New story on Swiss TV discloses dangers of Yaz and Yazmin

The courageous Swiss TV investigators have turned the public lights on the hazards of Bayer's Yaz and Yasmin.  In a documentary released earlier this month, Uebersetzung Beitrag Pille describes in great detail the number of deaths attributed to these drugs.  Although the story is in German, my friends in Switzerland have given me the following translation of the story:

Uebersetzung Beitrag Pille auf Englisch

Presenter:

There was love, there was desire – and the fear of getting pregnant. Then, 50 years ago, the first birth control pills hit the market and became a milestone on the way towards female sexual self-determination. But as other drugs, hormonal contraceptives do have side-effects: swollen legs, headaches, pulmonary embolisms. These rare subsequent damages are only documented in international databases of  regulatory authorities – and hard to access. Now, our reporter Mario Poletti achieved to have an in-depth look into these records – and he stumbled across hundreds of dead women. 

Story:

0.01
She was sweet 17, in rude health – and ended up with an embolism in Basel’s university hospital. A blood clot in her lung. The young woman died last November.

Chief physician Stephan Krähenbühl confirms the diagnosis: side-effect of a birth control pill.

0.18
Quote Stephan Krähenbühl:
"This is a known complication of birth control pills. Even though it is rare, I have to confirm: We had cases like this, yes.”

0.28
The young woman is Switzerland’s 11st officially documented deadly victim of birth control pills since the 1990s. But which contraceptive did she take? Hospital and authorities remain silent. 

The 17-year-old originated from a nearby German boarder district 

0.41
Now, Germany’s Federal Institute for Drugs and Medical Devices names the pill she used: Yasmin, a top-selling product worldwide. According to studies, it doesn’t carry a higher risk than other comparable products. 

0.52
Deadly side-effects – a taboo. Two months before the 17-year-old German woman died,

0.59
the same happened to this 22-year-old in the canton of Nidwalden. „She left us completely unexpectedly after a short disease.“ [the obituary states]

Dead after the intake of contraceptive pills - only a few cases can be found in international press archives and in specialist literature.

1.13
Pharmaceutical companies and European authorities have so far remained silent about worldwide death numbers.

1.19
This CD-ROM we receive from the FDA - after month-long insisting. A huge amount of data reporting worldwide side-effects of the most used hormonal contraceptives of the last 10 years – reported by medical doctors, hospitals, pharmaceutical manufacturers and private individuals.

Every report – also called spontaneous adverse event report – documents a side effect.

1.47
Harmless headache 

1.48
Swollen lips

1.50
dizziness

1.51
vomiting

1.53
insomnia

1.54
But we also come across hundreds of life-threatening pulmonary embolisms and, over and over again, the very one report: death.

These reports are not proven doctor’s reports, but signals of suspicion.

2.06
Death after embolism – age 16

2.10
Death after cerebro-vascular accident - age 20

2.13
Death after pulmonary embolism – age 46

2.17
Death after thrombosis – age 14

2.20
We present the reports – a total quantity of more than 10.000 and among them hundreds of death cases – to chief physician Stephan Krähenbühl.  As president of Swissmedic’s national drug admission commission, he is Switzerland’s highest ranking watchdog over side-effects of drugs.

2.33
Quote Krähenbühl:
“It is emotionally touching and very tragic that there are these death cases. But one knows: Every contraceptive pill can cause complications, i.e. deep venous thrombosis. And there are pulmonary embolisms as well – and if they [the blood clots] are big enough, they can always cause death.“

2.56
The top-selling products are, according to market researchers of IMS Health:

3.01
The contraceptive pills from Bayer: Yasmin, Yaz and Yasminelle

3.07
The contraceptive transdermal patch Evra from Janssen Cilag, which dispenses the hormons directly through the skin.

3.13
And the Nuvaring from Essex Chemistry, which dispenses the hormones within the vagina.


3.19
We comb through the reports of market leader’s products. The wider spread a contraceptive is, the more reports it creates. After extinguishing double reports, the following numbers remain:

3.28
Yasmin: about 140 dead ones

on the market only since 2006: Yas with about 50 dead ones

Nuvaring: around 40 dead ones
 
Evra: around 130 dead ones

3.44
Included in these numbers are miscarriages of women who started to take hormonal contraceptives when they were already pregnant. What is Krähenbühl’s comment on these numbers?

