Title: Houston County Health Care Authority, d/b/a Southeast Alabama Medical Center, d/b/a Dothan Surgery Center v. Cynthia Williams and Regina Clevenger (Appeal from Houston Circuit Court: CV-01-440). Application Overruled; Opinion of December 1, 2006, modified.
Citation: N/A
Docket Number: 1021253
State: Alabama
Issuer: Alabama Supreme Court
Date: January 12, 2007

This case was originally assigned to another Justice on
1
this Court; it was reassigned to Justice Harwood on May 10,
2006.
REL:12/01/2006 HOUSTON COUNTY HEALTH CARE V. WILLIAMS
REL:01/12/2007 AS MODIFIED ON DENIAL OF REHEARING
Notice: This opinion is subject to formal revision before publication in the advance
sheets of Southern Reporter.  Readers are requested to notify the Reporter of Decisions,
Alabama Appellate Courts, 300 Dexter Avenue, Montgomery, Alabama 36104-3741 ((334)
242-4621), of any typographical or other errors, in order that corrections may be made
before the opinion is printed in Southern Reporter.
SUPREME COURT OF ALABAMA
OCTOBER TERM, 2006-2007
____________________
1021253
____________________
Houston County Health Care Authority d/b/a Southeast Alabama
Medical Center d/b/a Dothan Surgery Center
v.
Cynthia Williams and Regina Clevenger
Appeal from Houston Circuit Court 
(CV-01-440)
HARWOOD, Justice.1
1021253
2
Houston County Health Care Authority d/b/a Southeast
Alabama Medical Center d/b/a Dothan Surgery Center ("SAMC")
appeals pursuant to Ala. Code 1975, § 6-5-642, from the order
of the Houston Circuit Court certifying a class action in a
lawsuit pending against SAMC.  We vacate the class-
certification 
order 
and 
remand 
the 
case 
for 
further
proceedings consistent with this opinion.
Background Facts
SAMC operates an ambulatory-surgery center ("the center")
in Dothan.  Two plastic surgeons, Dr. Dwight Baker and Dr.
Richard McClintock, frequently performed cosmetic breast
augmentation ("CBA") procedures at the center between May 1998
and August 2001 using saline-filled silicone breast implants.
Until January 31, 2001, they each used the "open bowl"
technique to fill the breast-implant shells with saline.  As
explained in a March 12, 2002, report (hereinafter "the CDC
report") prepared by the Centers for Disease Control and
Prevention of the United States Department of Health and Human
Services ("the CDC"):
"In the 'open bowl' technique, an empty, sterile
plastic bowl was placed on the instrument tray
before the woman arrived in the OR [operating room].
The circulating nurse (or assistant) then took a
1021253
3
bottle of saline for irrigation out of the warming
cabinet (across the hall from OR-2) ... and poured
the saline into the bowl.  The saline in the bowl
was exposed to the air and environment.  After the
woman arrived in the OR 5-55 minutes later, she was
prepped and anesthetized.  A tissue pocket then was
created in the right glandular and muscular tissue
for the implant.
"....
"The scrub nurse removed the breast implant from
its 
sterile 
packaging 
...[,] 
attached 
the
manufacturer's filling tube to the diaphragm valve
in the silicone shell ...[,] used a 60-ml syringe to
draw-up saline from the open bowl and injected the
saline into the implant via a filling tube. ...  The
scrub nurse detached the syringe from the filling
tube, repeated the procedure, and removed any
trapped air bubbles.  Next, the surgeon placed the
implant (filled with 120 m. of saline) into the
tissue pocket.  More saline was drawn up by the
scrub nurse and injected into the [implant] by the
assistant until the desired shape and size were
achieved.  A similar pocket was created on the left
side, and the procedure repeated for the other
implant."
On December 21, 2000, Dr. Baker removed an implant from
the right breast of a patient in whom he had inserted
bilateral implants at SAMC's surgery center on August 10,
2000.  The patient had developed chronic inflammation in her
right breast resulting in capsular contracture.  Upon removing
the right implant, Dr. Baker noticed an abnormal black
sediment in it.  The material was cultured and found to be
1021253
"Curvularia spp." designates species of the genus
2
Curvularia. 
 
Stedman's 
Medical 
Dictionary 
439, 
1659
(Lippincott Williams & Wilkins 2000).
4
Curvularia spp., a soil fungus that produces airborne spores
and can thus become present elsewhere in the environment.2
The patient's left implant was not removed.
On January 26, 2001, Lori Faust, another patient in whom
Dr. Baker had surgically placed implants at the center on
September 12, 2000, returned to him complaining of swelling
and intense pain in her right breast.  He surgically explored
the breast that day and found inflammation evidencing an early
infection; when he removed the implant he noticed many
particles of black residue in the implant itself.  Curvularia
was cultured from the residue in the implant, but not from the
inflamed breast tissue.  Dr. Baker elected to remove not only
the right implant but also the left implant; the fluid in the
left implant was clear, without any evidence of residue, and
there was no inflammation or other sign of infection in the
left breast.   
After this second discovery of Curvularia-contaminated
implant saline, Dr. Baker and Dr. McClintock discontinued
their use of the "open bowl" technique; Dr. Baker began using
1021253
In April 2001 Dr. Baker transferred his practice to
3
another surgery center, and in June 2001 Dr. McClintock
retired from practice. 
On June 22, 2001, Faust sued SAMC and McGahan Medical
4
Corporation, the manufacturer of her implants, in the Houston
Circuit Court. 
5
a "closed system," whereby the saline was transferred from the
bottle into the implant without any exposure to the air, and
Dr. McClintock began covering the bowl of saline with a
sterile drape.3
Dr. Baker presented the Faust implant-contamination case
to SAMC's infection-control committee on February 6, 2001.
The committee instituted a quality-assurance investigation
that month, obtaining in the process fungal cultures from the
air vents in the surgery center.  The cultures were negative
for Curvularia.  On May 29, July 12, and July 19, 2001,
respectively, Dr. Baker removed both implants from three women
for whom he had performed bilateral CBAs at the center on
August 31, June 1, and July 8, 2000, respectively.   The
4
removals 
("explantations") 
were 
performed 
for 
reasons
unrelated to any symptoms of breast discomfort or any signs of
possible infection.  As a purely incidental finding at each
explantation, Dr. Baker discovered abnormal residue in one of
1021253
6
the two implants removed.  When cultured, that residue was
identified as Curvularia.  All the women made a full recovery
from their explantations without any signs or symptoms of
fungal infection. (For convenience, these five cases of known
Curvularia-implant contamination will be referred to as "the
original five.")
The infection-control committee contacted the CDC on July
16, 2001, and, after a necessary liaison was established
through the appropriate local and state health officials, the
CDC was invited on July 20 to assist in an epidemiologic
investigation to identify the source and risk factors of the
Curvularia contamination.  CDC personnel arrived at the
surgery center on July 24 and began an on-site investigation,
which concluded with an "exit interview" with SAMC staff on
August 8.  The CDC report comprises 15 pages of single-spaced
typewritten text and five attachments.  The CDC noted that Dr.
