IVC Filters are not FDA approved. They were only cleared for use through the FDA’s 510(k) process. Were IVC blood clot filters formally approved by FDA through the agency’s regular device approval process, the people injured by them would have little to no legal recourse to pursue claims against IVC filter makers C.R. Bard, Cook Medical, Boston Scientific and others.
The 510(k) Approval Process
The popularity of 510(k) clearance among device makers stems from its relative lack of rigor – devices reach the market much more quickly and less expensively under this process than under other FDA avenues of review.
The traditional premarket approval process for a medical device typically involves some 1,200 review hours, as opposed to the 510(k) process, which is completed in an average of 20 hours.
The 510(k) process was not designed to evaluate the safety and effectiveness of a device. A finding of ‘substantial equivalence’ signifies only that the device is similar in certain respects to a previous predicate device. No determination about risks to safety or effectiveness comes as a result of clearance through the 510(k) process.
IVC filters stir controversy despite being implanted in millions of people in the last 30 years or so. Increasingly, learned professionals in the medical community question the safety and efficacy of IVC blood clot filters. As IVC filter lawsuits are being continuously filed across the country, more and more people seem to be paying attention to the IVC Filter Controversy.
Johnson & Johnson was hit with a DePuy Hip Verdict of $498 Million Thursday, March 16, 2016, in Dallas, Texas, in the second bellwether trial in the multidistrict litigation over Pinnacle hip prosthesis made by DePuy Orthopaedics Inc. Plaintiffs had presented the consolidated claims of five patients who testified that the Pinnacle hip replacement devices were defective and gave them problems.
Law 360 announced that after a two-month trial and several days of deliberations, a Dallas jury found in favor of all five plaintiffs, delivering a verdict that included $360 million in punitive damages.
Matthews & Associates has filed a Cook IVC Filter Consolidated complaint. The firm filed a “Master Consolidated Complaint for Individual Claims” in the Cook Medical federal multi-district litigation (MDL) court in Indianapolis, Indiana. The Master Complaint serves the administrative functions of efficiency and economy and presents certain common claims and questions of fact and law in the MDL Court.
The master complaint consolidates charges that are shared by all of the cases filed against Cook Medical. The master saves money and time for the courts, plaintiffs, their attorneys and the defense. Though each case presented to a jury will eventually be decided by its own individual facts and merits, any cases filed with the consolidated complaint also shares basic charges brought forth by plaintiffs.
A Mississippi woman filed a Cook Select Filter Lawsuit in Mississippi against Cook Medical Inc. 21 January, 2015 in U.S. District Court in the Southern District of Mississippi, Northern Division. She is represented by Matthews & Associates, a nationwide law firm headquartered in Houston, Texas.
Colonoscopies are promoted and priced for profit in America. Are they necessary? Do they help people, or do they help doctors and medical facilities pad their bottom line? In a word, or 14, is the colonoscopy profit motive so strong as to negatively impact a patient’s health?
Dr. Don Ardell, among many, believes the Western medicine profit motive compromises patient care. Dr. Ardell advises that you be wary and ready to verify anything you hear from your doctor. He believes you should obtain qualified opinions from others as well.
Doctors and other medical providers are not your enemies, says Ardell; but neither are they your friends. Though they may be highly trained professionals, they function in a dysfunctional system designed for profit. Most want to do the right thing, Ardell asserts, but financial and other pressures can lead even ethical practitioners to justify actions not in a patient’s best interest.
Matthews & Associates Law Firm is reviewing Laparoscopic Morcellator Lawsuits nationwide for women who were diagnosed with uterine cancer, including leimyosarcoma (LMS) or other types of cancer following a hysterectomy or fibroid removal which employed a power morcellator.
An estimated one of every 350 women undergoing a hysterectomy for removal of the uterus or uterine fibroids may have an undiagnosed sarcoma, which doctors cannot detect prior to the surgery. Additionally, they estimate that one in 500 women has an aggressive form of cancer called leiomyosarcoma (LMS). Laparoscopic power morcellators used in such cases can lead to serious problems.
Some doctors decry the latest FDA morcellator warning. At least 48 doctors decry an FDA morcellator warning for laparoscopic surgeries. The doctors – the self-described ‘Leiomyoma Morcellation Review Group’ – have proclaimed that the FDA erred in its warnings over power morcellators. In April 2014, the FDA first discouraged the use of power morcellators for minimally invasive surgery in women with uterine leiomyomas. The agency then wrote:
“Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
Then FDA strengthened its power morcellator position to a warning on Nov. 24, 2014, writing:
“The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”
A Mississippi woman filed a Bard IVC filter case in U.S. District Court in the Northern District of Mississippi, Oxford Division. Tonya Munson’s case against C.R. Bard was originally filed Dec. 31, 2014. (See: Munson v. Bard.) The plaintiff is from Sara, Mississippi, in Tate County.