Proctor v. Davis
State: Illinois
Court: 1st District Appellate
Docket No: 1-92-3151
Case Date: 07/11/1997
July 11, 1997
1-92-3151)
1-92-3513) Cons.
MEYER PROCTOR and MARJORIE PROCTOR, ) Appeal from the
) Circuit Court of
Plaintiffs-Appellants, ) Cook County.
Separate Appellees/ )
Cross-Appellants, )
)
v. )
)
MICHAEL J. DAVIS, M.D., )
)
Defendant-Appellee, )
)
v. )
)
THE UPJOHN COMPANY, a corporation, )
) Honorable
Separate Defendant-Appellant/ ) Leonard L. Levin,
Cross-Appellee. ) Judge Presiding.
PRESIDING JUSTICE HARTMAN delivered the opinion of the court
as modified upon rehearing:
Plaintiffs Meyer Proctor and Marjorie Proctor (sometimes
collectively Proctor) filed this medical malpractice and products
liability action against Dr. Michael J. Davis (Dr. Davis) and the
Upjohn Company (Upjohn), alleging serious injury resulting from Dr.
Davis' injection of the corticosteroid Depo-Medrol, manufactured by
Upjohn, directly into Meyer Proctor's left eye on November 7, 1983.
A jury exonerated Dr. Davis, but found against Upjohn, awarding
Proctor compensatory damages of $3,047,819.76, and punitive damages
of $124,573,750, the latter of which the circuit court remitted to
$35 million. Proctor and Upjohn appealed from that judgment.
Proctor also cross-appealed the denial of their motion for
sanctions and attorney fees.
On June 28, 1994, a unanimous opinion was filed by this court
affirming the jury's decision as to Dr. Davis and its award as to
Upjohn, but reducing the punitive damages to $3,047,819.76.
Upjohn's motion for rehearing was allowed and further oral argument
ensued. The June 28, 1994 opinion was withdrawn. Two members of
this court issued another opinion, affirming the verdict as to Dr.
Davis, but reversing outright the jury's award as to Upjohn
(Proctor v. Davis, 275 Ill. App. 3d 593, 656 N.E.2d 23 (1995)),
with a lengthy dissent. Proctor, 275 Ill. App. 3d at 613-27. Our
supreme court invalidated that opinion because one of the majority
judges, Justice McCormick, had retired before the opinion was to
become effective. This court was directed "to enter a
constitutionally valid opinion or order disposing of the matters
raised, briefed and argued subsequent to Upjohn's unanimously
allowed rehearing petition." Proctor v. Upjohn Co., 175 Ill. 2d
394, 397, 677 N.E.2d 918 (1997). Our opinion and companion Supreme
Court Rule 23 order follow.
Upjohn's claims regarding its duty to warn and punitive
damages will be considered, in part, in this opinion. All
remaining issues and contentions will be determined in a separate
Supreme Court Rule 23 order disseminated contemporaneously with
this opinion.
In 1959, the Food and Drug Administration (FDA) approved
Upjohn's "New Drug Application" (NDA) for Depo-Medrol, a sterile,
aqueous suspension containing methyl prednisone acetate, a
corticosteroid, for treatment of various inflammatory bodily
disorders. The FDA's approval was limited to intramuscular (in the
muscle), intra-articular (in the joint), and intralesional (in a
lesion) injections. According to the evidence, Depo-Medrol is an
insoluble, toxic material, which is intended to be released in the
body over a period of six to eight weeks in human tissue with
adequate blood supply; however, the human eye does not possess such
a blood supply. Depositing Depo-Medrol into the eye meant that the
drug would remain in the eye for a relatively long time. Because
of its insolubility, its crystals had an effect on the body's
response to it when inserted, including increased intraocular
pressure and other trauma. It became a foreign body in the eye,
which was very difficult, if not impossible, to remove once
injected into the eye.
Shortly after Depo-Medrol's FDA limited approval, two
ophthalmologists contacted Upjohn independently, each wishing to
use the drug clinically for the treatment of ophthalmic conditions
through an unapproved method of administration periocular (near
the eye) injections.[fn1] This use of Depo-Medrol was neither
approved by the FDA nor listed on Depo-Medrol's label (off-label
use). Nevertheless, Upjohn immediately provided both with vials of
Depo-Medrol without cautioning them that no animal studies had been
initiated to test the reaction of the drug upon living tissue
before embarking upon human use. Instead, Dr. Porter Crawford, an
Upjohn employee responsible for monitoring Depo-Medrol at the time,
encouraged this unapproved off-label use, as follows:
"Thank you very much for *** your interest in
Depo-Medrol for subconjunctival injection in
the treatment of uveitis. We do not have any
reports concerning this use for the
preparation and we would very much like for
you to evaluate it in this way." (Emphasis
added.)
Dr. Crawford sent vials of Depo-Medrol to the inquiring doctor and
asked him to let him know when he needed additional supplies. Dr.
Crawford also noted that Upjohn would "be anxious to learn how it
performs when used this way."
Upjohn dispensed not only vials of Depo-Medrol but, also,
financial assistance to doctors who would use Depo-Medrol for the
unapproved off-label use of periocular injections, granting one in
1959, $3,000. This doctor later wrote Upjohn that he had given two
talks in Chicago in the fall of 1960, extolling the use of
Depo-Medrol for subconjunctival injections, although he knew
otherwise, having written in the same letter that the "experimental
work *** fell flat since we are unable to find anything in the
aqueous." (Emphasis added.) In response, Upjohn wrote back that
the FDA "has not approved this use of Depo-Medrol because we have
had no clinical work to show to them." Upjohn asked the doctor to
prepare a write-up of his cases or publish an article in order to
document this off-label use for possible FDA approval. Upjohn
noted that "not too many people are actually using this type of
therapy and your good results suggest that the work should be
scattered about."
Upjohn itself undertook the task of "scattering about" the
unapproved off-label use of Depo-Medrol to the medical community.
In 1961, an article on the use of Depo-Medrol was written by the
experimenting doctor to whom Upjohn had given $3,000. This doctor
informed Dr. Crawford, on August 31, 1961, of the completion of the
article, noting separately, however, that he was unable to use any
of his animal experiments because the results were "very
unsatisfactory." (Emphasis added.) Proctor's expert, Dr. Philip
Walson, who reviewed this correspondence, believed the omission of
the animal studies created a serious problem because collected data
was ignored, and the animal studies, although "unsatisfactory,"
should have been included in the article touting this use of Depo-
Medrol.
Upjohn nevertheless ordered and distributed 2,500 reprints of
the article, 500 for "hospital sales" and 2,000 for "sales
education," thus becoming part of the "literature" to which the
ophthalmic community was exposed.[fn2] On November 16, 1961,
Upjohn requested reprints of another experimenting doctor's article
for distribution, which also mentioned the use of subconjunctival
injections of Depo-Medrol.[fn3] More "fodder" priming the sales
pump.
On March 8, 1963, Upjohn's Dr. Samuel Stubbs wrote to a
different experimenting doctor, requesting case histories on the
patients he had treated with Depo-Medrol, which Upjohn would use to
supplement its original NDA. Dr. Stubbs informed him that Upjohn
would compensate him for his time, and that of his secretary, in
preparing the case reports. In response, by letter dated March 14,
1963, the doctor stated that he would begin working on the case
reports and requested that Upjohn meanwhile send him more
Depo-Medrol, which, on March 19, 1963, Upjohn did without
mentioning the information and precautions suggested by its Dr.
Gerard to its salesmen in 1962. E.g., footnote 3.
Harry P. Davis, Jr., an Upjohn sales representative, wrote to
Mr. Crissman at Upjohn on June 12, 1963, informing him that two
Ohio physicians were using Depo-Medrol for "severe, chronic or
acute, uveitis by retrobulbar injection," but that neither
physician was aware that anything had been published on the use of
this drug. Dr. Stubbs wrote to these two Ohio doctors on June 26,
1963, informing them of Upjohn's interest and asking for case
reports of their experience with the drug. Further, if they were
interested in publishing their work, Dr. Stubbs would make the
"services of The Upjohn Writing Staff" available to them, would pay
for their secretary's time, and would compensate the doctors for
work on the case reports, admittedly intending to "plant the seed"
in those doctors' minds about publishing an article.
On July 1, 1963, the Ohio doctors responded with eight case
reports, which Dr. Stubbs referred to Harold Tucker, one of
Upjohn's medical writers, for potential publication.[fn4] An
article written as a result of Upjohn's "expert assistance"
proclaimed that positive results from the subconjunctival injection
of Depo-Medrol had been confirmed by others.[fn5] All the while,
Upjohn's own expert, Dr. Stubbs, himself questioned the validity of
the so-called studies. On September 19, 1963, he wrote to Jack
Toole, Upjohn's hospital representative, criticizing the data,
stating:
"I'm enclosing a copy of the letter I have
written to him, and it is a mild rebuff for
the lousy data he sent us. This sort of thing
may have gone through before the new [FDA]
regulations, but it certainly doesn't go now,
and at the risk of not getting any more data
at all I feel it's time to start setting down
on some of these rather loose individuales
[sic]. I think [this doctor] is a good friend
of ours and I don't have to [sic] many qualms
that he is going to be upset, but really the
stuff that he let you send to me is almost
worthless for reasons as I mentioned in the
letter to him." (Emphases added.)[fn6]
Dr. Stubbs nevertheless forwarded more vials of Depo-Medrol to this
doctor, followed by another supply of Depo-Medrol, on January 21,
1964.
