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Schedin v. Ortho-McNeil-Janssen Pharmaceuticals – Court Rejects Drugmaker’s Levaquin Appeal

The antibiotic Levaquin was marketed by drug manufacturer Ortho-McNeil Janssen (a subsidiary of Johnson & Johnson) as a safe way to treat many common bacterial infections, such as those of the sinuses, ears, lungs, airways, ears, skin, bones and joints.
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However, what a trial court ruled – and the Eighth Circuit appellate court recently affirmed – was that the company must pay $630,000 to patient who claims the firm deliberately failed to warn consumers of the risks associated with the drug. Specifically, the company never told consumers that there was an increased risk of rupturing their Achilles tendon if they took the drug (also known as levoflaxacin).

That $630,000 figure was down slightly from the $1.1 million the jury originally awarded in the case of Schedin v. Ortho-McNeil-Janssen Pharmaceuticals,. Still, the appellate court rejected the claim that the misconduct uncovered failed to justify overturning the award altogether.

Filing a Boston product liability claim against a major pharmaceutical firm can seem a daunting task, and it’s true these companies have deep pockets and aggressive defense lawyers. But as the Schedin case shows, they aren’t above the law.

This case represented one out of a numerous claims, called multi-district litigation. Patients who took the drug Levaquin were usually given a 10-day course of the drug for things like upper respiratory infections, pneumonia and other infections. At some point during their taking this medication and, in some cases, immediately after, patients experienced a rupture of their Achilles tendon.

Since the late 1990s, the drug’s insert or label has contained a warning of the drug’s elevated risk of tendon structure. The company updated its warning label in 2001 to indicate that the risk could be elevated for the elderly and persons receiving certain steroids.

Around 2005, the U.S. Food and Drug Administration began to receive requests that the prescriptions include a black box warning label of this risk. The FDA initially declined, but eventually pressed the issue in 2008, and the company was ordered to include this, as well as a “Dear Doctor” letter that warned of this danger.

In this particular case, the jury sided with the plaintiff.

While the case was pending an appeal, the drugmaker learned that the plaintiff’s expert witness hadn’t, as he’d previously claimed, turned over all of his relative-risk calculation evidence to the defense during the discovery process.

This is without question unacceptable. It rises to the level of misconduct. But does it warrant a new trial?

The drugmaker alleged that this “newly discovered” data was willfully withheld and that if it had been properly disclosed at trial, it would have undermined the doctor’s credibility and therefore the claim that the levoflaxacin carries a higher risk of tendon rupture than other antibiotics.

However, in weighing whether this would warrant a new trial, the court applied the standard set forth in the 2007 decision of Schwieger v. Farm Bureau Ins.Co. of Neb. By this standard under Rule 60(b)(2) of the Federal Rules of Civil Procedure, the drug maker would have needed to show that:

  • The evidence was discovered after trial;
  • Due diligence was exercised to discover the evidence;
  • The evidence is material and just cumulative or impeaching;
  • The evidence is such that a new trial would product a substantially different result.

While the first two criteria were met, the court found, the latter two were not.

If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:
Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Jan. 7, 2014, U.S. Court of Appeals for the Eighth Circuit
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Topamax Survivors: Cleft Palate Treatment Approved, Jan. 19, 2014, Boston Personal Injury Lawyer Blog