When Products Liability Intersects with Malpractice Strategy

Medical device products liability litigation and medical malpractice litigation have intersected for as long as physicians have been prescribing and implanting medical devices, but that overlap continues to increase and become even more intricate as medical devices become more sophisticated and more widely utilized by physicians and the public, and as plaintiffs increasingly seek to keep their cases in state court by including local diversity-destroying defendants in suits.

In order to avoid unfavorable precedent on federal preemption of state law claims based upon FDA-approved Class III medical devices, and to nullify the impact of the learned intermediary defense by having both manufacturer and intermediary present in the case, plaintiffs increasingly seek to join both medical provider and manufacturer in one suit. Such suits will contain both product liability claims against the medical device manufacturer and medical malpractice claims against diversity-destroying physicians and hospitals. As a result, physicians and device manufacturers, more frequently than ever, are finding themselves as uncomfortable and unwilling bedfellows in litigation involving a prescription medical device. Because the interests of medical providers and manufacturers may often seem at odds, certain strategic considerations should govern both parties' planning for the litigation in order to avoid common pitfalls. Many of these same situations will also arise in cases in which both pharmaceutical manufacturers and medical providers are defendants.

Another consideration is that, in cases involving both a medical provider and a device manufacturer, plaintiffs will often seek to create and exploit some natural friction between the interests of multiple co-defendants to their own advantage. Savvy defense counsel for physicians or hospitals would therefore be well-advised to watch for certain likely roadblocks that may arise or be placed in their way by plaintiffs. All defendants benefit when they can 'hold hands and play nice' together to defeat the plaintiffs' claims and present the strongest possible defense at trial.

We outline herein some basic trouble spots that may arise during the course of litigation in which both medical providers and device manufacturers are defendants, as well as best practices in order to avoid allowing such issues to negatively impact the defendant parties' interests in the litigation.

Federal Preemption

Because preemption is a prominent issue in cases involving most major prescription medical devices, counsel for medical providers should first familiarize themselves with this currently hot legal topic.

The FDA's Pre-market review and approval of Class III medical devices under the Medical Device Amendments to the Food, Drug and Cosmetic Act has generally been held to preempt most state tort law claims pertaining to claimed defects in such devices; all but one federal circuit Court of Appeals to decide the issue has ruled in favor of federal preemption. See, e.g., Riegel v. Medtronic Inc., 451 F.3d 104 (2d Cir. 2006), cert. granted, 127 S.Ct. 3000, 75 USLW 3065, (U.S. Jun 25, 2007) (NO. 06-179); Gomez v. St. Jude Medical Diag Div. Inc., 442 F.3d 919 (5th Cir. 2006); McMullen v. Medtronic Inc., 421 F.3d 482 (7th Cir. 2005); cert. denied, 126 S.Ct. 1464 (2006); Cupek v. Medtronic Inc., 405 F.3d 421 (6^th Cir. 2005), cert. denied sub nom. Knisley v. Medtronic Inc., 126 S. Ct. 420 (2005); Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica Inc., 273 F.3d 785 (8^th Cir. 2001)(en banc), cert. denied, 535 U.S. 1056 (2002). But see Goodlin v. Medtronic Inc., 167 F.3d 1367 (11^th Cir. 1999). As a result, in any case outside the Eleventh Circuit in which the plaintiff brings state law tort claims asserting either the existence of a defect or a failure to warn of particular risks, the manufacturer is likely to assert federal preemption of state tort law claims as a defense in a motion for summary judgment.

Summary judgment motions based on federal preemption generally are successful in most cases, thanks both to the strong precedent on the issue to date and the relatively high factual hurdle a plaintiff must leap over in order to convince a court to deny preemption. However, the occasional court, even outside the Eleventh Circuit, has been willing to depart from the majority and allow such claims to survive summary judgment. See, e.g., In re Medtronic Inc. Implantable Defibrillators Products Liability Litigation, 465 F. Supp. 2d 886 (D. Minn. 2006); In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability Litigation, 2004 WL 45503 (D. Minn. 2004); Woods v. Gliatech, 218 F. Supp. 2d 802 (D. W.Va. 2002). As a result, while preemption appears to be a strong defense that is often successful, it is not yet an absolute bar of state tort law claims against a medical device manufacturer for product defect or failure to warn.