The practice of publicizing unapproved uses of drugs, when
sponsored by the pharmaceutical company, is not approved by the FDA
as proper advertising; it results in continuing, unapproved,
potentially dangerous use. Dr. Stubbs was aware that those
experimenting physicians would subsequently write publications
which appeared in medical journals,[fn7] for which Upjohn paid
secretarial and editorial expenses. These writings, of course,
would be addressed to the medical community and become available to
ophthalmologists, thereby becoming, incredibly, part of the current
medical literature attempting to establish the standard of medical
expertise.
In 1965, Dr. Stubbs collected articles in the medical
literature and prepared a report for internal use by Upjohn.[fn8]
Based on that report, he and his immediate supervisor recommended
that Upjohn consider filing a supplemental NDA to obtain FDA
approval for periocular administration of the drug. Without FDA
approval, Upjohn could not include that use of Depo-Medrol as an
approved method of administration on the drug's labeling. In order
to supplement the NDA to provide for periocular administration of
Depo-Medrol, Upjohn knew that it was "likely that animal tissue
tolerance studies" would have to be performed.
Upjohn elected not to pursue a supplemental NDA for periocular
administration. A corporate memorandum recommended that "no
further Medical Development work be done with Depo-Medrol
administered by [periocular] injection," and that "tissue tolerance
studies in animals not be undertaken by Biomedical Research unless
a request for [an NDA] supplement is initiated by Marketing, and
approved in accordance with the currently effective Pharmaceutical
New Product System procedures."
Upjohn stipulated that prior to November 7, 1983, it "had the
capacity to perform in-house or refer out-of-house [experiments] to
be done by private consultants' research in the form of animal
studies and all four phases of human studies." Upjohn had in its
employ, or available to it, physicians, toxicologists,
pharmacologists, statisticians and epidemiologists. Dr. Stubbs
admitted that the animal tissue tolerance studies could have been
performed if the company had wanted to do them and had the funding
to do so. Such studies were already ongoing with other
applications of the drug. If Upjohn had begun the animal tissue
tolerance studies on the periocular use of Depo-Medrol in 1969 or
1970, it would have had the results well in advance of the casualty
involved in this and, perhaps, other cases. Dr. Stubbs
acknowledged that the decision whether to go forward with animal
studies and supplements on Depo-Medrol for subconjunctival use was
left to Upjohn's marketing staff. Dr. Walson believed that
marketing should not have been allowed to decide a medical safety
and scientific issue.
Upjohn knew of potential adverse reactions to the drug, of
which it learned over a period of preceding years from drug
experience reports (DERs),[fn9] yet its labeling never referred to
unapproved periocular injection of the drug, neither listing it as
an appropriate method of administration, including any recommended
dosages, nor stating any warnings regarding periocular use.
Ophthalmologists, not having been advised of adverse reactions,
began making extensive use of periocular injections of Depo-Medrol
because the benefits seemingly outweighed the risks. Defendant Dr.
Davis, himself, and four others testified to routine periocular
administration of the drug.
In October 1980, in response to the FDA's global restructuring
of labeling for all corticosteroids, Upjohn proposed a revised
Depo-Medrol package insert. The proposed insert included the
following statement:
"ADVERSE REACTIONS REPORTED WITH
NONRECOMMENDED ROUTES OF ADMINISTRATION ***
Ophthalmic: (Subconjunctival) Redness and
itching, obtuse, slough at injection site,
increased intraocular pressure, decreased
vision. (Retrobulbar) Blindness."
In September 1983, the FDA informed Upjohn that it should not
make its proposed changes, but rather should "continue using
currently approved labeling" until it received "notification" from
the agency. The FDA also told Upjohn that "[i]f important new
labeling information becomes available, you should revise your
approved product labeling under 21 C.F.R. 314.8." The circuit
court excluded this evidence.[fn10]
In April 1983, Meyer Proctor, a retired public relations
worker, consulted Dr. Davis with complaints of blurred vision. Dr.
Davis diagnosed Proctor's condition as uveitis, an inflammation of
the eye, which can be chronic and can lead to permanent blindness.
Dr. Davis began treating this condition with steroid medications
applied to both of Proctor's eyes by means of eye drops, which
proved to be of only limited value. In May 1983, Proctor developed
cystoid macular edema (CME) as a complication of the uveitis, and
the vision in his left eye deteriorated to the level of legal
blindness. Dr. Davis referred him to a retinal-vitreal specialist
for further evaluation and treatment, who concurred in the
diagnosis of CME and prescribed Nalfon, a nonsteroidal
anti-inflammatory medication. Some improvement in Proctor's vision
occurred, but his sight was not restored to normal. After treating
Proctor for several months, the specialist referred him back to Dr.
Davis, recommending the use of a nonsteroidal anti-inflammatory
drug (such as Nalfon), or the systemic or periocular administration
of a steroid (such as Depo-Medrol) if continued impairment of
vision made further treatment necessary.
On August 1, 1983, Dr. Davis examined Proctor and reinstituted
treatment with Nalfon; however, his vision again began to
deteriorate. On August 9, 1983, Dr. Davis decided to use
periocular injections of Depo-Medrol to treat Proctor's condition,
one shot around each eye. Within several weeks, Proctor's vision
improved almost to normal, but in November 1983, Proctor
experienced renewed problems with the vision in his left eye. In
response, on November 7, 1983, Dr. Davis administered another
periocular injection of Depo-Medrol near that eye.
All the ophthalmologists who testified at trial regarding the
standard of care concluded that Dr. Davis' decision to administer
Depo-Medrol via periocular injection both in August and again in
November of 1983 was appropriate and within the applicable standard
of care. None suggested that anything known at the time, or
subsequently discovered, would have made this treatment
inappropriate. There were risks associated with this treatment,
however. Dr. Davis himself testified that in November 1983 he knew
that an inadvertent intraocular injection was a risk of any
periocular injection; Depo-Medrol could be "toxic" if inadvertently
injected into the eye and cause damage to the eye, including
blindness; he had never penetrated the globe of the eye (made an
intraocular injection) in more than 1,600 prior periocular
injections of Depo-Medrol in his entire career; and, he believed he
would be able to deliver the drug to its intended location without
incident in this instance.
During the November 7, 1983 injection, however, Dr. Davis
mistakenly inserted the needle and Depo-Medrol into Proctor's left
eye. Dr. Davis then referred Proctor to a specialist for
evaluation and treatment, who determined that the appropriate
treatment was observation, waiting for the drug to clear from the
eye, and watching for possible retinal detachment, which eventually
occurred. Proctor underwent surgery on November 23, 1983, the
Depo-Medrol was removed from Proctor's left eye, and the retina was
reattached. The retina again detached, however, and two subsequent
operations, on December 13 and 29, 1983, failed to reattach it. In
April 1984, Proctor's left eye, having become blind and painful,
was surgically removed.
Proctor filed suit on February 14, 1984, against Dr. Davis and
Upjohn. Discovery proceeded over a period of seven years, and
trial began on September 4, 1991.
Proctor alleged that Dr. Davis violated the standard of care
in one or more ways, directly and proximately causing the injury.
Also alleged was negligence based on res ipsa loquitur and loss of
consortium. Proctor's allegations against Upjohn were based on
strict product liability, claiming that Depo-Medrol was defective,
unsafe, and unreasonably dangerous, and that Upjohn's failure to
warn Dr. Davis about the potential harm resulting from an
intraocular injection directly and proximately caused the injury.
Also alleged was loss of consortium and willful, wanton, or
reckless acts or omissions that would support punitive damages.
On October 18, 1991, the jury returned verdicts in favor of
Dr. Davis and against Upjohn. The jury awarded Meyer Proctor
$3,047,819.76 in compensatory damages and $124,573,750 in punitive
damages, and Marjorie Proctor $100,000 in compensatory damages. On
September 3, 1992, the circuit court entered an order remitting the
punitive damages to $35 million, but otherwise leaving the verdict
intact. Proctor filed a notice of appeal as to the Dr. Davis
verdict; Upjohn then filed its notice of appeal; and Proctor filed
a notice of cross-appeal against Upjohn.
I
Upjohn first argues that, after considering all the evidence
in the case in the light most favorable to Proctor, it was entitled
to either judgment notwithstanding the verdict or a new trial
because Proctor failed to prove that a warning was required,
because the risk was too remote to require a warning, and because
the specialized medical community was already aware of the risks.
The standards for judgment notwithstanding the verdict (see Pedrick
v. Peoria & Eastern R.R., 37 Ill. 2d 494, 229 N.E.2d 504 (1967)
(Pedrick)) and for a new trial (see Maple v. Gustafson, 151 Ill. 2d
445, 603 N.E.2d 508 (1992) (Maple)) differ; Upjohn's contentions
will be considered under both standards.
