As a global company with a diverse business portfolio,
the Bayer Group is exposed to numerous legal risks, particularly
in the areas of product liability, competition and antitrust
law, patent disputes, tax assessments, and environmental
matters. The outcome of any current or future proceedings
cannot be predicted with certainty. It is therefore possible
that legal or regulatory judgments could give rise to expenses
that are not covered, or not fully covered, by insurers’ compensation
payments and could significantly affect our revenues and
earnings.
Legal proceedings currently considered to involve material
risks are outlined below. The litigation referred to does
not necessarily represent an exhaustive list.
Lipobay/Baycol: As of January 13, 2006,
the number of Lipobay/Baycol cases pending against Bayer
worldwide was approximately 6,000 (approximately 5,900 of
them in the United States, including several
class actions). As of January 13, 2006, Bayer had settled
3,082 Lipobay/Baycol cases worldwide without acknowledging
any liability and resulting in settlement payments of approximately
US$ 1.147 billion. Bayer will continue to offer fair compensation
to people who experienced serious side effects while taking
Lipobay/Baycol on a voluntary basis and without concession
of liability. In the United States five cases have been tried
to date all of which were found in Bayer’s favor.
After more than four years of litigation we are currently
aware of fewer than 50 pending cases in the United States
that in our opinion hold a potential for settlement, although
we cannot rule out the possibility that additional cases
involving serious side effects from Lipobay/Baycol may come
to our attention. In addition, there could be further settlements
of cases outside of the United States.
In the fiscal years 2003 and 2004, Bayer recorded a total EUR 347
million charge to the operating result beyond the insurance
coverage. A further EUR 43 million charge to the operating
result was recorded in 2005, in respect of settlements already
concluded or expected to be concluded and anticipated defense
costs.
A group of stockholders has filed a class-action lawsuit
claiming damages against Bayer AG and Bayer Corporation and
two current or former managers. The suit alleges that Bayer
violated U.S. securities laws by making misleading statements,
prior to the withdrawal of Lipobay/Baycol from the market,
about the product’s commercial prospects and, after
its withdrawal, about the related potential financial liability.
In September 2005 the court dismissed with prejudice the
claims of non-U.S. purchasers of Bayer AG stock on non-U.S.
exchanges. Bayer believes it has meritorious defenses and
will defend itself vigorously
PPA: Bayer is a defendant in numerous product
liability lawsuits relating to phenylpropanolamine (PPA),
which was previously contained in a cough/cold product of
the company supplied in effervescent-tablet form. The first
PPA lawsuits were filed after the U.S. Food and Drug Administration
recommended in the fall of 2000 that manufacturers voluntarily
cease marketing products containing this active ingredient.
Plaintiffs are alleging injuries related to the claimed ingestion
of PPA.
As of January 13, 2006, 286 lawsuits were pending in U.S.
federal and state courts against Bayer, of which 136 name
Bayer as the only manufacturing defendant. An additional
295 cases are on appeal in federal court after the plaintiffs’ claims
had been dismissed for failure to comply with procedural
requirements. No lawsuits have been filed outside the United
States.
Three state cases have proceeded to trial. Two have resulted
in defense verdicts for Bayer. In one case, the plaintiff
was awarded damages of US$ 400,000. This case was settled
in July 2005 while on appeal.
As of January 13, 2006, Bayer had settled 247 cases resulting
in payments of approximately US$ 42 million,
without acknowledging any liability. In the fiscal year 2005,
Bayer recorded expenses in the amount of EUR 62 million
for settlements already concluded or expected to be concluded
and expected defense costs.
Bayer will defend itself vigorously in all Lipobay/Baycol and
PPA cases in which in our view no potential for settlement
exists or where an appropriate settlement cannot be achieved.
Due to the considerable uncertainty associated with these
proceedings, it is currently not possible to further estimate
potential liability.
Since the existing insurance coverage is exhausted (insurance
coverage for PPA exists for up to 5 percent of future costs),
it is possible – depending on the future progress of
the litigation – that Bayer could face further payments
that are not covered by the accounting measures already taken.
We will regularly review the possibility of further accounting
measures depending on the progress of the litigation.
