Date: 02-07-2008

Case Style: Gary Despain and Joy Dispain v. James L. Bradurn, M.D.; Soundtec, Inc.

Case Number: 07-714

Judge: Tom Gaze

Court: Supreme Court of Arkansas on appeal from the Circuit Court of Benton County

Plaintiff's Attorney: Unknown

Defendant's Attorney: Unknown

Description: Aside from two procedural issues, this appeal primarily concerns whether the 1976 Medical Device Amendment (MDA) to the federal Food, Drug, and Cosmetics Act preempts the statelaw productsliability and negligence claims of Appellant Gary Despain against Appellee Soundtec, Inc., the manufacturer of a medical device; in addition, the appeal considers whether Despain's claims are barred by the "learned intermediary doctrine." The Benton County Circuit Court granted summary judgment on these two grounds, and our court assumed jurisdiction of the appeal in order to consider these issues of first impression.

The facts leading to this lawsuit are not in dispute. Despain learned of a new hearing device manufactured by Soundtec, and he contacted the company in December of 2001 for more information. 1 Soundtec referred Despain to Dr. James Bradburn, who later surgically implanted the hearing device in Despain's right ear in April of 2002. Shortly thereafter, in May 2002, Despain suffered damage to his right ear, apparently as a result of interference between the magnet in his hearing device and some electronic welding equipment being used nearby in the plant where he worked. Despain consulted Dr. Bradburn, who eventually surgically removed the Soundtec hearing device from Despain's ear on June 27, 2002.

Despain initially filed suit against Soundtec, Dr. Bradburn, and Dr. Jack Hough in March of 2003, raising claims of products liability, negligence, breach of implied warranties of merchantability and of fitness for a particular purpose against Soundtec, as well as claims of medical negligence against Drs. Bradburn and Hough.

On April 22, 2004, Soundtec moved for summary judgment. First, it argued that Despain's state law claims were preempted by the MDA, and second, it contended that the "learned intermediary doctrine" precluded Despain from demonstrating that any alleged negligence on Soundtec's part was the proximate cause of his injuries. The circuit court granted Soundtec summary judgment and dismissed Despain's claims against Soundtec with prejudice.

After the trial court granted Soundtec's motion for summary judgment, Despain filed an amended complaint that named Dr. Bradburn as the sole defendant. This complaint alleged that Dr. Bradburn failed to advise Despain that the Soundtec device had not received final approval from the Food & Drug Administration and that Dr. Bradburn failed to provide Despain with warnings about exposing the hearing device to magnetic forces. The case proceeded to trial against Dr. Bradburn alone, and the jury returned a verdict in Dr. Bradburn's favor on February 7, 2007.

On February 20, 2007, Despain filed a motion for new trial against Soundtec. Citing Ark. R. Civ. P. 59(a) and Ark. R. Civ. P. 60(c), Despain urged that the order granting Soundtec summary judgment should be set aside because of the discovery of new evidence and due to fraud. Among the "newly discovered evidence" Despain cited was information that numerous patients who had received the same implant had complained of hearing the implanted magnets moving or rattling inside their ears. Despain also noted that he had discovered that Soundtec had withdrawn the product from the market in 2004, after his own device was implanted. Soundtec responded to Despain's newtrial motion, arguing that, besides the fact that Soundtec had not been named a defendant in Despain's second amended complaint, the issues regarding Soundtec's alleged defects raised in the newtrial motion were not the issues raised previously in the trial.

The trial court denied Despain's motion for new trial in an order entered on March 22, 2007. 2 Moreover, the court went on to conclude that it lacked jurisdiction to consider Despain's motion for new trial, finding that, after the court granted Soundtec summary judgment, Despain filed a secondamended complaint naming only Dr. Bradburn as a defendant. The court concluded that the filing of the amended complaint without realleging the claims against Soundtec "act[ed] as a waiver of all claims or rights to appeal." The trial court also rejected Despain's arguments concerning Rule 59 and Rule 60, finding that the newtrial rules did not apply in the aftermath of a summaryjudgment motion. In short, the court found there was no error in granting Soundtec summary judgment, and it denied Despain's motion for new trial.

