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Each States Governor Should Be Asking For Passage Of The Medical Device Safety Act

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Presently, Governors around the country are being asked to show support for the Medical Device Safety Act. The Act can restore the role of state law in protecting their residents’ consumer rights. This legislation will provide both consumers and patients with the much needed protections afforded by state and local laws when they have been injured by dangerous medical devices. This will do for medical device protection what the recent U S Supreme Court case of Levine vs. Wyeth will do for pharmaceutical consumers.

The American Association for Justice put together a stunning list of cases that depend upon this change.

The Medical Device Safety Act would fix the Supreme Court’s wrong decision and restore the ability of injured consumers to hold negligent medical device manufacturers accountable when their products cause injury and death.

Gary Despain (Arkansas)

· Problem: Gary Despain was implanted with a defective hearing aid manufactured by Soundtec. While working as a welder, he suffered damage to his right ear, apparently as a result of interference between the magnet in his hearing device and some electronic welding equipment being used nearby in the plant. The device caused severe ringing in his ear. The labeling for the device failed to warn of this potential risk. Gary eventually had the device surgically removed. He remains unemployed and disabled as a result of the device.

· FDA Involvement: The FDA approved this device under its premarket approval (PMA) process. The product remains on the market without any additional safety warnings to address Gary’s injuries.

· Status: In 2008, the Arkansas Supreme Court allowed Gary’s case to move forward. However, the Supreme Court issued its Riegel decision two weeks later, and the Arkansas Supreme Court subsequently summarily dismissed his claims against Soundtec based on Riegel. Soundtec now has total immunity, and Gary no longer has the ability to seek remedies for his injuries.

Negligent Manufacturers Must Be Held Accountable.

Bridget Robb (Pennsylvania)

· Problem: Bridget Robb is 33-years-old and has a 6-year-old daughter. She suffers from non-ischemic cardiomyopathy which was diagnosed at age 29. To treat her heart condition, she had a Medtronic cardiac catheter implanted on May 25, 2005. On the morning of December 31, 2007, she awoke to her implantable cardiac defibrillator (ICD) being discharged. The unit continued to discharge multiple times as she called 911 and was taken to the emergency room. Upon admission, it was determined that her device had malfunctioned and had delivered 31 inappropriate shocks in approximately 13 minutes due to a fractured lead (the wire that connects the device to the heart). After her initial treatment, she was transferred to another hospital to undergo surgery to replace her device and fractured lead. She continues to suffer extreme anxiety due to this traumatic event and near-death experience. She also must undergo another surgery to fix her new screw-in lead.

· FDA Involvement: The FDA approved this device under its PMA process. The fractured lead in her device is one of the Medtronic leads recalled on October 15, 2007, because of an increased risk of fracture. Concerned about the Medtronic recalls, Congressman Henry Waxman (D-CA) sent a letter to FDA Commissioner Andrew von Eschenbach requesting a thorough timeline of the recall and an overview of how FDA approves so-called "supplemental" parts of medical devices. He also cited reports that the FDA did not require Medtronic to submit clinical trial data on these recalled leads and requested an explanation for the FDA’s failure to do so. The FDA has not yet responded.

· Status: Bridget is waiting to file her case, because her attorneys know that her case will be dismissed pursuant to Riegel. She is hopeful that Congress will pass legislation, like the Medical Device Safety Act of 2008, to allow her to pursue her claim.

Negligent Manufacturers Must Be Held Accountable.

Calvin Timberlake (Texas)

· Problem: Calvin Timberlake, a 50-year-old former forklift operator, had a Prodisc implanted in his spine. Prodisc is an artificial metal and plastic spinal disk that is meant to relieve lower back pain by replacing a damaged disk between vertebrae of the spine. The Prodisc soon came apart in Calvin’s spine, requiring an emergency operation to remove it. Calvin remains in extreme pain, and has to take medication to control the pain.

· FDA Involvement: This component received FDA approval under the 510(k) approval process, which is an expedited approval process for devices that are “substantially equivalent” to those already on the market. Many of the surgeons who co-authored medical journal articles (which the FDA used to grant the application) had major investments in Prodisc, and at least some of them did not disclose their investments to the journal editors when they submitted their manuscripts for publication. Congress is investigating this issue.

· Status: Calvin’s claims are still pending.

Negligent Manufacturers Must Be Held Accountable.

David Brown (Colorado)

· Problem: To relieve his back pain, David Brown’s surgeon implanted the Charite disc between two vertebrae. Following implantation, David continued to suffer from severe and debilitating back and leg pain, problems walking, and new symptoms such as buttock and groin pain and numbness in the legs, and has incurred medical expenses and lost wages. One year later, David endured another surgery but that did not improve his condition. Doctors determined that the Charite disc caused abnormal loading and prohibited proper range of motion.

