Volume 3, Number 7 .July 2003
When Is Compliance
Pharmaceutical
By Frederick].
Necessary?
Manufacturers
and Prop. 65
Ufkes
T
he pharmaceuticalindustty has been heavily regulated for many years,starting with the original enactmentof the Food and Drug Act in 1906. Over the
years, a bewildering array of regulationshas been established that affect the
sale and consumption of drugs at both the federal and state levels. While many of
these past regulations have been subsumed into the FDA's rules and regulations,
one of the most difficult and currently pressing questions a pharmaceuticalmanufacturer must ask itself is whether to comply with California's Proposition 65. The
manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely,imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with
Proposition 65 in the pharmaceuticalcontext.
BACKGROUND
In 1986, California voters enacted Prop. 65, "The Safe Drinking Water and Toxic
EnforcementAct." SeeCal. Health and SafetyCode § 25249.5et seq.The purpose of
Prop. 65 is to provide individuals in the State of California with information concerning exposures to chemicals that a panel of experts has determined causecancer, birth defects and/or reproductive harm.-Any person or company employing
more than ten individuals is subjectto Prop. 65, and manufacturersand distributors
of products containing listed chemicalsare required to "give a c;learand reasonable
warning" before exposing anyone to a listed chemical,
BecauseProp. 65 was passedas part of the initiative process in California, not as
a result of legislative action, it has raised numerousconcerns for industty. For example, there is no risk/benefit analysisallowed; if a manufacturer or distributor knows
of the presence of a chemical that is subject to the regulations, it must provide a
warning. Furthermore,Prop. 65 allows for private parties or "bounty hunters" to file
: claims against supposed non-compliers, seeking penalties of up to $2500 per day
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Compliance
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per violation, as well as the payment
of attorneys fees.
RESOONsmn.ny
TO CoMPLY
Prop. 65 is applicable to pharmaceutical manufacturers. See Cal.
Health and Safety Code § 25249.6.
They, likewise, are required to provide a "clear and reasonable warning" unless they are somehow otherwise exempted from Prop. 65. The
California Health and Welfare
Agency (CHWA), the agency initially
designated to administer Prop. 65,
adopted an implementing regulation
(the Regulation) stating: "for prescription drugs,
the labeling
approved or otherwise provided
under federal law and the prescriber's accepted practice of obtaining a patient's informed consent shall
be deemed a clear and reasonable
warning." Cal. Code Reg. tit. 22,
Section 12601(b)(2.
Because there is an existing comprehensive
federal
regulatory
scheme concerning warnings on
drugs promulgated by the FDA, the
conflict for drug manufacturers is
obvious: FDA regulations require a
detailed review and approval process
for the information provided in package inserts and on labeling for prescription drugs. The FDA regulations
require similar information, particularly relating to safety, on any advertising for prescription drugs. Further,
once the FDA approves a label, no
changes may be made without its
prior approval. Any unapproved
FrederickJ. Utkes is a partner at the
Los Angeles Office of Kirkpatrick &
Lockhart, LLP, and has regional and
national counsel experience in product liability litigation. His experience
includes serving as trial counsel in
numerous toxic tort casesrepresenting Fortune 500 companies. Ufkes litigatesa wide range of issuesaffecting
the chemical and pharmaceutical
industry, including defending claims
of violations of Proposition 65. He
would like to thank Nicole Lee, an
Associate at Kirkpatrick & Lockhart,
LLP for her assistancein the preparation of this article.
changes to the label may render the
product "misbranded" under federal
law and subject the manufacturer to
substantial filles and penalties. See
Cantor v. Warner Lambert Company,
99 Cal.App. 4th 780 (2002).
& Medical Device
Law- Bu~
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THE OTC CoNTEXT
Prop. 65 complaints have been
filed both by the California Attorney
General'sOffice as well as by private
attorneys general in numerous cases
involving over-the-counterdrugs and
other medical products. For example,
manufacturers of dental amalgam
have fought a long, losing battle with
the State of California concerning
information provided to dental
patients as to the presenceof mercury in dental amalgam.
Recently,a private attorney general
initiated action againsta manufacturer
of an OTC nicotine patch for the
cessation of smoking. In Dowhal
v. SmithKline Beecham Consumer
Healthcare, Cal.App.4th8 (2002),the
Court of Appeals overturning the trial
court's entry of summaryjudgment on
behalf of the defendants,determined
that the Modernization Act of 1997
had a savings clausewhich explicitly
provided that Prop. 65 and federal
law were not in direct conflict. This
decision has recently been depublished, as the California Supreme
Court has granted review. Dowhal
v. SmithKline Beecham Consumer
Healthcare, No. S109306,(2002 WL
1486578)(October 23, 2002).
