FDA Label Requirements Fail Consumers Harmed by Generic Defective Drugs

Generic Drug Manufacturers Should Have a Duty to Warn Consumers of New Safety Concerns

Generic drugs account for seventy-five percent of filled prescriptions. Buying generic saves money and, often, the drug is just as effective as its name brand counterpart.

However, a 2011 Supreme Court decision Pliva v. Mensing has resulted in a negative consequence for people taking generics. If you or someone you love is injured while taking a generic version of a brand name drug, Pliva v. Mensing could prevent you from holding the manufacturer accountable in the court system.

Before this ruling, the law was unclear about who was responsible for warning consumers about the dangers of defective drugs – the original brand manufacturer or the generic brand manufacturer. Because of this, the Simmons Firm was able to help people who were seriously injured while taking generic drugs. Not anymore. This ruling clarified the issue, but came down on the wrong side for consumers. 

Because FDA regulations require that generic labels must mirror their brand name counterparts, the court ruled generic drug manufacturers can’t be held responsible when someone is seriously injured while taking a generic version of a defective drug.

Ensuring that generic drugs and their name brand counterparts have the same labels is a legitimate concern. However, no one ever considered what to do if those labels were outdated or if the company was not being completely straightforward about the drug’s actual side effects. 

Because of the way the FDA regulations are written, generic drug manufactures are unable to revise their labels until the brand name labels are changed. Most often, name brand drug manufacturers don’t want to change their label since doing so could result in fewer people buying their drug. As a result, there is little motivation for brand manufacturers to voluntarily change a label. While those who take name brand drugs still have legal recourse for an inadequate label, this type of foot dragging by the brand manufacturer regarding label changes leaves those injured while on generics without a similar remedy.

Despite their decision, some of the supreme court justices involved in the Pliva v. Mensing decision acknowledged that the current regulatory state is extremely unfair for users of generic drugs and urged consumers to impress upon Congress the need for a change.  

Thankfully, Congress is taking steps to safeguard consumers taking generic drugs. On April 18, Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety & Generic Labeling Improvement Act of 2012”.  A companion bill, the “Patient Safety and Drug Labeling Act,” was introduced in the U.S. House of Representatives by Reps. Bruce Braley (D-IA) and Chris Van Hollen (D-MD). In addition, Leahy joined Senators Tom Harkin and Al Franken in writing a letter to Dr. Margaret Hamburg of the FDA urging them to amend the label requirements to better protect consumers.

I applaud the Senators for their efforts and hope the FDA will take steps to ensure that all drug makers, including generics, have the ability to take appropriate steps to provide updated warnings to doctors and consumers. Doing this will restore the original intent of the FDA label requirements to keep consumers safe. It will also allow thousands of people harmed by defective drugs, through no fault of their own, to hold those responsible for their injuries accountable. 

U.S. Regulators Want FDA More Involved with Hip Replacements, Transvaginal Mesh and Other Faulty Medical Devices

Bloomberg reports that four Democratic lawmakers, led by Edward Markey of Massachusetts, have issued a bill that would give the FDA the ability to block medical devices based on a past history of safety concerns. This authority would also be valid to block a medical device that is similar to one previously pulled.

According to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, the agency needs this power to block unsafe products from the market and prevent repeats of faulty medical devices, such as hip replacement and transvaginal mesh implants that sparked patient lawsuits.

This is because the current lack of authority creates a “loophole” that has challenged the credibility of some device approvals, said Shuren. This loophole is created when companies voluntarily recall a device before it is ordered off the market. As a result, the devices can continue to serve as a basis for future products. 

While the article noted that Shuren doesn’t endorse the bill, it does say that the FDA would support a legislative fix. 

Shuren added: “It’s good for patients, and it’s good for companies, and it assures that if there’s a problem with the new device, it gets addressed before it goes to market.” 

Meanwhile, a Washington D.C. trade group, Advanced Medical Technology, cites issues with the Democratic proposal saying that manufacturers have to deal with enough FDA regulation. 

In response, Shuren said the bill could actually make things easier by reducing the amount of negotiations when there is cause for concern with a medical device design. 

For the sake of everyone’s safety, let's hope for a positive change.

