The Pelvic Mesh Battlegrounds are Set – Fraud and Punitive Damages
During the last week in February, 2013, a nine-person, Atlantic County, New Jersey jury delivered a $3.35 million compensatory damages award and a $7.76 million punitive damages award in the first case (Gross v. Gynecare, et al.) to go to trial in the multi-county, mass tort litigation known as In re Pelvic Mesh/Gynecare. The jury found that defendants, Johnson & Johnson and its subsidiary Ethicon, Inc., failed to adequately warn plaintiff, Linda Gross’ surgeon of the risks associated with its Prolift pelvic mesh product and fraudulently misrepresented those risks to Gross causing her damages. Gross, a 47-year-old South Dakota resident, had the Prolift surgically installed in July 2006 to address pelvic organ prolapse, a painful and limiting condition whereby the organs within the pelvic area drop from their normal position and push against the vaginal walls. The Prolift system consisted of a polypropylene mesh which is inserted into the vaginal wall. Gross claimed that she had an immunologic reaction to the mesh which caused profound irritation, inflammation and swelling as the body rejected the implant. Gross testified that she underwent 18 surgeries to repair the condition, is treated with a narcotics pain pump for constant pain, is unable to work, have sexual relations or sit for more than 20 minutes at a time.
The jury based its verdict upon Ethicon’s failure to warn Gross’ surgeon of the risks associated with the Prolift (by a vote of 7 to 2) and fraudulent misrepresentation of the those risks to Gross (also by a vote of 7 to 2). Notably, the jury unanimously found no design defect in the Prolift pelvic mesh product and that Ethicon did not fraudulently misrepresent the risks to the implanting surgeon (by a vote of 7 to 2). Finally, the jury found Ethicon’s wrongdoing willful and wanton and assessed punitive damages by a vote of 7 to 2. Recently filed post-trial motions are pending.
Two harbingers emerged from this bellwether case that pelvic mesh manufacturers and their insurers should be wary of as the thousands of nationwide pelvic mesh cases proceed toward trial in state and federal courts.
Fraud Claims Will Be Front and Center in Future Pelvic Mesh Litigation
Gross’ attorney revealed the plaintiffs’ strategy going forward after the verdict when he stated that it’s “a big deal to actually have fraud determined in a product liability case.” The plaintiffs’ bar prosecuting mesh cases would like nothing more than to have fraud claims tried as the primary focus in most cases. First, it removes the traditional focus of the jury from the design of the product to the acts or omissions of, in many cases, the corporate manufacturer. The entire Gross verdict rests upon Ethicon’s failure to disclose risks to Gross, her surgeon and the United States Food and Drug Administration (FDA). The Gross jury unanimously found no defect in the Prolift, but had determined an issue existed regarding the manner of bringing the product to market. Second, fraud claims often open the door for sensational and otherwise irrelevant evidence to get before the jury. Third, fraud claims and their intentional nature are much more likely to serve as a springboard for punitive damages as opposed to a defective product verdict.
The question then becomes how to best keep fraud claims from a jury. The most prevalent and perhaps strongest argument, a defense known as the learned intermediary doctrine (LID), is being advocated in Ethicon’s post-trial motions and should be considered in almost every pelvic mesh case where fraud-based claims are alleged.
The LID alters a product manufacturer’s traditional duty to warn of a product’s risks by holding that the duty runs to the physician and not the patient/consumer when the product at issue is a prescription drug, device or medical equipment. The LID requires the manufacturer to adequately warn the physician prescribing the product of the product’s risks and eliminates any duty to directly warn the patient/consumer. The rationale for the doctrine is that the prescribing physician is in the best position to consider the risks and benefits of a medical product and assess whether that product is the right fit for that particular patient. In that respect, the medical professional serves as the “learned intermediary” between the manufacturer and the patient/consumer.
The LID is a vigorous and widely applied defense throughout state and federal courts. It has been adopted in 35 states that have considered its application and fourteen state and federal courts have applied it in prescribed medical device cases. Only a distinct minority of jurisdictions (New Jersey, Massachusetts, West Virginia and the U.S. Court of Appeals, Tenth Circuit (applying Oklahoma law)) have held that a manufacturer maintains a duty to warn a consumer of a prescribed product. New Jersey, however, recognizes the LID but applies an exception in cases where the manufacturer has marketed a prescription drug directly to consumers.
