Here come the lawsuits

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Here come the lawsuits

Postby OddDuck » Tue Mar 08, 2005 5:28 am

Well, we all knew this was coming. The class action lawsuits. And so far these are only pertaining to securities on behalf of investors. What the SEC will do is anybody's guess right now, not to mention what Biogen may be facing from negligence, wrongful death and/or personal injury lawsuits. Just fighting these alone will cost Biogen millions, I'm sure.

This first one was interesting to me, of course, because this one includes the "allegations" that I was asking about back in November. I'll tell you why Biogen may have a real hard time defending themselves against this one in a minute.

Here 'tis:

Shareholder Class Action Filed Against Biogen Idec Inc. By The
Law Firm of Schiffrin & Barroway, LLP

RADNOR, Pa., March 2 /PRNewswire/ -- The following statement was issued today by the law firm of Schiffrin & Barroway, LLP:
Notice is hereby given that a class action lawsuit was filed in the United States District Court for the District of Massachusetts on behalf of all securities purchasers of Biogen Idec Inc., (Nasdaq: BIIB) ("Biogen" or the "Company") between February 18, 2004 and February 25, 2005, inclusive (the "Class Period").

If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Schiffrin & Barroway, LLP (Marc A. Topaz, Esq. or Darren J. Check, Esq.) toll-free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at info@sbclasslaw.com.

The complaint charges Biogen, William Rastetter, and James Mullen with violations of the Securities Exchange Act of 1934. More specifically, the Complaint alleges that the Company failed to disclose and misrepresented the following material adverse facts which were known to defendants or recklessly disregarded by them: (1) that TYSABRI posed serious immune-system side effects; (2) that TYSABRI, like other MS drugs, made patients susceptible to progressive multifocal leukoencephalopathy ("PML") by changing the way certain white blood cells function, thereby allowing PML, a normally dormant virus, to run rampant within the human body; (3) that defendants knew and/or recklessly disregarded documented facts that MS drugs can cause greater incidents of PML to occur; and (4) that defendants concealed these facts in order to fast track TYSABRI for FDA approval so that they could reap the financial benefits from the sales of the drug.

On February 28, 2005, before the market opened, Biogen announced a voluntary suspension in the marketing of TYSABRI(R) (natalizumab), a treatment for multiple sclerosis (MS), because of two serious adverse events that have occurred in patients treated with TYSABRI in combination with AVONEX(R) (Interferon beta-1a) in clinical trials. News of this shocked the market. Shares of Biogen fell $28.63 per share, or 42.44 percent, to close at $38.65 on unusually high trading volume.

Plaintiff seeks to recover damages on behalf of class members and is represented by the law firm of Schiffrin & Barroway, which prosecutes class actions in both state and federal courts throughout the country. Schiffrin & Barroway is a driving force behind corporate governance reform, and has recovered in excess of a billion dollars on behalf of institutional and high net worth individual investors. For more information about Schiffrin & Barroway, or to sign up to participate in this action online, please visit http://www.sbclasslaw.com .

If you are a member of the class described above, you may, not later than May 2, 2005 move the Court to serve as lead plaintiff of the class, if you so choose. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Schiffrin & Barroway, or other counsel of your choice, to serve as your counsel in this action.

CONTACT: Schiffrin & Barroway, LLP
Marc A. Topaz, Esq.
Darren J. Check, Esq.
280 King of Prussia Road
Radnor, PA 19087
1-888-299-7706 (toll-free) or 1-610-667-7706
Or by e-mail at info@sbclasslaw.com

SOURCE Schiffrin & Barroway, LLP
CONTACT: Marc A. Topaz, Esq. or Darren J. Check, Esq., Schiffrin & Barroway, LLP, +1-888- 299-7706, +1-610-667-7706, info@sbclasslaw.com -0- Mar/02/2005 23:30 GMT
Last Updated: March 2, 2005 18:30 EST


The problem for Biogen with this lawsuit, as I have said over and over again, is because of the following. Let me quote something to you that I mentioned to a business acquaintance friend of mine in an email. I said:

.... Remember, I gave you links to what I had posted back BEFORE Tysabri was approved. If you didn't read that information then, you might want to now. I mention and explain all about the "infection running rampant" issue, also, in those posts. I go on and on with biological explanations (and they were "basic", *name removed*. ANYBODY "should have known" what I did - and that's all they need to prove in court - i.e. "should have known" doctrine - which is easy in this case). Plus, you know me, I also posted the actual research findings that Biogen ITSELF had done a year earlier that PROVES they "knew" all of the probable dangers (they had previously found it and published it), but didn't adequately or specifically warn people. Any attorney will/can nail them to the wall with it.

No matter how this is "turned", how can it be explained that somebody like me (with NO formal education) was so "certain" all of this was "trouble", and then claim that none of the so-called "medical experts" did? ....

....What if some attorney calls ME into court? And the more someone tries to ruin my credibility, the worse it will make them look anyway. The fact still remains that I found biological and physical (the legal definition) evidence. It would be different if I had just been "rambling", but I wasn't, which a simple two-second perusal by anyone with medical knowledge would have been all that was necessary to show them that.


And then, of course, there is this type of lawsuit:

Law Offices of Brodsky & Smith, LLC Announces Class Action Lawsu

Law Offices of Brodsky & Smith, LLC Announces Class Action
Lawsuit Against Biogen Idec, Inc. -- BIIB

BALA CYNWYD, Pa., March 3, 2005 (PRIMEZONE) -- Law Offices of Brodsky & Smith, LLC today announced that a securities class action was commenced on behalf of shareholders who purchased, converted, exchanged or otherwise acquired the common stock of Biogen Idec, Inc., (Nasdaq:BIIB) between February 18, 2004 and February 25, 2005, inclusive (the "Class Period").

The case is pending in the United States District Court for the Northern District of Massachusetts against defendants. The action charges that defendants violated federal securities laws by issuing a series of materially false and misleading statements to the market throughout the Class Period, which statements had the effect of artificially inflating the market price of the Company's securities.

No class has yet been certified in the above action. Until a class is certified, you are not represented by counsel unless you retain one. If you are a member of the proposed class, you may move the court no later than May 2, 2005 to serve as a lead plaintiff for the proposed class. In order to serve as a lead plaintiff, you must meet certain legal requirements. To be a member of the proposed class you need not take any action at this time, and you may retain counsel of your choice.

If you acquired shares of Biogen Idec, Inc. during the Class Period indicated and want to discuss your legal rights, you may e-mail or call Evan J. Smith, Esquire or Marc L. Ackerman who will, without obligation or cost to you, attempt to answer your questions via email at clients@brodsky-smith.com or toll free at 877-534-2590, Brodsky & Smith, LLC, Two Bala Plaza, Suite 602 Bala Cynwyd, PA 19004 (fax) 610-667-9029.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca
Provider ID: 00073808

Last Updated: March 3, 2005 20:00 EST



http://quote.bloomberg.com/apps/news?pi ... DHL2_8qQMI

....The case is pending in the United States District Court for the District of Massachusetts against defendants Biogen, William Rastetter and James Mullen. The action charges that defendants violated federal securities laws by issuing a series of materially false and misleading statements to the market throughout the Class Period, which statements had the effect of artificially inflating the market price of the Company's securities. ....


I have to say, I wouldn't want to be a Biogen executive right now for anything! It'll probably take all those millions that they made on the market in order to try to get themselves out of all this, IF they are able to at all.

Deb
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Postby flora68 » Tue Mar 08, 2005 8:30 am

".......(2) that TYSABRI, like other MS drugs, made patients susceptible to progressive multifocal leukoencephalopathy ("PML") by changing the way certain white blood cells function, thereby allowing PML, a normally dormant virus, to run rampant within the human body;......"