In Illinois, there is no duty to warn of a risk that is
already known by those to be warned. Kokoyachuk v. Aeroquip Corp.,
172 Ill. App. 3d 432, 526 N.E.2d 607 (1988). A duty to warn exists
only when there is "unequal knowledge and the defendant, possessed
of such knowledge, knows or should know that harm might occur if no
warning is given." Kokoyachuk, 172 Ill. App. 3d at 439. In the
context of prescription drug litigation, this principle means that
a drug manufacturer need not provide a warning of risks known to
the medical community. See Wooten v. Johnson & Johnson Products,
Inc., 635 F. Supp. 799 (N.D. Ill. 1986). Further, pharmaceutical
warnings for prescription drugs are given to physicians as "learned
intermediaries." Northern Trust Co. v. Upjohn Co., 213 Ill. App.
3d 390, 572 N.E.2d 1030 (1991).
From the evidence it is clear that Upjohn knew or should have
known that Depo-Medrol is an insoluble, toxic material which,
because of its insolubility, when inserted in the eye, became a
foreign body, and was very difficult, if not impossible, to remove.
Upjohn, its manufacturer, must be held to the standard of an expert
in the field (McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375,
528 P.2d 522 (1974)) and had a "continuous duty *** to warn
physicians of the dangers incident to prescribing the drug, to keep
abreast of scientific developments touching upon the manufacturer's
product and to notify the medical profession of any additional side
effects discovered from its use." (Emphases added.) Schenebeck v.
Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970). If Upjohn
did not know what it should have known, it failed in its duty as an
expert. It could not fulfill that duty merely by waiting for what
it considered sufficient proof of a cause-effect relationship
before advising the medical profession with an appropriate alert or
warning of the possibility of risk in the use of one of its
products. See Mahr v. G.D. Searle & Co., 72 Ill. App. 3d 540, 564,
390 N.E.2d 1214 (1979) (Mahr). Nor can failure to do so be excused
merely by the fact that the potentially endangered users are few in
number. Mahr, 72 Ill. App. 3d at 560; Crocker v. Winthrop
Laboratories, Division of Sterling Drug, Inc., 514 S.W.2d 429, 432
(Tex. 1974). The injury here clearly was within the scope of the
dangerous propensities of the drug for which Upjohn must be held
accountable. See McMahon v. Eli Lilly & Co., 774 F.2d 830, 835
(7th Cir. 1985).
The evidence revealed that Upjohn knew of Depo-Medrol's
dangerous propensities before the instant occurrence took place in
1983 (e.g., footnote 3); yet, there was no reference in the 1983
label or insert that subconjunctival use of Depo-Medrol as
practiced upon Proctor in this case was not recommended by Upjohn,
nor that FDA approval was never secured for such application.
There was no mention on the label that one cc. amount of the drug
for use about and around the eye was an excessive dosage, according
to one of its own experts. E.g., footnote 3. Tissue atrophy
developed in some patients after injection, which could be
considered as evidence of a toxic effect, also known by Upjohn
before 1983. E.g., footnote 3. The 1983 package insert made no
reference to the fact, known by Upjohn, that the drug should be
administered intramuscularly as "probably the predominant steroid
effect is going to be a systemic effect anyway." E.g., footnote 3.
Nor did it point out that this preparation was a suspension and not
a solution, and that the crystalline material in the area of
sensitive subconjunctival tissue could be the cause in itself for
injury. E.g., footnote 3. Dr. Walson, Proctor's expert, was of
the opinion that, given Upjohn's knowledge of the foregoing facts
in 1962, the drug company should have warned that periocular use of
the drug was not recommended, and under the adverse reaction
section of the warning, should have listed the toxicity of the
drug. As previously noted, the FDA had approved the use of
Depo-Medrol only for certain other uses, involving three specific
means of administration: intramuscularly, intra-articularly, and
intralesionally; none of those approved uses included the
periocular use to which the drug was put in this case. Federal law
required Upjohn to include package inserts and labeling
recommendations which referred only to the three approved forms of
administration for its product. Upjohn should have warned Dr.
Davis and others of its potentially harmful effects about which
Upjohn knew soon after it went on the market.
The record demonstrates that by 1961, Upjohn had learned that
some ophthalmologists were administering Depo-Medrol through
periocular injection as an "off-label" use. Upjohn fostered and
encouraged this unapproved use as experimentation on human beings
with no prior basic scientific studies having been made. This
unauthorized use, encouraged by Upjohn, became more widespread in
the next two decades, although Upjohn never secured FDA approval
for it and never set forth the use, warnings or directions for such
periocular injections on its labels or in its literature. None of
the dangers attendant to such use, or any reported deleterious side
effects which may have developed of which Upjohn was apprised
through DERs, were made known to the prescribing or treating
physicians who made this unauthorized off-label use of it. Dr.
Davis testified that he did not know of the drug's dangerous
propensities, or he would not have used it. Dr. Thomas Deutsch,
Upjohn's own expert, asserted that, until he testified in this
case, he did not know Depo-Medrol would be difficult or impossible
to remove once injected into the eye.
Under such circumstances, physicians could not be deemed
"learned intermediaries" who were aware of these dangers of Depo-
Medrol; they required warnings because the medical community in
1983 was not aware of the risk of serious injury, including vision
loss. See Mahr, 72 Ill. App. 3d at 560. No physician or expert
witness testified that the medical community knew what Upjohn knew
with respect to dangerous toxicity and irremovability of this drug,
but shared with no one except its own employees.[fn11] There is
no record evidence to support the hypothesis that the medical
community knew of these dangerous propensities. See Tongate v.
Wyeth Laboratories, 220 Ill. App. 3d 952, 963, 580 N.E.2d 1220
(1991) (Tongate). The record supports the jury's determination in
this regard.
A drug such as Depo-Medrol may be deemed unreasonably
dangerous absent an adequate warning accompanying the product
because the product may be "unavoidably unsafe" without such a
warning. Kirk v. Michael Reese Hospital & Medical Center, 117 Ill.
2d 507, 517, 513 N.E.2d 387 (1987); Lawson v. G.D. Searle & Co.,
64 Ill. 2d 543, 550-51, 356 N.E.2d 779 (1976). A manufacturer of
ethical drugs cannot evade its responsibilities of warning
physicians of dangers and risks attendant to the use of its
products, by hoping, as in the present case, that the doctors will
learn of the dangers themselves. Upjohn's duty to warn was
nondelegable; the failure of prescribing and treating physicians to
learn of the risks of a drug from other sources does not relieve
the manufacturer of liability for harm resulting from its own
failure to adequately warn. Mahr, 72 Ill. App. 3d at 566. This
point was explicated in Mahr, 72 Ill. App. 3d at 561-62.[fn12]
Here, Upjohn knew of the risks, yet did not share this knowledge
with members of the profession acting in decision-making capacities
in administering drugs to their patients, and encouraged unapproved
use and misleading publicity.[fn13] When doctors are properly
warned of the possibility of side effects and advised of the
symptoms accompanying them, the chances that injury to the patient
can be avoided are enhanced, particularly if it takes place slowly,
as in the case with the injury in question here. Sterling Drug,
Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966).
Significantly, Upjohn knew how to warn, and did warn doctors
against certain uses of Depo-Medrol by advising them, for example,
against intrathecal administration of this drug, which it printed
on the insert distributed with the drug in 1983, before the instant
insertion of Depo-Medrol into Proctor's eye. Upjohn, in another
line or two of print on the insert, easily could have mentioned
potential adverse reactions to the drug when injected
intraocularly, of which it had learned over a period of preceding
years from the DERs. See footnote 9. Information regarding
questionable reactions or side effects to this Upjohn product
contained in DERs in Upjohn's possession was not shared by it with
the medical community by any other means.[fn14] According to Dr.
Walson, being on notice of that kind of information from the 1960s
up to 1983, there were methodologies and scientific means available
to Upjohn to confirm or disaffirm the toxicity of the drug. In his
opinion, Upjohn should have included a warning on its label or
package insert which said, in effect, do not use the drug in that
way, and if so used, this is what may be seen.[fn15] This was
never done. In light of this imbalance of access to information
about adverse propensities of Depo-Medrol, it cannot be concluded
that physicians had knowledge of the risks equal to Upjohn's.
The jury heard Upjohn's Dr. Stubbs testify. He was in charge
of Depo-Medrol development. He did not know about the
pharma-kinetic effects of Depo-Medrol when used in a local
injection rather than systemic. He did not know how difficult it
would be to remove Depo-Medrol from the eye. He did not have
anyone investigate by animal studies whether the drug would be
toxic if it got into the eye. Prior to November 7, 1983, Dr.
Stubbs never asked any Upjohn in-house personnel whether or not it
would be difficult to remove the substance once it was injected
into the eye.
A drug company cannot absolve itself from the duty to warn by
pointing to the unauthorized use of its drug by physicians with
whom it has not shared its knowledge of dangerous side effects and
injury. Violation of its duty to warn is even more egregious in
this case since, as the evidence heard by the jury demonstrated,
Upjohn encouraged and participated in disseminating misleading
information concerning the use of its drug to the "learned
intermediaries," through financial support, technical assistance,
and abundant supplies of the drug during the period when Upjohn was
receiving adverse information concerning this use of the drug.
