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Accoutability of med-device companies: injury/death from their products.

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When a medical device company manufactures a product they are "proud of," a product they claim will "save lives" and provide much needed relief to countless patients worldwide...THEY CELEBRATE in their accomplishments!! THEY TAKE FULL RESPONSIBILITY for designing and producing a new device; they hold themselves accountable for bringing this product to the medical world. WHEN THE DEVICE...fails, causes serious harm, disables or infects, causes irreversible damage and debililtating physical harm, when the device is responsible for the DEATH of a patient...

THE DEVICE MANUFACTURERS are not so quick to shout out to the world; "WE ARE RESPONSIBLE for producing this incredible new technology and WE SHOULD BE HELD ACCOUNTABLE for everything this technology does when implanted in a patient's body!" Equally important...are the responses by the FDA and US Supreme Court. The FDA is becoming more careless with their handling of these SERIOUS MATTERS and the US SUPREME COURT is protecting the device manufacturers against legal action stemming out of the product failures.

THE FOLLOWING lengthy and should be read with patience. IF you do not wish to read the entire letter...please read the last paragraph!! It will sum up this letter by stating the PURPOSE of this petition.

Millions of Americans are at risk from serious injury/illness, permanent medical conditions, and/or DEATH; as a result from the medical device/s implanted inside their bodies. Although an individual assumes there are risks associated with surgical implants of medical devices (explained to them by their doctor/surgeon, prior to signing any informed consent), there are many risks associated with these devices that are not disclosed to the patient and/or risks that develop over time that put the patient at risk for serious injury. When those risks, adverse events, and/or recalls happen; the device manufacturers have an obligation to immediately report to the FDA, who in turn; have an obligation to report to the "consumers." Unfortunately, since the "consumers" are the doctors, hospitals, medical supply businesses, etc; any vital information that should be reported DIRECTLY to the patients, rarely is.The FDA is a government body that is supposed to REGULATE and CONTROL the medical device industry (amongst other things); to prevent the industry from manufacturing devices under poorly planned/research circumstances, to ensure the devices are produced in strict compliance with standards/codes applying to safety/sanitation/sterilization/etc, to control the approval process to ensure that NO device be allowed onto the marketplace (whether for clinical trials, off-label use, or on-label use) without an EXTREMELY detailed examination of said device...analyzing ever possible error in the manufacturer's processes: research, development, production, packaging, transport, sales, marketing, education (including recommendation for proper clinical use), medical implantation, and finally; device manufacturer and company "reps" involvement with the consumer after implantation to ensure that any problems/errors/threats do not occur...or ensure the consumer's health and safety to have the device removed (when possible) should said problems occur.

In the past 6 years, the medical device industry in the US (which holds 7 of the world's 10 largest device manufacturers) drastically INCREASED the annual number of devices they developed/manufactured/implanted...while the FDA DECREASED the length of the approval process for medical devices. Additionally, the FDA has allowed a significant percentage of new and existing medical devices to be EXEMPT from the regulation/approval process. Under the FDA's 510(k) process, new devices can be approved without human testing if they are similar to devices already on the market. A stricter category, the pre-market approval process, requires scientific evidence, typically extensive testing that is similar to what is required of new medicines. According to Dr Nissen, Chairman of Cardiac Medicine at the Cleveland Clinic: "The 510(k) process is "a short-cut backdoor approach" stemming from a 1976 law, when there weren't many implanted devices meant to sustain life." The FDA even allows devices to be tested/regulated/analyzed in the approval process, by using artificial/electronically controlled body parts as the sole clinical trial application; subsequently, those devices are approved for use on/in the HUMAN BODY without a single clinical trial ever being performed with an actual HUMAN!

In 2005, hundreds of thousands of pacemaker and pacemaker-related implants were recalled by multiple device manufacturers...a device that is implanted for the sole purpose of keeping the consumer's heart "alive" in the event of a cardiac failure, providing that consumer with valuable time to get to a hospital to receive more intensive care. In 2006 alone, the FDA received reports of 2,830 potential device-related deaths and more than 100,000 injuries, with more than half of the deaths linked with devices approved under the less rigid process.

The FDA protects these device manufacturers from BEING held ACCOUNTABLE for injury/illness, permanent conditions, and/or deaths caused by their products; this protection comes in various forms. By shortening, not only the time, but also the SCOPE of the approval process for medical devices; the FDA is caving in to the wishes of the DEVICE MANUFACTURERS and POLITICAL AGENDAS, rather than PROTECTING the consumers the manner in which they were DESIGNED to do. The FDA provides hundreds of thousands; in some years even MILLIONS, of devices (regarding unit production, not individual approvals); exemption from the approval process…effectively giving those manufacturers a “green light” to produce a device without EVER testing its clinical implications in human trials. The US MED-DEVICE industry is a GREED MACHINE, bringing in over $100 BILLION in profits each year (over the past 5+yrs), the largest profit margin in the GLOBAL Med-Device market. The US Med-Device manufacturers bring in more profits than EVERY other country in the world…combined. The FDA ALLOWS US Med-Device companies to manufacture their devices OUTSIDE of the US, in unregulated and extremely cheap-labor markets/countries. By allowing these companies to outsource the manufacturing to other countries, the FDA is KNOWINGLY allowing these companies to manufacture in locations where the FDA has NO CONTROL, NO AUTHORITY, and NO ability to REGULATE the processes.