Deb, is that part in bold above a misprint? I didn't know that "other MS drugs" had caused PML. (But then the sum total of stuff I didn't or don't know could almost fill the entire internet.. :roll: )
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Postby Houdini » Tue Mar 08, 2005 8:49 am

The securities suits are not suprising and are certainly justified (if you believe Biogen failed to disclose relevant information to investors). The personal injury and/or wrongful death suits are another matter. If it is correct that the only two cases of PML occurred in patients involved in the trial, it's hard to imagine any suits on their behalf. Participants in even the most mundane trials sign wiavers and releases that almost invariably include a statement that participation in the trial could result in death, and for public policy reasons (i.e. trials are necessary to bring vital drugs to market) courts almost always uphold these releases.

Unless someone not enrolled in a trial contracts PML or is otherwise injured by Tysabri (unlikely becuase it was pulled before anyone not in a trial could get more than two infusions) there won't be any personal injury lawsuits that won't be immediately dismissed. The fact that Biogen did not disclose potential risks to patients, by itself, is not actionable without damages; and, unfortunately, the emotional trauma anyone might feel for having been infused without being fully informed does not constitute real damages in this type of case.
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Postby OddDuck » Tue Mar 08, 2005 9:06 am

the most mundane trials sign wiavers and releases that almost invariably include a statement that participation in the trial could result in death, and for public policy reasons (i.e. trials are necessary to bring vital drugs to market) courts almost always uphold these releases.


My "mundane" clinical trial "waiver and release" said no such thing. As a matter of fact, I mentioned to someone how if somebody wanted to, they could rip that particular form apart legally, it was so badly worded (in my opinion).

And if you will note in another thread I just posted under the General Discussions section, you will see where even the AMA advises physicians the following (to protect them from medical mal):

Forms that serve mainly to satisfy all legal requirements (stating for example that "all material risks have been explained to me") may not preclude a patient from asserting that the actual disclosure did not include risks that the patient unfortunately discovered after treatment.


Well, Houdini, we'll see, won't we? And I don't suspect that you're an attorney or have any legal background, because in my 30 years of experience, no attorney would speak and make such black and white statements with such CERTAINTY the way you just have.

Believe me, courts can and will do whatever is within the law, and the law can get pretty complex.

Flora: Hey, good catch! Well, I'm not sure, of course. But I did literally cut and paste that article. I would highly suspect that those allegations were obtained directly from the Complaint that was filed with the Court. Now you've got me curious. I'll go see if that particular suit is online. A lot of times, these Complaints are literally copied online on certain legal websites. Let's see if we can verify it.

If that IS exactly what they are alleging, then in order to do so (and not look like idiots in court, etc.) they MUST have some sort of physical evidence to produce in order to back up that allegation.

Interesting! I didn't notice that one!

Deb
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Postby OddDuck » Tue Mar 08, 2005 9:12 am

Ok........I was correct. You can find the actual Complaint at:

http://www.sbclasslaw.com/pr/biogen.complaint.pdf

I'm reading it now. Well, so far, these attorneys "appear" to have their act together, anyway.

Deb

EDIT: Ok, flora..........nope. Not a misprint. It's in the Complaint allright. We won't know exactly what those attorneys may have for substantive evidence, though, until such time as discovery starts taking place (if the public is told at all). Sometime down the line, by examining court pleadings and documents, we might be able to ascertain some additional information, but for now............yes, that is what is in this particular Complaint against Biogen.
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Postby OddDuck » Tue Mar 08, 2005 9:25 am

....and, unfortunately, the emotional trauma anyone might feel for having been infused without being fully informed does not constitute real damages in this type of case.


Really? Are you SURE about that?

Again, only time will tell.

Deb
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Postby OddDuck » Tue Mar 08, 2005 9:59 am

Flora.........I was thinking about this. My first thought went to what other extreme immunosuppressive drugs are used in MS, and I thought Oh! Novantrone! (And you know the precautions, prior tests, etc. etc. that you are informed of when taking that. Plus, you are only allowed to take it for a certain length of time, etc. etc.)

Ok.........I wonder if that is one of those "other MS drugs" that those attorneys are referring to.

