Is there a tougher federal district judge than Stephen Wilson in Los Angeles?  By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to Judge Wilson.   No, we mean in the sense of not suffering fools gladly.  (To borrow a phrase from the movie Rounders, if you are in court for a case for more than a few minutes and you cannot spot the fool, odds are that it is you.)  Judge Wilson, like Judge Rakoff in SDNY or Judge Posner on the 7th Circuit or Judge Kozinski on the 9th Circuit, has a sharp mind and sharp pen (or keyboard).  If he thinks your theory is wrong, he will say so.  If he thinks you are dumb, he will say so.  Sometimes Judge Wilson can come across as a wee bit impatient. When we were a prosecutor in C.D. Cal. (as Judge Wilson had been several years before us), Judge Wilson was the first judge we encountered who imposed strict time limits during trial.  If he decided that a witness examination had gone on long enough, he would halt the examination on the spot.  We remember a guilty plea in front of Judge Wilson that took place the day before trial was scheduled.  Guilty pleas can be messy affairs.  Some people, no matter how overwhelming the evidence, have a hard time admitting that they did the crime.  And yet, such admission is an essential part of the guilty plea.  Often, the defendant stumbles over the admission.  It can take some goading, some reassuring whispers from defense counsel, and simply some time before the defendant can bring him or herself to utter the magic words.  In our case, the defendant hemmed and hawed a little too much.  Judge Wilson said that there was not enough there for a valid guilty plea, he rejected it, ordered the parties to show up the next day for jury selection, and then called the next case.  It seemed to happen in an instant.  There was panic.  We had already told our witnesses that the case would plead out and that they did not need to come to the federal courthouse the next day.  For all we knew, our case agent was already well outside the jurisdiction, on a protection detail or going undercover.  On the other side of the ledger, the defendant knew what the result at trial would be, and wanted at least to get a couple of points off the sentencing guidelines for acceptance of responsibility.  Somehow the defendant and his lawyer got their act together and returned to court near the end of the day and performed the requisite guilty plea allocution, and all was right with the world.   Judge Wilson’s demonstration of impatience had worked.

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As anyone can tell from our class action scorecards (federal and state), plaintiffs have not done very well lately – lately being the last couple of decades – with class actions involving alleged injuries caused by prescription medical products.  Between the general predominance of individualized issues in personal injury cases and the specific focus on the actions of prescribing physicians in prescription-only product cases (thanks to the learned intermediary rule), plaintiffs have suffered defeat after defeat.  While things aren’t perfect, all in all successful class actions for purported prescription medical product injuries are pretty rare.

Each defeat drives the class action purveyors further towards the margins, and recently, in In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2015 WL 1736976 (E.D. Pa. April 16, 2015), one of the more marginal class action damages theories we’ve seen was swept away.

In Avandia, the would-be class representative did not claim to be injured in the slightest – either by the drug’s risks or by deprivation of the drug’s benefits.  As stated in the opinion, “Plaintiff received the drug she was prescribed, took the drug, and alleges neither that the drug failed to do its job (controlling Plaintiff’s blood sugar levels) nor that she was injured by taking the drug.”  Id. at *3.  The only damages that the plaintiff (and supposed class) sought were of the existential variety – some difference in subjective “worth” beyond what was reflected in the purchase price of the drug, purchase price being how value is necessarily determined in a free-market economy.  The complaint itself, doubtless to suppress the numerous individualized issues bubbling below the surface, was appallingly generalized and superficial.  The court observed:

Plaintiff does not allege when or for how long she took Avandia or how much she paid for it; nor does she identify the prescribing physician or allege any facts regarding her medical treatment.  Plaintiff also does not allege that Avandia was ineffective in treating her Type II diabetes, whether she took or would have taken another drug instead of Avandia, or the cost of such other drugs.  Plaintiff seeks damages “equal to the difference between the actual value of Avandia and the value of Avandia had it been as represented by Defendant.”

Id. at *1 (quoting complaint).


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The district court’s order denying class certification in Rahman v. Mott’s LLP, 2014 U.S. Dist.  LEXIS 167744 (N.D. Cal. Dec. 3, 2014), is a nail-biter in the same sense as the movies Argo and Captain Phillips.  We know the outcomes will be good because history tells us that the hostages leave Iran safely and the captain of the seized container ship Alabama will be rescued unharmed by the modern-day superheroes known as Seal Team 6.  But man, it sure was tense getting there.  If your heart was not beating quickly when the hostages were faking their way through the Tehran airport or when the Navy commandos were leveling their rifles at the ever-more-desperate Somali pirates, you are not human.

We at the Drug and Device Law Blog are human, and although we knew that the outcome of Rahman would be good (because the district court said it would be at the beginning of the order), we had to get through some tense moments to get there.

