LAURA BRICK et al. v. JOSEPH F. JOHN, JR., M.D., et al.

 

NOT FOR PUBLICATION WITHOUT THE

APPROVAL OF THE APPELLATE DIVISION

SUPERIOR COURT OF NEW JERSEY

APPELLATE DIVISION

DOCKET NO. A-0749-04T10749-04T1

LAURA BRICK and EDWARD BRICK,

Plaintiffs-Appellants,

v.

JOSEPH F. JOHN, JR., M.D., HEMISPHERX

BIOPHARMA, INC., and TAMMY HOJEIBANE, R.N.,

Defendants-Respondents.

___________________________________________

 

Submitted October 11, 2005 - Decided

Before Judges Lintner and Holston.

On appeal from the Superior Court of New Jersey, Law Division, Middlesex County,

L-5346-02.

Galex Wolf, attorneys for appellants (Richard Galex, on the brief).

Post, Polak, Goodsell, MacNeill & Strauchler, attorneys for respondents Joseph F. John, Jr., M.D. and Tammy Hojeibane, R.N. (Jay Scott MacNeill, of counsel; Thomas J. Pyle, Jr., on the brief).

McCarter & English, attorneys for respondent Hemispherx Biopharma, Inc. (David J. Cooner, of counsel; Mr. Cooner and Mitchell S. Kurtz, on the brief.

PER CURIAM

This case arises out of plaintiff Laura Brick's participation in a clinical medical study testing the safety and efficacy of Ampligen, a new drug manufactured by defendant Hemispherx Biopharma (Hemispherx) and used in the treatment of Chronic Fatigue Syndrome (CFS). On May 31, 2002, plaintiffs, Laura and Edward Brick, filed a complaint for personal injury alleging that defendants Joseph F. John, Jr., M.D., and Tammy Hojeibane, R.N., committed malpractice and defendant Hemispherx was negligent and strictly liable in tort for manufacturing, distributing, and disseminating medical literature concerning a drug that was not fit for its intended purpose.

Defendants answered and a Case Management Order was issued on November 7, 2003, extending discovery to February 12, 2004. On December 18, 2003, plaintiff served an expert report prepared by Dr. Paul Levine opining that John had deviated from standard medical care by admitting plaintiff into the clinical study. On February 18, 2004, another Case Management Order was entered requiring plaintiff to serve all expert reports on or before March 30, 2004. The February 18 Order also required that depositions of parties and witnesses be completed by March 30, defendants' expert reports be served by May 31, and expert depositions and discovery be completed by June 30. The Case Management Order also fixed a trial date of September 13, 2004.

On March 17, 2004, Dr. David Strayer, medical director for Hemispherx's study, was deposed. On April 28, 2004, Dr. Levine wrote to plaintiff's counsel and advised, after reviewing the transcript of Strayer's deposition, that Hemispherx should have used the 1994 definition of CFS rather than the 1988 definition and that Hemispherx "demonstrated negligence" because Dr. Strayer stated that he believed that it was possible to have CFS and sleep apnea at the same time. On May 5, 2004, plaintiff sought to amend answers to interrogatories with Levine's opinion that Hemispherx was negligent for using the 1988 definition of CFS. Hemispherx objected to plaintiff's amendment as being out of time. On May 25, 2004, plaintiff moved to amend interrogatories with Levine's supplemental report. She also moved to amend the complaint to delete the products liability claim against Hemispherx and substitute it with a claim of negligence. At the same time, Hemispherx moved for summary judgment.

Plaintiff's motions were denied on June 11, 2004, as was her subsequent motion for reconsideration. On June 25, 2004, the judge granted Hemispherx's motion for summary judgment. On September 10, 2004, defendants John and Hojeibane's motions for summary judgment based upon the Tort Claims Act immunity were granted. This appeal followed.

On appeal, plaintiff contends that the judge erred in denying her request to amend interrogatories with Levine's supplemental report. She also maintains that the judge should have permitted her to amend her complaint and erred in finding that John and Hojeibane were immune as public employees under the Tort Claims Act. We reject plaintiff's contentions and affirm.