3.52
Question of reporter

3.54
Quote Krähenbühl:
„It is surprising, but on the other hand, the taking is so wide-spread that one has to expect it.“

4.00
Overall, about 140 million women worldwide take hormonal contraceptives. All modern methods of hormonal contraception, Krähenbühl says, carry a comparable risk.

4.09
The FDA doesn’t grant us an interview related to the data it has provided to us itself. They just let us know: A large-scale study about the death cases is under way. Waiting for this study are also several law firms.

4.24
Quote lawyer:
„I am a lawyer for victims which have been hurt by or lost their lives.“

4.29
US law chambers do search for victims of hormonal contraceptives by TV commercials.

4.37
Bayer claims to be confronted with 1750 complaints in the US and 8 class actions in Canada.

4.47
Essex Chemie doesn’t comment on the complaints concerning the Nuvaring.

4.52
Jannssen Cilag doesn’t comment on complaints concerning Evra patch. Just this: that there weren’t any in Switzerland so far.

5.00
We also present the records of more than 10.000 reports including a couple of hundred deaths to Daniel Brügger, a committed gynecolist. For a long time, Brügger has warned about the new birth control pills, vagina rings and contraception patches – but he hasn’t expected such an amount of reported side-effects.

5.15
Qute Brügger :
„I’m shocked about the hight of this stack. And I’m even more shocked, figuring that each page documents at least one human destiny. The death rates should have been communicated better. Me as a gynecolist working at the front, I would be dependent on obtaining such figures.“

5.41
This critic refers to Swissmedic, Switzerland’s National board of drug admission control. We march up with the US figures – and they immediately turn to a matter for the boss. And for the first time, a regulatory authority comment on the FDA figures.

5.56
Question of reporter

6.03
Quote Mathys:
„If you take a look on the international securitiy data – the FDA figures don’t only contain US incidents – then they do meet this scale.“

Question of reporter:
Why don’t you inform the public?

Quote Mathys:
„If we published the adverse events of all pharmaceutical drugs – and there are many – we would cause uncertainty among the public – using numbers which are not reliable.”

6.33
Indeed, in the extreme case, a lot of drugs do have deadly side-effects.

The pharmaceutical manufacturers either aren’t willing to grant us an on-camera interview regarding the FDA-numbers:

Bayer , Jannsen Cilag and  Essex Chemistry just deliver general  congruent statements:

Adverse events, they point out, were

-    Not always complete, because information about simultaneously taken drugs are often missing. The reports
-    Don’t prove the cause of an incident, pre-existing conditions and predispositions might  as well be complicit. Adverse event reports would carry
-    No validity about the risk of a drug.

7.09
Adverse events reports of all drugs would show only a suspicion, authorities say, the frequency of a risk could only be evaluated with studies.

7.20
Quote Mathys, Swissmedic:
“It is for sure frightening that there are such kinds of side-effects, but one has to know that hormonal contraceptives are drugs, and drugs carry risks – one should therefore only intake them after clarifications with a physician. And, one has to be aware of the risks.”

7.37
Of 1000 women taking hormonal contraceptives over the period of a year, about one of them will suffer from a dangerous venous thromboembolism.

7.47
A year ago, the fate of 16-year-old Celine rocked Switzerland. After taking contraceptive pills for four weeks, she suffered from a grave pulmonary embolism. She barely survived and has been heavily handicapped ever since.

8.00
After investigations of Switzerland’s National board of drug admission control Swissmedic, Bayer had to aggravate the package insert of Yasmin, Yaz and Yasminelle. Now, it mentions that the pills can cause grave and lasting health damages or be deadly.

8.15
Bayer however states: „The benefit/risk profile of Bayer’s combined hormonal contraceptives has been confirmed as positive by experts, authorities as well as in extensive scientific studies.”

8.30
Janssen Cilag and Essex Chemistry state the same about their respective products.

8.37
Gynecolist Brügger is unsettled. How to interpret the death numbers? He impatiently awaits the US study from the FDA. 

