Posts Tagged ‘ Medtronic ’

Medtronic Under Fire with Questions of Financial Conflict

July 7th, 2011. By Hunter West

A blockbuster investigation by some print media outlets has spurred a US Senate Finance committee to start beating the bushes once again around the medical devices industry.

There are many questions:

How safe are the products that wind up in your body?

What do the manufacturers know about potential safety issues, but aren’t telling?

Why is it okay for a doctor or surgeon to be paid by a medical device manufacturer? And can you really trust what a doctor [who is paid by the device maker] says about that device?

Do you feel like a guinea pig?

It was revealed yesterday through a series of articles published by the Milwaukee Journal Sentinel and MedPage Today that there is some controversy surrounding Medtronic Infuse, a popular bioagent known as bone morphogenetic protein-2, designed to foster bone growth required for spinal fusions.

Infuse was approved by the US Food and Drug Administration (FDA) in 2002 and doctors love it. It’s easy to work with. And you don’t have to harvest a patient’s own bone from elsewhere, in order to accomplish the surgery. You have to love something that allows a surgery to proceed faster, and more easily.

But here’s the rub—and the reason for the Senate Committee investigation. It seems that a cadre of surgeons around the country were paid by the device manufacturer, Medtronic. Those same surgeons with financial ties to Medtronic were involved both in the clinical trials for Infuse, Read the rest of this entry »

Tags: Infuse, Medtronic
Posted in Defective Products, Drugs/Medical | 2 Comments »

5 of the Highest Settlement Awards for 2010

December 29th, 2010. By Kristine B

Once again we find ourselves at the end of a year—and it’s been a pretty big year for lawsuits. So, in celebration of the year that was, we’ve compiled some of the biggest settlements—in terms of amount of the award or settlement—of 2010. My deepest thanks to the incredibly talented, wonderful, smart, beautiful, fantastic duo of Lucy C. and Abi K. for helping me compile this list…

Personal Injury Lawsuits 

When it came to personal injury, wrongful death and negligence lawsuits, there were some pretty large awards and settlements given out in 2010. 

One settlement of $176 million was approved in a lawsuit filed after a 2003 nightclub fire in Rhode Island killed 100 people. The settlement money will go to survivors of the fire who suffered serious injury and to the children who lost parents in the fire. 

Meanwhile, in one of the largest jury awards ever in the US, a jury in El Paso awarded $132 million to victims of a bus crash in which two people were killed and several others were injured. The vehicle reportedly crashed when the driver began speeding and eating at the same time. The bus rolled down an embankment. 

Defective Products 

Speaking of automobiles, a settlement was reached earlier this year between Volkswagen of America, Inc. and vehicle owners who said their cars leaked during rainstorms. The defective product lawsuit alleged certain Volkswagen and Audi models contained design defects that allowed water to enter the passenger component and, in some cases, damaged electronic components of the vehicle. As part of the settlement, Audi was required to pay $10,000 to each of the class representatives, $9.2 million in fees and $675,000 in costs for the class-counsel firms. 

And in another defective product lawsuit, Medtronic agreed to pay $268 million to settle lawsuits regarding the company’s Sprint Fidelis Leads. The leads were alleged to have been defectively designed, allowing the wires to crack and causing unnecessary shocks to patients’ hearts. 

And, in a defective drugs lawsuit, the maker of Seroquel agreed to pay 17,500 patients a total of $198 million to settle allegations that the medication caused illnesses such as diabetes. 

Tags: 2010 Highest Settlements, Bus Accident, El Paso, Medtronic, Rhode Island, Seroquel, Settlements, Volkswagon
Posted in Emerging Issues, Settlement | 3 Comments »

Medtronic CD Horizon Spinal System: Buyer Beware

September 28th, 2009. By LucyC

We’re approaching the two year anniversary of the FDA recall of all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. So why bring it up? Well, in light of the seemingly endless number of defective products that make their way onto the market every year, the CD Horizon provides a cautionary tale. 

The device was developed to relieve spinal pain, and was surgically implanted. Sadly, the CD Horizon spinal system was prone to failure, causing patients more pain rather than less. 

The device was approved on the strength of risk analyses by Medtronic which allegedly claimed Read the rest of this entry »

Tags: CD Horizon Spinal System, Medtronic
Posted in Drugs/Medical | No Comments »

Calls for End to Medical Device Maker Immunity

May 13th, 2009. By Evelyn Pringle

On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.

In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleging injury from a device that received marketing approval from the FDA.

“The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings,” according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009. Read the rest of this entry »

Tags: immunity, medical devices, Medtronic
Posted in Defective Products | No Comments »