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Off-Label Marketing Metal-to-Metal Total Hip Replacement


In a healthy hip (a ball-and-socket joint), the bones are covered with smooth cartilage that enables the femoral head (the ball) and acetabulum (the socket) to glide painlessly against each other. A man underwent total hip replacement surgery, a procedure in which the femoral head and the acetabulum are both removed and replaced with a prosthetic device.

 

The hip replacement system that was used in the procedure was comprised of multiple components. Some components replaced the man’s femoral head with a metal head, metal sleeve, and a stem connecting the metal head to the femur. Another component rested on the man’s acetabulum. These components were all Class II devices approved through the FDA’s Section 510(k) process, which requires a medical device to be substantially equivalent to a preexisting approved medical device. A final component, the metal liner, mediated the connection between the acetabulum and the femur and was seated atop the acetabulum component. The liner underwent the FDA’s more rigorous premarket approval process for Class III devices as a supplemental component for a hip resurfacing system made by the same manufacturer. In hip resurfacing, the femoral head is not removed. Instead the femoral head is trimmed and capped with a smooth metal covering. The acetabulum is removed and replaced with a prosthetic device, just as in a traditional total hip replacement. In combination with the metal head and metal head sleeve that replaced the man’s femoral head, the metal liner created a metal-on-metal articulation at the man’s hip socket.

 

When the metal liner underwent the FDA’s premarket approval process, the FDA required that the liner’s label state that the metal liner was intended for use as part of the hip resurfacing system only and that the metal liner must be replaced with a polyethylene liner if the hip resurfacing system were abandoned or later revised in favor of a total hip replacement system. The manufacturer’s promotional materials marketed the metal liner as an option for the total hip replacement system that was used in the man’s procedure.

 

Approximately 21 months after the total hip replacement surgery, the man developed increasing pain and discomfort in the buttocks, groin, and thigh. The pain and discomfort limited the man’s daily activities. The man’s surgeon performed an aspiration procedure that revealed metallic debris within the man’s body, indicating that the pain was caused by metal sensitivity due to the degeneration of the metal-on-metal articulation at the man’s hip socket. The man underwent revision surgery to replace the metal liner. The revision did not relieve the pain. The man underwent subsequent surgeries to remove and replace the entire hip replacement system.

 

The man and the man’s wife sued the manufacturer of the hip replacement system for off-label promotion. The complaint asserted state law claims for negligence, strict liability, breach of implied warranty, and fraud.

 

The couple and the manufacturer agreed that the manufacturer’s promotional materials marketing the metal liner as an option for the total hip replacement system constituted off-label promotion. They also agreed that the metal liner’s use in the man’s total hip replacement system constituted off-label use.

 

The manufacturer filed a motion for summary judgment. The motion asserted that the Medical Device Amendments expressly preempted the couple’s state law claims. Also, the motion argued that the complaint failed to state a claim for off-label promotion.

 

The United States District Court for the Eastern District of Pennsylvania granted the manufacturer’s motion. The district court held that the Medical Device Amendments expressly preempted the couple’s state law claims and the complaint failed to state a claim for off-label promotion.

 

The Third Circuit United States Court of Appeals (1) affirmed the district court’s grant of summary judgment in favor of the manufacturer on the state law claims that were not related to the manufacturer’s alleged off-label promotion, (2) reversed the district court’s dismissal of the couple’s negligence and loss of consortium claims related to the manufacturer’s alleged off-label promotion, and (3) reversed the district court’s dismissal of the couple’s fraud claim related to the manufacturer’s alleged off-label promotion to the extent that it was with prejudice. The court held that (1) the couple’s negligence, strict liability, and breach of implied warranty claims that were not related to the manufacturer’s alleged off-label promotion were expressly preempted by the Medical Device Amendments because the claims would impose non-parallel state law requirements; (2) the couple met the pleading burden with respect to the negligence and loss of consortium claims related to the manufacturer’s alleged off-label promotion; and (3) the district court erred in dismissing with prejudice the couple’s fraud claim related to the manufacturer’s alleged off-label promotion.

 

The couple’s negligence, strict liability, and breach of implied warranty claims that were not related to the manufacturer’s alleged off-label promotion were expressly preempted by the Medical Device Amendments because the claims would impose non-parallel state law requirements. The court found that the metal liner was a Class III component that received premarket approval as part of the hip resurfacing system made by the same manufacturer. That premarket approval imposed requirements on the metal liner with respect to its composition, dimensions, and labeling, among other specifications. The man’s negligence, strict liability, and breach of implied warranty claims would impose requirements with respect to the metal liner that were different from, or in addition to, federal requirements because each of the state law claims challenged the safety and effectiveness of the metal liner.