On December 28, 1998, plaintiff consulted John after being referred to him by another physician. John diagnosed plaintiff with CFS. At that time, John was a principal investigator in a clinical study, sponsored by Hemispherx, testing the safety and efficacy of Ampligen for the treatment of CFS. John informed plaintiff about the study and she enrolled on January 26, 1999. The consent form signed by plaintiff on January 26 was on University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School (UMDNJ-RWJMS) letterhead and indicated John's address as the Robert Wood Johnson Medical School at 1 Robert Wood Johnson Place, New Brunswick. A disclaimer on the consent form indicated that treatment for any adverse effects would be arranged by UMDNJ. An amended consent form, signed by plaintiff on May 18, 1999, contained the same information.

Ampligen and a placebo were administered twice a week by infusion at Robert Wood Johnson University Hospital (RWJUH). Plaintiff claimed she suffered multiple side effects from administration of the drug. On September 14, 1999, a PIC line was inserted in plaintiff's left upper inside arm because of difficulties encountered in finding a vein for infusion. Claiming that she was experiencing worsening side effects, plaintiff withdrew from the study on June 2, 2000. Thereafter, according to plaintiff's interrogatories, she consulted a pulmonary specialist because she was experiencing breathing difficulties. She also claimed that the pulmonary specialist ordered a sleep study and rendered a diagnosis of sleep apnea. However, no report was submitted from plaintiff's doctor indicating that she was suffering from sleep apnea.

Levine's December 18, 2003, report asserted that John deviated from standard medical care by allowing plaintiff to enter into the study when she did not have more than two of the required criteria for a diagnosis of CFS. According to Levine, the first criterion for CFS is chronic fatigue for six months or longer. Although Levine acknowledged that plaintiff was tired for eight to ten years before seeing John, he did not believe that she suffered from CFS. He opined that in order to be diagnosed with CFS, plaintiff must manifest four or more of the following symptoms:

1) substantial impairment in short term memory or concentration;

2) sore throat;

3) tender lymph nodes;

4) muscle pain;

5) multi joint pain without swelling and tenderness;

6) headaches of a new type, pattern or severity;

7) unrefreshing sleep; and

8) post-exertional malaise lasting more than 24 hours.

Levine opined that plaintiff only demonstrated muscle pain and unrefreshing sleep. Although he indicated that plaintiff complained of having a sore throat in the morning, he did not believe it qualified as a typical CFS sore throat. Likewise, although plaintiff described general achiness, he did not believe she manifested symptom (5) because her complaint did not involve specific joint pain.

Levine's report was silent regarding Hemispherx and did not address issues related to Ampligen as a defective product, nor did it indicate that plaintiff was suffering from sleep apnea at the time she joined the clinical study. Instead, it focused only on John and concluded that John "deviated from the standard practice of medical care for allowing [plaintiff] into the study."

Strayer's deposition revealed the following. Strayer was the medical director of the Ampligen study. John was the principal investigator and took the main responsibility for conducting the study. In order to enroll a patient in the study, the investigator was required to submit a baseline case report to Strayer for his review to determine if the patient met the criteria for the protocol. If a patient failed to meet the criteria, the patient would be rejected. Strayer reviewed all the case report forms, including plaintiff's. As a prerequisite for the study, a patient was required to meet the 1988 Center for Disease Control (CDC) definition of CFS.

Strayer acknowledged that there was a change in the definition by the CDC in 1994. Hemispherx chose not to use the 1994 definition of CFS as the criterion for the study. Strayer explained that they used the 1988 definition because the 1994 definition was broader, thus relaxing a number of the symptoms, as a result of which patients who were not symptomatic to qualify under the 1988 definition met the 1994 definition. The use of the 1988 CDC definition was made clear to the Federal Drug Administration in the study's protocol.

Strayer did not examine plaintiff, instead he relied on the examination performed by John, which reported plaintiff had ten of eleven symptoms required by the 1988 CDC definition. He determined, based upon John's report, that plaintiff qualified for the study. Strayer agreed sleep apnea is a different condition from CFS, but that a patient suffering from sleep apnea would not necessarily be disqualified from an additional diagnosis of CFS. He stated it is possible to have both conditions at the same time.

Levine's April 28, 2004, letter to plaintiff's counsel stated:

I have reviewed the transcript of Hemispherx representative Dr. David Strayer. It is my opinion that Hemispherx should not have proceeded with the study using the [1988] definition of CFS rather than the modified 1994 definition because the 1994 definition corrected some of the flaws in the 1988 version. Hemispherx demonstrated negligence because their representative, Dr. Strayer, stated his belief that it was possible to have both chronic fatigue syndrome and sleep apnea at the same time, which is contrary to the protocol established by Fukuda et al.

