Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Lippman v. Ethicon, Inc.

Superior Court of New Jersey, Appellate Division

September 4, 2013

JOEL S. LIPPMAN, M.D., Plaintiff-Appellant,
v.
ETHICON, INC. and JOHNSON & JOHNSON, INC., Defendants-Respondents.

Argued January 19, 2012

On appeal from Superior Court of New Jersey, Law Division, Middlesex County, Docket No. L-9025-06.

Bruce P. McMoran argued the cause for appellant (McMoran, O'Connor & Bramley, attorneys; Mr. McMoran, of counsel; Mr. McMoran and Michael F. O'Connor, on the briefs).

Francis X. Dee argued the cause for respondents (McElroy, Deutsch, Mulvaney & Carpenter L.L.P. and Howard M. Radzely (Morgan, Lewis & Bockius L.L.P.) of the District of Columbia bar, admitted pro hac vice, attorneys for respondents; Mr. Dee and Mr. Radzely, of counsel; Mr. Dee,

Mr. Radzely, Stephen F. Payerle, and Elena Chkolnikova, on the brief).

Before Judges Fuentes, Harris, and Koblitz.

OPINION

FUENTES, P.J.A.D.

Plaintiff Joel S. Lippman, M.D., filed a complaint against his former employer, defendant Ethicon, Inc., a subsidiary of defendant Johnson & Johnson, Inc. (J&J), alleging a violation of the protections afforded to whistleblowers by the Legislature under the Conscientious Employee Protection Act (CEPA), N.J.S.A. 34:19-1 to -8. Plaintiff appeals from the order of the Law Division, granting defendants' motion for summary judgment and dismissing the cause of action as a matter of law.

Accepting plaintiff's allegations as true for purposes of deciding the summary judgment motion, the trial court held that plaintiff did not present a prima facie case under CEPA. The motion judge found that "[a]ll evidence indicates that [p]laintiff performed his job by notifying his supervisors of issues and Ethicon responded appropriately." Relying in part on this court's decision in Massarano v. New Jersey Transit, 400 N.J.Super. 474 (App. Div. 2008), the motion judge concluded that plaintiff admitted "it was his job to bring forth issues regarding the safety of drugs and products, " thus he "failed to show that he performed a whistle-blowing activity."

On appeal, plaintiff argues that the motion judge's "narrow interpretation of CEPA" runs counter to the Supreme Court's repeated admonitions that, as a remedial statute, CEPA should be construed liberally to effectuate its social goal of protecting employees who report workplace misconduct from retaliation. Battaglia v. United Parcel Service, __ N.J. __, (2013) (slip op. at 45-46) (citing Dzwonar v. McDevitt, 177 N.J. 451, 461-62 (2003)). According to plaintiff, the trial court misread our dictum in Massarano to create a class of employees who, as a matter of law, fall outside CEPA's protection merely because they were hired to monitor and express an opinion about the employer's compliance with relevant laws and regulations.

Defendants argue that "[t]he trial court correctly held that plaintiff did not engage in whistle-blowing under CEPA when, " in the course of performing his regular core job functions, he expressed an opinion about the safety of a product. According to defendants, the evidence shows that plaintiff's opinions were considered by his employer through an established deliberative process, that his colleagues and supervisors followed his opinions and recommendations in most cases, and that, in those cases where plaintiff's opinions did not prevail, his suggestions were given due consideration before they were rejected in accordance with established internal protocols. Stated differently, defendants argue that it is not a CEPA violation for an employer to disagree with or, in some cases, even disregard an employee's opinion about the safety of a particular drug or medical device as long as the employer does not retaliate against the employee for expressing such opinions.

As an alternative basis for affirming the trial court's final judgment, [1] defendants argue that: (1) the evidence shows that plaintiff was terminated from his position because he had an inappropriate sexual relationship with a subordinate employee; (2) plaintiff did not establish a prima facie causal nexus between his alleged whistle-blowing activities and his termination; and (3) plaintiff did not rebut the facially business-based, non-retaliatory reasons presented by defendants to justify plaintiff's termination.

In our view, the parties' polarized positions are primarily predicated on the motion court's incorrect legal assumption that an employee's job title or employment responsibilities should be considered outcome determinative in deciding whether the employee has presented a cognizable cause of action under CEPA. We disagree that this notion is consistent with the legal principles established by our Supreme Court in construing the protections afforded to whistleblowers under CEPA. Furthermore, to the extent that such a notion was approvingly expressed or implicitly adopted by the panel in Massarano, supra, 400 N.J.Super. 474, we explicitly decline to endorse it here.[2]

After conducting our own de novo review of the record, Town of Kearny v. Brandt, 214 N.J. 76, 91 (2013), viewing the factual record presented in the light most favorable to plaintiff, Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995); R. 4:46-2(c), and applying the standards established by the Supreme Court in Dzwonar, supra, 177 N.J. at 462, we reverse the trial court's decision to grant defendants' motion for summary judgment. We conclude that there are sufficient material issues of fact in dispute that can only be resolved by a trier of fact.

