently conflated strict liability and negligence in Webb v. Special Electric Co., Inc. (2016) 63 Cal.4th 167 when we observed that "there is little functional difference between the two theories in the failure to warn context." (Id. at p. 187.) Not so. Webb’s observation was merely that the sophisticated user and sophisticated intermediary defenses applied to both theories of liability. (Ibid.) We did not categorically alter our longstanding recognition that “California law recognizes the differences between negligence and strict liability causes of action.” (Johnson v. American Standard , Inc. (2008) 43 Cal. 4th 56, 71; see Saller v. Crown Cork & Seal Co., Inc. (2010) 187 Cal.App.4th 1220, 1239 ["Negligence and strict products liability are separate and distinct bases for liability that do not automatically collapse into each other because the plaintiff might allege both when a product warning contributes to her injury"].)

We likewise discount decisions from those jurisdictions that differ from California by categorically excluding from liability certain defendants (see, e.g., Huck v. Wyeth, Inc., 850 N.W.2d at p. 371 (plur. opn. of Waterman, J.) [“the tort of negligent misrepresentation does not apply to sellers of products but rather is limited to those in the business or profession of supplying information for the guidance of others”]) or certain injuries (see, e.g., Flynn v. American Home Products Corp. (Minn.Ct.App. 2001) 627 N.W.2d 342, 351 [“the Minnesota Supreme Court has recognized negligent misrepresentation involving damages only for pecuniary loss, and has expressly declined to recognize the tort of negligent misrepresentation involving the risk of physical harm”]) from the tort of negligent misrepresentation. And we find unhelpful the views of those jurisdictions that (federal courts predict) will recharacterize under their product liability act or similar rule all claims against a product manufacturer, no matter the theory, as product liability actions, which can be asserted only against the manufacturer of the product. (See, e.g., Germain, 756 F.3d at pp. 941-954 [construing the laws of Arkansas, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Mississippi, Nebraska, New York, North Carolina, Ohio, Texas, Washington, and West Virginia]; Phelps v. Wyeth, Inc. (D.Or. 2012) 857 F.Supp.2d 1114, 1121 [Oregon law]; Stanley v. Wyeth, Inc. (La.Ct.App. 2008) 991 So.2d 31, 33-34 [noting the “numerous cases where the negligent misrepresentation claims were . . . preempted by . . . a state’s enactment of products liability law”].)

We find that brand-name drug manufacturers have a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party (in reliance on the brand-name manufacturer’s warning) was dispensed the brand-name or generic version of the drug. We also conclude that a brand-name manufacturer’s sale of the rights to a drug does not, as a matter of law, terminate its liability for injuries foreseeably and proximately caused by deficiencies present in the warning label prior to the sale.

(Cal. S.C., Dec. 21, 2017, T.H. v. Novartis Pharmaceuticals Corporation, S233898).

Responsabilité civile et contractuelle (droit californien), déclaration inexacte ("misrepresentation") :

En droit californien, une action en dommages-intérêts fondée sur une déclaration inexacte peut être déposée contre d'autres défendeurs que le seul fabricant du produit. Par exemple, dans une procédure où le demandeur soutenait que des chaussures lui avaient causé un préjudice corporel, la cour a accepté comme défendeur un magazine très connu qui avait fait l'éloge de ces chaussures dans l'un de ses articles. La cour a reconnu que le magazine n'était ni le fabricant ni le vendeur des chaussures, mais qu'il était tout de même tenu par un devoir de diligence du fait qu'il s'était présenté comme une tierce partie désintéressée qui avait examiné les chaussures, les avait jugées satisfaisantes, et en avait fait ainsi la promotion. En outre, le demandeur s'était raisonnablement fié à dite promotion, et, du fait de celle-ci, avait acheté les chaussures. Une telle action reste une action en responsabilité pour faute, et non une action en responsabilité causale : le magazine n'a pas suggéré qu'il avait examiné ou testé chacune des chaussures mises sur le marché.

La responsabilité pour faute ("negligence") doit toujours être distinguée des cas de responsabilité objective ("strict liability"), même si un demandeur qui agit en responsabilité du fait des produits invoque ces deux notions juridiques.