Baker had performed the CBAs for all the original five.  It
determined that he had performed four of those CBAs in
operating room 2 ("OR-2") of the center's four operating rooms
and that each of those procedures had lasted longer than the
average of the 228 CBAs identified by the CDC as having been
1021253
If positive air pressure had been maintained, interior
5
air would have been pushed out into the corridor when the door
was opened.
7
performed at the center during the "study period"  selected by
the CDC: May 1 through September 30, 2000.  (As noted, the
CBAs for the original five were performed within that time
period.)  
Various features of the physical plant of the surgery
center immediately adjacent to one or more of the operating
rooms were considered likely contributors to fungal growth and
the spread of fungal spores, including moisture sources and
variances in air-current distribution.  Two of the operating
rooms, including OR-2, were found to have negative air
pressure, contrary to the established standard requiring that
operating rooms have positive air pressure.  As a consequence,
when the door to each of those two operating rooms was opened,
air from the adjacent corridor was drawn in.   The final
5
staging area for the saline bottles before they were delivered
into an operating room was the warming cabinet located only
six feet immediately across the corridor from the door to OR-
2.  This cabinet was opened 60-70 times a day and had never
been cleaned.  Curvularia was isolated from the nasal mucus of
1021253
8
35 percent of the center's staff, including Dr. Baker and the
nurse who had assisted him in the CBAs for four of the
original five.  No Curvularia was isolated from Dr.
McClintock's nasal mucus.  
The CDC report concluded that "[t]he saline used to fill
the silicone shells probably was contaminated while sitting in
an open bowl before and during the procedure in the OR."  It
noted that "OR-2 and duration of time in the OR were
associated with an increased risk of acquiring Curvularia spp.
contamination of implanted [implants]."  The CDC advanced the
following hypothesis as to how the implant contamination had
occurred:
"The source of the fungal spores could have been
the ambient air of the OR, [Dr. Baker], [his regular
nurse 
assistant], 
or 
other 
culture 
positive
personnel, or the surface of the saline bottle.  A
likely scenario to explain the contamination is that
the moist sheetrock ceiling in the sterile supply
room provided favorable growth conditions for fungi,
including Curvularia spp. Fungal spores, via air
currents, dust, or water droplets, then settled from
the ceiling onto the surface of the saline bottles
stored directly under the water-damaged ceiling.
The contaminated saline bottles then were placed
into the warming cabinet, where the constant opening
and closing of the cabinet door resulted in air
drafts laden with fungal spores.  The air-borne
fungal spores then were then drawn into OR-2 which
was at negative pressure and located directly
opposite the warming cabinet.  This scenario would
1021253
9
explain why women who had their surgical procedure
in OR-2 were at increased risk of [having a
Curvularia contaminated implant].
"One of [the original five] was operated on in
OR-1.  Curvularia spp. could have been dislodged
from the surface of the saline bottle as the saline
was being poured into the open bowl.  It is
plausible that [the nurse assistant] or [Dr. Baker]
shed [a species of Curvularia], although it was not
possible 
to 
establish 
linkage 
to 
either 
on
epidemiologic evidence."
The CDC noted that as of the time of the CDC report, 17
other women who had undergone bilateral CBAs at the center
later had explantations for various reasons, and the saline in
their implants had been found in every instance to be clear
and uncontaminated.  The CDC also noted that the time frame of
the CBAs of the original five overlapped the time when a new
air-handling system had been installed at the center and was
also a time of the year of greater relative humidity. 
The CDC report concluded with a reiteration of the
recommendations it had shared with SAMC personnel at its
August 8, 2001, exit interview. It recommended that only a
"closed system" be used to fill breast implants; that the
center be closed for all further surgery until its air-
handling system had been properly balanced, airflow direction
adjusted, and moisture-control problems corrected; and that
1021253
10
all women who had undergone a CBA using the open-bowl
technique between April 1, 2000, and January 31, 2001, be
notified that they might be at risk of having implants
contaminated with Curvularia.  The CDC explained that at the
time of the exit interview, it had suggested a beginning date
of May 1 for notification, but on November 15 had suggested
moving that date back to April 1 in order to afford a "two-
month buffer before the earliest operation date for one of
[the original five]."  The January 31, 2001, "cutoff" date was
chosen because Dr. Baker and Dr. McClintock had by then
stopped using the open-bowl method.  SAMC had already ceased
admitting patients to the center on August 29, 2001; it did
not reopen the center until extensive renovations and
remediations had been accomplished.
Responsive to the CDC's exit-interview recommendation, as
revised on November 15, SAMC sent identical letters on
December 5 to the 384 women who had undergone open-bowl CBA
surgery at the center during the time frame specified by the
CDC.  The letter read:
"We are contacting you to notify you about a
problem we identified with some saline-filled breast
implants used during the time period when your
breast augmentation surgery took place at [the
1021253
A pro tanto settlement between the plaintiffs and McGahan
6
eliminated it from the case, and its temporary involvement in
11
center].  Women who underwent breast augmentation
procedures with saline-filled implants at [the
center] during the period between April 1, 2000 and
January 31, 2001 may potentially be at risk for
having a fungal contaminant in the saline within
their implants.  We have conducted a formal
evaluation of the problem with the assistance of the
[CDC].
"While the majority of the women who had these
implants have had no symptoms or problems due to the
contaminant, the potential for an infection or
inflammatory reaction increases and exists if any
leakage from the implant occurs.  As of this time,
we know of only one patient who has developed a
medical problem as a direct result of the fungal
contaminant, and this was a localized inflammatory
reaction or infection in the breast.  The symptoms
of such an inflammatory reaction or infection would
include breast tenderness, hardness to the touch,
redness, or pain in the breast.
"It is important that you contact Dr. Dwight
Baker's office at [local and long-distance telephone
numbers provided].  An appointment will be made for
you to meet with Dr. Baker so that he can evaluate
your potential risks in connection with this fungal
contaminant and the options available to you.
Arrangements have been made so that this appointment
will be provided to you at no cost.  This number
should be contacted whether you were Dr. Baker's
surgical 
patient or Dr. McClintock's surgical
patient."
The Litigation
Faust sued SAMC and McGahan Medical Corporation, the
alleged manufacturer of the implant shells, on June 22, 2001.6
1021253
the litigation is not relevant to the issues hereinafter
discussed.
DeShazo was subsequently dismissed on her own motion, and
7
her temporary involvement with the action is irrelevant to the
issues now before the Court.  She claimed a fungal infection
associated with foot surgery performed at the center on June
1, 2001, by a third surgeon.
12
She filed a third amendment to her complaint on February 26,
2002, for the purpose of adding Cynthia Williams, Regina
Clevenger, and Wanda DeShazo as plaintiffs and recasting the
complaint into 15 numbered counts.   Williams averred that Dr.
7
Baker had performed a bilateral CBA on her at the center on
October 4, 2000, and that, after she received SAMC's December
5, 2001, letter, she arranged to have her implants removed on
December 26, 2001.  She averred further that subsequent
microbiological examination revealed that the saline within
one of her removed implants was contaminated with a fungus.