Ironically, some of these very reports became part of the
literature which was supposed to inform the "learned
intermediaries" about application of the drug intraocularly.
Proctor's expert testified that ophthalmologists were not aware of
the true facts but believed that periocular use of Depo-Medrol was
safe and efficacious. Significantly, in fact, Upjohn's own expert,
Dr. Thomas Deutsch, an ophthalmologist, testified he did not learn
that periocular injections of Depo-Medrol were difficult or
impossible to withdraw and were an unlabeled use until after he
became an expert in this case. Doctors who have not been
sufficiently warned of the harmful effects of a drug cannot be
considered "learned intermediaries" and the adequacy of warnings is
a question of fact, not law, for the jury to determine, as it did
in the instant case. Tongate, 220 Ill. App. 3d at 963; Batteast v.
Wyeth Laboratories, Inc., 137 Ill. 2d 175, 192-94, 560 N.E.2d 315
(1990).
The evidence convincingly supports the conclusion that Upjohn
promoted, encouraged and advertised the off-label use of Depo-
Medrol by providing financial and technical assistance to a limited
number of members of the medical community without attempting to
communicate to these physicians and the medical community at large
the dangers and risks attendant to this use.[fn16] Although it
is assumed that physicians will keep abreast of current medical
literature, here, part of the flawed literature was generated by
Upjohn. Upjohn even sought to "plant the seed" in doctors' minds
about contributing to the literature, and thereby help to mislead
the specialized ophthalmic community as to the potential harmful
effects attendant to the intraocular injection of a drug which
could be impossible to remove. To conclude that the existence of
literature in such a case constitutes knowledge on the part of
doctors and the medical community equal to that of a drug's
manufacturer, would encourage more writings of the type found in
this case, fostered by the very defendant upon whom responsibility
should be fixed. Such an insidious situation as here existed
should be neither countenanced, encouraged nor condoned. The
evidence demonstrates that Upjohn knew or should have known of the
risks and dangers attendant to the use of Depo-Medrol, thereby
requiring warning. Woodill v. Parke Davis & Co., 79 Ill. 2d 26,
35, 402 N.E.2d 194 (1980). Upjohn simply failed to do so.
Upon this record, the jury had the right to conclude that
Upjohn violated its duty to adequately warn and that it be held
accountable under these circumstances. The evidence on this point,
when "viewed in its aspect most favorable to [Proctor, does not] so
overwhelmingly favor[] [Upjohn] that no contrary verdict based on
that evidence could ever stand" (Pedrick, 37 Ill. 2d at 510), so as
to have warranted judgment notwithstanding the verdict entered in
this case. Nor was the grant of a new trial authorized under
Maple, 151 Ill. 2d at 455, on this point since the jury's verdict
was well supported by the evidence and Upjohn was not denied a fair
trial. Upjohn's contentions are rejected.[fn17]
II
Upjohn next contests the punitive damages judgment, asserting:
(1) there was insufficient evidence to support liability for
punitive damages; (2) a new trial must be awarded with respect to
punitive damages; and (3) the punitive damages award is grossly
excessive.
Illinois courts have long been concerned that punitive damages
not be awarded improperly or unwisely. Cornell v. Langland, 109
Ill. App. 3d 472, 475, 440 N.E.2d 985 (1982). The purpose of
punitive damages is not compensation of plaintiff, but punishment
of defendant and deterrence; therefore, these damages can be
awarded only for conduct that is outrageous either because
defendant's acts are done with an evil motive or a reckless
indifference to others' rights. Loitz v. Remington Arms Co., 138
Ill. 2d 404, 415-16, 563 N.E.2d 397 (1990), quoting Restatement
(Second) of Torts 908, comment b, at 464-65 (1979).
Punitive damages are similar to criminal penalties (Deal v.
Byford, 127 Ill. 2d 192, 203, 537 N.E.2d 267 (1989)) and are
permissible only in cases in which torts "are committed with fraud,
actual malice, deliberate violence or oppression, or when the
defendant acts willfully, or with such gross negligence as to
indicate a wanton disregard of the rights of others." Kelsay v.
Motorola, Inc., 74 Ill. 2d 172, 186, 384 N.E.2d 353 (1978). The
initial decision whether punitive damages may be imposed in a
particular case is a matter usually reserved to the circuit court
(Loitz, 138 Ill. 2d at 415), and its decision will not be reversed
absent an abuse of discretion. Levy v. Markal Sales Corp., 268
Ill. App. 3d 355, 379, 643 N.E.2d 1206 (1994). A reviewing court
"may reverse the amount of punitive damages only where 'it is
apparent that the award is the result of passion, partiality, or
corruption.'" Levy, 268 Ill. App. 3d at 379, quoting Deal, 127
Ill. 2d at 204.
There was evidence presented here that Upjohn not only knew of
the adverse effects of periocular use of Depo-Medrol, but promoted
and developed this off-label use through financial and technical
assistance to doctors. After those doctors wrote up their case
reports with Upjohn's assistance, Upjohn distributed them, thereby
helping to create the literature touting the periocular use of
Depo-Medrol. There was sufficient evidence of willful and wanton
conduct to justify the imposition of punitive damages.
Upjohn's contention that the jury instructions on punitive
damages were inadequate is not persuasive. The jury was instructed
that "willful and wanton conduct" means "a course of action which
shows an utter indifference to or conscious disregard for the
safety of others."[fn18] Given the status of Illinois law on
punitive damages discussed above, we cannot say that the
instructions do not state the law accurately. The circuit court
did not abuse its discretion in giving these punitive damages
instructions to the jury.
Upjohn also maintains the court erred in permitting argument
concerning Upjohn's net worth. Upjohn, however, cannot show the
court abused its discretion in admitting evidence of its net worth.
See E.J. McKernan Co. v. Gregory, 252 Ill. App. 3d 514, 536, 623
N.E.2d 981 (1993), quoting Deal, 127 Ill. 2d at 204-05. Upjohn has
failed to demonstrate that the evidence was irrelevant and
prejudicial with respect to either compensatory or punitive
damages.
Upjohn's most persuasive argument is that the punitive damages
awarded are excessive and should be reduced.
In reviewing punitive damage awards, the question of
excessiveness turns on whether the amount is so large that it
outruns the justification for exacting punitive damages, namely
retribution and deterrence of future outrageous conduct. Marek v.
Stepkowski, 241 Ill. App. 3d 862, 608 N.E.2d 285 (1992). A
reviewing court considers the degree of reprehensibility of
defendant's conduct, the relationship between the punitive damage
award and the harm caused by the conduct, defendant's gain from the
misconduct, and the financial condition of defendant. See Pacific
Mutual Life Insurance Co. v. Haslip, 499 U.S. 1, 113 L. Ed. 2d 1,
111 S. Ct. 1032 (1991); Deal, 127 Ill. 2d at 203-04. This court's
inquiry is thus one of degree: when arrayed along the spectrum of
wrongful acts, was the conduct at issue here so extraordinarily
outrageous as to justify extraordinary punitive damages? The
circuit court, in its review of the punitive damages awarded,
answered that question in the affirmative, although it remitted the
jury's award by almost 75%. The original award of more than $124
million amounted to precisely 7% of Upjohn's net worth; the
remitted amount is still more than 2% of the company's net worth
and more than eleven times the amount of compensatory damages
awarded.
When we consider the factors set out by the United States
Supreme Court and Illinois courts, we find that the amount of
punitive damages awarded in this case far outruns the justification
for imposing punitive damages. We agree with the circuit court
that Upjohn's conduct was sufficiently reprehensible to support an
award of punitive damages, however, there is no reasonable
relationship between the amount of the punitive damages and the
harm caused by the conduct. Further, although Upjohn is a large
corporation with a net worth of approximately $1.7 billion,
punishment in the amount of 2% of its net worth is excessive in the
extreme.
Illinois courts have recognized that the level of compensatory
damages may be an appropriate measure of punitive damages. See
Brown v. Farkas, 158 Ill. App. 3d 772, 780, 511 N.E.2d 1143 (1986).
It is important, however, not to belittle the meaning of the jury's
decision and the determination of the circuit court that a $35
million dollar award was proper given Upjohn's willful and wanton
conduct. We believe that a punitive damage award twice that of the
compensatory damage award will send a strong message to
pharmaceutical manufacturers of the necessity to warn of the known
potential adverse effects of their drugs. The twin goals of
retribution and deterrence would both be met by such an award.
Pursuant to Supreme Court Rule 366, we enter a remittitur of the
punitive damages to $6,095,639.52. 134 Ill. 2d R. 366.
For the foregoing reasons the judgment of the circuit court is
affirmed in part; vacated in part; and remittur is entered as noted
above.
Affirmed in part; vacated in part; and remittitur entered.
TULLY, J., concurs.
DiVITO, J., dissents.
JUSTICE DiVITO dissenting:
Meyer Proctor suffered a painful and tragic injury. For that,
however, Upjohn bears no responsibility. Succinctly stated,
Proctor's injury was the result of an accident involving Dr. Davis'
use of a needle, and Upjohn could not have prevented, nor was it
responsible for, the doctor's mistake. Judgment notwithstanding
the verdict should have been granted because Upjohn had no duty to
warn and, even if it did, there was no showing that any alleged
failure to warn was a proximate cause of Proctor's injury.