In fact, because the United States Supreme Court recently granted certiorari for the October 2007 term to decide the circuit split on whether such claims are preempted by the Medical Device Amendments to the Food Drug and Cosmetic Act, many courts may choose to simply hold motions for summary judgment based upon federal preemption in abeyance until issuance of a ruling by the U.S. Supreme Court. See Riegel v. Medtronic Inc., cert. granted, 127 S.Ct. 3000, 75 USLW 3065, (U.S. Jun 25, 2007) (NO. 06-179). As a result, courts may allow litigation involving both a device manufacturer and medical provider to proceed even after the filing of a motion for summary judgment on federal preemption grounds while they await a determinative ruling on the federal preemption defense from the high court. Once the Supreme Court issues its ruling ' which device manufacturers are hopeful will resolve the circuit split in favor of the majority rule that such state tort law claims are preempted ' manufacturers are likely to resume filing such motions early after the commencement of such suits.

Physician and hospital defendants may be initially reluctant to assist a device manufacturer with presenting an effective preemption defense because of a natural desire to keep more defendants in the litigation and to avoid being the primary target of the plaintiffs. However, dismissal of all or most of the claims against the manufacturer is often beneficial to all defendants as it may cause plaintiffs to lose interest in the remainder of the case. Therefore, counsel for medical providers should be cooperative with a medical device manufacturer who is pursuing a preemption defense, even if such a strategy on the part of the manufacturer may seem to clash with the interests of the medical provider. This is particularly true where a medical provider was joined into the litigation primarily (or solely) to destroy diversity or to rebut a learned intermediary defense. The sooner that a manufacturer may get its motion for summary judgment on file and obtain decision from the court, the sooner the parties can assess the exact nature of the case that will proceed through discovery and on to trial, and the sooner a plaintiff may decide it is no longer an attractive pursuit once most claims are dismissed on summary judgment.

Early Dismissal

Manufacturers may also have strategic reasons to seek early dismissal of the physician or hospital defendant(s) from the litigation. It may seem counter-intuitive, but often a manufacturer would prefer to defend litigation as the sole defendant rather than litigation in which the plaintiff seeks damages from both manufacturer and physician or hospital. For example, if a physician or hospital was joined in a suit solely or primarily for purposes of destroying diversity in order to keep the case out of federal court, the manufacturer may seek removal to federal court despite the presence of the diversity-destroying defendant. The manufacturer would then oppose any efforts by plaintiff or the court to remand the case to state court by arguing that the inclusion of the medical malpractice claims was an attempt at fraudulent joinder. See Pacheco de Perez v. AT&T Co., 139 F.3d 1368, 1380 (11^th Cir. 1998).

In order to defeat an attempted remand by showing that a diversity-destroying defendant was fraudulently joined, the manufacturer must demonstrate either: 1) that the plaintiff cannot possibly establish a cause of action against the diversity-destroying defendant in state court on the facts pleaded in the complaint; or 2) that the plaintiff's pleading of the jurisdictional facts is plainly fraudulent. See Pacheco, 139 F.3d at 1380. Often, manufacturers meet their burden by demonstrating that the plaintiff failed to fulfill a necessary pre-suit requirement, such as submitting the case to a medical malpractice tribunal, or proving that the claims against the non-diverse malpractice defendant are barred by an affirmative defense such as statute of limitations.

In addition, the parties may argue a fraudulent joinder has occurred if the complaint fails to plead specific allegations pertaining directly to the non-diverse defendant, or fails to establish a factual connection between the non-diverse defendant and the claims alleged. See, e.g., In re Baycol Prods. Litig., No. MDL 1431(MJD), Civ. 03-4954, 2004 WL 1118642, (D. Minn. May 17, 2004); In re Baycol Prods. Litig., No. MDL 1431(MJD), 02-4835, 2003 WL 21223842, (D. Minn. May 27, 2003); In re Rezulin Prods. Liab. Litig., No. 00 Civ. 2843(LAK), 2003 WL 43356 (S.D.N.Y. Jan. 6. 2003); In re Rezulin Prods. Liab. Litig., 133 F. Supp. 2d 272, 290 (S.D.N.Y. 2001); Louis v. Wyeth-Ayerst Pharms. Inc., Civil Action No. 5:00CV102LN, 2000 U.S. Dist LEXIS 22694 (S.D. Miss. Sept. 25, 2000). While proving fraudulent joinder can often be a high burden, a complaint alleging primarily product defect claims may be quite light on facts amounting to physician or hospital malpractice beyond their involvement as the implanting physician or facility, and may focus solely or primarily upon the alleged negligence of the device manufacturer. In addition, some manufacturers may also successfully accomplish removal to federal court even in the absence of pure diversity by arguing that because the defense of federal preemption is a federal question that will predominate the case, the case should be removed to federal court. See, e.g., Grable & Sons Metal Prods. Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005).

