Warning Adequacy

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This is actually a post from Reed Smith’s Rachel Weil.  While this is not her first post, she is still a mere “guest poster” at this point and takes sole responsibility for the content of her posts.  We have allowed her to use first person plural pronouns, though. 

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On this unseasonably warm day where we are, as we lament the passage of another summer and the demise of its bounty of strawberries, blackberries and peaches, we rejoice that a recent trip to our local grocery uber-chain revealed a silver lining in the return of perfect clementines.  Clementines, those
Lilliputian cousins of the tangerine, represent nature’s engineering at its best.  Easily accessible, their perfect sections are joined in a seamless whole, uniformly sweet and unmarred by “bad spots” or detritus.

Such are the attributes of a tidy little decision out of the Ortho Evra® MDL.  (We have blogged about other Ortho Evra® decisions, like here and here, for example, but this is the first that was postured in a fashion that facilitated total victory for the defendants in one shot.  Today’s breaking news post, also comes from the Ortho Evra® MDL.)   In Giffen v. Ortho McNeil Pharmaceutical, Inc., No. 3:12 oe 40001, 2014 U.S. Dist. LEXIS 136587 (N.D. Ohio. Sept. 26, 2014), Plaintiff was given samples of the Ortho Evra® birth control patch and used them for one month.  Alleging that the patch caused her to suffer a stroke, Plaintiff asserted the standard failure to warn, negligence, design defect, and warranty claims, along with a litany of fraud-based claims.  Defendants
moved in the alternative (wisely, as you will see) for judgment on the pleadings or for summary judgment on all of the Plaintiff’s claims.  Id. at *1-2.Continue Reading A Juicy Little Decision

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October 8 is a fine day to reflect on American heroism.  Eddie Rickenbacker was born on October 8, 1890.  He became America’s ace fighter-pilot in World War I, with 26 aerial victories.  Rickenbacker won the Congressional Medal of Honor. The French gave him the Croix de Guerre.  Rickenbacker was also a race-car driver.  He later headed Eastern Airlines.  Ninety-six years ago on this selfsame date, Alvin York led an attack on a German machine gun nest.  He killed 28 enemy soldiers and captured 132.  He, too, earned the Congressional Medal of Honor and the Croix de Guerre, along with many other honors.  York had to struggle with his strong religious belief in pacifism before he could bring himself to kill for his country.  Good thing he did, as he was a keen shot and saved many American lives.  He was a corporal at the time of his amazing act of bravery, but was forever known by the rank he attained at the end of the war:  Sgt. York.  In 1942, Gary Cooper won an Academy Award playing Sgt. York. There is a statue of Sgt. York on the grounds of the Tennessee Capitol building in Nashville.

Without people like Rickenbacker and York, it is not clear that we would have the freedom to haggle over fine points of law. So today we will discuss a mixed bag of a case with gratitude for the good points and restraint on the not-so-good.  We are in a no-snark zone.Continue Reading S.D. Illinois Dismisses Some Mirena Claims and Allows Others to Linger

Photo of Stephen McConnell

The other day ESPN’s Sportscenter ran a teaser entitled “Less of Maya Moore.”  WNBA player Maya Moore had what was for her a less than stellar night, but her teammates on the Minnesota Lynx picked up the slack and they won anyway.  Maya Moore is a fantastically gifted basketball player with the resume to prove it.  She has won team championships and MVP trophies on the collegiate and professional levels.  A scientist has measured Moore’s reflexes to approximate those of a striking rattlesnake.  Moore has also donned makeup to look like an old lady and, along with Kyrie Irving dressed up as Uncle Drew, scammed some recreational ballers on a neighborhood hoops court.  The video is here.

Maya Moore is very, very good at what she does.