Alternatively, reversal and a new trial are warranted because the
circuit court improperly excluded critical evidence favorable to
Upjohn.
DUTY TO WARN
In the 1995 opinion filed in this case (Proctor v. Davis, 275
Ill. App. 3d 593, 656 N.E.2d 23 (1995), invalidated by Proctor v.
Upjohn Co., 175 Ill. 2d 394, 677 N.E.2d 918 (1997)), I wrote that
Upjohn had no duty to warn. For the reasons I expressed in that
opinion, incorporated by reference here, some of which I reiterate
in this dissent, I continue to believe that Upjohn had no duty to
warn.
The majority holds that Upjohn is liable for Proctor's injury
because it knew that Depo-Medrol was toxic and difficult to remove
if injected into the eye, and it failed to warn ophthalmologists of
these risks. Slip op. at 14-15. The record, however, does not
justify that conclusion because it contains ample evidence that the
medical community, including Dr. Davis, was aware of the risks
associated with periocular injection of Depo-Medrol.
Drs. Walson, Deutsch, Giles, and Fagman testified that the
possibility of intraocular injection was a well-known risk of
periocular use of Depo-Medrol. Dr. Walson, plaintiffs' own expert,
also testified that he thought that, in 1983, ophthalmologists were
aware that inadvertent intraocular injection of Depo-Medrol had
caused the loss of an eye for some patients.
In addition, there were several reports in the medical
literature describing incidents in which vision loss resulted from
an inadvertent intraocular injection of Depo-Medrol. Physicians
are held to a standard of medical expertise (see, e.g., Kirk v.
Michael Reese Hospital & Medical Center, 117 Ill. 2d 507, 517-18,
513 N.E.2d 387 (1987)) and may be expected to have knowledge of
current medical literature (see, e.g., 40 Fed. Reg. 15394 (Apr. 7,
1975)).
Included in the literature of which ophthalmologists would be
expected to be aware was a 1981 article, which reported that a
patient became legally blind as a result of an intraocular
injection of Depo-Medrol. K. Zinn, Iatrogenic Intraocular
Injection of Depot Corticosteroid and Its Surgical Removal Using
the Pars Plana Approach, 88 Ophthalmology 13 (1981). A 1974
article discussed six cases in which corticosteroids were
accidentally injected intraocularly. Four of these cases involved
Depo-Medrol, and in two of those four cases, the patients suffered
a complete loss of vision. In the two cases involving the
injection of the other corticosteroid, the patients also suffered
severe vision loss. T. Schlaegel & F. Wilson, Accidental
Intraocular Injection of Depot Corticosteroids, 78 Transactions -
American Academy of Ophthalmology & Otolaryngology 847 (1974). A
1969 article by Moschini reported that a patient suffered a
complete loss of vision following an inadvertent intraocular
injection of Depo-Medrol. G. Moschini, Accidental Introduction of
Sustained-Action Corticosteroid in the Vitreous Humor, 48
Bollettino D'Oculistica 426 (1969) (as translated). Several other
articles and texts in the literature discussed the general dangers
associated with the intraocular injection of steroids; still others
reported no long-term adverse effects or reported adverse effects
less severe than blindness following the intraocular injection of
Depo-Medrol. A 1976 textbook also contained the information that
inadvertent intraocular injections of steroids had caused
blindness. F.T. Fraunfelder, Drug-Induced Ocular Side Effects and
Drug Interactions (1976).
Not only were the risks associated with periocular use of
Depo-Medrol well-known to the medical community, they were also
evident to Dr. Davis. Although he testified that he did not know
that Depo-Medrol could not be easily removed once injected into the
eye, Dr. Davis knew that injecting it into the eye could lead to
blindness. From reading medical literature, he knew that
accidental intraocular injection was possible and that piercing of
the eyeball could cause damage, including blindness. He also
testified that he knew Depo-Medrol was toxic to the eye. Even as
a medical resident, he and his fellow medical residents were well
aware of the drug's toxicity and knew that it should not be used
intraocularly.
The majority asserts that Upjohn had superior knowledge of the
risks associated with periocular use of Depo-Medrol because
physicians did not know of Depo-Medrol's toxicity and did not know
that it could not be removed once injected. Slip op. at 14. The
record, however, does not support a conclusion that
ophthalmologists were unaware in 1983 that Depo-Medrol could be
toxic if injected into the eye. No ophthalmologist testified that
he was unaware that the drug could be toxic if used in this way,
and Dr. Giles and Dr. Davis both testified that they were aware in
1983 that Depo-Medrol could be toxic if injected into the eye.
With respect to the removability of the drug, the relevant
question is whether Upjohn had greater knowledge than the medical
community about any difficulty in removing Depo-Medrol from the
eye. Dr. Stubbs, Upjohn's medical monitor for Depo-Medrol,
testified that, based on information in the medical literature
available in 1983 and information in drug experience reports sent
to Upjohn, he did not believe that Depo-Medrol would be
particularly difficult to remove from the eye. Likewise, in the
course of testifying about instances reported in the literature
concerning the injection of Depo-Medrol into the eye, Dr. Walson
made a similar statement concerning the removability of the drug.
In addition, two of the three drug experience reports received by
Upjohn that described an intraocular injection of Depo-Medrol
reported that the Depo-Medrol had been removed by performing a
vitrectomy. Thus, the record before us does not support the
conclusion that Upjohn had greater knowledge than the medical
community of any difficulty in removing the drug in the event of an
inadvertent intraocular injection.
Even with the evidence viewed in the light most favorable to
plaintiffs, therefore, Upjohn had no duty to warn in this case.
The record demonstrates that the medical community and Dr. Davis
were well-aware of the potential danger associated with periocular
injection of Depo-Medrol and that Upjohn did not have superior
knowledge of these risks.
FAILURE TO WARN AS PROXIMATE CAUSE
Also, there is no basis for the majority's conclusion, in its
unpublished Rule 23 order, that plaintiffs established that
Upjohn's failure to warn was a proximate cause of Proctor's
injuries. Unpublished order under Supreme Court Rule 23 at 5-8
(Rule 23 order). As the majority states, in order to prove
proximate cause, plaintiffs were required to show that Dr. Davis'
treatment decision would have been altered if he had received the
warning they argue Upjohn should have provided. Rule 23 order at
5, citing Ashman v. SK & F Lab Co., 702 F. Supp. 1401 (N.D. Ill.
1988).
Dr. Davis did testify that he would not have given Proctor a
periocular injection of Depo-Medrol had he known it was difficult
to remove and might cause blindness. Certainly, it was the role of
the jury to evaluate his credibility and to resolve conflicts in
the evidence. See Maple v. Gustafson, 151 Ill. 2d 445, 452-53, 603
N.E.2d 508 (1992). Nevertheless, judgment notwithstanding the
verdict was appropriate because, even viewing the evidence in the
light most favorable to plaintiffs, it is clear that, despite his
testimony to the contrary, Dr. Davis' treatment decision would have
been the same had he received the warnings plaintiffs contend were
required.
Dr. Davis' testimony that he would not have treated Proctor
with periocular injection of Depo-Medrol if he had received these
warnings was completely contradicted by the remainder of his
testimony. For example, he testified that he had found this
treatment to be safe and effective and had used it without problem
on 1,600 occasions prior to the accidental injection of Proctor's
eye. In fact, he had used it to restore Proctor's vision when no
other treatment had worked.
Also contrary to his testimony that he would not have used
Depo-Medrol periocularly if he had known the risks, Dr. Davis
testified that, at the time he treated Proctor, he was aware that
accidental intraocular injection and blindness were possible
consequences of periocular injection of Depo-Medrol. Perhaps the
best indicator of how knowledge of these risks would have affected
his treatment decision was his testimony that, even after he
accidentally penetrated Proctor's eye, he continued to treat
patients with periocular injections of Depo-Medrol.
Dr. Davis' testimony that periocular injection of Depo-Medrol
was the only treatment alternative for Proctor also contradicted
his testimony that warnings would have changed his treatment
decision. The majority states that there were alternative
treatments available (Rule 23 order at 6), but the record does not
support this conclusion. Dr. Davis explained that further use of
Nalfon was not a feasible alternative because it had been used
without success to treat Proctor's condition. Dr. Davis also
explained that intramuscular, that is, systemic, administration of
steroids, was contraindicated by certain health conditions Proctor
had. As for the majority's suggestion that Dr. Davis could have
used a different formulation of Depo-Medrol, the record does not
indicate that a different formulation would have been effective.
By contrast, Dr. Davis knew that periocular injection was an
effective treatment for Proctor because it had restored his vision
in the past, and it was not contraindicated by Proctor's other
medical conditions.
The testimony of other ophthalmologists also indicated that
the warning plaintiffs claim was required would not have changed
Dr. Davis' treatment decision. Expert witnesses, Drs. Giles,
Fagman, and Deutsch, all testified that Davis' decision to inject
Depo-Medrol periocularly was in accordance with the applicable
standard of care. Dr. Giles also testified that, even after he
accidentally injected Depo-Medrol intraocularly, he continued to
treat patients using periocular injection of the drug and found it
to be safe and efficacious.
