D.J.L. v. Armour Pharmaceutical Co.

Citation307 N.J.Super. 61,704 A.2d 104
PartiesD.J.L., Plaintiff, v. ARMOUR PHARMACEUTICAL COMPANY, et al., Defendants. Middlesex County
Decision Date29 September 1997
CourtSuperior Court of New Jersey

Page 61

307 N.J.Super. 61
704 A.2d 104
D.J.L., Plaintiff,
Superior Court of New Jersey,
Law Division,
Middlesex County.
Decided Sept. 29, 1997.

[704 A.2d 107]

Page 69

Robert F. Williams and George W. Conk, South Orange (Tulipan & Conk, attorneys) for plaintiff, D.J.L.; Mr. Williams, Mr.Conk, Ronald B. Grayzel, Edison (Levinson, Axelrod, Wheaton, Grayzel, Caulfield, Marcolus & Dunn, attorneys) and Eric H. Weinberg, New Brunswick, on the brief.

Michael R. Cole (Riker, Danzig, Scherer, Hyland & Perretti) for defendant, Armour Pharmaceutical Company; Mr. Cole, Susan M. Sharko, Morristown (Shanley & Fisher, attorneys) and Sara J. Gourley, Chicago, IL (Sidley & Austin, attorneys, admitted Pro Hac Vice) on the brief.

John L. Thurman, Princeton (Mason, Griffin & Pierson, attorneys) on behalf of the State of New Jersey; Mr. Thurman and George W. Fisher, Lawrenceville, on the brief.

[704 A.2d 108] WOLFSON, J.S.C.


This case involves plaintiff's claim that he contracted AIDS after taking anti-hemophiliac factor (AHF), a medicine prescribed for the treatment of hemophilia, and manufactured by the defendant, Armour Pharmaceutical Company (Armour). The question before the court is whether N.J.S.A. 2A:14-26.1 (the Act) which effectively extended the limitations period for certain civil suits against the proprietary plasma processors (the fractionators) is constitutional. By declaring July 13, 1995, to be the accrual date for all causes of action against the fractionators, the Act is alleged to destroy Armour's vested rights by breathing life into D.J.L.'s

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complaint. 1 Plaintiff simultaneously moves to strike this affirmative defense, urging that N.J.S.A. 2A:14-26.1 is constitutional.

Armour contends that the Act violates the Substantive Due Process and Equal Protection clauses of the New Jersey Constitution and is contrary to the ban on special legislation. 2


A. Hemophilia and HIV

Hemophilia is a genetic bleeding disorder characterized by a deficiency of one or more of the proteins necessary for normal human blood to clot. Approximately 85% of all hemophiliacs suffer from a deficiency in the level of a Factor VIII protein, known as hemophilia A. The remaining 15% suffer an absence of Factor IX, known as hemophilia B.

The level of clotting factor present in the blood determines the severity of the condition. Effective blood clotting requires a factor concentration of at least 25%. Those with clotting factors of more than 5% but less than 25% of the normal level are

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considered "mild"; those with levels of 1% to 5% are considered "moderate"; and those with less than 1% of the normal clotting factor are classified as "severe."

The principal threat associated with hemophilia is the inability to heal from spontaneous internal bleeding into the joints, muscles, organs, brain, and body cavities, or from bleeding resulting from trauma, surgery or injuries to the vascular system. Often, such bleeding episodes, if not treated immediately, result in serious injury or death.

Although treatment for hemophilia has evolved over the years, all treatments depend, at least to some extent, on some method of infusion of normal clotting factor into the bloodstream. Historically, these methods have included infusing of whole blood, frozen plasma, or blood products containing the factor necessary for clotting to occur. 3

The use of "factor concentrate" is the preferred method for treating hemophilia. The manufacture of this product requires concentrating the clotting proteins from large quantities of human plasma, which plasma is then pooled and subjected to a process of separation,[704 A.2d 109] fractionation, purification and freeze-drying. 4 The result is a highly concentrated dose of clotting factors, maintained in a powder form, which, when mixed with sterile water, is administered intravenously. 5

Acquired Immunodeficiency Syndrome (AIDS) is caused by a retro virus called Human Immunodeficiency Virus (HIV) which

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invades and destroys the human immune system, rendering the immune system unable to protect the body from opportunistic infections. The disease is known to be fatal in 100% of the cases, has no known cure, and is spreading at a horrifying rate, having "increased more than 100 fold since [it] was discovered in 1981." Marsha F. Goldsmith, "Critical Moment" at Hand in HIV/AIDS Pandemic, New Global Strategy to arrest its Spread Proposed, 268 JAMA 445 (1992); De Milio v. Schrager, 285 N.J.Super. 183, 188-89, 666 A.2d 627 (Law Div.1995). HIV is not spread casually. Rather, it has specific and well-known modes of transmission through sexual contact, exposure to infected blood, or blood components, and perinatally from mother to infant. De Milio, supra, 285 N.J.Super. at 188-89, n. 2, 666 A.2d 627, and authorities cited therein. The development of clinical AIDS symptoms after the infection is typically lengthy and an HIV infected person may live for many years without knowing of the infection or exhibiting any symptoms of the disease.

