Bayer HealthCare, the makers of blood thinning drug , was recently told a bellwether trial would move forward after Bayer requested a summary judgment.
This bellwether trial, citing mainly Bayer’s failure to warn about severe bleeding injuries, is the third bellwether trial to be heard in this massive multidistrict litigation.
A bellwether trial is essentially a test trial to help determine the outcomes of a large number of other trials. A multidistrict litigation, or MDL, is a federal process that groups large numbers of similar lawsuits together so that discovery and other pretrial issues can be streamlined.
Often, a few cases are chosen from the MDL and are tried to answer big issues or determine the value of something that may be universal to all cases. These are called bellwether trials.
The issue at hand in the MDL is that Bayer HealthCare Pharmaceuticals and Janssen Pharmaceuticals, a Johnson & Johnson division, asked for the third bellwether trial to be decided quickly rather than going through with a full trial.
If they had been granted their request for a partial summary judgement, this could have been the third bellwether trial Bayer and Janssen would have won.
This bellwether trial focuses on a lawsuit brought by Dora M. who alleges that Bayer and Janssen knew about potential problems with their medication, yet failed to warn the public or the medical community about the risks.
Dora received a hip replacement surgery in 2015. After her surgery, she developed deep vein thrombosis. Essentially, DVT is a condition in which a clot forms deep in the veins of the leg and if it comes loose, this can travel to the heart, lungs or brain. A blood clot that travels to a vital organ can be life threatening.
Blood thinning medication can help combat this condition. But Dora developed a different potentially fatal complication: gastrointestinal bleeding. She was forced to be hospitalized for her condition.
In her lawsuit, Dora alleges that the drugmakers knew about the possibility of gastrointestinal bleeding but did not do anything to make sure the public was aware and that patients had all the information to make informed health decisions.
Bayer and Janssen, in their bellwether trial request for judgement, stated that they could not change the labels for to make sure doctors run a certain test on their patients to determine the prognosis for safety because this was an off-label use for the test.
They also claimed that the U.S. Food and Drug Administration rejected a label that the drug makers had suggested.
The judge responded by saying that virtually all drug manufacturers can choose how they will label their products even after the FDA has approved a product. Also, there are “clear pathways pathways through which a brand name drug manufacturer can make changes to their label without FDA approval.”
The judge also said that a single rejection does not mean they should stop trying, especially if there is a true safety concern.
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