PRODUCT LIABILITY UPDATE Presented and Prepared by:
Michael D. Schag
mschag@heylroyster.com
Edwardsville & Chicago, Illinois • 618.656.4646
Prepared with the Assistance of:
Brett M. Mares
bmares@heylroyster.com
Edwardsville, Illinois • 618.656.4646
Heyl, Royster, Voelker & Allen
PEORIA • SPRINGFIELD • URBANA • ROCKFORD • EDWARDSVILLE • CHICAGO
© 2012 Heyl, Royster, Voelker & Allen
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PRODUCT LIABILITY UPDATE
I.
POST-JABLONSKI METHODS OF PROOF .............................................................................................J-3
A.
B.
C.
D.
II.
THE INTERPLAY OF DUTY AND RELATIONSHIP ................................................................................J-6
A.
B.
C.
III.
Competing methods .....................................................................................................................J-3
The Panther Platform and Fuel Tank Integrity ....................................................................J-4
The Jablonski Court’s Analysis ...................................................................................................J-5
Jablonski’s Lasting Impact ...........................................................................................................J-6
Simpkins v. CSX Corp. ...................................................................................................................J-7
Holmes v. Pneumo Abex ...............................................................................................................J-7
Why These Cases Are Important ..............................................................................................J-9
THE LEARNED INTERMEDIARY DOCTRINE ..........................................................................................J-9
A.
B.
C.
Wendell v. Johnson & Johnson...................................................................................................J-9
Hernandez v. Schering Corp. .................................................................................................... J-10
A Continued Strengthening of Protections for Drug Manufacturers ...................... J-13
The cases and materials presented here are in summary and outline form. To be certain of their applicability and use
for specific claims, we recommend the entire opinions and statutes be read and counsel consulted.
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PRODUCT LIABILITY UPDATE
I.
POST-JABLONSKI METHODS OF PROOF
A.
Competing methods
Product liability cases based on negligence adhere closely to common law jurisprudence.
Looking past the conventional formula of the need to prove duty, breach of duty, injury and
proximate causation, the key question in a negligent design case is whether the manufacturer of
the product at issue exercised “reasonable care” in designing the product. Calles v. Scripto-Tokai
Corp., 224 Ill. 2d 247, 270, 864 N.E.2d 249 (2007). In evaluating this question, one must ask
“whether in the exercise of ordinary care the manufacturer should have foreseen that the design
would be hazardous to someone.” The plaintiff must therefore prove that the manufacturer
“knew or should have known of the risk posed by the product design at the time of
manufacture.” Calles, 224 Ill. 2d at 271.
In 2007, the Illinois Supreme Court’s oft-criticized decision in Calles v. Scripto-Tokai Corp.
upheld, as part of this evaluation, implementation of the “risk-utility balancing test” in order to
determine the reasonableness of the manufacturer’s actions. Id. at 269. As described in the
Restatement (Second) of Torts § 291, the test compares “the risks inherent in the product
design” and “the utility of benefit derived from the product.” Thus, negligence results if the risk
caused by the product is of such magnitude that it outweighs the utility of the product. The two
primary factors to be considered in turn are whether there were feasible alternative designs
available at the time of manufacture, and whether the design the manufacturer used conformed
to industry standards, authoritative voluntary organizations, or regulatory criteria. Id. at 267.
For example, at one end of the risk-utility spectrum would be a child’s toy that contains lead
paint. This product offers an allegedly high risk of medical problems to the children who come
into contact with it, and only the slight utility of entertainment. On the other end of the riskutility spectrum would be a pencil, providing users with a great deal of utility and very little risk
of injury. Most products, such as cars, fall somewhere in between these two extremes.
The risk-utility test is just one of several ways to approach a negligent design case. In 2008, the
Illinois Supreme Court decided Mikolajczyk v. Ford Motor Co., 231 Ill. 2d 516, 901 N.E.2d 516
(2008), in which it held that the risk-utility test is not a “theory of liability,” but is instead one of
several “methods of proof by which a plaintiff ‘may demonstrate’ that the element of
unreasonable dangerousness is met.” Mikolajczyk, 231 Ill. 2d at 548. Another theory of liability,
the “consumer expectation test,” laid out in Restatement (Second) of Torts § 402A, demands that
a plaintiff prove that a product is “dangerous to an extent beyond that which would be
contemplated by the ordinary consumer who purchases it, with ordinary knowledge common to
the community as to its characteristics.” Id. at 526. Thus, liability is the product of both the
community’s “ordinary knowledge” and the level of danger associated with the product. A gun
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manufacturer is therefore likely to escape liability, while the maker of a defective over-thecounter cold medication would, under this analysis, be held liable for resulting injuries.