We now address the first procedural issue regarding the trial court's ruling that, when Despain failed to reallege his claims against Soundtec in his secondamended complaint, he waived his right to appeal the trial court's dismissal of his claims. The trial court concluded that "[t]he only way for a plaintiff to amend his complaint and preserve postjudgment relief against the party is to actually restate the allegations in the amended complaint, or incorporate the original complaint into the amended complaint." However, Soundtec does not cite any Arkansas case law in support of this theory, citing instead to cases from other state and federal courts.

It is true that, under Arkansas law, an amended complaint, unless it adopts and incorporates the original complaint, supersedes the original complaint. See, e.g., Edward J. DeBartolo Corp. v. Cartwright, 323 Ark. 573, 916 S.W.2d 114 (1996). However, that case dealt with a procedurally different situation, and the general rule in most jurisdictions is that the courts will "refuse to require a plaintiff to replead dismissed claims in order to preserve the right to appeal the dismissal." See Young v. City of Mount Ranier, 238 F.3d 567, 572 (4 th Cir. 2001). The Fourth Circuit explained that "a rule requiring plaintiffs who file amended complaints to replead claims previously dismissed on their merits in order to preserve those claims merely sets a trap for unsuspecting plaintiffs with no concomitant benefit to the opposing party." Id. (quoting Davis v. TXO Prod. Corp., 929 F.2d 1515, 1518 (10 th Cir. 1991)). In Parrino v. FHP, Inc., 146 F.3d 699 (9 th Cir. 1998), the Ninth Circuit noted that the repleading rule does not apply to claims dismissed by summary judgment, and it held that, "[i]f the plaintiff were required to reallege claims dismissed on summary judgment to avoid waiving them, plaintiff's counsel would be forced to bear the risk of sanctions to preserve his client's right to appeal." Parrino, 146 F.3d at 704. In Young, the Fourth Circuit concluded as follows:

We [hold] that it is needlessly formalistic to require a plaintiff to replead his claims already dismissed without leave to amend in order to preserve the right to appeal the dismissal. By dismissing the claims in such a manner, the district court has quite clearly given its view of the viability of the claims, a view not made any clearer or more final by requiring the plaintiff to reallege the already rejected claims. Accordingly, we conclude that, if a claim is dismissed without leave to amend, the plaintiff does not forfeit the right to challenge the dismissal on appeal simply by filing an amended complaint that does not reallege the dismissed claim. Young, 238 F.3d at 57273.

We agree with this reasoning, and it comports with our rules of civil procedure. Our law is well settled that the failure to adjudicate all of the claims involving all of the parties at the circuit court level will result in a dismissal for failure to appeal a final order. See Ark. R. Civ. P. 54(b); Wilson v. Weiss, 368 Ark. 300, ___ S.W.3d ___ (2006); Sims v. Fletcher, 368 Ark. 178, ___ S.W.3d ___ (2006). Our court has been "resolute in its enforcement of Rule 54(b) in order to assure that we only review final orders and do not engage in the appellate practice of some other states of entertaining piecemeal appeals." Wilson, 368 Ark. at 305, ___ S.W.3d at ___.

In this case, when Despain's complaint against Soundtec was dismissed by summary judgment, the trial court did not include a Rule 54(b) certification. Therefore, Despain could not have appealed the order granting Soundtec's summaryjudgment motion. See Lee v. Martindale, 363 Ark. 249, 213 S.W.3d 1 (2005) (a summary judgment that does not dispose of all parties and claims and does not include the required certification under Rule 54(b) is not a final appealable order). Accordingly, we adopt the logic of the Fourth Circuit and other federal circuit courts cited above that have considered the issue, and we hold that one does not waive or forfeit one's right to appeal an earlier dismissal simply by not realleging the dismissed claims in an amended complaint.