To determine if a diversity-destroying defendant was fraudulently joined, the court will often 'pierce the pleadings' and consider facts beyond those stated in the complaint when presented as admissible evidence. See Legg v. Wyeth, 428 F.3d 1317, 1319 (11^th Cir. 2005). A physician or hospital defendant can help the manufacturer achieve dismissal by providing admissible evidence supporting the fraudulent joinder motion with specific factual support, such as an affidavit or deposition testimony. While a medical provider may be concerned that a successful fraudulent joinder motion will simply result in a separate medical malpractice action against the provider in state court, the provider will often have many more procedural alternatives to defeat such a case, due to the advent of tort reform in many states for malpractice cases, even if claims do proceed separately against the provider. In addition, the grant of a successful fraudulent joinder motion based upon a likely procedural bar or affirmative defense to plaintiff's claims against the medical provider is likely to dissuade the plaintiff's counsel from pursuing such claims in state court if they are likely to be barred. In most instances, dismissal of the medical provider on fraudulent joinder grounds will be beneficial to the litigation strategy of both defendants, and cooperation on such a motion should be considered early after commencement of the case.

Case Scheduling Considerations

When efforts to obtain early dismissal are either not possible or have been unsuccessful, the manufacturer will be likely to resist immediate commencement of discovery in favor of seeking dismissal or an expedited hearing on a motion for summary judgment on preemption grounds as discussed previously. Medical device manufacturers often successfully argue that discovery is unnecessary to decide a motion for summary judgment based upon federal preemption, because preemption is a pure question of law that does not require facts adduced through discovery in order for a court to decide. See, e.g., Cox v. Shalala, 112 F.3d 151, 153 (4^th Cir. 1997); Ultra-Precision Mfg., Ltd. v. Ford Motor Co., 411 F.3d 1369, 1376 (Fed. Cir. 2005); David P. Coldesina v. Estate of Simper, 407 F.3d 1126, 1136 (10th Cir. 2005); Horn v. Thoratec Corp., 376 F.3d 163, 166 (3^rd Cir. 2004). Thus, a manufacturer has little incentive to proceed to expensive and time-consuming factual discovery when it can file its motion for summary judgment with the hope of extricating itself early in the litigation. In contrast, a physician or hospital defendant may be understandably eager to commence aggressive discovery including depositions of the plaintiff, treating physicians, and other fact witnesses. The manufacturer may therefore be stuck in a position of relative conflict with that of the medical provider as to how quickly to proceed with discovery.

In fact, engagement in factual discovery may thwart the manufacturer's argument that no discovery need proceed before the court hears and rules upon the summary judgment motion, because the plaintiff will likely assert in response to such a motion their need to conduct detailed discovery in search of evidence to support their claims of product defect or failure to warn. Defendants should therefore consider negotiating an agreement with the plaintiff on discovery that benefits both defendants, such as a stipulation that each defendant may take separate non-duplicative depositions of the plaintiff and other fact witnesses. While plaintiffs may be reluctant to agree to such an arrangement, and many malpractice defendants prefer to depose the plaintiff and all treating physicians as soon as possible in order to put pressure upon the plaintiff, manufacturers will attempt to persuade the parties to agree to some sort of mutually beneficial arrangement in order to avoid the necessity of seeking a stay of discovery from the court.

If efforts at negotiation prove unsuccessful, manufacturers may seek court intervention to set out a staggered discovery schedule in a pretrial scheduling order providing for either separate depositions of the plaintiff or staying certain discovery prior to submission of and decision on a motion for summary judgment. Where such agreement can be reached through negotiation or ordered by the court, the parties are likely to avoid the conflicts that will arise if a malpractice defendant charges headlong into discovery and forces the manufacturer to engage in unnecessary and premature factual discovery when it may be dismissed from the litigation anyhow. While seemingly minor, disputes over scheduling should be avoided whenever possible through flexibility and negotiation, in order to avoid discord between the defendants and resort to court intervention and exposure of that discord to the plaintiff.

Learned Intermediary Doctrine

One of the primary sources of trouble spots between manufacturer and physician is likely to arise in cases in which the plaintiff alleges either failure to warn of particular risks associated with a device or failure to obtain adequate informed consent prior to prescription or implantation. The manufacturer is likely to rely on the learned intermediary doctrine as a defense to both claims. Under established doctrine recognized in most courts, a manufacturer is generally required only to educate the physician about the risks of implanting or utilizing the device, and then the duty of the manufacturer to fully and adequately warn of all known risks is fulfilled. See, e.g., Larkin v. Pfizer Inc., 153 S.W.3d 758 (Ky. 2004) (outlining the history of recognition, adoption and codification of the learned intermediary doctrine by a majority of state courts and federal courts.); see also Restatement (Third) of Torts: Prod. Liab. ' 6 (1998) (applying learned intermediary doctrine to prescription medical devices). The learned intermediary defense is based on the physician's 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or used on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co., 256 F.3d 1013, 1018 (10^th Cir. 2001). Once a manufacturer has adequately warned the physician of the risks, the physician's duty to adequately inform the patient takes over and the manufacturer owes no direct duty to warn to the patient. See, e.g., McCombs v. Synthes, (U.S.A.), 587 S.E.2d 594 (Ga. 2003).

