Recalled Product Lawsuits Getting Harder, Children’s Tylenol Edition

One thing you learn as a personal injury lawyer is that many everyday products are far more dangerous than you thought. Until I became a lawyer and began screening cases and receiving calls, I hadn’t a clue that Children’s Motrin could cause Stevens-Johnson Syndrome.

Tylenol is another example. I’ve used acetaminophen safely for years without a problem, and I thanked my lucky stars for it when 1,000mg of the stuff brought me back from the delirium caused by a 104+ fever. Every week, though, approximately ten people die and one-thousand are sent to the emergency department by acetaminophen overdosing.

Which brings us to In re McNeil Consumer Healthcare, Marketing & Sales Practices Litigation, 10-md-02190 (E.D. Pa.). The Amended Complaint is available on RECAP. The claims arise from a string of recalls of various children’s and infant’s Tylenol, Motrin, Zyrtec, and Benadryl prompted by FDA investigations that uncovered some ugly problems, like:

155. In May and June of 2009, the FDA discovered that from April through June 2008, McNeil had used microcrystalline cellulose, an ingredient used in liquid adult and children’s Tylenol products, that had been potentially contaminated with a gram negative bacteria, Burkholder cepacia.

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160. Beginning in approximately the Fall of 2008, McNeil began receiving reports regarding musty, moldy odors emanating from McNeil Tylenol pills manufactured at its Las Piedrad, Puerto Rico facility.
161. McNeil did not fully investigate these reports for approximately one year notwithstanding McNeal’s obligation to notify the FDA of such reports within three days.
162. Only after the FDA insisted that McNeil conduct a thorough investigation was it discovered that the odor was the result of contamination by a product called 2,4,6-Tribromoanisole (“TBA”), a pesticide used on the wooden pallets that stored and
transported packaging materials for the medications.

***

169. In April of 2010, McNeil recalled approximately 40 types of children’s and infants’ products manufactured at its Fort Washington, Pennsylvania plant because of filth and contamination, including acetaminophen, cellulose, nickel and
chromium particulate contamination, involving McNeil’s liquid infant and children’s products including Tylenol, Motrin, Benadryl, Zyrtec and Tylenol Infants’ Drops.

You can read the first “Form 483″ reports generated by the FDA here. Obviously something went very wrong with the McNeil compliance process, prompting recalls, an unknown amount of physical injury, and economic loss to the many consumers who bought those products (including myself).

The Amended Complaint was just dismissed, with leave to amend against Johnson & Johnson and McNeil.

The fatal flaw for the plaintiffs, [U.S. District Judge Mary A.] McLaughlin found, was a lack of standing due to the vagueness of their allegations and failure to cite specific injuries suffered by individual named plaintiffs.

“The plaintiffs assert in conclusory terms that they suffered out-of-pocket expenses and were not made whole, but do not make any specific allegations as to how,” McLaughlin wrote.

McLaughlin found the plaintiffs’ injuries were “abstract and hypothetical, rather than distinct and palpable.”

Among the legally significant holdings in McLaughlin’s opinion is her rejection of the plaintiffs’ argument the mere purchase of a recalled product, in and of itself, is sufficient to establish injury-in-fact.

The opinion is also on RECAP. Unsurprisingly, the pharmaceutical and medical device defense lawyers at Drug & Device Law are cheering the result:

Some of our readers may be asking a simple question of their own – why?  MCH was multi-district litigation. That kind of litigation attracts the best lawyers on both sides.  Good plaintiff lawyers certainly know how to plead the fundamental elements of product identification, causation and injury that were totally lacking from this complaint.  Heck, even bad ones can do that if forced.  So what gives?

We think we know.  The complaint dismissed by MCH was a class action.  Even more after Dukes, but also under abundant prior precedent, the commonality and predominance requirements for certification of class actions place a huge premium on every claim being the same.  What was left out of MCH were the particulars of each plaintiff’s claim – the what, where, and when that establish any individual’s right to sue.

So to the extent that the plaintiffs opt to replead in compliance with MCH, they’re only cutting their own throats down the road at the class certification stage.  And without class certification, this sort of pure economic loss claim – even assuming it could state a claim under some bizarre theory – is simply not worth pursuing.

It’s an astute observation. Haviland Hughes, the lead plaintiffs’ counsel, knows how to litigate cases against pharmaceutical companies; last year they cleaned up with similar unfair trade practices and consumer protection claims against a variety of drug companies arising from overcharging of state Medicaid / Medicare funds.

I don’t agree that the plaintiffs necessarily “cut their own throats” as to the commonality element when they start pleading specifics about their purchases — really, is there an irreconcilable difference between plaintiffs purchasing Children’s Tylenol in grape flavor versus cherry, or 0.5oz versus 1.0oz? — but it is an important issue and one that Haviland Hughes probably didn’t want to deal with at the pleading stage.

In the big picture, although class actions were intended to permit many disparate plaintiffs with similar claims to aggregate their claims against defendants, courts now, particularly after the Dukes v. Wal-Mart opinion, expend a ton of time focusing on the small differences among the plaintiffs instead of focusing on the common conduct by the defendants that caused the harm in the first place. Divide and conquer, as they say. Whether this type of focus comports with the purposes of Federal Rule of Civil Procedure 23 is left for the reader.

Back to this injury-in-fact issue. The court is entirely right that a plaintiff must allege an actual injury to have Article III standing in federal court. The problem, though, is the intersection between the MDL, class actions, and that standing. A plaintiff in a class action brings claims on their behalf and on behalf of the class. Analyzing the plaintiffs’ connection to products they didn’t buy at the pleading stage puts the cart before the horse; the court has to accept as true that the plaintiff brought one of those products, and the question of which one isn’t the pertinent issue at this point, it’s the pertinent issue at the class certification stage.

I don’t agree with The Legal Intelligencer that the opinion is a “huge victory” for Johnson & Johnson. Indeed, the court could just be looking for more specific pleading, and once the new amended complaint comes in, the court could end certifying exactly the same class action for exactly the same products and allegations. But it’s certainly not a “huge victory” for the plaintiffs, or for consumers in general.

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  • Ron Miller

    Really, who was injured in these cases? Do we really need a mass tort every time there is a bad odor in a J&J product?

    • Anonymous

      I look at it in terms of deterrence. AFAIK, they haven’t paid a fine and the refunds have been minimal. If there’s no additional cost for selling people crappy products, then the ‘free market’ will create a market of crappy products. Obviously FDA regulation and internal corporation controls weren’t enough, so liability is the last hope.

      • Ron MIller

        I feel ya, Max. But if market puts out on crappy products, I think we have an easy solution: the free market economy will create order.

        • Anonymous

          Unless everyone’s producing crappy products!