It is clear from this evidence that the ophthalmologic
community, including Dr. Davis, considered Depo-Medrol to be an
appropriate treatment for Proctor's condition and found periocular
injection of this drug to be safe and effective despite the
possibility of intraocular injection and vision loss.
This uncontradicted evidence compelled the jury to conclude
that Upjohn's alleged failure to warn was not a proximate cause of
Proctor's injury. The only proximate cause of Proctor's loss of
his eye was Dr. Davis' accidental injection of Depo-Medrol into the
eye rather than periocularly. Consequently, the circuit court
should have granted the motion for judgment notwithstanding the
verdict.
ERRORS IN EVIDENTIARY RULINGS
Upjohn was prevented from presenting compelling evidence both
on the issue of proximate cause and on the issue of punitive
damages.
1. Post-1983 Usage of Depo-Medrol
The circuit court excluded evidence of post-1983 usage of
Depo-Medrol, but Upjohn made offers of proof that, after 1983, Drs.
Giles, Deutsch, and Fagman continued to use periocular injection of
Depo-Medrol to treat their patients. The evidence that, even after
1983, ophthalmologists continued to view periocular injection of
Depo-Medrol as a safe and efficacious treatment severely undermines
the argument that Dr. Davis would have treated Proctor differently
had he known more about the drug. Moreover, such evidence was
highly relevant to the issue of punitive damages. The circuit
court erred in excluding this evidence.
The majority holds that this evidentiary ruling was proper
because it was consistent with the court's exclusion of post-1983
labeling changes. Rule 23 order at 13-14. The majority's
"consistency" rationale, however, is not persuasive because,
although there are public policy considerations that support the
exclusion of the evidence of post-1983 labeling changes, there is
no legitimate basis for the exclusion of the evidence of post-1983
usage.
Generally, evidence of subsequent remedial measures is
inadmissible in negligence and product liability actions for public
policy reasons: courts do not want to discourage defendants from
making safety improvements, evidence of subsequent remedial
measures is not probative, and the jury may view this evidence as
proof of negligence. See Herzog v. Lexington Township, 167 Ill. 2d
288, 300-01, 657 N.E.2d 926 (1995); Smith v. Black & Decker (U.S.),
Inc., 272 Ill. App. 3d 451, 456, 650 N.E.2d 1108 (1995). These
policy concerns supported the circuit court's exclusion of the
post-1983 labeling changes, but they do not justify the exclusion
of the post-1983 usage of Depo-Medrol. Despite the discretion
accorded to trial courts in ruling on the admissibility of
evidence, because this evidence was highly probative with respect
to the issue of proximate cause and to the issue of punitive
damages, the circuit court erred in excluding it.
2. Upjohn's Effort to Add a Warning
Also troubling is the circuit court's exclusion of evidence of
Upjohn's attempt to add a warning to its labeling and its exclusion
of evidence of FDA labeling controls. The majority acknowledges
that, in Rucker v. Norfolk & Western Ry., 77 Ill. 2d 434, 396
N.E.2d 534 (1979), Moehle v. Chrysler Motors Corp., 93 Ill. 2d 299,
443 N.E.2d 575 (1982), and Hatfield v. Sandoz-Wander, Inc., 124
Ill. App. 3d 780, 464 N.E.2d 1105 (1984), Illinois courts have held
that evidence of compliance with federal requirements, including
FDA requirements, is admissible. The majority distinguishes these
cases, however, on the basis that the parties in those cases
demonstrated compliance, and Upjohn did not prove that it complied
with FDA requirements in this case. The majority, therefore,
concludes that Upjohn was not entitled to present evidence of its
attempted labeling change or of FDA labeling requirements because
these were not relevant either to its duty to warn or to punitive
damages. Rule 23 order at 11.
Although, unlike this case, in Rucker, Moehle, and Hatfield,
there was never any question as to the defendants' compliance with
federal standards, these cases do not support the exclusion of the
FDA evidence in this case. In those cases, the courts held that
evidence of compliance with federal standards is admissible; they
did not hold that evidence of federal standards is inadmissible
absent a showing of compliance. Evidence is relevant if it tends
to prove a fact at issue or shows that a matter in dispute is more
or less probable. Herman v. Will Township, 284 Ill. App. 3d 53,
61, 671 N.E.2d 1141 (1996). Even absent proof of compliance, the
evidence of Upjohn's attempted labeling change and FDA labeling
requirements was highly relevant to the issue of punitive damages
because it tended to show that Upjohn's conduct was not willful and
wanton.
Even assuming, as the majority does, that Upjohn should have
interpreted the FDA letter as requiring it to "submit its proposed
change in the proper manner" (Rule 23 order at 11), evidence of
Upjohn's attempt to add a warning should have been presented to the
jury. This evidence was relevant to the issue of punitive damages
because it would have permitted the jury to conclude that Upjohn
did not disregard the safety of its customers because it had
attempted, albeit improperly and unsuccessfully, to add a warning
to its label.
Furthermore, there was no basis for concluding from the record
that Upjohn was not complying with an FDA directive when it
continued to use labeling that did not contain a warning with
respect to ophthalmic use. In response to the FDA's request for
format changes to all corticosteroid labels, Upjohn submitted a
supplemental application, in which it proposed to revise the Depo-
Medrol label to, among other things, include a new warning for
ophthalmic uses. In September 1983, the FDA informed Upjohn that
it was conducting further review of the labeling format and
instructed it to continue to use existing labeling until the FDA
notified it of the status of its supplemental application. The FDA
further instructed Upjohn to revise its labeling through another
supplemental application (see 21 C.F.R. 314.8 (1984)) if
"important new labeling information becomes available."
Unlike the majority, I do not interpret the FDA letter as
requiring Upjohn to submit an additional supplemental application
in order to add a warning to its label. At the time it received
this letter, Upjohn had a supplemental application that included
ophthalmic warnings pending before the FDA, and it did not have any
"new" information about ophthalmic uses to add to the warning it
had already submitted for approval. It was, therefore, logical for
Upjohn to wait for the FDA to act on its pending application and to
follow the FDA's instruction to use its existing labeling until the
FDA notified it of the status of its application. Had the jury
been allowed to consider this letter, it may have reached the same
conclusion as to Upjohn's actions.
3. Evidence Concerning FDA Labeling Controls
Upjohn also should have been allowed to present evidence of
FDA labeling controls. The jury heard Dr. Walson's testimony that
the format of the Depo-Medrol labeling was misleading, but Upjohn
was not permitted to counter this testimony with evidence that the
FDA dictates the format of prescription drug labels. The exclusion
of this evidence unfairly prejudiced Upjohn in its ability to
justify its failure to warn of the risks associated with ophthalmic
use of Depo-Medrol and likely contributed to the jury's punitive
damage award.
The majority opinion itself demonstrates the prejudice that
resulted from the exclusion of evidence of FDA requirements.
According to the majority, Upjohn knew how to warn because it had
warned against intrathecal use, and "Upjohn, in another line or two
of print on the insert, easily could have mentioned potential
adverse reactions to the drug when injected intraocularly" (slip
op. at 16). This statement ignores the restrictions that the FDA
places on labeling. See W. Kip Viscusi, et al., Deterring
Inefficient Pharmaceutical Litigation: An Economic Rationale for
the FDA Regulatory Compliance Defense, 24 Seton Hall L. Rev. 1437,
1440 (1994) ("the FDA possesses virtually total control over the
content of the package inserts that accompany all prescription
drugs"); Lars Noah, The Imperative to Warn: Disentangling the
"Right to Know" from the "Need to Know" about Consumer Product
Hazards, 11 Yale J. on Reg. 293, 359 (1994) ("Although in theory
drug manufacturers are free to add warnings in advance of FDA
approval, they may not enjoy any real flexibility to alter
previously approved labeling"). The Depo-Medrol labeling included
a warning against intrathecal use because the FDA required this
warning. It is not clear what sort of warnings, if any, the FDA
would have permitted for periocular use. The FDA must approve all
post-marketing labeling changes (see Viscusi, at 1447-48 n.48) and,
therefore, would not necessarily have permitted Upjohn to "easily"
include a warning involving periocular use of the drug. In fact,
the record demonstrates that when Upjohn submitted such a warning,
it took the FDA several years to respond, and the response
instructed Upjohn to continue to use its existing labeling.
This evidence was relevant; there was no legitimate basis for
its exclusion. The circuit court erred in refusing to allow Upjohn
to present it, and its ruling unfairly prejudiced Upjohn.
UPJOHN'S INVOLVEMENT IN THE OFF-LABEL USE OF DEPO-MEDROL
Finally, the majority's description of Upjohn's activities
with respect to the off-label use of Depo-Medrol must be addressed.
The majority suggests that Upjohn acted improperly when it provided
financial assistance, writing support, and free Depo-Medrol to
ophthalmologists who wished to put the drug to an off-label use.
See slip op. at 2-7, 18-19. The majority also criticizes Upjohn
for ordering and distributing reprints of articles discussing the
periocular injection of Depo-Medrol. Slip op. at 4. According to
the majority, "The practice of publicizing unapproved uses of
drugs, when sponsored by the pharmaceutical company, is not
approved by the FDA as proper advertising; it results in
continuing, unapproved, potentially dangerous use." Slip op. at 6.