· FDA Involvement: The FDA granted PMA for the disc, but a former FDA Chief Medical Officer testified that the manufacturer did not provide complete, accurate, and timely information to the FDA during the PMA process. The manufacturer also failed to notify the FDA that it had to modify earlier versions of the Charite disc sold in Europe because of safety and effectiveness concerns. Further, the company failed to provide adequate post-market reporting to the FDA.

· Status: The Massachusetts Superior Court denied the manufacturer’s claim that it was immune by virtue of its FDA approval and allowed David to move forward with his case.

Negligent Manufacturers Must Be Held Accountable.

Sylvia Lane (Washington)

· Problem: Sylvia Lane, age 34, was seventeen weeks pregnant when she went into a diabetic coma while she was at home alone. Her husband was serving as a lieutenant in the Persian Gulf. Sylvia had recently received an insulin pump, which had a safety feature designed to stop the insulin flow in case of emergencies. However, the device that Sylvia received had arrived with the safety feature turned off, and the device’s 48-minute instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used. As a result, the device continued to pump insulin into her body, starving her brain and making it more unlikely she would ever wake up. She suffered severe and permanent brain damage.

· FDA Involvement: The manufacturer received approval under the 510(k) process and bypassed the FDA’s requirement for clinical studies showing the safety and effectiveness of the pump, claiming instead that the device was “substantially equivalent” to a generic infusion pump used for medical fluids. Medtronic failed to disclose her injury to the FDA.

· Status: Medtronic, the device manufacturer, settled Sylvia’s claims. The terms of the settlement were confidential.

Negligent Manufacturers Must Be Held Accountable.

Barry Notmeyer (California)

· Problem: In 2004, Barry Notmeyer underwent total left hip arthroplasty and was implanted with a prosthetic hip replacement called the Trident. Two months later, a component of the Trident shattered, and Barry required additional surgery.

· FDA’s Involvement: This component had received FDA approval under the 510(k) approval process. The company eventually issued a voluntary product recall. The recall came out of an FDA investigation of Stryker’s New Jersey manufacturing facility during the summer of 2007. The FDA determined that since 2005, Stryker had received numerous complaints from patients experiencing serious health complications and resulting from defects in two of Stryker’s hip replacement cups: the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. The FDA issued a letter to Stryker on November 28, 2007, warning that the company had to take prompt action to address consumer complaints regarding pain and discomfort and additional surgeries needed as a result of the Trident implants or face severe penalties. Shortly after the letter was made public on January 15, 2008, Stryker issued the product recall.

· Status: At the federal trial court level, the judge denied the manufacturer’s claim that it was immune by virtue of its FDA approval and allowed Barry to move forward with his case.

Negligent Manufacturers Must Be Held Accountable.

Connie Hill (Arkansas)

· Problem: In 1981, surgeons implanted a copper intrauterine device (IUD), a CU-7, in Connie Hill. Three years later, she gave birth to a child and underwent tubal ligation surgery the next day. During this surgery, it was discovered that the CU-7 had perforated Connie’s uterus and was partially embedded in her small bowel, requiring additional surgery.

· FDA Involvement: The device received premarket approval in 1974. Documents made public only as the result of IUD litigation indicate that the manufacturer hid its safety concerns from FDA regulators. The manufacturer has since discontinued sale of the product.

· Status: Connie, as well as thousands of others injured by the device, was able to have her day in court to hold the manufacturer accountable for her devastating injuries.

Negligent Manufacturers Must Be Held Accountable.

Lisa Goodlin (Florida)

· Problem: In January 1991, Lisa Goodlin received a Medtronic pacemaker and its related components, including Medtronic’s 4004/M lead. The pacemaker lead is a wire that transmits the heartbeat-steadying electrical impulse from the pulse generator to the heart. Lisa depends on the pacemaker to support her life. Lisa underwent open-heart surgery to replace the lead after she learned that it had failed in numerous patients.

· FDA Involvement: Medtronic received PMA for its 4004/M lead for use in the United States on February 10, 1989. Sometime after Lisa received her pacemaker, however, an FDA inspection revealed a significant risk that the 4004/M lead would fail due to degradation of the lead’s polyurethane insulating material. The FDA, therefore, instructed Medtronic to issue a Health Safety Alert letter to inform physicians about the risk of defect in the lead. The letter advised physicians to consider prophylactic replacement for pacemaker- dependent patients, but the FDA did not recall the product.