La Cour rejette par ailleurs la jurisprudence d'autres états qui exclut catégoriquement la responsabilité pour déclaration inexacte de certains défendeurs (est citée comme exemple une décision d'un autre état qui exclut le vendeur des défendeurs possibles dans le cadre d'une action en responsabilité pour faute du fait d'une déclaration inexacte, et qui ne retient comme défendeurs possibles que ceux dont le métier en lui-même consiste à donner des informations) ou qui limites dite responsabilité à certains types de dommages (par exemple la jurisprudence de certains autres états qui limite au dommage matériel la responsabilité pour déclaration inexacte, et la prohibe s'agissant du préjudice corporel).

Dans la présente espèce, la Cour juge que le fabricant d'un produit pharmaceutique doit aviser des risques de ses produits. Il peut être recherché à cet égard en responsabilité même par un demandeur à qui le générique a été prescrit. Ce devoir d'avis des risques se prolonge même si le fabricant cède ses droits sur le produit.

T.H. v. Novartis Pharmaceuticals Corporation, S233898

Labeling: Drug labeling: Warning: Failure to warn: Medical devices: Pre-emption:

If the policy of preventing harm has special relevance to any particular endeavor, surely prescription drug labeling is one. (Sindell v. Abbott Laboratories, 26 Cal.3d at p. 611.) A substantial body of state law serves to protect California consumers from the dangers posed by false, misleading, and inadequate labeling of prescription medications. (See, e.g., Bus. & Prof. Code, §§ 4070-4078.) The United States Supreme Court, too, has recognized the pivotal role of state tort actions “as a complementary form of drug regulation” with respect to drug labeling. (Wyeth, 555 U.S. at p. 578; see id. at p. 579 [“State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times”]; accord, Stevens v. Parke, Davis & Co., 9 Cal.3d at p. 65 [recognizing that federal warning-label regulations alone may be insufficient to protect patient safety].)

(…) Cases involving a challenge to the adequacy of a medical device label. Federal law preempts state tort actions based on deficient warnings for medical devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 329; cf. Wyeth, supra, 555 U.S. at p. 574 [“despite its 1976 enactment of an express pre-emption provision for medical devices, Congress has not enacted such a provision for prescription drugs”].)

(Cal. S.C., Dec. 21, 2017, T.H. v. Novartis Pharmaceuticals Corporation, S233898).

Exigences en matière d'étiquetages et notices, ici de médicaments et de dispositifs médicaux

Le droit des états, ici californien, protège substantiellement les consommateurs de médicaments des dangers posés par des étiquetages et des notices faux, trompeurs ou inadéquats. La Cour Suprême fédérale a reconnu en la matière le rôle fondamental du droit de la RC des états, qualifié de réglementation complémentaire des médicaments s'agissant de l'étiquetage et des notices. Ces actions en RC peuvent permettre de découvrir des risques associés à la prise des médicaments, et incitent les fabricants à divulguer sans délai des risques nouvellement apparus.

Par le mécanisme de la préemption, seul le droit fédéral s'applique aux actions fondées sur un étiquetage ou une notice défectueuse remise avec un dispositif ou un équipement médical.

T.H. v. Novartis Pharmaceuticals Corporation, S233898

Product liability: Tort: Warning: Product warning: Failure to warn:

(Cf. Groll v. Shell Oil Co. (1983) 148 Cal.App.3d 444, 449 [manufacturer of bulk fuel owed no duty to the ultimate consumer where the manufacturer provided adequate warnings to the distributor, “who subsequently packages, labels and markets the product,” and the manufacturer thus “did not have the ability to prepare the warning”].)

(Cal. S.C., Dec. 21, 2017, T.H. v. Novartis Pharmaceuticals Corporation, S233898).

Le producteur d'un carburant vendu en gros n'est redevable d'aucun devoir d'aviser des risques envers le consommateur final, lorsque le producteur a donné un avis adéquat au distributeur, auquel revient les tâches de conditionner et d'écouler le produit.