B.
The Panther Platform and Fuel Tank Integrity
In 2003, as John and Dora Jablonski were travelling through Madison County, Illinois in their
1993 Lincoln Town Car, another car, travelling at approximately 65 miles per hour, rear-ended
the Jablonskis after they had come to a complete stop in traffic. Jablonski v. Ford Motor Co., 2011
IL 110096, ¶ 3. A large pipe wrench in the trunk of the Town Car pierced the forward wall of the
trunk, rupturing the car’s gas tank and resulting in a fire. Mr. Jablonski died as a result, and his
wife was severely and permanently disfigured. Mr. Jablonski’s estate and his surviving wife
brought suit against Ford Motor Company, alleging that the company negligently designed and
located the fuel tank in the 1993 Lincoln Town Car. Much of the trial focused on whether the
location of the fuel tank was “reasonably safe.” Jablonski, 2011 IL 110096, ¶ 9.
In the 1960s and 1970s, most passenger cars had “aft of axle” fuel tanks, which were located
behind the car’s rear axle and laid parallel between the bottom of the car’s trunk (the “package
tray”) and the road. Id. at ¶ 7. This meant that, in many cases, the fuel tank came within inches of
the vehicle’s rear bumper. The aft of axle tanks resulted in a relatively high incidence of fuel-fed
fires upon impact, even at low speeds. Auto makers started searching for a new, safer place to
locate the fuel tank. In 1979, Ford introduced the Panther platform, upon which the bodies of
many of their four door passenger vehicles sat for over a decade of model years. Id. at ¶ 8.
The Panther platform enlisted a “vertical behind the axle” fuel tank, still located aft of the rear
axle, but protected on either side by the rear wheels, and situated vertically between the forward
wall of the car’s trunk and the rear passenger seats. Id. at ¶ 8. This left approximately 40 inches
of trunk space between the fuel tank and the rear bumper of the car. By 1991, a majority of Ford
vehicles had switched to fuel tanks situated forward of the rear axle, likely as a result of the
growing consumer preference for front wheel drive vehicles. Id. at ¶ 9. Still, the Panther platform
and the Ford Mustang, both rear wheel drive, made use of vertical behind the axle tanks. Other
car makers, including Audi, BMW, Chrysler, General Motors and Volvo, continued to use aft of
axle tanks.
During trial, the plaintiffs’ experts testified that all aft of axle fuel tanks had a heightened risk of
failing to maintain system integrity during a crash. Id. at ¶ 12. Specifically, “he stated that the aftof-axle tank was defective because it was located in the ‘crush zone’ in rear-impact collisions
and was vulnerable to being punctured by trunk contents and vulnerable to being pushed into
sharp objects in front of the tank.” Id. The plaintiffs’ experts testified that locating tanks forward
of the axle, or horizontally above the axle, were the safest solutions, as puncture by trunk
contents was a “well-recognized problem.”
Ford engineers looked into these issues, and determined that they did not pose serious risk of
harm. A 1970 internal memorandum indicated that placing the tank over the rear axle would be
the best location, as it would be “[a]lmost impossible to crush the tank from the rear.” Id. at ¶ 19.
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This location would also provide enough distance from the back bumper to avoid deformation
upon rear impact, while also protecting the tank from lateral impact with the tires, axle, and
wheel houses. The memorandum indicated that the tank could be placed high enough above
the package tray to avoid most puncturing objects. However, in the event it was punctured by
trunk contents, engineers were confident that fuel would remain in the trunk, not the passenger
compartment. Id. at ¶ 20. Moving the tank from this position was likely to cost $9.95 per car, and
might result in other unforeseen risks. Id. at 22.
C.
The Jablonski Court’s Analysis
The Illinois Supreme Court began its analysis by noting that a manufacturer has a non-delegable
duty to design a reasonably safe product, and therefore the fundamental question that is to be
answered in a negligent design case is whether the manufacturer exercised reasonable care in
the designing of the product alleged to have caused the injury. Calles, 224 Ill. 2d at 270. The
Jablonski court maintained, as in Calles, that the inquiry centers around “whether in the exercise
of ordinary care the manufacturer should have foreseen that the design would be hazardous to
someone,” and the plaintiff must demonstrate that “manufacturer knew or should have known
of the risk.” Id. at 271.
