It was an interesting year for legal issues surrounding pharmaceutical drugs and medical devices in 2014. This litigation covered the waterfront, ranging from “free speech” arguments under the First Amendment, to preemption of claims under state law thought to violate duties under federal law, to changes in expert differential diagnosis requirements. Clearly, the legal framework surrounding these very complex cases continues to evolve and open new opportunities for Plaintiffs that have been previously foreclosed.
Off-label use is the use of pharmaceutical drugs or medical devices for an unapproved reason (indication), age group, dosage, or form of administration. Doctors routinely prescribe medications for conditions other than what the drugs were initially approved to treat, and many times, this practice is attributable to aggressive sales representative promotion of these unapproved indications to the physicians they detail. While it is legal for a physician to prescribe a drug for reasons other than its listed indications, the gray area is whether or not pharmaceutical companies are allowed to promote and market these off-label uses.
In 2011, the U.S. Supreme Court in Sorrell v. IMS Health Inc. held that pharmaceutical marketing is a form of expression protected by the Free Speech Clause of the First Amendment, and the progeny of cases following it determined that the government could not prosecute drug manufacturers or their representatives for promoting off-label use of an otherwise U.S. Food and Drug Administration approved drug. However, a recent whistleblower case in the Eastern District of California has raised the issue of whether truthful speech to doctors is truly protected, or whether off label promotion is evidence of intent to incite doctors to submit false claims for insurance reimbursement, or if it provides loopholes for companies to circumvent the need to seek FDA approval for additional indications for their drugs.
Why is this important? Off-label uses, in many instances, can treat less serious conditions that do not carry the same risk-benefit analysis as they would for more serious indications. As such, an off-label use for a less serious indication may not be worth the risks inherent in the drug itself. It will be interesting to see how the California case plays out, as a victory for Defendants on this issue could result in more unregulated off-label promotion and potentially more harm for consumers.
In 2011, the United States Supreme Court held in Pliva v. Mensing that generic
drug manufacturers could not be held liable for failing to strengthen or update their warnings to include information about adverse events because doing so would violate their duties under federal law to be the same, in both medicinal content as well as labeling, as the brand manufacturer’s drug. This court decision preempted claims against most generic manufacturers and resulted in dismissal of many cases when the injured Plaintiff could only prove use of the generic drug.
The theory of Innovator Liability sought to shift the responsibility to the brand manufacturers, who were responsible for both the design and labeling of their drugs, even though the injured Plaintiff never consumed the brand manufacturer’s product. Many jurisdictions failed to embrace this theory of liability, arguing that the lack of product identification fails to show that the brand manufacturer owed Plaintiffs any duty under state law. However, in 2014, the Alabama Supreme Court in Weeks v. Wyeth, Inc, surprisingly joined a minority of jurisdictions who have determined that a brand manufacturer can be held liable for fraud or misrepresentation based on statements it made in connection with the manufacture or distribution of the brand-name drug, even if the Plaintiff only consumed the generic drug.
The Court rejected the notion that their decision created a new “innovator liability” cause of action, and instead stated that under a foreseeability analysis, the brand manufacturer could reasonably foresee that generic manufacturers would copy the brand labeling, therefore the innovator owed a duty of care to the generic drug user. Even though this decision is favorable for Alabama clients (as well as those in California and Vermont, the only other two states to have recognized this theory of liability) most Plaintiffs who consume generic drugs around the country will not be able to apprise themselves of the benefits of these decisions.
In the context of medical devices, an en banc panel of the Ninth Circuit Court of Appeals held in Stengel v. Medtronic that there is no preemption of a state law claim for violating a state law duty that parallels a federal law duty. In other words, preemption would only apply if there is conflict or impossibility to comply with both state and federal requirements. At issue in the case is whether the device manufacturer could comply with a state law duty to report adverse events to the FDA without violating federal law. The court held that these duties paralleled but did not add to federal requirements for manufacturers. This decision tips favorably toward Plaintiffs and opens the door to claims that argue that a device manufacturer breached its general duty to warn by failing to inform the FDA of newly discovered safety risks.
When it comes to the use of experts to prove causation in an injury case, the standard is that the expert must make a differential diagnosis, or they must distinguish a particular disease or condition from others that present similar symptoms, in order to diagnose that a particular prescription drug or medical device is the cause of the injury. Generally speaking, experts must rule out all possible alternative explanations for their opinions to be sufficiently reliable and admissible.
However, in June 2014, the Eighth Circuit Court of Appeals held to the contrary of most courts, and held in Johnson v. Mead Johnson & Co. LLC, that experts do not necessarily have to rule out all possible alternative explanations for their opinion to be admissible. The court’s rationale was that under Daubert and Federal Rule of Evidence 702, doubts should be resolved in favor of admitting evidence, and that weighing conflicting expert opinions is the role of the jury, not the court.
Therefore, at least in the Eighth Circuit, attempts to exclude expert opinions will be more challenging going forward. If you need more information, contact Danielle Mason, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.
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