A History of Defective Medical Devices

Posted on Friday, March 9th, 2018 at 7:50 pm    

Many medical devices manufactured for public use work well and pose little to no risk to the general public when used as prescribed, but the success rate is nowhere near perfect. Even the most well intentioned medical professionals can do more harm than good by using faulty medical products while treating patients.

This mismatch between intent and execution is nothing new. It was society’s most knowledgeable people who, thousands of years ago, began advocating for bloodletting to alleviate symptoms or cure illnesses. There were some who advocated for its use as late as the 19th century.1

Medical professionals are, thankfully, more knowledgeable in modern times, but that doesn’t mean they, or the manufacturers who create the medical devices on which modern health care relies, are infallible.

Health care is also a huge business, and improved technology has resulted in the availability of many more medical devices. In the not-too-distant past, people likely would not have imagined replacing a joint would be possible, but today, millions of people are living fuller, more active lives with reduced pain and improved mobility thanks to cutting-edge medical technology.

Despite the many improvements medical devices have brought to the lives of modern people, they also add another risk to patients – the chance that the device is defective, was improperly designed or uses materials that don’t last or can’t handle the strain to which they’re subjected.

Medical professionals, unlike workers in many other fields, have a legal duty to their patients. When doctors, nurses or other medical professionals or the devices they use fail, the consequences can be severe. People can die, joint replacement surgeries may need to be performed again, serious infections can occur and many other consequences could potentially result. This often means increased rehabilitation and healing time that could have been avoided had the device or drug functioned properly, as the patient was led to believe it would.

With the increased prevalence of medical devices has come an accompanying increase in medical device recalls and lawsuits. In 2003 there were only 604 FDA recalls. In 2017, the FDA recalled an astonishing 3,202 medical devices.2

The Origins of Holding Drug and Medical Device Manufacturers Accountable

The first real efforts in the U.S. to hold manufacturers accountable for their medical products arrived in 1938 with the passage of the Federal Food, Drug, and Cosmetic Act (FFDCA), which essentially gave authority to the FDA to monitor and set safety standards for food, drugs and cosmetics.

The FFDCA was passed after a mass poisoning caused by the S. E. Massengill Company’s Elixir Sulfanilamide, which contained diethylene glycol (DEG) as one of the ingredients. DEG is poisonous to mammals and at least 100 deaths were attributed to the drug. One of the new requirements included mandatory testing of new drugs on animals.3

The FFDCA was later updated with the Medical Device Amendments of 1976, the same year an estimated 900,000 women were injured by an intrauterine device known as the Dalkon Shield. The amendments included the introduction of classifications for medical devices.

Low-risk medical devices that are well known and aren’t designed to play a crucial role in the supporting or sustaining of human life are classified as Class I medical devices. Devices which still require more research and information to provide a reasonable assurance of safety and efficacy, but have had enough research performed to at least prove a set of performance and safety standards can be achieved, are categorized as Class II medical devices. Establishing a performance standard is necessary for a Class II device to be re-categorized as a Class I device.

Devices that are still in the premarket approval phase of development and haven’t met the requirements to progress into Class II or Class I status, especially those that may play a significant role in sustaining or supporting life, are considered Class III medical devices. Something like a pacemaker that, if it malfunctioned, could result in the death of the patient, would likely be categorized as Class III during development.4

Giving Patients and Their Families an Avenue of Recourse

The initial FFDCA established clauses that laid out both civil and potentially criminal penalties for releasing improperly researched and vetted drugs or medical devices that could cause harm. Patients and their families were given the ability to seek civil damages for drugs or medical devices that didn’t provide the advertised results, or worse, caused injury to a patient who was expecting a cure or relief from their ailments. If a manufacturer repeatedly violated the FFDCA or it could be proven that they intentionally or fraudulently marketed or sold their potentially dangerous products to the public, criminal charges were a real possibility.

Current High Profile Drug and Medical Device Issues

There are several medical device and drug class action cases that have made national headline news lately in the United States. You may have even seen or heard commercials for some of these class actions on the television or radio.

Transvaginal Mesh Devices – This is essentially a mesh that is attached to the vaginal wall to address a pelvic organ prolapse and treat the resulting urinary incontinence. Some patients who have had transvaginal mesh devices – from manufacturers such as Endo and Johnson & Johnson subsidiary Ethicon – have suffered several complications such as infection, organ perforation, mesh erosion and ultimately recurrence of the prolapse and incontinence.5

Metal on Metal Hip Replacement Devices – Although heralded as a longer lasting solution for many people suffering from serious hip problems, the metal hip replacement devices from companies such as Stryker and Johnson & Johnson subsidiary DePuy have a history of causing issues for some patients. The metal on metal friction can result in metal shavings making their way into the body, resulting in metal poisoning and metallosis. Some hip replacements have also outright failed unexpectedly, resulting in additional painful surgeries and long recoveries.6

Xarelto® – This drug thinner has been linked to several types of internal bleeding, including gastrointestinal and brain bleeding, which can be fatal.

Talcum Powder – Some women who had used talcum powder, such as Johnson & Johnson’s Baby Powder, for years or even decades as a feminine hygiene product began developing ovarian cancer at higher rates than the general population. Research on the link is still ongoing but several lawsuits are currently being played out.7

Have You or a Loved One Suffered an Injury or Death Due to a Defective Drug or Medical Device?

If you or a loved one has experienced pain and suffering and been forced to endure additional procedures or treatments due to the failure of a prescribed device or drug, you may be entitled to compensation. We encourage you to contact the experienced drug and medical device lawyers at Farris, Riley & Pitt, LLP to schedule a free case evaluation by calling (205) 324-1212.

1http://broughttolife.sciencemuseum.org.uk/broughttolife/techniques/bloodletting
2https://www.raps.org/news-articles/news-articles/2018/1/device-recalls-in-2017-making-sense-of-the-numbers
3https://www.fda.gov/AboutFDA/History/ProductRegulation/default.htm
4https://www.congress.gov/bill/94th-congress/house-bill/11124
5https://www.classaction.com/transvaginal-mesh/settlement/
6https://www.recallcenter.com/hip-replacement/lawsuit/
7https://www.huffpost.com/entry/the-talcum-powder-lawsuit_b_10609474

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