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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Transvaginal Mesh Lawsuit Information

Transvaginal Mesh Lawsuit Information

Transvaginal mesh (TVM) is a synthetic tissue placed in the vagina to strengthen an area of weak tissue.  Prominent urogynecology institue Austin Urogynecology writes that “The [United States] FDA released a safety communication that relates specifically to transvaginal placement of surgical mesh for the treatment of pelvic organ prolapse. Synthetic mesh is also used to treat stress urinary incontinence and synthetic mesh is used in abdominal sacrocolpopexy. However, the FDA Safety Communication on serious complications associated with transvaginal placement of surgical mesh relates specifically to mesh placed vaginally for the treatment of pelvic organ prolapse.”[1]

Over 1,000 reports of complications have been documented by the FDA.  Commenting on the reports of adverse health events associated with TVM, the FDA states, “These reports include problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence. Some reports involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Most patients described in the adverse event reports needed medical or surgical intervention, and some required hospitalization.”[2]

If you or a loved one used a transvaginal mesh product and suffered injury, you may be entitled to financial compensation through a vaginal mesh lawsuit.  For a free consultation, contact our team of vaginal mesh lawyers at Justinian PLLC.

(855) 452-5529
justinian@justinianpllc.com

Currently, 56 brands of transvaginal mesh products manufactured by five companies are under review for association with adverse health events.  Products associated with this risk are (by manufacturer):

[Bard Medical] The Align Urethral Support System; The Align TO Urethral Support System; The Avaulta Anterior BioSynthetic Support System; The Avaulta Posterior BioSynthetic Support System; The Avaulta Plus Anterior Support System; The Avaulta Plus Posterior Biosynthetic Support System; The Avaulta Solo Anterior Synthetic Support System; The Avaulta Solo Posterior Synthetic Support System; The InnerLace BioUrethral Support System; The Pelvicol Acellular Collagen Matrix; The PelviLace BioUrethral Support System; The PelviLace TO Trans-obturator BioUrethral Support System; The PelviSoft Acellular Collagen BioMesh; The Pelvitex Polypropylene Mesh; The Uretex SUP Purbourethral Sling; The Uretex TO Trans-obturator Urethral Support System; The Uretex TO2 Trans-obturator Urethral Support System; and The Uretex TO3 Trans-obturator Urethral Support System

[American Medical Systems] Apogee; Perigee; MiniArc Sling; Monarc Subfascial Hammock; SPARC; In-Fast; BioArc; Elevate; Straight-In

[Boston Scientific Products] The Uphold Vaginal Support System; The Pinnacle Pelvic Floor Repair Kit; The Advantage Transvaginal Mid-Urethral Sling System; The Advantage Fit System; The Lynx Suprapubic Mid-Urethral Sling System; The Obtryx Transobturator Mid-Urethral Sling System; The Prefyx PPS System;

The Solyx SIS System

[Ethicon] Prolift; Prolift +M; Gynemesh/Gynemesh PS; Prosima; TVT; TVT-Oturator (TVT-O); TVT-SECUR (TVT-S); TVT-Exact; TVT-Abbrevo

[Coloplast] T-Sling-Universal Polypropylene Sling; Aris-Transobturator Sling System; Supris-Suprapubic Sling System; Novasilk-Synthetic Flat Mesh; Suspend-Tutoplast Processed Fascia Lata; Exair-Prolapse Repair System; Axis-Tutoplast Processed Dermis; Restorelle; Smartmesh; Omnisure; Minitape; Coloplast Mesh Product(s)

The United States FDA also provides a set of precautionary measures one may take to help lower the risk for adverse health events: “Although treatment with mesh may have helped many women, in others it’s caused complications affecting quality of life.3,4 A literature review demonstrates conflicting information on success rates for transvaginal mesh placement, but everyone agrees on the need for controlled trials.5 If you care for a patient undergoing a transvaginal mesh placement procedure, consider this advice:

  • Become familiar with the types of mesh and procedures used for the repair of pelvic organ prolapse and treatment of stress urinary incontinence.
  • Ensure that your patient has given her informed consent. Make sure she’s received appropriate information about her choice of treatment, the type of procedure she’s undergoing, and possible adverse events.
  • During preoperative teaching sessions, tell your patient about possible adverse reactions, the signs and symptoms of infection, and when to notify her healthcare provider.
  • If you’re an OR nurse, follow your facility’s policies and procedures for recording information about implanted materials. Record the name of the mesh used and its catalog number, lot number, and size in the patient’s medical record.
  • Provide your patient with a written copy of the patient labeling from the surgical mesh manufacturer, if it’s available.
  • If your patient has surgery to remove mesh, follow your facility’s policies and procedures for properly handling the explanted mesh. Additionally, follow your facility’s policies and procedures for reporting adverse events.”[3]

Transvaginal Mesh Lawsuits

“The complications mentioned in the FDA safety communication on the transvaginal placement of surgical mesh for pelvic organ prolapse include mesh erosion, mesh contraction, pelvic pain, and painful sexual intercourse.

