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In Re Pelvic Mesh/

June 1, 2012

IN RE PELVIC MESH/ GYNECARE LITIGATION.


On appeal from Superior Court of New Jersey, Law Division, Atlantic County, Docket No. L-6341-10.

The opinion of the court was delivered by: Ashrafi, J.A.D.

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

APPROVED FOR PUBLICATION

Argued March 26, 2012

Before Judges A. A. Rodriguez, Sabatino and Ashrafi.

The opinion of the court was delivered by ASHRAFI, J.A.D.

Several hundred plaintiffs from many states have individually filed suit in New Jersey against defendants Johnson & Johnson and Ethicon, Inc., alleging they have suffered injuries caused by a line of defendants' medical products. The Supreme Court assigned the cases to the Law Division, Atlantic County, for joint case management. Subsequently, we granted defendants leave to appeal from the Law Division's May 26, 2011 pretrial order barring defendants from consulting with or retaining as an expert witness any physician who has at any time treated one or more of the plaintiffs. We now reverse that order.

I.

Johnson & Johnson and Ethicon, Inc. designed, manufactured, marketed, and sold pelvic mesh medical devices*fn1 used primarily to treat pelvic organ prolapse and stress urinary incontinence. The devices contain synthetic polypropylene mesh and are surgically implanted as a "vaginal sling" to support weakened vaginal walls.

In a Public Health Notification issued on October 20, 2008, the Food and Drug Administration warned healthcare practitioners about "serious" complications associated with transvaginal placement of surgical mesh, including mesh erosion, vaginal scarring, infection, pain, urinary problems, dyspareunia (painful sexual relations), recurrence of prolapse and incontinence, and perforation of bowel, bladder, and blood vessel during insertion.*fn2

A few months earlier, in February 2008, the first of the plaintiffs in these New Jersey cases had filed suit against defendants alleging injuries sustained as a result of the surgical implantation of a pelvic mesh/Gynecare product. In October 2008, defendants retained as a consulting expert Halina Zyczynski, a physician from the University of Pittsburgh who specializes in obstetrics, gynecology, and urogynecology. From October to December 2008, four more pelvic mesh/Gynecare cases were filed against defendants in the Law Division.

In March 2009, defendants retained as a consulting expert Elizabeth Kavaler, a urologist from New York City. For the next several months, defense counsel consulted with Dr. Kavaler about the approximately thirty cases that had been filed by that time. In October 2009, while reviewing medical records of a plaintiff who had filed suit two months earlier, defense counsel discovered that Dr. Kavaler had surgically implanted a Gynecare product in treatment of that plaintiff. Defense counsel immediately informed plaintiffs' liaison counsel and advised Dr. Kavaler not to disclose to the defense any information about the plaintiff she had treated. Defense counsel then discontinued discussions with Dr. Kavaler pending determination of her eligibility to serve as a defense expert. Later, the plaintiff who had been treated by Dr. Kavaler testified in deposition that she stopped seeing Dr. Kavaler in July 2008, that is, some eight months before defendants first engaged her services as an expert.

Defense counsel identified another prospective expert and scheduled an introductory meeting for January 2010. When defense counsel learned that the prospective expert was the treating surgeon for another plaintiff in the litigation, defendants abandoned their intent to retain the proposed expert.

In September 2010, while reviewing medical records of a plaintiff who had filed suit nine months earlier, defense counsel discovered a largely illegible handwritten progress note with a reference to a "Dr. Zcycysky." The plaintiff had not identified a doctor by that name in her preliminary disclosures of treating physicians. Plaintiffs' counsel confirmed that the reference in the progress note was to a single consultation that the plaintiff had with defendants' expert Halina Zyczynski. Defense counsel informed plaintiffs' counsel in October 2010 that defendants had retained Dr. Zyczynski as a consultant in 2008, advised Dr. Zyczynski that a patient with whom she had consulted was now a plaintiff in the litigation, and discontinued their discussions with Dr. Zyczynski.

