First Trial Set to Start for Bayer's Baycol
(Law.com / February 18, 2003) - The sixth and last cholesterol fighter
to be approved by the U.S. Food and Drug Administration was meant to
be Bayer Corp.'s billion-dollar drug, says Texas plaintiffs' lawyer Mikal
C. Watts.
Instead, Baycol has become the target of 7,655 products liability suits
filed against the company. Complaints allege that the drug caused debilitating
muscle damage and, in approximately 100 instances, death. Today, Watts
will take the first Baycol case to trial when jury selection begins in
Haltom v. Bayer Corp., No. 02-60165-2, in a Corpus Christi, Texas, state
court.
Noting that only a handful of mass tort cases actually go to trial,
Watts says, "It's extremely important that the first case be tried
so that Bayer can see what these cases are worth."
Bayer's chief outside counsel, Philip S. Beck of Chicago's Bartlit Beck
Herman Palenchar & Scott, disputes that, saying he doubts the outcome
of the Corpus Christi trial will be a harbinger of things to come for
either side. "These cases are going to trial to rise and fall on
their individual merits," he says.
Watts, who is seeking more than $100 million in punitive damages, represents
1,500 plaintiffs who are suing Bayer over Baycol. None of his cases has
settled yet.
Beck says that even though this case will be tried, Bayer is aggressively
pursuing a claims-settlement policy and has settled more than 400 cases
so far for amounts ranging from $100,000 to more than $1 million.
He emphasizes that each case must be examined for its individual merits.
He says more than 900,000 people took Baycol, but that only a tiny percentage
experienced serious side effects. "Some side effects are unavoidable," he
says.
Watts, declining to reveal the details of his negotiations with Bayer
in the Haltom case, disparages the other deals as offering "grossly
inadequate compensation" to Baycol's victims. "This company
knew this drug was going to kill people and they sold it anyway," he
alleges.
Meanwhile, in a U.S. district court in Minneapolis, 4,616 Baycol cases
filed in various federal courts against Bayer recently were administratively
consolidated into a multidistrict litigation (MDL) before Judge Michael
J. Davis. A class-certification motion is pending.
BAD SIDE EFFECTS
Watts said that his client, 82-year-old Hollis Haltom, took Baycol for
just two weeks before developing rhabdomyolysis. Called "rhabdo" for
short, rhabdomyolysis is a condition where large skeletal muscle cells
die. As those dead cells break down, toxins are released into the bloodstream,
where they ultimately flow into the kidneys, causing acute and potentially
fatal renal-system failure.
Haltom was taking sample doses of the drug when he was felled. Now he
is "significantly weakened and unable to care for himself," Watts
says. Haltom's own internist, Dr. Lee Guinn, will likely testify at the
trial as both a fact witness and as an expert, Watts says. Guinn had
been treating Haltom with other cholesterol fighters without incident,
he says.
But Beck, calling Haltom "a medical miracle," says the octogenarian's
medical problems were caused by poor health -- he has high cholesterol
and had already undergone coronary bypass surgery and was at high risk
for a heart attack.
Those ailments and others accounted for Haltom's debilitated condition,
Beck says, adding that Haltom had recovered from his bout with rhabdo.
SCIENTIFIC EVIDENCE
Jurors at the trial are expected to hear expert testimony about the
class of drugs called statins, of which Baycol is a member. Statins block
an enzyme the body needs to make cholesterol, lowering the body's low-density
lipoprotein, or "bad" cholesterol, levels.
The FDA had approved five cholesterol-lowering drugs before Baycol:
Zocor, Lipitor, Mevacor, Pravachol and Lescol. Bayer is sure to point
out during the trial that rhabdomyolysis is a potential side effect of
all of them.
Beck claims that Haltom had used the other drugs without success. While
he stopped short of faulting Guinn, Beck says that the doctor had given
Haltom an 0.8-milligram dosage when a 0.3-milligram dose was available.
Attorney Charles S. Zimmerman of Minneapolis' Zimmerman & Reed and
co-lead plaintiffs' counsel in the MDL, says that Baycol's flaw was that
the dosage had to be at least 0.8 milligrams for the drug to be effective.
Under pressure from the FDA, Bayer withdrew the medication from the
market in August 2001 after a four-year run.
At trial, the plaintiffs will introduce a letter written by an FDA director
that states that the agency had "grave reservations regarding the
overall safety of this drug." Dr. David G. Orloff, the author of
the letter, wrote that what piqued the agency's concern was what he called "an
alarming number of spontaneous reports of rhabdomyolysis" in patients
taking those pills.
What set Baycol apart from the other statins, Orloff wrote, was it had
a higher incidence of that side effect. And, the higher the dosage of
Baycol, the more severe the reaction.
In addition, Watts will rely on internal documents from Bayer that he
uncovered during pretrial discovery. He called them "the most damning
documents I've ever reviewed." He says the documents, which are
under seal until trial, show that Bayer withheld from the FDA negative
results of Baycol's clinical trials and rammed through testing of its
0.8-milligram version even though Bayer's own testing revealed that it
could by highly cytotoxic.
"All of that is false," Beck says. "Rhabdo is a well-known
and well-recognized side effect of all the statin drugs ... and we warned
about it."
Watts asserts that Bayer was less than candid with the FDA about its
efficacy. "Frankly, they just lied to the FDA about the clinical
testing of the drug," he says.
Beck says "the evidence is going to show that's just not true." He
says he will call as witnesses employees from Bayer who will testify
about Bayer's research and development, about why Bayer decided to withdraw
the drug and about how doctors were warned about Baycol's side effects.
Beck will also have to counter another piece of evidence from the plaintiffs
at trial. Plaintiffs' research shows that the serious side-effect rate
of Baycol is closer to 10 percent to 12 percent, as compared to the 2
percent rate for competitor Lipitor, says Minneapolis lawyer Richard
A. Lockridge, the other lead counsel for the MDL plaintiffs.
Beck called that figure "very very very high," adding, "that's
not a figure that came out of our files and not from the FDA."
The trial is expected to last two to three weeks. Lockridge says, "We're
all watching it carefully." |
