This post is from the non-Reed Smith side of the blog.
Is anyone else watching the CW’s “Penn & Teller: Fool Us”? It is perfect summer TV – easy, funny and interesting. Each week aspiring, talented magicians perform to try to fool Penn & Teller. If at the end of the trick, the comedy-magic duo can’t figure out how the trick was performed, the magician gets to appear on Penn & Teller’s enormously popular Las Vegas show. Recorded on your dvr so you can skip commercials, it’s 45 minutes of stage performances, most of which are quite good and entertaining. And that’s where we like to see magic – on the stage. Who isn’t intrigued when a torn up playing card turns up tucked into a magician’s wallet whole again? Or when a dove appears where only an egg was before? Slight of hand, hidden compartments, mirrors, trap doors – all things designed to make an audience think they are seeing something more than they really are.
When magic is at work in legal opinions, we aren’t as enthusiastic. Especially, where the result is the conjuring of a case out of thin air. That is precisely what happened in Fields v. Eli Lilly and Co., slip op., Case No. 2:13-CV-35-WKW (M.D. Ala. Jul. 20, 2015). Plaintiff alleged that because she ingested Prozac in 1996 during the first 8 months of pregnancy, her son was born with a congenital heart defect. But she has NO proof of two of the most fundamental aspects of any prescription drug case – that she ingested the drug and that an alleged inadequate warning caused the injury. We would have thought that a complete lack of evidence on two key elements is enough for summary judgment, but plaintiffs managed to pull a rabbit out of a hat.
Let’s sum up all of the missing evidence. Plaintiff has no pharmacy records showing that a Prozac prescription was ever filled. She alleges her pharmacy no longer has those records. She has no financial records (bank statements, receipts, credit card statements) showing a purchase of Prozac. Id. at 9. Presumably she also doesn’t have insurance records reflecting a Prozac prescription. She has no medical records that Prozac was ever prescribed. Id. at 8. There isn’t a single reference in any of her medical records that confirms that Prozac was ever prescribed to plaintiff.
The only mention of Prozac at all is in a note by one doctor that stated that he wanted lab work done and then he would decide whether or not to start Prozac. That note was made for an appointment on May 23, 1996. Just eleven days later, Plaintiff returned to her doctor to report a positive pregnancy test. There is no mention that Prozac was discussed at that second appointment. Nor was Prozac ever discussed with plaintiff’s treating obstetrician/gynecologist. Id. at 5-6. Allow me to break our blogging rule about first person for a minute. As a woman who has been pregnant twice – I cannot conceive of an ob/gyn who upon assuming the care for a pregnant woman does not ask her, even 19 years ago, what medications she was currently taking. The fact that no place in those records is Prozac mentioned is a huge red flag for me.
Back to blogging. So the only “evidence” of Prozac usage is plaintiff’s self-serving statement that at that May 23 appointment where he had not yet decided to prescribe Prozac, her doctor gave her a sample packet and a prescription with three refills. Plaintiff claims she got the blood work done, heard nothing from the doctor’s office, assumed no news was good news and started taking Prozac. Id. She also stated that she stopped taking Prozac around her 8th month of pregnancy on her own decision. Id. at 7. Conveniently, not only did she never discuss with any doctor whether she should be taking Prozac while pregnant, neither did she discuss with any doctor the impact of stopping the drug either. Plaintiff’s husband also alleged that he remembers seeing Prozac prescription bottles in their home. Id. at 7.
At this point you may be asking yourself, why not just ask the alleged prescriber? Because he died in 2009, four years before this lawsuit was commenced. Id. at 10. So, this is truly a case where absolutely the only evidence that Plaintiff took a prescription drug is her say so. That cannot be enough. The court looked at the question as one of credibility not admissibility. Id. at 15. The court was also unwilling to find that plaintiff’s self-serving testimony was directly contradicted by the pharmacy and medical records such that her testimony should not be accepted for purposes of a summary judgment motion. The court found that the “absence of physical evidence” (no pharmacy records) is not the same as “the presence of physical evidence that directly contradicts a fact.” Id. at 16. Finally, defendant argued that the rule regarding viewing the facts in a light most favorable to the non-moving party should be different “in pharmaceutical cases where the plaintiff cannot produce medical or prescription drug records to substantiate a self-serving affidavit or declaration that he or she actually used the drug at issue.” Id. at 17. The court didn’t agree, but we do.
