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Ortho Evra Punitive Damage Ruling in Ohio Hurts Consumers

Jan 2, 2008 | Parker Waichman Alonso LLP

A former Ortho Evra Birth Control Patch user who suffered a series of potentially-fatal blood clots while using the defective drug will not be able to receive more than $250,000 in punitive damages should she win her lawsuit against patch maker Johnson & Johnson, an Ohio court has ruled.  The Ohio Supreme Court’s 5-2 decision to uphold a state law capping punitive damages is unfortunate not just for patients injured by Ortho Evra, but for anyone in that state injured by a defective drug or medical devices.

When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives. But in 2005, the Food & Drug Administration warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

Since then, Ortho Evra has been named in well over 2,000 lawsuits.  As those Ortho Evra lawsuits have made their way through the courts, evidence has been presented that Johnson & Johnson knew the patch put users at a higher risk of developing blood clots.  In Ohio, lawyers have filed papers detailing two separate Ortho Evra studies that showed the patch was dangerous, but where altered or suppressed by Johnson & Johnson.   In August, the New Jersey Supreme Court released a letter written to Johnson & Johnson CEO William Weldon in 2005 by an unnamed Johnson & Johnson vice president responsible for overseeing the safety of reproductive medicine stating that he or she had resigned from the company because of its decision to downplay safety concerns regarding Ortho Evra.

Melisa Arbino, of Cincinnati, suffered a series of potentially fatal blood clots in her brain and lungs in 2005 that she maintains were the result of  Ortho Evra side effects.  Arbino’s attorneys had asked the Ohio Supreme Court to overturn the state’s $250,000 cap on punitive damages, claiming it was unconstitutional.  The law does not limit punitive damages in catastrophic cases, such as those involving paralysis or loss of limb. It also does not limit economic damages — lost wages, medical costs, and other measurable out-of-pocket damages — in less serious cases.

But the Ohio Supreme Court declined to strike down the law, and now, the state’s legislature could use the 5-2 ruling as an excuse to limit lawsuit damages even more.   That was the fear of one dissenting justice, who wrote “Under the court’s reasoning, there is nothing in the Ohio Constitution that restrains the General Assembly from limiting non-economic damages to $1… After today, what meaning is left in a litigant’s constitutional right to have a jury determine damages?"

As the case of Ortho Evra illustrates, medical devices and drug makers won’t necessarily warn the public of dangerous products when they know about them.  The threat of paying out large damages in product liability lawsuits is often the only thing that prompts these corporations to do what is right.   Without that threat, consumers have much less protection against dangerous products.