Next we consider Despain's second procedural argument that the trial court erred in denying his motions for new trial pursuant to Ark. R. Civ. P. 59(a)(6) and (a)(7). Rule 59(a)(6) permits a new trial to be had in cases in which "the verdict or decision is clearly contrary to the preponderance of the evidence or is contrary to the law"; Rule 59(a)(7) provides that a new trial may be granted when "newly discovered evidence material for the party applying, which he could not, with reasonable diligence, have discovered and produced at the trial[.]" Despain's motion further argued that the summary judgment should be set aside pursuant to Ark. R. Civ. P. 60(c)(1) and (c)(4), which respectively allow for a new trial in the face of newly discovered evidence and permit a trial court to set aside an order "[f]or misrepresentation or fraud . . . by an adverse party."

We conclude that the trial court correctly denied Despain's motion for new trial under Rule 59, as we have held that the "purpose of [Rule 59] is to afford relief in the form of a new trial after the case has been tried, not after disposition by summary judgment." Similarly, because Rule 60(c)(1) also permits a trial court to grant a "new trial," that rule likewise has no bearing in the aftermath of an order granting summary judgment.

Rule 60(c)(4), on the other hand, does not provide for a new trial, but rather grants a trial court the authority to set aside an order after the expiration of ninety days for fraud practiced by the party who obtained the judgment. A party seeking to set aside a judgment for fraud has the burden of proving fraud by clear, cogent, and convincing evidence. See Bullock v. Barnes, 366 Ark. 444, 236 S.W.3d 498 (2006). To demonstrate fraud, one must show, first and foremost, "a false representation of a material fact." Id. at 450, 236 S.W.3d at 502 (emphasis added) (citing Tyson Foods, Inc. v. Davis, 347 Ark. 566, 66 S.W.3d 568 (2002)).

Despain's fraud claims were founded on two premises. First, he alleged that he did not learn until after summary judgment had been granted that Soundtec had withdrawn its hearing device from the market. Second, he contended that, in his interrogatories, he had asked Soundtec to reveal "any claims involving the Soundtec Direct Ear Device not resulting in litigation," and Soundtec had replied that there were "none other than the present case."

As noted above, Despain's lawsuit against Soundtec was based on injuries he suffered when the magnet in his hearing aid interacted negatively with a strong magnetic field.

However, the evidence he cited in support of his fraud claims pertained to Soundtec's withdrawal of the hearing aid from the market due to an entirely different problem, unrelated to external magnetic interference, which consisted of complaints that the internal magnet would move or make rattling noises in consumers' ears and cause distortion. 3 Simply put, the withdrawal was not due to complaints of magnetic interference and resulting injury, or the failure to warn of the dangers thereof. Further, Despain argued that Soundtec failed to reveal the existence of "claims" against it, but the "claims" Despain cited in his newtrial motion all dealt with the problem of magnet movement. The magnetmovement claims were immaterial and irrelevant to Despain's contention that Soundtec failed to warn of the dangers of getting too close to a strong magnetic field. Because the claims did not involve a false representation of a material fact, the trial court correctly determined that Despain had failed to allege sufficient fraud to warrant relief under Rule 60(c)(4).

We turn, then, to the merits of Despain's argument that the trial court erred in granting Soundtec's motion for summary judgment. Our standard of review in such cases is well settled. Summary judgment is to be granted by a circuit court only when it is clear that there are no genuine issues of material fact to be litigated, and the party is entitled to judgment as a matter of law. Pugh v. Griggs, 327 Ark. 577, 940 S.W.2d 445 (1997). Here, the relevant facts appear to be not in dispute, and the appeal presents only questions of law, which this court reviews de novo. Craven v. Fulton Sanitation Serv., Inc., 361 Ark. 390, 206 S.W.3d 842 (2005). The circuit court's findings of fact will not be set aside unless they are clearly erroneous or clearly against the preponderance of the evidence. Ark. R. Civ. P. 52; Holt v. McCastlain, 357 Ark. 455, 182 S.W.3d 112 (2004).