Prescription drugs are heavily regulated and as such there are numerous records kept regarding how they are dispensed – doctors, pharmacies, insurers. If a plaintiff can’t offer up even one record from one source that indicates he/she was prescribed a drug – the case should not proceed. One of the problems in this case is the time between the alleged ingestion/injury and the filing of the suit. We understand the long statute of limitations to protect the interests of minors who may wish to file suit after they become adults. But we again find it slightly disingenuous that plaintiff waited 16 years to file suit and in all that time did nothing to preserve any of the evidence either she or her son would need to pursue this case. That burden should fall to plaintiff and plaintiff should not reap a benefit when all of the supporting documents and witnesses are no longer available.
Finding plaintiff’s statement was enough to survive summary judgment on the issue of ingestion, the court next looked at defendant’s argument that plaintiff could not prove causation on her failure to warn claim. Because Alabama recognizes the learned intermediary doctrine, “the success of [plaintiff’s] failure-to-warn claims is contingent upon whether she can show that an adequate warning would have altered [her doctor’s] prescribing practices.” Id. at 21. Defendants logically argued that therefore, the prescriber’s testimony was necessary for plaintiff to carry her burden on causation. Again, the court disagreed, but at least acknowledged that the plaintiff’s path forward was a “rocky one.” Id. at 24.
The court appears to agree with defendant that plaintiff could not satisfy her burden with objective evidence of how a reasonable physician would have acted upon receiving a different warning. Id. at 23-24. But then goes on to find that plaintiff, absent the prescriber’s testimony, could still meet her burden. First the court examined the parties’ competing views of what needs to be proven under the learned intermediary doctrine. Both sides agreed that the issue is the impact of the warning on the prescriber, not the plaintiff. But they differed on what that really means. Defendant argued that plaintiff had to demonstrate that if the prescriber had received a different warning he would not have prescribed the medication – a fact to which only the prescriber could testify. Id. at 28. Plaintiff, on the other hand, took a broader view and argued that the question is whether the doctor would have behaved differently if he had received a different warning. Id. at 26. And “behaved differently” is not limited to not prescribing – it included whether the doctor would have warned the plaintiff differently.
[Plaintiff] can demonstrate factual causation by proving that had [defendant] given [the prescriber] a strong warning about the association between the ingestion of Prozac during pregnancy and an increased risk of birth defects, [the prescriber] would have informed [plaintiff] of the risk and his warning would have resulted in a different outcome for [plaintiff] in that she would not have taken Prozac. This theory is not predicated upon the effect an adequate warning would have had on [plaintiff] but rather upon the effect an adequate warning would have had on [the prescriber]’s prescribing practices.
Id. at 29.
This still leaves open the question of how plaintiff demonstrates, without the prescriber’s testimony, whether her prescriber would have changed his risk discussion with plaintiff. According to plaintiff and the court – through his long time nurse. The nurse testified that it was the doctor’s “standard practice to discuss with all of his patients the risk and benefits disclosed on a drug’s package insert.” Id. at 31. The court found that a reasonable inference could be drawn from that testimony that if the Prozac label disclosed the increased risks of birth defects, the doctor would have discussed it with plaintiff. Id. This seems like a stretch in a more typical case – testimony that the doctor was diligent in discussing risks means he would have discussed a particular risk with a particular patient. Feels more like that objective reasonableness standard that the court was disinclined to allow. But now put it in the context of this case. Based on the doctor’s standard practice, we are supposed to infer that he would have discussed a risk of use during pregnancy with a woman who was not pregnant at the time and for whom he was only considering starting the medication? You can’t look at each piece of the case in a vacuum. You have to look at the whole. And here the whole adds up to a whole lot less than the sum of its parts. Inference, upon inference, upon speculation, upon self-serving testimony should not get a case to the jury.
Plaintiff here really pulled off a quite a magic trick. She had nothing up her sleeves; nothing in her pockets; nothing tucked in her socks. And poof, she made a case appear. If this was “DDL Blog: Fool Us” – the answer is, she didn’t.