8.47
So does the highest ranking Swiss drug safety official.
The President of Swissmedic’s national drug admission commission, Prof. Stephan Krähenbühl of Basel University, comments

8.52
Quote Krähenbühl:
“If I was the head of a body receiving such a big amount of death case reports, I as well would want to further investigate this.” 

9.01
The risk may be marginal. Nevertheless, Krähenbühl recommends women to go see a doctor if they have symptoms such as swollen legs, shortness of breath and increased pulse. Rather a day too early that a day too late.

Length of pictures: 9.20

Congratulations and thanks go to
Mario Poletti
Schweizer Fernsehen
Fernsehstrasse 1-4 8052 Zürich
www.sf.tv
For strength, courage and honor in standing up for the rights of women in the face of the powerful Bayer Corporation.

If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney.  You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com. 

Teva admits making false claims about Gianvi, the latest generic version of Yaz

Teva went public with a generic version of Yaz.  The combination oral contraceptive (COC), Gianvi, is made by Teva Pharmaceutical Industries.  On Thursday Teva admitted before a federal court to making false statements about the generic oral contraceptive (drospirenone and ethinyl estradiol).  The admission came in a lawsuit filed in federal court by Bayer HealthCare Pharmaceutical, the US distributor of Yaz.

Bayer had sued Teva in the U.S. District Court for the Northern District of Illinois for false advertising and patent infringement, accusing the world’s largest generic drug maker of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.

Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the United States for three months that contain corrected prescribing information and had already provided the corrected information to the Food and Drug Administration. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.

Teva received FDA approval for its version of the drug on June 1. Yaz had $782 million in sales in 2009, according to IMS Health.

Teva jumped into the generic Yaz market this month, no doubt in a big hurry to rake in some profits off Yaz before it loses the ability to do so because of the rash of injuries and deaths being attributed to the drug.

Personally I find it highly ironic that Bayer would criticize Teva for making false claims about Yaz.  Bayer's reckless failure to disclose the harm its Yaz and Yasmin cause to women is the real crime.

If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney.  You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com.

Judge Herndon Orders Bayer to produce records from Sales people in Yaz litigation

On June 10, U.S. District Judge David Herndon ordered production of files from any sales representative who had contact with plaintiffs' doctors.  This is very critical because Bayer spent millions of dollars marketing this dangerous drug directly to the prescribing physicians. 

The order covers "all written materials, video and or audio tapes in the possession of the sales representative."

Judge Herndon ordered Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Barr Laboratories and Teva Pharmaceuticals to produce records from their facilities, third party storage vendors, or homes and automobiles of sales representatives.  Sales representatives who handled hormone replacements Yasmin, Yaz, Ocella, and Gianvi must produce their complete files.

The U.S. Judicial Panel on Multi District Litigation appointed Judge Herndon last year to preside over suits from federal courts around the nation claiming the drugs harmed women.  Judge Herndon has ordered that Bayer provide important information. 

We have begun submitting individual fact sheets, and defendants must respond with fact sheets of their own in 45 days.  Defendants must produce files of sales representatives no later than 60 days before plaintiffs start taking depositions.

Bayer must also produce:

• Training materials related to "physician detailing and obstacle handling," including workbooks and forms representatives completed.
• E-mails, bulletins, memoranda, activity reports, call notes, belief notes, tactical plans, voice mail transcripts, and summaries of meetings.
• Materials from national, regional or district sales meetings.
• Physician prescribing data and ratings.
• Incentive plans and goal attainment reports.
• Promotional and cross promotional marketing materials.
• All documents representatives signed reflecting business and ethics practices and policies.
• Documents representatives provided to doctors.
• Budgets and materials for speaker's programs.
• Materials relating to tests representatives took.
• All communications between representatives and managers.

So far over 20 million pages of documents have been produced, making this one of the largest document productions in the history of pharmaceutical litigation.

Yesterday I was in Philadelphia attending the Pennsylvania State Court Yaz status conference.  A number of agreed orders were also entered at the state court level.  The litigation continues to progress very well.  We have a great team of lawyers working for injured women and their families around the country.