Clevenger stated that Dr. Baker performed a bilateral CBA on
her at the center on November 30, 2000, and that she likewise
had received a copy of the December 5, 2001, letter.  
Against SAMC the plaintiffs asserted claims labeled
"breach of implied warranty"; "medical malpractice"; "AEMLD,"
i.e., a claim under the Alabama Extended Manufacturer's
Liability Doctrine for allegedly providing defective products
1021253
13
unreasonably dangerous for the use for which they were
intended; 
"premises 
liability"; 
"duty 
to 
warn"; 
"suppression";
"res ipsa loquitur"; and "class action complaint," seeking
certification of their action as a class action.  In that
final claim, the plaintiffs asserted that the questions of law
and fact common to the class included "whether SAMC's' conduct
constituted outrageous conduct which caused plaintiffs and the
class members to suffer severe and genuine emotional distress,
including a reasonable fear of developing life-threatening and
debilitating disease."  The "class action complaint" also
sought "equitable relief in the form of a Court-ordered and
supervised medical monitoring program, funded by defendants to
assist Plaintiffs and the Class Members in early detection and
treatment of illnesses caused by their exposure to the various
fungi."  Thereafter, DeShazo and Faust filed motions asking
that their claims against the defendants be severed and that
the class action be dismissed as to them, with Williams and
Clevenger to continue to serve as representative plaintiffs
for the class action.  The circuit court granted those motions
on August 27, 2002, and the case proceeded with only Williams
1021253
14
and Clevenger as named plaintiffs and putative class
representatives.  
The Law Applicable to Class Actions
"In order to obtain class certification, [the
plaintiffs] must establish all of the criteria set
forth in Rule 23(a), [Ala. R. Civ. P.,] and at least
one of the criteria set forth in Rule 23(b). Ex
parte AmSouth Bancorporation, 717 So. 2d 357, 362
(Ala. 1998). Rule 23(a) provides:
"'(a) Prerequisites to a Class Action.
One or more members of a class may sue or
be sued as representative parties on behalf
of all only if (1) the class is so numerous
that 
joinder 
of 
all 
members 
is
impracticable, (2) there are questions of
law or fact common to the class, (3) the
claims or defenses of the representative
parties are typical of the claims or
defenses 
of 
the 
class, 
and 
(4) 
the
representative parties will fairly and
adequately protect the interests of the
class.'
"Rule 23(b) provides, in pertinent part:
"'(b) Class Actions Maintainable. An
action may be maintained as a class action
if the prerequisites of subdivision (a) are
satisfied, and in addition:
"'....
"'(3) the court finds that
the questions of law or fact
common to the members of the
class 
predominate 
over 
any
questions  
affecting 
only
individual members, and that a
1021253
15
class action is superior to other
available methods for the fair
and efficient adjudication of the
controversy. 
The 
matters
pertinent 
to 
the 
findings
include: (A) the interest of
members 
of 
the 
class 
in
individually 
controlling 
the
prosecution 
or 
defense 
of
separate actions; (B) the extent
and nature of any litigation
concerning 
the 
controversy
already commenced by or against
members of the class; (C) the
desirability or undesirability of
concentrating the litigation of
the claims in the particular
forum; 
(D) 
the 
difficulties
likely to be encountered in the
management of a class action.'
"In reviewing a class-certification order, this
Court looks to see whether the trial court exceeded
its discretion in entering the order; however, we
review de novo the question whether the trial court
applied the correct legal standard in reaching its
decision. Reynolds Metals Co. v. Hill, 825 So. 2d
100, 104 (Ala. 2002).
"'We note that an abuse of discretion in
certifying a class action may be predicated
upon a showing by the party seeking to have
the class-certification order set aside
that "the party seeking class action
certification failed to carry the burden of
producing sufficient evidence to satisfy
the requirements of Rule 23." Ex parte
Green Tree Fin. Corp., 684 So. 2d 1302,
1307 (Ala. 1996). Thus, we must consider
the sufficiency of the evidence submitted
by the plaintiff customers.'
1021253
16
"Compass Bank v. Snow, 823 So. 2d 667, 672 (Ala.
2001). If [the plaintiffs] failed to meet the
evidentiary burden as required by Rule 23, then the
trial court exceeded its discretion in certifying a
class action. Smart Professional Photocopy Corp. v.
Childers-Sims, 850 So. 2d 1245, 1248 (Ala. 2002).
"As noted above, Rule 23(b)(3) requires a
finding that 'questions of law or fact common to the
members of the class predominate over any questions
affecting only individual members, and that a class
action is superior to other available methods for
the 
fair 
and 
efficient 
adjudication 
of 
the
controversy.' 
This 
requirement 
'"tests 
whether
proposed 
classes are sufficiently cohesive to
warrant adjudication by representation."' Reynolds
Metals, 825 So. 2d at 104 (quoting Amchem Prods.,
Inc. v. Windsor, 521 U.S. 591, 623, 117 S.Ct. 2231,
138 
L.Ed.2d 
689 
(1997)). 
In 
making 
this
determination, '[c]ourts examine the substantive law
applicable to the claims and determine whether the
plaintiffs presented sufficient proof that common
questions of law or fact predominate over individual
claims.' Voyager Ins. Cos. v. Whitson, 867 So. 2d
1065, 1071 (Ala. 2003). 'When individual issues
predominate over the common claims, manageability of
the action as a class is not possible.' Voyager
Ins., 867 So. 2d at 1077. Therefore, this Court must
determine 
whether 
[the 
plaintiffs] 
presented
sufficient evidence that common questions of law or
fact predominate over individual issues as to each
of [the plaintiffs'] claims."
University Fed. Credit Union v. Grayson, 878 So. 2d 280, 285-
86 (Ala. 2003).
Section 
6-5-641(e), 
Ala. 
Code 
1975, 
provides, 
in
pertinent part, as follows:
1021253
17
"When deciding whether a requested class is to be
certified, the court shall determine, by employing
a rigorous analysis, if the party or parties
requesting class certification have proved its or
their entitlement to class certification under Ala.
R. Civ. P. 23. The burden of coming forward with
such proof shall at all times be on the party or
parties seeking certification, and if such proof
shall not have been adduced, the court shall not
order certification of the class. In making this
determination, the court shall analyze all factors
required by Ala. R. Civ. P. 23 for certification of
a class and shall not order certification unless all
such factors shall have been established."
This Court has explained:
"In determining whether the questions of law or
fact common to the class members predominate over
those questions that affect only individual class
members, the court must initially identify the
substantive law applicable to the case and identify
the proof that will be necessary to establish the
claim. Alabama v. Blue Bird Body Co., 573 F.2d 309,
316 
(5th 
Cir. 
1978). 
This 
consideration 
is
particularly important in cases where one or more of
the claims will require proof of subjective factors
...."
Ex parte Green Tree Fin. Corp., 723 So. 2d 6, 9 (Ala. 1998).
"We have held that the necessity of individualized
testimonies from each class member to prove an
essential element of the cause of action defeats
class certification.  Reynolds Metals Co. v. Hill,
825 So. 2d 100 (Ala. 2002); Compass Bank v. Snow,
[823 So. 2d 667 (Ala. 2001)]." 
