Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-alnd-2_13-cv-00733/USCOURTS-alnd-2_13-cv-00733-2/pdf.json

Nature of Suit Code: 360
Nature of Suit: Other Personal Injury
Cause of Action: 28:1391 Personal Injury

---

IN THE UNITED STATES DISTRICT COURT

NORTHERN DISTRICT COURT

SOUTHERN DIVISION

BILLY RYAN LOONEY, ET AL., )

)

Plaintiffs, )

)

v. ) CIVIL ACTION NO. 

) 2:13-CV-00733-KOB

SHEILA D MOORE, ET AL., )

)

Defendants. )

MEMORANDUM OPINION

This case involves a clinical research trial performed on premature infants with low birth

weights. The purported class action suit brought by the infant Plaintiffs, by and through their

parents, alleges that the members of the University of Alabama at Birmingham Institutional

Review Board were negligent and lacked the informed consent of the participants, among other

allegations. (Doc. 32).

This matter comes before the court on “Plaintiffs’ Motion to Compel Production of

Institutional Review Board Documents Allegedly Protected by the Peer-Review Privilege.” (Doc.

45). In their motion, Plaintiffs ask the court to compel UAB to produce the documents generated

by the Institutional Review Board (“IRB”) relating to “Surfactant Positive Pressure, and

Oxygenation Randomized Trial” (“SUPPORT”). Defendants argue that the IRB’s documents are

privileged under Alabama Code § 22-21-8. (Doc. 46). The substance of both parties’ arguments

focuses on whether § 22-21-8 applies to the UAB IRB. 

For the reasons discussed below, the court finds that the privilege from § 22-21-8 applies

1

FILED

 2014 May-12 PM 02:56

U.S. DISTRICT COURT

N.D. OF ALABAMA

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 1 of 6
to the UAB IRB. Therefore, the court will deny the motion to compel without prejudice to

Plaintiffs refiling at a later time, if necessary. 

I. Alabama Code § 22-21-8 Applies to the UAB IRB

The key point of contention among the parties is whether Alabama Code § 22-21-8

applies to the UAB IRB documents and, even if it applies, whether federal regulations preempt

its use here. The application of this particular statute to an IRB is a matter of first impression in

Alabama, although other state and federal courts have addressed the peer review privilege

statutes of other states that have varying degrees of similarity to the Alabama version. 

The function of § 22-21-8 is to render certain materials confidential and prevent those

materials from being “subject to discovery or introduction in evidence in any civil action against

a health care professional or institution arising out of matters which are the subject of evaluation

and review for accreditation, quality assurance or similar functions, purposes, or activities.” Ala.

Code § 22-21-8 (1975). On its face, § 22-21-8 applies to “materials prepared by an employee,

advisor, or consultant of a hospital, clinic, or medical staff and to materials prepared by an

employee, advisor or consultant of an accrediting, quality assurance or similar agency or

similar body . . . .” Id. (emphasis added). 

The Alabama Supreme Court has noted the title of the Act creating the statute—“To

provide for the confidentiality of all written materials and activities concerning the accreditation,

quality assurance, or similar function of any hospital, clinic, or medical staff”—and interpreted

§ 22-21-8 expansively, “[g]iven the broad language used by the Legislature in the title of the

Act.” Ex parte Krothapalli, 762 So. 2d 836, 838-39 (Ala. 2000) (holding that physician’s

applications for staff privileges were protected by § 22-21-8, but that the statute would not

2

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 2 of 6
preclude discovery of records obtained from sources other than the hospital review committee).

As such, the primary questions for this court are whether (1) the IRB’s documents were

created for quality assurance purposes, (2) the IRBs documents are needed to guarantee the high

quality of care for patients, and (3) the confidentiality of the reports and statements is necessary.

See Ex parte Fairfield Nursing & Rehab. Ctr., L.L.C., 22 So. 3d 445, 450 (Ala. 2009). In support

of its position that the privilege applies, UAB submitted affidavits describing the purpose,

function, and practices of the UAB IRB. (Docs. 46-1, 46-2). The affidavits for Sheila Moore and

Dr. Ferdinand Urthaler provide compelling evidence that the IRB’s function regarding

SUPPORT involved evaluating and seeking to improve the quality of health care, as well as

evaluating the qualifications, competence, and performance of providers of health care. The

affidavits also address the necessity of confidentiality to the integrity of the IRB process. Thus,

the IRB documents appear to fall in the protection of § 22-21-8. 

Plaintiffs rely on three cases finding that IRBs are not entitled to protection under state

peer review statutes. In two of these cases, however, the underlying statute at issue, unlike the

Alabama statute, made no mention of quality assurance. See P.J. v. Utah, 247 F.R.D. 664 (D.

Utah 2007) (examining Utah Code Ann. § 26-25-3); Esdale v. Am. Cmty. Mut. Ins. Co., No.

