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 However, no one ever considered what to do if those labels were outdated or if the company was not being completely straightforward about the drug’s actual side effects.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. 

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FDA Requires Labels of Drospirenone Birth Control, Like Yaz, to Include Increased Blood Clot Risk Warning

The requirements levied against Bayer and its popular birth control Yaz became stricter today. The Food & Drug Administration has issued a safety alert regarding birth control that contains drospirenone, like Yaz and Yasmine, saying that they may be associated with a higher risk for blood clots than other progestin-containing pills.

As a result, Bayer must revise all labels of Yaz and Yasmin to include this FDA warning. Specifically, the labels must include that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots while other epidemiological studies found no additional risk. 

While the labels being updated is a move in the right direction, the warning is watered down by the second half which acknowledges the studies conducted by Bayer which found no additional risk. As a member of the Yaz Multidistrct Litigation Steering Committee and an attorney representing hundreds of women injured due to Yaz and Yasmin, I have seen the harm this drug has caused thousands of woman first-hand.

Thousands lawsuits have been filed against Bayer over Yaz/Yasmin. More than 267 deaths have been linked to drospirenone-containing pills and similar birth controls, according to an FDA study. Plus, it can cause numerous other serious medical problems like stroke, heart attack, kidney failure and gall bladder problems.

Perhaps the FDA recognized including both study results sends consumers a mixed message because it has also required that the label include a summary of the FDA-funded study of the blood clot risk. The FDA study confirmed that women who take contraceptives that contain drospirenone are 75 percent more likely to suffer serious side effects from blood clots compared to older birth control methods.

While the FDA did not include the summary wording that would go on the label in its wording, hopefully it will be enough for women to fully understand the risks.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help victims of contraceptives.  Learn more in our Yaz/Yasmin section.

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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/

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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

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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.

Learn more about transvaginal surgical mesh.

 

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FDA to Review Popular Birth Control Pill Yaz

Women who take birth control know doing so comes with a risk of blood clots, especially if they’re a smoker over 35. However, two new studies by the British Medical Journal found that women who take contraceptives like Bayer’s Yaz or Yasmin have a two to threefold higher risk of blood clots.

As a result of the findings, the Food & Drug Administration issued a statement Tuesday saying it’s conducting a new safety review of birth control pills that contain drospirenone, the hormone that’s alleged to increase blood clot risk. The results of their investigation should be released later this summer.

Drospirenone, in addition to Yaz and Yasmin, is also used in Ocella, Beyaz, and Safyral. For a complete list, click here.

Despite the new findings, Bayer continues to insist its oral contraceptives are safe, according to the NYTimes. Yet, nearly 7,000 lawsuits filed against the company tell a different story. Approximately 200 reported deaths have been linked to Yaz/Yasmine and numerous other serious medical problems such as stroke, heart attack, kidney failure and gall bladder problems.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help United States victims of contraceptives.  Learn more in our Yaz/Yasmin section. Comments (0)

Health Risks Underestimated for Popular Smoking-Cessation Drug Chantix

A Pharmaceutical watch dog group has reported that the risks of smoking cessation drug Chantix (Varenicline) have been underestimated in the latest round of the Food & Drug Administration reporting.

The Institute for Safe Medication Practices has recommended that the FDA conduct an investigation after discovering Chantix’s manufacturer, Pfizer, failed to submit 589 reports about serious and fatal adverse events linked to the drug between 2006 and 2010. Exactly 150 of these reports were for completed suicides.

“These additional cases more than doubled the total suicides (linked to Chantix) that were in the AERS system and available to the FDA and others for safety analysis,” according to the nonprofit organization’s report.

Drug manufacturers are required to report “serious adverse drug events” to the FDA AERS monitoring system within 15 days. Other reports take place on a quarterly basis.

Pfizer instead, included the 589 serious and fatal adverse events, with more than 26,000 non-serious adverse events for the 2010 third quarter reporting cycle, according to the Institute.

“To classify a suicide or suicide attempt as an ‘expected adverse event’ rather than submitting it promptly as a 15-day report where it would have been immediately available is troubling in our view,” the report read.

Completed suicides were not the only problems underestimated, according to the Institute’s report. Other problems included attempted suicides, hostility/aggression, depression and possible psychosis.

The Simmons Law Firm is one of the firms spearheading the Chantix national litigation dedicated to representing people who have been harmed by this dangerous drug. For more information visit our Chantix Lawsuit Section. Comments (0)