As a result, plaintiffs may assume an 'either/or strategy' for any failure-to-warn claims, by arguing that either the manufacturer failed to provide adequate warning information to the physician, or the physician failed to adequately pass that information on to the plaintiff. Either way, the plaintiff will argue, one of the defendants is liable for plaintiff's claimed lack of sufficient information about the risks of implantation or use of a device.

While such a posture seems ripe for conflict between manufacturers and physicians, the defendants will be much better served by arguing together that the warning provided by the manufacturer and approved by the FDA was adequate, and that it was delivered accurately to the physician who then passed it on to the patient. The critical question concerning failure-to-warn claims is whether the additional or alternative warning advocated by the plaintiff, if included in the product labeling, would have caused the physician to make a different choice of device or to provide different warnings to the patient. See, e.g., Guzman v. Synthes, 20 S.W.3d 717, 721 (Tx. App. 1999) (where a physician testified he would still prescribe the medical device even with additional alternative warnings proposed by plaintiff, plaintiff cannot meet burden of proof as to causation on failure to warn claim). Absent such a showing, the patient will not be able to meet his or her burden of proof on causation on asserted failure-to-warn claims, even if he or she presents expert testimony advocating the alternative warning. See Id. Thus, defendants are much more likely to prevail on failure to warn claims if they work together to demonstrate that the alternative warning proposed by the plaintiff would not have changed the decisions made by physician or patient, thereby providing a causation defense. In fact, a physician defendant can assist all defendants in obtaining such a defense on a failure-to-warn claim through deposition testimony or an affidavit stating that he or she would not have changed his or her behavior, including selecting a different device or providing different warnings to the plaintiff, even if alternative 'stronger' warning language had been provided by the manufacturer.

In addition, in this modern age in which some medical device manufacturers advertise their brand name generally on television and in print, and in which consumers have the ability to inform themselves more than ever before about complex medical devices through internet research on manufacturer websites and independent Web sites, plaintiffs may seek to further avoid the applicability of the learned intermediary doctrine by asserting that a manufacturer engaged in direct-to-consumer marketing of a particular brand or device. See, e.g., Hill v. Searle Laboratories, 884 F.2d 1064 (8^th Cir. 1999). While such arguments have not proven persuasive to most state or federal courts to date, plaintiffs continue to attempt to utilize arguments that a manufacturer marketed directly to chip away at the learned intermediary doctrine's bar to failure to warn claims against a manufacturer. The physician defendant may be tempted to support such a tactic by suggesting that the patient arrived at his or her office already requesting a particular device model or manufacturer, or that such patient had independently reviewed information on the internet about his or her device beyond the information provided by the manufacturer to the physician, or the physician to the patient. Such a temptation should be avoided, however, because an asserted preference for a particular device by a patient lacking medical training does not absolve the physician of his or her responsibility to provide adequate and fully informed warnings about all material risks prior to prescription or implantation of a device. Traditionally, the physician bears sole responsibility for determining which medical device to prescribe or utilize on a particular patient. See, e.g., West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991). An argument that a physician adhered to his client's preference of device because of the influence of advertisements will give the appearance that the physician abdicated this responsibility to a patient inappropriately, and is likely to backfire on the physician.

Rather than questioning the adequacy of the information provided in product literature or warning information included with a particular device or pointing to marketing that may have influenced the patient's preference of device, a physician can best assist the defenses of all defendants by standing firm on his or her choice of which device to prescribe or implant based on the information known and provided at the time they made the decision, and stating unequivocally that his or her choice would not change even if additional warnings had been provided at the time. In the event the physician seeks to criticize the warning provided by the manufacturer in litigation in which both are defendants, the physician may end up demonstrating his or her malpractice at the same time as he or she supports a fraud claim against the manufacturer. That would only injure the positions of all defendants.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder with the law firm of Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by the National Law Journal as one of 'The 50 Most Influential Women Lawyers in America' and 'Top 40 Under 40,' which highlights the most successful 40 litigators under the age of 40 in the country. Sara K. Thompson, an associate with the firm, focuses her practice on medical device products liability and medical malpractice litigation.

