JANE TRICHE MILAZZO, District Judge.
Before the Court are six Motions for Summary Judgment. Three are based on statute of limitations defenses. One is against Deborah Johnson (Doc. 5734), one is against Barbara Earnest (Doc. 6079), and one is against Tanya Francis (Doc. 6081). The other three are based on the learned intermediary doctrine. One is against Jacqueline and Victor Mills (Doc. 5732), one is against Barbara Earnest (Doc. 6078), and one is against Tanya Francis (Doc. 6080).
For the following reasons, the Motions based on the statute of limitations against Johnson (Doc. 5734) and against Francis (Doc. 6081) are
Plaintiffs in this multidistrict litigation ("MDL") are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel,
Summary judgment is warranted where "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law."
According to the Master Complaint, Plaintiffs' injuries — disfiguring permanent alopecia — manifested six months after the completion of chemotherapy.
In these Motions, Defendants move for summary judgment against these Plaintiffs on the basis that their claims are time-barred under Louisiana prescription law. The Court heard oral argument on the Motion against Johnson on April 4, 2019 and on the Motions against Earnest and Francis on May 22, 2019.
Defendants argue that each Plaintiff was aware of her alleged injury six months after she completed chemotherapy. Defendants argue that this triggered the start of the prescriptive period for each Plaintiff and that she should have filed her complaint within a year after she became aware of her injury. Specifically, Defendants argue that summary judgment is warranted for three reasons: (1) the untimeliness of these cases is apparent from the pleadings; (2) discovery and deposition testimony confirms this untimeliness; and (3) no exception applies to toll the statute of limitations and save Plaintiffs' cases.
Relying on the Louisiana doctrine of contra non valentem, Plaintiffs argue that the prescriptive period begins running only when a plaintiff has knowledge of the underlying tortious conduct of the defendant. Plaintiffs emphasize that during the relevant period the generally accepted medical and scientific belief known to Plaintiffs' physicians was that Taxotere could cause only temporary hair loss, not permanent hair loss. Plaintiffs note that as late as 2015, the Taxotere label did not mention permanent hair loss; yet, according to Defendants, Plaintiffs should have realized before then — before the Taxotere manufacturers knew — that the drug caused permanent hair loss.
Under Louisiana Civil Code Article 3492, the prescriptive period for products liability claims is one year.
The doctrine of contra non valentem "provides some grace for those plaintiffs who are unaware that their injury was caused by a tort."
Plaintiff Johnson testified that she did not think anything other than her chemotherapy had caused her hair loss.
Plaintiff, however, did not act until she saw a television ad describing the link between Taxotere and permanent hair loss. She did not consult counsel until after she saw the ad, and she did not file suit until October of 2016. The doctrine of contra non valentem does not suspend prescription for this kind of inaction. "It is not the rule in Louisiana . . . that the prescriptive period does not begin until conclusive dispositive proof of a causal connection between the suspected injury and the putative tortfeasor is established."
Plaintiff relies on Hoerner v. Wesley-Jensen,
Unlike the plaintiff in Hoerner, Johnson has presented no evidence demonstrating that she investigated her injury. Nor has she presented evidence to show that, like the plaintiff in Hoerner, she relied on information she discovered from such an investigation.
Because Johnson had a duty to investigate and failed to do so, contra non valentem is inapplicable to her claims. Johnson completed her chemotherapy in December 2010, meaning her injury was realized six months later in June 2011. Her claims prescribed no later than June 2012.
Like Johnson, Earnest testified that she attributed her hair loss to her chemotherapy treatment.
Earnest's testimony distinguishes her case from Johnson's case. Like the plaintiff in Hoerner, Earnest inquired with her doctor about her injury, and she was led to believe that she had no actionable injury. Relying on her doctor's statements, she acted reasonably in waiting and remaining hopeful for her hair to return. When she learned in 2016 of the association between Taxotere and permanent hair loss, she realized that, contrary to what she initially thought, she did have an actionable injury.
