We have said it before – birth defect cases are hard.

Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter.  We have also said that we do not like it when judges frame the insistence of the defendant on things like proof of proximate cause as an attempt to avoid liability, as if liability were the default where the plaintiff has a tangible injury.  We may or may not have said that we do not like it when opinions refer to plaintiffs by their first names, especially when only women and children get that discourtesy.  We have said over and over that we do not like it when the decision in Levine is held up like an anti-drug preemption talisman, particularly after Mensing and Bartlett.  So, we are not terribly surprised that the large trial verdict over birth defects in the child of a woman taking her mother’s anti-seizure medication while pregnant was affirmed in Gurley v. Janssen Pharms., Inc., No. 239 EDA 2014, 2015 Pa. Super. LEXIS 112 (Pa. Super. Mar. 16, 2015), but we were still somewhat perturbed by the tone and less-than-probing analysis of the opinion.

Plaintiffs were a minor child born with a cleft lip, his mother, and his father.  The minor plaintiff was referred to by his first name, as was his mother.  The father was only ever referred to by his full name or as the “husband” of the mother (listing her first name).  The mother’s mother, who was taking the same anti-seizure drug on a prescription from another doctor and was the sole source for her daughter’s use of the drug while pregnant, was also referred to by her first name.  We have been known to parse words, but that is some paternalistic nonsense.  Maybe we would not read it like that if the opinion had been written by a judge from a different demographic, but it does seem to fit with the rest of the opinion.  Plaintiff’s mother was first prescribed the medication for “juvenile myoclonic seizures” in March 2006, and received and filled refills that should have carried her through July 2007, three months before she became pregnant.  She would not have taken the medication while pregnant if not for taking medication obtained by her own mother on her (the minor’s  grandmother’s) own prescription for a different indication (migraines).  The opinion never addresses 1) whether it was legal for the minor plaintiff’s mother to take the drug (as we addressed here), 2) whether it was foreseeable—the only claim presented to the jury was for negligent failure to warn, after all—for the minor plaintiff’s mother to take the drug while pregnant under these circumstances, or 3) the knowledge of the physician who prescribed the drug to the minor plaintiff’s grandmother about the risk of birth defects or the impact of additional information on the decision to prescribe to her.  Even though one of the issues on appeal highlighted the lack of evidence of proximate cause through either prescribing physician, the opinion’s only discussion of the grandmother’s prescription—the one that allegedly caused the injury—was  that “Sandra [grandmother] testified that her family was having financial difficulties and she filled her prescription instead of Haley’s [mother] to save money on the insurance co-pay.”  2015 Pa. Super. LEXIS 112, *2 n.4.  This would be the “financial hardship” exception to both the requirement of proximate cause or the in pari delicto defense.  But we are getting ahead of ourselves.


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We have had some time now to ruminate over the South Carolina Supreme Court’s opinion in State of South Carolina ex rel. Wilson v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2012-206987, 2015 WL 775094 (S.C. Feb. 25, 2014).  In Wilson, the state attorney general brought an enforcement action against the manufacturer of the atypical antipsychotic Risperdal under the state’s Unfair Trade Practices Act (having the dysphonius acronym “SCUTPA” in the opinion) and recovered $327 million in civil penalties. Although the Supreme Court reduced the award to $136 million, it mainly affirmed a verdict that, in our view, has multiple problems.  What problems?  Well, how about a nine-figure civil penalty for “deceptive” conduct when the state neither alleged nor proved that a single person was deceived or that the conduct had any adverse impact on anyone?  We call that a problem, but we’ll get back to that particular point in a moment.

Those who read our 2014 Ten Best column and those who dialed into our teleseminar in January on those cases know a little about Risperdal and the various states’ lawsuits against the drug’s manufacturer.  What happened was that the FDA asked all manufacturers of atypical antipsychotics to review data on diabetes, which resulted in a new warning on diabetes being added to the labels.  The FDA also required a Dear Healthcare Provider Letter, which the manufacturer of Risperdal sent, but the letter included information that was technically off label.

That resulted in an FDA warning letter in April 2004 stating that the DHCP Letter was “false or misleading” in violation of the FDCA, which in turn resulted in the manufacturer sending a corrective DHCP Letter.  Wilson, 2015 WL 775094, at **5-6.  That seems to be when various state attorneys general and their contingent-fee lawyers took interest.  Two of our Ten Best cases of 2014 were state false claims act cases arising out of these events where the states of Louisiana and Arkansas recovered very large judgments against this manufacturer.  Both verdicts were reversed on appeal, which was good news.


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OK, we made that up.  It is not true at all.  A complete lie, much like “The Dallas Cowboys are America’s Team.”  Or “Eating turkey makes you sleepy because of its high tryptophan content.”  Or “The pilgrims left England because of their desire to wear stylish hats.”  Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.”  If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today.  You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football.  Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.