To do so, the Court again turned to the familiar risk-utility balancing test. The Court reasoned
that “[w]hen the risk of harm outweighs the utility of a particular design, there is a determination
that the manufacturer exposed the consumer to a greater risk or danger than is acceptable to
society.” Jablonski, 2011 IL 110096, ¶ 84. Among the factors to be considered are availability of
alternative designs at the time that the manufacturer produced the product; the used design’s
conformity to industry standards, design guidelines provided by an authoritative voluntary
organization; the utility of the product; safety aspects of the product; and the manufacturer’s
ability to eliminate unsafe characteristics of the product without sacrificing utility or affordability.
Id. at ¶ 85.
In the end, the Illinois Supreme Court held that “[a] manufacturer is not required to guard
against every conceivable risk, regardless of the degree of harm.” Id. at ¶ 96. Instead, the
manufacturer’s obligations are more accurately reflected under the risk-utility balancing test,
and plaintiffs were required to prove that Ford’s conduct in designing and locating the fuel tank
was unreasonable by demonstrating “that the risk was foreseeable and that the risks inherent in
the product design outweighed the benefits.” Id.
Here, plaintiffs were unable to do so. First, the 1993 Lincoln Town Car “satisfied the specific
federal fuel system integrity standards promulgated by the NHTSA for rear-end collisions,” and
after an investigation, the NHTSA chose not to require that the tank be moved. Further, the car
exceeded Ford’s more stringent internal crash test ratings. Id. The fact that Ford’s placement of
the fuel tank was consistent with industry practices carried out by a large swath of carmakers at
the time also tipped the risk-utility balancing test in Ford’s favor. Id. at ¶ 97.
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In order to outweigh these factors, plaintiffs would have had to prove that the foreseeable risk
of the tank placement outweighed its utility. Id. at ¶ 98. However, Ford demonstrated at trial that
moving the tank would have required a complete redesign of the vehicle, a drastic change that
would have introduced other risks of equal or greater magnitude, “including fuel-fed fires from
the filler pipe and tank rupture from other parts of the vehicle.” Id. at ¶ 101. Regarding
supplemental shielding that could have been installed around the tank, the Court found that it
would not have prevented the puncture that occurred in the present case. Id. at ¶ 106.
The Court consequently concluded that “after balancing the foreseeable risks and utility factors,
plaintiffs failed to present sufficient evidence from which a jury could conclude that at the time
of manufacture, Ford’s conduct was unreasonable or that it had acted unreasonably in failing to
warn about the risk of trunk contents puncturing the tank.” Id. at ¶ 107.
D.
Jablonski’s Lasting Impact
Jablonski marks a significant shift for the Illinois Supreme Court. The Court overruled not only
the jury’s more than $38 million verdict, but also its factual findings. Once there was a significant
split in jurisprudence between the risk-utility test and the consumer expectation test, the use of
each resting on the subject matter of the suit, the type of injury sustained, and a number of
other factors. Jablonski demonstrates the Court’s growing preference for a product liability
scheme which is more uniform, but also remains flexible for application to a wide variety of
lawsuits.
By refusing to use the consumer expectation test, but including a “non-exhaustive” list of factors
to be included in a risk-utility analysis, it is likely that Jablonski represents a shift towards a riskutility test that includes consumer expectations within its analytical framework. This might leave
plaintiffs with more challenging proof problems in product liability cases. The consumer
expectation test was flexible, resting heavily upon “community knowledge,” and therefore
leaving much to be decided by the intuitions and personal experiences of jurors.
II.
THE INTERPLAY OF DUTY AND RELATIONSHIP
Illinois personal injury jurisprudence has long held that some relationship must have existed
between the plaintiff and the defendant in order for the defendant to be held liable for injuries.
