Class Action

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Data privacy is a hot topic. We regularly speak on data privacy at Reed Smith’s annual California continuing legal education day, and it takes hours to prepare because the landscape changes so rapidly. The law changes day-by-day, both legislatively and in our courts, and entire emerging industries (e.g., the “apps” industry) are organized around the collection and monetization of personal information disclosing what we do, when we do it, for how long, and where we are located. The very definition of “privacy” is now robustly debated, which is a significant change from the days when everyone knew that “private” information meant name, date of birth, social security number, account numbers, or some combination thereof. Today if you asked 25 privacy professionals to define “private” information, you might get 25 answers, and some would say “everything.”

When we expanded our drug and medical device practice into the data privacy realm a few years ago (along with the co-author of this post, Reed Smith’s Joshua Marker, an outstanding privacy lawyer and active blogger in his own right), we found that the healthcare industry was, for the most part, ahead of the game because the rules were relatively clear. Everyone agreed that personal health information was private, and there was HIPAA, the ubiquitous federal law that has regulated the security and privacy of personal health information since enacted in 1996. Drug and medical device companies typically are not HIPAA-covered entities, but they often have possession of personal health information in connection with patients who use their products, and our experience is that our clients and the lawyers who represent them take patient privacy very seriously.

One thing that has not changed is that there is no private right of action under HIPAA. That does not mean, of course, that plaintiffs have not tried to sue over breaches of security involving their private information. A handful of cases have permitted state law claims supported in part by alleged HIPAA violations, pleaded as claims like “negligence per se.” And there are numerous state laws regulating medical information that have garnered more attention as data privacy has become front-page news.Continue Reading Privacy of Medical Information: No Harm, No Foul, No Private Right of Action

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Class actions are strange and dangerous things.  A cornerstone of American jurisprudence is that the government (including its courts) cannot deprive people (such as our clients) of their property without due process of law.  In civil litigation, the question of what process is “due” is easy, answered by the right to a jury trial in most instances.  Defendants get to put plaintiffs to their burdens of proof, and defendants are generally guaranteed the opportunity to challenge that proof on an individual basis and introduce cases of their own, all before the court will invoke the power to the state to transfer wealth from one party to another, or not, depending on the proof and the verdict.

Class actions turn this neat and impeccably fair model on its head.  In a class action, one person presents his case alone, purporting to represent others “similarly situated,” and the result can be binding on people who are complete strangers to the litigation.  Depending on the outcome, absent class members can lose their right to pursue claims for their own benefit, even though they had no involvement and no voice in the proceeding. Worse yet, a defendant can be obligated to pay money to people—maybe thousands of people—who have done nothing to prove their entitlement to payment at the defendant’s expense.  We watched a little bit of the U.S. Open tennis tournament over the weekend, and the signature phrase of a great player turned broadcaster comes to mind:  “You cannot be serious!”

The rules underlying class actions, and particularly class certification, exist to protect against these travesties of justice.  We all know the familiar quartet of numerosity of class members, commonality of issues, typicality of claims, and adequacy of representation.  These requirements aim to ensure that a class action judgment cannot bind absent class members or force collective remedies on defendants without first guaranteeing that the class action is the worthwhile and best way to proceed.  They also see that proof of one person’s claim stands as a fair proxy for the absent many and that individual class representatives pursuing their individual interests to not sell out the absent class members.  There are many other requirements—a proper class definition, predominance of common issues, the superiority of a class action over other proceedings, manageability of a class action trial, fair and adequate notice, the opportunity to opt out.
Continue Reading Ascertainability Gets Its Day in the Sun