This article can be read in detail at: http://www.bloomberg.com/news/2012-02-28/fda-device-chief-says-approval-loophole-needs-closing.html

Faulty Hip Implants Can Cause Issues Even After Removal

A February 2, 2012 article entitled, “Faulty hip implants may cause long-term health, joint damage,” by Janice Lloyd, published on yourlife.usatoday.com, reports that patients with all-metal hip implants, such as DePuy, may continue to experience problems for years after removal. Research on this issue was presented at the annual meeting of the American Academy of Orthopedic Surgeons in San Francisco.

In the article, Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City, said that damage to the body occurs when the implant pieces break off due to friction from movement. The metal pieces then can become lodged in nearby soft tissue and/or bone and can eventually make their way to the blood stream. The result is inflammation of the tissue around the joint and heart or a rare but more serious nervous system problem from the toxins in the blood.

Research findings listed in the article mention:

• A study in the Netherlands which found 33% (202 out of 614) had adverse soft tissue reactions. 
• A study in England which found 24% of patients who had revision surgery after their implants had worsening symptoms, while a third of those had additional surgery.  In all cases, problems were due to disease progression around the joint. 
• Another study which found 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved implants, according to orthopedic surgeon, Douglas Padgett, of the Hospital for Special Surgery. 

Learn more about Depuy hip implant failures.http://www.simmonspharmalaw.com/practices-info-depuy-hip-failures.html

Qnexa: Should A Weight Loss Drug with Topamax and Phentermine Get Approval Before Testing? Consumer Reports Weighs In

A ConsumerReports.org article disagrees with experts who recently voted in an overwhelming majority that the Food and Drug Administration should approve the weight loss drug Qnexa and postpone important studies to monitor it for side effects until after its approval.  Instead, the article argues that studies should be done before FDA approval because Qnexa contains Topamax and phentermine, both drugs that have been associated with dangerous side effects.

Topamax (topiramate) carries with it warnings about glaucoma, depression, mood problems, and more importantly, an increased risk of birth defects in pregnant women, which is the current subject of Topamax lawsuits, and Phentermine carries with it a warning about possible heart-valve problems.

As you might guess, it is due to these significant warnings that Marvin Lipman, M.D. chief medical advisor for Consumer Reports, writes this in respones to the 20-to-2 vote, “Post-approval surveillance is not a very safe quid pro quo since this drug will be used by millions—perhaps with dire consequences. The components of Qnexa are known entities with impressive side effects.”

The article goes on to give great advice, recommending that weight-loss drugs and supplements should be avoided because of marginal weight loss benefits combined with side effects that can be troublesome or dangerous.

“If you need to lose weight,” the article concludes, “increasing exercise and limiting portion size when it comes to food are better options."

Read this article in full detail at: http://news.consumerreports.org/health/2012/02/panel-recommends-fda-approve-weight-loss-drug-qnexa.html

All FDA Committee Members Should Get to Speak Out Regarding Yaz

In a previous blog post, we shared a news story regarding the FDA and the recent Yaz, Yasmin vote that has come under scrutiny. Is the FDA in bed with big pharmaceutical companies? Why doesn’t it seem like all FDA committee members get to express their opinions? Does the FDA even care about public safety? Read more and make your own opinion.

Recently, an online news source, a December 20, 2011 article by Martha Rosenberg, printed in Dissident Voice* revealed that the Yaz, Yasmin committee meeting vote was not the first time the FDA has kept Dr. Sidney Wolfe from speaking out against a drug manufacturer.

Rosenberg’s article states that in 2010, at hearings for a different manufacturer’s drug “Wolfe’s microphone was turned off when he asked why the manufacturer’s guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings.”

Why was his microphone turned off? His question wasn’t relevant to the issue at hand, according to Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products.

Interestingly enough, though, published reports said the FDA didn’t know about the legal issue before Wolfe’s disclosure, according to Rosenberg’s article.

The article goes on to point out other failings by the FDA to communicate effectively internally as well as other “conflicts of interest,” like the Psychopharmacologic Drugs Advisory Committee being chaired by a drug company speaker even while they reviewed that very manufacturer’s drugs.