Most troubling is the manner in which the FDA handles the reporting and regulating of devices that have or continue to cause injury/illness/permanent medical conditions/death. The FDA does not strictly enforce their “medical device safety reporting and recall” system, allowing millions of consumers to unknowingly allow healthcare providers to IMPLANT dangerous devices in their bodies under the impression that those devices have a “clean bill of health and safety.” Product “safety warnings” are the FDA’s way of APPEARING as if they actually care about or wish to inform the consumers of potential product dangers. The harsh reality is; as a consumer seeking to have or who’s already been implanted with a device, you are more likely to find out about potential product threats/failures/consequences AFTER being implanted, than you are trying to get any safety/health info about that product prior to implantation. The FDA simply DOES NOT enforce or PROVIDE that medical device warnings/recalls are made PUBLIC the INSTANT the problem/s are discovered…and even months/years after a threat/problem caused by a device is discovered, the FDA does NOTHING to ensure that the device manufacturers have taken responsibility in CONTACTING every single patient consumer with said device, WARNING them of the related issues! EVEN IF a device is recalled, the FDA does not actively enforced/regulate or ensure that the manufacturers notify the public, but specifically…notify consumers who are thinking of having or already have that recalled device implanted.

The "MED WATCH" program is the FDA's system through which adverse events (regarding medical device problems) are reported in by health professionals and consumers. The FDAs MED WATCH website states: "Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program..." TAKE NOTE...this statement does not include any reference to PATIENTS reporting an adverse event. WHY? Patients are NOT required, nor expected; to report their adverse event to the FDA. It is the ethical, professional, and LEGAL responsibility of the patient's device representatives and hospital/facility where the event report the event to the FDA. The system is designed so that patient's should not have to "worry" about these matters, with the understanding; that their device manufacturer, medical providers, and device company reps are ALL taking responsibility in ensuring that every aspect of care related to their device is being handled properly and according to regulations. THIS IS NOT HAPPENING. Countless adverse events are never reported to the FDA, raising an important question: "if large numbers of adverse events are not being reported to the FDA as REQUIRED by law, how inaccurate are the statistics the FDA releases to the public related to device recalls and adverse events?" The FDA dose NOT require a patient's health care provider to report ANY adverse event to the FDA...WHY? There is no clear reasoning or answer to that question.

IF A PATIENT DOES WISH TO REPORT AN ADVERSE EVENT TO THE FDA, the reporting system is neither easy to understand, practical to complete, and requires significant details related to the event that a patient would typically NOT have access to (regarding details of treatment, facility info, details of diagnosis, etc). Many patients are unaware that if an adverse event occurs with their medical device implant, the FDA actually REQUIRES this event to be reported within a VERY brief timeframe. The said penalties for violation of non-reporting are very severe, in some cases; non-reporting of an adverse event could jeopardize a device manufacturer's entire operation. Of course, none of these requirements/regulations are being enforced on a consistent basis, allowing both the FDA and the device manufacturers to make $$ without consequence for their actions.

When it comes to being held accountable for these unethical, unprofessional, and irresponsible wrongdoings, RARELY are the FDA or the medical device manufacturers ever allowed to be SUED. The US Supreme Court does not BLINK at medical device lawsuits, even though medical devices kill thousands and injure hundreds of thousands EVERY YEAR; the US government does NOTHING to ensure RESPONSIBILITY on the behalf of the offenders…the device manufacturers AND the FDA. Pharmacuetical manufacturers have class-action lawsuits against them on a regular basis, only after 100s of thousands or even millions of consumers have been exposed to and put at risk by dangerous or even potentially fatal RX-drugs. If BIG PHARMACEUTICAL companies must be held accountable for the dangers/risks/deaths associated with their products, medical device manufacturers should be NO DIFFERENT. The HARD FACT: a RX drug can be discontinued in a person’s clinical therapy/treatment regimen (bringing HOPE to the patient that any potential harm may be averted)…a medical device CANNOT simply be taken out of a person the moment something starts to go wrong; quite contrary, more often than not, medical devices STAY IMPLANTED in consumers for months/years after a threat/problem presents itself, exposing that patient consumer to further risk of injury/illness/permanent conditions or even fatality. In many cases, the risks associated with explanting a faulty medical device outweigh the benefits, therefore; by the time a recall or serious safety warning is issued for an implanted device...some patients have already had that device in their body causing serious damage for far too long, leaving that patient with one option...keeping the device inside their body.