These comments are unfair. Off-label use of drugs is not
unusual or illegal (see Note: A Meaningful Choice: Two FDA
Approved Drugs Are Combined to Perform Medical Abortions, 18
Women's Rights L. Rep. 49, 56 n.116 (1996) (the American Medical
Association estimates that 40% to 60% of all prescriptions in
America are for off-label uses of drugs), and even the FDA has
acknowledged that off-label use of a drug may be appropriate and
rational (see Use of Approved Drugs for Unlabeled Indicators, FDA
Drug Bulletin (Public Health Service, Md.) April 1982, vol. 12, No.
1, 4-5).
In addition, contrary to the majority's implication that
Upjohn acted improperly by funding research into off-label uses and
distributing reprints of articles discussing off-label uses, these
practices have been common among drug manufacturers. See Comment:
Products Liability and "Off-Label" Uses of Prescription Drugs, 63
U. Chi. L. Rev. 275, 279 (1996) (Comment). Dr. Stubbs testified
that it was not unusual to supply drugs to physicians who requested
them, that fulfilling reprint requests was part of normal sales
education, and that, in 1963 and 1964, it was normal for drug
manufacturers to compensate doctors for secretarial help in
preparing case reports and to supply writing support services.
The FDA has recently restricted the manner in which
manufacturers may communicate with physicians about off-label uses,
but its policy with respect to such communications was not as
strict during the period of time relevant to this suit. See
William L. Christopher, Off-Label Drug Prescription: Filling the
Regulatory Vacuum, 48 Food & Drug L.J. 247, 249-54 (1993); Comment,
at 279. The majority offers no authority for its suggestion that
Upjohn's activities would not have been approved by the FDA and the
record does not permit such a conclusion.
RESPONSE TO MAJORITY'S REPLY TO THIS DISSENT
In four footnotes (see slip op. at nn.11, 13, 16, 17), the
majority replies to what I have said in this dissent. For example,
in footnote 11, after pointing out what I have said about the
medical community being aware of the risks associated with
periocular injections of Depo-Medrol, the majority states that its
"decision also is based upon the insolubility and toxicity of Depo-
Medrol of which Upjohn knew or should have known." Slip op. at 14-
15 n.11. The majority then accuses me of "fail[ing] to recognize
this issue." This accusation is surprising given the considerable
amount of space I have dedicated to the matter (see slip op. at 24-
28). Moreover, as the majority itself recognizes (see slip op. at
12), there is no duty to warn of a risk that is already known by
those to be warned. Kokoyachuk v. Aeroquip Corp., 17 Ill. App. 3d
432, 526 N.E.2d 607 (1988), appeal denied, 123 Ill. 2d 559, 535
N.E.2d 402 (1988). I repeat: in this off-label use of Depo-Medrol,
the risks were known to the medical community. Dr. Davis and every
ophthalmologist who testified knew that an accidental penetration
of the eye was a risk inherent in periocular injections. They, and
the entire ophthalmological community, were well aware of the risk
of vision loss following the accidental intraocular injection of
the drug.
Regarding the connection of the alleged failure to warn to the
issue of proximate cause, the majority claims that I have
disregarded the standard of review and have "usurp[ed] the role of
the fact finder." (Slip op. at 16 n.13.) The majority insists
that this court is required to uphold the jury verdict because Dr.
Davis testified that he would not have treated Proctor with the
periocular injection if he had received warnings and his statement
that systemic use of Depo-Medrol was not contraindicated.
The majority's reliance on these isolated statements
demonstrates a failure to view them in the context of the entire
record. Although the standard of review requires us to view the
evidence in the light most favorable to the non-moving party, it
does not require us to accept evidence that the remainder of the
record demonstrates is implausible.
As I have explained, except for the single statement on which
the majority relies, Dr. Davis' testimony overwhelmingly
demonstrated that warnings would not have changed his treatment
decision because he was already aware of the relevant risks and
because, even after accidentally causing Proctor's eye loss, he
continued to use Depo-Medrol periocularly. In addition, although
he may have testified that systemic use of Depo-Medrol was not
contraindicated, he also testified that systemic use was
contraindicated by Proctor's medical conditions. The evidence in
this case, therefore, does not support a finding of proximate
cause.
In footnote 17 (slip op. at 20 n.17), the majority accuses me
of not applying the proper standard of review concerning the
circuit court's evidentiary rulings. Let there be no doubt: the
abuse of discretion standard is the one I applied in concluding
that the circuit court had erred in making these rulings. The
excluded evidence was highly relevant to the issue of proximate
cause. Can its relevance to the issue of punitive damages be
seriously questioned--in this case where the jury was not informed
that a drug was deemed so efficacious that, at the time of trial,
ophthalmologists were still using it in exactly the same way the
majority deems so pernicious as to warrant over $6 million in
punitive damages, and where the jury, not having information so
relevant to Upjohn's effort to counter evidence of its alleged
willful and wanton conduct, returned a verdict of almost $125
million?
CONCLUSION
For the reasons given, the judgment against Upjohn should be
reversed. Alternatively, because of the rulings that denied
admissibility of evidence highly relevant both to the issue of
proximate cause and to the issue of punitive damages, the judgment
should be reversed and a new trial should be required.
Accordingly, I respectfully dissent.
[fn1] At trial, defendant Dr. Davis testified that he believed that
by 1983, the technique of periocular injections was widely used in
the medical community; he believed physicians were using this
technique an estimated one million times each year. Physicians had
previously used periocular injections with other steroids to avoid
the side effects from other methods of administration, and to
provide more direct action on the point of inflammation in the eye.
As a new, longer-acting steroid, Depo-Medrol appeared to offer
advantages for this type of use. Dr. Davis did not then know of
the drug's dangerous propensities, or he would not have used it.
[fn2] Dr. Samuel Stubbs, Upjohn's Depo-Medrol expert, admitted
that if a doctor wanted information about periocular injections of
Depo-Medrol, Upjohn would forward a copy of this article.
[fn3] Yet, on January 9, 1962, when Bob Fuoto, one of Upjohn's
salesmen in Manhattan, sent an inquiry to Upjohn's medical
department, asking why the eye became "very red," and whether that
condition could be prevented, following subconjunctival injections
in cataract surgery patients, Dr. Gerard, an Upjohn employee,
responded, in a letter dated February 14, 1962:
"I know of no way of giving a definite answer
*** as to why the eye becomes red after the
subconjunctival use of Depo-Medrol. I do
think that it should be pointed out, however,
that it has never been recommended that
Depo-Medrol be used this way. Our
recommendations for Depo-Medrol is that the
injection be given deep intramuscularly or if
used for intralesional treatment of the skin,
that the injections be kept as small as
possible. It seems to me that 1 cc. of
Depo-Medrol subconjunctivally is a rather
large dose to place in this area. When this
amount is given subcutaneously in other areas
of the body, it can occasionally cause tissue
atrophy. I would think that our best
recommendation *** would be that at this
dosage level of Depo-Medrol, *** the
medication [should be given] intramuscularly,
as probably the predominant steroid effect is
going to be a systemic effect anyway. This
preparation is a suspension and not a
solution, and it may well be that the
crystalline material in the area of such a
sensitive tissue as a subconjunctiva is the
cause in itself for the redness." (Emphases
added.)
[fn4] Plaintiff's expert, Dr. Philip Walson, testified
that so few cases did not constitute sufficient
experience with the drug. Further, the material received
from these doctors did not provide complete data for
purposes of making any scientific use according to
accepted principles. No double blind studies were done,
(for example, making it difficult to evaluate whether the
patient had improved spontaneously, or because of the
therapy or treatment received), although that scientific
methodology was available to do these kinds of studies.
[fn5] Dr. Walson also testified that those papers could
not be used to justify the statement, because they were
merely anecdotal, not scientific studies, and there was
no proof for the claim that the procedure they employed
was "simple and effective in those inflammatory ocular
processes for which steroids are indicated."
[fn6] Dr. Stubbs knew what was needed for FDA approval,
but what he did not get, from these reports, writing on
September 19, 1963:
"I would be most happy to pay your secretary a
little bit extra for these case reports if she
would be willing to re-work them, perhaps with
an occasional word from you to cover the
following points: patient's identification;
age; sex; diagnosis; duration of illness;
therapy used, and in this instance
Depo-Medrol; the strength of the Depo-Medrol,
in other words how many milligrams per cc; the
amount given; the frequency of injection, with
dates as you have done to a certain extent;
the results of therapy; and finally any side
effects. This information is what the [FDA]
requires as a minimum and is certainly not my
idea, although I think that their requirements
are [] minimal particularly for a type of
therapy which is not completely accepted in a
general way as yet." (Emphases added.)
[fn7] One such article, published in 1964, stated:
"Maximum local response may be expected with
only minimal or no systemic steroid effects.
A voluminous mass of reports testifies to the
efficacy and safety of this report in general
medicine and in surgery[!]" (Emphasis added.)
The article went on to state:
"Similarly, an ophthalmologist has recently
reviewed indications for and the fine results
to be expected from some subconjunctivally
injected steroids. This experience has been
confirmed by others." (Emphasis added.)