“The touchstone of [the] court’s duty analysis is to ask whether a plaintiff and a defendant stood
in such a relationship to one another that the law imposed upon the defendant an obligation of
reasonable conduct for the benefit of the plaintiff.” Marshall v. Burger King Corp., 222 Ill. 2d 422,
436, 856 N.E.2d 1048 (2006). This relationship analysis is based upon public policy
considerations, including the reasonable foreseeability of the injury, the likelihood of injury, the
magnitude of the burden of guarding against the injury, and the consequences of so burdening
the defendant. Marshall, 222 Ill. 2d at 436-37. Illinois courts also consider special relationships,
which may give rise to an affirmative duty “to aid or protect another against unreasonable risk
of physical harm.” Id. at 438. The question of duty has been the subject of some controversy, as
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exemplified by the “take home” asbestos litigation, in which an employee is alleged to have
taken asbestos fibers home with him on his person or clothes, and subsequently exposed his
family members to asbestos fibers, resulting in the family member’s asbestos-related illness.
A.
Simpkins v. CSX Corp.
In 2010, the Illinois Fifth District Court of Appeals found in Simpkins v. CSX Corp., 401 Ill. App. 3d
1109, 929 N.E.2d 1257 (5th Dist. 2010) that “employers owe the immediate families of their
employees a duty to protect against take-home asbestos exposure.” Simpkins, 401 Ill. App. 3d at
1119. In doing so, the Fifth District held that, while a duty still requires that the two parties stand
in an applicable relationship to one another, “[t]he term ‘relationship’ does not necessarily mean
a contractual, familial, or other particular special relationship. . . . As the Supreme Court has
noted, ‘the concept of duty in negligence cases is very involved, complex, and indeed
nebulous.’” The court added, “[E]very person owes every other person the duty to use ordinary
care to prevent any injury that might naturally occur as the reasonably foreseeable consequence
of his or her own actions.” Id. at 1113. (citations omitted). The court touched upon the four
public policy considerations mentioned in Marshall. Still, the exception appeared poised to
swallow the rule.
The court’s analysis in Simpkins did little to illuminate the holding. The issue, the court writes, is
not whether the employer “actually foresaw” the risk, but whether it “should have foreseen the
risk.” “[W]e believe that it takes little imagination to presume that when an employee who is
exposed to asbestos brings home his work clothes, members of his family are likely to be
exposed as well.” Therefore, the harm was foreseeable. Id. at 1116. The court also finds that
preventing against take-home exposure through substitution of products, issuance of warnings,
and updating of hygienic practices is not unduly burdensome. Id. at 1118.
Despite its findings of foreseeability and preventability, the opinion does not address the
“likelihood of injury” in any detail. Instead, the court writes that the likelihood of contracting
mesothelioma varies depending on exposure, and “the likelihood of developing such a disease
from anything more than incidental exposure is not remote.” Id. at 1117. Additionally, several
other jurisdictions have found that the relationship present here is not substantial enough that a
duty can be built upon it. Id. at 1114. Thus, in the wake of Simpkins, defendants were left with a
fluid and largely undefined schematic upon which Illinois’ relationship requirement is based,
knowing only that “the scope of liability will be inherently limited by the foreseeability of the
harm.” Id. at 1118.
B.
Holmes v. Pneumo Abex
In May 2006, a month after Jean Holmes died of peritoneal mesothelioma at the age of 93, her
estate brought an action to recover damages for wrongful death. Holmes v. Pneumo Abex, LLC,
2011 IL App (4th) 100462, ¶ 1. Her husband, Donald, worked at a Unarco asbestos plant in
Bloomington, Illinois from 1962 to 1963. Holmes, 2011 IL App (4th) 100462, ¶ 7. Both JohnsManville and Raybestos supplied asbestos to the plant during that time period. The action
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alleges that, while working at the Unarco plant, Donald brought home asbestos fibers on his
person and on his clothes, resulting in his wife’s exposure, illness, and death.
The science of take home asbestos exposure was slower to develop then the understanding of
the dangers of direct exposure. The plaintiff argued that literature “going back as far as 1913
showed the potential for disease as a result of workers bringing home toxic substances,” but
which did not specifically address asbestos. Id. at ¶ 25. In Martin v. Cincinnati Gas & Electric Co.,
561 F. 3d 439 (6th Cir. 2009), the Sixth Circuit noted that “other courts have found there was no
knowledge of bystander exposure in the asbestos industry in the 1950’s,” and found that the
“first studies of bystander exposure were not published until 1965.” Martin, 561 F.3d at 445.