In the early 1980's, during the onset of the AIDS epidemic, it was still not known what caused the disease, and testing for potentially HIV-infected-blood was not available. As a consequence, the use of contaminated blood or tainted blood products was high. Eventually a heat treatment was developed through which blood-borne diseases such as hepatitis and HIV would be inactivated. Ultimately every producer of factor concentrate developed a heat treatment process for its own product and, by 1985, had obtained the requisite licenses from the FDA to produce the heat-treated product. 6

B. The Legislative History

1. Senate Bill No. 1476

In 1994, the Hemophilia Association of New Jersey lobbied the New Jersey Legislature to eliminate all time barred defenses for

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all claims brought by persons with hemophilia, their families, or their estates, for injuries or death resulting from the infusion of blood products that caused the transmission of AIDS. In response, on September 26, 1994, the New Jersey Senate introduced Senate Bill No. 1476 (S. 1476), which proposed to revive any such cause of action for a period of one year. In its original form, the Bill provided for a reopening of claims against any potential defendant, but was later amended to delete hospitals, doctors, blood banks, suppliers of whole blood, and non-profit factor concentrate processors from its reach, leaving only those claims against "proprietary manufacturers of blood products" to be reopened.

Although the Bill was passed 38-0 by the Senate and 73-1 in the Assembly on June 22, 1995, the bill was conditionally vetoed by the Governor on September 28, 1995, largely in response to the Attorney General's formal opinion that the legislation was "constitutionally deficient."

2. Senate Bill No. 433

Thereafter the New Jersey Senate introduced Senate Bill No. 433 (S. 433) an amended version of S. 1476, through which it sought to remedy the potential constitutional flaws of the prior bill, by setting a date certain for the accrual of the cause of action for those hemophiliacs infected with HIV. According to S. 433, the statute of limitations period would not be deemed to be triggered until July 13, 1995, the date upon which the [704 A.2d 110] Committee to Study HIV Transmission Through Blood and Blood Products of the Institute of Medicine (I.O.M.) released its findings that, "[i]n the Committee's judgment, heat treatment processes to prevent the transmission of hepatitis could have been developed before 1980, an advance that would have prevented many cases of AIDS in individuals with hemophilia." 7

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On February 7, 1996, a Senate substitute for S. 433 was introduced by Senators John Lynch and John Matheussen. Two weeks later the Assembly version was introduced. After being passed by the Senate 37-0 on March 21, 1996, S. 433 passed in the Assembly on May 6, 1996, by a vote of 76-1. On May 8, 1996, it was signed into law by the Governor and thereafter codified by N.J.S.A. 2A:14-26.1 as follows: 8

1. a. The Legislature finds and declares:

(1) Over one-half of the people with hemophilia in this country were infected with the human immunodeficiency virus (HIV) in the early 1980's from contaminated blood products.

(2) AIDS, unlike any other disease, stigmatizes and isolates its victims. Victims, their families and survivors have been reluctant to step forward and seek compensation for their injuries through the legal system because of their legitimate fear of attendant publicity.

(3) Because of this fear, many did not seek timely redress. They also were unaware that blood product manufacturers may have had the technical capacity at the time to address the situation and may have been responsible for their injuries. It is only very recently that a government-sponsored report was issued indicating that the blood products could have been virally inactivated prior to the advent of the AIDS epidemic among blood product recipients.

(4) The scientific complexity of the issue, the compelling psychological and emotional trauma associated with the disease, the lack of publicly available information and the lack of definitive studies at the time combined to create a singular, unique circumstance which existing limitations principles are ill-suited to address.

(5) This act will provide a remedy for the bar which may be imposed by the statute of limitations in these cases by setting a date certain for the accrual of the cause of action.

(6) The Legislature expresses no opinion as to whether any blood product manufacturers may, or may not, have actually been at fault for the contracting of HIV and AIDS among blood product recipients. It is simply the intent of the Legislature to allow these particular victims "Their day in court" in light of the unique and extraordinary circumstances of their plight.


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