A subsidiary of drug manufacturing giant Johnson & Johnson lost its appeal recently in the case of a man who alleged the company failed to warn about the dangers of an antibiotic known as Levaquin, or generically, levoflaxacin.

According to the product liability lawsuit, he was never told of the increased risk of tendon damage he might incur as a result of consuming this drug.

Court records reveal the man was prescribed the drug after suffering a lung infection. Typically, the drug is prescribed on a 10-day schedule. Several days after beginning this course, the man suffered serious and permanent damages to his Achilles tendon.

The case, Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, went before a jury, which awarded him nearly $2 million in compensatory and punitive damages.

Ortho-McNeil-Janssen (OMJ) would later appeal, alleging the judge had abused his discretion in the case by refusing to order a new trial after the defense discovered information it believed the plaintiff’s expert witness had deliberately withheld during trial.

This is a serious accusation, and one that the appellate court did not find entirely without merit.

According to court records, the doctor testifying on behalf of the victim was repeatedly asked by the defense to produce relative-risk calculations. Basically, a relative risk calculation is a statistical term used to describe what is the risk of an adverse event occurring in one group versus another. So in other words, how many people might incur tendon injuries while taking Levaquin as opposed to while simply taking another form of antibiotic.

However, these calculations weren’t produced prior to trial. The drug company stated he wrongfully withheld them, and that if he had produced them prior to the trial, it would have undermined his claim that the drug in question carries a greater risk of ruptured tendon than other antibiotics.

The defense argued that this “new evidence” was evidence of misrepresentation or fraud by the other party and, per Rule 60(b)(2), provided for extraordinary relief. In order for this to occur, the defendant would have to show that the evidence was discovered after trial, that due diligence was exercised to discover the evidence prior to trial, that it is material to the case, not merely cumulative and that it is so important it would likely produce a different result.

But conduct of the witness did not rise to fraudulent, the court found. Further, the court wasn’t convinced that the drug company had done everything it could to discover the evidence prior to trial. However, even if due diligence was followed, there was nothing about it that prevented the drug company from mounting a vigorous defense. What’s more, the documents in question, if presented at trial, wouldn’t likely have had any substantial impact on the outcome of the case, the court found.

There would be no retrial, though the award of the plaintiff was ultimately reduced to $630,000 in compensatory damages.

Given how routinely this drug has been prescribed, we fully expect that additional litigation arising from the use of it will be seen in the near future.