At the time of the Supreme Court's September 13, 2010 order assigning the cases for joint case management, approximately seventy-eight pelvic mesh cases had been filed in New Jersey against defendants. The same attorneys represent the parties in many of the cases. The Supreme Court's order allows one judge in the State to become closely familiar with the cases and to coordinate discovery, motion practice, settlement discussions, and scheduling of initial representative trials.

In January 2011, defendants moved to establish a protocol similar to ones used in some federal litigation for consulting with and possibly retaining as defense experts physicians who had treated a plaintiff in the pelvic mesh litigation. Defendants proposed that a treating physician would have no communication with the defense about his or her own patient-plaintiff and would not be used as an expert witness in the patient-plaintiff's own case.*fn3

In support of their motion for a protocol and order, defendants submitted a certification stating:

The pelvic floor repair and incontinence "sling" surgeries at issue in this litigation are performed by a relatively small group of surgeons in the United States, which is comprised of urogynecologists, urologists, gynecologists and obstetrician/gynecologists. While it is impossible to determine precisely how many surgeons use mesh products in general, or even the products at issue in this litigation, Ethicon estimates that the number of surgeons who use the Gynecare pelvic floor repair products (such as Gynemesh PS and Prolift) is between 1,000 and 2,000, and the number who use the Gynecare TVT family of products is between 1,500 and 3,000. Given that many surgeons use both types of products, these numbers likely overlap to a significant extent.

Defense counsel also represented that in ten of the eighteen pelvic mesh cases for which counsel had received medical records, the plaintiffs appeared "to have ceased their physician-patient relationships with the surgeons who implanted the devices at issue."

Plaintiffs' counsel opposed the motion and cross-moved for a protective order barring defendants from retaining or consulting with any physician who at any time had treated any of the plaintiffs in the pelvic mesh litigation.

The trial court ordered plaintiffs to prepare a list of their treating gynecologists, urologists, and urogynecologists. The court also ordered defendants to submit, ex parte and under seal, estimates of the number of physicians currently using or trained to use the defendants' pelvic mesh products and information about defendants' consultations with Drs. Zyczynski and Kavaler.

After the parties provided the additional information, the court issued an order and written decision dated May 26, 2011, barring defendants from consulting with or retaining any physician who had at any time treated any plaintiff in the pelvic mesh litigation as identified in plaintiffs' list. At the time of the court's order, the number of plaintiffs had risen to more than 220. Defendants estimated that more than 1,000 physicians were thus disqualified as potential defense experts. According to defendants and amici curiae, the list of plaintiffs and their treating or consulting physicians has grown steadily while this appeal has been pending. At the time appellate briefs were filed in December 2011, the list numbered about 450 plaintiffs and about 1,300 physicians.

The trial court's decision also barred defendants from further engagement of Drs. Zyczynski and Kavaler as defense experts. In response to defendants' argument that any new defense expert would also face potential disqualification as new plaintiffs file suit, the court stated that defendants could move in the future to exempt a physician from the disqualification order. The court also stated it would consider modifying its order more generally if future events reveal that defendants are unable to retain satisfactory expert assistance in this litigation.

We granted defendants' motion for leave to appeal, and we subsequently stayed discovery to the extent it applies to defense experts.

II.

We emphasize at the outset that defendants do not seek to employ any treating physician as an expert witness in his or her own patient's individual case. We have not been asked to decide whether a current or past treating physician can under any circumstances be retained as an expert witness or consultant for the defense in a patient-plaintiff's own case. Compare Piller v. Kovarsky, 194 N.J. Super. 392, 399 (Law Div. 1984) (treating physician was precluded from testifying as a liability expert against patient-plaintiff's claims in medical malpractice action); Serrano v. Levitsky, 215 N.J. Super. 454, 460 (Law Div. 1986) (defendant could not make use at trial of opinion in treating physician's report that defendant-doctor did not commit malpractice) with Kurdek v. W. Orange Bd. of Educ., 222 N.J. Super. 218, 226 (Law Div. 1987) (treating physician was permitted to testify on behalf of the defendant that patient-plaintiff's injury was not permanent); Cogdell v. Brown, 220 N.J. Super. 330, 334 (Law Div. 1987) (in malpractice action, plaintiff was permitted to call as an expert witness a non-treating physician who was originally retained as an expert by defendant doctor).

