For The Defense, October 2010 - DRI Today

D R U G A N D M E D I C A L D E V I C Etative had a duty to affirmatively tell thephysician while the physician was performingsurgery that the physician should notreplace only the catheter connector.On the off- label theory, the court notedthat the FDA does not regulate the practiceof medicine, and a physician may lawfully“vary the conditions of use from thoseapproved in the package insert.” Id. at 1283.Fundamentally, theFDA does regulatemanufacturer’srepresentatives through thepremarket approval process.The court reasoned that the FDA does notdistinguish between on- label and off- labeluses. Regarding the representative specifically,the court recognized that the Food,Drug, and Cosmetic Act prohibits off- labelpromotion, but no private right of actionexists to enforce the act. In any event, “acomplete absence of evidence” existed as toany claim that, by attending and observingthe revision procedure, the representativeengaged in “‘off- label’ marketing and promotion.”Id. at 1292.The court’s preemption holding hingedupon the reasoning that a jury could findliability even if the manufacturers followedand complied with all FDA regulationsand practices for the device. Hence,the claims imposed requirements “differentfrom, or in addition to” the FDArequirements. Significantly, while the bulkof the preemption analysis focused on theclaims directly against the manufacturer,the court adopted the same reasoning andreached the same conclusion regarding thenegligence claim against the representativeand the accompanying vicarious liabilityclaims.None of the factual allegations againstthe representative affected the holdingabout preemption or amounted to a parallelclaim, including the allegations regardinginformed consent and the device’s removal.Indeed, the court’s further analysis of those30 n For The Defense n October 2010claims and additional reasons for grantingsummary judgment were only alternativeholdings. Instead, the court determinedthat all of the claims related to the representativeinvolved “different from” or“additional” requirements.In this respect, Wolicki- Gables countersthe view taken in Adkins. The representativespecificclaims in Wolicki- Gables were insome instances virtually the same as thosein Adkins: the plaintiffs in both cases arguedthat the representative owed a duty toinstruct or educate the physician and a dutyto ensure that the device functioned properly.In other instances, the Wolicki- Gablesclaims were far broader than those in Adkins,encompassing consent and spoliation.Yet, regardless of the claims’ breadth, all ofthe Wolicki- Gables’ claims were preempted.The end result of Wolicki- Gables is that, if astate law claim seeks to impose liability fora representative’s actions, but nothing inthose actions results in federal regulatorycompliance transgressions by the manufactureror representative, then the statelaw claim seeks to impose different or additionalrequirements than those mandatedby federal law, and it is preempted.Additional Defense ArgumentsThe Wolicki- Gables court took a straightforwardapproach and simply comparedthe nature of the state law liability andwhether it could coexist with completeFDA compliance. While that approach isuseful, additional defense arguments existthat build more directly upon Riegel andthe MDA.The Reasoning Followed by Cases Suchas Adkins Is Inconsistent with RiegelThe essence of cases such as Adkins isthat the FDA generally does not regulatephysician- representative interaction duringsurgery. That reasoning ignores severalimportant points. Fundamentally, theFDA does regulate manufacturer’s representativesthrough the premarket approvalprocess. When the FDA approves a medicaldevice under premarket approval, the FDAapproves not only the device’s design, manufacturing,and labeling, but also considerswhether and how to regulate other areas.As a condition of approval, the FDA mayimpose various other requirements on thedevice’s sale and distribution. See 21 U.S.C.§360j(e)(1)(B) (The Secretary may impose“such other conditions” on the “sale, distribution,or use” of the device as the Secretarydeems appropriate). Those “other conditions”may include training, instructional,or tutorial requirements for physicians thatrequire a representative’s participation orguidance. In turn, those requirements maybe set forth in the premarket approval letterand the device’s labeling. For example,regarding devices approved in 2010alone, the FDA’s website indicates severalapproval letters stating that “[t]he device isfurther restricted under section 515(d)(1)(B)(ii) of the [FDCA] insofar as the labelingmust specify the specific training or experiencepractitioners need in order to use thedevice.” See http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm202715.htm(last accessed on September 20, 2010). Thelabeling for those devices then states thatthe physician must attend training conductedby the representative. See id. Thus,the FDA makes regulatory choices relatingto a representative’s actions and any statelaw claim that a representative should haveconveyed different or additional “otherconditions” is preempted.Similarly, premarket approval imposesspecific labeling requirements. See Riegel,128 S. Ct. at 1004–05. “The premarket approvalprocess includes review of the device’sproposed labeling. The FDA evaluatessafety and effectiveness under the conditionsof use set forth on the label, §360c(a)(2)(B), and must determine that the proposedlabeling is neither false nor misleading,§360e(d)(1)(A).” Id. Therefore, any statelaw claim that a representative should havecommunicated other instructions or warningsto a physician is an attempt to imposea requirement “different from, or in additionto” the federal requirements.Overall, then, if the FDA regulates representativesto the extent of requiring certainconduct in some situations and choosingnot to impose specific requirements inother situations, then a plaintiff’s attemptthrough a tort claim to require any otherconduct must impose a “different from”or “additional” requirement. A court cannotdeem that claim “parallel” to federalrequirements.This point recognizes that the federalpreemption of claims under Riegel is broad