July 2, 2015, Trial News
Off-label Infuse case preempted, Second Circuit says
The Second Circuit has affirmed the dismissal of a plaintiff’s case against Medtronic for the off-label promotion of its Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion device. The court found that the plaintiff’s state law claims were preempted under section 360k(a) of the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act.
The Second Circuit has affirmed the dismissal of a plaintiff’s case against Medtronic for the off-label promotion of its Infuse Bone Graft device. The court found that the plaintiff’s state law claims were preempted under section 360k(a) of the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act. (Otis-Wisher v. Medtronic, Inc., No. 14-3491 (2d.Cir. June 9, 2015).)
Koleen Otis-Wisher brought eight claims against Medtronic, including design defect and failure to warn, for injuries resulting from the use of Infuse in her 2009 spinal surgery. The plaintiff alleged that the surgical method used for implanting the device was not FDA approved and that Medtronic promoted and sold Infuse off-label. The Second Circuit reiterated the lower court’s reasoning that the Medical Device Amendments prohibit state law claims that seek to impose any different or additional requirements related to the safety or effectiveness of a device that has been approved by the FDA.
The Second Circuit’s decision adds to the murky case law surrounding preemption and follows the Tenth Circuit’s decision in Caplinger v. Medtronic from the end of April. The plaintiff’s claims in Caplinger also were dismissed because the court found that there either was no parallel federal claim to the plaintiff’s state claims or the state law claims imposed requirements beyond federal law. The plaintiff further argued that her claims should have survived preemption because the FDA did not contemplate the device’s off-label uses when assessing its safety, making those off-label uses outside the scope of the FDA’s approval. The court, however, found that nothing in the Medical Device Amendments or prior case law distinguishes between on-label and off-label uses of a device, noting that the law preempts “any effort to use state law to impose a new requirement on a federally approved medical device.”
Marlene Goldenberg, a plaintiff attorney in Minneapolis who handles Infuse cases, said that “by this logic, your doctor could implant a pacemaker into your shoulder and that would be OK because the device is approved for use in people’s hearts.” Goldenberg said that plaintiff attorneys need to think of the “product plus its intended use” and that once a product is used for a purpose other than the intended one, it has been adulterated and misbranded in violation of federal law.
One judge in Caplinger appears to agree with Goldenberg, writing in his partial dissent that a plaintiff’s state law claims based on the device being misbranded or adulterated could survive preemption. Judge Carlos Lucero wrote that “§360(k) does not expressly preempt” state law claims and remedies for harm caused by devices that have been misbranded or adulterated in violation of federal law. “Immunizing from liability . . . a device for untested, unapproved, and potentially unsafe uses would completely subvert the purpose of the PMA process,” he noted. He found that the plaintiff’s claims for failure to warn and negligence were sufficiently pleaded parallel state claims.
Goldenberg said that the inconsistency in preemption analyses across the country has created a “convoluted body of case law.” Goldenberg said that even in jurisdictions where some decisions have been favorable to plaintiffs, there is “no guarantee of similar results in the future. There is some good case law in the Seventh and Ninth Circuits, but it is still unpredictable.”
Louis Bograd, chief litigation counsel for the Center for Constitutional Litigation in Washington, D.C., said that while these recent decisions may not seem great for plaintiffs, it does not necessarily mean that no claim against Infuse can survive. “The courts have twisted and turned to find that state claims are not parallel. Caplinger was a significant federal court decision, but there are many other cases out there and the record is a mixed bag,” he said. Caplinger, Otis-Wisher, and other similar cases “shouldn’t be viewed as the last word. There are many legal issues that have not been squarely addressed, and we will continue to muddle through them.”
“The bottom line,” Goldenberg said, “is that you have a device that’s not safe and shouldn’t be promoted for that off-label use.” Goldenberg suggested that considering the current landscape, it is essential for plaintiff attorneys pursuing Infuse cases to write a strong complaint. “Your complaint should read like an opposition to the defendant’s motion to dismiss,” she said.
For more on Infuse and preemption, see “Taking on Infuse and Preemption” in the July issue of Trial.