Medical device products liability litigation and medical malpractice litigation have intersected for as long as physicians have been prescribing and implanting medical devices, but that overlap continues to increase and become even more intricate as medical devices become more sophisticated and more widely utilized by physicians and the public, and as plaintiffs increasingly seek to keep their cases in state court by including local diversity-destroying defendants in suits.

In order to avoid unfavorable precedent on federal preemption of state law claims based upon FDA-approved Class III medical devices, and to nullify the impact of the learned intermediary defense by having both manufacturer and intermediary present in the case, plaintiffs increasingly seek to join both medical provider and manufacturer in one suit. Such suits will contain both product liability claims against the medical device manufacturer and medical malpractice claims against diversity-destroying physicians and hospitals. As a result, physicians and device manufacturers, more frequently than ever, are finding themselves as uncomfortable and unwilling bedfellows in litigation involving a prescription medical device. Because the interests of medical providers and manufacturers may often seem at odds, certain strategic considerations should govern both parties' planning for the litigation in order to avoid common pitfalls. Many of these same situations will also arise in cases in which both pharmaceutical manufacturers and medical providers are defendants.

Another consideration is that, in cases involving both a medical provider and a device manufacturer, plaintiffs will often seek to create and exploit some natural friction between the interests of multiple co-defendants to their own advantage. Savvy defense counsel for physicians or hospitals would therefore be well-advised to watch for certain likely roadblocks that may arise or be placed in their way by plaintiffs. All defendants benefit when they can 'hold hands and play nice' together to defeat the plaintiffs' claims and present the strongest possible defense at trial.

We outline herein some basic trouble spots that may arise during the course of litigation in which both medical providers and device manufacturers are defendants, as well as best practices in order to avoid allowing such issues to negatively impact the defendant parties' interests in the litigation.

Federal Preemption

Because preemption is a prominent issue in cases involving most major prescription medical devices, counsel for medical providers should first familiarize themselves with this currently hot legal topic.

The FDA's Pre-market review and approval of Class III medical devices under the Medical Device Amendments to the Food, Drug and Cosmetic Act has generally been held to preempt most state tort law claims pertaining to claimed defects in such devices; all but one federal circuit Court of Appeals to decide the issue has ruled in favor of federal preemption. See, e.g., Riegel v. Medtronic Inc. , 451 F.3d 104 (2d Cir. 2006), cert. granted , 127 S.Ct. 3000, 75 USLW 3065, (U.S. Jun 25, 2007) (NO. 06-179); Gomez v. St. Jude Medical Diag Div. Inc., 442 F.3d 919 (5th Cir. 2006); McMullen v. Medtronic Inc. , 421 F.3d 482 (7th Cir. 2005); cert. denied , 126 S.Ct. 1464 (2006); Cupek v. Medtronic Inc. , 405 F.3d 421 (6 th Cir. 2005), cert. denied sub nom. Knisley v. Medtronic Inc. , 126 S. Ct. 420 (2005); Horn v. Thoratec Corp. , 376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica Inc ., 273 F.3d 785 (8 th Cir. 2001)( en banc ), cert. denied , 535 U.S. 1056 (2002). But see Goodlin v. Medtronic Inc ., 167 F.3d 1367 (11 th Cir. 1999). As a result, in any case outside the Eleventh Circuit in which the plaintiff brings state law tort claims asserting either the existence of a defect or a failure to warn of particular risks, the manufacturer is likely to assert federal preemption of state tort law claims as a defense in a motion for summary judgment.

Summary judgment motions based on federal preemption generally are successful in most cases, thanks both to the strong precedent on the issue to date and the relatively high factual hurdle a plaintiff must leap over in order to convince a court to deny preemption. However, the occasional court, even outside the Eleventh Circuit, has been willing to depart from the majority and allow such claims to survive summary judgment. See, e.g., In re Medtronic Inc. Implantable Defibrillators Products Liability Litigation, 465 F. Supp. 2d 886 (D. Minn. 2006); In re St. Jude Medical, Inc . Silzone Heart Valves Products Liability Litigation, 2004 WL 45503 (D. Minn. 2004); Woods v. Gliatech , 218 F. Supp. 2d 802 (D. W.Va. 2002). As a result, while preemption appears to be a strong defense that is often successful, it is not yet an absolute bar of state tort law claims against a medical device manufacturer for product defect or failure to warn.

