in the COURT OF APPEALS OF MARYLAND

APPELLEE'S MOTION FOR PARTIAL RECONSIDERATION AND
MODIFICATION OF OPINION

Attorneys for Appellee Kennedy Krieger Institute, Inc.

Date:  September 17, 2001

Appellee, Kennedy Krieger Institute, Inc. (“Kennedy Krieger”) moves this Court to reconsider and modify certain aspects of its August 16, 2001 Opinion in these two cases, pursuant to Rule 8-605(a).  Kennedy Krieger does not ask the Court to change its remand of these cases for trial.

Kennedy Krieger does, however, respectfully request that the Opinion be modified in three respects, summarized in Sections  II, IV, and V of this Motion.

I.                   INTRODUCTION

On the day the mandate in this case issues, hundreds of fully accredited medical research projects now conducted in Maryland will terminate.  These projects, involving the dedicated efforts of countless scientists, are conducted by institutions of international renown.  The projects give hope not only to the thousands who participate in the research, but to countless others who hope to reap the benefits of these studies.  Each of these research projects was initiated only after careful review by Institutional Review Boards of the sponsoring institutions and, in most cases, only after review by other accrediting and funding agencies such as The National Institutes of Health.  The design of each project complied with federal regulations developed over an extended period after intense scrutiny and debate in a process involving the most experienced scientists and most respected bio-ethicists in the world.  The cost to the State of Maryland and its citizens, and the damage done to the institutions as a result of terminating these projects, will be incalculable.  Significantly more important than this damage will be the devastating curtailment of medical research directed to understanding, treating, and curing diseases that impact our most vulnerable populations, the young and the disabled.  And upon issuance of the mandate, the reputation of one of these sponsoring institutions will be indelibly and undeservedly tarnished in a way that no trial on remand can overcome.

These vast and presumably unanticipated consequences stem, in part, from the fact that the Opinion of the Court extends far beyond the relief requested by the appellants either below or in these appeals.  The Opinion thus decides several important and novel policy questions in a summary judgment context and without the benefit of a focused factual record or the filing of briefs by the parties.  The Opinion not only assumes as true every fact put forward by plaintiffs, but does not appear to recognize that as to the broader propositions not urged below by plaintiffs, contrary facts were not in the record because these broader propositions were not placed before the trial courts by plaintiffs and the invidious historical comparisons were never made in a setting where Kennedy Krieger could respond.  At the very least, Kennedy Krieger should be given its day in court.

II.                THE “ANCILLARY” ISSUE SHOULD NOT BE DECIDED ON THIS RECORD.

The far reaching impact of the Opinion stems largely from its resolution of what the Court characterized (Slip Op. at 46) as an “ancillary issue.”  The Court (Slip Op. at 94) held that:

in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child or other person under legal disability in non-therapeutic research or studies in which there is any risk of injury or damage to the health of the subject.

The Court applied that new “ancillary issue” rule to Kennedy Krieger by finding that “based on the record before us, no degree of parental consent, and no degree of furnished information to the parents could make the experiment at issue here, ethically or legally permissible.  It was wrong in the first instance”  (Slip Op. at 93-4).

Kennedy Krieger seeks reconsideration of the Court’s undertaking to reach out and decide in this fashion the sweeping “ancillary issue” – an issue so broad and novel as to more closely resemble the kind of policy issue typically decided by legislative bodies.  The issue was not presented or urged by any of the parties to these proceedings.  The notion of a “per se” rule was first (and only) presented in the amicus brief of the Public Justice Center.  Even in their supplemental briefs filed after the Public Justice Center weighed in, the plaintiffs did not ask this Court to reach beyond the issues presented below and consider a broad per se rule  See, e.g., pp. 14-15 of Appellant Higgins’ Supplemental Brief.  In its positing and disposition of the “ancillary issue,” the Court held, for the first time in this State or any other jurisdiction, that any “non-therapeutic” research that poses “any risk of injury” to participants who are either minors or otherwise under legal disability cannot be undertaken in Maryland even with the informed consent of responsible parents or other appropriate persons, in the absence of prior judicial approval of the research (Slip Op. at 89-94).  At the very least, such a far-reaching and unprecedented holding should be reserved for a case where the issue is squarely presented by the parties in the context of a contested case first at the trial court level, where a proper record responsive to the issue can be developed, and then on appeal.