Soundtec based its summaryjudgment motion on two grounds, the first of which was that Despain's statelaw claims were preempted by federal law. 4 The United States Supreme Court has noted that preemption of state law by federal statute or regulation is not favored "in the absence of persuasive reasons - either that the nature of the regulated subject matter permits no other conclusion, or that the Congress has unmistakably so ordained." Chicago & North Western Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317 (1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963)). The Kalo Brick Court continued as follows:

The underlying rationale of the preemption doctrine, as stated more than a century and a half ago, is that the Supremacy Clause invalidates state laws that interfere with or are contrary to, the laws of Congress. The doctrine does not and could not in our federal system withdraw from the States either the power to regulate where the activity regulated is a merely peripheral concern [of] a federal law, or the authority to legislate when Congress could have regulated a distinctive part of a subject which is peculiarly adapted to local regulation, but did not. But when Congress has chosen to legislate pursuant to its constitutional powers, then a court must find local law preempted by federal regulation whenever the challenged state statute stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Kalo Brick, 450 U.S. at 317 (internal citations and punctuation omitted); see also CibaGeigy Corp. v. Alter, 309 Ark. 426, 438, 834 S.W.2d 136, 14243 (1992).

As noted above, the question presented to us is whether the 1976 Medical Device Amendment (MDA) to the Food, Drug, and Cosmetic Act preempts statelaw products liability and negligence claims against the manufacturer of a medical device. The purpose of the MDA was "to provide for the safety and effectiveness of medical devices intended for human use." See Medtronic, Inc. v. Lohr, 518 U.S. 470, 474 (1996) (citing 90 Stat. 539).

The MDA classifies medical devices into three categories based on the risk that they pose to the public. Lohr, 518 U.S. at 476. Devices that are designated as Class III devices are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or . . . present[ ] a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii)(I)( II). The Soundtec hearing device in this case is a Class III device.

Before a Class III device may be introduced into the market, the manufacturer must provide the Food and Drug Administration (FDA) with a "reasonable assurance" that the device is both safe and effective. See Lohr, 518 U.S. at 477; 21 U.S.C. § 360e(d)(2)(A)( B).

The process of establishing such a "reasonable assurance" "is a rigorous one." Lohr, 518 U.S. at 477. To obtain approval, a proposed Class III medical device must undergo the FDA's "premarket approval" (PMA) process, as defined and described in 21 U.S.C. § 360e.

The PMA process requires a manufacturer of a Class III medical device to submit an extremely detailed application to the FDA. Among other things, the application must include full reports of all information and investigations related to the product's safety and effectiveness; a statement of the components and properties of the device; a full description of the methods used in the manufacture, processing, packing, and installation of the device; samples of the device itself; samples of the labeling proposed for the device; and "such other information relevant to the subject matter of the application as the Secretary . . . may require." 21 U.S.C. § 360e(c)(1)(A)( H).

Following submission of an application, the FDA refers it to a panel of experts for further evaluation. See 21 U.S.C. § 360e(c)(3). The FDA must approve or reject the application within six months, unless an extension of time is obtained. 21 U.S.C. § 360e(d)(1)(A). In making the determination whether to approve or deny the application, the FDA "shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed label is neither false nor misleading." 21 U.S.C. § 360e(d)(1)(A). A Class III device "may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 C.F.R. § 814.80.

There are two exceptions to the PMA process. The first involves devices that were created prior to 1976 that were already in the stream of commerce; these devices were "grandfathered" in until the FDA could initiate and complete the PMA process. See 21 U.S.C. § 360e(b)(1)(A). This exception was intended to allow such preexisting devices to compete with new devices that came out after the enactment of the MDA. See Medtronic, Inc. v. Lohr, 518 U.S. at 478. The second exception covers devices that are "substantially equivalent" to medical devices in existence at the time that the MDA was enacted. See 21 U.S.C. § 360e(b)(1)(B). Manufacturers of "substantially equivalent" Class III devices must submit to a limited form of review called "premarket notification," which allows the device to be marketed without the substantial inquiry and investigation into the product's safety and effectiveness that accompanies a PMA.