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Several years ago we vacationed in Toronto. Back then, the Drug and Device Law Son split his time between hockey and videogames. He was a goalie, so, like his dad, he was always on defense. We visited the Hockey Hall of Fame, tap-danced on the glass floor in the CN Tower, had dinner at Wayne Gretzky’s restaurant, took in a Maple Leafs game, and wandered around the huge underground mall. With the sort of weather that reigns in the True North, an underground mall (really an entire underground city) makes a lot of sense. We noticed that many of the stores had a slogan on the walls: “The World Needs More Canada.” It’s hard to argue with that. Canada has pretty much everything we like (a nice standard of living, cultural offerings, and poutine), and not so much of those things we don’t like (crime, arrogance, and crocodiles).   How can you not admire a country that has given us Joni Mitchell, Bobby Orr, and Pamela Anderson, as well as the inventors of the zipper, basketball, and Trivial Pursuit?  And we look back with fondness at a college road trip adventure, when we drifted across the border to empty the town of Magog of Molson Brador.  (Bexis points out that Canada is also responsible for the rock groups Rush and BTO.  Hmmmm.  That fact might prompt us to reconsider the whole premise of this paragraph.)

Every once in a while we have the opportunity to blog about drug and device developments north of the border, involving matters also being litigated in the USA. As we said above, there’s a lot to like about Canada.  But its class action law is usually something we don’t like so much.  Canada’s application of class action certification rules is considerably more liberal than the corresponding rules here — excepting, perhaps, certain rogue counties in Southern Illinois.  Nevertheless, we are pleased to relay some good news from the Canadian courts.  Our friends at Covington, specifically Michael Imbroscio, sent us a decision by the Quebec Superior Court rejecting certification (what they call “authorization” in Quebec) of a proposed class action alleging that Accutane (isotretinoin) caused inflammatory bowel disease (IBD), in Lebrasseur v. Hoffmann – La Roche Limitee, (Quebec Superior Court file no. 500-06-000512-109). The decision is in French, which we cannot read (though the Drug and Device Law Son says he can, and even has the grades to prove it), so we are trusting Covington’s summary.  But for those of you who claim the ability to read Proust and Moliere in the original, here is a copy of the Quebec court’s opinion.Continue Reading Quebec Court Denies Accutane Class Certification

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People usually think it’s a good thing to be “on a roll.”  But that is not always the case.  We have defended client depositions where there was nothing worse than a witness on a roll, especially if that was a roll of Yeses (“Q:  You have worked at the company since 2002, right?  A:  Yes.  Q:  And you obtained a degree in biochemistry from Rollins College, right?  A:  Yes. Q:  And you think puppies are adorable, don’t you?  A: Yes.  Q:  And your company has a responsibility to warn of all known risks, right?  A:  Yes.  Q:  And your IFU omits a number of key risks, doesn’t it?  A:  Yes.  Q:  And don’t you hate it when people talk during movies?  A:  Yes.  Q:  And the court ought to direct a verdict against your company, right?  A: Yes.  Q:  And would it be fair to say that this is a splendid case for punitive damages?  A:  Yes.  Q:  And don’t you agree that an Audemars Piguet Royal Oak watch would look great on my wrist, especially if that wrist was wrapped around the wheel of a Maserati Quattroporte?  A:  Yes.”  Etc.)

Sometimes courts can get on a bad roll, too.  When a court is determined to deny a defense motion to dismiss claims, it will find a way to tube every argument in sight, even those oozing merit.  That’s what happened in Hwang v. OHSO Clean, Inc., 2013 WL 1632697 (N.D. Cal. April 16, 2013).  In Hwang, the plaintiff brought a purported class action on behalf of a nationwide class of consumers who purchased the defendants’ sanitizing products.  The issue was whether the labels on the cleaners overstated the efficacy of the products – by saying, for example, that the cleaners “kill 99.9% of the harmful germs that can make you sick.” The legal claims sounded in various theories, including: 1) breach of express warranty; 2) deceit; 3) concealment; (4) False Advertising Law (“FAL”); 5) California’s notorious Unfair Competition Law (“UCL”); 5) Consumers Legal Remedies Act (“CLRA”); and 6) the federal Magnuson Moss Act.