In this case, the Court has staked out a unique position based upon a record that the Court repeatedly describes as sparse and inadequate. ^[1]   The record that was sparse and inadequate for summary judgment purposes was woefully inadequate for purposes of dealing with the “ancillary” issue (of barring all parental or other surrogate consent) – not surprisingly, since that issue and the determination announced in the Opinion was not raised or urged at any time by either of the plaintiffs below or here. 

In order to understand and apply the Court’s unique rule for research involving persons under disability, one must focus on whether (a) the research subjects the participants to “any risk,” and (b) the research is “non-therapeutic” as to any participants.

A.     What is the meaning of “any risk”?  The first critical part of the unique “ancillary issue” holding is that no one except a judge may consent to a non-therapeutic research study involving a person under disability if it “carries with it any risk of injury or damage to the health of the subject” (emphasis added). ^[2]   This “any risk” part of the formulation would appear to prohibit the Kennedy Krieger Study, even though it was expected to and did reduce lead exposure by 80% or more.  It also will make countless already approved and underway research studies involving Maryland residents unethical and illegal upon the issuance of a mandate reflecting the Court’s per se holding on the ancillary issue, even though they may have been developed in complete conformance with applicable federal regulations and been approved by one or more federal agencies.

Although the Opinion refers to the “minimal risk” threshold test (defined by the federal regulations as “risks beyond that which a child confronts in everyday life”) (Slip Op. at n.38), the Court’s threshold formulation and ultimate statement of the prohibition of non-therapeutic research on minors is in terms not of “minimal risk” but “any risk.”

The “not any risk” rule formulated by the Opinion is extraordinary because of its categorical nature and because it is unprecedented.  The formulation is extreme because it does not tolerate or contemplate even minimal or normal everyday risks.  Normal, everyday risks to the children participating in the Kennedy Krieger Study would include an overwhelming likelihood that they would live in (or visit or play in) homes with unabated lead paint, or would live in units that had not received the benefit of the 80% plus reduction in lead dust levels obtained in the Study homes. ^[3]   It is unique and unprecedented because no Court anywhere has formulated a rule or prohibition of such breadth.  This unique rule was not advocated by the plaintiffs at any stage of these cases.  Plaintiffs continued to press appropriately only the issues and claims they had raised below – that fully informed consent was lacking, that special duties were owed, that the Study failed to conform to applicable federal regulations, that the execution of the Study accordingly made Kennedy Krieger liable, and that the resolution of these issues should be taken to trial rather than decided on summary judgment.

B.            What is “non-therapeutic”?  Although several definitions of non-therapeutic research are alluded to in the Opinion, the Court appears to adopt the “definition” contained at footnote 2 of its Opinion that:

non-therapeutic research generally utilizes subjects who are not known to have the condition the objectives of the research are designed to address, and/or is not designed to directly benefit the subjects utilized in the research, but, rather, is designed to achieve beneficial results for the public at large (or, under some circumstances, for profit).

Aside from the inherent ambiguity of the use of the phrase “and/or,” other elements of the definition are uncertain, vague, and troublesome.  As to the first part of the suggested definition about the subjects not being known to have the condition being studied, that is almost invariably the case when a study looks at the efficacy of a vaccine or of some other preventive (vs. curative) treatment.  Does the Court thereby mean to suggest that all such research is by its very nature non-therapeutic? 

