What's the Problem?
Dangerous or defective medical equipment can give rise to a potential liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result. Although closely monitored by the U.S. Food and Drug Administration (FDA), medical devices can be defective in their design, manufacturing process, or marketing strategy.
In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention.
Our Current List of Defective Medical Devices
Our lawyers are currently investigating defective device lawsuits on behalf of individuals who were injured by the following products:
B. Braun Aesculap Knee Replacement
A recent lawsuit alleges that the B. Braun Aesculap knee replacement device is defective and prone to severe complications including metallosis (metal allergy), early failure, and the need for invasive revision surgery.
The lawsuit, filed in California on behalf of 25 knee replacement medical device patients, claims that B. Braun concealed from regulators problems with its Aesculap artificial knee implant and promoted the medical device, despite knowing it was prone to early failure and other adverse health consequences.
The complaint further alleges that Aesculap medical device ceramic joints are defective because they don't adhere properly to cement used to bond them with the patient's bones. Plaintiffs claim they were or will be required to undergo painful revision surgery and other procedures to correct problems caused by the B. Braun Aesculap medical device.
Biomet Shoulder Replacement
Zimmer Biomet in February 2017 issued a Class I Recall for its Comprehensive Reverse Shoulder medical device because the implants may fracture after surgery, which may cause permanent loss of shoulder function, infection or even death.
Zimmer initiated the recall after receiving a higher than expected number of reports of its Comprehensive Reverse Shoulder medical device fracturing.
The Zimmer Reverse Shoulder is a medical device that is designed to help restore arm movement in many patients with rotator cuff tears who have severe arthritis and previously failed shoulder joint replacement.
Boston Innova Stent
Boston Scientific in 2011 recalled a stent for leg arteries after numerous complaints of no deployment or partial deployment of the medical device were received by the Food and Drug Administration.
The design defect could result in vessel wall injury and / or emergency surgery to remove the partially deployed medical device. The stent is designed for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and / or proximal popliteal artery.
Our lawyers are reviewing potential medical device lawsuits for people who were harmed by the following recalled catheter devices:
Penumbra Catheter Recall
Penumbra Inc. in December 2020 recalled the following catheter medical devices over potential risks of unexpected death or serious injury while used for removing clots in many patients:
- Penumbra JET 7 Xtra Flex catheter medical device, originally cleared under K190010 on June 16, 2019.
- Penumbra JET 7MAX configuration medical device (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
The recall was initiated after the Food and Drug Administration "... received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries caused, and malfunction," the agency said in the recall letter. "Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter."
Teleflex subsidiary Vascular Solutions in June 2017 issued a Class I Recall for its Venture Catheter medical devices over a problem with excess material on the device. Class I medical device recalls are reserved by a judicial panel for allegedly defective medical devices that can cause serious adverse events or death.
The recall includes 3 lots of Venture Catheters, including 4,679 distributed in the U.S., due to the potential for excess material to be present within the inner lumen of the distal catheter tip.
The material could separate from the medical device and cause a serious injury due to embolism, according to the U.S. Food and Drug Administration (FDA).
The recall covers all unexpired lots of the Rapid Exchange, Over-the-Wire and Coronary Sinus versions of Venture Catheter medical devices. Affected product codes include 5820, 5821 and 5822, with an associated 72 different lot numbers.
Vascular Solutions said it has contacted purchasers with affected products, and advised any facilities with the products to remove them from their inventory and return the medical devices.
DePuy Orthopedics in August 2010 issued a voluntary hip recall for the ASR XL Acetabular medical device and the ASR Hip Resurfacing hip implant system, which were found to be failing at a higher rate than other types of hip implants like metal-on-plastic medical devices.
Metal-on-metal hip implant systems have metal balls and metal sockets, which create friction. The friction caused by the rubbing together of these two parts can lead to the shedding of particles of metal into surrounding tissue and even the bloodstream.