Smart Prof'l Photocopy Corp. v. Childers-Sims, 850 So. 2d
1245, 1249 (Ala. 2002).
1021253
18
"The mandate to identify the 'substantive law
applicable to the case' requires more than a simple
statement of which state's law governs; the trial
court is required to identify the elements of the
claims to be certified and to discuss, in the
context of the class-certification criteria, the
proof the plaintiffs must present to establish each
of those elements. It is only by specifically
discussing the elements of each claim in the context
of the Rule 23 criteria that the trial court may
determine whether the plaintiffs can establish the
Rule 
23(a) 
and 
23(b) 
elements 
of 
class
certification. See e.g., Mann [v. GTE Mobilnet of
Birmingham Inc., 730 So. 2d 150, 152 (Ala.1999)]; Ex
parte Green Tree Fin. Corp., 723 So. 2d 6 [(Ala.
1998)]."
Bill Heard Chevrolet Co. v. Thomas, 819 So. 2d 34, 41-42 (Ala.
2001).
In connection with the plaintiffs' burden to demonstrate
that class certification is proper, "[t]he trial court may not
merely rely on assurances of counsel that any problems with
predominance or superiority ... can be overcome."  Ex parte
Green Tree Fin. Corp. 723 So. 2d at 10.  "'If serious
manageability problems exists, it is no answer to say that
they will be resolved later in some unexplained or uncertain
manner.'"  Compass Bank v. Snow, 823  So. 2d 667, 675 (Ala.
2001) (quoting with approval an unpublished order issued by a
federal district judge in a case involving claims virtually
identical to those asserted in Snow).
1021253
19
"If a named plaintiff has not been injured by the wrong
alleged in the complaint, then no case or controversy is
presented and the plaintiff has no standing to sue either on
his own behalf or on behalf of a class."  Ex parte Prudential
Ins. Co. of America, 721 So. 2d 1135, 1137 (Ala. 1998).  This
Court has noted that  
"'[t]he definition of a class cannot be so broad
that it includes persons without standing to bring
the action on their own behalf. Each class member
must have standing to bring the suit in his own
right.' Slaughter v. Levine, 598 F. Supp. 1035, 1041
(D.Minn. 1984) (emphasis added), aff'd, 801 F.2d 288
(8th Cir. 1986), rev'd sub nom. on other grounds,
Gardebring v. Jenkins, 485 U.S. 415, 108 S.Ct. 1306,
99 L.Ed.2d 515 (1988); see also Rios v. Marshall,
100 
F.R.D. 
395, 
407 
(S.D.N.Y. 
1983) 
('class
definition 
... 
should 
be 
limited 
to 
those
individuals who were adversely affected by the
practices of which the named plaintiffs complain')."
Ex parte Central Bank of the South, 675 So. 2d 403, 406-07
(Ala. 1996).  "There would be no reason to certify a class on
a claim  that is not viable."  Mutual Sav. Life Ins. Co. v.
James River Corp. of Virginia, 716 So. 2d 1172, 1180 (Ala.
1998).
The Class-Certification Hearing
At the class-certification hearing convened on October
14, 2002, the plaintiffs presented expert testimony from Dr.
1021253
20
Stephen Moser, an associate professor of pathology and
associate director of the diagnostic microbiology laboratory
at the University of Alabama at Birmingham ("UAB") Health
System; Dr. Bayard Tynes, an internist and professor of
medicine and infectious diseases at UAB; and Dr.  Paul Howard,
an associate clinical professor of plastic surgery at UAB.
Williams and Clevenger also testified, and they introduced the
deposition of Dr. Baker.  Additionally, the plaintiffs
introduced "every deposition that has been taken" by either
side, 
and 
the 
parties 
introduced 
over 
140 
exhibits,
contributing to the voluminous record in this appeal. SAMC
presented expert testimony from Dr. Trish Perl, an associate
professor of medicine in infectious diseases and a hospital
epidemiologist at Johns Hopkins Hospital in Baltimore, and Dr.
Ronald Nichols, a professor of surgery and microbiologist at
Tulane Medical School in New Orleans, with special expertise
in surgical infection control.
Dr. Baker testified that he had used the "open bowl"
method from the time he arrived at the center in January 1999
until he began using a closed system after January 31, 2001.
He acknowledged that microscopic fungal spores in the air in
1021253
21
an operating room could have gotten into the saline in the
open bowl.  He had used equally all four operating rooms at
the center.  At the time of his June 1, 2002, deposition, he
had performed 143 explantations on returning patients.  All
removed implants had been clear and apparently uncontaminated
except for the second implant removed from one of the original
five; it, like her first explanted implant, contained black
particles in the saline.  He further testified, and the other
experts concurred, that the only way to determine whether
fungal contamination is present in an implant is to remove the
implant for examination.   
By the time of the class-certification hearing, more
women who had had CBAs at the center had elected to have their
implants removed.  The CDC had tested all the implants and
provided culture reports reflecting that only the second
implant Dr. Baker had removed from one of the original five
had tested positive for Curvularia.  Out of a total of over
180 sets of implants removed following SAMC's December 5
notification letter and sent to the CDC for testing, all had
tested negative for Curvularia except the second implant from
one of the original five.
1021253
22
Dr. Moser, retained by counsel for the plaintiffs,
conducted an inspection of the center on September 18, 2001.
By then it had been closed for several weeks, and operating
rooms 1, 2, and 3 had undergone extensive demolition.  In the
report Dr. Moser submitted following the inspection, he noted
that because of the demolition, the center at the time of his
inspection was "heavily contaminated with dust," precluding
"meaningful quantitative counts of airborne fungi."  Dr. Moser
did observe extensive evidence of mold contamination and
"[t]he presence of moisture on sheetrock [indicated] that this
might be a longer-term problem."  Based on the details
provided by the CDC report and other information available to
him, he believed that conditions conducive to fungal growth
were "more than likely consistent throughout [the time from
1998 until the center was closed] and the probability of
exposure would be high."  Dr. Moser opined that "during that
period of time it would be highly probable that organisms were
in the environment and potentially could have exposed people
in that environment."  He acknowledged that the amount of
fungi in the air to which patients might be exposed would
differ according to the date and duration of the surgery, how
1021253
23
long the saline sat in the open bowl, the amount of saline
injected, and the humidity condition of the time of year.  He
also recognized that a woman undergoing a CBA in OR-2 would be
at greater risk of exposure than if the CBA had been performed
in another operating room.  Dr. Moser's definition of exposure
was "whether or not the fungus was probably present in the
environment at the time"; he explained that "the conditions,
whether they be periodic or not, over this period of time
favored that exposure."  As to whether that created any risk
to a particular patient, or what that risk would be, Dr. Moser
indicated, "you need to ask the physicians."  Dr. Moser
explained further that even if a fungal spore was present in
implant saline when it was inserted, it might not "persist"
and grow.  
Dr. Tynes testified that the moisture problems at the
center and "high humidity problems" were conducive to mold
growth and that the negative pressure in two of the operating
rooms meant that there was "a higher degree of outside
organisms coming into the operating room rather than having a
sterile condition inside and pushing these to the outside."