In this appeal, defendants and amici curiae argue that the May 26, 2011 disqualification and protective order profoundly impairs defendants' ability to defend these lawsuits because it prevents them from employing qualified experts in cases against plaintiffs other than their own current or past patients. They say that the surgeons and other specialists in the United States who have experience with defendants' pelvic mesh products are best qualified to provide vital information and testimony as experts on the use of defendants' products, but those same physicians are also likely to have treated or consulted with a patient who is now a plaintiff or in the future may become a plaintiff in this jointly-managed, multi-plaintiff litigation.

According to defendants, not only does the order severely limit the pool of qualified and willing physicians that defendants can consult and engage as expert witnesses but it places defendants in the precarious position of consulting and preparing experts only to have them later disqualified as new plaintiffs are added to the litigation, as already occurred with Drs. Zyczynski and Kavaler. Defendants contend the court's order will force them to rely on physicians who have less direct patient experience and knowledge of their pelvic mesh products, or perhaps experts who do not practice medicine in the United States. On the other hand, plaintiffs will have the advantage of consulting with and presenting testimony at trial from American physicians who have treated patients and are personally familiar with the use of defendants' pelvic mesh products.

A.

One of the reasons the trial court gave for its disqualification and protective order was that employment of a treating physician as a defense expert "could interfere with the doctor-patient privilege." But the physician-patient privilege, N.J.R.E. 506; N.J.S.A. 2A:84A-22.1 to -22.7, has limited significance in this dispute.*fn4 Because plaintiffs have filed suit, they have waived a claim of privilege with respect to any medical condition relevant to their claims. Stigliano v. Connaught Labs., Inc., 140 N.J. 305, 311 (1995); Stempler v. Speidell, 100 N.J. 368, 373 (1985); see N.J.R.E. 506; N.J.S.A. 2A:84A-22.4.

A plaintiff in these cases cannot claim the privilege as to the diagnosis and treatment of her medical condition that is the subject of the lawsuit, and a treating physician can be compelled to testify as a fact witness regarding those subjects, including the doctor's determination of the cause of the plaintiff's disorder. Stigliano, supra, 140 N.J. at 314; Ginsberg v. St. Michael's Hosp., 292 N.J. Super. 21, 32-33 (App. Div. 1996); see Hague v. Williams, 37 N.J. 328, 336 (1962); Spedick v. Murphy, 266 N.J. Super. 573, 592 (App. Div.), certif. denied, 134 N.J. 567 (1993).

In Stempler, supra, 100 N.J. at 373, which the trial court cited as supporting its ruling, the Supreme Court acknowledged that the physician-patient privilege may extend only to "those elements of [plaintiff's] prior medical history that are not relevant to the litigation." Here, the treating physicians that defendants seek as experts are gynecologists, urologist, and urogynecologists. The treatment and consultations provided by those specialists most likely involved only medical conditions that are relevant to plaintiffs' claims of injuries in this litigation, including the medical history that was provided to the specialists. If treating physicians have knowledge of a plaintiff's medical history or condition that is irrelevant to this litigation, the privilege can be protected by defendants' proposed protocol against disclosure of patient-plaintiff specific information.

Doctors can be expected to understand they are subject to ethical constraints against disclosure of confidential patient information. See id. at 375 (citing Principles of Med. Ethics ยง 9 (Am. Med. Ass'n 1957)). Moreover, the order proposed by defense counsel, see Proposed Order, supra, note 3, would inform any potential physician-expert about the list of plaintiffs in this litigation and instruct the physician about the continuing confidentiality of patient information. As we will discuss later in this opinion, additional requirements in the ...


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