Regarding the preemptive effect of the MDA, the MDA contains a specific provision addressing the intended scope of its preemption. Congress has spoken to the effect of state and local requirements respecting medical devices regulated by the MDA, stating the following:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement:

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). The associated federal regulations clarify that state or local requirements "are preempted only when . . . there are . . . specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements." 21 C.F.R. § 808.1(d). See also Medtronic, Inc. v. Lohr, 518 U.S. at 500.

The Court in Lohr makes it clear that the MDA preempts a state law only if (1) the state law constitutes a requirement "with respect to a device," see 21 U.S.C. § 360k, rather than of being "of general applicability," see 21 C.F.R. 808.1(d); and (2) "there are specific requirements applicable to the device under the act." Id. In Lohr, the Court addressed the issue of whether state commonlaw causes of action are within the preemptive scope of the MDA, 5 and a majority of the Court opined that tort litigation does not constitute a requirement specific to a medical device for preemption purposes:

[T]he general state commonlaw requirements in this suit were not specifically developed "with respect to" medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate for the Lohrs' negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a statelaw duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a work force. These state requirements therefore escape preemption, not because the source of the duty is judge made common law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be "with respect to" specific devices such as pacemakers. As a result, none of the Lohrs' claims based on allegedly defective manufacturing or labeling are preempted by the MDA.

Id. at 50102.

Numerous courts have accepted that Lohr stands for the proposition that not all state commonlaw claims regarding devices that are approved through the PMA process are preempted and have held that state commonlaw requirements are preempted only when they are shown to require a specific kind of modification to a device that has received FDA approval. For example, in Horn v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004), the Third Circuit acknowledged that not all commonlaw requirements qualify as substantive requirements that are subject to preemption. Nonetheless, that court held that the commonlaw requirement in the case before it was preempted because it alleged that a specific component of the device was faulty and would "require [the manufacturer of the device] to alter [its] design," and any design changes "would require further FDA review and approval." Horn, 376 F.3d at 176. Similarly, in Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000), the Sixth Circuit agreed that "a claim premised on the violation of FDA requirements established for a Class III device through the PMA process is not automatically preempted," but concluded that, in the case before it, where the manufacturer's negligence was based on a finding that a device should have been made with a platinum sputter barrier of a uniform thickness of 500 angstroms, the negligence finding was based on a devicespecific state requirement and was therefore subject to preemption.

In the case before us, the complaint does not reveal any claim by Despain that would require a specific change in the way the hearing device was manufactured. Instead, Despain's claims are general tort claims in nature and can be summarized as follows: (1) Soundtec is strictly liable for introducing into the stream of commerce a hearing device that was in a defective condition and unreasonably dangerous when used for its reasonably anticipated use; (2) Soundtec was negligent in its design, manufacture, engineering, inspection and testing of the hearing device; (3) Soundtec was negligent in failing to give adequate warnings to patients and doctors regarding the dangers of the hearing device when used in the anticipated and proper manner; (4) Soundtec was in breach of the implied warranty of merchantability and of fitness for a particular purpose, because the hearing device was not fit for the purpose for which Soundtec recommended it to Despain. In sum, Despain alleges that the hearing device was defective because of the way it reacted to a strong magnetic field and that Soundtec failed to adequately warn Despain of this danger.

He does not allege that any particular part of the device should have been designed in any specific manner.