Rates of mesh erosion and mesh contraction are minimized by placing the mesh meticulously in the correct anatomic plane. When placed correctly, the vaginal portion of the mesh is lying identically as if the mesh were placed abdominally during sacrocolpopexy.

The FDA communication explains that pelvic pain and painful sexual intercourse are the result of mesh erosion and mesh contraction. However, these symptoms are known to occur even when the mesh does not erode or contract. Further, these symptoms occur during all prolapse procedures that involve the sacrospinous ligament, whether mesh is used or not. These symptoms also are less likely to occur abdominally, where the elevation point of the mesh is the sacrum and not the sacrospinous ligament.”[4]

Other contemporary research has demonstrated that about 10% of vaginal mesh insertion surgeries will eventually result in vaginal mesh erosion.[5]

Transvaginal Mesh Lawsuit

Due to such high rates of adverse health events with insufficient relevant warnings about these risks by product manufacturers, a number of transvaginal mesh lawsuits are currently being filed.   If you or a loved one used a transvaginal mesh product and experienced an adverse health event as a result, please do not hesitate to contact our team of Transvaginal Mesh Lawyers at the information provided below for a free case consultation.

More Information on Transvaginal Mesh

If you have a question about Transvaginal Mesh that isn’t answered here, feel free to give my office a call at (855) 452 – 5529 or email me at justinian@dangerousdrugs.us.  Also, every blog post we’ve written about Transvaginal Mesh is available for you to review here.


 

Here is a recent item from a transvaginal mesh lawsuit:

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 1 of 16 PageID #: 10651

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

AT CHARLESTON

IN RE ETHICON, INC., PELVIC REPAIR

SYSTEM PRODUCTS LIABILITY

LITIGATION Master File No. 2:12-MD-02327 MDL 2327

JOSEPH R. GOODWIN

U.S. DISTRICT JUDGE

CHERYL A. EIFERT

U.S. MAGISTRATE JUDGE THIS DOCUMENT RELATES TO:

Tonya Edwards, et al. v. Ethicon, Inc.., et al.

Case No. 2:12-CV-09972

DEFENDANTS’ SUPPLEMENTAL BENCH BRIEF REGARDING

POST-IMPLANT COMPANY DOCUMENTS AND OTHER ISSUES

Defendants Johnson & Johnson and Ethicon, Inc. (collectively, “Ethicon”), respectfully submit this supplemental bench brief addressing the issues raised by the Court during the July

31, 2015 hearing regarding the parties’ deposition designations.

ARGUMENT

  1. The Post-Sale Company Documents Authored by Dr. Chen are Inadmissible.

Exhibits T-3322, T-3324, T-3325, and T-3326 were authored by Dr. Meng Chen of

Ethicon in 2008 or 2009, more than three years after Mrs. Edwards was implanted with the TVT-

O device in July 2005. See Ex. A. The documents concern Dr. Chen’s investigation into whether to update the TVT-O Instructions For Use (“IFU”) with information regarding the risks of chronic erosion and dyspareunia. Contrary to Plaintiffs’ argument, these documents did not trigger a “post-sale” duty to warn, nor did Ethicon’s failure to issue any warning about them impact the medical treatment received by Mrs. Edwards. The documents should be excluded as irrelevant.

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 2 of 16 PageID #: 10652

  1. The 2008 and 2009 documents did not trigger a duty to warn because the risks discussed in them are not new.

The issue of whether Ethicon adequately warned Dr. Wittcoff, the implanting surgeon, in

July 2005 of the risk of erosion (which is specifically included in the TVT-O IFU, see ECF No. 83-1, Page ID # 2184) and the risk of dyspareunia (which Dr. Wittcoff testified is a complication that “can occur with any type of surgery” his office performed, see ECF No. 203-1, Page ID # 9639) is a question of fact for the jury.

The company documents in dispute do not speak to that issue, given that they were authored three to four years after the July 2005 surgery. Rather, the 2008 and 2009 documents are relevant to Plaintiffs’ “post-implant” failure to warn claim only if Plaintiffs can show, among other things, that the documents “constituted information of a new risk or defect.” Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195, 2013 WL 3821280, at *2 (S.D. W. Va. July 23, 2013). Plaintiffs contend that the documents do reveal a “new” risk, because they show that the risks of erosion and dyspareunia were more common or more severe than Ethicon originally believed. Georgia law does not support Plaintiffs’ position.