Dr. Stubbs admitted that this article did not mention the need to
conduct double blind studies to assess the effectiveness of
subconjunctival injections with Depo-Medrol; that the article,
which had been written by Upjohn staff writers and submitted by
Upjohn for publication, was already stating to the ophthalmic
community that the use of this drug for subconjunctival injections
was "safe, simple and effective," without performing double blind
or animal studies by Upjohn for the subconjunctival use of
Depo-Medrol, and without FDA approval.
[fn8] [fn8] Much of the material Dr. Stubbs collected, however, was
supported and promoted by Upjohn. Additionally, Dr. Stubbs knew
that one doctor's case reports omitted animal studies. Proctor's
expert, Dr. Walson, criticized the studies which Dr. Stubbs relied
upon, maintaining that they were unstandardized, did not refer to
animal studies, and failed to demonstrate Depo-Medrol's efficacy.
Notwithstanding the many infirmities in the underlying information
and case reports, which were initially developed based upon
Upjohn's promotion and sponsorship, Dr. Stubbs concluded that there
were no reports of Depo-Medrol's toxicity.
[fn9]When a pharmaceutical company receives a report about an
adverse reaction associated with the use of its product, it records
it in a DER and forwards it to the FDA. Between the first
marketing of Depo-Medrol and the injection of Meyer Proctor that
led to this suit, Upjohn received 23 reports indicating adverse
experiences associated with its use. The DERs based on these
communications were forwarded to the FDA, usually accompanied by a
cover letter stating that the use involved was not recommended.
Three of these reports (one in 1977 and two in 1983) concerned
vision loss following periocular injections with unintentional
intraocular injection. Additionally, the medical literature had
reported other instances of accidental intraocular injections of
corticosteroids like Depo-Medrol, some of which were followed by
vision loss.
[fn10]A more expanded discussion of this incident appears in the
contemporaneously issued Rule 23 order, point IV.
[fn11] The dissent, in concluding that "Proctor's injury was the
result of an accident involving Dr. Davis' use of a needle, and
Upjohn could not have prevented, nor was it responsible for, the
doctor's mistake" (slip op. at 24), usurps the role of the finder
of fact. Such appropriation is particularly unwarranted where
Upjohn seeks judgment notwithstanding the verdict. See Pedrick, 37
Ill. 2d at 510. In reaching its conclusion, the dissent reasons
that the medical community was aware of the risks associated with
periocular injections of Depo-Medrol, but reduces the risks to the
"inadvertent intraocular injection of Depo-Medrol" (slip op. at
25), whereas our decision also is based upon the insolubility and
toxicity of Depo-Medrol of which Upjohn knew or should have known.
Slip op. at 12. The dissent's failure to recognize this issue
leads it to proclaim that the medical community was aware of "the
risks associated with periocular use of Depo-Medrol" (slip op. at
26) while ignoring the abundant evidence, including Dr. Walson's
acknowledgement that Upjohn should have warned that periocular use
of the drug was not recommended. Slip op. at 13. Finally, in
discussing the removability of Depo-Medrol, the dissent overlooks
critical testimony of Drs. Stubbs and Walson. E.g., footnotes 14,
15. The dissent's repeated omissions, in Upjohn's favor, refute
its assertion that it viewed the evidence in the light most
favorable to plaintiffs. Slip op. at 28.
[fn12] The Mahr court stated:
"The nature of prescription drugs and the
ethics involved in the professional practice
of medicine are such that it is a physician
who decides what medications, if any, a
patient is to take. Thus, while the
manufacturer's duty to warn is for the benefit
of the ultimate consumer of its products, the
physician, in the role of a learned
intermediary, is the person to whom the
warnings are to be communicated. [Citations.]
Contrary to Searle's position, however, the
adequacy of the communication of the warning
is not judged solely by reference to the
information supplied by the manufacturer to
the prescribing physicians. *** Searle had
the duty to adequately communicate the adverse
effects of Enovid to all members of the
medical profession who came into contact with
[the patient] in a decision-making capacity
during the time she was using the drug.
(Emphases added.)
[fn13] The dissent disagrees with our conclusion that
plaintiffs established that Upjohn's failure to warn was
a proximate cause of Proctor's injuries apparently
because "Dr. Davis' treatment decision would have been
the same had he received the warnings plaintiffs contend
were required." Slip op. at 29. This assertion is, as
the dissent acknowledges, contrary to Dr. Davis'
testimony. Nevertheless, the dissent believes that Dr.
Davis' remaining testimony contradicts his statement
"that he would not have treated Proctor with periocular
injection of Depo-Medrol if he had received" warnings.
Slip op. at 29. Inexplicably, the dissent demonstrates
a willingness to disregard direct testimony, usurp the
role of the fact finder, and dismiss the standard of
review in reaching its desired end. Notwithstanding the
dissent's outright rejection of Dr. Davis' statement, the
fact that Dr. Davis found periocular injection of Depo-
Medrol to be safe and effective prior to using it on
Proctor does not contradict his testimony that had he
known of the risks of Depo-Medrol, he would not have used
it; there is no basis to conclude that he would adhere
blindly to his belief in Depo-Medrol's safety and
efficacy when confronted with contradictory evidence.
The dissent would have Dr. Davis assume its mantle of
omission, but such a conclusion is contrary to common
sense, contravenes the standard of review, and opposes
Dr. Davis' testimony. Contrary to the dissent, Dr. Davis
testified that there were alternative treatments
available. He specifically stated that systemic
administration of Depo-Medrol was an alternative for
Proctor that was not contraindicated. The dissent's
focus on Dr. Davis' testimony regarding "accidental
intraocular injection and blindness" (slip op. at 29)
further distorts the issue and reveals the dissent's
misunderstanding of our decision and the risks of Depo-
Medrol. E.g., footnote 11.
[fn14] From June of 1963 through September of 1983,
Upjohn received numerous adverse DERs relating to
repository Depo-Medrol therapy for intraocular disorders.
Some of these are abstracted in the Appendix attached to
the Rule 23 order. It should be noted, however, that in
Dr. Walson's experience, the frequency of DERs is less
than the adverse effects which actually occur; in other
words, not every adverse reaction was reported. He noted
that the observations contained in DERs to Upjohn, such
as abscesses at the injection site, sloughing at the
subconjunctiva, swelling at the injection site, residue
being left in the area where the eye was injected,
increased ocular pressure after the injection, blurred
vision, anaphylaxis, and sudden blindness, could be
evidence of the toxicity of the drug. He held the
opinion that loss of vision, small white spots of
residue, diminished vision, and any kind of allergic
response could also indicate toxicity of the drug.
[fn15]Dr. Stubbs, one of Upjohn's Depo-Medrol overseers,
testified that the book "Drug Induced Ocular Side Effects
and Drug Inter-reactions" by Fraunfelder was in Upjohn's
medical library in Kalamazoo. In the 1976 edition, it
states "inadvertent intraocular steroid injections have
caused blindness probably as a result of direct drug
toxicity to the retina or optic nerve." (Emphasis
added.) Dr. Stubbs admitted that it was part of his
duties and responsibilities to be aware of this kind of
information. Dr. Stubbs also knew that there had been
several articles reporting the accidental injection of
Depo-Medrol into the eye itself. Dr. Stubbs admitted
that prior to the incident, he knew that if Depo-Medrol
got into the eye, its white substance might obscure a
physician's ability to identify any damage from the
injection. He was aware of articles which reported that
the substance remained in the eye. None of this
information was contained in Upjohn's labels or inserts.
Another writing concluded that Depo-Medrol remains
active as long as it is visible. This text was dated
1978. Neither the package nor the label insert for
Depo-Medrol stated, to November 7, 1983, how long the
drug remained active around the eye.
[fn16]The dissent claims our analysis is unfair, but this
proclamation is itself unfair when carefully scrutinized.
First, we noted Upjohn's actions of aggressively
promoting and advertising the off-label use of Depo-
Medrol despite evidence known to Upjohn of its risks.
The dissent claims that off-label use of drugs is not
unusual or illegal, but this does not address nor
contradict our analysis; rather, it speaks past our
assertion and distorts the basis and reasoning of our
holding. Next, the dissent states that Upjohn's actions
of funding research into off-label uses and distributing
reprints of articles discussing off-label uses is a
common practice among drug manufacturers. Slip op. at
38. This criticism misses the point; Upjohn's actions
may have been a common practice among drug manufacturers,
but its actions assume a pernicious quality when coupled
with its knowledge of the dangers of the off-label use of
Depo-Medrol. E.g., footnotes 3, 14, 15.
[fn17] The dissent's arguments concerning alleged errors
in evidentiary rulings places itself into the position of
circuit judge and decides the issues de novo. The
standard of review, however, does not permit a reviewing
court to reverse absent an abuse of discretion.
[fn18] The jury also was instructed that:
"[i]f you find that the defendant Upjohn
Company's conduct was willful and wanton and
proximately caused injury to the plaintiff,
and if you believe that justice and the public
good require it, you may in addition to any
damages to which you find the plaintiff
entitled, award an amount [which] will serve
to punish the defendant, Upjohn Company, and
to deter others from the commission of the
like offenses.
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