Now THAT is a conflict of interest, and public safety continues to be in jeopardy until the FDA does their job to explore the good as well as the bad instead of just silencing the naysayers and allowing drugs to be pushed to market.

Get more information about Yaz lawsuits nationwide.

* http://dissidentvoice.org/2011/12/fda-critic-stripped-of-voting-rights-at-birth-control-pill-hearings/

FDA’s Recent Yaz, Yasmin Vote Under Scrutiny

A recent MedPage Today article printed in EveryDay Health* reports that four FDA medical advisors voting on the risks versus benefits of birth control medications, like Yaz and Yasmin, had ties to Bayer.

These FDA medical advisors had performed research studies, clinical trials, and/or consulting services either for Bayer, its sister company (Bayer-Berlex) or one of this partnering companies (Barr/Duramed). On top of that, they received either payment or funding in exchange for their work.

All of the panelists then voted in favor of oral contraceptive containing drospirenone, leaving the final outcome of the vote to be 15-11 that the benefits of popular Bayer AG birth-control pills outweigh the blood-clot risk.

While the panelists did disclose their affiliation with Bayer to the FDA and the FDA subsequently determined they did not have conflicts of interest, the disclosures were made in confidential rather than public documents.

Meanwhile, another panelist, Sidney Wolfe, MD, director of health research at the consumer advocacy group Public Citizen, was banned from voting because of his conflict of interest.

Dr. Wolfe is an author of the consumer guide "Worst Pills, Best Pills." This guide warns its readers to avoid drospirenone-containing products because the ingredient increases the risk of blood clots. According to an FDA spokesperson Karen Riley, Dr. Wolf did not disclose this “intellectual conflict of interest” to the FDA, states news sources.

How is it that the panelists’ obvious financial gains were deemed not a conflict of interest? Well, the FDA has an answer: Financial conflicts of interest cannot disqualify unless they are ongoing or have occurred within the past 12 months.

But, like the article points out, the same goes for appearance conflicts, but the Riley explains this away by saying they didn’t identify the panelists as having an appearance conflict.

As if the conflicts of interest dispute isn’t enough, there is even more controversy. The article reports that court documents were unsealed days before the meeting. In these documents, former FDA commissioner David Kessler, MD, accused Bayer of: (1) not disclosing all the data on the blood clot risks associated with Yaz and Yasmin and (2) doing extensive off-label promotions to increase sales.

Yet, this information was not given to the FDA committee. Why? The FDA said it was because the date to submit such documents for review had passed.

Contact the Simmons Law Firm for more Yaz lawsuit information today.

* http://www.everydayhealth.com/sexual-health/0113/fda-yaz-panel-had-ties-to-industry.aspx

More News Sources on This Subject:

Wall Street Journal Online

FDA Requires Manufacturers to Study Surgical Mesh Risks

The Food & Drug Administration has required the makers of transvaginal surgical mesh, used to treat complications of pelvic organ prolapse, to study the risks associated with the medical device, according to the New York Times.

The move comes after the FDA earlier reported the number of adverse events associated with surgical mesh devices has increased fivefold from 2008 to 2010.

Transvaginal surgical mesh, like DePuy ASR and Pinnacle hip replacements, is an implantable medical device. There is no law requiring that these kinds of medical devices be studied and tested before being marketed to physicians and their patients. Instead, the FDA issues an order for manufacturers to study the devices after consumers experience serious complications.

This means that a number of women who underwent transvaginal POP repair with surgical mesh were unaware of the seriousness of the complications of the procedure.

Complications associated with transvaginal mesh include infection, painful sexual intercourse, urinary problems, and overall discomfort and bleeding, all caused by the mesh eroding through tissue or the skim contracting too tightly around the device.

The FDA estimates that about 100,000 women a year with pelvic organ prolapsed are treated with the plastic mesh. The irony is that the medical condition can most often be treated without mesh and thereby avoiding the increased risked associated with the medical device.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, chief scientist of the FDA division that oversees medical devices, in a TVM press release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

The top producers of vaginal mesh, which will be responsible for studying the risks associated with these medical devices, include Boston Scientific, C.R. Bard, Ethicon and W.L. Gore & Associates.