 

The couple met the pleading burden with respect to the negligence claim related to the manufacturer’s alleged off-label promotion. To state a parallel negligence claim, the couple was required to plead (1) a duty arising from federal requirements applicable to a medical device, (2) a breach of that duty, and (3) a causal connection between the breach and the man’s injuries. The court held that the man’s complaint alleged each of these required elements. First, as to duty, the complaint alleged that the metal liner received premarket approval as part of the manufacturer’s hip resurfacing system and was approved only for use with the manufacturer’s hip resurfacing system, leading to the reasonable inference that the metal liner was a restricted device under the Medical Device Amendments, and that federal law therefore imposed a duty on the manufacturer to refrain from publishing false or misleading advertising with respect to the metal liner, even if such advertising was for the purpose of marketing a separate device. Second, as to breach, the complaint asserted that, even though the FDA did not approve the metal liner for use with any device other than the manufacturer’s hip resurfacing system, the manufacturer actively marketed the metal liner as an option for the manufacturer’s hip replacement system. The court found that the complaint’s factual allegations gave rise to the reasonable inference that the manufacturer’s marketing was misleading regarding the FDA-approved uses of the metal liner and that the manufacturer breached its duty under federal law not to advertise its medical device in that misleading manner. Third, as to causation, the man’s complaint alleged that the man’s surgeon either read or was aware of the information in the manufacturer’s marketing material, the surgeon proceeded to find the metal liner appropriate for the man, and the man endured pain caused by metal sensitivity due to the degeneration of the metal-on-metal articulation in his hip replacement system. The court found that the complaint’s factual allegations lead to the reasonable inference that the manufacturer’s marketing materials caused the man’s surgeon to recommend the metal liner and to install it within the man’s hip replacement system, a course of action which in turn caused the subsequent injuries. The court concluded that the district court erred in dismissing the couple’s negligence claim related to the manufacturer’s alleged off-label promotion.

 

The couple met the pleading burden with respect to the loss of consortium claim related to the manufacturer’s alleged off-label promotion. Because the court held the couple adequately pleaded a negligence claim premised on the man’s injuries, the court held that the couple had also adequately pleaded the derivative claim of loss of consortium. The court found that the complaint’s factual allegations lead to the reasonable inference that, due to the manufacturer’s misleading marketing, the metal liner’s subsequent use in the man’s hip replacement surgery, and the man’s ensuing physical injuries, the man’s wife suffered a loss of the man’s services, society, and conjugal affection. The court concluded that the district court erred in dismissing the wife’s loss of consortium claim related to the manufacturer’s alleged off-label promotion. The court reversed the district court’s dismissal of the negligence and loss of consortium claims and allowed those claims to proceed to discovery.

 

The district court erred in dismissing with prejudice the couple’s fraud claim related to the manufacturer’s alleged off-label promotion in violation of federal law. To plead fraud under Pennsylvania law in federal court, a plaintiff must allege with sufficient particularity to place the defendant on notice of the precise misconduct with which it is charged the following: (1) a representation, (2) which is material to the transaction at hand, (3) made with knowledge of its falsity or recklessness as to whether it is true or false, and (4) made with the intent of misleading another into relying on it; (5) justifiable reliance on the misrepresentation; and (6) the resulting injury was proximately caused by the reliance. The complaint alleged that the manufacturer made representations by including and incorporating representations the manufacturer made regarding the metal liner. The complaint alleged materiality by describing those representations’ importance in influencing surgeons, such as the man’s surgeon, to use the metal liner off-label. The complaint alleged falsity by stating that, contrary to the manufacturer’s representations, the manufacturer received FDA approval regarding the metal liner’s use only as part of the manufacturer’s hip resurfacing system. The complaint alleged intent by contending that the manufacturer represented that the metal liner was available for use within other hip systems, even though the company had never sought FDA approval for use within any system other than the hip resurfacing system. However, the court found that the complaint did not plead the element of justifiable reliance on the manufacturer’s misrepresentation with the particularity required. To be sufficiently particular, the complaint had to contain details about the relationship of the parties involved and the nature of the transaction. In asserting that the man’s surgeon read or was aware of the manufacturer’s marketing materials about the metal liner, the complaint did not provide any details about how the marketing materials induced or influenced the surgeon’s course of conduct. The bald assertion that the marketing materials’ claims influenced the surgeon did not suffice because that statement was merely a naked assertion devoid of further factual enhancement amounting to nothing more than a formulaic recitation of one element of the cause of action. The court affirmed the district court’s dismissal of the claim because the complaint did not state the circumstances of the alleged influence on the man’s surgeon with sufficient particularity to place the manufacturer on notice of the precise misconduct with which it was charged. However, the court held that the district court should have allowed the couple to supplement the complaint with additional factual content after discovery. The court vacated the district court’s dismissal of the fraud claim to the extent that it was with prejudice and without leave to amend.

 

The Third Circuit United States Court of Appeals affirmed the district court’s grant of summary judgment in favor of the manufacturer on the state law claims that did not that were not related to the manufacturer’s alleged off-label promotion, reversed the district court’s dismissal of the couple’s negligence and loss of consortium claims related to the manufacturer’s alleged off-label promotion, and reversed the district court’s dismissal of the couple’s fraud claim related to the manufacturer’s alleged off-label promotion to the extent that it was with prejudice.

 

See: Shuker v. Smith & Nephew, PLC, 2018 WL 1096185 (C.A.3 (Pa.), March 1, 2018) (not designated for publication).

 

See also Medical Law Perspectives Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory

 

See also Medical Law Perspectives Report: New Hips, New Knees, New Problems: Hip and Knee Replacements

 

See the Medical Law Perspectives Blog: Jury Instruction in Product Liability Case That Violation of the FDCA is Negligence Per Se; Preemption Considerations

 

 

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