Essure Birth Control
An article published in the New York Times in May 2015 reported that the Food and Drug Administration had received over 4,000 adverse event reports associated with the Essure contraceptive medical device. These injuries included severe back / pelvic pain, heavy menstrual periods, and coils that pierced recipients’ Fallopian tubes and became lodged in the patient's body.
In a pre-approval clinical trial that involved 269 women ages 23 to 45, Essure medical devices were successfully inserted into 200 patients. However, in 9 women the contraceptive perforated the Fallopian tube, was expelled or became stuck elsewhere in the body. Additionally, nearly 1 in 10 women complained of painful intercourse, and 1 in 8 reported painful menstrual periods during the first 3 months after being implanted with the medical devices.
Ethicon Physiomesh Hernia Mesh Patch
The Ethicon Physiomesh hernia patch was withdrawn globally in May 2016 after being linked to high failure rates and the frequent need for revision surgery.
Ethicon Physiomesh Flexible Composite Hernia Mesh Patch entered the U.S. market in 2010 via the FDA’s 510(k) approval process, which clears medical devices that are “substantially equivalent” to products that are already on the market.
A number of different types of Physiomesh medical devices were introduced to repair hernias and other fascial deficiencies. However, it now appears that the products were defectively designed and/or manufactured, posing an unreasonable risk of severe complications.
Since August 2010, the FDA has been raising concerns about patients who suffered complications associated with IVC filter medical devices. Hundreds of reports have been filed with the agency involving incidents where parts of the device fractured or migrated to other parts of the body, particularly the heart and lungs.
Our lawyers are reviewing potential medical device lawsuits for people who were injured by the following brands of IVC filter medical devices:
Bard IVC Filter
Cook IVC Filter
Other Retrievable IVC Filter Medical Devices
- Argon Medical OptionELITE IVC Filter
- ALN IVC Filter
- B. Braun IVC filters (Tempofilter IVC filter, Tempofilter II IVC filter, VenaTech LGM IVC filter and VenaTech LP IVC filter)
- Cordis OptEase IVC Filter
- Crux Vena Cava Filter
Philips HeartStart Defibrillator
The FDA in December 2013 warned that thousands of defibrillators made by Philips Healthcare may not work correctly during medical emergencies because of an electrical component failure. According to the Wall Street Journal, the agency received approximately 1,100 complaints and 580 adverse event reports associated with the Philips Healthcare HeartStart Defibrillator medical devices.
Medical device lawsuits are being filed over the use of power morcellators, medical devices used during hysterectomy and myomectomy surgeries. The FDA has warned that morcellators can spread undetected cancer cells into other parts of women’s bodies.
The medical device lawsuits are for women whose cancer spread throughout their bodies after undergoing surgery with a laparoscopic power morcellator.
In April 2014, the FDA issued a Safety Communication advising surgeons not to use laparoscopic morcellators during hysterectomy or myomectomy procedures due to the risk that the devices may spread cancerous uterine tissue to other parts of the body. Based on current data, FDA estimates that of the approximately 600,000 hysterectomy surgeries performed in the U.S. each year:
- 30% are performed laparoscopically in women younger than 40
- 44% in women ages 40 to 49
- 16% in women ages 50 to 59
The agency has determined that about 1 in 350 women who undergo a hysterectomy or myomectomy surgery for uterine fibroids have an unsuspected form of cancer called uterine sarcoma. If laparoscopic power morcellators are used on these women, there is a significant risk that the device will spread cancerous tissue into the abdomen and/or pelvis.
Stryker Corp. in June 2012 announced a recall for its Rejuvenate and ABG II modular-neck hip devices due to the risk of corrosion, which could result in tissue damage, pain, swelling, and other hip surgery complications. The company said the recall cost between $190 and $390 million for patient testing and treatment, revision surgeries, replacement hip lawsuits, and insurance payments.
