Verdicts

First Levaquin Test Case Results in Seven-Figure Award

In the first test case to go to trial over side effects from Levaquin, Johnson & Johnson's popular and powerful antibiotic, a federal jury has awarded more than $1.8 million to a Minnesota octogenarian who claims the drug caused his Achilles tendons to rupture.

The jury's award of both compensatory damages and punitive damages to plaintiff John Schedin is sure to reverberate nationwide, because it was the first of several bellwether cases to go to trial from a pool of more than 2,600 cases pending in state and federal courts.

U.S. District Judge John R. Tunheim of the District of Minnesota is presiding over a federal multidistrict litigation that includes nearly 800 cases and New Jersey Superior Court Judge Carol E. Higbee is presiding over a mass tort litigation that includes more than 1,400 cases.

Attorney Brian J. McCormick Jr. of the Sheller firm in Philadelphia, who was on the trial team in Minnesota and serves on the plaintiffs liaison committee in the New Jersey cases, said the Schedin verdict could lead to global settlement talks, especially if it is followed by significant verdicts in test cases expected to go to trial early this year.

In the suits, plaintiffs lawyers claim that Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc. failed to warn doctors that Levaquin showed a significantly higher rate of side effects, including tendon ruptures, than other drugs in its class. McCormick said that Schedin, 82, suffered ruptures in both Achilles tendons and was not a candidate for surgery due to his age. The injury has had lasting effects, McCormick said, leaving Schedin with a limp and unable to walk up stairs. A court transcript of an oral argument before Tunheim shows that the issue of punitive damages was hard fought.

Ronald S. Goldser of Zimmerman Reed in Minneapolis, MN, told Tunheim that revenue from Levaquin from 2001 through 2009 was about $13 billion and that Johnson & Johnson and Ortho-McNeil wanted to protect it from negative regulatory action in both Europe and the United States that could have devastated those sales figures, according to the transcript. Goldser said the companies “deliberately disregarded patient rights” by failing to include more detailed warnings on the drug packaging, and that there was evidence that they “manipulated the scientific literature for their own economic purposes.” While evidence was mounting of the drug's dangers, Goldser said, the companies bowed to pressure in Europe and sent “Dear doctor” letters in six countries, but never sent such letters to doctors in the United States.

But lead defense attorney John Dames of Drinker Biddle & Reath's Chicago office urged Tunheim to bar the plaintiffs from seeking punitive damages because there was no evidence of a disregard for patients, according to the transcript. “Levaquin is efficacious and is very valuable. It is a good drug,” Dames said. “Levaquin is in fact the most efficacious, the best antibiotic for upper respiratory tract infections.” Dames also disputed the claim that Levaquin has a higher rate of side effects than other drugs in its class.

Dames refuted the claim that a major study in Europe was manipulated, according to the transcript. Tunheim later issued an order that said the plaintiffs were entitled to seek punitive damages. Dames did not return a call seeking comment on the verdict.

' Shannon P. Duffy, The Legal Intelligencer

Second Circuit Upsets Class Certification for Third-
Party Payers in Zyprexa Case

A federal appeals court rejected class certification for third-party payers who claim Eli Lilly and Co. made misrepresentations about the effectiveness and safety of the drug Zyprexa. UFCW Local 1776 v. Eli Lilly and Company, 09-0222. The Second U.S. Circuit Court of Appeals reversed Eastern District of New York Judge Jack B. Weinstein, who in 2008 had certified a class of third-party payers, such as insurance providers, claiming that Lilly's misrepresentations caused them to overpay for Zyprexa between June 20, 2001 and June 20, 2005.

The plaintiffs were seeking to recover damages from Lilly as a racketeering enterprise that forced them to pay excess prices. The panel first decided that there was “no question” that under RICO the plaintiffs must allege and prove “third-party reliance as part of their chain of causation …

Because reliance is a necessary part of the causation theory advanced by the plaintiffs, we must ask whether reliance can be shown by generalized proof.”

The circuit found that the excess price theory “is not susceptible to generalized proof with respect to either but-for or proximate causation theory.” Weinstein's decision to certify the class, Lynch said, was an abuse of discretion.

The panel said the record showed that “prescribing doctors do not generally consider the price of a medication when deciding what to prescribe for an individual patient,” so that reliance by doctors on the safety and effectiveness of Zyprexa “was not the but-for cause of the price” ultimately paid for each prescription. Furthermore, the plaintiffs' claim of proximate causation was not susceptible to generalized proof for class action purposes, he said, because of the “attenuated link between the alleged misrepresentations made to doctors and the ultimate injury to the TPPs” (third-party payers).

The court vacated the class certification decision as well as Judge Weinstein's denial of summary judgment on excess pricing theory and remanded the case, directing the judge to reconsider Lilly's request for summary judgment.

