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profitable and fast-growing category of pharmaceuticals.

5

Cerivastatin

potential for Bayer.

It was the most

the market and its 0.4 much higher dosages of

mg dose had an competitors’

appeared to have significant powerful statin available on effect comparable to that of

statins.

6

Since LDL-lowering effect

was the

for sales

of statins, cerivastatin’s

potency

most important criterion

hopeful that this would reinvigorate its in the United States (Angelmar, 2007).

appeared

useful.

Bayer

was

profits

and

sales,

particularly

While in general, statins have relatively few side effects, one of

the most serious is the potential to cause rhabdomyolysis.

Rhabdomyolysis muscle protein

is a breakdown of muscle myoglobin being released

fibers which results in the

into

the

bloodstream.

The

myoglobin is toxic and can substantially damage the kidney. diagnosed by the observation of creatine kinase (CK) levels approximately ten times above upper normal levels and muscle rare cases, the renal failure caused by the myoglobin can be

It can

pain. fatal.

be

In

When cerivastatin was developed, this seemed like an isolated

problem.

In clinical trials of

percent of consistent

patients experienced with rhabdomyolysis.

earlier statins, between 0 and .5 elevated CK levels and muscle pain In only a single previous clinical

trial there

had was

a statin led to a some knowledge of

hospitalization.

Moreover, even though

the

problem

of

rhabdomyolysis

with

statins,

there was little sense that risk of statins (Chong, P.H., Seeger, J.D.,

rhabdomyolysis differed and Franklin C., 2001).

among A Bayer

This chapter only considers Bayer’s litigation strategy in the United States. Merck & Co had released Mevacor (lovastatin) in 1987, and Zocor 5

(simvastatin) in 1988. (pravastatin) in 1991.

Bristol-Myers Squibb introduced Pravachol Novartis had Lescol (fluvastatin) released in

1994.

Finally, Lipitor was released in February of 1997, just

Baycol after being (Angelmar, 2007).

developed

by

Warner-Lambert

and

co-marketed

before by Pfizer

6 The .4mg dose of Baycol had the same efficacy as 10mg Lipitor, 20mg Zocor, 40mg Mevacor and 80mg Lescol (Angelmar, 2007).

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