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Cardiac problems after dialysis? Visit new site, Dialysis Lawsuit Attorneys, for info and legal help

This is just a quick post to say that, together with the litigation firms of Yearout & Traylor, P.C. and Gathings Law, I’ve launched a new website for people who experienced cardiac problems after dialysis. We’re looking at the drugs NaturaLyte and GranFlo, as well as problems after kidney dialysis at a Fresenius Medical Care dialysis center.

For more details, see our GranuFlo, NaturaLyte and Fresenius press release, or visit http://www.DialysisLawsuitAttorneys.com.

Actos Recall is Overdue: Reasons It’s Time For An Actos Recall in the U.S

The diabetes drug Actos was recalled in France and Germany in June 2011 because studies showed it increased patients’ risks of developing bladder cancer and congestive heart failure. But instead of requesting an Actos recall n the U.S., the FDA merely issued a warning about the risk of bladder cancer.

In the time since France and Germany recalled Actos, there have been two new studies confirming the bladder cancer risk (June 1, 2012 and July 3, 2012). There has also been a study (June 11, 2012) showing that Actos increases the risk of macular edema, which causes blurred vision.

Actos bladder cancer victims have filed so many lawsuits that the federal lawsuits have been consolidated in Actos Multidistrict litigation. Both California and Illinois have a number of consolidated Actos lawsuits filed in their state courts.

According to an Associated Press article, Takeda Pharmaceutical Co., Ltd. (“Takeda”), the maker of Actos, took in $3.4 billion in sales of Actos in the U.S. in 2011. Pardon me if I wonder if the maker of Acts cares more about profits that it does the health of people with diabetes.

Money in medicine bottles.To try to build public support for an Actos recall, I’ve created a Recall Actos Facebook Page, a Recall Actos Google+ Page, a RecallActos Twitter account, and a RecallActos.com website where people can sign a petition calling for a recall.

I’ve also created a website where Actos patients who developed bladder cancer (and their family members) can get information and obtain a free legal evaluation of their potential Actos lawsuit.

The Actos lawsuit website includes shocking excerpts from an Actos whistleblower lawsuit filed by a former medical researcher for Takeda. The website also offers people with bladder cancer (and their family members) the opportunity to obtain a free Actos lawsuit review by calling 800-671-0996 toll free, 24 hours a day, 7 days a week or using the website’s Free Actos Lawsuit Review Form.

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If you take Actos, you should continue taking it until you can schedule an appointment to discuss the drug’s risks with your doctor. And between now and your appointment, do some research on the risks of the drug. A good place to begin your research is the Actos Lawsuit Background post at Actos-Lawsuit.pro. That post gives a good history of the regulatory background and the studies regarding Actos and bladder cancer.

Actos® is one of the trade names under which the drug pioglitazone is marketed. ACTOS, ACTOplus met, ACTOplus met XR, and Duetact are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals U.S.A., Inc.

Yaz, Yasmin ads must be updated to add risks of thromboembolism

The Food and Drug Administration is requiring Bayer, the maker of Yaz/Yasmin birth control pills, to change its ads and promotional materials to add information about the risk of thromboembolism.  Bayer recently changed the drugs’s warning labels to include information about the risk of thromboembolism in women using Yasmin compared to contraceptives using other progestins. [Read more…]

Finally, an FDA that may care more about consumer protection than politics.

The New York Times reported September 24, 2009 that the Food and Drug Administration (FDA) admitted “that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.” [Blogger’s note: all emphasized text throughout this post is mine.]

This admission by the FDA may shock some, but it will come as no surprise to lawyers for consumers who were killed or injured by dangerous drugs and medical devices approved by the FDA under the previous administration.  To lawyers engaged in the heated drug and medical-device litigation, it became obvious that some business men and women were willing to sit in their offices and boardrooms and take actions that would kill and permanently injure people.  The motive was greed, and the perpetrators were secure in their knowledge that, if the litigation went awry, the damages would be paid from the profits of the shareholders.  There was little or no personal responsibility for the decision-makers.  Sadly, some executives inside Big Pharma are still enjoying high compensation and fancy corporate perks after killing and injuring hundreds.  Contrast that with the day-to-day existence of someone serving prison time for killing or injuring just one person during a robbery, and it becomes clear why some became so outraged at the FDA under the previous administration.

The New York Times article goes on to report:

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money.

The New York Times later wrote an editorial about the corrupting effect of lobbying and political contributions on patient safety, concluding:

This shabby episode carries an important warning for policy makers as they debate health care reform. Decisions on what treatments work best have to be insulated from political lobbying. Otherwise there will be little hope for reining in spending on unproven treatments that may be ineffective or harmful.

Later the business press began to describe the story.  An Oct. 8, 2009 Wall Street Journal article discussed the effect of the FDA’s potentialy more stringent approval process on various medical-device manufacturers.  And, surprise, surprise, a securities analyst voiced the opinion that he is “‘very much concerned’ about tighter regulations that could slow the pace of innovation.” Even the pro-business Journal immediately followed that quote with this observation: “Device companies commonly rely on upgraded products cleared through 510(k) [the “fast-track approval process] that can fetch higher prices from hospitals.”

My thoughts after reading this disgusting saga:

  • Some people in a few big drug and medical-device companies really will kill you for your money, as some consumer attorneys have claimed for years.
  • Patients are safer under the current FDA Commissioner, but the bad guys are still out there, and they won’t quit trying simply because it’s gotten tougher.
  • Just because four congressmen from New Jersey wear the label “Democrat,” don’t expect them to protect consumers when business lobbyists are throwing money at them.  There are a few Republicans (Charles Grassley comes to mind) who seem to care more about patient safety and what’s going on at the FDA than the four guys from Jersey who ReGen’s money and pressured the FDA to approve an unsafe knee patch.  This isn’t a defense of Republicans; it’s more of an indictment of the current political and regulatory system, and my belief that a politician’s personal integrity and stand on the issues is more important than party labels.

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