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The FDA clearance process for certain devices can have deadly consequences.The controversial FDA clearance process known as 510(k) Premarket Notification is a prime example of the law of unintended consequences. In the 1970s, this provision became law with the purpose of making life-saving medical devices available to patients in the shortest possible time. Instead, it has in many cases given medical device manufacturers the ability to bring untested, dangerous and sometimes deadly health care products to the market, foisting them onto an unsuspecting public, including doctors and health care providers.

Public scrutiny of the 510(k) review process recently got a boost when John Oliver presented this segment on This Week Tonight:

Critics say that as a result of inadequate research and testing, the number of injuries and lawsuits has grown exponentially. Defective medical devices approved under the 510(k) FDA clearance process are among the most common causes of action in tort litigation today. Shockingly, many of these companies may be aware of the dangers of their products, but are apparently willing to gamble with patients’ lives in order to extract as much in the way of profits as possible.

Brief History of the FD&C Act

The federal Food, Drug and Cosmetic Act (FD&C) was passed by Congress and signed into law by President Franklin D. Roosevelt in 1938. The origins of the law can be traced to the Pure Food and Drug Act, signed by President Theodore Roosevelt in 1906.

Before then, the “patent medicine” industry was thriving on the sale of “remedies” that at best, were useless and at worst, deadly. Many of these contained large amounts of alcohol, while some were made with opium extracts or other highly-addictive substances. Furthermore, the industry had a stranglehold over the newspapers of the time, which were highly dependent upon ad revenue. Purveyors of patent medicines had “red clauses” with these papers, which stated that ads would be withdrawn if there was any support for attempts at government regulation.

The 1906 bill was motivated by investigative reporters of the time such as Upton Sinclair, and pressure from socio-political activists like Florence Kelley, who had the courage to stand up to the industry. Originally, the Pure Food and Drug Act’s primary purpose was to ensure that product labeling was forthcoming about ingredients, while making illegal the manufacture, sale and transport of toxic products. Later on, attempts were made to place similar prohibitions on harmless, but ineffective products.

While the Pure Food and Drug Act was an important first step in controlling existing products and forcing the industry to provide accurate label information on ingredients, the government had little authority to require testing of new drugs to ensure their safety before they came on the market. Unlike today, no regulatory approval was required.

This loophole led to tragedy in 1937 when chemists at the pharmaceutical firm S.E. Massengill (predecessor of GlaxoSmithKline) developed a medication called elixir sulfanilamide, which was indicated for everything from sore throats to gonorrhea. Instead, the medication wound up killing more than 100 people, including 34 children.

What came to be known as “The Elixir Tragedy” spurred the passage of the FD&C Act the following year. The Act gives full power, authority and responsibility to the FDA to regulate and evaluate the safety of pharmaceuticals and medical devices. The agency also oversees food safety and cosmetics.

The FD&C Act Today

The FD&C Act has been updated and amended over the years. In 1968, during President Lyndon Johnson’s administration, the law was amended to include the regulation of electronic devices and provide for investigations into the efficacy of currently available medications. More recent amendments give the FDA authority to protect the public from acts of bioterrorism (i.e., deliberate poisoning or contamination of food, water and medicine supplies).

Medical Device Categories

In May 1976, Congress expanded the FDA’s authority under the FD&C Act, giving the agency regulatory control over medical devices. This part of the law requires such devices to be listed under three classifications.

Meddeviceonline.com explains the classifications. Class I devices are those for which no premarket testing or formal FDA approval is required, although the manufacturers must adhere to certain controls for general safety. They are considered to be of low risk, and include products such as:

  • dental floss
  • bandages
  • bedpans
  • enema kits
  • instruments such as stethoscopes
  • patient safety restraints.

Approximately 47 percent of medical devices fall into this category.

Class II devices are those that have been deemed to pose a “moderate to high” risk to patients and users. Some Class II devices are:

  • powered wheelchairs
  • home testing kits (such as pregnancy tests)
  • glucose meters and blood pressure monitors

Class III is the most stringent category, and covers devices designed to support or extend life, are surgically implanted, or have the potential to cause serious illness or injury. Examples of Class III devices include:

  • pacemakers
  • prosthetic joints
  • insulin pumps
  • HIV diagnostic kits
  • defibrillators

Completely new Class III devices are required to undergo strict clinical studies and safety testing, and must have premarket approval before the manufacturer is allowed to put it on the market. Section 510(k), however, provides an exception.