The limits of the LID defense are being tested in Gross and will likely be similarly tested in other courts handling pelvic mesh cases in the future. Although the Gross court held that the LID applied to bar plaintiff’s claim for failure to warn her, it also held that the LID did not apply to plaintiff’s claims that defendants fraudulently misrepresented the Prolift to her.  In other words, Ethicon had no duty to warn Gross directly regarding the Prolift but did have a duty to refrain from fraudulently misrepresenting the risks associated with the Prolift to Gross. The jury found that Ethicon breached this latter duty.
Ethicon argues in post-trial motions that the Gross court erred when it permitted the jury to consider whether Ethicon fraudulently misrepresented the risks of the Prolift to Gross because the LID precludes such an analysis. Ethicon points to several Texas state cases and multiple other federal court cases which have held that the LID bars all claims, including fraudulent misrepresentation, where the “crux of the suit” is based upon a manufacturer’s failure to adequately warn the consumer of the product’s risks. Ethicon argues that since Gross claims Ethicon fraudulently misrepresented information about risks associated with the Prolift, that claim is nothing more than a “repurposed” failure to warn claim and such is barred by the LID. Ethicon also argues against any exception being applied to the LID for direct marketing of the Prolift to Gross by pointing out that Gross’s treating physician directed her to Ethicon’s patient brochure on its website during the evaluation process.
Ultimately, the question to be answered, likely by New Jersey’s appellate court or its Supreme Court, is whether the Gross court correctly predicted that South Dakota courts would adopt the LID but limit its scope to failure to warn claims and not fraud-based claims. There is solid support amongst the Texas state and federal courts and U.S. District Courts sitting in at least six other states, including South Dakota, that fraudulent misrepresentation to consumer claims are barred by the LID. The New Jersey courts’ rulings on this issue will likely have significant impact upon how future mesh cases throughout the country are evaluated, litigated, settled or tried. Mesh plaintiffs have prevailed in this first battle; it will be up to manufacturers and their insurers to make sure they don’t win the war.
By no means, however, should manufacturers and insurers be sitting idle waiting for the New Jersey rulings. Several avenues can be explored in order to combat this push toward fraud. First, determine what state law will apply to liability issues and then determine whether the LID applies. If the LID has not been adopted in that state, develop an argument early on to adopt it since it’s the overwhelming majority rule throughout the country. If the LID applies, then determine whether the governing state has addressed whether fraud-based claims have been barred by the LID. If it has not, then develop facts that plaintiff’s fraud claims are based upon allegations that the manufacturer inadequately warned the plaintiff of the risks associated with the mesh in order to make the argument that these fraud claims are nothing more than failure to warn claims which are barred by the LID. In order to avoid application of any direct-to-consumer marketing exception to the LID, develop facts which show the plaintiff didn’t come to the product information on her own but rather at her treating physician’s direction and during her consultation/evaluation of whether mesh was right for her. Of course, the physician’s role as a potential defendant must be considered in regards to potential bias of such a witness’ testimony on causation. Addressing the fraud-based claims early on will facilitate substantive evaluation and strategic planning which will likely reap benefits down the road.
The Scope of Punitive Damage Immunity Will Be Contested to the End
Not surprisingly, Ethicon is challenging the court’s decision to allow punitive damages to go before a jury. The $7.76 million punitive verdict constitutes approximately 70% of the overall award to the plaintiffs. More importantly, the Gross court applied New Jersey law with regard to punitive damages and with more than 3,000 total pelvic mesh cases currently venued in New Jersey, the possibility of punitive damages being assessed in those cases has tremendous financial implications for the defendants.
The New Jersey Products Liability Act (PLA) precludes punitive damages in cases where the medical device at issue:
- “was subject to premarket approval or licensure by the [FDA] and was approved or licensed; or
- is generally recognized as safe and effective pursuant to conditions established by the [FDA]…”
The Gross court found this section of the PLA to be inapplicable because “there was no approval and there was no clearance” and “no review by the FDA at all” at the time the Prolift was implanted in Gross. Consequently, the trial judge allowed the jury to consider punitive damages.
Ethicon argues that the Gross court read this section of the PLA too narrowly and punitive damages should not have been considered. Ethicon contends that because Prolift was marketed after going through an FDA guided process, it was effectively “approved or licensed” by the FDA or was “generally recognized as safe and effective” under FDA conditions and applicable regulations. The question of whether Gross keeps her punitive damages will likely hinge on court interpretation of the scope of this section of the PLA.
