New Hope for Plaintiffs Who are Harmed by Generic Drug Manufacturers

For the first time in years, Plaintiffs who have been harmed by generic drugs have new hope that they claims can be heard in court. In a major victory for plaintiffs, the United States Supreme Court denied to review a decision by a California appellate court who ruled that when a generic manufacturer fails to update warning labels as required.

For the first time in years, Plaintiffs who have been harmed by generic drugs have new hope that they claims can be heard in court. In a major victory for plaintiffs, the United States Supreme Court denied to review a decision by a California appellate court who ruled that when a generic manufacturer fails to update warning labels as required for the brand counterparts, a plaintiff can prosecute a defective product claim against the generic manufacturer.

The California decision was in a case called Teva Pharmaceuticals USA INC v. Superior Court. In that case, Olga Pikerie sued Teva Pharmaceuticals USA Inc. after she allegedly suffered injuries from ingesting the generic form of the medication Fosamax. Fosamax is used to treat osteoporosis in women specifically caused by menopause. It is also prescribed to men and women for treatment of osteoporosis caused by taking steroids. It works by slowing bone loss.

The complaint alleged that Ms. Pikerie was prescribed and used Fosamax and alendronate sodium from 2006 to 2011. In April 2011, Ms. Pikerie suffered a left femur fracture as the result of taking Fosamax or its generic form, alendronate sodium.

The complaint asserted several claims including strict liability and negligence. The primary allegation of the complaint was that while the labels of the brand name version of the drug were updated, the generic drug manufacturers failed to update their labels accordingly. The generic drug manufacturers demurred to the complaint claiming that under the Pliva, Inc. v. Mensing (decided in 2011), federal law preempted state law on all of the relevant claims.

In Pliva, the United States Supreme Court held “any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand name drug are preempted by federal law.” The Court also held that under federal law, generic drug manufacturers must ensure that their labels are identical to that of brand name manufacturers and cannot add any additional warnings. Essentially, generic drug manufacturers must comport the information on their labels including warnings to the standard set or changes made by brand name drug makers (of the same drug) as mandated by the FDA.

Teva in Contrast to Pliva
In Teva, the trial court and California Court of Appeal ruled that in contrast to the Pliva decision, Ms. Pikerie’s complaint alleged that generic drug manufacturers had failed to update their labels along with the updates implemented by brand name manufacturers and in doing so failed to warn of specific dangers associated with the drug. Given the gravity of the Teva decision, generic drug companies appealed to the California State Supreme Court who declined to review the decision. The defendants followed with an appeal to the U.S. Supreme Court for review but it was not granted.

The Implications
The highest Court’s decision not to review could open the door for more litigation against generic drug manufacturers who fail to update their labels in time, along with the brand name manufacturer’s updates. This decision could signal a shift in the tide for more claims to be heard under state law against the generic manufacturers.

Experienced Representation and Here to Help
If you or a loved one has suffered an injury due to taking a dangerous prescription drug, the attorneys associated with Jacoby & Meyers can help you receive compensation for your damages. Our lawyers can review the facts of your case to determine whether you have a valid defective drug claim.

Please contact the Jacoby & Meyers defective drug lawyers today to schedule your free initial consultation.

Zachary Mayberry, student intern Jacoby & Meyers.