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    8-

patients with a dose lower than the 0.8 dose. Bayer also stopped shipping .8mg samples to U.S. doctors (Angelmar, 2007).

On sales of 7, Bayer

August 1, 2001, however, Bayer suspended all marketing and

the 0.8 decided

dose of cerivastatin in the United States.

to

completely

withdraw

cerivastatin

from

all

On August

markets

except Japan.

9

stock

Following the price fell by

announcement of cerivastatin’s withdrawal, Bayer’s

25%.

Most

observers

attributed

the

loss

to

the

anticipation of were filed both

lost profits and massive litigation.

Numerous

by

plaintiffs

who

suffered

from

rhabdomyolysis

claims and those

whose theories of causation were more speculative.

Plaintiffs sought

compensatory

(economic

and

non-economic)

and

punitive

damages

(Langley,

2004).

Given the chronology explained above, and other damaging

documents revealed during discovery, plaintiffs could that Bayer concealed information about the dangers of

plausibly argue cerivastatin and

continued to market the drug even after it knew of the dangers.

10

Bayer

could argue that it acted as quickly as feasible under the circumstances and that it should not be held responsible for prescribing physicians’ failure to abide by the contraindication for gemfibrozil co-therapy when

prescribing to be large

cerivastatin.

Nonetheless, Bayer’s liability was expected

and

most

observers

anticipated

a

mass

tort.

In

the

wake

of

American expected

Home Products experience with fen-Phen litigation, observers large litigation costs and perhaps attempts to reach a global

settlement with plaintiffs.

Bayer was expected to agree to mass

settlements

in

order

to

control

potential

losses

and

to

press

for

the

____________ Bayer did not withdraw cerivastatin from Japan because gemfibrozil was not available there and because the higher dosages of 9

cerivastatin were not sold there. cerivastatin in Japan was .15 mg.

The highest approved dosage of On August 23, 2001 Bayer withdrew

cerivastatin from the Japanese market, partly

because

of

the

impending

approval

of

gemfibrozil.

(Angelmar,

2007)

10 One damaging internal document stated: “If the FDA asks for bad news, we have to give, but if we don’t have it, we can’t give it to them.” (Berenson, 2003).

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