94C4600, 1995 WL 263479, at *2 (N.D. Ill. May 3, 1995) (examining Texas Health and Safety

Code, § 161.032 and § 5.06 of Texas Revised Civil Statutes Annotated 4495b). Furthermore, in

all three of these cases that Plaintiffs cite, the courts narrowly construed the underlying peer

review privileges. See Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993) (turning on the

fact that the Minnesota Supreme Court considered the privilege to be “narrowly limited”); P.J.,

247 F.R.D. at 671 (noting that caution should be used in expanding the role of the federal

3

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 3 of 6
common law of privilege in discovery); Esdale, 1995 WL 263479, at *3 (noting that “because

evidentiary privileges operate to exclude relevant evidence and therefore to block the judicial fact

finding function, they are not favored and, where recognized must be narrowly construed.”). In

Esdale, the one case where the federal court itself imposed the narrow construction rather than

relying on a narrow construction from the state court, the Office of the Attorney General of Texas

subsequently issued an opinion disagreeing with the Northern District of Illinois’s interpretation

of Texas law in Esdale. Tex. Atty. Gen. Op. OR2001-0912 (Tex. A.G.) (“[I]n contrast to the

Esdale court, this office does believe the Texas legislature intended to cover entities such as the

IRB . . . .”). 

Here, however, Alabama courts have broadly interpreted § 22-21-8. See Krothapalli, 762

So. 2d at 838-39. Thus, this case becomes more analogous to those cases finding IRBs to be

protected under the peer review privilege. See KD, 715 F. Supp. 2d at 593 (quoting Baltimore

Sun Co. v. Univ. of Md. Sys. Corp., 584 A.2d 683, 687 (1991)) (finding the peer review privilege

applied to the IRB, in part, because Maryland’s statute “provided ‘broad statutory protection’”);

Pomona Valley Hosp. Med. Ctr. v. Supreme Ct. of Los Angeles Cnty., 209 Cal. App. 4th 687, 686

(Cal. Ct. App. 2012) (holding that “California’s protection is broader than Minnesota’s peer

review statute.”); Doe v. Ill. Masonic Med. Ctr., 696 N.E. 2d 707, 710 (Ill. App. Ct. 1998)

(holding that “the Illinois statute is broader than the Minnesota statute construed in Konrady”). 

Given the broad scope of the Alabama privilege supported by the language of the statute, the

court finds that the documents generated by the IRB are privileged under § 22-21-8 because they

involve quality assurance review of the SUPPORT program.

4

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 4 of 6
II. Federal Law Does Not Preempt Alabama Code § 22-21-8 

Plaintiffs argue that the federal statutes and regulations governing Institutional Review

Boards—42 U.S.C. § 289 and 45 C.F.R. §§ 46.101 et seq.—preempt the application of Alabama

Code § 22-21-8. Whether these federal statutes and regulations preempt any state peer review

privileges is an issue of first impression in the Eleventh Circuit. The court finds that nothing in

these statutes or regulations evidences a Congressional intent to preempt state peer review

privileges. The federal statutes and regulations in question make no mention of civil discovery

much less peer review privileges, and “congressional and regulatory silence usually defeats a

claim of preemption, not the other way around.” Planned Parenthood of Ind., Inc. v. Comm’r of

Indiana State Dept. Health, 699 F.3d 962, 985 (7th Cir. 2012) (citing Wyeth v. Levine, 555 U.S.

555 (2009) (Thomas, J., concurring in the judgment)). 

Moreover, the fact that a division of HHS, the agency promulgating the regulations in

question, argued under similar circumstances that Maryland’s peer review privilege protected its

IRB strongly suggests that the IRB regulations were not intended to preempt Alabama’s peer

review privilege. See KD v. U.S., 715 F. Supp. 2d 587, 588 (D. Del. 2010) (finding the National

Heart Blood and Lung Institute’s IRB documents were protected under Maryland’s peer review

privilege). As a result, the court finds that 45 C.F.R. §§ 46.101 et seq. do not preempt Alabama

Code § 22-21-8.

III. Conclusion

For these reasons, the court finds that the § 22-21-8 privilege applies to the UAB IRB.

However, the parties have argued in generalities about certain documents at issue without

identifying the precise documents sought by Plaintiffs or withheld by Defendants. In fact, the

5

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 5 of 6
Defendants admit that the privilege does not apply to some documents within the IRB records

that can be obtained from other sources but without precise description. In short, the court has

insufficient information concerning what documents have been produced and which withheld

documents Plaintiffs still seek to determine whether specific documents are within or without the

protection of the privilege. This imprecision prevents the court from carefully crafting limitations

to guide the parties in discovery. 

The court ORDERS the parties to communicate in an attempt to agree among themselves

on which documents should be covered by the privilege based on this court’s finding that the

privilege generally applies to the UAB IRB. The court DENIES the motion to compel

WITHOUT PREJUDICE to Plaintiffs’ refiling at a later time if the parties are unable to agree on

the scope of the privilege as to particular documents.

DONE and ORDERED this 12th day of May, 2014.

 ____________________________________

 KARON OWEN BOWDRE

 CHIEF UNITED STATES DISTRICT JUDGE

6

Case 2:13-cv-00733-KOB Document 50 Filed 05/12/14 Page 6 of 6