Bayer Settles Cases Over Clotting Drug

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Bayer Settles Cases Over Clotting Drug
Amaris Elliott-Engel

09-14-2010

Drugmaker Bayer AG has agreed to settle about 200 of 2,000 cases in which plaintiffs alleged that the use of Trasylol to control bleeding during their heart surgeries caused injuries such as kidney failure and fatal heart problems.

One Pennsylvania lawyer, James R. Ronca of Anapol Schwartz Weiss Cohan Feldman & Smalley, said he has settled 39 cases for a total of $19.9 million, which would work out to an average settlement of $510,000.

Ronca, who is co-lead plaintiffs counsel for the Trasylol multidistrict litigation centered in the U.S. District Court for the Southern District of Florida and plaintiffs' liaison counsel for the Philadelphia Common Pleas Court Trasylol mass tort program, said he has settled his entire inventory except for one case. Twenty of the cases were federal cases, and 19 of the cases were state cases.

Bloomberg reported in August that Bayer, which has its U.S. headquarters in Pittsburgh, had agreed to settle 150 cases for $60 million.

Neal L. Moskow of Ury & Moskow in Fairfield, Conn., said that he has settled 60 cases so far in the MDL, but he did not want to release the aggregate amount of the settlements.

Moskow said that the first Trasylol case scheduled to go to trial earlier this year was his firm's case and that case involved a much more serious injury than other plaintiffs'; the plaintiff in that case is on permanent dialysis and now is on the kidney transplant list.

Scott Love, co-lead plaintiffs counsel in the MDL and of Clark Burnett Love & Lee in Houston, said he has settled 20 cases recently, but he did not want to release the aggregate amount of the settlements because the settlement payments are still pending.

No cases have gone to trial either in the federal MDL, where around 1,800 cases have been filed in the litigation, or in the Philadelphia Common Pleas Court's Trasylol mass tort program, where 200 cases have been filed in the litigation. Around 200 cases have been dismissed, Ronca said in an interview.

According to Bayer's financial statements, there were 1,450 Trasylol lawsuits pending as of July 12.

During a status conference July 30 in the federal MDL, Bayer counsel Patricia E. Lowry of Squire Sanders & Dempsey in West Palm Beach, Fla., said that Bayer settled a total of 152 cases and had plans to meet with 10 law firms who represent 700 plaintiffs.

During the same conference, Ronca said there are 1,800 cases in the MDL and 200 cases in Pennsylvania state court.

Stanley Thompson, director of the Philadelphia Common Pleas Court's Complex Litigation Center, said that as of Thursday there were 188 Trasylol cases pending with six having left the court's dockets just last week.

Bayer's lead counsel is Steven E. Derringer of Bartlit Beck Herman Palenchar & Scott in Chicago.

Derringer referred comment to Bayer. A Bayer spokeswoman said she could confirm that Bayer reached settlements, without admission of liability, with 120 plaintiffs as of July 6.

"The cases involve people with different medical histories," said Bayer spokeswoman Tracy Funk in an e-mail. "After consideration of the facts of each individual case, Bayer will consider the option of settling individual lawsuits, without admission of liability, on a case-by- case basis. The company will continue to defend itself vigorously against all claims that are not considered for settlement."

Trasylol was approved by the federal Food and Drug Administration in 1993 to help stem the loss of blood for patients undergoing high-risk heart bypass surgery, according to Bayer's 2009 annual report.

When the drug was given further approval for use in even more bypass surgeries, the drug went from generating $40 million in annual revenue to $200 million in annual revenue, Ronca said.

Three studies in 2006 and 2007 raised concerns about a higher incidence of kidney failure or death from the use of Trasylol. The FDA began to conduct a review of Trasylol because one study showed an increase of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other drugs and because another study showed an increase in kidney dysfunction compared to another drug, according to a 2006 FDA news release.

Following those two studies, Bayer conducted its own safety study, which found that the use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes; however, this data was not provided to the FDA when the regulatory agency held a meeting on Trasylol safety in September 2006, the FDA said.

The FDA changed the Trasylol warning in 2006 to warn of a higher risk of kidney damage and to limit the use of Trasylol to patients with an increased risk of blood loss during bypass surgery, the agency said.

In the fall of 2007, the Ottawa Health Research Institute stopped its study on Trasylol because the drug appeared to increase the risk of death for patients, even though fewer patients taking Trasylol experienced serious bleeding events, the FDA said.

Then, upon the FDA's request, Bayer suspended marketing of Trasylol in November 2007, Bayer's annual report said.

Ronca said that Bayer is settling cases through an analysis of each case's liabilities, rather than striking a universal settlement in which plaintiffs are awarded their recoveries based on a point system, such as was used in the Vioxx global settlement.

When settling his firm's inventory, Ronca said that all of the clients were provided information on how their potential recoveries stacked up against other plaintiffs' on the bases of their age, if they went on dialysis, how long they went on dialysis, when their surgery was conducted in relation to the plaintiffs' evidence on what Bayer knew about the risk factors of Trasylol, and other factors.

Clients were provided that information before they gave approval to settling their cases, Ronca said. The settlements were also reviewed by an independent settlement master, Ronca said.

"The clients have to have complete transparency and independent review to make sure everybody is being treated equitably," Ronca said.

Bayer has been willing "to pay value for decent cases in order to avoid trial but is taking a hard line on" cases Bayer views as noncompensable, Moskow said.

Moskow said there will be Trasylol trials in cases in which the plaintiffs bar thinks there is value, but Bayer does not want to settle those cases because of the opinion that those cases are noncompensable.

Love said he does not think there will be more than one trial because Bayer understands it has some exposure over Trasylol, but he said there may be a trial in a case in which the plaintiffs bar, but not Bayer's defense counsel, thinks that plaintiffs have compensable injuries based on the allegations that their only injuries from Trasylol were from a heart attack or other heart condition.

While Bayer is working through each firm's inventory to settle cases, Bayer is not requiring the firms to settle all of their inventories in order to reach accords, Moskow said.

Moskow said he has heard that Bayer settled some cases in which the plaintiffs did not have to go on dialysis but still had demonstrable kidney function impairment.

Bayer's settlement process is different from many other pharmaceutical companies' processes, Love said.

"The way they approach it is certainly not the norm," Love said. The norm involves setting the value of cases through bellwether trials or through settlement negotiations until a global settlement is struck, he said.

The settlement process has been successful because Bayer and the plaintiffs have not been too far apart on the value of most cases, Love said. But the process has taken a while because of the individualized review that Bayer's settlement team gives to cases, Love said.

Bayer got tough on settlement in light of its successful motion in the MDL to bar testimony from a plaintiffs expert, Dr. Suzanne Parisian, Ronca said. Then another plaintiffs expert, Dr. Curt D. Furberg, withdrew his representation, but the plaintiffs were allowed to retain another expert whose testimony would cover the same areas as Furberg and Parisian's.

Ronca said that the effect on the litigation from the changes in the plaintiffs experts still has to be shaken out.

The decision to preclude Parisian's testimony has not affected the litigation too much because there has not yet been a Trasylol trial in which the expert testimony turned out to be crucial, Love said.

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