By Joan E. Lisante
ConsumerAffairs.com
May 17, 2008 Let's say youre a cardiac patient and your doctor suggests that your arrhythmia can be stopped by replacing a heart valve. So, along with 11,000 other Americans, you have the device implanted and think the problems fixed.
Two years later, you feel okay, but start hearing about other patients with the same artificial valve whove experienced blood clots and even strokes. You may feel as though theres a ticking time bomb in your chest, but youre hard pressed to show damage. Do you have a case against the valves manufacturer?
Eleven thousand cardiac patients think so.
All received a silver-coated Silzone prosthetic heart valve manufactured by St. Jude Medical, Inc, based in St. Paul, Minnesota.
These valves were designed to be protective, since the silver was thought to help fight infection in cardiac tissue, which often accompanies heart-valve implants. However, it turns out that Silzone valves were prone to leak and put patients at higher risk of thrombus (blood clot) formation and stroke.
The valve, first introduced in 1997, was recalled in early 2000.
Valve recipients filed a class action in Minnesota, alleging that St. Jude violated several consumer protection statutes by misrepresenting facts and hiding information about how unsafe the device was. The federal District Court certified a nationwide class, ruling that although plaintiffs were from various states, all could file using Minnesotas consumer protection statutes.
Set adrift
For those still symptom-free, patients asked that a medical monitoring program be set up to screen them for indications of a defective heart valve.
Last month, the Eighth Circuit Court of Appeals reversed the District Courts certification, setting plaintiffs adrift. The Court listed several reasons for throwing out (decertifying) the class:
1) St. Jude didnt get a chance to show that specific patients had not relied on misrepresentations regarding the valves;
2) St. Jude had the right to review each plaintiffs charges that the valve caused their injury or illness;
3) class certification is inappropriate when each case relies on many personal facts with respect to medical treatment and history.
Likewise, said the Court, a medical monitoring class is inappropriate when so many individual issues are involved.
These facts show the trickiness of getting any medical class action certified without being decertified later.
Mass tort
The St. Jude case is an example of a mass tort. Mass tort cases originate when a large number of claims are associated with one product, and plaintiffs have common factual and legal issues.
When causes or degrees of individual injuries vary widely, courts are reluctant to jam them together into one class.
Consumers can see other cases mirrored in the St. Jude situation, whether involving implants, contraceptives, diet pills or replacement knees. Because of the extreme expense of proving that a defective product caused your injury and getting medical experts to attest to that, the appeal of joining a medical class action is clear. But as the St. Jude case shows, the courts are not always receptive.
If you find yourself in such a situation, what to do?
Here are some tips:
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Make sure your case meets crucial criteria for class action consideration. Broadly speaking, there must be: a substantial number of people similarly harmed; common questions of law or fact; plaintiffs who seek similar relief from the court, whether monetary damages of replacement of a defective product; and competent legal representation for the whole class.
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Check the Web If your claim relates to a specific product or service, you can check the Web for the latest developments or to see if any class actions have been filed. Many Web sites offer such information, including www.classactionconnect.com, www.classactionlitigation.com, www.lawyersandsettlements.com, and www.medicalnewstoday.com.
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Pick the right lawyer Class action litigation is specialized and any lawyer taking such a case should have adequate experience prosecuting class actions as well as knowledge of the subject area. There are a number of options for finding competent counsel, including the American Bar Association listings found at www.abanet.org/legalservices, www.findlaw.com, and www.lawinfo.com/attorney/class-action.
Joan E. Lisante is an attorney who writes frequently on consumer issues.
