Defective Medical Devices in Austin, Texas
Some product recalls aren’t too worrisome for consumers. They may receive a notice in the mail that a product they purchased has been recalled due to a defect, which usually means they can get a refund or a different product. But when a manufacturer recalls a medical device, consumers may be in serious danger.
According to the Food and Drug Administration, between 2003 and 2012, annual recalls of medical devices increased by 97 percent. Many of those recalls concerned parts or devices that had been surgically implanted in patients. The people affected by those recalls face an uncertain future – they may suffer from illnesses or injuries caused by defective products and require subsequent surgeries.
Types of Defects
Unfortunately, defects in medical devices often are not discovered until they cause harm. In 2010, medical device manufacturer DePuy issued a recall for its ASR Hip System, after a joint-replacement registry in the United Kingdom discovered problems with the product. Registry data showed that 12 percent of patients with an implanted resurfacing device and 13 percent of patients with a total hip replacement required correctional surgery within five years.
Between 2002 and 2013, 578 recalls were issued for replacement hips and components, among six manufacturers: Biomet; DePuy; Smith & Nephew; Stryker; Wright, and Zimmer. More than 10 percent of those recalls were Class I – the most serious type of recall, which indicates a device may cause serious injuries or death. The majority of the recalls were Class II, which means a device could cause temporary or medically reversible adverse health consequences.
Sometimes, the devices that surgeons need to help their patients are found to be dangerously defective. Stryker – the company that issued 231 hip recalls in 11 years – recalled a surgical device in 2015, due to risk of serious injury or death. The device is called a Fuhrman Pleural & Pneumopericardial Drainage Set and is used to remove air for the sac surrounding the heart, or to remove air or fluid from the outer protective lining of the lungs. Stryker received two reports of the drainage set catheter breaking off inside of a patient’s body, necessitating medical intervention.
Johnson & Johnson, owner of DePuy, bought the medical device company Synthes in 2012 and merged the two companies to become DePuy Synthes. In 2016, that company issued an urgent recall for two of its products. The two small devices – power sources for bone-drilling and bone-cutting surgical equipment – could explode, injuring or killing patients, surgeons, and bystanders.
In December 2015, a company recalled ventilators that provide breathing assistance to hospital patients, due to a software problem that reduces battery run times and interferes with a warning alarm. The ventilators are supposed to issue an alarm five minutes before the battery runs out of power, but that function wasn’t working in the 2,422 recalled ventilators.
A synthetic hip, surgical instrument, or piece of complex machinery are all medical devices, but the term “medical devices” also applies to simple items like knee braces and crutches.
According to MedSun, the FDA’s medical product safety network, a physical therapist reported that a brand new crutch fell apart as a patient was using it and coming down steps. That patient was uninjured, but another patient who was discharged from an emergency room was injured when the wing nut on a crutch came loose on the hand grip, causing her to fall.
Sometimes, products are recalled for what seems like impossible oversights: missing parts, mislabeled parts, incorrect instructions, unsafe packaging, and even improperly sized parts. Those are the kind of problems one might expect when buying a cheap piece of furniture.
Medical product manufacturers earn billions of dollars off the sale of their products. In the second quarter of 2016, Johnson & Johnson earned $18.5 billion, and Medtronic earned $7.166 billion, just before announcing a recall of 82,278 microcatheters because they can separate and send debris into a patient’s bloodstream.
These companies are putting people in grave danger by cutting corners on quality testing and rushing their products to market. Many of these companies issue recalls year after year, for a wide variety of products, and when their defective medical devices injure or kill someone, manufacturers should be held accountable.
If you’ve suffered an injury due to a defective medical device, call the Evans & Herlihy Law Firm today at 1-855-414-1012, or fill out our online form, to request your free, no-obligation consultation.