In Georgia, manufacturers of medical devices have the duty to warn physicians of possible adverse events associated with their products. A manufacturer discharges its duty to warn if it provides “a warning as to possible danger in its use to the prescribing physician.” Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1279 (11th Cir. 2002). Yet no Georgia court applying Georgia law has held that this duty also requires manufacturers to provide incidence, severity, and frequency rates of a particular adverse event.[1]

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 3 of 16 PageID #: 10653

To the contrary, a drug and device label without frequency rates has been held to be sufficient as a matter of law. In Hurley v. Lederle Laboratories, 651 F. Supp. 993 (E.D. Tex. 1986), rev’d on other grounds, 863 F.2d 1173 (5th Cir. 1989), the district court held that the label for defendants’ DPT vaccine was sufficient as a matter of law to apprise doctors of the side effects of the vaccine despite the absence of frequency rates. 651 F. Supp. at 1002-03. The

Hurley court, quoting Smith v. Wyeth Laboratories, No. 84-2002, 1986 U.S. Dist. LEXIS 21331

(S.D.W.V. Aug. 21, 1986), held:

The plaintiff cites no authority for the proposition that a drug manufacturer has a duty to warn prescribing physicians of the rate of adverse reactions. As a practical matter, this would be extremely difficult, perhaps impossible, with respect to a drug like the DPT vaccine, which has many possible harmful side effects. Moreover, the warning states “The below-listed serious, and occasionally fatal adverse reactions have been reported . . . .” Thereafter, the warning lists with specificity seven serious reactions, one of which ultimately inflicted the minor plaintiff. The warning also refers the physician to medical resource material further explaining the possible consequences of administering the DPT vaccine. Based upon the foregoing, it is clear that the warning adequately warns of the severity and nature of adverse reactions as a matter of law . . . .

Hurley, 651 F. Supp. at 1002 (quoting Smith, 1986 U.S. Dist. LEXIS 21331, at *26-27 (emphasis added)). Other courts agree that a warning need not refer to the incidence or rate of potential complications.2

                                                                                                                                                          

a risk. This Court’s observation in Cisson that “[o]ther courts have found that a failure to warn about the rate or severity of potential injury creates a jury question over the adequacy of warnings” is inaccurate for the same reason. Two of the “other courts” referenced in Cisson are federal courts that relied on Thornton; the third “other court” is a federal district court that cited no authority whatsoever.

2See, e.g., Alston v. Caraco Pharm., Inc., 670 F. Supp. 2d 279, 286-87 (S.D.N.Y. 2009) (New York); Ames v. Apothecon, Inc., 431 F. Supp. 2d 566, 573 (D. Md. 2006) (Maryland); Percival v. Am. Cyanamid Co., 689 F. Supp. 1060, 1063-64 (W.D. Okla. 1987) (Oklahoma); Smith v. Wyeth Labs., 1986 U.S. Dist. LEXIS 21331, at *26-27 (S.D.W.Va. 1986) (West Virginia); Calabrese v. Trenton State College, 392 A.2d 600, 604 (N.J. App. Div. 1978).

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 4 of 16 PageID #: 10654

The sound reason for this rule is simple: frequency or incidence rates are a constant and regular subject of study and debate best sorted out by the peer-reviewed medical literature and physicians’ independent judgment. They also will depend in part on the individual surgeon’s technique. Studies of complication rates vary in their sample size, duration, methodology, definitions, controls, quality, and outcomes (to name but a few examples). Debate over the merits and quality of a study can be enduring, and reasonable doctors may reach different conclusions. Labels are incapable of conveying this sort of detail—much less keeping it current—or resolving debates between articles.[2] Requiring manufacturers to attempt these feats would at once dilute warnings, thereby diminishing their effectiveness, and also risk impinging on physicians’ independent assessments of the medical literature. See Ames, 431 F. Supp. 2d at 573 (“[W]arnings must be brief and focused to be effective. It would require an extended discussion, in the nature of a medical journal article, to lay out the debate between Drs. Blume and Stern.”).

There is no indication Georgia would deviate from this rule. The 2008 and 2009 documents from Dr. Meng Chen did not trigger a duty for Ethicon to warn of the severity or frequency rates of erosion and dyspareunia.

  1. Plaintiffs cannot prove Ethicon’s failure to issue a post-implant warning caused Mrs. Edwards’s injuries
  2. The relevant legal standard

Georgia courts have routinely held that to satisfy the element of causation under the learned intermediary doctrine, a plaintiff must demonstrate that the learned intermediary would Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 5 of 16 PageID #: 10655

have acted differently had he or she received adequate warnings.[3] This Court recognized as much in Cisson, observing that, under Georgia law, “the failure to warn must have been the cause-in-fact of the plaintiff’s injuries,” meaning the plaintiff “must show that [the prescribing physician] would not have implanted the [device] if [the manufacturer] had provided the warnings the plaintiffs allege should have been provided.” Cisson v. C.R. Bard, Inc., No. 2:11cv-00195, 2013 WL 5700513, at *8 (S.D. W. Va. Oct. 18, 2013). This causation standard, which focuses on whether the learned intermediary would have acted differently in the face of adequate warnings, is not unique to Georgia and finds support in case law from jurisdictions across the country.[4]