I

Plaintiff received his degree as a medical doctor from New York Medical College and has a master's degree in public health from Harvard University School of Public Health. From 1983 to 1987, plaintiff had a private medical practice specializing in obstetrics and gynecology. He also served as a clinical assistant professor of obstetrics and gynecology at Tufts University School of Medicine in Boston, Massachusetts during the last year of his private practice. Plaintiff left the private practice of medicine to work at Wyeth-Ayerst Laboratories as an associate director of medical affairs and eventually as a director in the clinical development division of medical affairs.

Plaintiff began his employment association with defendants in 1990, when J&J's subsidiary Ortho-McNeil Pharmaceutical (OMP) hired him to serve as their director of medical services. OMP was, at the time, a manufacturer of pharmaceutical products. Plaintiff received a number of promotions during his ten-year tenure at OMP. He was first promoted to senior director of clinical affairs, then to executive director for clinical affairs, and in 1998 to vice-president of clinical trials.

According to plaintiff, his function at OMP with respect to new products was,

[t]o work with the folks in PRI[3] that were . . . developing these products. To work with the folks at Ortho-McNeil in the group that was called New Product Development as they were looking to launch the product bringing it to market.
So really it was twofold. I had a responsibility to work with the folks actually developing the product and then I had a responsibility to work with the folks who were actually going to market and sell the product once it became available and launched.

ORTHO-PREFEST®

Plaintiff alleges that his first "whistle-blowing" activity occurred between 1998 and 1999 while he was employed at OMP as the vice-president of clinical trials. It is undisputed that plaintiff's position gave him direct responsibility over product quality and safety. Plaintiff alleges that, in 1999, he expressed concerns about the safety of a hormone replacement product developed by PRI called Ortho-Prefest®.

Based on data received from clinical trials in which patients participated in a control study to assess the drug's efficacy and potential risks and side effects, Ortho-Prefest® was shown to cause a higher rate of endometrial hyperplasia, a precursor to endometrial cancer. Plaintiff was concerned about the safety of this drug and made his opinion known to his supervisor Michael Kafrissen. Plaintiff also shared his views with the Ortho-Prefest® team as well as Robert Wills, the vice-president of PRI, and Clair Peterson, PRI's chairperson.

At the time, plaintiff objected to launching Ortho-Prefest® because he believed that marketing the product would violate both the Food, Drug and Cosmetic Act (FDCA) regulations and New Jersey's products liability laws and was "incompatible with the clear mandate of public policy against marketing defective products that present a reasonably foreseeable risk of injury" to the public. Although plaintiff claims that he was reprimanded for expressing this opinion, the record does not support his assertion.

When specifically asked at his deposition to describe the reaction he received from OMP or PRI management for expressing his safety concerns about Ortho-Prefest®, plaintiff responded as follows:

A. I remember feeling pretty bad when I heard what they were saying.
Q. What did they say?
A. They said they didn't agree with it. That this is going to prevent progression of the product. That, you know, to evaluate this it would involve doing a whole new study. This could effect [sic] FDA approval. I don't remember specific comments, but I know it was long [sic] those lines, yes.
Q. Who said that?
A. I don't remember who said it . . . .
Q. You don't remember?
A. I don't remember exactly, no. It was 12 years ago.[4]

The only other evidence of an ostensible "reprimand" concerns an email sent by Wills to six people, including plaintiff. In the email, Wills stated: "All of you created this issue and all of you will fix it." According to plaintiff, although he was not the only one at OMP who had these concerns[5]about Ortho-Prefest®, he was "the one that raised" them. OMP eventually ceased marketing the drug and began a new study. Plaintiff was not demoted, reassigned, or otherwise adversely affected for expressing his opinion about the safety of Ortho-Prefest®.

ORTHO-EVRA®

In late 1999, while serving as vice-president of clinical trials, plaintiff began reviewing data concerning the efficacy and safety of the ORTHO-EVRA® Contraceptive Patch, a transdermal patch that delivered contraceptive agents. As plaintiff explained in response to defendants' interrogatories:

At the time, OMP was a market leader in oral contraceptives. However, many of its oral contraceptive products were going off patent and needed to be replaced with new products or OMP's revenue and market share would decrease.
PRI was developing a new oral contraceptive regimen to replace the older products that were going off patent. [ORTHO-EVRA®] was also in development at this time. [ORTHO-EVRA®] was intended to be a secondary option for consumers that had compliance problems, i.e., they forgot to take their pill each day. It was not intended to be the product of choice.