He believed that all the patients were "potentially exposed"
1021253
24
to fungal spores, although the more recent CDC data "shows
that there are maybe less than we thought there might be
initially."  He agreed that a patient whose CBA had been
performed in OR-2 was at greater risk for Curvularia; that the
identity of the surgeon who did the CBA was a risk factor; and
that the duration of the surgery and how long the saline bowl
was left open were also risk factors.  Dr. Tynes explained
that sooner or later all breast implants will leak.  He
testified that breast-implant Curvularia could cause serious
health consequences if a leak occurs, but it is also possible
for Curvularia-contaminated saline to leak out of a breast
implant and cause no health problems.  The CDC report,
introduced at the class-certification hearing, stated that if
breast implants
"remain intact, the risk of local or disseminated
disease should be minimal.  However, the incidence
of [implant] deflation through leakage is estimated
to be 1% to 4% per year for the first 10 years. ...
The relative high leakage rate of [implants] is
concerning 
because 
Curvularia 
spp. 
or 
other
pathogens may escape during leakage and result in
local 
soft 
tissue 
infection 
or 
disseminated
disease."
Dr. Howard testified that breast implants leak at the
rate of 1 to 2 percent per year and that the chance of an
1021253
25
implant rupturing after 8 to 10 years is probably greater than
50 percent.  Dr. Howard therefore tells all his patients that
they should have their implants replaced at that point in
time.  He has never used the open-bowl technique in performing
a CBA.  According to Dr. Howard, a woman having a CBA in an
operating room contaminated by fungus would "probably be okay"
if nothing was placed in her body that was contaminated with
the fungus, but if the open-bowl technique was selected by the
surgeon, "I would say [contamination is] more likely."  An
implant is not contaminated just because there is fungus in
the air; contamination occurs only if the fungus ends up in
the implant.  Dr. Howard testified that a decision to use the
open-bowl technique is the surgeon's, but that the standard of
care would dictate that the surgeon follow the manufacturer's
instruction on use of the silicone implant, which usually
recommends a closed system for the saline.  A contaminated
implant creates the possibility of future inflammation or
infection, but, based on the latest CDC test results on the
removed implants, Dr. Howard placed the risk of Curvularia
infection at less than two percent. 
1021253
26
SAMC's two expert witnesses likewise viewed the risk of
Curvularia contamination for any particular patient as quite
low, in light of the negative test results reported by the
CDC.  Dr. Nichols characterized the risk for infection as
"very, very, a very low," believing it to be less than one
percent.  Dr. Perl testified that "the risk of contamination
[of a proposed class member] is extremely low, although I will
admit that it probably varies from patient to patient."  Given
that only one of the six known cases of implant fungal
contamination 
involved 
possible 
infection, 
Dr. 
Perl 
calculated
the risk of infection for the class members to be .25 to .5
percent. 
Williams testified that after she received SAMC's letter
she went to see Dr. Baker, and he recommended that she have
her implants taken out and tested, explaining that there was
no other way to determine if fungal contamination was present
in them.  He told her that SAMC would pay for the
explantation.  Because of the mistrust Williams had by then
developed for Dr. Baker and SAMC, she elected to have her
implants removed by another surgeon in Dothan on December 26,
2001, at her own expense.  The removal surgery cost Williams
1021253
27
$3,200.  Williams testified concerning her emotional upset
after she received SAMC's letter and the financial hardship
imposed on her by the cost of the explantation surgery.
Apparently, her removed implants were not sent to the CDC but
rather were turned over to Dr. Moser.  He testified that he
tested them and found a fungus present in the left implant but
not in the right one.  He was unable to determine the type of
fungus involved because it was "a sterile isolate"; he could
classify it only as some sort of fungus, "a mold," and he
could not rule out the possibility that it was Curvularia.
Clevenger testified that she telephoned Dr. Baker's
office after she had received SAMC's notification letter, and
Dr. Baker's office arranged a conference call between
Clevenger and Dr. McClintock.  He advised her that it would be
in her best interest to have her implants removed and replaced
and that he would have Dr. Baker call her back, but she never
heard from Dr. Baker.  As of the date of the hearing, she had
not had her implants removed, although she testified that she
wanted to have that done eventually. She knew that SAMC would
pay for the procedure if she had Dr. Baker perform the
explantation at the center, but she no longer trusted him or
1021253
28
SAMC, and she wanted to have the procedure done in her
hometown of Macon, Georgia.  At the time of the hearing,
however, she did not have the money to pay for the surgery.
She testified that she has not yet experienced any signs or
symptoms of any problems with her breasts.
The Class-Certification Order
On March 12, 2003, the trial court entered its class-
certification order, certifying a class composed of "[a]ll
women who underwent breast augmentation at [the center] with
saline breast implants (not pre-filled from the manufacturer)
between April 1, 2000, and January 31, 2001."  After reciting
the factual background of the case, the court discussed
application to the facts of the various requirements of Rule
23(a) and (b), Ala. R. Civ. P., discussing in turn
"numerosity," "commonality," "typicality," "adequacy," and
finally "predominance" and "superiority."  With respect to
predominance, the court declared:
"An exposure type mass tort is 'particularly
appropriate' for class action treatment.
 In this
13
particular matter it is the view of the Court that
the question of predominance requires an analysis as
to whether questions of law and fact regarding
liability predominate over questions of law and fact
as to the individual class members' damages.
Counsel 
for 
Plaintiffs 
outlined 
a 
number 
of
1021253
29
liability issues common to all members of the class.
Among those issues, which are compelling to the
Court, are the cause of the fungus, the exposure to
the fungus, the source of the fungus, matters
involving informed consent, the use of the open bowl
method, the same filling method, and the same
storage of the saline at the Center.  The court
would add to this list that all class members used
just two physicians at one facility.  Also all were
exposed during roughly the same time period as the
women whose contaminated implants were removed.  In
addition to these common facts, the questions of law
regarding liability are the same with all of the
class.
"Even in questions of damages the law would be
the same with each member of the class.  In the
event the jury determines liability, factual issues
of damages will vary from member to member; however,
issues of non-compensatory damages will be fairly
common to all members of the class.  For example,
the question of lost income, if any, will vary from
member to member;
 however, should the jury award
14
mental anguish or punitive damages, many common
issues of law and fact would be involved.
________________
"
Ex parte Russell Corp., 703 So. 2d 953 (Ala.
13
1997).
"
On the other hand, present medical expenses
14
of the large majority of the subclass who have had
their explants removed have already been absorbed by
[SAMC] thus obviating a jury determination of these
amounts."
With respect to the introductory sentence of this section
of the trial court's order, we note the following: This
Court's opinion in Ex parte Russell Corp., which the trial
1021253
30
court cites as authority, although vacating the order
certifying the class, does contain the statement that the
facts and issues involved in that case "make it particularly
appropriate for class relief."  703 So. 2d at 965.  That
statement was clearly dictum, as the special writing of
Justice Houston, joined by Chief Justice Hooper, points out.
703 So. 2d at 966 (Houston, J., concurring in the result).  Of
the seven Justices participating in the case, only the author
of the opinion and two other Justices approved the statement.