The lawsuit is one of the sillier cases that we have seen:  The plaintiff filed a class action alleging that an apple juice seller violated California’s Unfair Competition Law (UCL) by printing “No Sugar Added” on the label.  Id. at *2.  Why is that silly?  Because there was no sugar added.  The statement was completely true, yet it purportedly formed the basis for a class action claiming consumer fraud.  Before you bite your nails to the nub in frustration, bear in mind that the phrase “no sugar added” is regulated under the FDCA.  Under the regulations, a food seller can include “no sugar added” on a product’s label only if the product meets certain conditions, including that “the food that it resembles and for which it substitutes normally contains added sugars.”  Id. at **5-6 (citing 21 C.F.R. § 101.60(c)(2)(iv)).  Apparently, you can put “no sugar added” on the label of a frozen desert, but not a frozen pizza, because ice cream “normally contains added sugar” and pizza does not.  You also have to state on the label that the product is not “low calorie” or “calorie reduced.”  Id. at *5 (citing 21 C.F.R. § 101.60(c)(2)(v)).


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We don’t discuss damages much, except to fulminate about punitive damages.  Why is that?  We’re not entirely sure, but to some extent not discussing damages means not discussing losing.  We “win” for our clients when we prevail on liability, and that’s what we like to do most.  Getting into damages means that we didn’t achieve our primary goals in litigation, which are to win all the cases we can and settle the rest.

But not every case is a good case.  Sometimes, particularly in real (not made up “parallel claims”) manufacturing defect cases, there simply isn’t a good defense on the merits.  Give credit to the other side’s skill, too.  They can often make hay with bad cases.  Even when our side doesn’t think there’s liability, there can still be damages.


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We have another case in which a plaintiff claimed that a pharmaceutical company is under a duty to supply its drug.  We blogged about the other one here.  These cases are interesting.  They tend to illustrate how, in litigation, you can claim almost anything.  In Bartlett, for instance, the plaintiff claimed that a company should stop selling its drug to avoid liability.  In these cases, it’s the opposite.  The defendant must sell its drug to avoid liability.  It’s no wonder
that in all these cases the plaintiffs have lost.

In this recent case, Schubert v. Genzyme Corp., Case No. 2:12CV587DAK (D. Ut. Sept. 4, 2013), the defendant, Genzyme, manufactured a drug called Fabrazyme, an enzyme replacement that is used by patients who have difficulty metabolizing their lipids.  Genzyme experienced a shortage of the drug after it found a virus contamination at its manufacturing facility.  So Genzyme rationed its supply to the market.  The plaintiff’s husband received only about 70% of his ordinary dose and eventually died.  Slip Op. at 2-3.  Afterward, plaintiff sued and claimed that the defendant failed to use reasonable care to ensure an adequate supply of Fabrazyme.

Unfortunate as the circumstances of this and other cases like it may be, the court reached the only conclusion it could.  Genzyme was under no affirmative duty to supply the drug.  While Utah, like many jurisdictions, will at times impose a duty and perhaps liability upon a defendant who has acted and brought about certain consequences (called malfeasance), it will not do so for a mere failure to act (nonfeasance) absent some sort of special relationship.  And plaintiff’s negligence claim, at bottom, was about a failure to act, whether she claimed that Genzyme didn’t supply the drug at all or didn’t supply enough:

[T]he court finds no distinction between the duty of a company that exits the market altogether and a company that does not supply enough product to meet full market demand.  In both instances, the harm is the shortage of the medication and it is an act of nonfeasance.  Genzyme should not be penalized for producing as much of the product as it could.

Slip Op. at 9-10.


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Remember that weird case where the plaintiff was suing because the defendant removed a drug he liked from the market?  Well, it was affirmed the other day, by the Eleventh Circuit.  See Lacognata v. Hospira, Inc., No. 12-14078, slip op. (11th Cir. June 7, 2013) (unpublished).  The affirmance isn’t much – all of one

We couldn’t make this stuff up, folks.

Here’s the description of the basis of the lawsuit in Lacognata v. Hospira, Inc., 2012 U.S. Dist. Lexis 102707 (M.D. Fla. July 2, 2012):

Plaintiff . . . brings this action individually and on behalf of all others similarly situated based on [defendant’s] failure to provide Plaintiff

The New Yorker occasionally runs squibs called “There’ll Always Be an England”– little ditties highlighting charming English eccentricity, often involving gardening for some reason.

We’re thinking of posting entries called “There’ll Always Be Posner,” comments on opinions by Judge Posner, which typically are brilliant and snappily written, typically address jurisdictional issues that nobody raised, typically