In his certification submitted in opposition to defendants' motion for summary judgment, plaintiff indicated that he objected to the launching and marketing of the ORTHO-EVRA® patch because "[t]he data showed that patients were experiencing increased [deep venous thrombosis (DVT) a/k/a blood clots] due to the estrogen dosage in the patch." Plaintiff certified that DVTs "can travel through the bloodstream to different parts of the body and cause emboli, strokes, heart attacks[, ] or blindness." In lieu of launching the patch at that time, plaintiff suggested that PRI conduct additional research on these potentially negative side effects. Plaintiff opined that, as originally proposed, the patch presented "an unreasonable risk of substantial harm in violation of the FDCA and applicable regulations and the public policy they reflect."

Defendants note, and the record reflects, that OMP heeded plaintiff's recommendations. As plaintiff acknowledged in his deposition, after discussing the problems with an advisory board comprised of scientists employed by PRI, external experts, and plaintiff, it was mutually decided to stop the launching and marketing of ORTHO-EVRA® pending the results of a clinical study to examine the DVT issue as well as the other known risk factors. When asked specifically if he thought this was an acceptable outcome, plaintiff answered: "I was okay with it at the time." Plaintiff clarified that, although the study was started, it stopped after he left OMP sometime after 2000 because the company "stopped selling the product."

In response to defendants' interrogatories, plaintiff claimed that OMP launched ORTHO-EVRA® in 2002 despite insufficient information about "how much estrogen was getting into the patient." Although he left OMP in June 2000, plaintiff claimed that "[i]n late 2003 and 2004, OMP began receiving reports of deaths caused by pulmonary emboli, heart attacks[, ] and strokes." Because these alleged developments occurred after plaintiff's separation from OMP, their relevance to his claims of retaliation is, at best, tangential. The veracity and probative value of these claims are further undermined by plaintiff's own deposition testimony, in which, in response to the question: "But do you know whether - - how it got on the market or what happened in terms of looking at this issue that you raise?, " plaintiff answers, in relevant part: "I only know that after I saw from [sic] the information in the media that the product was on the market I think in 2002 . . . ."

II

EMPLOYMENT AT ETHICON

Plaintiff characterizes his employment at Ethicon as a "transfer, " which he implicitly attributes to the concerns he expressed about ORTHO-EVRA®.[6] Plaintiff elaborated on this point in an answer he gave to defendants' interrogatories:

In the spring of 2000, at the same time plaintiff was raising his complaints about the safety and efficacy of [ORTHO-EVRA®], he received a call from Cliff Holland, the [p]resident of Ethicon. [Holland] offered plaintiff the position of [vice-president of] [m]edical [a]ffairs for Ethicon. Plaintiff did not go through any formal interviews other than his conversation with [Holland]. He joined Ethicon in July 2000, approximately one and a half months later even though there was a hiring freeze at the time.

In an effort to rebut plaintiff's characterization of his move to Ethicon as a "transfer, " defendants emphasize that at all times relevant to this case, OMP and Ethicon were separate corporate entities with their own presidents and management structures, notwithstanding their subsidiary affiliation to J&J. Whether these assertions are technically correct is not germane to the issues before us.

The record shows that major decisions at both OMP and Ethicon were made and implemented only after they were discussed with and approved by J&J's senior management liaison. Paraphrased in the vernacular used by Ethicon's senior management: "we need to run it by and get approval from corporate in New Brunswick." And with respect to governmental oversight, both OMP and Ethicon were subject to the FDCA, 21 U.S.C.A. §§ 301-399f, and its Medical Device Amendments, 21 U.S.C.A. §§ 360c-360m, and regulated by the Food and Drug Administration (FDA).

In the interest of balance, the record also shows that plaintiff received a significant increase in salary as a result of his new position at Ethicon. When plaintiff separated from OMP in June 2000, his annual salary was $228, 000; six months later, plaintiff's annual salary at Ethicon was $242, 000. Finally, to dispel any lingering doubts, plaintiff specifically stated in his May 5, 2010 deposition that, at the time, he viewed his new position at Ethicon as "better for [his] career."

Dorothy A. Donnelly-Brienza was Ethicon's vice-president of human resources when plaintiff began working for the company. According to Donnelly-Brienza, plaintiff's direct superior and the person to whom he reported was Dennis Longstreet, Ethicon's company group chairperson. Longstreet, who served in this capacity until July 2005, reported to Michael J. Dormer, J&J's chairperson for the medical devices and diagnostic group.

Donnelly-Brienza explained that, as the vice-president of Ethicon's medical affairs, plaintiff was "responsible for safety, ensuring that safe medical practices occurred in clinical trials of [Ethicon's] products; . . . medical reviews, information from a medical standpoint; [and] medical writing." By virtue of these responsibilities, plaintiff was required to serve on a number of internal review boards designed to provide an environment for senior management and policy makers to express their views and suggestions within their particular areas of expertise.

The first of these boards was Ethicon's global management board (GMB). Plaintiff testified that Longstreet created the GMB sometime between 2001 and 2002. Plaintiff's role as a member of the GMB was "to work with the other [GMB] members[, ] [s]trategically make decisions, evaluate the pipeline, make ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.