However, even if a state commonlaw tort claim did constitute a devicespecific requirement that was subject to preemption by the MDA, the lack of devicespecific federal regulations from the FDA applicable to the hearing device at issue in the instant case would still render federal preemption inapplicable. Although the PMA process is rigorous, it does not involve the "specific counterpart regulations or . . . other specific requirements applicable to a particular device under the act," which are a prerequisite for preemption. 21 C.F.R. § 808.1(d). Instead, PMA is a manufacturerdriven process, with the maker of a proposed device supplying information regarding the device to the FDA for approval, rather than the FDA supplying guidelines for how a device is to be designed or manufactured. See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1375 (11th Cir. 1999) ("In the typical PMA review and approval . . . the FDA issues no regulation, order, or any other statement of its substantive benchmark. The approval represents only a finding that the manufacturer's proposal to market a device has reasonably assured the FDA of the device's safety and effectiveness.") (citations omitted). Furthermore, it is the manufacturer who determines the "components, ingredients, and properties" of the device. 21 U.S.C. § 360e(c)(1)(B) (2000).

And it is the manufacturer who determines the "methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation" of the device. Id. at (C). Lastly, it is the manufacturer who supplies "specimens of the labeling proposed to be used for such device." Id. at (F).

The Illinois Supreme Court has considered a case very similar to the instant case, but involving pacemakers for the heart, and it concluded:

The design of the pacemakers at issue in this case originated solely with the manufacturer of the device, not the FDA. The FDA did not require the pacemakers to take any particular form for any particular reason. The FDA merely gave permission to market the design for the pacemaker submitted by the manufacturer. Premarket approval imposes no ascertainable substantive requirement on the manufacture or design of the device. Weiland v. Telectronics Pacing Sys., Inc., 188 Ill.2d 415, 420 (Ill. 1999). The Illinois Supreme Court went on to explain that the FDA could, if it wished, promulgate a devicespecific standard, such as requiring all pacemakers to use ceramic insulators. Id. If it chose to do so, then any negligence action based on the use of such insulators would be preempted. Id. However, there was no indication in Weiland that there were any such specific, FDA driven parameters. Nor are there regulatory parameters for hearing devices in the present case. As the 11 th Circuit Court of Appeals has noted, "the PMA process is proactive rather than reactive; it concerns the manufacturers' ability to market minimally safe devices but makes no attempt to announce substantive safety standards that might determine the outcome of a product liability suit." Goodlin, 167 F.3d at 1380.

This court has previously held that federal preemption did not occur in an analogous situation. See Ciba Geigy Corp. v. Alter, 309 Ark. 426, 834 S.W.2d 136 (1992). In that case, we emphasized the distinction between federal regulations requiring a product to take a certain form and federal approval of a form chosen by a manufacturer. Id. at 443, 834 S.W.2d at 144. Specifically, we considered whether the Environmental Protection Agency's (EPA) approval of a pesticide label as required by the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA") preempted a commonlaw tort claim for inadequate labeling. Id. at 438, 834 S.W.2d at 141. In CibaGeigy, this court noted that FIFRA contains a preemption clause requiring that a state "not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter." Id. at 440, 834 S.W.2d at 143 (emphasis added). That is very similar to the language of the MDA. CeibaGeigy, like the present case, required this court to determine whether the scope of preemptive language contained in a federal statute expressly or impliedly covered commonlaw claims. In CibaGeigy, this court determined that there was neither express nor implied preemption of such claims. 309 Ark. at 438, 440, 834 S.W.2d at 14343.

In finding that there was no preemption, this court said, "[t]he fact that manufacturers submit their own labels implies a duty to provide a label that gives adequate warnings about the risks associated with the product's use." 309 Ark. at 443, 834 S.W.2d at 144. The court held, accordingly, that there was "no conflict between the EPA determination that a label is adequate for the purposes of FIFRA and a jury determination that a label is inadequate for purposes of state tort law." Id. at 442, 834 S.W.2d at 144. In so holding, we noted that "after a jury determines a pesticide label to be inadequate the manufacturer can simply petition the EPA to allow the label to be made more comprehensive. By doing so, the manufacturer would be in compliance with state tort law and with EPA regulations." Id. at 834 S.W.2d at 144. In short, the process in the case before us is similar to the process under FIFRA, but here the manufacturer supplies information not only about labeling, but also about the design, manufacture, and effectiveness of the medical device, making the scope of FDA's approval under the MDA much broader than the EPA's under FIFRA. As with FIFRA, the manufacturer of a Class III medical device can change a device's design and labeling after completion of the PMA process by application for FDA approval of that change.

