When products aren’t held to a high enough standard, it’s consumers who are at risk. This week, we take a look at some recent legal battles regarding medical devices, cars and drugs that have lead to deadly results.
FDA to Crack Down on Opioids
A new FDA study will examine the addictive properties of oxymorphone.
Last week FDA commissioner Scott Gottlieb spoke powerfully about the ongoing opioid epidemic in the U.S. Previously, he stated, the drug issue has been “five steps ahead of us,” and now requires “dramatic action.” Gottlieb referenced a recently commissioned study that will look at the addictive properties of oxymorphone. The results may impact regulatory actions in the future. Gottlieb did not specify if already-approved opioids were at risk of being taken off shelves, like Opana ER was earlier this year. Rather, he noted that all information is used by the FDA in a risk-benefit framework.
GM Pays up in Ignition Switch Settlement
A court verdict has General Motors paying out $120 million to settle with consumers after defective ignition switches led to dozens dead and many more injured. Although some of these accidents happened before GM filed for bankruptcy in 2009, the Supreme Court would not allow the company to dodge legal action. This newest verdict adds on to other hefty penalties; GM already owes approx. $2.5 billion regarding the defective part.
Fire Risks Lead to Huge BMW Recall
About one million BMW vehicles have now been recalled over concerns of under-the-hood fires. The recall affects several models produced from 2006 to 2011. In some cars, the culprit appears to be a defective heater, while in others, wiring issues have lead to fires. While BMW maintains that fires can be caused by a number of factors, not all of which are linked to manufacturing defects, they will be repairing affected cars for free, starting next month. See the list below from ABC to determine if your vehicle may have been affected.
BMW Recalled Models
- PCV valve heater recall models:
- 128i from 2008 through 2011
- 328i, 525i, 528i, 530i, X3. X5 and Z4 from 2007 through 2011
- Blower motor system connectors recall models:
- 323i, 325i, 325xi, 328i, 328xi, 330i, 330xi, 335i, 335xi and M3 from 2006 through 2011
- 335is from 2007 through 2011
- the 335d from 2009 through 2011
IVC Bellwether Prepares for Jury Trial
The first bellwether trial regarding Cook Medical’s IVC filter is now well under way. The named plaintiff in this case, Elizabeth Jane Hill, was implanted with a Cook Celect IVC filter; after implantation, the device migrated and perforated her vena cava and small intestine, causing intense pain and damage. The initial removal procedure failed, and a second procedure was needed to remove the filter.
The case resumed on Monday, November 6th, and a jury verdict is expected in the next few weeks. Meanwhile. Attorneys are already preparing for the first IVC filter bellwether against another company, C.R. Bard, Inc., which will begin in March 2018.
EpiPen Failures Lead to Deadly Possibilities
Last year, the makers of EpiPens, Mylan, came under fire for dramatically raising prices on the devices, which can be life-saving in the event of a severe allergic reaction. Now there are different, but also devastating concerns. EpiPen or EpiPen Jr. failures have been reported over 200 times this year, including 7 resulting deaths.
Some of these failures are due to issues with the application device on the Pen. In March, a set of the devices were recalled. Mylan calls the defects “rare.” In other cases, the issue was with the contents of the Pen, the epinephrine (adrenaline) itself; reports of leaking could lead to an insufficient dose in an emergency.
Four million people were prescribed EpiPens last year, with Mylan controlling about 70% of the market. While 7 deaths, or even 200 failures seem like small numbers in comparison, for those patients, the defect could have cost them their life.