Lawsuit against Ethicon Results in $3.35 Million Dollar Award to Plaintiff
In what is considered to be a victory for all women with a pending case against Ethicon and Johnson & Johnson—as well as other manufacturers of mesh devices—Linda Gross was awarded $3.35 million dollars for injuries she suffered following the implantation of Ethicon's Prolift device. There are currently over 4,000 cases pending against Ethicon for damages suffered by the Prolift, with nearly half of those to be heard in the same Atlantic County court as Gross v. Ethicon.
Gross v. Ethicon—MDL and Bellwether
Prolift cases have been consolidated in what is known as multi-district litigation or MDL with Gross's case being bellwether trial. A bellwether is considered an indicator of future trends, particularly in a large caseload of similar cases with no other feasible way for the courts to proceed. The overall goal of MDL consolidation is to get them to trial more quickly, however an MDL is not the same as a class action suit. Once an MDL is established all federal courts in the country which have cases of the same nature will transfer those cases to the MDL court.
Jury's Decision on Compensatory Award
The jury apportioned Gross's award with $185,000 to her husband for lack of consortium, $680,000 for past, current and future lost wages to her inability to work, and the remainder for necessary household help, pain and suffering, mental anguish, impairment and disability. The trial will have a second phase in which jurors may consider whether punitive damages are appropriate in this particular case. New Jersey law permits punitive damages of up to five times the amount of compensatory damages. This first trial lasted six weeks, with the jury deliberating for five days. In the end, seven of the nine jurors, while rejecting claims of defective design, did find that Ethicon and Johnson & Johnson were guilty of failure to warn patients and surgeons of the risks. They further found that Ethicon was guilty of making fraudulent representations to Gross and her physician.
Claims by the Plaintiff
While on the witness stand Gross, a 47-year old former hospice nurse, claimed she suffered debilitating injuries following her 2005 implantation of the Prolift mesh to correct pelvic organ prolapse. Since the first implantation of the Prolift, Gross has undergone 18 surgeries, 400 doctor visits and currently takes over 20 medications daily in an attempt to control her severe, chronic pain. Characterizing her life following the implantation of the Prolift as a "living hell," Gross detailed the complications suffered such as erosion of the implant, scar tissue formation, inflammation and neurologic compromise. Gross claimed the Prolift implantation left her unable to continue to work in her chosen profession, unable to sit for longer than 20 minutes without experiencing excruciating pain and unable to engage in sex with her husband.
The Troubled History of the Prolift
Ethicon and Johnson & Johnson withdrew the Prolift voluntarily from the market in 2012, claiming the mesh implant lacked commercial practicality rather than addressing any safety concerns even though lawsuits were mounting alarmingly at that time. Internal company documents presented during the trial showed Ethicon was well aware of the potential for chronic pain and other serious complications among Prolift patients. Further, the Prolift circumvented FDA approval before sales were launched in March, 2005. There was no substantially similar device on the market at the time the Prolift was marketed therefore the FDA's 510(k) process was not deemed the appropriate method of approval.
It took the FDA nearly three years to realize the omission of the Prolift approval—three years during which thousands of women were implanted with the device which was being marketed in a pre-cut kit. The FDA approved the Prolift in 2008, perhaps not realizing that the pre-cut mesh was of a much larger volume than the Gynemesh PS, greatly increasing the risk of inflammatory reactions. Nothing was stated in the Prolift's literature, website or instructions for use regarding the potential complications or the need for special training by surgeons who implanted the Prolift. Ethicon's representatives continued to maintain that the changes made to the Prolift were not significant enough to warrant 510(k) approval. Gross's victory is considered good news for all those women harmed by a Prolift mesh implant.
Gross v. Ethicon—MDL and Bellwether
Prolift cases have been consolidated in what is known as multi-district litigation or MDL with Gross's case being bellwether trial. A bellwether is considered an indicator of future trends, particularly in a large caseload of similar cases with no other feasible way for the courts to proceed. The overall goal of MDL consolidation is to get them to trial more quickly, however an MDL is not the same as a class action suit. Once an MDL is established all federal courts in the country which have cases of the same nature will transfer those cases to the MDL court.
Jury's Decision on Compensatory Award
The jury apportioned Gross's award with $185,000 to her husband for lack of consortium, $680,000 for past, current and future lost wages to her inability to work, and the remainder for necessary household help, pain and suffering, mental anguish, impairment and disability. The trial will have a second phase in which jurors may consider whether punitive damages are appropriate in this particular case. New Jersey law permits punitive damages of up to five times the amount of compensatory damages. This first trial lasted six weeks, with the jury deliberating for five days. In the end, seven of the nine jurors, while rejecting claims of defective design, did find that Ethicon and Johnson & Johnson were guilty of failure to warn patients and surgeons of the risks. They further found that Ethicon was guilty of making fraudulent representations to Gross and her physician.
Claims by the Plaintiff
While on the witness stand Gross, a 47-year old former hospice nurse, claimed she suffered debilitating injuries following her 2005 implantation of the Prolift mesh to correct pelvic organ prolapse. Since the first implantation of the Prolift, Gross has undergone 18 surgeries, 400 doctor visits and currently takes over 20 medications daily in an attempt to control her severe, chronic pain. Characterizing her life following the implantation of the Prolift as a "living hell," Gross detailed the complications suffered such as erosion of the implant, scar tissue formation, inflammation and neurologic compromise. Gross claimed the Prolift implantation left her unable to continue to work in her chosen profession, unable to sit for longer than 20 minutes without experiencing excruciating pain and unable to engage in sex with her husband.
The Troubled History of the Prolift
Ethicon and Johnson & Johnson withdrew the Prolift voluntarily from the market in 2012, claiming the mesh implant lacked commercial practicality rather than addressing any safety concerns even though lawsuits were mounting alarmingly at that time. Internal company documents presented during the trial showed Ethicon was well aware of the potential for chronic pain and other serious complications among Prolift patients. Further, the Prolift circumvented FDA approval before sales were launched in March, 2005. There was no substantially similar device on the market at the time the Prolift was marketed therefore the FDA's 510(k) process was not deemed the appropriate method of approval.
It took the FDA nearly three years to realize the omission of the Prolift approval—three years during which thousands of women were implanted with the device which was being marketed in a pre-cut kit. The FDA approved the Prolift in 2008, perhaps not realizing that the pre-cut mesh was of a much larger volume than the Gynemesh PS, greatly increasing the risk of inflammatory reactions. Nothing was stated in the Prolift's literature, website or instructions for use regarding the potential complications or the need for special training by surgeons who implanted the Prolift. Ethicon's representatives continued to maintain that the changes made to the Prolift were not significant enough to warrant 510(k) approval. Gross's victory is considered good news for all those women harmed by a Prolift mesh implant.
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