As the Court recognized during the July 31 hearing, case law involving the standard for establishing causation in the context of the post-sale duty to warn a learned intermediary is far less prevalent. In the most relevant (and perhaps only) decision on point, however, the district court in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation—which Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 6 of 16 PageID #: 10656

involved the same type of product and the same substantive law at issue here—applied the same causation standard and examined whether the failure to issue a post-sale warning affected the actions of the learned intermediary. Specifically, the court held that, to prevail on a continuing duty to warn theory under Georgia law in a case involving a permanently-implanted medical device, a plaintiff had to “prove that if [the manufacturer] had provided an adequate post-implant warning, her doctors would have taken a different approach that would have prevented or mitigated her injuries.” In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-MD-2004, 2015 WL 4425787, at *4 (M.D. Ga. July 17, 2015).

The causation standard applied in In re Mentor Corp. appropriately focuses the causation inquiry on the actions of the learned intermediary. If the plaintiff’s doctors would have followed the same course of treatment irrespective of any post-implant warning by the manufacturer, then the manufacturer’s failure to issue a post-implant warning could not have caused the plaintiff’s injuries. Concentrating on anything other than the treatment decisions of the plaintiff’s medical providers would be inconsistent with Georgia’s learned intermediary doctrine.

In examining the relevance of Dr. Chen’s 2008 and 2009 documents, this Court must likewise consider whether Plaintiffs can show that Ethicon’s failure to issue warnings in 2008 and 2009 regarding erosions and dyspareunia altered the medical treatment Mrs. Edwards received. Plaintiffs’ counsel apparently agrees, given his argument to the Court that, if Ethicon had issued a warning, Mrs. Edwards “could have received treatment sooner and arguably would be in a better position today than she is, having not been correctly diagnosed and received an explant [surgery] until 2012.” Ex. B, Transcript of July 28, 2015 Hearing at 18:2-13. But there is no expert testimony to support this claim. And when Mrs. Edwards’s medical history is considered, it is clear that a warning would not have had any effect on her treatment.

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 7 of 16 PageID #: 10657

  1. Mrs. Edwards’s relevant medical history

Mrs. Edwards’s first post-implant pelvic exam occurred on December 6, 2007, when she was seen by Certified Nurse Practitioner Linda Myrick. Mrs. Edwards complained of “vaginal staining with odor for 6 months; some dysuria [or painful urination]; [and] irritation.” See Ex. C at 1. Mrs. Edwards made “[n]o other . . . GU [genitourinary] complaints.” Id. at 2. CNP Myrick’s records do not reflect complaints of pelvic pain, tenderness, or dyspareunia, all of which CNP Myrick would have recorded had Mrs. Edwards so complained.[5] Mrs. Edwards advised CNP Myrick that she was sexually active, yet there is no record of any complaints of painful intercourse. Ex. C at 2. CNP Myrick diagnosed Mrs. Edwards with dysmenorrhea (or painful menstruation) and possible urinary incontinence. Id. at 3.

Mrs. Edwards’s next relevant examination occurred on October 30, 2008, when she was seen by Dr. LaJune Oliver for a yearly physical. See Ex. E at 1. Dr. Oliver—a family practitioner—did not perform a pelvic exam, but recorded in her notes that Mrs. Edwards “denies abnormal vaginal bleeding, discharge or unusual pelvic pain,” and reports “no dysuria [or] frequency.” Id. Dr. Oliver described Mrs. Edwards as a “[h]ealthy adult female.” Id. at 4.

Again, there are no indications of pelvic pain or dyspareunia.

On September 29, 2010, Mrs. Edwards called and requested an office visit with CNP

Myrick, complaining of “really bad cramping at the time of periods.” See Ex. F at 1. Mrs. Edwards denied any “pain or vag[inal] bleeding.” Id. The following day, she saw CNP Myrick, whose records reflect complaints of dysmenorrhea, heavy menstrual periods, and urinary Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 8 of 16 PageID #: 10658

incontinence. See Ex. G at 1. There is no mention of dyspareunia in CNP Myrick’s records

from the September 30 visit.

Just over a year later on October 31, 2011, Mrs. Edwards—after seeing an advertisement by a plaintiff’s law firm concerning mesh litigation[6]—was seen by Dr. Niall Galloway. For the first time, she complained of “pelvic pain following sling procedure” and “painful sexual intercourse.” See Ex. I at 2. Despite no medical records to support this claim, Mrs. Edwards told Dr. Galloway her “symptoms have been progressive since her sling placement approximately 6 years ago.” Id. Dr. Galloway performed a revision surgery less than three months later on January 4, 2012.

