Tag

Medical Products Archives | Osborne & Francis

Did a Deadly Blood Clot Filter Get FDA Approval For Use With a Fraudulent Signature?

By | Defective Medical Devices, Medical Products Liability | No Comments

C.R. Bard’s Recovery filter is linked to hundreds of injuries and several deaths, calling approval process into question

NBC News recently opened an investigation into the Recovery filter by C.R. Bard, Inc., a medical device designed to help decrease a patient’s risk of blood clots hitting the lungs or heart. Reports from hundreds of patients about serious medical issues after implantation, as well as at least 27 deaths, show that the device may cause more harm than good.

When patients or doctors argue that a medical device is defective, one of the first questions asked is about how such a product made it to the general market. Many are calling the approval process into question as it relates to the Recovery filter, since further research has highlighted the serious risks associated with implantation.

C.R. Bard’s march toward approval for this device started back in 2002, when the company hired a regulatory specialist by the name of Kay Fuller to help them obtain clearance from the Food and Drug Administration (FDA). The FDA had already rejected one of Bard’s applications. The device is a small metal trap, designed for implantation inside a patient’s inferior vena cava to stop blood clots from entering the heart or lungs.

Fuller has since shared her own concerns with the device as a result of a small clinical trial early on. She said she was not allowed to see the results of that vital performance test, raising red flags for her. When she shared those concerns with officials at Bard, she felt they did not want to hear what she had to say. According to Fuller, the company made it clear that she would not be a part of the process unless she let the issue go. Her response was to deny signing the document for the FDA application. The FDA application, however, bears her name on the signature line.

When Fuller had the chance to review the document, she was firm in her belief that it was not her signature and provided a sample of her signature to NBC News as proof. There was a notable difference in the two signatures. Fuller shared her concerns about the device with the FDA, but resigned from her position at Bard. Once C.R. Bard obtained regulatory clearance to market the Recovery filter, it was implanted in at least 34,000 patients.

If you or someone you love has suffered the consequences of the Bard IVC Recovery filter, contact premier Boca Raton defective device attorneys at Osborne & Associates Law Firm, P.A. for a consultation. We can be reached by phone at 561-293-2600 or contact us online. Our attorneys have more than 50 years of combined experience helping injured victims throughout South Florida recover the compensation they deserve.

.

See the NBC News story by clicking the links below.

Part 1 – Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

Part 2 – Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?

http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246

Dangerous Blood Clot Filter May Put Patients at Risk

By | Defective Medical Devices, Medical Products Liability | No Comments

Why the Recovery filter is getting negative press for fatal and serious injuries

In a time when defective medical devices and medications are unfortunately all too common, now questions are being raised about the Recovery filter, which allegedly has put thousands of Americans at risk for deadly blood clots. Perhaps what’s most alarming about this story is not that the device has flaws- but that there is evidence indicating the manufacturer, C.R. Bard, Inc. may have known about it and sold the devices in spite of the potential risks.

The device works by inserting into a patients largest vein, the inferior vena cava, to prevent blood clots from reaching the lungs or heart — a pulmonary embolism. To date, at least 27 patients have died after having the Recovery filter implanted. According to an investigation by NBC News, there are hundreds of other patients who have suffered non-fatal issues, too.

One patient, Dodi Froehlich, had the filter implanted after a serious car accident that put her at a high risk for blood clots. Dodi considers herself lucky to have escaped death after being a victim of this supposedly-helpful filter. Just a few months after it was implanted, she passed out after getting a serious headache. What doctors discovered was that part of the filter broke off and penetrated her heart, initiating immediate and risky open-heart surgery. Even though Dodi’s life was saved by the surgeons who were able to remove the piece of the filter, other patients have suffered a deadly fate.

Shortly after patients began reporting issues with the filter, C.R. Bard hired a public relations firm. The PR firm created a crisis management plan to minimize the defective device’s impact on the manufacturer’s reputation and stock prices. Bard also hired a private physician to conduct an in-house study, the results of which showed that this particular filter came with a higher risk of fracture, movement, and death when compared to IVC filters manufactured by Bard’s competitors.

Rather than recalling the device at this point, the company continued to sell this version of the filter for three more years before replacing it with a modified device known as the G2. This development is concerning, given that nearly a quarter of a million blood clot filters are implanted in patients every year from 11 different companies, but Bard’s first version showed signs of problems early on.

If you or a loved one have been injured by a defective medical device like the Recovery filter, contact leading Boca Raton defective medical device attorneys at Osborne & Associates Law Firm, P.A. to learn about your legal options. Our office is conveniently located in Boca Raton and we serve clients in Boca Raton, West Palm Beach, Broward County and throughout South Florida. Call 561-293-2600 or contact us online.

 

Clink the links to see the full story by NBC News.

Part 1 – Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

Part 2 – Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?

http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246

Granuflo Lawsuits Are On The Rise

By | Medical Products Lawsuit, Medical Products Liability | No Comments

Following a Class I FDA Recall, GranuFlo and NaturaLyte Lawsuits on the Rise

Fresenius Medical Care is one of the largest manufacturers and suppliers of dialysis machines and disposable products. In addition to its own clinics, Fresenius also supplies many other dialysis treatment centers and clinics. GranuFlo is a powdered chemical that uses sodium diacetate to create bicarbonates. NaturaLyte is the same type of chemical but is administered in liquid form. High levels of bicarbonates are known to cause significant health problems. Dialysis patients receiving GranuFlo or NaturaLyte treatments may be six to eight times more likely to experience fatal cardiac arrest.

Following a dramatic increase in the number of complaints and adverse events linked to GranuFlo, the Food and Drug Administration (FDA) issued a Class I Recall on March 29, 2012. A Class I recall is the highest level of recall and is issued for products which present a strong danger of serious injury or death.

Currently, there are more than 1,800 pending lawsuits against GranuFlo and NaturaLyte with the first trial slated to begin in January 2016. These lawsuits allege that Fresenius “intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects and disadvantages of GranuFlo and NaturaLyte.”

Current evidence supports claims that Fresenius was aware of the dangers associated with GranuFlo, specifically an increased risk of cardiac arrest, and willfully failed to warn all clinics and doctors that used these chemicals. An internal memo from Fresenius claimed that 914 patients undergoing dialysis treatments at Fresenius-owned clinics experienced cardiac arrest in 2010. Company employees concluded that these patients all had excessive levels of bicarbonates in their blood.

If you or a loved one suffered health complications due to dialysis treatments you may be able to recover significant damages for:

  • Medical expenses
  • Lost wages
  • Emotional and physical suffering
  • Wrongful death

It is important to seek legal advice as soon as possible to ensure you have the best chance at receiving maximum compensation. Schedule a free initial consultation with the Florida medical product liability attorneys at Osborne & Associates to explore your options.We can be reached at 561-293-2600 or online.