The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator.  As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements.  21 U.S.C. §360k(a).  This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers.  Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject.    A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims.  We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer.  Like here.

We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is.  We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.


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Today we feature a case that exemplifies two principles that we routinely encounter in our practices, but rarely at the same time.  First, there is no more sympathetic plaintiff than a disabled military veteran.  We come across and write on cases involving sad facts with some regularity, which is an occupational hazard of our practice in the drug and medical device arena.  The most compelling cases we see involve patients who have experienced actual injuries, a fact that we always bear in mind as we report on what the law is and what we believe the law should be.  Moreover, while everyone has a point of view on what kinds of cases provoke the greatest sympathy, we have learned in our many years on Reed Smith’s Pro Bono Committee that disabled veterans garner the broadest imaginable support.  Some people champion children’s issues; others promote immigration reform, or perhaps they favor housing rights.  But everyone gets behind programs supporting disabled veterans.  And rightfully so.  Today’s veterans are young men and women who have completed their service and have their whole lives ahead of them, often with significant challenges.

The second principle that today’s case brings to mind is that civil litigation cannot and should not provide a remedy if the law and facts are not there to support one, no matter how sympathetic the plaintiff may be.  The district court’s order granting summary judgment in Carnes v. Eli Lilly & Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16, 2013), brings together these two principles by presenting a disabled Army veteran and physicians who prescribed prescription drugs with full knowledge of all the relevant risks.  In Carnes, the plaintiff injured his spinal cord while attempting to rescue fellow soldiers in Iraq, and as a result he is wheelchair bound, has significant physical limitations, and suffers from chronic pain.  Id. at *1.  One physician prescribed Lyrica, an antiepileptic drug indicated for treating pain associated with spinal cord injury, but after about three years on the drug, the plaintiff asked to stop.  Id. at *2.  The doctor therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake inhibitor that is also indicated for treatment of chronic pain.  After a few months, the plaintiff changed doctors and asked to switch his medication again because he thought the drug was causing him to gain weight.  Id. at *2.  The new doctor therefore tapered the plaintiff off Cymbalta and restarted Lyrica. Id. at **2-3.  According to the doctor, she tapered the plaintiff’s dose “to avoid potential side effects from stopping Cymbalta suddenly.”  Id. at *3.

As the second doctor’s remarks suggest, discontinuing Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and which the product’s label disclosed at all relevant times.  Id. at **4-5.  The physician who first prescribed the drug similarly was aware of the risk of withdrawal symptoms “having learned about them in medical school, during his residency, and from patients who experienced withdrawal symptoms.” Id. at *16.  Alas, the plaintiff experienced post-discontinuation symptoms that he attributed to the drug, including sharp headaches, nightmares, anger, and shaking. He therefore sued the drug’s manufacturer, who moved for summary judgment under South Carolina’s learned intermediary doctrine.


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There have been two recent state supreme court decisions concerning PMA medical device preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  One of them, Cornett v. Johnson & Johnson, ___ A.3d ___, 2012 WL 321094 (N.J. Aug. 9, 2012), will be the subject of Monday’s post, as our Dechert colleagues are

Both the blogosphere and MSM covered the South Carolina Supreme Court’s recent reversal of a $31 million verdict in a Ford Bronco rollover case. Branham v. Ford Motor Co., 2010 S.C. LEXIS 291 (South Carolina August 16, 2010). Most of the discussions of the Branham case focused on the plaintiff lawyer’s inflammatory closing argument and/or the strange (and prejudicial) alignment of parties. But even though it was not a drug or device case, the Branham opinion contains other rulings that might affect our clients in significant (and positive) ways.

The facts are straightforward. Hale was driving her 1987 Ford Bronco under the speed limit. The passengers were children, including her daughter in the front passenger seat and Plaintiff Branham in the backseat. The children were “all excited.” Branham, 2010 S.C. LEXIS 291 at *1. No one was wearing a seatbelt. Hale turned to the backseat to tell the kids to quiet down. (You just know a bunch of jurors at this point are nodding and thinking, “Been there.”) When she took her eyes off the road, the Bronco veered. Hale overcorrected and the vehicle rolled over. Branham suffered a brain injury.

Branham sued both Ford and Hale. Branham brought negligence and strict liability claims against Ford regarding the rear seatbelt system and the vehicle’s handling and stability. Branham alleged that Ford negligently failed to test the rear seatbelt sleeve and that Ford should have used a different suspension system. One of the witnesses called by Plaintiff was a former vice-president at Ford. That sort of thing is what we defense lawyers politely call a “challenge.” The jury awarded $16 million in compensatory damages and $15 million in punitives.


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