Likewise, the Fourteenth District Court of Appeals of Texas found, in a 2007 case, that “the risk of
‘take home’ asbestos exposure was, in all likelihood, not foreseeable by defendant while [the
plaintiff] was working at defendant’s premises from 1954 to 1965.” In re Certified Question from
the Fourteenth District Court of Appeals of Texas, 740 N.W.2d 206, 218 (2007). Studies on nonoccupational asbestos exposure were also not first published until 1965. Alcoa, Inc. v. Behringer,
235 S.W.3d 456, 461 (Tex. App. 2007).
In Holmes, William Dyson, an industrial hygienist who testified at trial on behalf of the
defendants, said that he had found only a 1960 article by Dr. J.C. Wagner that discussed
mesothelioma that allegedly resulted from a worker who was directly exposed bringing home
asbestos fibers, resulting in his family’s exposure. Holmes, 2012 IL App (4th) 100462, ¶ 12. Even
the plaintiff’s own expert admitted at trial that the first epidemiological study “showing an
association between disease and asbestos fibers brought home from the workplace” was
presented and published in October 1964. The court’s analysis, therefore, came to hinge upon
what was known about the likelihood of injury from secondary, non-occupational exposure to
asbestos during the pertinent time.
The court ultimately found that the defendants did not owe a duty to Jean Holmes. The
likelihood of injury from secondary exposure was simply too abstract of a theory at the time her
husband worked with and around asbestos products for the defendants to have realistically
anticipated the possibility of injury to a worker’s immediate family. Even if the requisite
relationship did exist between defendants and Jean Holmes, “we would find no duty existed
because of the lack of foreseeability in this case.” Id. at ¶ 24.
The court wanted something more in order to establish that the defendants owed a duty to
plaintiff. “To show the injury was reasonably foreseeable here, plaintiff had to establish that
when decedent’s husband worked at Unarco from 1962 to 1963, it was reasonably foreseeable
asbestos affixed to a worker’s clothes during work would be carried home and released at levels
that would cause an asbestos-related disease in a household member.” Id. (emphasis added). In
other words, foreseeability had to be based upon knowledge during the pertinent time period,
and the plaintiff was not able to demonstrate this knowledge.
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C.
Why These Cases Are Important
Certainly asbestos defendants had been hoping the court would issue a definitive ruling
shutting the door on most “take home” claims forever. That did not occur, and as a result
defendants continue to receive claims arising from “take home” based theories. Nevertheless,
the court does leave open the ability of a defendant to develop a defense theory hinged to the
factual circumstances of a given case surrounding foreseeability. Perhaps an even more
interesting question is how Illinois courts might extend the duty and foreseeability based
reasoning to products liability cases not involving asbestos. In deciding these issues it appears
the answers will be tied more closely to the concept of foreseeability under a given set of facts
than to bright lines centered on the relationship status of the parties.
III.
THE LEARNED INTERMEDIARY DOCTRINE
Successful negligence actions require that the defendant owes the plaintiff a duty, breaches the
duty, and that the breach proximately causes plaintiff’s injury. However, application of these
requirements is rarely so straightforward. One area that has been subject to significant changes
of late is the analysis of the requisite duty and the “learned intermediary doctrine.” “[U]nder the
learned intermediary doctrine, the duty to warn of the side effects of a drug is owed by the
manufacturer to the patient’s physician, not the patient.” Hernandez v. Schering Corp., 2011 IL
App (1st) 093306, ¶ 27; see also Wendell v. Johnson & Johnson, No. C 09-04124 CW, 2011 WL
6291792, *6 (N.D. Cal. Dec. 15, 2011).
By refusing to impose upon manufacturers a direct duty to warn patients, courts recognize that
receipt of highly technical health information from more than one source is more likely to
confuse a patient than inform a patient. Courts also recognize that while manufacturers
specialize in making and marketing safe and effective drugs, doctors specialize in discussing
treatment options with patients. Therefore, manufacturers have a duty to convey information
regarding treatment risk to doctors, who, using their “medical judgment,” have a duty to inform
patients.
A.
Wendell v. Johnson & Johnson
In Wendell v. Johnson & Johnson, a recent case which came out of the Northern District of
California, the plaintiffs sued pharmaceutical companies on behalf of their son, Maxx, who died
from hepatosplenic T-cell lymphoma in December 2007. Wendell, 2011 WL 6291792 at *5. The
plaintiffs claimed that the defendant pharmaceutical manufacturers “failed adequately to warn
about certain risks posed by their products, specifically two prescription drugs: Humira and
mercaptopurine (6-MP). . . .” Id. at *1. Summary judgment was granted to the defendants
because there was no showing that different warnings would have resulted in other or different
courses of treatment.