By contrast, the Maya litigation in our fair city is very, very bad.  First, there was the trial here in the Philly Court of Common Pleas, where the plaintiff won a $10 million verdict when a jury found that the defendant failed to warn that over-the-counter Motrin could cause SJS/TEN (a rare but life-threatening disease that causes severe blistering and sloughing off of skin, together with serious damage to the mouth, eyes, throat and esophagus).Continue Reading More Maya

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The genius who devised the theory of evolution.  The statesman who defended Western Civilization against the Nazis.  The man who freed a subcontinent via the majesty of nonviolent resistance.  The greatest basketball player of all time.  The composer of Shaft. The Pope’s favorite saint.  Our national emblem.

What do these heroes have in common?

Today’s case is Dimieri v. Medicis Pharm. Corp., 2014 U.S. Dist. LEXIS 95409 (M.D. Fla. July 14, 2014).  Dimieri ingested Solodyn for the treatment of acne.  He discontinued use of Solodyn after experiencing “numbing pain in the crown of his head” and noticing alleged hair loss.  He alleged that Solodyn was making him bald.  That, apparently, ranks as an injury.  He brought a complaint against the defendant for failure to warn, strict liability, breach of warranties, misrepresentation, negligence, and fraud.Continue Reading Court Dismisses Balderdash Solodyn Complaint

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We have discussed before (here and here) how the defendant manufacturer in Fosamax litigation took advantage of a fairly unique regulatory history to meet the Supreme Court’s unprecedentedly high “clear evidence” standard from Levine and preempt an entire MDL’s worth of warnings claims from before the drug’s label changed in 2011. For us, this was noteworthy and welcome. Prescription drug cases are fundamentally about warnings and many plaintiffs base their claims on the purported need for labeling that never would have been approved in the real world. Without devolving into a Bexisish rant on why Levine was wrong and many courts have been unduly frightened away from applying preemption because of facile readings of Levine—our own version of Charybdis—we can say that a clean preemption win in a prescription drug case was long overdue.

The Fosamax plaintiffs, not surprisingly, did not share our view and persisted in trying to keep their litigation going with post-labeling change cases. Well, they kind of persisted. Mostly, it seems that they desperately wanted to avoid a consideration of the merits of their remaining claims while keeping the litigation pending. This required a series of maneuvers that ultimately ended up with the plaintiff in In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 12-1492, 08-08, 2014 U.S. Dist. LEXIS 82003 (D.N.J. June 17, 2014), squarely between—you guessed it—a rock and a hard place when the defendant moved for summary judgment. We suspect many other plaintiffs in the litigation will end up in the same place.

A brief recap of the labeling and litigation history is in order. The drug had been on the marker for osteoporosis for more than a dozen years when FDA asked all manufacturers of the class of drugs to report back on the issue of atypical femur fractures (AFF) based on adverse events it had received. Even though defendant and FDA agreed there was no evidence that Fosamax increased the risk of such fractures, in September 2008, the defendant proposed to revise its label to add Precautions and Adverse Reactions information about reports of them. FDA allowed the Adverse Reactions change, but rejected the Precautions change in May 2009. By this point, it looks like the plaintiffs had already started bringing their AFF suits. In 2010, FDA issued three Drug Safety Communications on AFF with the class of defendant’s drug, shifting from a position of no established increased risk to requiring manufacturers to add Precautions on AFF and limit the duration of use in the Indications and Usage section based on a report from the American Society of Bone and Mineral Research stating there was an association between long term use of the drugs and AFF. Defendant responded in January 2011 by adding a detailed section in Warnings and Precautions—we assume PLR reformatting was due—in the physician label and language in the patient Medication Guide. Based on this, in a two-step process, all labeling claims for AFF before the 2011 labeling change were held to be preempted. Thereafter, the court wanted to bring to a head the issue of whether there could be a warnings claim for cases where the plaintiff took the drug with the revised label. And then the plaintiffs started dancing.Continue Reading Fosamax Plaintiffs Between A Rock And A Hard Place