The second part of the Court’s definition (following the “and/or”) and the Court’s apparent conclusion that the Kennedy Krieger Study was not designed “in any way to directly benefit” the participating subjects is especially puzzling.  The very definition of “non-therapeutic” ostensibly adopted by the Court seems not to apply to the plaintiffs in these cases, because there were multiple benefits to them as the Study was designed.

The Kennedy Krieger Study was designed to and did confer benefits on all of its participants – by getting children into housing safer than the vast amounts of housing in the community and by monitoring their progress in maintaining low blood lead levels while in this safer housing.  The Study did not and could not place all of its participants in inner city housing that was certifiably and conclusively determined to contain no lead based paint, or it would have been useless.  But the Study was based on the premise that every single Study participant’s exposure to lead based paint in the home would be significantly reduced (if not entirely eliminated) when compared to what they were likely to encounter in the vast majority of the housing stock not subject to the Study’s ameliorating actions located in the areas in which they lived.  In order to appreciate this, one must understand that approximately 95% of the inner city housing stock in the high risk neighborhoods where the Study was conducted and the participants/plaintiffs lived had high levels of lead dust that had not been abated.  It is clear that the designers of the Study reasonably expected that the “at home” lead paint exposure of the Study participants would be significantly less than it would have been without their involvement in the Study.  The Study protocol was designed to assure that every child enrolled would be in a home with at least 80% less lead dust than other homes in the neighborhood and that reasonable expectation was borne out here by actual study experience with the plaintiffs. ^[4]

III.             PREEMPTION AND THE ANCILLARY ISSUE

If the “ancillary issue” ruling is not withdrawn, it will conflict with federal regulations.  Although this Court briefly alluded to the question of federal preemption, it did so only to point out that the regulations allow states to require additional information in order to make consent effective.  That does not address the more basic question of whether state law conditions may be imposed that render it illegal to perform large categories of research involving minor participants, thus significantly frustrating an important federally-funded research program.  This Court prohibits what the federal regulations would permit.  The Court’s ruling would appear to be preempted by the federal regulations and in violation of the Supremacy Clause of the U.S. Constitution.  See, e.g., Alexis Geier, et al. v. American Honda Motor Co., 120 S. Ct. 1913 (2000), holding that a federal motor vehicle safety standard preempted state tort claims against manufacturers who failed to install airbags.  If the Court does not withdraw or alter its ruling on the “ancillary issue,” it should permit all parties to brief the preemption issue, since it could not have been briefed before.

IV.              The characterization of the study as “unethical” and Comparable to several historical atrocities is unfair and should be withdrawn

Kennedy Krieger cannot understand how a study funded by the federal government and in compliance with federal regulations can be said to be unethical in its design (Slip Op. at 94) or comparable to the atrocities cited in this Court’s Opinion. ^[5]   Even more difficult to understand is why the Court, without offering Kennedy Krieger any opportunity to demonstrate to a fact finder that these characterizations were 180° off the mark, would place such a permanent stain on the character of Kennedy Krieger.

The type of research at issue here has a long-standing history.  It was approved by the federal government, performed in accordance with federal regulations, and conducted with funds supplied by two federal agencies – HUD and the EPA.  The lead abatement was funded by loans made available by the Maryland State Department of Housing and Community Development in conjunction with the government’s Residential Lead Paint Abatement Program.  The Study is the type of research commonly conducted in other states and other civilized countries.  Indeed, this Study was influential in bringing national recognition to the value of newly developed lead abatement measures, many of which have been incorporated in state and local laws and in the federal HUD lead-safety regulations for federally assisted housing.  The Study has been replicated by HUD in 1,200 houses in 13 other cities.

The Court’s Opinion states (at pp. 10-11) that the “apparent protocols” of the Kennedy Krieger research project at issue here “present similar problems” as those in the intentional exposure and gross misrepresentations of the Tuskegee Syphilis Study, the intentional exposure of soldiers and Navajo miners to radiation, the secret administration of LSD to soldiers, the injection of chronically ill patients with cancer cells without their consent, the malicious typhoid experiment conducted by the Nazis at Buchenwald, and the notorious use of the “plague bombs” by the Japanese military in World War II.  Those statements have been widely repeated in the local and national press.