Not only is Smith Kline Beecham
challenging the Dowhal court's decision, but the FDA likewise is challenging it, arguing that it specifically
rejected the proposed Prop. 65 warning as scientifically unreliable and
one that might dissuade pregnant
women from trying to stop smoking,
a result that would not be in the
interest of good public health. The
FDA argues that it carefully considers
the warnings that it requires on
products and, based on its expertise,
has mandated the precise warning
language that it concludes provides
all material information relating
to safety. The FDA has stressed
that strict compliance with Prop. 65
may result in a narrow focus that
disregards entirely the product's
continued on page 4
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Compliance
continued from page 2
significance in reducing known
health risks, which the FDA takes
into consideration when approving
warnings and labeling.
PREscRlPnON
DRUGS
The rules to be applied to prescription drugs are more precise than
for OTC products. Not only do the
enabling regulations to Prop. 65 provide a "safe harbor," but recent trial
court decisions have determined that
to the extent Regulation 12601(bX2)
does not provide for an absolute safe
harbor, the imposition of Prop. 65 liability for prescription drugs is preempted by federal law.
In State of California v. Alpbanna
USPDInc., CaseNo. 992915,the San
Francisco Superior Court granted
summary judgment on behalf of
Alpharma against a claim by the
Attorney General that Alpharma violated Prop. 65 in the labeling for its
Lindane shampoo and lotion. The
Attorney General sued defendant
Alpharma, claiming that there were
chemicals in Lindane shampoo that
were "known to the people of the
State of California to cause cancer."
Alpharma moved for summary judgment on the grounds that its Lindane
products contained a label approved
by the FDA. The trial court agreed
with Alpharma, finding that its only
obligations under Prop. 65 were
satisfied by the FDA-approved label,
thimersosal-containingvaccines,and
together with the "prescriber's
thimerosal manufacturers. Further,
the court determined that any impoaccepted practice of obtaining a
patient's informed consent." The
sition of Prop. 65 liability in the context of prescription drugs would subcourt did not reach the issue of
implied or expresspreemption.
stantially interfere with and impede
the FDA's responsibilities to ensure
A very recent California trial court
that safe and efficacious drugs are
decision, however, specifically deteravailable to the consuming public.
mined that Prop. 65, to the extent
that it requires additional information
Judge Chaney held that the FDA
requirements govern all product
other than the FDA-approved label
information materials relating to preand package insert, is pre-empted.In
scription drugs, including advertisThe Vaccine Cases,JCCP No. 4246
ing, brochuresand postings,whether
(Los Angeles Superior Court), plainphysically attached to the product or
tiffs made claims, inter alia, for vionot Plaintiffs have recently filed a
lation of Prop. 65. Plaintiffs claimed
notice of appeal.
that they themselvesor their children
were poisoned with thimerosal-conCoNCLUSION
Clearly, Prop. 65 is a trap for the
raining vaccines, causing personal
injury and violating Prop. 65. They
unwary. Substantial penalties and
claimed that thimerosalcontainsmerattorneysfees can be collected either
cury, one of the listed chemicals on
by the stateAttorney General or by a
the Governor's"List, and that thereprivate litigant acting as a private
fore there was a requirement that
attorney general under the public
usersbe warned of reproductive toxbenefit portion of Prop. 65. However,
icity. However, the defendants sucrecent trends seem to indicate a
cessfully challenged the plaintiffs'
retrenchment from strict compliance
claim. Sustaininga demurrer without
with Prop. 65, especially in the pharleave to amend on the Prop. 65 claim
maceutical context. The California
Supreme
Court's acceptance of
(Master Complaint No.3), Judge
Victoria G. Chaney determined that
Dowhal, and recent trial court decithe manufacturersof thimerosal and
sions in Aipharma and The Vaccine
thimerosal-containing vaccines were
Cases, inqicate that state judges
entitled to judgment in their favor on
are more likely to view Prop. 65
that issue. The court determined that
as impeding the FDA's regulatory
provisions, and thus pre-empted by
Regulation 12601(b)(2) provided
an absolute safe harbor for the manfederal law.
ufacturers and distributors of
.
c