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In 1998, Maxx was diagnosed with inflammatory bowel disease (IBD), and was treated by
Dr. Edward Rich, a pediatric gastroenterologist. Dr. Rich tried a series of drugs and drug
combinations in treating Maxx, including Prednisone and 6-MP. Approximately three years into
treatment, Dr. Rich began giving Maxx Remicade with the goal of weaning him off of steroids.
“Dr. Rich considered Remicade . . . as part of a class of anti-tumor necrosis factor drugs, also
known as ‘anti-TNF drugs’ and ‘TNF inhibitors.’” Id. at *2. Maxx took his last dose of Remicade in
March of 2006. Id. at *3. After a period of good health, he relapsed in November of 2006, and
began a regimen of Humira in combination with 6-MP. A rheumatologist at Dr. Rich’s hospital
had to prescribe the Humira, as it was placed under limited release by the hospital’s formulary.
Then, in July of 2007, Maxx was diagnosed with lymphoma, a disease that resulted in his death
less than six months later. Id. at *5.
Predictably, much of the trial focused on what drug warnings were issued, and by whom.
“Dr. Rich testified that it was not his ‘regular practice to look at drug labeling.’ He received
information on medications from multiple sources, including meetings, other professionals in
the field, articles and occasional meetings with drug representatives.” Id. at *1. He also stated
that, when he did read drug labeling, it was part of his decision-making process. Id. Also
germane to plaintiffs’ argument was that in May 2006, when the Food and Drug Administration
approved Remicade for treatment of pediatric Crohn’s disease, they required inclusion of a
“black box warning” which read,
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA HAVE
BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN’S DISEASE TREATED WITH REMICADE. THIS TYPE OF T-CELL LYMPHOMA
HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY FATAL. ALL OF
THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH REMICADE HAVE OCCURRED
IN PATIENTS ON CONCOMITANT TREATMENT WITH AZATHIOPRINE OR 6MERCAPTOPURINE.
Id. at *3.
Dr. Rich testified that, when he prescribed 6-MP, he was aware of a medical paper reporting the
occurrence of lymphoma in adults taking the drug, at a rate of approximately 1 percent. Id. at *2.
He later became aware of a study that showed occurrence of malignancies at approximately the
same rate in patients using Remicade, but the Physicians’ Desk Reference stated that these rates
of incident were similar to the general population. At this time, Dr. Rich was aware of no studies
that combined exposure to 6-MP and Remicade.
All of this did have an effect on how Dr. Rich treated Maxx. Dr. Rich considered the findings of
the studies to be “’significant,’ prompting him to warn patients of a ‘small but non-zero
increased risk of serious infections or malignancies’ when discussing 6-MP treatment with
patients. Dr. Rich testified that he may or may not have included the word ‘lymphoma’ when
providing the warning.” Id. He also testified that some of these conversations may not have
been documented. Further, Dr. Rich claimed that he avoided prescribing Remicade as a result of
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the black box warning that was included with the product, but he did not recall a similar warning
with Humira. Id. at *4. For their part, Maxx’s parents testified that they had not known about the
black box warning, and Dr. Rich informed them only that taking Humira would be more
convenient for their son. Id. at *5.
“A plaintiff asserting causes of action for failure to warn must prove not only that no warning
was provided or that the warning was inadequate, but also that the inadequacy or absence of a
warning caused the plaintiff’s injury.” Id. at *6. As such, California law grants summary judgment
if “stronger warnings would not have altered the conduct of the prescribing physician.” Motus v.
Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004). That is because under these circumstances, the
causal connection between the representations or omissions and the injury could not be
established. Wendell, 2011 WL 6291792, at *5.
Here, Dr. Rich testified that he sometimes read warnings when working with new drugs, or new
uses for drugs. Id. at *6. In fact, Humira was a relatively new drug for treating IBD when plaintiffs’
son was prescribed the drug for his condition. However, even if Dr. Rich would have read each of
the warnings available for Humira and 6-MP, summary judgment was still warranted in favor of
defendants, as he prescribed the drug even knowing the heightened risk of malignancy. The
evidence was insufficient to establish that these warnings would have changed the course of
Maxx’s treatment under Dr. Rich. Though the doctor spoke with his patients about the “nonzero
increased risk” associated with the drug, he did not stop prescribing the regimen. Id.