The resulting firestorm of criticism, shock, embarrassment, and inflammatory publicity in the public press has been enormously unfair to an institution with an outstanding record dedicated to helping children, especially poor children, with serious medical problems.  What Kennedy Krieger and its dedicated scientists sought to do here bears no resemblance whatsoever to the atrocious examples of study participants being affirmatively poisoned and/or intentionally deceived about the availability and appropriateness of medical attention.

Baltimore’s inner city is dominated by housing filled with lead paint, posing hazards for all young children ingesting lead dust and lead paint chips.  For several decades, Kennedy Krieger has been treating lead poisoned children who live in Baltimore.  But rather than merely treating the results of lead poisoning, Kennedy Krieger also has been a national leader in attempting to learn how to safely reduce and control residential lead-based paint hazards.

In the late 1980’s, Kennedy Krieger’s research disclosed the dangers of traditional dust-generating de-leading policies, e.g., burning off lead paint, and directed attention to the dangers of lead dust and the value of testing in empty housing.  In the early 1990’s, Kennedy Krieger tested lead reduction methods in empty properties and was able to demonstrate that rather inexpensive lead reduction techniques were effective in reducing lead dust in properties by about 80%.  These interventions included paint stabilization, a range of window and floor treatments, and specialized cleaning.

In 1992, with the encouragement of the EPA and other agencies, Kennedy Krieger first conceived of the Study, which was designed to encourage landlords and owners to take advantage of loan programs to make lead-safety repair interventions in high-risk housing to reduce lead poisoning risks to children and to allow Kennedy Krieger to measure whether all were equally effective.  Kennedy Krieger knew from prior research in empty houses that all of these interventions safely and significantly reduced lead dust levels, and hoped that the results of the Study could be used to set standards and shape practice to protect other children.  Before the Study began, the EPA conducted internal and external reviews of the Study.  The National Centers for Disease Control reviewed the Study.  The Kennedy Krieger Quality Assurance Officers and the Joint Committee on Clinical Investigation of The Johns Hopkins University School of Medicine and The Johns Hopkins Hospital reviewed the Study.

The repair interventions financed through the State program were developed by experts around the country and performed on the properties in the Study by a respected firm in Baltimore with extensive experience in reducing lead hazards in pre-1978 properties.  While they were not done by Kennedy Krieger, they were designed to provide health benefits to the families occupying or moving into the homes.

The Study called for periodic blood lead level testing by Kennedy Krieger for all children in the Study.  If the test showed an increase of 5 or more micrograms per deciliter in lead blood levels or if a blood lead level reached 20+ micrograms per deciliter, Kennedy Krieger then would inspect the home, provide advice on repair and cleaning, and recommend contacting the health care provider.  (These interventions likely would not have occurred absent the Study.)

If blood lead tests showed elevated lead levels, the family received the test results promptly.  Kennedy Krieger also reported blood lead levels to the Maryland Department of Environment’s Lead Registry, which, in turn, reported them to the Baltimore City Health Department Lead Poisoning Prevention Program for case management.

Kennedy Krieger respectfully requests that the Court withdraw its “similar problems” historical comparisons.  After all, Kennedy Krieger sought to provide the families involved in this Study with a dramatically better lead paint environment than they otherwise would have experienced in 95% of the inner city housing stock.  In the case of one of the plaintiffs, all lead paint had, to Kennedy Krieger’s knowledge, been fully abated from the home three years earlier.  In the other, State prescribed dust samples indicated that the lead paint dust in the property was below clearance levels, and a small fraction (3-16%) of what it had been before the work had been undertaken.  For Kennedy Krieger to be likened to the evil Nazi experimenters and others because, in the interest of improving the health and safety of inner city residents everywhere, it encouraged a loan program which dramatically reduced lead paint exposure conditions and then monitored the effect of these interventions, rather than totally eliminating these hazards, is fundamentally unfair.  It has already led to severely damaging media descriptions of Kennedy Krieger.  The plaintiffs have never charged Kennedy Krieger with fraud or with evil or with intentional misconduct or urged that Kennedy Krieger be linked with these historical atrocities.  The suits are for negligence.  As Justice Holmes observed in The Common Law, even a dog distinguishes between being stumbled over and being kicked.  The historical analogies are misguided.

