On April 16, 2013, a federal jury in Kentucky returned a $7.25 million verdict in favor of a little girl whose cochlear implant (a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing) failed due to moisture leakage that caused her to suffer several shocks. The plaintiffs (the girl’s parents) alleged that the cochlear implant manufacturer, Advanced Bionics (“AB”), knew of the risk and ignored it, placing its profits above the safety of its patients. The jury awarded $1,000,000 in compensatory damages and an additional $6.25 million in punitive damages.
The Underlying Facts As Alleged By The Plaintiffs
The plaintiffs’ little girl had received an allegedly defective cochlear implant in January 2006. In December 2009, the child was violently shocked by the device inside of her head. The shocks were so severe that they knocked her to the ground, where she convulsed and vomited. She spent at least two months of her life living in utter fear, and she still remains in fear as evidenced by a recent episode when she screamed that she did not want to die by being shocked. In 2010, she would not wear glasses or hearing aids, fearing both would shock her and lead to more convulsing and vomiting. On one occasion, an ambulance was called because the child screamed that her face was on fire and melting. As alleged by her parents, their young daughter “lived in a cold, dark, deaf world, while Advanced Bionics shareholders enjoyed their millions of dollars in sales-based bonuses.”
The plaintiffs’ attorneys filed a trial brief with the Court before trial in which they stated that the plaintiffs intended to prove the following time line of events during the trial:
December 2001: AB admits it will not wait until all risk is evaluated before manufacturing the HiRes90k (then called the C-III). It must ramp up the manufacturing process to maximize revenues.
February 2004: AB confirmed that its manufacturing vacuum bake-out process was so effective in reducing “baked-in” moisture that became trapped in the device during the manufacturing process that AB petitioned to allow it to reduce the bake-out process time from 48 to 24 hours. In other words, a “baked in” moisture theory is a total sham.
March 2004: AB internal emails between the Head of Regulatory Affairs, Ms. Adair and Mr. McLain, head of Quality Assurance, acknowledge that AB has not performed the accelerated life testing in an environment that mimics the human body that the FDA requires per 21 C.F.R. 820.30(g) (communication between the quality assurance department and head of regulatory affairs discussed the fact that saline soak tests that it did conduct did not mimic the human body).
April 2004: AB’s head of quality acknowledges that there is a “total deficiency” in “life cycle testing,” which the same witness has admitted in his deposition is nothing more than the testing required by 21 C.F.R. 820.30(g).
June 2004: Internal documents confirm that moisture in the HiRes90k is not fully understood, yet the bake out process is able to remove retained moisture.
August 2004: Three AstroSeal devices used in a “Long Term High Temp Soak Test” which involved immersing devices in saline at 50C, failed device testing. When these devices were finally tested for moisture intrusion after the second recall and after the plaintiffs’ young child was implanted, all had high moisture. This test, named ER818 by AB, was testing under actual or simulated use conditions, required by 21 C.F.R. 820.30(g).
August and September 2004: The FDA conducted a “for cause” inspection at AB noting significant deviations from the federal PMA requirements that was causing the HiRes90Ks to fail due to moisture. During this inspection, AB fraudulently stopped testing returned devices.
September 2004: AB recalls the HiRes90k, but never stops making devices. The company keeps the assembly line going at full speed, even though it has still not fully qualified the HiRes90k using an AstroSeal feedthru, and has not performed testing required by 21 C.F.R. 820.30(g).
October 2004: Mr. Polack confirms that the failed HiRes90K devices identified by the FDA in its Form 483 observation could not have been attributed to moisture being baked in during manufacturing because they “would never have functioned.” In other words, the baked-in moisture theory was a total sham.
October 2004: Mr. Phil Segel, who is currently employed by the world market leader Cochlear of Americas, testified in this litigation that Advanced Bionics knew that HiRes 90K implants were leaking after implantation in the human body. Mr. Segel confirmed in his deposition that Advanced Bionics ignored signs that devices were leaking after implantation in the human body. Mr. Segel confirmed that doctors were not told that there was leaking of devices after implantation in the human body.
October 2004: Email from Janusz Kuzma to Dave Morley and Van Harrison confirms that AB was not properly or adequately addressing the likely cause of the device failures, as he explains that “[i]t has long been my belief that the hermeticity of our devices has been handled very poorly, and the current attempts to solve the problems are not only inadequate, but based on wrong assumptions. I have tried, in the past, to address this issue, but was unable to break through the impenetrable wall of resistance by a few individual who could not understand simple physical facts.” Kuzma, who was the Designer of the HiRes90k, was ignored.
October 2004: The FDA asks AB “[h]ave any of the component manufacture, including the epoxy supplier, changed since the initial distribution of the device?” In response, AB does not inform the FDA that it changed the feedthru supplier.
November 2004: Mr. Polack requests that a column be added to the “high moisture explant data” spreadsheet to account for the different feedthru manufacturers and explains that you can tell the difference between the PA&E and AstroSeal feedthrus by visual inspection. Despite such an action, there is no full qualification and proper testing of AstroSeal devices.
December 2004: AB Head Engineer Josh Polack advises that “signs point to” devices leaking after implantation in the human body. AB does nothing to stop implanting devices, including the device received by the plaintiffs’ child.
February 1, 2005: AB receives FDA warning letter listing 18 federal regulatory violations in the manufacturing of the HiRes90K.
February 5, 2005: Email from AB auditory president Jim Miller indicates that “product failures continue to occur at an alarming rate, we are in significant danger of losing all our key accounts.”
March 1, 2005: Mr. Polack requests that “at a minimum to complete the corrective action for moisture the feedthru must be identified as PA&E or AstroSeal,” yet this “minimum” action was not implemented.
March 2, 2005: AB receives an explanted device with excessive moisture that was manufactured after the manufacturing changes that followed the 2004 recall and continues to receive such devices until the second recall in March 2006.
October 10, 2005: Advanced Bionics received notice from a third party consultant that the chances of baking high moisture in a cochlear implant is 1 in 10,000. AB has received enough high moisture devices to know it is a statistical impossibility that moisture is baked in. Advanced Bionics received actual device failures in August 2004 from testing in a simulated use environment. Devices are failing at an alarming rate. Yet the company still does not stop shipping, and allows the palintiffs’ child to receive her device.
Source: TBR Document 186 Filed 03/26/13 (Brian and Michelle Sadler, Individually and on behalf of their Minor Child, B.S. v. Advanced Bionics, LLC, Case No. 3:11-cv-450 H, U.S. District Court for the Western District of Kentucky (Louisville Division)).
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