Instead of attempting to amend interrogatories by sending a copy of Levine's letter, plaintiff's counsel provided a quoted version of the April 28 report as an amendment to interrogatories. Defense counsel objected to the submission on the grounds that it was out of time, lacked foundation, and was a net opinion.

Both Hojeibane and John were employees of UMDNJ-RWJMS. Neither was an employee of RWJUH. The monies paid by Hemispherx went to the University as direct costs. According to a Certification by David Keller, Claims Manager for UMDNJ, filed in support of John's motion for summary judgment, during the period in question John was the Chief of the Division of Allergy, Immunology, and Infectious Diseases at UMDNJ-RWJMS where he was afforded medical malpractice insurance through UMDNJ's self-insurance program. UMDNJ controlled John's compensation and UMDNJ-RWJMS provided him with his office facilities and support staff. Moreover, all billings for professional services rendered by John were done through UMDNJ.

We first examine plaintiff's contention that the judge erred in denying her motions to supplement Levine's expert report and amend the complaint to include a claim of negligence against Hemispherx. Initially, we note that in granting Hemispherx's motion, the judge cited plaintiff's concession that she did not have a products liability action against Hemispherx and the fact that she had previously denied plaintiff's motion to amend the complaint and extend discovery.

R. 4:24-1(c) provides in pertinent part, "[a]bsent exceptional circumstances, no extension of the discovery period may be permitted after an arbitration or trial date is fixed." On appeal, plaintiff asserts that she met the exceptional circumstances requirement because it was necessitated by a "twelfth hour submission of new information," specifically Strayer's testimony that the study used the 1988 CDC definition for CFS rather than the more recent 1994 definition. She also argues that the denial of her motions to extend discovery and amend the complaint to include a negligence claim against Hemispherx resulted in substantial injustice.

Although mindful of the importance of maintaining effective and efficient management control of cases and of adhering to the practices and deadlines prescribed by the Best Practices rules, we have observed that:

The Best Practices rules were "designed to improve the efficiency and expedition of the civil litigation process and to restore state-wide uniformity in implementing and enforcing discovery and trial practices." Vargas v. Camilo, 354 N.J. Super. 422, 425 n.1 (App. Div. 2002), certif. denied, 175 N.J. 546 (2003). They were not designed to do away with substantial justice on the merits or to preclude rule relaxation when necessary to "secure a just determination." R. 1:1-2.

[Tucci v. Tropicana Casino & Resort, Inc., 364 N.J. Super. 48, 53 (App. Div. 2003).]

Under all of the circumstances presented, however, we are not persuaded that the interests of justice require relief to be afforded plaintiff, nor are we convinced that the judge's determination resulted in unfair prejudice. Firstly, we note that the original complaint indeed alleged negligence on the part of Hemispherx. As such, plaintiff's proposed amendment was not necessary.

More importantly, our Legislature has consolidated negligence, breach of warranty, and strict liability theories of liability for harm caused by a product under the Products Liability Act, N.J.S.A. 2A:58C-1b(3). Plaintiff's argument that Hemispherx should be held responsible under a common law negligence theory runs contrary to the Products Liability Act, which defines a "[p]roduct liability action" as "any claim or action brought by a claimant for harm caused by a product, irrespective of the theory underlying the claim, except actions for harm caused by breach of an express warranty." N.J.S.A. 2A:58C-1(b)(3). Interpreting this section, we explained, "it is clear that common-law actions for negligence or breach of warranties (except express warranties) are subsumed within the new statutory cause of action, if the claimant and harm also fall within the definitional limitations of section 1," which speaks in terms of physical harm caused by a product. Tirrell v. Navistar Int'l, Inc., 248 N.J. Super. 390, 398 (App. Div.) (footnote omitted), certif. denied, 126 N.J. 390 (1991); N.J.S.A. 2A:58C-1b. Here, the claim falls within the sphere of the Act because plaintiff is claiming that a product caused her harm, that is, personal physical injury, albeit because she was not properly screened for the study. Thus, the denial of plaintiff's motion to amend the complaint was appropriate.