Defendants argue that Earnest was in possession of information years earlier that should have put her on notice of the connection between Taxotere and permanent hair loss. Earnest's surgeon, Dr. Marie Celeste Lagarde, gave Earnest a handbook when she was first diagnosed with breast cancer, and as a side effect of Taxotere, the handbook listed "rare reports of permanent hair loss."
Because Earnest investigated her injury and was led to believe she had no actionable injury, contra non valentem is applicable. Accordingly, the prescriptive period on Earnest's claim did not begin to run until she associated Taxotere with permanent alopecia in 2016. Because Earnest filed suit within a year of this realization, her claim is not prescribed.
Like Johnson and Earnest, Francis attributed her hair loss to her chemotherapy, which she completed in October of 2009.
Francis argues that contra non valentem should apply because she had no way of determining that her hair loss was attributable to Taxotere rather than one of the other chemotherapy drugs she took. This argument falls flat because Francis made no effort to investigate her injury or to identify which drug and which manufacturer was responsible for her injury. "[W]hen a plaintiff suspects something is wrong, he must seek out those whom he believes may be responsible for the specific injury."
Because Francis had a duty to investigate and failed to do so, contra non valentem is inapplicable to her claims. Francis completed chemotherapy in October 2009, meaning her injury was realized six months later in April 2010. Her claims prescribed no later than April 2011.
Plaintiffs in the Mills case are Jacqueline Mills and Victor Mills. Plaintiffs assert eight counts under Georgia law: (I) strict products liability for failure to warn; (II) strict products liability for misrepresentation; (III) negligence; (IV) negligent misrepresentation; (V) fraudulent misrepresentation; (VI) fraudulent concealment; (VII) fraud and deceit; and (VIII) breach of express warranty. Counts II and VIII were dismissed under Pretrial Orders 61 and 73. In the Motion against the Mills Plaintiffs, Defendants move for summary judgment on all remaining claims brought by Plaintiffs. Defendants argue that Plaintiffs cannot establish the essential element of causation. The Court heard oral argument on the Motion against Mills on April 4, 2019.
Plaintiffs Barbara Earnest and Tanya Francis each assert two claims under Louisiana law: (1) a claim that Defendants provided an inadequate warning in violation of the Louisiana Products Liability Act; and (2) a claim for breach of warranty in redhibition. In their Motions against Earnest and Francis, Defendants move for summary judgment, arguing that the learned intermediary doctrine is dispositive of both the inadequate warning claims and the redhibition claims. Alternatively, Defendants argue that Plaintiffs have no redhibition claims because Taxotere had no defect rendering it useless. The Court heard oral argument on these Motions on May 22, 2019.
Defendants first argue that under Georgia law they are entitled to summary judgment on Plaintiffs' failure to warn and negligence claims. Relying on the learned intermediary doctrine, they argue that Plaintiffs have failed to introduce evidence that a different warning from Defendants would have led Jacqueline Mills's oncologist, Dr. Shefali Shah, to change her decision to prescribe medication containing Taxotere/docetaxel. In other words, Defendants argue that the causation chain is broken due to Dr. Shah's actions as an intermediary. Defendants note that Dr. Shah "testified that a label change would not have affected her decision to prescribe the life-saving TCH chemotherapy regimen to Plaintiff because the regimen remains the `standard of care in this setting.'"
Plaintiffs agree that the Georgia learned intermediary doctrine bears on cases involving prescription drug manufacturers. Plaintiffs argue, however, that this case presents triable issues of fact for a jury to assess. Plaintiffs argue that the adequacy of Defendants' warning is a question for the jury, as is whether Dr. Shah would have taken a different course of action if Defendants had warned her of the increased risk of permanent hair loss associated with Taxotere/docetaxel. Plaintiffs note that Dr. Shah testified that "she would have respected her patient's wishes, had she expressed a desire to try an alternative treatment to avoid the risk of permanent hair loss."
Under Georgia law, a failure to warn claim has three elements: (1) the defendant had a duty to warn; (2) the defendant breached that duty; and (3) the breach was the proximate cause of the plaintiff's injury.
In cases involving prescription drugs, Georgia courts employ the learned intermediary doctrine, "which alters the general rule that imposes liability on a manufacturer for failing to warn an end user of the known risks or hazards of its products."
