Reading through several articles on federal cases around liability for name brand and generic pharmaceuticals, I took a moment to read some of the comments. One said a case should have been filed as failure-to-warn instead of design defect. Another said the prescribing physician should have been sued. Still another wondered about hospital liability.
If you are looking at a case file and feeling a similar set of symptoms, you may be missing an expert witness or two to help you dimension your claims and damages.
Many of the principles of medical malpractice and products liability are time-honored. But with the recent volatility of federal court and state court rulings on brand name versus generic drug manufacturer liability, don’t overlook the importance of a pharmaceutical expert witness.
In 2011, the US Supreme Court issued a pivotal ruling in Pliva, Inc. vs. Mensing, 131 S.Ct. 2567 (2011) that federal FDA labeling regulations for manufacturers of generic pharmaceuticals pre-empted certain claims filed in state court based upon their labels. Since then, according to the NY Times, more than 40 judges have dismissed similar claims, citing Pliva.
Pharmaceutical expert witnesses can offer expertise in drug formulas, patent dates, market entry points, and regulatory requirements. Chief among those regulatory issues that a pharmaceutical expert witness can present is FDA labeling, updates made to labels by brand-name manufacturers, and corresponding generic labeling requirements.
And, sometimes, a successful claim turns on details like a physician prescribing a brand-name drug that the pharmacist fills with a generic. It’s this kind of detail that makes the pharmaceutical expert witness indispensable in drug liability cases.
Another use for the pharmaceutical expert in these types of cases is preparation of the appellate brief. Complex product liability suits often involve more than one expert witness. It’s a big plus when you can bring a pharmaceutical expert witness into your conference room to assist your review of trial transcripts, exhibits, and the expert reports. This is true even if your role is preparation of an amicus brief.
By: Paloma A. Capanna, Attorney at Law