703  So. 2d at 968 (Cook, J., dissenting, joined by Shores,
J.).  Therefore, as this Court later pointed out in Regions
Bank v. Lee, 905 So. 2d 765, 771 n. 5 (Ala. 2004): "[T]he law
[on the adequacy issue] as stated in Russell is not binding on
this Court."
The class-certification order in the instant case
certified the entire action for class-action treatment without
discussing, or discriminating among, the various claims
involved, much less the elements of those claims.  The court
did state that "because Plaintiffs seek monetary damages, the
requirements of Rule 23(b) must be established.  This
subsection 
requires 
a 
showing 
of 
predominance 
and
1021253
In connection with its challenge to the "adequacy" of the
8
class representatives, SAMC seeks to have this Court order
that the record be supplemented pursuant to Rule 10(f), Ala.
R. App. P., to include materials generated in Faust's severed
action subsequent to both the class-certification order and
the date the appeal was taken in this case.  We deny SAMC's
motion in that regard, agreeing with the plaintiffs that Rule
10(f) does not allow, under the circumstances of this appeal,
for the addition to the record on appeal of matters not before
the trial court when it entered its decision on class
certification.  Cowen v. M.S. Enters., Inc., 642 So. 2d 453,
454-55 (Ala. 1994); Richburg v. Cromwell, 428 So. 2d 621, 622
(Ala. 1983); Williams v. City of Northport, 557 So. 2d 1272,
1273 (Ala. Civ. App. 1989).  As to the basis of the adequacy
challenge otherwise, we find the principles expressed in
Regions Bank v. Lee, supra, sufficient to show that the trial
court did not exceed its discretion in rejecting, on the
record before it, the arguments SAMC advanced.
31
superiority."  Obviously, the court's reference related
specifically to Rule 23(b)(3).
Discussion
In 
attacking 
the 
class-certification 
order, 
SAMC
challenges the trial court's findings as to all the Rule 23(a)
and (b) requirements save "commonality."  We focus on the Rule
23(b)(3) requirements of "predominance" and "superiority."8
As pointed out earlier, in order properly to perform the
predominance inquiry, a court must examine the substantive law
applicable to the various claims asserted in the case and
identify the elements of those claims, giving consideration to
the proof that the plaintiffs must present to establish each
1021253
32
element.  In the process, the court must be mindful that "the
necessity of individualized testimony from each class member
to prove an essential element of the cause of action defeats
class certification."  Smart Prof'l Photocopy Corp., 850 So.
2d at 1249.  See also State Fire & Cas. Co. v. Evans, [Ms.
1021370, June 16, 2006] ___ So. 2d ___ (Ala. 2006).  Because
we find that one or more essential elements of the majority of
the claims involved in this case will require individualized
testimony, we need discuss only those particular elements in
our analysis.
Because the plaintiffs allege a "medical injury" arising
in the context of their patient-hospital relationship as the
basis for each of their claims, see Ex parte Addiction &
Mental Health Servs., Inc., [Ms. 1041820, July 7, 2006] ___
So. 2d ___ (Ala. 2006), all the claims are governed by the
Alabama Medical Liability Act of 1987, § 6-5-540 et seq., Ala.
Code 1975 ("the AMLA").  Collins v. Ashurst, 821 So. 2d 173
(Ala. 2001); and Mock v. Allen, 783 So. 2d 828 (Ala. 2000).
This includes claims under the Alabama Extended Manufacturer's
Liability Doctrine ("the AEMLD"), claims alleging fraud, and
claims alleging lack of informed consent.  Mock, supra.  
1021253
[Substituted page 33]
"In any action for injury or damages or wrongful
death, whether in contract or in tort, against a
health care provider for breach of the standard of
care, the plaintiff shall have the burden of proving
by substantial evidence that the health care
provider failed to exercise such reasonable care,
skill, and diligence as other similarly situated
health care providers in the same general line of
practice ordinarily have and exercise in a like
case."
§ 6-5-548(a).  A hospital is a health-care provider under the
AMLA. § 6-5-542(1).  In addition, to prove causation with
respect to any of their claims, the plaintiffs must prove by
substantial evidence that the acts or omissions of SAMC
"probably caused" their injuries.  Shanes v. Kiser, 729 So. 2d
319 (Ala. 1999); McAffee v. Baptist Med. Ctr., 641 So. 2d 265
(Ala. 1994).
In their brief to this Court, the plaintiffs assert that
"[i]n this particular case, the exposure is the injury."
(Plaintiffs' brief, p. 42.)  We disagree.  Under current
Alabama caselaw, mere exposure to a hazardous substance
resulting in no present manifestation of physical injury is
not actionable under the AMLA where the exposure has increased
only minimally the exposed person's chance of developing a
serious physical disease and that person has suffered only
mental anguish.   Thomas v. BSE Indus. Contractors, Inc., 624
1021253
[Substitute page 34]
So. 2d 1041 (Ala. 1993); Hinton v. Monsanto Co., 813 So. 2d
827 (Ala. 2001); and Southern Bakeries, Inc. v. Knipp, 852 So.
2d 712 (Ala. 2002).  In Pfizer, Inc. v. Farsian, 682 So. 2d
405 (Ala. 1996), a plaintiff attempting to proceed on a theory
of fraudulent suppression of information relating to a
preexisting history of component failures in a heart valve,
resulting in numerous deaths, could not recover damages based
solely on the risk that his heart valve might one day fail,
when he could not prove that the valve was not then working
properly.  This Court held that, whether viewed in terms of
the law as it relates to fraud or as it relates to product
liability, the heart-valve recipient's "concern that his heart
valve, which is presently functioning normally, could later
malfunction is not an injury recognized by Alabama law."  682
So. 2d at 407.  A person exposed to a known hazardous
substance but not claiming a present physical injury or
illness as a result may not recover as damages the costs of
medical monitoring.  Hinton, supra.  "Opening the courts
generally for compensation for fear of future disease would be
a dramatic change in the law and could engender significant
unforeseen and unforeseeable consequences; awarding such
1021253
[Substituted page 35]
compensation is better left to the Legislature."  Southern
Bakeries, 852 So. 2d at 718.  The plaintiffs do not argue on
appeal that we should overrule or depart from this precedent.
Under this Court's previous holdings, therefore, those
proposed members of the class who have not undertaken
explantations and who have no signs of any infection or other
adverse effects have not suffered a legal injury.  Their only
present detriment would be the fear arising from the
possibility that when put in place, one or both of their
implants contained saline that had been exposed to Curvularia
spores, 
which 
might 
have 
developed 
into 
Curvularia
contamination, which might survive within the implant and
eventually escape its confines, which might then result in an
infection.  As the evidence at the class-certification hearing
demonstrated, the level of such fear would vary from patient
to patient; some could be expected to take a stoic view and,
based on the very low statistical risk shown to be involved,
have little apprehension about their individual situation.  We
do not denigrate the fear of future complications entertained
by any woman electing thus far to forgo explantation.  We
simply recognize that under existing precedent, that fear does
1021253
36
not constitute a present legal injury and is not actionable,
where no other present injury can be demonstrated.  