Under this doctrine, a threshold inquiry is whether the manufacturer provided the learned intermediary, the physician, with an adequate warning.
Regarding the adequacy of Defendants' warning, Plaintiffs in this MDL allege that from the time of Taxotere's FDA approval in 1996 through December of 2015, Taxotere's label contained no reference or warning regarding permanent hair loss.
The next step in the inquiry is whether the inadequate warning proximately caused Ms. Mills's permanent hair loss. Defendants argue that Plaintiffs have no evidence that "a different warning would have resulted in a different prescribing decision."
The decision to prescribe an antidepressant differs from the decision to prescribe chemotherapy. As illustrated by the testimony of these Plaintiffs and their oncologists, a patient facing a cancer diagnosis can reasonably expect more involvement and guidance from her doctor than she would in another context. A cancer patient looks to her oncologist to educate her about what options are available, what serious side effects she will likely suffer, and how she can prepare for those side effects.
Because the chemotherapy decision-making process is unique, the application of the learned intermediary analysis in this context is not as simple as Defendants suggest. The question is not simply "what would the doctor have prescribed" but whether and how the doctor would have advised the patient of the risk of permanent alopecia associated with Taxotere, whether the patient would have inquired about other options, what the doctor would have recommended, and what decision the plaintiff would have ultimately made. The Court will consider these questions with the goal being to assess what the doctor and the patient would have decided together. While a doctor may testify that his or her recommendation would not have changed, the issue is whether the plaintiff's ultimate decision would have changed.
In the Mills's case, the evidence is sufficient to create an issue of fact on whether Ms. Mills and Dr. Shah would have decided on a non-Taxotere regimen for her treatment if Dr. Shah had been adequately warned by Defendants. At her deposition in 2018, Dr. Shah testified that she had recently become aware of the risk of permanent alopecia associated with Taxotere.
Although Dr. Shah testified that she has no doubt in her mind that the regimen she prescribed to Ms. Mills was the right choice for Mills's aggressive form of cancer,
In addition to this, testimony from Ms. Mills creates an issue of fact on whether she would have followed the recommendation of Dr. Shah. The evidence suggests that Ms. Mills was very involved in this decision-making process. At some point during her treatment, Ms. Mills complained to Dr. Shah of her side effects, and Dr. Shah mentioned that Ms. Mills could reduce her dosage.
Considering the testimony of both Dr. Shah and Ms. Mills, the Court finds an issue of fact on whether the causation chain is broken here. There is an issue of fact on whether Dr. Shah would have warned Ms. Mills of the risk of permanent hair loss associated with Taxotere, and there is an issue of fact on whether Ms. Mills would have ultimately chosen to take Taxotere if she had known of this risk.
Defendants argue that Georgia law does not recognize a distinction between a failure to warn claim and a misrepresentation claim. In their response, Plaintiffs state that they do not intend to continue pursuing Count IV for negligent misrepresentation and Count V for fraudulent misrepresentation. Accordingly, these claims are dismissed.
Defendants further argue that the learned intermediary doctrine requires the dismissal of Plaintiffs' remaining claims — Count VI for fraudulent concealment and Count VII for fraud and deceit. For the same reasons the learned intermediary doctrine does not warrant summary judgment on Plaintiffs' negligence and failure to warn claims, the doctrine does not warrant summary judgment on Plaintiffs' remaining claims.
Defendants raise an alternative argument for the dismissal of Plaintiffs' fraud-based claims. Defendants argue that Plaintiffs have no evidence of two essential elements of these claims — namely, a misrepresentation by Defendants and Plaintiffs' reliance on such a representation.
Under Georgia law, a fraud claim has five elements: (1) a false representation by the defendant; (2) scienter; (3) intention to induce the plaintiff to act or refrain from acting; (4) justifiable reliance by the plaintiff; and (5) damage to the plaintiff.
The Court rejects Defendants' argument. Defendants made express statements to Dr. Shah through Taxotere's label. In their Motion, Defendants admit that while the Taxotere label has since its inception warned of hair loss, it did not warn of permanent hair loss until December of 2015.