Cipro®: 39 putative class-action lawsuits,
one individual lawsuit and one consumer protection group
lawsuit (which has been dismissed) against Bayer involving
the medication Cipro® have been filed since July 2000
in the United States. The plaintiffs are suing Bayer and
other companies also named as defendants, alleging that a
settlement to end patent litigation reached in 1997 between
Bayer and Barr Laboratories, Inc. violated antitrust regulations.
The plaintiffs claim the alleged violation prevented the
marketing of generic ciprofloxacin as of 1997. In particular,
they are seeking triple damages under U.S. law. After the
settlement with Barr the patent was the subject of a successful
re-examination by the U.S. Patent and Trademark Office and
of successful defenses in U.S. Federal Courts. It has since
expired.
All the actions pending in federal court were consolidated
in federal district court in New York in a multidistrict
litigation (MDL) proceeding. On March 31, 2005, the court
granted Bayer’s motion for summary judgment and dismissed
all of plaintiffs’ claims in the MDL proceeding. The
plaintiffs are appealing this decision. Further cases are
pending before various state courts. Bayer believes that
it has meritorious defenses and intends to defend these cases
vigorously.
Rubber, polyester polyols, urethane:
Proceedings involving the former rubber-related lines of
business
Investigations by the E.U. Commission and the U.S. and Canadian
antitrust authorities for alleged anticompetitive conduct
involving certain products in the rubber field are pending.
In two cases Bayer AG has already reached agreements with
the U.S. Department of Justice to pay fines, amounting to
US$ 66 million for antitrust violations relating to rubber
chemicals and US$ 4.7 million for those relating to acrylonitrile-butadiene
rubber (NBR). In December 2005, the E.U. Commission imposed
a fine of EUR 58.9 million for antitrust violations
in the area of rubber chemicals. Further investigations by
the named authorities are ongoing.
Numerous civil claims for damages including class actions
are pending in the United States and Canada against Bayer
AG and certain of its subsidiaries as well as other companies.
The lawsuits involve rubber chemicals, EPDM, NBR and polychloroprene
rubber (CR). Bayer has reached agreements or agreements in
principle to settle a number of these court actions. Some
of these agreements or agreements in principle remain subject
to court approval. These settlements do not resolve all of
the pending civil litigation with respect to the aforementioned
products, nor do they preclude the bringing of additional
claims.
Proceedings involving polyester polyols, urethanes and urethane
chemicals
Bayer Corporation has reached agreement with the U.S. Department
of Justice to pay a fine of US$ 33 million for antitrust
violations in the United States relating to adipic-based
polyester polyols. A similar investigation is pending in
Canada.
A number of civil claims for damages including class actions
have been filed in the United States against Bayer involving
allegations of unlawful collusion on prices for certain polyester
polyols, urethanes and urethane chemicals product lines.
Similar actions are pending in Canada with respect to polyester
polyols.
Proceedings involving polyether polyols and other precursors
for urethane end-use products
Bayer has been named as a defendant in multiple putative
class-action lawsuits involving allegations of price fixing
of, inter alia, polyether polyols and certain other precursors
for urethane end-use products. Bayer has reached an agreement
in principle, subject to court approval, to settle all of
the class-action cases relating to claims from direct purchasers
of polyether polyols, MDI and TDI (and related systems).
The foregoing settlements do not resolve all of the pending
civil litigation with respect to the aforementioned products,
nor do they preclude the bringing of additional claims. Bayer
was served with a subpoena from the U.S. Department of Justice
seeking information relating to the manufacture and sale
of these products.
Impact of antitrust proceedings on Bayer
In consideration of the portion allocated to LANXESS, expenses
in the amount of EUR 336 million were accrued in the
course of 2005 which led to the establishment of a provision
for the previously described civil proceedings in the amount
of EUR 285 million as of Dec. 31, 2005. Bayer created
a provision of EUR 80 million as of Dec. 31, 2005
in respect of the rubber-related E.U. proceedings noted
above, although a reliable estimate cannot be made as to
the actual amount of any expected additional fines.