It is essential that all clients promptly complete their Plaintiff Fact Sheets and return to us in a timely manner so we can keep the pressure on Bayer and obtain the critical sales records from the detailers who pushed the pills on the doctors.

  Story in Madison / St. Clair Record.

Thanks!

Litigation Update - Yaz, Yasmin and Ocella Injury and Death Cases: FAQ

I want to update everyone on the status of the Yaz / Yasmin / Ocella litigation.  I will try to answer the most Frequently Asked Questions we get from potential clients.

These cases are for women who have been injured or killed after taking Yaz, Yasmin or Ocella.  There are 3 basic types of injuries:

1. Venous Thrombotic Events (VTEs) which include stroke, pulmonary embolism (PE) or deep vein thrombosis (DVT)
2. Gallbladder or pancreatic injuries, usually involving the removal of the organ, and
3. Heart problems caused by hyperkalemia.

The cases are being filed in four different jurisdictions.  Each jurisdiction has particular advantages.

1. Philadelphia State Court, Philadelphia County, PA.  These cases are consolidated under Judge Sandra Moss and are the furthest along.
2. Federal court in East St. Louis, Illinois.  This is the "MDL" where most cases are filed.  The litigation is progressing very well and is almost as advanced as the PA cases.  Jurisdiction is based on diversity of citizenship.
3. New Jersey State Court.  These cases are just getting organized.  The first status conference has been held and Pretrial Orders are being entered.
4. California State Court.  These cases are also in the process of getting underway.

Generally we are filing most of our cases in the MDL, but we also have a good number of cases in New Jersey and Pennsylvania.   The choice of where to file a particular case is a complex one.  Each attorney will use his or her best judgment on where to file the case, based on a host of factors including the state of citizenship of the Plaintiff, the statute of limitations, choice of law issues, the particulars of the individual case and other matters.

Discovery is well underway in the MDL and PA.  The first deposition has been taken and over 4 million pages of documents have been produced.  The documents are housed in an electronic depository accessible only by attorneys on the discovery team.  These attorneys (including lawyers from our law firm) review documents produced by Bayer to establish liability on the part of Bayer.  Most all of these documents are marked confidential and cannot be discussed or shared publicly.  All reviewing attorneys are bound by confidentiality, although eventually many of these critical documents will be made public in a courtroom at trial.

Many women ask about settlement.  Some advertisements seem to imply that there has already been a settlement.  The truth is that there has NOT been any settlement yet.  There is still lots of hard work we must complete before Bayer will pay up.  I am confident that eventually, however, these cases will be settled; however in my 33 years of experience representing injured clients the ONLY way to handle these cases is to work very very hard and get them ready for trial.  You cannot sit back and hope.  You must work hard.  And that is what we are doing.

Another question we get is what about class actions?  Can I just sit back and wait for money under a class action?  The truth is that in the Yaz, Yasmin and Ocella cases there will NOT be a class action settlement.  Under the law, class actions are NOT appropriate in cases where there are individual injuries UNLESS there is a limited fund.  This is a common misunderstanding that many lawyers don't even understand.  For example, in Vioxx, the settlement was NOT a class action.  Each injured person needed to file a claim to be eligible for the settlement.  So it is important that each woman or her surviving family hire a qualified attorney.

Finally, we are asked what the chances are of success? The likelihood of success in these cases is excellent.   Based on our careful review of the science and medicine, including the pharmacology and epidemiology underlying these cases, we are very confident that these cases are strong cases and do have significant merit.  For that reason we strongly urge any woman or her surviving family to immediately seek qualified legal advice.  There is a lot of work to be done in each case, including ordering medical records, expert review, and filing of claims.  Some states only have a one year statute of limitations, while there may be savings clauses or other methods to save a statute of limitations in a particular case.

Please feel free to browse this blog for more information, or call us toll free at 1-888-841-9623 during regular business hours (8:30 a.m. - 5:00 pm Eastern Time) or email us anytime at pamela@toledolaw.com michelle@toledolaw.com or malina@toledolaw.com.  Our attorney / doctor, Donato Borrillo, will review your case along with the rest of our team.  You can also learn more by watching our You-Tube video recorded by Dr. Borrillo and ZKB partner Pamela Borgess.