B.
Hernandez v. Schering Corp.
Hernandez v. Schering Corp., 2011 IL App (1st) 093306, a learned intermediary case from Illinois,
also contributed to this evolving field this year. Here, Mr. Hernandez sued the makers of PEGIntron, a drug used in the treatment of hepatitis C for injuries to his optic nerve and loss of
vision resulting from his use of the medication. Hernandez, 2011 IL App (1st) 093306, ¶¶ 1-2. The
Illinois court also upheld the fundamentals of the learned intermediary doctrine, finding that by
offering classes to hepatitis C patients on the side effects associated with the drug,
manufacturers did not forego the protection offered by the learned intermediary doctrine, and
therefore did not assume a physician’s duty to warn patients of the side effects resulting from
use.
In December 2001, after testing positive for hepatitis C, Hernandez began seeing Dr. Suleiman
Hindi, a physician specializing in diseases of the liver. Dr. Hindi recommended a drug
combination known as PEG-Intron/Rebetol, which included an interferon called Pegylated and
Rebetol. Hernandez began taking it in August of 2002. Approximately one month later, he had
an episode in which he vomited and his vision became blurred, and his eyesight did not recover.
After four days, Hernandez went to an emergency room, where it was found that he sustained
damage to his optic nerve as a result of taking the medication. Id. The result was permanent
vision loss.
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“As part of the medication regime, Dr. Hindi also expected his patients to attend an educational
class sponsored by [drug maker] Schering. The class was an additional way to instruct patients
how to use the medication and about any possible side effects. Dr. Hindi’s nurse would arrange
for the classes when there were enough patients for a class to be held.” Id. at ¶ 7. The class made
no mention of side effects associated with vision impairment, but did include some discussion
on the topic in reading materials that were passed out. At the conclusion of the class, the nurseinstructor encouraged patients to follow up with their doctors regarding side effects.
While other drugs were available that offered similar benefits, Dr. Hindi was more comfortable
with this combination because of its more extensive history of success. Still, he acknowledged
that “as a physician prescribing medication, the standard of care required him to inform patients
as to the potential side effects of the medication. He did not believe that Schering’s class
relieved him of his duty to provide information as to the side effects of the medication.” Id. at
¶ 8. However, Dr. Hindi was not aware of any vision related side effects.
The Hernandez court’s analysis again touched upon the fact that in order for negligence to be
found, there must have been a duty owed by the defendant to the plaintiff. This duty can be
voluntarily undertaken, in which case it binds the defendant just the same as in any other case.
The plaintiffs in this case contend that the drug manufacturer undertook a voluntary duty to
warn by holding classes on the drugs’ side effects. They rely heavily on the Restatement
(Second) of Torts, which states that
[o]ne who undertakes, gratuitously or for consideration, to render services to
another which he should recognize as necessary for the protection of a third
person or his things, is subject to liability to the third person for physical harm
resulting from his failure to exercise reasonable care to protect his undertaking, if
(a) his failure to exercise reasonable care increases the risk of such harm, or (b) he
has undertaken to perform a duty owed by another to the third person, or (c) the
harm is suffered because of reliance of the other or the third person upon the
undertaking.
Id. at ¶ 26.
The court held that the learned intermediary doctrine still served to protect the drug
manufacturers from liability to the plaintiff, despite the fact that they voluntarily undertook the
responsibility of providing classes on the possible side effects of one of their drugs. This is
because Dr. Hindi accepted responsibility for informing his patients about the possible side
effects. One amicus curiae brief submitted in this case urged the court to find that an exception
to the learned intermediary doctrine where “a manufacturer and seller of a drug replaces the
patient’s physician as the primary provider of information as to the risks and benefits of a drug.
However, such an exception would not apply here as this case does not involve direct-toconsumer advertising.” Id. at ¶ 35.
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C.
A Continued Strengthening of Protections for Drug Manufacturers
The learned intermediary doctrine is a very important protection offered to drug manufacturers.
In a highly regulated field such as medicine, courts continue to recognize that doctors are in the
best position to guide their patients through the often complicated process of obtaining
treatment for a serious illness. While courts appear to maintain a serious and stringent
obligation on the part of drug companies to inform health care providers of the risks associated
with each drug, this obligation is not always owed directly from the manufacturer to the patient.