  1. The medical providers Mrs. Edwards saw in 2008 and 2009 would not have seen any post-implant warnings.

CNP Myrick is a gynecological nurse practitioner whose practice consists of annual exams and Pap smears. Ex. C, Myrick Dep. at 10:18-19. She is not a urogynecologist and has received no training on urinary incontinence, let alone surgeries to repair the condition. Id. at 23:9-11, 25:6-15. During her deposition, she routinely denied even basic understanding of the TVT-O device.[7] Dr. Oliver, meanwhile, practices family medicine. She has never implanted any type of mesh product and does not hold herself out as “an expert in slings and pelvic mesh products.” Ex. J, Oliver Dep. at 17:17-24.

Even assuming Ethicon had issued a warning in 2008 or 2009 regarding the rates and severity of erosions and dyspareunia, it is clear CNP Myrick and Dr. Oliver would not have received that warning. Ethicon’s duty to warn under the learned intermediary doctrine extends only to the prescribing physician—in this case, the doctors and hospitals known to Ethicon to have implanted the TVT-O device. SeeLance v. Am. Edwards Labs., 452 S.E.2d 185, 187-188 (Ga. Ct. App. 1994). CNP Myrick and Dr. Oliver do not fall within that group. Their treatment of Mrs. Edwards would not have changed—even if Ethicon had issued a warning—because they would not have received any warning.

  1. The medical providers would not have altered their treatment of Mrs. Edwards because she did not complain to them of dyspareunia or pelvic pain.

Even if Ethicon had a duty to issue a post-implant warning in 2008 or 2009 based on the observations in Dr. Chen’s documents regarding the severity and frequency of erosion and dyspareunia, and even if CNP Myrick and Dr. Oliver were the types of medical providers who would have received such a warning, their treatment of Mrs. Edwards would not have changed. Mrs. Edwards never complained to CNP Myrick or Dr. Oliver of dyspareunia, even though she reported being sexually active. See Ex. C at 2. And her complaints of pain were associated with menstrual abdominal cramping, not the type of vaginal or leg pain that might have suggested a problem with her TVT-O. See Ex. G at 2 (“Patient presents with: MUSCLE CRAMPS – abd cramping per patient”). Not until October 2011 did Mrs. Edwards report pelvic pain and dyspareunia, and she underwent a revision surgery shortly thereafter.

Under these circumstances, Plaintiffs cannot reasonably suggest Mrs. Edwards would have received different medical treatment had Ethicon issued post-implant warnings regarding dyspareunia and erosions. Without any complaints from Mrs. Edwards that could even possibly have been related to the TVT-O, CNP Myrick and Dr. Oliver had no reason to alter their medical treatment of Mrs. Edwards. As a result, Plaintiffs cannot show that Ethicon’s failure to issue warnings in 2008 or 2009 regarding dyspareunia and erosions caused or worsened their injuries.

The post-implant documents of Dr. Chen are irrelevant and inadmissible.

  1. The same warnings Plaintiff alleges Ethicon should have issued were part of the FDA’s October 2008 Public Health Notification.

Finally, and perhaps most significantly, Dr. Chen authored each of the four documents at issue after the FDA issued its Public Health Notification on October 20, 2008. The notice warned of “over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair [pelvic organ prolapse] and [stress urinary incontinence].” See Ex. K. The most frequent complications, according to the FDA, included erosion that in some cases “led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.” Id.

The FDA’s notification warned of the very risks that Plaintiffs now claim Ethicon should have warned of (increased rates and severity of erosion and dyspareunia) at exactly the same time Plaintiffs claim Ethicon should have issued its warning (2008). Despite this widespread notification, no medical provider suggested to Mrs. Edwards that she might have an erosion. And for good reason, seeing as how she never (1) visited a physician that would have received a warning such as the FDA notification or (2) complained about pelvic pain or dyspareunia.[8]

The FDA notification also belies Plaintiffs’ contention that, had Ethicon issued an appropriate warning in 2008 or 2009, Dr. Wittcoff could have “contact[ed] former patients,” which would have caused Mrs. Edwards to receive different medical care. Ex. B at 18. Dr. Wittcoff received the 2008 notification, yet apparently saw no need to issue any additional warning to his patient. See Ex. L, Dr. Wittcoff Dep. at 34 (testifying about FDA warnings in 2008). Plaintiffs simply cannot prove that Dr. Wittcoff would have acted any differently had the warning come from Ethicon rather than the FDA.

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 11 of 16 PageID #: 10661

In short, the FDA issued a public health notice containing the very warnings Plaintiffs contend Ethicon should have provided, yet Mrs. Edwards’s medical providers did not associate her as having mesh-related injuries. Plaintiffs cannot prove that had Ethicon issued a similar warning, her medical treatment would have been different.

  1. Injuries and Conditions Not Suffered by Mrs. Edwards are Irrelevant and Prejudicial
  2. This Court has repeatedly excluded evidence of conditions not suffered by the plaintiff.

In the Lewis bellwether case, Ethicon moved to exclude “any evidence or argument that the TVT can cause adverse reactions or events other than those alleged by Mrs. Lewis.” See Lewis v. Ethicon, Inc., No. 2:12-cv-04301, ECF No. 208, Page ID #16919. The basis of

Ethicon’s motion was straightforward: “evidence of potential adverse reactions other than those alleged here is irrelevant to the case and would serve only to confuse and inflame the jury.” Id.

