But now a group of federal lawmakers are stepping up to take on medical device manufacturers and the Food and Drug Administration, the gatekeeper for deciding if such devices go on the market.

A report from Safety Research & Strategies Inc. details how four members of Congress are attempting to tighten the rules that were eased during the Bush Administration to allow medical devices on the market with far less strict review. Some types of devices can now make it to market with no clinical testing or proof of efficacy.

The legislation is being pushed by by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), who all sit on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.. A fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

Meanwhile, Consumers Union has stepped up its efforts to prod Washington to boost oversight. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to the Capitol to meet with lawmakers in a bid for improvements to the Medical Device User Fee Act (MDUFA).  That act has been the subject of intense scrutiny as problems with various medical devices have continued to make headlines.

“Most Americans would be surprised to learn of the lax oversight of medical implants,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press release announcing the effort.  “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Astonishingly, 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale, according to Consumers Union. The group is also pushing for a better system to monitor and track devices on the market so problems can be quickly identified and patients alerted.

Among the most notable problems have been among patients who received metal-on-metal replacement hips or hip resurfacing treatments. The group  US Drug Watchdog this week launched a campaign designed to  identify every US citizen, who is the recipient of any type of metal on metal  hip implant device since 2004.

A fact sheet on problems with medical device problems on Consumer Union’s web site also calls on changes so the FDA can to use its recall authority more effectively and for lawmakers to provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.

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Quaid has produced a documentary film springing from his own experiences with medicine gone wrong: The nearly fatal overdose of medication administered to his newborn twins in 2007.

In a recent interview with the Associated Press following a speech to the National Press Club in Washington, Quaid said, “There were 41 hours where their lives were in the balance.” He said it was the most frightening day of his life and left him and his wife, Kimberly, in “shock, anger and confusion.”

In the documentary, “Chasing Zero: Winning the War on Healthcare Harm,” slated to run April 24 on Discovery Channel, Quaid details the toil of medical mistakes on society. He appeared this past week at the National Press Club in Washington to talk about the nation’s medical malpractice epidemic, and in a TV interview talked about how the 98,000 preventable deaths due to medical error each year in America make such mistakes the third leading killer in the nation.

Quaid, 56, is no stranger to taking a stand. CBC 60 Minutes has done a piece on the twins’ medical travails. In 2008, just months after his twins — Thomas and Zoe — recovered from an overdose of the blood thinner heparin, Quaid spoke to Congress about his concerns with mounting medical malpractice and with the limits on legal challenges established in California and other states. In written testimony Quaid said:

I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people.  For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.

Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.

We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.

It is hard for me to imagine that this is what Congress intended. You tell me, Mr. Chairman: When it passed the Food, Drug, and Cosmetic Act in 1938, did Congress intend to give appointed bureaucrats at the FDA the right to protect a drug company from liability, even when the company cuts corners and jeopardizes our safety? A federal ban on lawsuits against drug companies would not just deny victims compensation for the harm they experience. It would also relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered – years after their drugs are on the market.

Permitting bureaucrats who are under pressure from their bosses and the drug companies themselves to yank our access to the courts is incomprehensible. We have all heard about understaffing and backlogs at the FDA, and about drug-safety scrutiny that is patchy at best. If the Supreme Court rules in favor of the drug companies, it will eliminate one of the most effective deterrents to letting the bottom line win out over public health and safety.

We can hope that the Supreme Court will not put more barriers in front of patients who are harmed by drug companies. But if the Court goes along with the FDA and rules for the drug companies, I respectfully ask this Congress to pass corrective legislation on an emergency basis, just as it should do immediately to correct the recent Supreme Court decision immunizing the makers of defective and mislabled medical devices. We Americans need some balance on the scales of justice in our country.

–Eric Bailey

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It turns out there is.  RAND’s report “investigates the relationship between safety outcomes in hospitals and malpractice claiming against providers, using data for California hospitals and insurers from 2001 through 2005,” in the words of the researchers.  They analyzed more than 365,000 “in-hospital events and complications with potential to harm patients” over the five-year period from such things as post-surgical problems to infections originating in a hospital.  The researchers also examined a database of about 27,000 claims from four of the largest medical malpractice insurers in the state.

The upshot: A correlation between better health care and fewer malpractice lawsuits. The authos say that a county with a decrease of 10 adverse events would see 3.7 fewer malpractice claims. Similary, an increase of 10 events would suggest 3.7 more malpractice claims. 

Rand researchers say their study is the first to suggest that efforts to improve patient safety could contribute to fewer medical malpractice claims.

The report concludes by yanking the bandage off wounds left by the state’s long-running tort wars: 

“Arguments about the merits of statutory tort intervention will surely continue in the future,
but to the extent that improved safety performance can be shown to have a demonstrable
impact on malpractice claims, that offers another focal point for policymakers in seeking to
address the malpractice crisis. Based on the results of the current study, we would suggest that that focal point may be more immediately relevant than has previously been recognized.”

That’s a nice, academic way of saying something simple: Fewer medical errors, fewer lawsuits.

–J.G. Preston

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Unfortunately, the pills may be dangerous.  They contain a new synthetic hormone, drospirenone, which has never before been used in a birth control pill.  Some women who take Yaz or Yasmin have suffered harmful side effects.  One of the most common is blood clots. That, in turn, may lead to strokes, pulmonary emboli and heart attacks.  Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.

Of course, all birth control drugs carry risks.  But the problem with Yaz and Yasmin is that, because they contain drospirenone, the risks appear to be greater than those of other birth control pills.  Although the drugs carry additional risk, they are no more effective than traditional birth control pills.  That’s according to two recent studies involving Dutch and Danish women published in the British Medical Journal.   For that reason, the consumer advocacy group Public Citizen warns women against using either Yaz or Yasmin, and instead suggests more traditional pills from other manufacturers that do not contain drospirenone.

And what about Bayer’s aggressive advertising?  The U.S. Food and Drug Administration has repeatedly ruled that Bayer’s television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits.  As the FDA explained in its 2008 Warning Letter:

These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over promise the benefits and minimize the risks associated with YAZ.

The FDA has required Bayer to change its commercials.  It even required Bayer to run a ”corrective” ad campaign.  However, according to some, the “corrective” commercials, like this one, are too confusing and jargon-filled to be effective.

Lawyers Mike Danko of the Danko Law Firm and A.J De Bartolemeo of Girard Gibbs represent more than 50 women who have been seriously injured by Yaz and Yasmin.  They also represent the families of some of those killed.  “The damage these pills have wrought has been devastating,” says Danko.  ”Bayer just isn’t telling women what they need to know. No woman would take Yaz if she knew that it was no more effective than other birth control pills but was more risky.”

One of Danko’s clients is Susan Galinas of Newark, California.  She took the drug because it was being promoted as a way to ease pre-menstrual symptoms.  It left her with brain damage after a debilitating stroke.  Her injuries have changed her life and that of her family forever.

Galinas has sued Bayer in federal court.  Her suit, along with more than one hundred others, are now part of a multidistrict legislation proceeding pending before the Southern District of Illinois.  Bayer has agreed to turn over more than 30 million pages of documents in that suit.  Danko and De Bartolomeo will soon begin combing through the documents to determine what Bayer knew of the risks, and why it failed to disclose them.

Danko hopes that the lawsuit will result in the Yaz and Yasmin being pulled from the market.  But for now, Bayer continues to promote the drugs to women worldwide.  Why?  According to Danko, there is just too much money to be made.

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