Search results for: benzene

More than once have we taken note of the current plaintiff lawyer infatuation with enlisting “independent” (ha ha ha) laboratories that will manage to detect contaminants in any drug, cosmetic, or puddle of unicorn tears.  For example, see our coverage of the Zantac MDL magnum opus ruling where the court was less than impressed by…

In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues.  Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene.  

The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy.   Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts.  Valisure calls itself “the pharmacy that checks.”  Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA.  Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene.  (Sound familiar?) The FDA had not responded to the Citizen’s Petition.  The defendant voluntarily implemented a recall of certain batches of the antiperspirant.  

Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint.  The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings.  The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA.  Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana.  Not that we’re complaining.  The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint?  

Continue Reading E.D. Louisiana Dismisses Antiperspirant/Benzene Claims

Last week, we (along with many of you, we assume) attended the DRI Drug and Medical Device conference in Chicago. We re-connected with friends dating to the beginning of our lengthy career (literally – ran into the head of our decades-ago summer associate program), met lots of new people, and attended great parties.  (Perhaps we are biased, but we thought the reception Reed Smith co-sponsored was particularly fabulous – stunning venue, fantastic food, great company and ambiance.)

Squeezed in among the parties was a whole seminar program, covering all manner of hot topics in the mass tort space in which we practice. We were (as we always are) awed by the sheer intellectual firepower the speakers brought to bear and by the depth of their knowledge and the thoroughness of their preparation.  We also enjoyed observing the diversity of presenters’ styles.  Some were earnest and academic, some deceptively casual and colloquial, still others politician-impassioned.  As wordsmiths, we always delight in this, and we count it among the reasons we like today’s case, which follows a mostly serious and measured (albeit dismissive) majority opinion with a snarky and stylized dissent.  (Guess which one was more fun to read.)

Milward v. Rust-Oleum Corp., 2016 U.S. App. LEXIS 7470 (1st Cir. Apr. 25, 2016), is not a drug or device case. It is the First Circuit’s review of the District of Massachusetts’s exclusion of the plaintiffs’ specific causation expert in a benzene-exposure toxic tort case, but the issues are identical to Daubert issues we face in our cases.Continue Reading First Circuit: Plaintiffs’ Specific Causation Expert Fails to Pass Muster in Benzene Case

We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene.  Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.

Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania

We have seen a recent plague of purported class actions against various FDA-regulated OTC products that include allegations of contamination (usually benzene) that are purportedly supported by “independent laboratory” testing. Fortunately, we have also seen these cases dismissed one after another for a variety of reasons, including lack of standing. Today’s case is a great…

Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation.  That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.”  In the spate of litigation…

A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions.  The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025)…

Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene.  That post also commented:

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure −  which proceeded to file a citizen’s petition with the FDA seeking action against [these] products.  Sound familiar?

Last month, the FDA responded to the petition.  The agency was not impressed.  Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about.  It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id.  Only six of 95 products were recalled, and even then, only specified lot numbers.  FDA Statement ¶7.

Continue Reading It’s About Time – FDA Calls Foul on Valisure

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