In fact, because the United States Supreme Court recently granted certiorari for the October 2007 term to decide the circuit split on whether such claims are preempted by the Medical Device Amendments to the Food Drug and Cosmetic Act, many courts may choose to simply hold motions for summary judgment based upon federal preemption in abeyance until issuance of a ruling by the U.S. Supreme Court. See Riegel v. Medtronic Inc. , cert. granted , 127 S.Ct. 3000, 75 USLW 3065, (U.S. Jun 25, 2007) (NO. 06-179). As a result, courts may allow litigation involving both a device manufacturer and medical provider to proceed even after the filing of a motion for summary judgment on federal preemption grounds while they await a determinative ruling on the federal preemption defense from the high court. Once the Supreme Court issues its ruling ' which device manufacturers are hopeful will resolve the circuit split in favor of the majority rule that such state tort law claims are preempted ' manufacturers are likely to resume filing such motions early after the commencement of such suits.

Physician and hospital defendants may be initially reluctant to assist a device manufacturer with presenting an effective preemption defense because of a natural desire to keep more defendants in the litigation and to avoid being the primary target of the plaintiffs. However, dismissal of all or most of the claims against the manufacturer is often beneficial to all defendants as it may cause plaintiffs to lose interest in the remainder of the case. Therefore, counsel for medical providers should be cooperative with a medical device manufacturer who is pursuing a preemption defense, even if such a strategy on the part of the manufacturer may seem to clash with the interests of the medical provider. This is particularly true where a medical provider was joined into the litigation primarily (or solely) to destroy diversity or to rebut a learned intermediary defense. The sooner that a manufacturer may get its motion for summary judgment on file and obtain decision from the court, the sooner the parties can assess the exact nature of the case that will proceed through discovery and on to trial, and the sooner a plaintiff may decide it is no longer an attractive pursuit once most claims are dismissed on summary judgment.

Early Dismissal

Manufacturers may also have strategic reasons to seek early dismissal of the physician or hospital defendant(s) from the litigation. It may seem counter-intuitive, but often a manufacturer would prefer to defend litigation as the sole defendant rather than litigation in which the plaintiff seeks damages from both manufacturer and physician or hospital. For example, if a physician or hospital was joined in a suit solely or primarily for purposes of destroying diversity in order to keep the case out of federal court, the manufacturer may seek removal to federal court despite the presence of the diversity-destroying defendant. The manufacturer would then oppose any efforts by plaintiff or the court to remand the case to state court by arguing that the inclusion of the medical malpractice claims was an attempt at fraudulent joinder. See Pacheco de Perez v. AT&T Co., 139 F.3d 1368, 1380 (11^th Cir. 1998).

In order to defeat an attempted remand by showing that a diversity-destroying defendant was fraudulently joined, the manufacturer must demonstrate either: 1) that the plaintiff cannot possibly establish a cause of action against the diversity-destroying defendant in state court on the facts pleaded in the complaint; or 2) that the plaintiff's pleading of the jurisdictional facts is plainly fraudulent. See Pacheco, 139 F.3d at 1380. Often, manufacturers meet their burden by demonstrating that the plaintiff failed to fulfill a necessary pre-suit requirement, such as submitting the case to a medical malpractice tribunal, or proving that the claims against the non-diverse malpractice defendant are barred by an affirmative defense such as statute of limitations.

In addition, the parties may argue a fraudulent joinder has occurred if the complaint fails to plead specific allegations pertaining directly to the non-diverse defendant, or fails to establish a factual connection between the non-diverse defendant and the claims alleged. See, e.g., In re Baycol Prods. Litig., No. MDL 1431(MJD), Civ. 03-4954, 2004 WL 1118642, (D. Minn. May 17, 2004); In re Baycol Prods. Litig., No. MDL 1431(MJD), 02-4835, 2003 WL 21223842, (D. Minn. May 27, 2003); In re Rezulin Prods. Liab. Litig., No. 00 Civ. 2843(LAK), 2003 WL 43356 (S.D.N.Y. Jan. 6. 2003); In re Rezulin Prods. Liab. Litig., 133 F. Supp. 2d 272, 290 (S.D.N.Y. 2001); Louis v. Wyeth-Ayerst Pharms. Inc., Civil Action No. 5:00CV102LN, 2000 U.S. Dist LEXIS 22694 (S.D. Miss. Sept. 25, 2000). While proving fraudulent joinder can often be a high burden, a complaint alleging primarily product defect claims may be quite light on facts amounting to physician or hospital malpractice beyond their involvement as the implanting physician or facility, and may focus solely or primarily upon the alleged negligence of the device manufacturer. In addition, some manufacturers may also successfully accomplish removal to federal court even in the absence of pure diversity by arguing that because the defense of federal preemption is a federal question that will predominate the case, the case should be removed to federal court. See, e.g., Grable & Sons Metal Prods. Inc. v. Darue Eng'g & Mfg. , 545 U.S. 308 (2005).