V.                 THE UNCERTAIN ISSUES ON REMAND

Many of the other sweeping statements in the Opinion, which do not directly involve the “ancillary” issue, relate to issues that were not raised below, and, as a result, there is little or no evidence in the record pertaining to them.  It is not clear from the Opinion whether those issues can be addressed on remand.  While the Opinion’s conclusion that “[b]ased on the record before us, no degree of parental consent, and no degree of furnished information to the parents could make the experiment at issue here, ethically or legally permissible” (Slip Op. at 93-94) strongly suggests that the record can be supplemented on remand, its formulation of the ancillary issue rule suggests otherwise.  The Court’s Opinion refers on numerous occasions to the “sparse” or “not extensive” record below (Slip Op. at n.12 and 14).  The Opinion ends by vacating the rulings below and by remanding “these cases to [the trial] court for further proceedings consistent with this opinion”  (Slip Op. at 95).  Kennedy Krieger believes that this directive means that these cases are being remanded so that both sides can develop a full factual record, and so a trier of fact can consider and decide the liability and damages issues raised by the plaintiffs in their negligence claims.

Other passages in the Opinion, however, can be read as precluding the re-opening of a number of those issues.  Trial judges are likely to founder between categorical statements and “sparse record” caveats. ^[6]   Given the fact that these cases were decided without the benefit of a full factual record and given the desirability of avoiding confusion at the trials, with the possibility of multiple appeals, Kennedy Krieger requests that the Court explicitly confirm that evidence relevant to those issues can be submitted to the trial courts.  Those issues include the following:

·        Did the Study violate federal regulations? The Court seems to both reserve compliance with the federal regulations as an issue for remand, and yet conclude (at p. 76) that Kennedy Krieger did not comply.

·        Are there “any risks” caused by Study? Are the parties free to develop a record on the issue of whether the Study posed, or Kennedy Krieger caused, an impermissible risk?

·        May Kennedy Krieger put in evidence bearing on the extent of its obligations and duties – either in contract by reason of the consent document or in tort by reason of a “special relationship”?  While this Court has clearly indicated that consent forms can impose contractual obligations and research projects generally do create special relationships that can lead to liability, the Court appears to have left open for decision on remand the precise scope of such obligations and duties, as well as issues of breach and causation.

·        Has this Court preclusively determined that no amount of informed consent is effective or permissible relative to the Kennedy Krieger Study, or are the parties free to develop a record on that issue?

VI.              CONCLUSION

The common law has developed over many centuries a rich tradition to help courts deal with sea-changes in the law.  That tradition, taught in every law school, asks judges to look at such factors as reliance on the old law, the expressions of other policy-makers, and, most important, the record developed by the parties.  In that way, courts are able to gauge the harm that its opinion might cause to those who have justifiably relied on the old law; to ascertain the reactions of other players in the policy-making process, especially those who are subject to, or responsible for, policy-making; and to develop law based on facts brought forward through the adversarial process, rather than by intuition and innuendo.  That tradition counsels that this Court should reconsider its broad statements concerning the validity of the research at issue here, and of future research involving persons under legal disability.