Exactly as Plaintiffs do here, the plaintiffs in Lewis opposed Ethicon’s motion by citing the Texas risk-utility standard for design defect claims. See Lewis v. Ethicon, Inc., No. 2:12-cv-

04301, ECF No. 221, Page ID #17601. The risk-utility analysis, they argued, “is not victimspecific” but instead “involves a risk-utility analysis of the product in general to determine whether the product should have been marketed to anyone (not just the plaintiff).” Id. They quoted Texas case law for the proposition that a product is “defectively designed” if it is “unreasonably dangerous, taking into consideration the utility of the product and the risk involved in its use.” Id. (quoting Hernandez v. Tokai Corp., 2 S.W.3d 251, 257 (Tex. 1999)). In short, the Lewis plaintiffs argued that, under Texas law, the trier of fact must weigh “the panoply of risks” against “the utility of the product to the users and to the public as a whole” to determine whether the product is unreasonably dangerous and hence defective. Id. (quoting Texas case law).

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 12 of 16 PageID #: 10662

The Court dismissed the Lewis plaintiffs’ argument out of hand and granted Ethicon’s motion to exclude evidence of complications not suffered by Mrs. Lewis. See Lewis v. Ethicon,

Inc., No. 2:12-cv-04301, ECF No. 250, Page ID #18809. The Court explained that, because “a plaintiff in a design defect case [in Texas] must prove, among other things, that the defect was the ‘producing cause’ of the plaintiff’s injury . . . , evidence that the TVT causes injuries not experienced by Ms. Lewis is not probative of the design defect claim.” Id. (emphasis added) (quoting Timpte Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009)).

Undeterred, the plaintiffs in Bellew raised a similar argument in opposition to Ethicon’s Daubert motion, contending that their experts should be able to offer opinions regarding all of the risks—even those not suffered by Mrs. Bellew—under Arizona’s risk-utility standard. Once again, however, the Court dismissed their argument. In no uncertain terms, the Court held that

“[e]vidence of complications that the plaintiff did not experience is irrelevant and lacking in probative value.” Bellew v. Ethicon, Inc., No. 2:13-cv-22473, ECF No. 265, Page ID # 19171 (S.D. W. Va. Nov. 20, 2014). The Court acknowledged that the risk-utility test in Arizona included as a factor the “likelihood of injury,” which the plaintiffs in Bellew interpreted to mean the “likelihood of any injury.” Just as it did in Lewis, however, the Court rejected this position because “a strict liability claim requires ‘the defective condition proximately cause the plaintiff’s injury.” Id. (emphasis in original) (quoting Arizona case law). The Court concluded that, “[r]eading the elements of the prima facie case and the risk/benefit factors together, the pertinent injury is clearly that which the plaintiff actually suffered.” Id.

  1. Lewis and Bellew control the outcome here.

The Court’s rulings in Lewis and Bellew are dispositive of the same issue here. Like Texas and Arizona, Georgia law has long required a plaintiff in a design defect case to prove that her injury was “the proximate result of a defect in the product which existed at the time sold.” Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 13 of 16 PageID #: 10663

Talley v. City Tank Corp., 279 S.E.2d 264, 269 (Ga. Ct. App. 1981). In other words, “[s]trict liability is imposed for injuries which are the proximate result of product defects, not for the manufacture of defective products.” Id. Just as the Court held in Lewis and Bellew, this causation requirement renders irrelevant any evidence of conditions or injuries not suffered by Mrs. Edwards. Evidence that the TVT-O can cause infections, cancer, or any other condition or injury not suffered by Mrs. Edwards “is not probative of the design defect claim” because Plaintiffs cannot show the TVT-O’s purported tendency to cause these conditions injured Mrs. Edwards.

Plaintiffs’ reliance on Georgia’s risk-utility analysis is unavailing, as the Court rejected the same argument in Lewis and Bellew. Georgia’s risk-utility standard, like the standard in

Texas and Arizona, focuses on the “reasonableness” of a product’s design given the “probability and seriousness of the risk posed by the design, the usefulness of the product in that condition, and the burden on the manufacturer to take the necessary steps to eliminate the risk.”10 In all three states, the risk-utility standard involves weighing factors such as the gravity and likelihood of injury; the avoidability of the risk; and the general public’s knowledge or anticipated awareness of the dangers inherent in the product. Compare Banks, 450 S.E.2d at 675 n.6 (listing Georgia’s factors), with Am. Tobacco Co., 951 S.W.2d at 432 (Texas) and Dart, 709 P.2d at 879 (Arizona). Indeed, as recently explained by Judge Goodwin, the same risk-utility standard employed in Texas, Arizona, and Georgia that examines whether a product’s risks exceed its utility has been adopted by “the vast majority of courts,” all of which generally apply some

                                              

10Compare Banks v. ICI Ams. Inc., 450 S.E.2d 671, 673 (Ga. 1994), with Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 432 (Tex. 1997) (“In determining whether a product is defectively designed, the jury must conclude that the product is unreasonably dangerous as designed, taking into consideration the utility of the product and the risk involved in its use.”) and Dart v. Wiebe Mfg., Inc., 709 P.2d 876,

879 (Ariz. 1985) (observing that “the question of defective and unreasonably dangerous condition may be determined by applying [Dean John] Wade’s risk/benefit factors to decide ‘whether the benefits of the challenged design . . . outweigh the risk of danger inherent in such design”).