The FDA identifies Prolift as a Class II device. As such, it need not go through the FDA’s Premarket Approval process. The FDA views Premarket Approval (PMA) in essence as “a private license granted to the applicant for marketing a particular medical device.” PMA is regarded as a “scientific and regulatory review to evaluate the safety and effectiveness . . .” The FDA has established three regulatory classes for medical devices (Class I, Class II, and Class III) based upon the degree of control necessary to assure that the devices are safe and effective. The most regulated devices are in Class III and PMA is only required for Class III devices. A less onerous process, known as 510(k) approval, is required for any other device (i.e., Class II) intended for human use for which PMA is not required. The Prolift was subject to the 510(k) process.
A medical device manufacturer must obtain 510(k) approval from the FDA to market a new device or where a manufacturer wants to modify an existing product in a significant manner. In the latter circumstance, for a manufacturer to obtain 510(k) approval, it must demonstrate that the safety and effectiveness of the modified device is at least as much as that of a substantially equivalent product that is already on the market. If the manufacturer determines that the modification does not affect safety or efficacy, further 510(k) approval may not be necessary.
Ethicon argues that because a predecessor to Prolift, a product called Gynemesh PS had gone through the 510(k) process to gain FDA clearance to be marketed, further approval of the Prolift from the FDA was not necessary. Since Ethicon determined before it marketed Prolift that the modifications made in changing the product from Gynemesh PS to Prolift did not significantly affect safety or effectiveness, further 510(k) approval was not required. In other words, because Gynemesh PS had received the 510(k) approval from the FDA and because Prolift did not involve any substantial modifications in safety or effectiveness from Gynemesh PS, the 510(k) approval given to Gynemesh PS should also apply to Prolift.
Ethicon argues that its determination that any modifications to the Prolift from Gynemesh PS did not “significantly affect safety and effectiveness” was tantamount to obtaining “premarket approval or licensure” and being “generally recognized as safe and effective” pursuant to FDA conditions, both of which alone trigger punitive damages immunity under the PLA. Ethicon also secondarily argues that it should have been immune from punitive damages because the FDA did grant 510(k) approval to Prolift, albeit after it was implanted into Gross.
The Gross plaintiffs argue for a strict interpretation of the medical products punitive damages section of the PLA. They argue that the phrase “premarket approval” within the PLA only refers to the Premarket Approval required of Class III devices and therefore is inapplicable to the Class II Prolift device. Additionally, plaintiffs argue that 510(k) approval does not equate to a medical device being “generally recognized as safe and effective” by the FDA. Instead, they contend that “generally recognized as safe and effective” is a term of art utilized by the FDA for prescription drugs and is not meant to address medical devices. In sum, the Gross plaintiffs argue that the punitive damages immunity portion of the PLA is wholly inapplicable to the facts of this case and their punitive damages award should stand. The FDA has stated that “[a] 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.” Thus, because the FDA clearly states that 510(k) approval recognizes the general safety and efficacy of a device, there appears to be a strong argument for the defense that 510(k) approval should provide a medical device manufacturer immunity from punitive damages under the PLA. Furthermore, there is no language in the section of the PLA on punitive damages that suggests “generally recognized as safe and effective” should be limited to only to pharmaceutical drugs. Manufacturers should be emphasizing that if there had been no changes in the pelvic mesh device between the time it went to market and the time of 510(k) approval, it must be “generally recognized as safe and effective.”
Resolution of the scope of immunity from punitive damages under the PLA for medical device manufacturers will be critical for all parties to properly evaluate trial/settlement strategy going forward for the remainder of the pelvic mesh litigation. Given the potentially enormous financial impact of this issue to the medical device manufacturers and their insurers we can expect all judicial remedies will be exhausted.
About the authors: Mr. Devine, Chairman of the Litigation Department and the Catastrophic/Excess Liability Practice Group, Mr. Horner, a partner in the Product Liability Practice Group, and Mr. Morgan, a senior associate in the Product Liability Practice Group, all regularly represent product manufacturers in multiple jurisdictions, including New Jersey, and also counsel manufacturers’ excess/umbrella insurers in regard to such matters.
 Jointly referred to as Ethicon herein.