We consider next the contents of Levine's supplemental expert report. When interrogatories require copies of experts' reports, R. 4:17-4(e) provides that the answering party must "annex . . . an exact copy of the entire report." Although plaintiff's amendment to interrogatories accurately quoted Levine's April 28 letter, it did not annex a true copy as required by the rule. Additionally, we are satisfied, contrary to plaintiff's contention on appeal, that Levine's supplemental report, even if properly submitted as an amendment, was fatally deficient to establish liability on the part of Hemispherx, whether based upon negligence or strict liability.

The report set forth two conclusions: (1) "Hemispherx should not have proceeded with the study using the [1988] definition of CFS rather than the modified 1994 definition because the 1994 definition corrected some of the flaws in the 1988 version," and (2) "Hemispherx demonstrated negligence because . . . Dr. Strayer[] stated his belief that it was possible to have both chronic fatigue syndrome and sleep apnea at the same time." Plaintiff contends that Levine's supplemental report is sufficient to establish negligence on the part of Hemispherx for using the wrong criteria in diagnosing CFS and based upon Strayer's improper conclusion that a person could be suffering from CFS and sleep apnea at the same time. We disagree.

A "net opinion" is an expert's opinion unsupported by factual evidence. Lanzet v. Greenberg, 126 N.J. 168, 186 (1991); Nesmith v. Walsh Trucking Co., 123 N.J. 547, 549 (1991); Buckelew v. Grossbard, 87 N.J. 512, 524 (1981). The rule "frequently focuses . . . on the failure of the expert to explain a causal connection between the act or incident complained of and the injury or damage allegedly resulting therefrom." Buckelew, supra, 87 N.J. at 524.

Thus, "the net opinion rule requires the expert witness 'to give the why and wherefore of his expert opinion, not just a mere conclusion.'" Kaplan v. Skoloff & Wolfe, P.C., 339 N.J. Super. 97, 102 (App. Div. 2001) (quoting Jimenez v. GNOC Corp., 286 N.J. Super. 533, 540 (App. Div.), certif. denied, 145 N.J. 374 (1996)). Generally, a court will not grant leave to amend a complaint to permit a futile claim or where a motion to dismiss would have to be granted. See, e.g., Interchange State Bank v. Rinaldi, 303 N.J. Super. 239, 256-257 (App. Div. 1997) (denial appropriate when the amendment is so without merit that a motion to dismiss would be granted); Miltz v. Borroughs-Shelving, 203 N.J. Super. 451, 466-69 (App. Div. 1985) (judicial discretion allows for the denial of such a motion in the interest of justice); Hudson Foam Latex Prods., Inc. v. Aiken, 82 N.J. Super. 508, 517 (App. Div. 1964) (denial appropriate if the amendment would violate a court's order).

Levine's April 28 conclusions do not address how the use of the narrower 1988 CDC definition or Strayer's conclusion regarding sleep apnea are causally related to plaintiff's alleged improper selection as a participant in the clinical study or her alleged injuries. Strayer did not perform an independent diagnosis of plaintiff, but instead relied upon John's conclusions. Moreover, although plaintiff claims in her interrogatory answers that she is presently being treated for sleep apnea, she has not provided any medical reports indicating that she is either currently suffering from sleep apnea or was suffering from sleep apnea at the time she entered the clinical study. The amendments sought by plaintiff, even if granted, would not have saved the day. Simply stated, Levine's report failed to explain or provide an adequate causal connection between the acts or incidents complained of and the injury or damage allegedly resulting to plaintiff.

As we have recently reiterated in the summary judgment context, the court is not required, out of deference to the province of the jury as the fact finder, "to turn a blind eye to the weight of the evidence; the 'opponent must do more than simply show that there is some metaphysical doubt as to the material facts.'" O'Loughlin v. Nat'l Cmty. Bank, 338 N.J. Super. 592, 606-07 (App. Div.) (quoting Big Apple BMW, Inc. v. BMW of N. Am., Inc., 974 F.2d 1358, 1363 (3d Cir. 1992), cert. denied, 507 U.S. 912, 113 S. Ct. 1262, 122 L. Ed. 2d 659 (1993)), certif. denied, 169 N.J. 606 (2001). On this record we are satisfied that plaintiff's cause of action against Hemispherx, whether phrased in terms of negligence or strict liability, was based upon no more than mere speculation and conjecture in the realm of the "metaphysical doubt" that we found insufficient to avoid summary judgment in O'Loughlin. Levine's last minute report represented a failed attempt to add a new theory beyond that which had previously been asserted, namely John's alleged malpractice in diagnosing plaintiff with CFS.

