Attorneys involved in pharmaceutical product liability litigation have been living with a United States Supreme Court decision in Pliva v. Mensing. In this case, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers.

For consumers, often times, the first time they hear of preemption is when their attorney informs them they have no case because the product they used was a generic drug and not a branded drug.  So what is preemption? Most pharmaceutical product liability are based on a failure to warn. This means the drug label failed to warn the user of the true risk or risks associated with the drug.  Because Congress wanted to promote the generic drug industry they created a different path for approval of generic drugs and branded drugs. A company seeking approval of a generic drug must only show that the drug is a bioequivalent of the branded drug.  On the other hand, the branded drug must show the drug is safe and effective as labeled. The branded drug creates the label and the generic manufacturer of the drug adopts the branded drugs label. The generic manufacturer has no control over the label.

Multi-district litigation is not the same thing as a class action lawsuit. Multi-district litigation is a process where an individual lawsuit must stand on its own.  The James Esparza Law Group routinely represents injured consumers in individual lawsuits in multidistrict litigation. An example of multidistrict litigation is the Testosterone Litigation.

When a pharmaceutical drug or medical device is defective, it typically causes a similar type of injury to thousands of users. In most instances the legal issues involved are similar yet each case is unique. When cases are filed in federal court, they are often soon consolidated into what is known as multi-district litigation, or “MDL” before a single federal judge.

In the federal court system there is a Panel on Multi-district Litigation.  The panel meets frequently and it acts on petitions for creation of a multi-district litigation.  After hearing a petition, the Panel decides to create multi-district litigation and also what federal district court will preside over the case.

Once created, the Judge overseeing the MDL creates a set of uniform rules that govern the behavior of plaintiffs and the defendants.  In the MDL the exchange and the obtainment of information isaccomplished, common depositions are taken, and evidence is preserved.  Often times there are bellwether trials. A bellwether trial is simply an individual trial in the MDL Court where the parties look for patterns that can be used to resolve other cases.

The purpose of an MDL is to spread the costs among many plaintiffs thereby making it cheaper for individual plaintiffto gather, obtain and exchange information.  Once this process is finished, and the judge decides the issues that all of the plaintiffs share in common, each case is sent back for trial to the court where they were originally filed. This is called remand. In most instances, remand rarely occurs.  However, the Esparza Law Grouphas been involved in a remand cases that ultimately went to trial.

Unlike class actions, MDL cases are tried individually. That is, each plaintiff gets his or her day in court, and if the drug or device company settles the cases before trial, they are settled individually. Sometimes in multidistrict litigation an aggregate settlement occurs

The Esparza Law Group believes that bringing individual cases instead of as a class action is better because each case is treated separately and must stand on its own merits.  Injured persons are compensated according to the unique facts of the case and the severity of injury caused by the defendants.  In addition, the costs of bringing one lawsuit against a large corporation can be significant and the spreading out of those costs is advantageous.

Finally, a big advantage to representing many individuals against the same company, as the James Esparza Law Firm does, is that our work product can be efficientlyused by many clients and the common costs of the lawsuit arespread out among several plaintiffs.