MILLIONS of AMERICANS with medical device implants have or will experience: mild to severe injury/illness, development of a permanent medical condition, or even DEATH…in the next 5 years. The disgusting fact is that the majority of these individuals have NO idea that their life will be drastically changed almost overnight and that there is NOTHING they can do to prevent it. WHY? There is NO WAY for them to know the dangers exist because the FDA/MedDeviceCompanies/Supreme Court are NOT DOING anywhere near enough to ensure that patient consumers are implanted with unflawed and non-exempt medical devices that have been put through a rigorous evaluation/testing/clinical application/approval process, PRIOR to said devices becoming available to those patient consumers. Whats worse? Almost EVERY single one of the patient consumers who will experience a problem or serious complication (or death) in the next 5 years…WILL EVER BE ALLOWED TO SEE THE INSIDE OF A COURTROOM, where the company/ies who knowingly made a defective/dangerous/unsafe/recalled/poorly tested & regulated device available for that patient consumer’s clinical therapy. Those patients will suffer needlessly, they will spend BILLIONS of dollars trying to become healthy again, many will likely lose the ability to work or be a productive member of society AGAINST their will or knowledge of the impending threat, and EVERY one of those patients has a legal RIGHT to sue the device manufacturer for: loss of earnings, medical expenses related to the injury/illness/condition/death, & pain and suffering.

Statutes of limitations make holding the device manufacturers responsible even more difficult. At the time a patient becomes aware there is a problem, the statute will likely begin; however, most patients are unaware of the details...they have no idea what kind of impact the problem will have on their life, if any at all...they may not even know a problem exists because the warnings/recalls never make their way to the patient at all. The device manufacturers USE THIS TO THEIR ADVANTAGE...making FULL claim that they've followed EVERY law/regulation, they've reported EVERY event, and they've notified the consumers immediately upon the initial event warning/recall. The manufacturers claim that "its not their fault" if a patient did not become aware of the problem within the statute of limitations timeframe, because; they have no control over what happens after they issue the warnings/recalls. The point here...if the device manufacturers issue warnings/recalls TO BEGIN WITH, they NEVER notify the patient directly, nor does the FDA hold them accountable to do so. If the device companies notify a patient's health care provider and the FDA does NOT require the health care provider to report adverse events, the FDA and device manufacturers are sending MIXED SIGNALS to each other, while the patient is receiving NO INFORMATION whatsoever.




**SUMMARY: This is not simply a question of device manufacturer responsibility…it’s a question of ethics and greed, involving the manufacturers, the organizations who are meant to monitor those companies (the FDA), and the organization that is meant to enforce legal statutes and responsibility against those companies (the US Supreme Court)...

-The device approval process must be RE-EXAMINED...device manufacturers should be REQUIRED to go through a LONGER and more HEAVILY regulated and analyzed "device review and approval process." The 510K device approval process needs to be COMPLETELY DISPOSED of, removed from the options for device approval. If a device manufacturer releases a new device that "resembles" an old device, the new device should be required to go through the SAME EXACT review/approval process as any other new device, with ZERO EXCEPTIONS and ZERO EXEMPTIONS.

-Adverse event reporting should be the RESPONSIBLITY of: the health care providers, the device manufacturers, device company representatives, and hospitals/facilities where the event may've taken place. IMMEDIATE action should be required on the part of the FDA; SUSPENDING any and all production, sales, promotion/advertising, and therapeutic/surgical implantation of said devices; pending a FULL INVESTIGATION, to determine the need for a device recall and/or safety warning.

-RECALLS AND SAFETY WARNINGS...should be reported DIRECTLY TO the patients, WITHOUT EXCEPTION. If a device is recalled or if a device poses a health risk that could seriously injure or disable the patient, and these risk factors were never explained to the patient...or...if these risk factors were already KNOWN by the device manufacturers but never disclosed: there should be NO statute of limitations on lawsuits againts these device manufacturers.

-The US Supreme Court should uphold all lawsuits againts these device manufacturers (on device recalls/safety warnings as described above, that pose serious harm/injury, disability, and/or death to the patient); additionally, if a patient is injured, disabled, and/or killed by these devices (that are recalled/issued for safety warnings); the US Supreme Court should uphold lawsuits by the patient and/or patient's familiy against the device manufacturer for any and all expenses related to the medical care (related to the device and subsequent health implications) and compensation for pain and suffering without a cap. If device manufacturers have a class action suit against them, the US SUPREME COURT should require that the device manufacturers NOT BE ALLOWED to put a "cap" on the "fund" and/or money set aside to pay out to the claimants.

These are MULTI-BILLION DOLLAR corporations...they injure/disable/kill THOUSANDS of people because of irresponsible, unethical, and criminal negligant practices...setting aside a few hundred million dollars to pay out on a class action suit, when they bring in tens of BILLIONS of dollars each year, is ABSOLUTELY RIDICULOUS. THE BOTTOM LINE: if a medical device manufacturer can be PROUD ENOUGH and BOLD ENOUGH to accept FULL RESPONSIBILITY and ACCOUNTABILITY for developing/producing a new device that they claim will help the medical community...they MUST BE HELD RESPONSIBLY and ACCOUNTABLE for both POSITIVE and NEGATIVE factors related to their products. They cannot REAP the financial reward of their product, without having to accept responsibility if that product causes SERIOUS HARM to the patients WHO TRUSTED THE DEVICE MANUFACTURER enough to have that product SURGICALLY IMPLANTED in their body.

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