We turn our attention to plaintiff's contention that the judge erred in granting summary judgment in favor of John and Hojeibane. Plaintiff asserts that John and Hojeibane were not public employees and if they were, they waived their Tort Claims Act immunity because they never moved to dismiss plaintiff's complaint for failing to file a notice of claim.

We note both John's and Hojeibane's answers asserted in their Sixth Separate Defense that recovery was barred by the New Jersey Tort Claims Act, N.J.S.A. 59:1-1 to 59:12-3. Both John's and Hojeibane's interrogatories, as well as John's deposition, indicated that the Ampligen study was conducted at UMDNJ-RWJMS. Their interrogatory answers also indicated that their malpractice insurance was provided through UMDNJ's self-insurance program governed by the New Jersey Tort Claims Act. Moreover, the consent forms signed by plaintiff were on UMDNJ/RWJMS letterhead. The record is replete with information indicating that John and Hojeibane were employed by UMDNJ-RWJMS and entitled to immunity under the Tort Claims Act. See Eagan v. Boyarsky, 158 N.J. 632 (1999); Lowe v. Zarghami, 158 N.J. 606 (1999). Plaintiff's contention that they were not public employees is devoid of merit and does not warrant further discussion in a written opinion. R. 2:11-3(e)(1)(E).

Likewise lacking merit is plaintiff's assertion that John and Hojeibane waived their defense of Tort Claims immunity. A defendant's failure to plead specifically N.J.S.A. 59:9-2d does not constitute a waiver of immunity so long as the Tort Claims Act generally appears in the answer. Rivera v. Gerner, 89 N.J. 526, 535 (1982). "[T]he plaintiff bears the continuing burden of overcoming each and every limitation of a cause of action." Ibid. Further, a defendant's failure to move to dismiss a complaint for failure to file a notice of claim does not constitute a waiver. Generally, the goals of the notice requirements are:

(1)"to allow the public entity at least six months for administrative review with the opportunity to settle meritorious claims prior to the bringing of suit"; (2) "to provide the public entity with prompt notification of a claim in order to adequately investigate the facts and prepare a defense[]"; (3) "to afford the public entity a chance to correct the conditions or practices which gave rise to the claim"; and (4) to inform the State "in advance as to the indebtedness or liability that it may be expected to meet."

[Beauchamp v. Amedio, 164 N.J. 111, 121-22 (2000) (citations omitted).]

Although the filing of a notice of claim in accordance with the Tort Claims Act is a procedural prerequisite to a plaintiff filing a complaint, N.J.S.A. 59:8-3, it does not create a substantive right of immunity. A public entity may be estopped from raising the failure to provide notice as a defense. Hill v. Bd. of Educ. of Middletown, 183 N.J. Super. 36, 40-42 (App. Div.), certif. denied, 91 N.J. 233 (1982); Anske v. Borough of Palisades Park, 139 N.J. Super. 342, 348-350 (App. Div. 1976). The failure to move to dismiss on procedural notice of claim grounds, however, does not constitute a waiver of either a public entity's or public employee's substantive immunity defenses when properly pled in responsive pleadings.

N.J.S.A. 59:9-2d provides:

No damages shall be awarded against a public entity or public employee for pain and suffering resulting from any injury; provided, however, that this limitation on the recovery of damages for pain and suffering shall not apply in cases of permanent loss of a bodily function, permanent disfigurement or dismemberment where the treatment expenses are in excess of $3,600.00.

 
Defendants' motions for summary judgment were predicated on the complete lack of any medical reports or records, following over two years of discovery, indicating plaintiff suffered from a permanent loss of bodily function as required by N.J.S.A. 59:9-2d. In order to "vault the pain and suffering threshold under the Tort Claims Act, a plaintiff must satisfy a two-pronged standard by proving (1) an objective permanent injury, and (2) a permanent loss of a bodily function that is substantial." Gilhooley v. County of Union, 164 N.J. 533, 540-41 (2000). Plaintiff never satisfied her continuing burden to overcome the limitation of her medical malpractice cause of action against John and Hojeibane by presenting evidence that she suffered a permanent injury. The judge correctly granted summary judgment based upon Tort Claims immunity, N.J.S.A. 59:9-2d.

Affirmed.

As Laura allegedly suffered the injuries for which she seeks damages, we refer to her as plaintiff.

(continued)

(continued)

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A-0749-04T1

November 15, 2005