A recent article from the Washington Legal Foundation (WLF), examined the trend of “pharmaceutical manufacturers becoming the target of plaintiff’s attorneys across the country.” They assert that one of the reasons the focus has moved to the pharmaceutical is based on tort reform. Since “state legislatures have begun to impose caps on the amount of damages a plaintiff can recover from a defendant, it has become more worthwhile for plaintiffs' attorneys to resort to a volume model—class action—in which they sue a single defendant on behalf of many plaintiffs.” Bringing a class action “increases the attorneys' potential award exponentially by the number of plaintiffs that can be identified.” The article then goes on to examine a few recent cases, and the way that pharmaceutical companies defended themselves, as well as the outcome.
Levine.
In Wyeth v. Levine, 129 S. Ct. 1187 (2009), which was decided by the U.S. Supreme Court last March, the case arose from Diana Levine who filed suit against Wyeth alleging that Wyeth failed to adequately warn of the risk of directly injecting Wyeth's anti-nausea medication, Phenergan, into a patient's vein.
Wyeth's defense, federal preemption, rested on the Supremacy Clause of the Constitution, which provides that federal law is the supreme law of the land and supersedes state law where inconsistencies exist. Specifically, “Wyeth argued that it could not comply with both Vermont law (tort common law) and with federal law (regulations promulgated by the Federal Drug Administration ("FDA")) with regard to the warnings contained in Phenergan's labeling.”
Contrary to Wyeth’s defense, “the Supreme Court held that there was no direct conflict between FDA regulations and Levine's state law claims because Wyeth could have strengthened its warnings without FDA approval.” As a result, Levine’s trial court verdict was affirmed, and the hope for preemption defenses for drug companies was dealt a blow.
Learned Intermediary
Another defense WSL describes it “the learned intermediary doctrine, which was first clearly defined in the mid-1960s.” See Sterling Drug v. Cornish, 370 F.2d 82 (10th Cir. 1966). According to WSL, “every state high court to have addressed application of the learned intermediary doctrine to prescription pharmaceutical products, with the exception of West Virginia, has adopted it.”
The article further explains that “this doctrine, as applied to prescription pharmaceutical products, provides that when a drug manufacturer owes any warnings, it must give them to a patient's healthcare provider rather than directly to the patient.” As the U.S. Fifth Circuit reasoned in Reyes v. Wyeth Labs., 498 F.2d 1264, 1276:
“Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.”
In the courtroom, “the learned intermediary doctrine focuses solely on the warnings that the pharmaceutical manufacturer provides to the healthcare provider. The plaintiff must prove that the manufacturer owed a duty to warn, that the manufacturer breached that duty (i.e., the warning was inadequate), and that the breach caused of the plaintiff's injuries.” WSL notes that the duty to warn “is a purely legal issue which must be determined by the judge rather than a jury. A pharmaceutical manufacturer may establish that it owed no duty to warn in circumstances such as where the plaintiff's complained-of injury had never previously been reported.”
In the case of manufacturer who does provide a warning, “the adequacy of that warning often becomes a question of fact for the jury,” unless, “the manufacturer's warning specifically addresses the plaintiff's complained-of injury, or if the physician was already familiar with the risk based on training or experience,” in which case a judge can determine the adequacy as a matter of law. Otherwise, jury’s are instructed to consider “the testimony of the plaintiff's and the manufacturer's labeling experts, as well as weigh factors such as whether the warning was prominent enough, whether it was placed in the appropriate location in the label, and whether it was clear enough for a prescriber to understand the risk involved.”
Causation
The last factor to consider is that “the manufacturer cannot be found liable unless there was a causal connection between the inadequate warning given to the prescribing physician and the injury,” or causation. As a result, the prescribing physician’s testimony is critical because “a pharmaceutical manufacturer can negate causation by establishing that the prescribing physician received the product with the adequate labeling, “but he did not read it at any time prior to prescribing the product to the plaintiff.”
What is more likely to happen is that a prescribing physician was aware of the potential risks, and the jury then has to decide “whether the physician was aware of the specific risk of which the plaintiff complains at the time he prescribed the medication to the plaintiff.” Such an issue is “further bolstered by testimony from the prescriber that even if the warning had been worded differently, placed in a different location in the labeling, or some other aspect of the warning had been different, it would not have changed his decision to prescribe the medication.”
“In Ebel v. Eli Lilly and Co., the family of a man who committed suicide sued Lilly, claiming that ingestion of Zyprexa, a pharmaceutical agent manufactured by Lilly, caused the decedent to commit suicide. 321 F. App'x 350, 2009 WL 837325 (5th Cir. 2009).” Before the case reached trial, Eli Lilly filed a motion for summary judgment, requesting that the court dismiss the case based on the learned intermediary doctrine.
The motion for summary judgment was granted—the case was dismissed—for lack of causation because the “physician who prescribed Zyprexa to the decedent had testified that he was aware of some association between the class of medications of which Zyprexa is a member and suicide.”
Another case important for drug company defense is Ackermann v. Wyeth Pharms., 526 F.3d 203 (5th Cir. 2008), in which “the court noted that the so-called "read and heed presumption" does not apply to cases involving a learned intermediary.” WSL explained that the "read and heed" presumption is a rebuttable presumption, typically applied to product manufacturers, which provides that had adequate warnings been provided, the plaintiff would have heeded them.” In other words, if the warning or labels are adequate and correct, the prescribing physician would have made the correct decision to prescribe based on his or her knowledge of the patient. As a result, “the inapplicability of this doctrine to learned intermediary cases is a significant factor in reducing the pharmaceutical manufacturer's burden in a warnings case.”
Additionally, in Bodie v. Purdue Pharma Co., 236 F. App'x 511, 2007 WL 1577964, the 11th Circuit held that a pharmaceutical manufacturer was not responsible for plaintiff's injuries because prescribing physician testified that he was aware of the potential for the side effect from which the plaintiff complained and that he had chosen to prescribe the product independent of the warnings.” Also, in Latiolais v. Merck & Co., 302 F. App'x 756, 2008 WL 5157705, the 9th Circuit held that the manufacturer “was not liable for failure to warn where the prescribing physician testified that the product labeling did not play a role in his decision to prescribe the product to the plaintiff.”
Conclusion
Ultimately, WSL recommended that for “pharmaceutical manufacturers it may be more cost effective and may result in a better outcome to rely on the learned intermediary doctrine, in battling failure-to-warn claims.” Consequently, such defenses are crucial for drug companies in preserving their integrity to advance science and medicine and to bring patients and physicians more options and better treatments to make people healthier. Since “every prescription medication has associated risks, a prescribing physician must weigh those risks as well as the potential benefits to his patient.” These cases highlight the importance of prescribing physicians to decide whether the potential benefits outweigh the risks every time they prescribe a medication.
The problem is, that overwhelmingly, the only way for physicians to gain valuable risk and benefit information about the drugs they prescribe is through journal articles and CME programs that are often funded by industry related to the products they prescribe—simply because there is no other source of funding. What happens then, when a physician says he learned about the risks and benefits from an industry funded program in court? The media and attorneys will say he or she has a conflict of interest. It seems like prescribing physicians will either get sued by patients or screwed by everyone else.
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