· Status: The 11th Circuit Court of Appeals overturned the lower court’s decision to afford immunity to Medtronic by virtue of its FDA approval, allowing Lisa to have her day in court.

Negligent Manufacturers Must Be Held Accountable.

Elysa Kealoha (Hawaii)

· Problem: Elysa Kealoha visited an oral surgeon to address a problem with her jaw. Her surgeon implanted a medical device in Elysa’s mouth known as the Vitek Proplast Interpositional TMJ Implant to correct problems in her temporomandibular joint (TMJ). The implant, which contained Teflon, caused her, and many others who received the implant, to suffer debilitating tissue reactions when the implant fragmented. Some patients even committed suicide to escape the pain from their Vitek TMJ implants.

· FDA Involvement: This component had received FDA approval under the 510(k) expedited approval process. In 1991, after 26,000 patients had received the implant, the FDA banned the devices and advised surgeons to remove all the implants that had failed. However, independent surveys indicated that the FDA failed to notify thousands of victims of the recall, and one victim even was implanted with the device after it was pulled from the market.

· Status: Elysa was able to have her day in court to hold the manufacturers accountable for her devastating injuries.

Negligent Manufacturers Must Be Held Accountable.

Arthur Bowling (Ohio)

· Problem: Arthur Bowling was one of approximately 50,000 to 100,000 individuals implanted with the Bjork Shiley convexo-concave (BSCC) heart valve. By 1992, approximately 450 of these valves had fractured resulting in approximately 300 deaths. When the strut breaks, the heart contracts and explodes, and without emergency surgery, the person can die within minutes. It later became known that company inspectors had found poor welds on the valves, but rather than throw them out, they ordered the valves to be ground down and polished to look smooth, after which they were sold all over the world. Employees at the factory intentionally filled out paperwork to disguise the practice of polishing over the cracks and an internal memo that surfaced, written by a supervisor, complained about the policy that disguised cracked valves. In 1990, a Congressional report concluded that the company had “aggressively marketed the device despite internal knowledge of serious problems in the manufacturing and quality assurance procedure.”

· FDA Involvement: The BSCC valve received FDA approval under the PMA approval process. Between 1979 and 1983, when Shiley (the manufacturer) was learning of these valve fractures, the company sent a set of letters to doctors and to the FDA reassuring them that these incidents did not compromise the integrity, safety, or effectiveness of the device. Despite a redesign of the manufacturing process, continuing strut fractures forced Shiley to recall those valves which had not been implanted in 1980, 1982, and 1983. Because of continuing problems with valve failures, Shiley recalled its larger size valves and ceased production of those sizes in October 1985. Finally, on November 24, 1986, Shiley withdrew all its remaining valves from the market and ceased production of any heart valves. On March 21, 1990, Shiley asked the FDA to withdraw its PMA approval. The Department of Justice eventually filed a lawsuit against Shiley under the False Claims Act, claiming that the company made false statements to the FDA to obtain approval of the valve, and again post-approval to keep the product on the market. The company eventually agreed to pay $10.75 million to settle the false claims case.

· Status: Arthur was part of a settlement in which the manufacturer established a fund to cover patients’ medical costs, replacement surgeries, and related financial needs.

Negligent Manufacturers Must Be Held Accountable.

Thomas Michael Pouch (Texas)

· Problem: Thomas Michael Pouch has worn contact lenses since July 2005. In the Spring of 2006, he began to use Bausch & Lomb’s ReNu with MoistureLoc Multi-Purpose Solution that he had bought at a WalMart. When the WalMart staff recommended the solution, he did not think twice about a potential problem. Not long after he began using the new solution, he began to have pain and loss of vision in his right eye. When he returned to the vision center at Wal-Mart, the doctor diagnosed him with Fusarium Kerasitis, an infection of the eye. It was not until that point that he was made aware of the problems associated with this specific brand of contact solution. Although the same eye disease affected Asian users in December 2005, the company sold the cleanser in the United States until May 2006. The company only halted sales after the May 2006 New York Times article publicized the CDC’s findings that 122 cases of fungal infections were attributed to the cleanser.

· FDA Involvement: The FDA approved the solution under the 510(k) approval proves. Bausch & Lomb voluntarily withdrew the ReNu with MoistureLoc contact lens solution from the market in the United States.

· Status: Thomas’ claims are still pending in court.

There are more cases just like these happening all over the country. You can help by contacting your Governor and asking them to support this change. Locally, the story of 13 deaths from Medtronic heart defibrillator lead wires, known as the Spring Fidelis, should have many people contacting Governor Pawlenty’s Office. It’s important that each state protect their citizens as they see fit.