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Sometimes it’s that simple.  Melton v. Ortho-McNeil Pharm., Inc., 2014 U.S. Dist. LEXIS 78917, at *1-2 (N.D. Oh. June 10, 2014), is another Ortho Evra birth control patch case in which the plaintiff suffered a pulmonary embolism.  The manufacturer’s label and one of its dear health care provider letters explicitly warned of this risk;…

Photo of Steven Boranian

Imagine our surprise at learning that people are still filing cases alleging rhabdomyolysis resulting from Lipitor use.  Lipitor is the best known prescription drug ever (except maybe for Viagra), and the association between rhabdomyolysis and statins is one of the most warned-of drug risks in history.  Every doctor knows about it, and litigation involving another…

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We sometimes read decisions and think we must have already read the same decision under a different caption.  Critical as we are, we might even give a moment’s thought to the possibility that somehow the same decision was reissued under an alias. The more likely explanations for this phenomenon—setting aside glitches in the space-time continuum—are…

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Even a casual reader of the blog would know that we like it when drug or device manufacturers defeat dubious claims.  It is also no secret that we are enamored of the learned intermediary doctrine and challenging the link of proximate cause for failure to warn.  We also value decisions that use common sense, at least what our biased perspective allows us to see as common and sensical.  When these things come together, we are as pleased as a robin finding juicy, wriggling worms after the spring thaw.

The decisions in Averhart v. Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. Dist. LEXIS 38446 (N.D. Ohio Mar. 24, 2014), and Casso v. Ortho-McNeil Pharm., Inc., No. 1:11 oe 40006, 2014 U.S. Dist. LEXIS 38443 (N.D. Ohio Mar. 24, 2014), largely satisfy our annelid cravings.  First, the defense won summary judgment on the warnings claims they moved on in each case.  (The defense moved for judgment on the pleadings on some other claims and apparently raised some new arguments for summary judgment in reply briefs. Defendants were rebuffed in almost all of those attempts.  We cannot tell from the decisions why summary judgment was not sought across the board or if the plaintiffs had any evidence for their non-warnings claims, so we will focus of the warnings part of the decisions.)  Second, the warnings claims fell because the prescribers testified to their understanding of the risk at issue and the plaintiffs had nothing else suggesting that the warnings were inadequate in any material way.  Third, the warnings analysis, despite some quirks of the phrasing of the applicable Mississippi and Minnesota law, was pretty straightforward, focusing on the actual testimony of the prescribers and some of the basics of how drugs are prescribed to patients.

The drug at issue in these cases was Ortho-Evra, a combination hormonal contraceptive patch; “combination” means that there is estrogen with the progestin.  It has long been common knowledge in the medical community, and, we think, the population of patients who use hormonal contraceptives, that this class of products has a risk of blood clots.  Patient package inserts started forty years ago because of this risk with these products. Advertisements for these products on television and in popular magazines have identified this risk since the 1990s. There has been litigation for decades over various hormonal contraceptives and their risk of blood clots (among other things).  Because of this, to say nothing of medical journals, medical schools, and medical education, it is hard to imagine healthcare providers making decisions on prescribing hormonal contraceptives without being aware of the risk of blood clots and at least thinking about what to tell the patient about the risk with the product or products that might be prescribed.  Because of the nature of hormonal contraception, it is particularly important that the prescriber and patient work together to identify the particular medication that the patient will actually use as directed.  The risk of blood clots present in all marketed prescription combination hormonal contraceptives goes up with pregnancy–that is, when contraception fails—so the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations. Thus, for warnings claims on blood clots, there are some obvious challenges for plaintiffs:  (1) that the claims are for inadequate warnings rather than failure to warn completely, (2) that prescribers will typically be well-versed in the risks regardless of the label, and (3) decisions to prescribe one combination hormonal contraceptive instead of another will usually not be based on a comparison of their blood clot risk.  This means the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.Continue Reading Common Sense Contraceptive Warnings Cases

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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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