California Personal Injury Blog - Medical Devices & Implants

Cardiovascular Systems ViperSheath Sheath Introducer Recalled Due to Fracturing

Rick Patterson — Wed, 18 Nov 2009 15:02:49 GMT

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.

In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

Originally posted at InjuryBoard by Rick Patterson

Manufacturer Responsibility for Defective Medical Devices is Getting Closer

Todd Slaughter — Wed, 05 Aug 2009 12:21:21 GMT

Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer responsibility for defective medical devices. This law will overturn the holding in the U.S. Supreme Court case of Reigel v. Medtronic decided two years ago. Background on that case can be found at the author's website.

Though the opposition claims that this law will give unsophisticated juries more authority than the FDA experts, the FDA has conceded for years that it does not have the wherewithall to monitor and control the medical product performances in the field. The FDA has relied on state court actions brought by injured consumers as a "complimentary review" of the medical devices it authorizes into the marketplace.

Following the Reigel decision, the FDA has had to rely on manufacturers to correct defects in their products, something that manufacturers are naturally reluctant to do. Contrary to the opposition's view, profit most often motivates the actions of the manufacturers. The "initiative" and "inventiveness" that the opposition claims will be stifled by the law seldom overrules the profit motive in favor of safety innovations. This is particularly true when the manufacturer is made completely immune from responsibility to those hurt by its defective products.

We commend Congress for its work to correct the "black hole" that the Supreme Court created, and to return responsibility to those that place defective medical products into the medical marketplace and our bodies.

Originally posted at InjuryBoard by Todd Slaughter

WSJ: New Study Spurs Concern About Chemical in IV Bags

Paul Kiesel — Thu, 21 May 2009 19:38:02 GMT

From The Wall Street Journal:

Hospital IVs are ubiquitous. But what are the bags made of?

Cyclohexanone, a chemical that can leach from many plastic medical devices -- including most intravenous bags and tubing -- impairs rats' heart function and nervous system, according to a study in the American Journal of Physiology. The findings could explain some debilitating side effects of medical procedures, including heart bypass surgery and kidney dialysis, that require large amounts of blood to pass through such plastic tubing.

For info: ajpheart.physiology.org

Caveat: Performing a similar study on humans is not feasible, since this would raise substantial ethical concerns.

Also, click here for another interesting article on cyclohexanone.

Originally posted at InjuryBoard by Paul Kiesel

Science Was Made Criminal at FDA

Todd Slaughter — Thu, 29 Jan 2009 17:18:13 GMT

The continuing revelations about the ordeals that FDA scientists endured when they voiced scientific concern about the Bush approval process for medical devices, engenders not only alarm but horror.

The New York Times reported today that the nine scientists of the Food and Drug Administration who complained to Congress about the inadequacies of the approval process of medical devices during the Bush years, were made the targets of criminal investigations for their perceived acts of defiance. As we previously wrote, these scientists had been critical of the efforts of the Bush appointed management to continually decrease the requirements of testing and scientific evaluation before approval. The Bush team put commercial expedience at the head of the class, and science in the back row. Now to learn that the agency's management sought retaliation through the initiation of an internal criminal investigation against these scientist is, in the scientists' apt words, "an outrage."

The positive side of the report of this embroilment is, hopefully, that science again will lead the way, rather than be shuffled aside for profit. With these recent revelations, it feels as if the last eight years took us to the brink of a return to the Dark Ages. Science and technology must be fostered and nutured for it to flourish. Did we learn nothing from the Inquisition?

Originally posted at InjuryBoard by Todd Slaughter

The Second Presidential Debate and the Mortgage Crisis

Paul Kiesel — Wed, 08 Oct 2008 19:44:08 GMT

The beginning of last night's Presidential Debate focused on the economy, naturally. Both candidates laid out their plans for how they would "fix" the economic woes many Americans face and will continue to face in the coming months. Focusing on one of the more important economic issues, the mortgage crisis (and credit crunch), both candidates expressed what they'd do to mitigate the problem, however, John McCain mentioned a form of mortgage relief that already exists, as if he came up with the plan just a few nights ago.

McCain discussed a plan to buy up troubled mortgages; a plan that was part of the bill signed into law by President Bush last week after Congress passed the $700 billion "Rescue Package."

McCain said he would "buy up the bad home loan mortgages in America and renegotiate [. . .] at the diminished value of those homes, and let people be able to make those payments and stay in their homes."

But he prefaced that statement by saying, "We’ve got to give some trust and confidence back to America. I know how to do that, my friends, and it’s my proposal. It’s not Senator Obama’s proposal. It’s not President Bush’s proposal." That statement is false.

Senators Barack Obama and Joe Biden have both echoed similar plans (and Biden revealed how porous John McCain's bailout proposal was just two weeks ago), as Biden, in his only debate appearance last Thursday, said Barack and he support "allowing bankruptcy courts to be able to re-adjust not just the interest rate you're paying on your mortgage to be able to stay in your home, but be able to adjust the principal that you owe, the principal that you owe." That's exactly the same plan McCain proposed last night, just with the government doing it directly. Either plan would require the government's involvement at this point in time.

Biden said earlier in the debate: "Two years ago Barack Obama warned about the sub prime mortgage crisis. John McCain said shortly after that in December he was surprised there was a sub prime mortgage problem. John McCain, while Barack Obama was warning about what we had to do, was literally giving an interview to "The Wall Street Journal" saying that I'm always for cutting regulations. We let Wall Street run wild. John McCain and he's a good man, but John McCain thought the answer is that tried and true Republican response, deregulate, deregulate."

As I pointed out over the past six months, McCain has drastically switched his position recently on the mortgage crisis, even though the facts surrounding it and how we got into it have been apparent for well over a year now, if not two years. His most recent take, buying $300 billion worth of troubled mortgages, isn't a terrible idea, but it's an idea that's part of the current bailout package under Sec. 110.

Section 110. Assistance to Homeowners (and Section 109) states that the FHA, as the Federal property manager, "shall implement a plan that seeks to maximize assistance for homeowners and use its authority to encourage the servicers of the underlying mortgages, and considering net present value to the taxpayer, to take advantage of the HOPE for Homeowners Program under section 257 of the National Housing Act or other available programs to minimize foreclosures."

The Hope for Homeowners Program sounds very similar to McCain's plan (that was first mentioned last night), which he dubbed the "Homeownership Resurgence Plan." But also, McCain's plan over simplifies the larger problems that prevent a broad remedy for troubled homeowners. McCain’s plan fails to address the complications of securitization, through which investors buy bundles of loans. The current system is not structured for servicers to distinguish and modify individual mortgages from other securitized loans, an issue overlooked by McCain’s move for the government to buy mortgages directly from servicers. That's why Sec. 110 states that the Treasury Secretary must encourage the sevicers to take a loss on the loan before its modified by a bankruptcy court, the government, or the servicer.

The fundamentals of McCain's plan to attack the mortgage crisis are fundamentally weak and myopic; however, it shouldn't be much of a surprise as he has stated that, "The issue of economics is not something I've understood as well as I should."

Originally posted at InjuryBoard by Paul Kiesel