To determine if a diversity-destroying defendant was fraudulently joined, the court will often 'pierce the pleadings' and consider facts beyond those stated in the complaint when presented as admissible evidence. See Legg v. Wyeth , 428 F.3d 1317, 1319 (11 th Cir. 2005). A physician or hospital defendant can help the manufacturer achieve dismissal by providing admissible evidence supporting the fraudulent joinder motion with specific factual support, such as an affidavit or deposition testimony. While a medical provider may be concerned that a successful fraudulent joinder motion will simply result in a separate medical malpractice action against the provider in state court, the provider will often have many more procedural alternatives to defeat such a case, due to the advent of tort reform in many states for malpractice cases, even if claims do proceed separately against the provider. In addition, the grant of a successful fraudulent joinder motion based upon a likely procedural bar or affirmative defense to plaintiff's claims against the medical provider is likely to dissuade the plaintiff's counsel from pursuing such claims in state court if they are likely to be barred. In most instances, dismissal of the medical provider on fraudulent joinder grounds will be beneficial to the litigation strategy of both defendants, and cooperation on such a motion should be considered early after commencement of the case.

Case Scheduling Considerations

When efforts to obtain early dismissal are either not possible or have been unsuccessful, the manufacturer will be likely to resist immediate commencement of discovery in favor of seeking dismissal or an expedited hearing on a motion for summary judgment on preemption grounds as discussed previously. Medical device manufacturers often successfully argue that discovery is unnecessary to decide a motion for summary judgment based upon federal preemption, because preemption is a pure question of law that does not require facts adduced through discovery in order for a court to decide. See, e.g., Cox v. Shalala , 112 F.3d 151, 153 (4 th Cir. 1997); Ultra-Precision Mfg., Ltd. v. Ford Motor Co., 411 F.3d 1369, 1376 (Fed. Cir. 2005); David P. Coldesina v. Estate of Simper , 407 F.3d 1126, 1136 (10th Cir. 2005); Horn v. Thoratec Corp. , 376 F.3d 163, 166 (3 rd Cir. 2004). Thus, a manufacturer has little incentive to proceed to expensive and time-consuming factual discovery when it can file its motion for summary judgment with the hope of extricating itself early in the litigation. In contrast, a physician or hospital defendant may be understandably eager to commence aggressive discovery including depositions of the plaintiff, treating physicians, and other fact witnesses. The manufacturer may therefore be stuck in a position of relative conflict with that of the medical provider as to how quickly to proceed with discovery.

In fact, engagement in factual discovery may thwart the manufacturer's argument that no discovery need proceed before the court hears and rules upon the summary judgment motion, because the plaintiff will likely assert in response to such a motion their need to conduct detailed discovery in search of evidence to support their claims of product defect or failure to warn. Defendants should therefore consider negotiating an agreement with the plaintiff on discovery that benefits both defendants, such as a stipulation that each defendant may take separate non-duplicative depositions of the plaintiff and other fact witnesses. While plaintiffs may be reluctant to agree to such an arrangement, and many malpractice defendants prefer to depose the plaintiff and all treating physicians as soon as possible in order to put pressure upon the plaintiff, manufacturers will attempt to persuade the parties to agree to some sort of mutually beneficial arrangement in order to avoid the necessity of seeking a stay of discovery from the court.

If efforts at negotiation prove unsuccessful, manufacturers may seek court intervention to set out a staggered discovery schedule in a pretrial scheduling order providing for either separate depositions of the plaintiff or staying certain discovery prior to submission of and decision on a motion for summary judgment. Where such agreement can be reached through negotiation or ordered by the court, the parties are likely to avoid the conflicts that will arise if a malpractice defendant charges headlong into discovery and forces the manufacturer to engage in unnecessary and premature factual discovery when it may be dismissed from the litigation anyhow. While seemingly minor, disputes over scheduling should be avoided whenever possible through flexibility and negotiation, in order to avoid discord between the defendants and resort to court intervention and exposure of that discord to the plaintiff.

Learned Intermediary Doctrine

One of the primary sources of trouble spots between manufacturer and physician is likely to arise in cases in which the plaintiff alleges either failure to warn of particular risks associated with a device or failure to obtain adequate informed consent prior to prescription or implantation. The manufacturer is likely to rely on the learned intermediary doctrine as a defense to both claims. Under established doctrine recognized in most courts, a manufacturer is generally required only to educate the physician about the risks of implanting or utilizing the device, and then the duty of the manufacturer to fully and adequately warn of all known risks is fulfilled. See, e.g., Larkin v. Pfizer Inc. , 153 S.W.3d 758 (Ky. 2004) (outlining the history of recognition, adoption and codification of the learned intermediary doctrine by a majority of state courts and federal courts.); see also Restatement (Third) of Torts: Prod. Liab. ' 6 (1998) (applying learned intermediary doctrine to prescription medical devices). The learned intermediary defense is based on the physician's 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or used on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co. , 256 F.3d 1013, 1018 (10 th Cir. 2001). Once a manufacturer has adequately warned the physician of the risks, the physician's duty to adequately inform the patient takes over and the manufacturer owes no direct duty to warn to the patient. See, e.g., McCombs v. Synthes, (U.S.A.), 587 S.E.2d 594 (Ga. 2003).