In the present case, Soundtec did not provide any evidence of any devicespecific requirements related to the hearing device at issue. It is true that the FDA's approval of the hearing device was subject to certain "Conditions of Approval." These conditions, however, are all general in nature, requiring, for example, use of approved labeling, the submission of an updated PMA before making a change affecting the safety or effectiveness of the device, and the submission of certain postapproval reports, including adverse incident reports.

There is no indication that the Conditions of Approval contained any devicespecific requirements. Accordingly, we conclude that the circuit court erred in granting Soundtec's summary judgment motion on the basis of federal preemption.

We also find error in the court's granting of summary judgment on the basis of the learned intermediary doctrine. As a general rule, a manufacturer of a drug or, as in this case, a medical product or device, has a duty to warn the ultimate user of the risks of its products.

See West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608 (1991). This duty exists under either a negligence or strict liability theory. Id. at 42, 806 S.W.2d at 613. However, there is an "almost universally applied exception to this general rule," known as the learned intermediary doctrine. Id. This doctrine provides that a drug manufacturer may rely on the prescribing physician to warn the ultimate consumer of the risks of a prescription drug. The physician acts as the "learned intermediary" between the manufacturer and the ultimate consumer. Id. An Eighth Circuit opinion has discussed the issue further as follows:

The learned intermediary doctrine provides that a pharmaceutical manufacturer has a duty to warn a physician of the risks involved with a pharmaceutical, and the physician then acts as a "learned intermediary" between the manufacturer and the physician's patient. Thus, a warning to the physician is deemed a warning to the patient; the manufacturer need not communicate directly with all ultimate users of prescription drugs. Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 101617 (8 th Cir. 2004) (internal citations and punctuation omitted).

The learned intermediary doctrine is justified by the existence of "an independent medical decision by the learned intermediary" that a device is appropriate for use by a given patient. West, 305 Ark. at 42, 806 S.W.2d at 613. However, the doctrine "does not alter the duty of a manufacturer to provide adequate warnings of the risks with each product sold." 63A Am. Jur. 2d Products Liability § 1700 (1997). The doctrine "simply substitutes the physician for the consumer as the person to receive those warnings. The drug manufacturer must utilize methods of warning which will be reasonably effective to bring the warning home to the prescribing and treating physicians." Id.

In the present case, Despain contends that there was a factual question as to whether the warnings provided by Soundtec to Dr. Bradburn about the danger of exposure to magnetic fields were sufficiently conveyed. We agree and conclude that it is inappropriate to apply the learned intermediary doctrine because it has not been established that, as a matter of law, the warnings given to Dr. Bradburn were sufficient to make him "fully aware of the risks associated" with the hearing device. West, 305 Ark. at 44, 806 S.W.2d at 614. It is not disputed that Dr. Bradburn, who implanted the hearing device, was made aware, through his training and through the Clinician's Guide provided to him by Soundtec, that patients implanted with the product "should not undergo an MRI examination, enter a room where MRI exams are performed, or get close to other strong magnetic fields."

(Emphasis added.) However, the question of whether such a general warning was sufficient to inform a physician that a detailed investigation of the patient's workplace or other environment was necessary before making a decision as to whether implantation of the device was appropriate is one of fact, not of law. As such, we reverse the trial court's granting of summary judgment to Soundtec and remand for further proceedings.

Outcome: Reversed

Plaintiff's Experts: Unknown

Defendant's Experts: Unknown

Comments: None