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 14 of 16 PageID #: 10664 variation of the same “seven factor test” when evaluating risk and utility. See Mullins v. Ethicon, Inc., No. 2:12-cv-02952, ECF No. 38, Page ID #184 (S.D. W. Va. Aug. 4, 2015).

In sum, the risk-utility standards in Georgia, Texas, and Arizona—along with the same standards applied in countless other jurisdictions—are virtually identical. The Court rejected the argument in Lewis and Bellew that evidence of conditions not suffered by the plaintiff was relevant under the Texas and Arizona risk-utility standards. It should reject the same argument here concerning Georgia law.

  1. Evidence of conditions not suffered by Mrs. Edwards should be excluded under Rule 403.

Finally, even if somewhat relevant, evidence of conditions and injuries not suffered by Mrs. Edwards should be excluded under Rule 403. First, there is a significant risk of confusing the issues. After all, the document that triggered Ethicon’s objection—Exhibit T-1206—is a

2004 study regarding “[c]onceptual advances in the surgical management of genital prolapse.” See Ex. M (emphasis added). Plaintiffs should not be permitted to confuse the jury with documents describing risks of injuries (not suffered by Mrs. Edwards) that are associated with products for the treatment of a different medical condition and that employ a different mesh. The Court excluded a TVT document in Bellew (which involved the Prolift, a prolapse product with a different mesh) for this very reason, explaining that the document and the witness’s testimony about it were “misleading, confusing, and its prejudicial nature outweighs any probative value.” See Ex. N, Transcript of Nov. 24, 2014 hearing at 209, Bellew v. Ethicon Inc., No. 2:13-cv-22473.

Second, the evidence is unduly prejudicial, insofar as Ethicon would have to devote a portion of its limited trial time to rebut Plaintiffs’ theories of defect. For example, even though Mrs. Edwards did not suffer an infection related to her TVT-O, Ethicon would be required to present the expert testimony of its infectious disease doctor, lest the jury believe that TVT-O Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 15 of 16 PageID #: 10665

causes high rates of infection. Ethicon should not have to waste its limited time and the jury’s limited attention to conditions and risks that Mrs. Edwards did not suffer and that cannot be the basis of her design defect claim.

CONCLUSION

For the reasons set forth above, Ethicon respectfully requests that the Court exclude postimplant company documents authored by Dr. Meng Chen and documents or evidence relating to injuries or conditions not suffered by Mrs. Edwards. The parties are continuing to negotiate other outstanding objections concerning deposition designations, and Ethicon is confident these remaining issues will be resolved without the need for Court intervention.

Respectfully submitted,

/s/ David B. Thomas

David B. Thomas (W. Va. Bar No. 3731)

Thomas Combs & Spann PLLC

300 Summers Street

Suite 1380 (25301)

P.O. Box 3824

Charleston, WV 25338 (304) 414-1807

dthomas@tcspllc.com

COUNSEL FOR DEFENDANTS ETHICON,

INC. AND JOHNSON & JOHNSON

 

Case 2:12-cv-09972   Document 215   Filed 08/05/15   Page 16 of 16 PageID #: 10666

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

AT CHARLESTON

IN RE ETHICON, INC., PELVIC REPAIR

SYSTEM PRODUCTS LIABILITY

LITIGATION Master File No. 2:12-MD-02327 MDL 2327

JOSEPH R. GOODWIN

U.S. DISTRICT JUDGE

CHERYL A. EIFERT

U.S. MAGISTRATE JUDGE THIS DOCUMENT RELATES TO:

Tonya Edwards, et al. v. Ethicon, Inc.., et al.

Case No. 2:12-CV-09972

CERTIFICATE OF SERVICE

I certify that on August 5, 2015, I electronically filed this document with the Clerk of the Court using the CM/ECF system which will send notification of this filing to CM/ECF participants registered to receive service in this MDL.

