I am a lawyer in Florida who sues companies that make hip implants and defective drugs and I believe that Federal Preemption is a primary reason we are witnessing the decline and near extinction of jury trials in Florida. Federal Preemption is the legal concept that the laws of the United States that emanate from any Federal branch of the government–such as Congress, the United States Supreme Court, the President, or any of the Federal administrative agencies–have legal superiority over any state, county, or city law. That is, Federal laws supersede local laws and must be followed even when there is a conflict.
The procedure for approving and regulating the sale of drugs and medical devices–like artificial hips, vaginal mesh, or Mirena IUDs–falls under the Federal jurisdiction of the Food and Drug Administration. Pursuant to the concept of preemption, the FDA’s rulings preempt any state or city’s efforts to establish laws that would be contrary to the FDA’s. For instance, if the City of Miami wanted to mandate that makers of a particular drug, like Pradaxa, include a Spanish warning label, the City would not have the jurisdiction to make such a demand. To learn more about how the FDA approves drugs read my recent blog for the Huffington Post: “The FDA’s Dangerous Death Race.”
The laws that apply to generic drugs recently shifted in favor of the manufacturers at the expense of injured consumers in 2011 when the United States Supreme Court ruled in the case of Pilva, Inc. v. Gladys Mensing that generic drug makers could not be sued for inadequately warning consumers about dangerous side effects. In the Mensing case, the Court’s rationale was based on the assumption that the warning labels on generic drugs were somehow engraved in stone and could not be altered. As a result of the Mensing opinion, dozens of severely injured people with pending cases and claims against generic drug makers had their cases dismissed from courthouses across the country.
PENDING IN FRONT OF THE U.S. SUPREME COURT
Today, both the makers or dangerous pharmaceuticals and the lawyers who sue them on behalf of those who are harmed by such drugs are closely watching and nervously waiting for the United States Supreme Court to release its opinion in the case of Karen Bartlett of New Hampshire, who is suing the Mutual Pharmaceutical Company. Her claim is different because she is not suing Mutual over its warning labels but rather over the alleged defectiveness of the drug itself. Ms. Bartlett suffered a severe adverse reaction after taking an anti-inflammatory medication called Sulindac. The drug was prescribed to treat her shoulder pain, but instead she ended up admitted into a burn unit and in a medically induced coma for several months after shedding more than half the skin across her entire body.
She successfully sued the manufacturer, and a jury returned a verdict in her favor for $21 million dollars. The verdict was appealed to the 1st Circuit Court of Appeal, which affirmed and upheld the verdict. The manufacturer than appealed to the United States Supreme Court, which heard oral arguments on March 19, 2013. As of today, they have yet to rule.
The primary issue is whether or not the appellate court’s ruling in favor or Ms. Bartlett conflicts with Federal Preemption and the Supreme Court’s opinion in Mensing. Ms. Bartlett has argued that the cases are distinctly different in that Mensing’s opinion was limited to suits against generic drug makers for not properly warning consumers of known dangers and risks associated with taking their drug while her case claims that the drug itself has a defective design. Listen to the Supreme Court’s oral argument and hear Justice Sotomayor’s brilliant questioning of the drug maker’s lawyer.
The Supreme Court’s ruling will have an enormous effect on the claims of many people who have been injured and on the families of those killed by the use of a dangerous and defective generic drug. Should the court rule in favor of the drug maker, it will effectively slam the courthouse doors in the faces of those who seek justice through a trial by jury, thus entirely closing access to compensation and accountability in our country.