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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.

The crux of plaintiffs’ case was that the drug was Pregnancy Category C according to the FDA-approved label when the minor plaintiff’s mother took the drug.  Category C is the middle category, but the required labeling language is fairly serious:  “(Name of drug) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”  21 CFR 201.80(f)(6)(i)(c) (the current version is quoted).  The opinion does not quote the drug’s actual label, what exactly plaintiffs contended it should have said instead, or what new post-approval evidence allegedly required different labeling.  It does say that FDA reclassified the drug up one category to Category D in 2011 without saying what evidence led to that change.  Under the current regulation, Category D’s mandatory labeling template language is “(Name of drug ) can cause fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.)  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.”  The trial court had already determined that the defendant was unable to unilaterally change the Pregnancy Category or how the label described the risk of birth defects, but let the plaintiffs argue that the defendant could have requested a change.  With this as their theory of liability, plaintiffs won an $11 million verdict and defendant
appealed following the denial of its post-trial motions.

The first issue on appeal was preemption of the sort we have called impossibility preemption.  The court only needed to consider three cases to determine that preemption did not bar plaintiffs’ claim:  LevineMaya v. Johnson and Johnson, 97 A.3d 1203 (Pa. Super. 2014), and Mensing, which the court dismissed out of hand as applying only to generic drugs.  The discussion of Levine noted that the availability of the Changes Being Effected (CBE) route for a labeling change prior to FDA approval for the particular drug and labeling change at issue in Levine meant that complying simultaneously with state and federal law was not impossible.  2015 Pa. Super. LEXIS 112, **12-16.  Mayawhich was not dismissed out of hand as applying only to OTC drugs—merited an honorable mention in our ten worst list last year.  Faced with these cases, the defendant offered a “specious” argument to try to “circumvent” and “evade” Levine.  In between the vitriol, the court’s reasoning came down to the unexamined statement that “the FDA’s CBE regulation allows drug manufacturers to make certain changes to update and strengthen safety information in its label before receiving the FDA’s approval.”   Id. at *16 (emphasis added). If it had wanted to, the court could have looked to many of our posts on when CBEs can be used, when they cannot, and the implications of the difference. It could have looked to the recent FDA draft guidance on “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format.”  It could have looked to the record as to whether plaintiffs had post-approval evidence that allowed an argument that a CBE would have been allowed for the proposed labeling change.  Or it could have just realized that the trial court’s motion in limine ruling precluding the claim that defendant could have changed its label unilaterally was based on the unavailability of a CBE, which distinguished the case from Levine, particularly if Bartlett and its progeny had been considered.  It did none of these.  Instead it looked to whether evidence that FDA had rejected a Prior Approval submission to change the Patient Package Insert to discuss a different birth defect satisfied Levine’s unique “clear evidence” standard—it did not and the unspoken presumption against preemption held.  Id. at **18-19.

The treatment of the second issue—the lack of evidence of proximate cause—was no more rigorous.  To start, the court framed the issue as whether the drug “proximately caused Brayden’s [minor plaintiff’s] cleft lip,” which is not the issue.  The proper issue is whether the alleged negligent act—not requesting, at some point between the drug’s approval and the drug’s use during pregnancy, that FDA permit a revision of the drug’s label consistent with recategorizing the drug from Pregnancy Category C to Pregnancy Category D proximately caused the minor plaintiff’s injury.  There should be three parts to this inquiry under South Carolina’s learned intermediary doctrine and the allegations here:  1) whether the record evidence supported that a request should have been made, 2) whether the record evidence supported that such a request would have led to a timely labeling change, and 3) whether the record evidence supported that such a timely labeling change would have avoided the birth defect (by leading the prescriber to do something different).  The court did not address the first two parts.  Because it was plaintiffs’ burden to prove proximate cause, the conclusion on preemption based on the lack of clear evidence that FDA would not have accepted the proposed labeling change does not obviate the need for plaintiffs to have proved that FDA would have accepted it.  Without such proof, the impact of a theoretical labeling change on the physician who prescribed to the minor plaintiff’s mother or the physician who prescribed to the minor plaintiff’s grandmother is irrelevant.

As noted above, the knowledge or decision making of the doctor who prescribed the pills that the minor plaintiff’s mother took while pregnant was not examined at all.  The reasoning for ignoring these issues was as follows:  “The fact that Haley obtained the Topamax for a few months using her mother’s prescription instead of her own because of the family’s financial difficulties does not permit Appellant to evade liability for Brayden’s injuries.”  Id. at **24-25.  We might have said it like “The fact that the drug used during pregnancy was illegally obtained when minor plaintiff’s mother did not have her own legal prescription creates an obvious break in the causal chain between defendant’s alleged negligence and the plaintiffs’ injuries.”  We might have added something about the lack of evidence that the proposed labeling change would have meant the minor plaintiff’s grandmother would not have received a prescription.  But nobody asked us.  There is also an obvious gap in the evidence of proximate cause from the testimony of the physician who last prescribed the drug to the minor plaintiff’s mother several months before she became pregnant, with plaintiffs relying on:

Q: Did you have any knowledge in March of 2006 of Topamax putting a patient at an increased risk for cleft lip or cleft palate, more specifically, the unborn child at risk for cleft lip or cleft palate?

A: No.

* * *

Q: If you had been aware of a risk with Topamax and a risk of a cleft lip or cleft palate to an unborn fetus, is that a risk that you would have taken into consideration when prescribing it to Haley in March of 2006?

A: Yes.

Q. If you had been aware of cleft lip or cleft palate as a risk with Topamax when you prescribed it to Haley in March of 2006, would it have altered your prescribing habits?

A: It would have had a major impact, I think.

Id. at *23.  This testimony does not come close to indicating that the proposed labeling change would have come to the prescriber’s attention, let alone changed his decision to prescribe to the minor plaintiff’s mother.

The third issue urged on appeal was that the $11 million verdict for a birth defect that was largely repaired through a relatively simple surgery was excessive.  Much like an NCAA bracket after a few thirteen and fourteen seeds pull off upsets, this argument is usually dead in the water.  It was here too, as damages for an apparently life-long impact on the minor plaintiff’s “self-esteem, confidence and his ability to have a simple conversation with others” can be set high—the non-economic damages were about 97% of the verdict—by a sympathetic jury without shocking the court’s “sense of justice.”  We assume that this case will be heading up to the Pennsylvania Supreme Court, which may have its own sense of justice about allowing an $11 million verdict to stand where the proposed labeling change could not have been made unilaterally, there was no evidence that FDA would have acceded to a request to make it, and there was no evidence that making it would have prevented the minor plaintiff’s exposure with pills prescribed to his grandmother.