Clevenger, the representative of patients who have not
had either of their breast implants removed, has not
experienced any signs of infection or other complications that
might be thought attributable to Curvularia contamination.  No
evidence was introduced to suggest that any of the class
members who have not undergone explantations have experienced
any symptoms of adverse effects.  Accordingly, this subset of
patients, and Clevenger as their representative, have suffered
no actual injury and thus lack standing to maintain this
action.  Ex parte Prudential Ins. Co. of America, supra;
Mutual Sav. Life Ins. Co., supra; and Ex parte Central Bank of
the South, supra.  Consequently, the class-certification order
must be vacated as to them.
One of the original five, Faust, has removed herself from
this action.  The other four, with the exception of the one
who had her second implant removed following issuance of the
SAMC notification letter, had no knowledge or apprehension of
the potential for a fungal contamination before it was
detected in one of their removed implants.  They did not
1021253
37
undergo their explantations as a result of any awareness of
the potential for Curvularia contamination.  Only one of those
other three may have experienced some difficulty as a result
of the contamination of one of her implants.  The CDC report
states that "they all made a full recovery."  As explained,
they cannot recover simply for a fear they may have that their
exposure to Curvularia may cause problems in the future.
Moreover, their small number would clearly not satisfy the
subclass "numerosity" requirement of Rule 23(a)(1), i.e., that
"the class is so numerous that joinder of all members is
impracticable."  See Cox v. American Cast Iron Co., 784 F.2d
1546, 1553 (11th Cir. 1986) ("As the trial judge who
originally certified the class pointed out, citing  3B
Moore's Federal Practice ¶ 23.05[1] at n. 7 (1978), while
there is no fixed numerosity rule, 'generally less than
twenty-one is inadequate, more than forty adequate, with
numbers between varying according to other factors.'").  When
a subclass is created out of a class, the subclass must itself
be treated as a class for the purpose of Rule 23, and must
independently meet all the requirements of Rule 23 for
maintenance of a class action.  Johnson v. American Credit Co.
1021253
38
of Georgia, 581 F.2d 526 (5th Cir. 1978); LaBauve v. Olin
Corp., 231 F.R.D. 632 (S.D. Ala. 2005); Pickett v. IBP, Inc.,
197 F.R.D. 510 (M.D. Ala. 2000); Woodward v. Nor-Am Chem. Co.,
(No. Civ. A. 94-0780-CB-C, May 16, 1996)(S.D. Ala. 1996)(not
reported in F. Supp.).
Thus, the three women who had the explantations before
they reviewed the notification letter from SAMC and who had
the explantations for reasons unrelated to any fear or
symptoms of Curvularia contamination and who have made a full
recovery without any known complications are not eligible for
subclass certification. Even if their demonstrated implant
contamination should be recognized as a present injury and
their claims could be merged with those of the larger cohort
of women who underwent explantation following receipt of the
notification letter, class certification would still be
inappropriate, for the reasons hereinafter explained.
Those patients who underwent explantations following
receipt of the notification letter have experienced an actual
injury by virtue of undergoing that surgery, even in those
instances where SAMC paid for it.  SAMC makes no claim that
the decision by any of those women to have her implants
1021253
39
removed was in any way unreasonable.  The evidence from Dr.
Baker, Williams, and Clevenger was to the effect that Dr.
Baker recommended such removal, and several of the other
experts who testified would recommend removal of the implants
to every patient.  The detriment to these patients is the
explantation surgery, independent of any contamination or fear
of infection.  Therefore, any woman undergoing explantation
surgery as a result of receiving the notification letter would
have 
standing 
to 
bring 
an 
action, 
and 
Williams 
is
representative of this group.   
Accordingly, we look to see if those plaintiffs with
standing carried their burden of proving that, with respect to
this potential class, common questions of law or fact
predominate over individual issues.  To that end, we consider
the elements of certain of the claims included within the
certified class action.  To prove their claim specifically
labeled as one for medical malpractice, as well as all of
their other differently denominated claims, the plaintiffs
must prove a breach of the standard of care.  See, e.g., Ala.
Code 1975, § 6-5-548(a).  Any breach of the standard of care
would be a function of the evolving conditions existing at the
1021253
40
center at a particular point during the course of the time
frame in the class-certification order.  Individualized proof
would therefore be required to establish that a breach of the
standard of care had occurred as of the date of any particular
patient's CBA.
To prove their AEMLD claim, the plaintiffs must prove
that they suffered injury from a Curvularia-contaminated
implant provided by SAMC.  See Skelton v. Druid City Hosp.
Bd., 459 So. 2d 818 (Ala. 1984).  They must prove that at
least one of the implants inserted in their breasts was "in a
defective condition unreasonably dangerous" to the plaintiff
at the time of implantation and that she probably suffered
injury as a result.  Casrell v. Altec Indus., Inc., 335 So. 2d
128, 132 (Ala. 1976).  For any individual patient to show that
her 
implant 
was 
inserted 
in 
"a 
defective 
condition
unreasonably dangerous" to her and that she probably suffered
injury as a result, she will have to present individualized
proof concerning the condition of her implant and its effect
on her.  All of the members of this potential class of
patients have had their implants removed and the contents
cultured, and only the second implant removed from one of the
1021253
41
original five was found to have any fungal contamination.  The
very low risk of actual contamination agreed upon by the
experts at the class-certification hearing precludes any
reliance upon an assumption that mere exposure to the varying
conditions of the ambient air in the operating room probably
led to contamination for any given patient.  Actual defective
condition of the implants must therefore be proved for each
individual patient.  
To prove her interrelated claims of premises liability
and duty to warn of the condition of the premises, each
plaintiff would have to show by substantial evidence either
that the center was not kept in a reasonably safe condition at
the time of her CBA or that SAMC failed to warn her of a
danger of which it knew or ought to have known at the time of
her surgery.  Mills v. Bruno's, Inc. 641 So. 2d 777 (Ala.
1994).  SAMC's actual knowledge over the course of the time
frame specified by the class-certification order of a possible
problem of fungal contamination at the center, its eventual
actual 
knowledge 
of 
the 
detected 
presence 
of 
fungal
contamination, and what SAMC should have known as information
came to its attention over the course of that time frame were
1021253
42
not static.  What SAMC knew or should have known varied along
the entire course of that time line.  Thus, individualized
inquiry will be required to determine whether SAMC failed to
keep its premises in a reasonably safe condition at any given
point in time and whether it knew or ought to have known of
conditions potentiating fungal growth, or actual fungal
growth, and ought to have warned its patients accordingly.  
The count of the complaint captioned "suppression"
asserts that SAMC "actively suppressed and concealed" from the
plaintiffs 
"known 
dangers 
presented 
by 
the 
fungal
contamination 
of 
its 
premises 
and 
operating 
rooms,"
withholding dissemination of information that would have
warned the plaintiffs of the risks associated with the
contamination.  As thus pleaded, and as the plaintiffs
acknowledge in their brief, to establish their suppression
claim, the plaintiffs must prove that SAMC had actual
knowledge of the fungal contamination. See also  State Farm
Fire & Cas. Co. v. Slade, 747 So. 2d 293, 323-24 (Ala. 1999).