First, the research here had been approved and funded by two federal agencies, and the partial and full abatements were funded by the State.  The research has been carried out in various forms, under federal auspices, in 13 other cities.  An impressive number of primary policy-makers, representing the elected and regulatory branches of governments in many jurisdictions, have approved the protocols.  No other court or legislature or executive or agency has disapproved of this research program.  That this Court did not know of that unanimity of opinion on the Study’s ethical validity is attributable to the sparseness of the record and the fact that plaintiffs’ claims were far more limited in scope.

Moreover, the Opinion radically upsets settled expectations.  Many studies, not only the one at issue here, have been and are now being conducted on the understanding that they were permissible if they conformed to well-understood societal norms and governing federal regulations.  Major portions of these regulations, known as “the Common Rule” designed for the “protection of human subjects” are made applicable to 15 federal agencies (including EPA, DHHS and HUD) and are codified at 15 different locations in the Code of Federal Regulations.  The protocols governing the conduct of all such studies were set up to comply with that understanding; the reciprocal understanding was that properly conducted and authorized projects would be free from the risk of civil liability. That suddenly is no longer the case.

If the Court believes that something as far reaching as its announced rule, going well beyond the federal regulations, needs to be considered in Maryland by the judicial branch, it should suggest that possibility and remand the cases so that the parties can litigate that issue and develop an appropriate record, which would also bring to bear the wisdom and experience of the research, bio-ethical and youth advocacy communities in a contested proceeding.  That is what the federal government did in developing its extensive regulatory scheme and its multiple protections.  Such record development is even more important when a court, rather than the agencies with the specific expertise on the subject, is the ultimate decision-maker on an issue of this type and magnitude.

The adversarial process must be permitted to work.  Where summary judgment is inappropriate, facts can only be learned through the crucible of cross-examination and a trial.  The process may be lengthy, but it is efficient and fair; those involved get a chance to respond to all allegations.  Because the key issues here were only raised on appeal by an amicus brief, none of those checks on the fact-finding process took place.  Key facts/issues, ranging from the therapeutic/non-therapeutic distinction to the overriding of the extensive federal regulations, were examined by this Court in a vacuum.  The results, by definition, are suspect and should be reconsidered.

Accordingly, Kennedy Krieger respectfully requests that this Court reconsider its Opinion in this case and either grant a re-hearing or withdraw and clarify/modify the Opinion issued.

Respectfully submitted,

_________________________________

Shale D. Stiller
George A. Nilson

William L. Reynolds

Evelyn Pasquier

PIPER MARBURY RUDNICK &

   WOLFE LLP

6225 Smith Avenue

Baltimore, Maryland 21209-3600

(410) 580-3000

_________________________________

S. Allan Adelman

Michael I. Joseph

GODARD, WEST, ADELMAN, SHEFF &

   SMITH, LLC

200-A Monroe Street, Suite 310

Rockville, Maryland  20850

(301) 340-1140

Attorneys for Appellee Kennedy Krieger Institute, Inc.

This motion was printed in 13 point proportionally spaced type, Times New Roman font.

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on this 17th day of September, 2001, a copy of the foregoing Motion for Reconsideration was served by first-class mail, postage prepaid to:

Suzanne C. Shapiro, Esquire
Saul E. Kerpelman & Associates, P.A.
10 North Calvert Street, Suite 600
Baltimore, Maryland  21202
Attorneys for Appellant Myron Higgins

Kenneth W. Strong, Esquire
11 East Chase Street, Suite 4B
Baltimore, Maryland  21202
Attorneys for Appellant Ericka Grimes

Deborah Thompson Eisenberg, Esquire
Marc E. Steinberg, Esquire
Tara Andrews, Esquire
Public Justice Center
500 East Lexington Street, Suite 200
Baltimore, Maryland  21202

Counsel for Amici Curiae the Public Justice Center, the National Health Law Program and East Harbor Village Center

Angus R. Everton, Esquire
Morgan Shelsby Carlo Downs & Everton P.A.
4 North Park Drive, Suite 404
Hunt Valley, Maryland  21030

Counsel for Amicus Curiae The National Center for Lead-Safe Housing

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