' Mark Hamblett, New York Law Journal

First Levaquin Test Case Results in Seven-Figure Award

In the first test case to go to trial over side effects from Levaquin, Johnson & Johnson's popular and powerful antibiotic, a federal jury has awarded more than $1.8 million to a Minnesota octogenarian who claims the drug caused his Achilles tendons to rupture.

The jury's award of both compensatory damages and punitive damages to plaintiff John Schedin is sure to reverberate nationwide, because it was the first of several bellwether cases to go to trial from a pool of more than 2,600 cases pending in state and federal courts.

U.S. District Judge John R. Tunheim of the District of Minnesota is presiding over a federal multidistrict litigation that includes nearly 800 cases and New Jersey Superior Court Judge Carol E. Higbee is presiding over a mass tort litigation that includes more than 1,400 cases.

Attorney Brian J. McCormick Jr. of the Sheller firm in Philadelphia, who was on the trial team in Minnesota and serves on the plaintiffs liaison committee in the New Jersey cases, said the Schedin verdict could lead to global settlement talks, especially if it is followed by significant verdicts in test cases expected to go to trial early this year.

In the suits, plaintiffs lawyers claim that Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc. failed to warn doctors that Levaquin showed a significantly higher rate of side effects, including tendon ruptures, than other drugs in its class. McCormick said that Schedin, 82, suffered ruptures in both Achilles tendons and was not a candidate for surgery due to his age. The injury has had lasting effects, McCormick said, leaving Schedin with a limp and unable to walk up stairs. A court transcript of an oral argument before Tunheim shows that the issue of punitive damages was hard fought.

Ronald S. Goldser of Zimmerman Reed in Minneapolis, MN, told Tunheim that revenue from Levaquin from 2001 through 2009 was about $13 billion and that Johnson & Johnson and Ortho-McNeil wanted to protect it from negative regulatory action in both Europe and the United States that could have devastated those sales figures, according to the transcript. Goldser said the companies “deliberately disregarded patient rights” by failing to include more detailed warnings on the drug packaging, and that there was evidence that they “manipulated the scientific literature for their own economic purposes.” While evidence was mounting of the drug's dangers, Goldser said, the companies bowed to pressure in Europe and sent “Dear doctor” letters in six countries, but never sent such letters to doctors in the United States.

But lead defense attorney John Dames of Drinker Biddle & Reath's Chicago office urged Tunheim to bar the plaintiffs from seeking punitive damages because there was no evidence of a disregard for patients, according to the transcript. “Levaquin is efficacious and is very valuable. It is a good drug,” Dames said. “Levaquin is in fact the most efficacious, the best antibiotic for upper respiratory tract infections.” Dames also disputed the claim that Levaquin has a higher rate of side effects than other drugs in its class.

Dames refuted the claim that a major study in Europe was manipulated, according to the transcript. Tunheim later issued an order that said the plaintiffs were entitled to seek punitive damages. Dames did not return a call seeking comment on the verdict.

' Shannon P. Duffy, The Legal Intelligencer

Second Circuit Upsets Class Certification for Third-
Party Payers in Zyprexa Case

A federal appeals court rejected class certification for third-party payers who claim Eli Lilly and Co. made misrepresentations about the effectiveness and safety of the drug Zyprexa. UFCW Local 1776 v. Eli Lilly and Company, 09-0222. The Second U.S. Circuit Court of Appeals reversed Eastern District of New York Judge Jack B. Weinstein, who in 2008 had certified a class of third-party payers, such as insurance providers, claiming that Lilly's misrepresentations caused them to overpay for Zyprexa between June 20, 2001 and June 20, 2005.

The plaintiffs were seeking to recover damages from Lilly as a racketeering enterprise that forced them to pay excess prices. The panel first decided that there was “no question” that under RICO the plaintiffs must allege and prove “third-party reliance as part of their chain of causation …

Because reliance is a necessary part of the causation theory advanced by the plaintiffs, we must ask whether reliance can be shown by generalized proof.”

The circuit found that the excess price theory “is not susceptible to generalized proof with respect to either but-for or proximate causation theory.” Weinstein's decision to certify the class, Lynch said, was an abuse of discretion.

The panel said the record showed that “prescribing doctors do not generally consider the price of a medication when deciding what to prescribe for an individual patient,” so that reliance by doctors on the safety and effectiveness of Zyprexa “was not the but-for cause of the price” ultimately paid for each prescription. Furthermore, the plaintiffs' claim of proximate causation was not susceptible to generalized proof for class action purposes, he said, because of the “attenuated link between the alleged misrepresentations made to doctors and the ultimate injury to the TPPs” (third-party payers).

The court vacated the class certification decision as well as Judge Weinstein's denial of summary judgment on excess pricing theory and remanded the case, directing the judge to reconsider Lilly's request for summary judgment.

' Mark Hamblett, New York Law Journal