Thus, the plaintiffs will need to prove what SAMC actually
knew at different points along the evolving course of the time
line in the class-certification order.  Additionally, a
1021253
43
plaintiff in a suppression case must prove that she was
induced to act by her reasonable reliance on the state of
affairs as it appeared in the absence of the suppressed
information (Voyager Ins. Co. v. Whitson, 867 So. 2d 1065,
1074 (Ala. 2003); Ex parte Household Retail Servs., Inc., 744
So. 2d 871, 879 (Ala. 1999)) and that she suffered an actual
injury as a result of the suppression.  Southern Bakeries, 852
So. 2d at 716. 
"When fraudulent suppression is at issue, the trial
court 'must examine the facts to determine whether
the defendant had a duty to disclose.' Ex parte
Government Employees Ins. Co., 729 So. 2d [299] at
305 [(Ala. 1999)]. 'The impact of this law ... on
the class certification decision, is fatal.' Mack
[v. General Motors Acceptance Corp.], 169 F.R.D.
[671] at 677 [(M.D. Ala. 1996)]."  
Regions Bank v. Lee, 905 So. 2d at 774.  "Whether the
[defendants] had a duty to disclose and breached that duty as
to any of the [plaintiffs] are also individual issues that are
inappropriate for class certification."  Compass Bank v. Snow,
823 So. 2d at 674.  Again, what SAMC actually knew about the
dangers of fungal contamination of its premises and,
consequently, what duty it had to disclose information to the
patients at the center, would have been different at different
points in time along the time line in the class-certification
1021253
44
order.  Thus, "the trial court would be forced to make a
detailed inquiry as to each and every class member to
determine whether [SAMC] owed that member a duty to disclose
and whether [SAMC] had induced each individual to act."
University Fed. Credit Union v. Grayson, 878 So. 2d at 289.
Because of the need for such a constellation of individualized
proofs, suppression cases are rarely, if ever,  eligible for
class-action treatment.  Regions Bank, supra; Grayson, supra;
Voyager Ins. Cos., supra; Compass Bank, supra; Ex parte
Household Retail Servs., Inc., supra; and Ex parte Government
Employees Ins. Co., supra.
The plaintiffs have otherwise insinuated into the class-
action-certification proceedings claims of "lack of informed
consent" and "outrageous conduct."  To sustain a claim of
outrageous conduct, each particular plaintiff will need to
show, as an essential element of the cause of action, that her
level of emotional distress meets the level of extreme
emotional distress for which an action for the tort of outrage
will lie.  Thomas v. BSE Indus. Contractors, 624 So. 2d at
1045.  
1021253
45
To prove lack of informed consent, each patient will need
to establish what disclosure of information is required by the
standard of care applicable to a hospital, establish what  she
was in fact told, and prove that had she been given certain
inappropriately withheld information she would not have
submitted to the medical treatment in question.  Craig v.
Borcicky, 557 So. 2d 1253 (Ala. 1990).  Although Dr. Baker
testified in his deposition that in advance of performing a
CBA he provided the patient with certain prepared materials
and generally discussed the risks associated with the surgery
in the same manner each time, he also testified he would try
to answer any individual questions a patient might have.  The
claim in this case, however, is that SAMC failed to obtain the
informed consent it independently was obliged to obtain and
there was no evidence concerning what discussions its
personnel routinely had with patients.  For the reasons
already explained, what information SAMC should have included
in any informed-consent disclosure would have varied over the
course of time according to the level of knowledge it had by
then acquired concerning fungal contamination of the center.
Likewise, individualized inquiry would need to be made
1021253
46
concerning the effect appropriate disclosure would have had on
the decision-making process of a particular patient.  The
requirement for individualized inquiry into the state of mind
of each plaintiff makes the claim inappropriate for class
certification.  Funliner of Alabama, LLC v. Pickard, 873 So.
2d 198, 211 (Ala. 2003).  See also Avis Rent-a-Car Sys., Inc.
v. Heilman, 876 So. 2d 1111, 1123 (Ala. 2003).
The plaintiffs seek to recover for each patient in the
proposed class damages for mental anguish and emotional
suffering and punitive damages.  
"Under 
Alabama 
law, 
recovery 
of 
damages 
for
emotional distress requires individualized proof.
See Kmart Corp. v. Kyles, 723  So. 2d 572 (Ala.
1998).  For this reason, class certification of
claims seeking damages for emotional distress is
inappropriate.  See Allison v. Citgo Pet. Corp., 151
F.3d [402] at 417 [(5th Cir. 1998)]."
Funliner, 873 So. 2d at 210.
Individualized proof also would be required to prove the
costs of explantation for any patient who elected not to have
Dr. Baker perform the explantation at the center; the costs of
any replacement augmentation; the loss of time and income
associated 
with 
the 
explantation 
and 
the 
associated
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47
convalescence; and any disfigurement or cosmetic detriment
resulting from the explantation surgery.
Punitive damages in this case would have to relate to,
and therefore require time-correlated proof of, what SAMC knew
or should have known about fungal contamination at any given
point in time and consciously or deliberately withheld
oppressively, fraudulently, wantonly, or maliciously. Ala.
Code 1975, § 6-11-20.
Given this array of individualized inquiries that
necessarily must be undertaken in the trial of this action as
comprehensively certified by the trial court, it is clear that
the plaintiffs did not carry their burden under Rule 23(b)(3)
of proving, among other things, that questions of law or fact
common to the class members predominate over questions
applicable only to individual class members.  Similarly, the
plaintiffs have failed to sustain their Rule 23(b)(3) burden
of proving that class-action treatment of this entire case
would be superior to any other method for the fair and
efficient adjudication of the controversy.  "When individual
issues predominate over the common claims, manageability of
the action as a class is not possible," and the plaintiffs'
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48
claims "fail to meet the superiority requirement of Rule
23(b)(3)."  Voyager Ins. Co., 867 So. 2d at 1077.  "Because
individual 
issues 
predominate over the common claims,
manageability difficulties render the claims unfit for class
certification."  Smart Prof'l Photocopy, 850  So. 2d at 1252.
Because, as noted, we deal with the certified action as
an entirety, there having been no separation and analysis of
the various claims and their elements in the class-
certification order, we do not now undertake to investigate
whether any of the claims not discussed above might properly
be susceptible to class-action treatment.  "We conclude that
the trial court is in a better position to determine whether,
based on the facts of this case and this Court's conclusion
that individual issues of fact exists as to the fraudulent-
suppression claim" and the other identified claims, "class
certification is proper as to [any remaining] claims."
Regions Bank v. Lee, 905 So. 2d at 776 n. 11.
Conclusion
Because, as to a majority of the claims certified for
class-action treatment, the plaintiffs failed to carry their
burden of proving their entitlement to class certification
1021253
49
under Rule 23(b)(3), the trial court erred in certifying the
class.  We therefore vacate the class-certification order and
remand this case for further proceedings consistent with this
opinion.
ORDER VACATED AND CAUSE REMANDED.
Nabers, C.J., and See, Lyons, Woodall, Stuart, Smith,
Bolin, and Parker, JJ., concur.