/s/ David B. Thomas              

David B. Thomas

[1] The Eleventh Circuit, in a case involving Georgia law, held that “[f]or a warning to be adequate, it must provide a ‘complete disclosure of the existence and extent of the risk involved.’” Thornton v. E. I. Du Pont de Nemours & Co., Inc., 22 F.3d 284, 289 (11th Cir. 1994). The case quoted for this proposition, however, was a Fifth Circuit decision involving federal maritime law, not Georgia common law. Thus, Thornton does not support the argument that Georgia law requires warning of the “extent” of

(footnote cont’d)

[2] If, for example, Ethicon cited in the IFU a mesh erosion rate of approximately two percent based on the FDA’s 2013 “Considerations about Surgical Mesh for SUI,” Plaintiffs would rely on a different study showing a slightly higher rate and claim that Ethicon’s IFU is misleading.

[3]See, e.g., Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d 1351 (N.D. Ga. 1999) (“Regardless of the sufficiency or insufficiency of the warnings at issue here, Plaintiff still cannot recover. Where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, . . . the causal link is broken and the plaintiff cannot recover.”); see also Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 (11th Cir. 2010) (applying Georgia law and holding that prescribing physician’s testimony that he would have prescribed prescription drug even with warning “severs any potential chain of causation”).

[4]See, e.g., Sauls v. Wyeth Pharm., Inc., 846 F. Supp. 2d 499, 502 (D.S.C. 2012) (applying South

Carolina law and holding that plaintiff’s “failure to warn claim can succeed only if she can demonstrate that an adequate warning would have altered [physician’s] prescription decision”); Sanchez v. Boston Scientific Corp., 38 F. Supp. 3d 727, 732 (S.D. W. Va. 2014) (applying California law and holding that plaintiff “must demonstrate that the prescribing physician would have acted differently had he or she received adequate warnings”); Cochran v. Wyeth, Inc., 3 A.3d 673, 676-77 (Pa. Sup. Ct. 2010) (“Assuming that a plaintiff has established both duty and a failure to warn, a plaintiff must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.”); WyethAyerst Labs. Co. v. Medrano, 28 S.W.3d 87, 95 (Tex. App. Ct. 2000) (“In order to prove causation, the plaintiff must show that a proper warning would have changed the decision of the intermediary to prescribe the product.”).

[5]See Ex. D, Myrick Dep. at 31:19-32:2 (“Q. All right. Now going back to your visit with Mrs. Edwards on December 6, 2007 . . . when a patient comes to see you, do you try to write down their complaints to you? A. Yes, ma’am. Q. And . . . you’re fairly accurate in that; is that right? A. I like to think so, yes, ma’am.”); id. at 41:12-15 (“Q. Okay . . . if you saw something out of the ordinary, you certainly would have documented that, right? A. Yes.”); id. at 44:7-10 (“Q. And when you did the pelvic examination, you would have noted that in your records, is that right? A. Yes, ma’am.”).

[6]See Ex. H, Tonya Edwards Dep. at 46:2-47:7 (testifying she began researching doctors after seeing “commercial . . . about other people having issues with a sling”); id. at 254:12-23 (testifying she knew, when she first went to see Dr. Galloway, that problems were associated with TVT-O because she “saw the commercial that was on TV”).

[7]Id. at 35:7-9 (“Q. Have you had any experience implanting or explanting TVT-O? A. No, ma’am. [I] [k]now nothing about the process.”); id. at 47:3-5 (“Q. And are you aware that the sling does not treat urge incontinence? A. Not my area of expertise, ma’am.”); id. at 47:13-16 (“Q. So you can’t give me an opinion as to what type of incontinence she had? A. I work with patient’s symptoms and refer her to the specialist that handles bladder issues.”)

[8] Indeed, even when Mrs. Edwards complained to Dr. Galloway of dyspareunia and pain associated with her TVT-O, he examined her and saw “[n]o obvious signs of erosion.” Ex. I at 3.

 


[1] “Austin Urogynecology | What is Transvaginal Mesh or TVM?” Austin Urogynecology. © 2013 Austin Urogynecology. Available at <http://www.austinurogynecology.com/what-is-transvaginal-mesh-or-tvm/> Accessed 17 April 2013.

[2] “Tips and Articles on Device Safety > Looking Into Problems with Transvaginal Surgical Mesh” U.S. Food and Drug Administration. U.S. Dept of Health and Human Services. Available at <http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm> Updated 21 March 2013, Accessed 17 April 2013

[3] “Tips and Articles on Device Safety > Looking Into Problems with Transvaginal Surgical Mesh” U.S. Food and Drug Administration. U.S. Dept of Health and Human Services. Available at <http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm> Updated 21 March 2013, Accessed 17 April 2013

[4] “Austin Urogynecology | What is Transvaginal Mesh or TVM?” Austin Urogynecology. © 2013 Austin Urogynecology. Available at <http://www.austinurogynecology.com/what-is-transvaginal-mesh-or-tvm/> Accessed 17 April 2013.

[5] Ganj, F.A. “Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapsed repair” Int Urogynecol J (2009) 20:919-925

[This page updated 10/14/2015 to correct a typographical error regarding Boston Medical.  Boston Medical has no relation to the products described herein.]