FDA Clearance Under 510(k)

In 1976, the FD&C Act was amended to include the 510(k) Premarket Notification (PMN). The purpose was to provide a pathway to regulatory approval that would save the manufacturer time and financial resources, helping to get potentially life-saving medical devices on the market within a shorter timeframe. It allows the manufacturers of Class III medical devices to bypass the usual clinical trials and safety studies if it can be demonstrated that the new product is “substantially equivalent” to an older product that has been subject of such studies and has current FDA approval.

FDA clearance under 510(k) Premarket Notification “…requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance” if they intend to introduce a new product that was not on the market prior to the 1976 amendments. This is to allow the FDA to determine which class the device falls under.

Here is the loophole: if a manufacturer can demonstrate that its new device is “substantially equivalent” to another device that received FDA approval after May 1976, the usual requirements for clinical trials and safety studies are waived. Critics say this has resulted in many dangerous and deadly devices in the marketplace and into patients’ hands, too often with tragic results.

510(k) Abuses

Clinical trials and safety studies constitute a major expense for medical device manufacturers. Understandably, these companies will look for other legal opportunities to avoid – or more accurately, externalize – these costs.

Even though the FDA has determined that many devices qualify for 510(k) exemptions due to their “substantial equivalence” to “predicate” devices, the fact is that the lack of testing has had serious consequences for patients.

Two notorious examples are surgical mesh (used for the treatment of pelvic organ prolapse and hernia repair) and metal-on-metal hip prostheses. Because the devices’ manufacturers convinced the FDA that its products were similar enough to previously-approved devices, neither device was subject to clinical testing before being allowed on the market.

In order to get FDA clearance under 510(k) PMN, the manufacturers of metal-on-metal (MoM) hip devices relied on earlier prostheses made from plastic or ceramic as “predicate” devices. What these companies failed to anticipate is how the friction of the metal parts moving against each other would result in wear and corrosion, releasing metal debris into the patient’s tissues. The result: infections, metal toxicity, and device failure, requiring revision surgery.

Similarly, the 510(k) PMN loophole enabled medical device manufacturers to market surgical mesh for purposes that were not originally intended, or were inappropriate, causing serious patient injury and leading to massive litigation.

Did the Manufacturers Know About Defects?

This is the multi-billion dollar question that is disputed in product liability lawsuits. It’s likely that companies involved in the manufacture of dangerous medical devices were simply in a hurry to get their products into the hands of medical professionals while saving on the expense of clinical trials.

However, there is a more sinister theory that comes up periodically: the manufacturers knew that its products might be dangerous, yet chose to sell them anyway. They knew people would be injured and possibly killed, and that lawsuits would follow, according to critics. Patient advocates suspect that after analysts had crunched the numbers, these companies determined that the potential profits were greater than the legal costs and possible judgments they might have to pay out. In other words, the manufacturers determined legal fees and judgments to simply be the “cost of doing business.”

Time for FDA Clearance Reform?

According to a recent New York Times article, the 510(k) PMN exemption has cost 80,000 lives and more than 2 million injuries. The FDA is failing in its mission to ensure patient safety, and manufacturers of dangerous medical devices are not being held fully accountable, according to the Times. Increasingly, consumer advocates are calling for major reforms and stronger oversight.

It is the same fight undertaken more than 120 years ago. Passage of the 1906 Pure Food and Drug Act took 27 years of battles against an entrenched, powerful industry. Will it take that long to finally force similar legislation to end the abuses of 510(k) FDA clearance?

 

3 thoughts onFDA Clearance Under 510(k): a Controversial Process

  1. Cheryl McCall says:

    When does it stop.. FDA is just a broker for these device companies. Cook Medical merged with Ambu 510k clearance on devices made and imported to this country free of tax liabilities. “Quote simar to device already in use is a deadly farce.

  2. Joey Hill says:

    Add me

  3. Sandra Buckett says:

    I wonder if my brothers death would be covered by this. In 2000 he died because a mesh he had in his urethra collapsed, causing blood poisoning because he couldn’t urinate . He was in so much pain, but by then it was too late.

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