As a result, plaintiffs may assume an 'either/or strategy' for any failure-to-warn claims, by arguing that either the manufacturer failed to provide adequate warning information to the physician, or the physician failed to adequately pass that information on to the plaintiff. Either way, the plaintiff will argue, one of the defendants is liable for plaintiff's claimed lack of sufficient information about the risks of implantation or use of a device.

While such a posture seems ripe for conflict between manufacturers and physicians, the defendants will be much better served by arguing together that the warning provided by the manufacturer and approved by the FDA was adequate, and that it was delivered accurately to the physician who then passed it on to the patient. The critical question concerning failure-to-warn claims is whether the additional or alternative warning advocated by the plaintiff, if included in the product labeling, would have caused the physician to make a different choice of device or to provide different warnings to the patient. See, e.g., Guzman v. Synthes , 20 S.W.3d 717, 721 (Tx. App. 1999) (where a physician testified he would still prescribe the medical device even with additional alternative warnings proposed by plaintiff, plaintiff cannot meet burden of proof as to causation on failure to warn claim). Absent such a showing, the patient will not be able to meet his or her burden of proof on causation on asserted failure-to-warn claims, even if he or she presents expert testimony advocating the alternative warning. See Id. Thus, defendants are much more likely to prevail on failure to warn claims if they work together to demonstrate that the alternative warning proposed by the plaintiff would not have changed the decisions made by physician or patient, thereby providing a causation defense. In fact, a physician defendant can assist all defendants in obtaining such a defense on a failure-to-warn claim through deposition testimony or an affidavit stating that he or she would not have changed his or her behavior, including selecting a different device or providing different warnings to the plaintiff, even if alternative 'stronger' warning language had been provided by the manufacturer.

In addition, in this modern age in which some medical device manufacturers advertise their brand name generally on television and in print, and in which consumers have the ability to inform themselves more than ever before about complex medical devices through internet research on manufacturer websites and independent Web sites, plaintiffs may seek to further avoid the applicability of the learned intermediary doctrine by asserting that a manufacturer engaged in direct-to-consumer marketing of a particular brand or device. See, e.g., Hill v. Searle Laboratories , 884 F.2d 1064 (8 th Cir. 1999). While such arguments have not proven persuasive to most state or federal courts to date, plaintiffs continue to attempt to utilize arguments that a manufacturer marketed directly to chip away at the learned intermediary doctrine's bar to failure to warn claims against a manufacturer. The physician defendant may be tempted to support such a tactic by suggesting that the patient arrived at his or her office already requesting a particular device model or manufacturer, or that such patient had independently reviewed information on the internet about his or her device beyond the information provided by the manufacturer to the physician, or the physician to the patient. Such a temptation should be avoided, however, because an asserted preference for a particular device by a patient lacking medical training does not absolve the physician of his or her responsibility to provide adequate and fully informed warnings about all material risks prior to prescription or implantation of a device. Traditionally, the physician bears sole responsibility for determining which medical device to prescribe or utilize on a particular patient. See, e.g., West v. Searle & Co. , 806 S.W.2d 608, 613 (Ark. 1991). An argument that a physician adhered to his client's preference of device because of the influence of advertisements will give the appearance that the physician abdicated this responsibility to a patient inappropriately, and is likely to backfire on the physician.

Rather than questioning the adequacy of the information provided in product literature or warning information included with a particular device or pointing to marketing that may have influenced the patient's preference of device, a physician can best assist the defenses of all defendants by standing firm on his or her choice of which device to prescribe or implant based on the information known and provided at the time they made the decision, and stating unequivocally that his or her choice would not change even if additional warnings had been provided at the time. In the event the physician seeks to criticize the warning provided by the manufacturer in litigation in which both are defendants, the physician may end up demonstrating his or her malpractice at the same time as he or she supports a fraud claim against the manufacturer. That would only injure the positions of all defendants.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder with the law firm of Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by the National Law Journal as one of 'The 50 Most Influential Women Lawyers in America' and 'Top 40 Under 40,' which highlights the most successful 40 litigators under the age of 40 in the country. Sara K. Thompson, an associate with the firm, focuses her practice on medical device products liability and medical malpractice litigation.