Regarding Plaintiffs' Earnest and Francis, Defendants rely on the Louisiana learned intermediary doctrine, arguing that an adequate warning from Defendants would have been futile. They argue that because the doctors of these Plaintiffs did not read the Taxotere labeling, these doctors would have prescribed Taxotere regardless of whether the label warned of the risk of permanent hair loss. Plaintiffs argue that these doctors stayed informed of updates to the label through other means.
Under Louisiana law, failure to warn claims involving prescription drugs are subject to the learned intermediary doctrine.
The Fifth Circuit has held that there is a two-prong test governing inadequate warning claims under the Louisiana Products Liability Act (LPLA) when the learned intermediary doctrine is applicable:
Regarding the second prong, the law is well established that, to prove causation, "the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that but for the inadequate warning, the treating physician would not have used or prescribed the product."
As the Court has discussed, the chemotherapy decision-making process is unique. The Court must consider not only whether an oncologist would have warned his or her patient of the risk of permanent alopecia but also how patient choice then would have steered the conversation and the ultimate prescribing decision. For Plaintiff Earnest, the evidence is sufficient to create an issue of fact on whether she and her doctor, Dr. James Carinder, would have decided on a Taxotere regimen regardless of the risk of permanent alopecia.
Dr. Carinder testified that at the time Earnest was treated, he had two drugs he could choose from for her treatment — docetaxel or paclitaxel.
Earnest testified that if she had the option of taking a drug other than Taxotere/docetaxel, she would have relied on Dr. Carinder to make sure this drug would be as effective as Taxotere.
The testimony from Dr. Carinder and Earnest creates an issue of fact. The testimony shows that Earnest had a viable alternative to Taxotere. The jury will need to hear the testimony at trial and decide whether Earnest would have chosen paclitaxel despite her neuropathy or whether she would have still chosen Taxotere knowing of its risk of permanent alopecia.
Although the Court is dismissing Plaintiff Francis's claim as prescribed, the Court notes that she could have defeated Defendants' summary judgment motion on causation. Testimony from her oncologist, Dr. Cherian Verghese, suggests that, had Defendants issued a proper warning, Dr. Verghese would have learned of it and advised Francis of it. He testified that he learned of the association between Taxotere and permanent alopecia through literature and case reports.
Dr. Verghese testified that after learning about the potential risk of permanent hair loss associated with Taxotere, he began to educate his patients about this risk.
Dr. Verghese testified that he has a "comprehensive discussion" with a patient facing chemotherapy.
In addition to this, testimony from Francis suggests that her input in the decision-making process may have led Dr. Verghese to prescribe a non-Taxotere regimen for her. Francis played an active role in her healthcare. She testified that she did her own research on the chemotherapy drugs that her doctor recommended. In her deposition, she stated, "I stayed on a computer through the whole process of me having breast cancer, just finding out any and everything. Whatever they told me, I went and researched it myself, as well."
She reviewed the pamphlets that she received from the hospital, and she remembers that the pamphlets warned of temporary hair loss.
Francis further testified that before starting her chemotherapy treatment, she attended a program at her hospital called "Look Good, Feel Better."
Taken together, the testimony of Dr. Verghese and Francis show that had Defendants adequately warned of the risk of permanent hair loss associated with Taxotere, Dr. Verghese and Francis may have decided on a different drug for Francis. This would have been a question for the jury.
Defendants argue that they are entitled to summary judgment on Earnest's and Francis's redhibition claims. Article 2520 of the Louisiana Civil Code provides that a defect is redhibitory if it "renders the thing useless" or renders its use "so inconvenient that it must be presumed that a buyer would not have bought the thing had he known of the defect."
Plaintiffs took Taxotere to increase their chances of survival. Given that Plaintiffs are alive today, Taxotere worked and was far from being "useless." Indeed, Plaintiffs' doctors still prescribe Taxotere today. Dr. Carinder testified that the drug is effective, and he continues to prescribe it today "because it works."
Accordingly, for the foregoing reasons,