These provisions taken may not be sufficient to cover the
ultimate outcome of the above-described matters. The amount
of provisions established in 2005 for civil proceedings was
based on the expected payments under the settlement agreements
described above. In the case of proposed settlements in civil
matters which have been asserted as class actions, members
of the putative classes have the right to “opt out” of
the class, meaning that they elect not to participate in
the settlement. Plaintiffs that opt out are not bound by
the terms of the settlement and have the right to independently
bring individual actions in their own names to recover damages
they allegedly suffered. We cannot predict the size or impact
of the opt-out groups on the settlement agreements.
Bayer will continue to pursue settlements that in its view
are warranted. In cases where settlement is not achievable,
Bayer will continue to defend itself vigorously.
The financial risk associated with the proceedings described
above beyond the amounts already paid and the financial provisions
already established is currently not quantifiable due to
the considerable uncertainty associated with these proceedings.
Consequently, no provisions other than those described above
have been established. The Company expects that, in the course
of the regulatory proceedings and civil damages suits, additional
charges will become necessary.
Patent and contractual disputes: Further risks arise from
patent disputes in the United States. Bayer is alleged to
have infringed third-party patents relating to the blood
coagulation factor Kogenate®. In another dispute, Bayer
has filed suit against several companies, alleging patent
infringement in connection with moxifloxacin. These companies
are defending the action, claiming, among other things, that
the patents are invalid and not enforceable.
In August 2005, Abbott filed suit against, among others,
Bayer for alleged patent infringement in connection with
blood glucose monitors. The Japanese manufacturer of the
product Ascensia® Contour® system is contractually
obligated to indemnify Bayer against the potential liability.
Risks also exist in connection with court or out-of-court
proceedings in which Bayer is alleged to have violated contractual
or pre-contractual obligations. For example, Aventis Behring
LLC alleges that Bayer violated contractual obligations relating
to the supply of Helixate® and is seeking damages.
Limagrain Genetics Corporation has filed suit against Bayer – as
legal successor to Rhône-Poulenc – for indemnity
against liabilities to third parties arising from breach
of contract.
Bayer and Lyondell Group have asserted claims against each
other in a binding arbitration proceeding arising from a
joint venture agreement in the manufacture of propylene oxide
generally relating to differences in contractual interpretation.
Bayer believes it has meritorious defenses in these patent
and contractual disputes and will defend itself vigorously.
Product liability and other litigation: Legal
risks also arise from product liability lawsuits other than
those concerning Lipobay/Baycol and PPA. Numerous actions
are pending against Bayer seeking damages for plaintiffs
resident outside of the United States who claim to have
become infected with HIV or HCV (hepatitis C virus) through
blood plasma products. Further actions have been filed by
U.S. residents who claim to have become infected with HCV.
Bayer is also a defendant in cases in which plaintiffs are
asserting claims alleging damage to health from the substance
thimoseral, used especially in immunoglobulin therapies.
Bayer, together with other manufacturers, wholesalers and
users is a defendant in the U.S. state of Alabama in cases
seeking damages, including one nationwide putative class
action, for personal injuries alleging health damages through
exposure to diphenylmethane diisocyanate (“MDI”)
used in coal mines.
Bayer, like a number of other pharmaceutical companies in
the United States, has several lawsuits pending against it
in which plaintiffs, including states, are seeking damages,
punitive damages and/or disgorgement of profits, alleging
manipulation in the reporting of wholesale prices and/or
best prices.
A further risk may arise from asbestos litigation in the
United States. In the majority of these cases, the plaintiffs
allege that Bayer and co-defendants employed third parties
on their sites in past decades without providing them with
sufficient warnings or protection against the known dangers
of asbestos. One Bayer affiliate in the United States is
the legal successor to companies that sold asbestos products
until 1976. Should liability be established, Union Carbide
has to completely indemnify Bayer.
Bayer, among others, is named as a defendant in a putative
nationwide class action pending in federal court in North
Carolina in the United States which alleges violations of
antitrust laws in the marketing of the pest control product
Premise®.
Bayer believes it has meritorious defenses in these product
liability and other proceedings and will defend itself vigorously.
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