In their Motion to Dismiss, the defendants contended that all of the plaintiff’s claims were preempted under the Federal Food Drug and Cosmetic Act (our beloved “FDCA,” the hook that permits us to discuss a case that is otherwise far afield from our usual stuff) and/or foreclosed by Pom Wonderful LLC v. v. Coca-Cola Co., 678 F.3d 1170 (9th Cir. 2012), a case that we have commented on (here, for example) at least as many times as we have enjoyed the fine beverages manufactured by either Pom Wonderful or the Coca-Cola Company. Here is a little pause to refresh your memory of that case:  in Pom Wonderful the Ninth Circuit held that the plaintiff’s Lanham Act claim that the defendant’s juice product label was misleading was barred by the FDCA and the regulations promulgated thereunder by the FDA, because those regulations indicated that the FDA had already considered and spoken to what content a label must bear and had apparently authorized the defendant’s labeling. The Pom Wonderful decision was really about the doctrine of primary jurisdiction more
than preemption.  It was still pretty wonderful.Continue Reading A Stale Roll and a Dismal Clean Sweep

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We appreciate being on Joe Hollingsworth’s mailing list – we really do.  Much of the Aredia/Zometa stuff he sends us is manifestly blogworthy.  That, and all things being equal, we’d rather discuss a defense win than a defense loss.  Joe doesn’t send us his bad ones (although certain plaintiff lawyers do pass…

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The big developments – the Caronia opinion, and the Supreme Court’s grant of certiorari in Bartlett – along with other distractions, such as our ABA Blawg 100 award, have left us with a pile of unblogged stuff that we think is of interest to our readers.  Today we’re taking a crack at that pile.  We apologize in advance if these discussions aren’t as detailed (and thus aren’t as useful) as our usual posts.
California Leans Daubert
California has long gone its merry, idiosyncratic way in the Daubert/Frye wars.  The California Supreme Court has fashioned something called “Kelly/Leahy” after the names of the two most important opinions.  However, in Sargon Enterprises, Inc. v. University of Southern California, ___ P.3d ___, 2012 WL 5897314 (Cal. Nov. 26, 2012), the court spoke about California expert admissibility with a distinct Daubert accent.  Sargon (great name – it evokes space aliens, unknown elements, or even ancient Sumer) is a drug/medical device case only in the loosest sense.  It’s about an alleged “breach of a contract for the [defendant] to clinically test a new implant the [plaintiff] had patented.”  Id. at *1.  The expert testimony at issue involved lost profits.  Id. at *2.  The testimony was vague and tautological, involving the expert’s supposition that the defendant, because it was “innovative,” would have joined the “big six” dental implant manufacturers.  But he measured “innovation” according to “the proof is in the pudding” – successful companies were “innovative,” less successful ones less so.  Why was the plaintiff company “innovative” even though it was small?  That opinion was a bunch of gobbledygook and jargon amounting to “because I think so.”  See Id. at *3-5.  The trial court threw the expert out.  The Court of Appeals reversed and found the testimony admissible, then the California Supreme Court granted review.
This blog doesn’t care all that much about the ins and outs of calculating lost profits, but we do care about the standards for expert admissibility.  Sargon is noteworthy for the court’s repeated reliance on the federal precedent that we have (usually) come to know and love, starting with “[u]nder California law,
trial courts have a substantial ‘gatekeeping’ responsibility.”  Sargon, 2012 WL 5897314, at *14 (footnote citing Joiner and Kuhmo Tire omitted).  That leads to “[e]xclusion of expert opinions that rest on guess, surmise or conjecture is an inherent corollary to the foundational predicate for admission of the expert testimony.”  Id.Continue Reading Stuff

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If you make a habit of checking our Cross-Jurisdictional Class Action Tolling scorecard on a daily basis, then you already know that the Louisiana Supreme Court recently skewered cross-jurisdictional tolling.  They beat it with a red stick.  But let’s assume for a moment that you have a life.  So blenderize a Hurricane, fry up some

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Our interest is piqued by a pair of recent California class action wins – well, mostly wins, on the class action parts, anyway.  The first of the decisions, Arroyo v. Chattem, Inc., 2012 WL 5412295 (N.D. Cal. Nov. 6, 2012), was a complete win.  The plaintiff complained that the defendant’s dietary supplement (but it

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Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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