A properly informed doctor can break the causal chain between the manufacturer and the
patient.
To have found that such a duty exists would have seriously complicated both the patient’s
decisions in obtaining treatment, and a doctor’s role guiding a patient through an illness. By
upholding a strong learned intermediary rule, courts recognize that drug manufacturers are
rarely in a better position to communicate with patients than are doctors. Moreover, these cases
allow manufacturers to continue to offer supplemental classes on their drugs, including benefits
and side effects, without fearing a disruption to the learned intermediary doctrine.
From the standpoint of a medical care provider, they must continue to meet their heavy
obligation of ensuring that patients are adequately informed. Physicians are less likely to
implement successfully a legal defense that rests upon shifting that burden to drug
manufacturers. Doing so would require proof that the patient’s harm was the result, not of the
doctor’s insufficient warning to the patient, but instead the manufacturer’s insufficient warning
to the doctor. This would encompass a more complex theory associated with FDA labeling
compliance, and therefore might be feasible only under limited circumstances.
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Michael D. Schag
- Partner
Mike is a partner at Heyl Royster's Edwardsville office
focusing his practice in toxic tort, commercial,
insurance litigation, and government contracts law. He
also handles cases in the firm’s Chicago office. He is
experienced in jury trials, appellate practice,
administrative/regulatory litigation, and alternative
dispute resolution. He has handled cases entailing
products liability, mass tort, commercial contract,
government contract and insurance law.



"10 Principles for Receiving High-Quality Legal
Services," Contract Mgmt (2005)
"The Consequences of Mutually Mistaken Facts
in Contracting," Contract Mgmt (2005)
"Developing Basic Trial Skills," The Civil Litigator
(2004)
Public Speaking
 “Issues of Justice and Dignity in the Law”
John Marshall University Law School (2011)
 “Mortgage Foreclosures: The Meltdown
Continues”
Illinois Institute of Continuing Legal Education
(2010)
 “Servicemembers Civil Relief Act”
Southern Illinois University (2009)
 “Business Implications of Servicemembers Civil
Relief Act”
Illinois State Bar Association (2006-2008)
Mike is a career Air Force Reserve officer holding the
rank of Lieutenant Colonel. He is a Judge Advocate
and serves on a headquarters legal staff in Air
Mobility Command at Scott Air Force Base. He is a
trial advocacy instructor and sits as an administrative
hearing officer. He was recently awarded his fifth
Meritorious Service Medal for his work as a JAG
lawyer.
As an Adjunct Professor for Embry-Riddle
Aeronautical University for 10 years, Mike taught over
25 graduate and undergraduate courses in insurance,
environmental, labor and employment, business, and
aviation law. During law school, Mike was a Merit
Scholar and Articles Editor of the Law Review.
Professional Associations
 National Contract Management Association:
Board of Directors 2003-2004
 American Bar Association, Litigation and Public
Contracts Sections
 Illinois State Bar Association
Significant Cases
 Ridenour v. Kaiser-Hill Co., 397 F.3d 925 (10th
Cir. 2005) - Successful defense of government
contractor in False Claims Act appeal averting
revelation of classified information and
adopting the Sequoia standard of review.
Court Admissions
 State Courts of Illinois and Colorado
 United States Court of Federal Claims
 United States District Court, District of
Colorado
 United States District, Southern District of
Illinois
 United States Air Force Court of Criminal
Appeals
 United States Court of Appeals, Armed Forces
 United States Court of Appeals, Federal Circuit
 United States Court of Appeals, Tenth Circuit
 Supreme Court of the United States
Transactions
 Serves as an arbitrator, either at the request of
the insurer or insured, at arbitrations involving
insurance claims.
Publications
 Servicemember and Veterans Rights, co-author,
Matthew Bender (2011)
 Co-author, "Servicemembers Civil Relief Act,"
chapter in Military Service and the Law, Illinois
Institute for Continuing Legal Education (2009)
 "Finding Your Way Around the Servicemembers
Civil Relief Act," Illinois Bar Journal (2007)
 "The Dynamics of State and Local Protest
Litigation," Contract Mgmt (2006)
Education
 Juris Doctor (Cum Laude), Oklahoma City
University School of Law, 1994
 Bachelor of Science-Business Administration,
University of Illinois, 1989
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Learn more about our speakers at www.heylroyster.com