 As of April 6, 2013, the multi-county New Jersey pelvic mesh litigation, all venued in Atlantic County, consists of 468 cases against C.R. Bard, Inc., a manufacturer domiciled in Murray Hill, N.J., and 2,537 cases against Johnson & Johnson/Ethicon/Gynecare. Multi-district mesh litigation is also currently in the United States District Court for the Southern District of West Virginia against Ethicon, Boston Scientific, American Medical Systems and Coloplast Corp. The first bellwether case amongst those is scheduled to begin trial in June 2013 against C.R. Bard. Numerous non-mass tort pelvic mesh cases are pending against many other manufacturers in state courts throughout the country. The first of these cases to go to verdict was in a Northern California state court and resulted in a $5.5 million award to the plaintiff.
 The Restatement (Third) of Torts, Products Liability, also adopts the LID at §6.
 Perez v. Wyeth Labs. Inc., 161 N.J. 1 (1999).
 Prior to trial the parties stipulated that liability issues would be governed by South Dakota law and punitive damages would be governed by New Jersey law, the home state of the defendants.
 The Court declined to apply the LID because the plaintiff’s claim for fraudulent misrepresentation was distinct from the failure to warn claim due to the alleged deliberate deceit of the defendants. It is interesting to note that the trial judge who presided over Gross in Sager v. Hoffman-La Roche, Inc., a case involving the drug Accutane, previously declined to apply the LID under Florida law. The New Jersey Appellate Division reversed that decision based upon Florida case law that held where the treating physician admits that the drug would have been prescribed even if the appropriate warnings were included, proximate cause cannot be established. See Sager v. Hoffman-La Roche, Inc., 2012 WL 3166630 (App.Div.2012).
 See Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. Sup. Ct. 2012) and Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 960652 (U.S. Dist. Ct. S.D. Tex 2013) and cases cited therein.
 Beale v. Biomet, Inc., 492 F.Supp.2d 1360 (S.D. Fla. 2007); Lee v. Mylan, Inc., 806 F.Supp.2d 1320 (M.D. Ga. 2011); Doe v. Solvay Pharmaceuticals, Inc., 350 F.Supp.2d 257 (D. Me. 2004); Huntman v. Danek Medical, Inc., 1998 WL 663362 (U.S. Dist. Ct. S.D. Cal. 1998); See In re Diet Drugs, 2009 WL 902351 (U.S. Dist. Ct. E.D. Pa. 2009)(applying Missouri law).
 Although no South Dakota state court has adopted the LID, the Gross court predicted it would, at least with respect to failure to warn claims. The Gross court, however, found that the LID’s scope did not extend to plaintiff’s fraudulent misrepresentation claim because that claim is distinct from her failure to warn claim. One U.S. District Court case in South Dakota, Schilf v. Eli Lilly and Co., 2010 WL 4024922 (2010), rev’d on other grounds at 687 F.3d 947 (8th Cir. 2012), predicted that South Dakota state courts would adopt the LID andthat fraudulent misrepresentation/deceit claims that allege a manufacturer omitted known risks of the product in its warnings directly to consumers was barred by the LID since such claims are nothing more than failure to warn claims.
 Ethicon argues that even if South Dakota were to adopt the direct-to-consumer marketing exception that New Jersey follows, Perez v. Wyeth Labs. Inc., 161 N.J. 1 (1999), the facts in Gross fall outside that exception because Gross’ physician directed her to the online brochure which is no different than a doctor furnishing a manufacturer’s brochures in his/her office to a patient which New Jersey courts have held is not direct-to-consumer marketing triggering the exception. Banner v. Hoffmann-LaRoche Inc., 383 N.J. Super. 364, 376-77 (App. Div. 2006), certif. den. 190 N.J. 393 (2007).
 Note that alternative arguments to preclude fraud-based claims may exist and vary depending upon which state’s liability laws apply. For instance, in New Jersey, all claims for “harm caused by a product” are subsumed by New Jersey’s Product Liability Act, N.J.S.A. 2A:58C-1 et. seq., including those based upon fraud. See Sinclair v. Merck & Co., Inc., 195 N.J. 51, 65-66 (2008).
 More than likely the law of the state where the plaintiff resided at the time he/she sustained damages from the mesh product will govern.
 Note that although the punitive damages law of the resident state of the manufacturer was stipulated and applied in Gross, it will not necessarily apply in each case and may need to be analyzed on a case by case basis.
 N.J.S.A. 2A:58C-5.
 See FDA Publication, PMA Approvals, available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm
 See FDA Publication, Premarket Notification 510(k), available at
 21 C.F.R. 807.81(a)(3).
 See FDA Publication, Is a New 510(k) Required For a Modification To the Device?, available at
 See FDA Publication, Premarket Notification 510(k), available at