In May 2017, at least 95% of eligible patients registered for a settlement program intended to resolve product liability lawsuits filed over injuries alleged from Stryker Rejuvenate and ABG II Modular-Neck hip stems. The company indicated that it would soon begin making payments to eligible parties.
Transvaginal mesh implants have been linked to tens of thousands of severe complications including mesh erosion, infections, and perforation of the bowel, bladder and blood vessels.
To date, there has been at least 3 recalls for surgical meshes. Back in 1999, Boston Scientific pulled its ProteGen brand vaginal mesh off the market amid safety concerns.
The ProteGen was a groundbreaking female pelvic medicine device due to the fact that it was not only the first surgical mesh designed exclusively for transvaginal applications, but it also paved the way for a huge number of other shoddy products to reach the U.S. market.
Within a year of the ProteGen gaining approval from the FDA, several other major medical device manufacturers copied the defective design and released mesh of their own.
Due to the similarities between these devices and the ProteGen, all of them were rushed to market via the FDA’s controversial 510(k) clearance loophole, which approves products without clinical testing. And while the ProteGen was recalled after 3 years on the market, the vaginal mesh devices created in its image have yet to be recalled.
Our lawyers are accepting potential lawsuits for people who were injured by the following medical device companies:
Johnson & Johnson
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems or AMS
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Zimmer Hip Implants
There have many reports of failure and prior results in patients implanted with Zimmer Durom Acetabular Components (“Durom Cup”), which were recalled in 2008. Device manufacturer Zimmer suspended the marketing and distribution of the Durom Cup after some U.S. surgeons reported higher-than-normal revision surgery rates (up to 5.7%) using the Durom cup.
Since it was first sold in the United States in 2006, the Durom cup has been implanted in more than 12,000 patients.
The orthopedic-device maker has since poured tens of millions of dollars into settlements, setting aside money for future lawsuits.
Zimmer Knee Replacement
Zimmer also faces numerous complaints against the newer High Flex version of NexGen knee implants. To date, over 700 Zimmer High Flex NexGen knee lawsuits have been filed against the large medical device manufacturer. The defective High Flex knee implants caused increased pain, loosening of the device, premature knee implant failure, and expensive revision surgery.
While most knee replacement systems are designed to last up to 15 years with prior results, there have been reports of device failure in the Zimmer NexGen knee system in two years or less. According to a recent study, 36 percent of these implants were loose and nearly 10 percent required revision surgery due to looseness and serious pain.
Zimmer Biomet in February 2017 issued a Class I Recall for its Comprehensive Reverse Shoulder because the implants may fracture after surgery, which may cause permanent loss of shoulder function, infection or even death.
Zimmer initiated the recall after receiving a higher than expected number of reports of its Comprehensive Reverse Shoulder implant fracturing.
The Zimmer Reverse Shoulder is a shoulder replacement device designed to help restore arm movement in patients with rotator cuff tears who have severe arthritis or similar outcome and previously failed shoulder joint replacement.
Can I Sue Over a Defective Medical Device?
Defective medical devices often cause severe pain or injury to the patient, and in the worst cases, they can result in death, even through standard use. In the event of a defective device causing such injury, death or similar outcome, the person may have legal rights to pursue against the drug companies or hospital that supplied the individual with the device.
Instances of injury through the use of a defective medical device when operated through standard or instructed use may provide the opportunity to sue the device manufacturer or medical health facility that provided the device. However, for a clear understanding of how to proceed in the legal system, the individual should consult first with an experienced law firm.
Evidence is important in product liability claims, and the device may need analysis to determine if it does possess a defect that could harm a person through standard or instructed performance. Then, the plaintiff’s legal team would need to connect the defendant to the liability in the claim.
Related article: Cochlear ear implant lawsuit
Get a Free Medical Device Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the legal rights of plaintiffs in a product liability lawsuit. Our law firm is handling individual litigation nationwide and currently filing product liability claims in all 50 states.