Here's why I am thinking of that possibility. I took this quickly off of the NMSS's website. Again, I highlight.



Brand Name
Chemical Name

Novantrone
(U.S. and Canada)
Mitoxantrone for injection concentrate (mye-toe-ZAN-trone)

Primary Usage in MS Disease-modifying agent

Generic Available No

Description
Novantrone belongs to the general group of medicines called antineoplastics. Prior to its approval for use in MS, it was used only to treat certain forms of cancer. It acts in MS by suppressing the activity of T cells, B cells, and macrophages that are thought to lead the attack on the myelin sheath.

The use of Novantrone for the treatment of MS has been evaluated in a series of European studies over a period of ten years. In a recent randomized, placebo-controlled, multi-center clinical trial involving patients with secondary-progressive or progressive-relapsing disease, participants received 12mg/m2 of Novantrone by short IV infusion once every three months for 24 months. Novantrone was found to delay the time to first treated relapse and time to disability progression. It also reduced the number of treated relapses and number of new lesions detected by magnetic resonance imaging.

Based on findings from these studies, the FDA approved Novantrone in October, 2000 for reducing neurologic disability and/or the frequency of clinical relapses (attacks) in:

1. patients with secondary progressive MS (disease that has changed from relapsing-remitting to progressive at a variable rate)

2. progressive-relapsing MS (disease characterized by gradual increase in disability from onset with clear, acute relapses along the way);

3. worsening relapsing-remitting MS (disease characterized by clinical attacks without complete remission, resulting in a step-wise worsening of disability.

Novantrone has not been approved for the treatment of primary-progressive MS (characterized by progression from disease onset with no acute attacks or remissions).

Proper Usage
Evaluation of cardiac output is necessary before treatment is started. The drug should be used only in those with normal cardiac function, once every three months at a dose of 12mg/m2. Periodic cardiac monitoring is required throughout the treatment period.

The lifetime cumulative dose is limited to 140 mg/m2 (approximately 8-12 doses over two to three years) because of possible cardiac toxicity.

Because Novantrone can increase the risk for infection by decreasing the number of protective white blood cells, blood counts and liver function should be evaluated prior to each dose.

Precautions
It is important that your doctor check your progress at regular intervals to make sure that this medicine is working properly and to check for unwanted effects.

While being treated with this medication, and during the period following treatment, do not have any immunizations (vaccinations ) with live virus vaccines without your doctor's approval. Mitoxantrone may lower your body's resistance to infection, making you susceptible to the infection that the immunization is designed to help you avoid. Neither you nor anyone in your household should take the oral polio vaccine.

If possible, avoid people with infections. Contact your physician if you think you are getting an infection, or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


When receiving Novantrone, it is important for your physician to know if you are taking any of the following:

Amphotericin B by injection
Antithyroid agents
Azathioprine
Chloramphenicol
Colchicine
Flucytosine
Ganciclovir
Plicamycin
Probenecid
Sulfinpyrazone
Zidovudine
or if you have previously been treated with:

radiation
other cancer medications
The presence of other medical problems may affect the use of Novantrone. Let your doctor know if you have any of the following:

chicken pox or recent exposure to it
herpes zoster (shingles)
gout or history of gout or kidney stones
heart disease
liver disease
The fluid for infusion is dark blue and may cause your urine to become blue-green in color for a period of 24 hours after each administration. The whites of the eyes may also appear bluish in color.

Tell your doctor if you are pregnant or intending to have children. This medicine may cause birth defects if either the man or woman is receiving it at the time of conception. A pregnancy test is recommended prior to each treatment for women of child-bearing age. Many medications of this type can cause permanent sterility. Be sure you have discussed this with your physician before taking this medication.

Novantrone is excreted in human milk. Breast-feeding should be discontinued before a woman starts treatment.

A higher incidence of leukemia has been reported in cancer patients, previously treated with chemotherapy, who were then treated with higher doses of Novantrone than is prescribed for treating MS.

Possible Side Effects
Side effects that may go away as your body adjusts to the medication and do not require medical attention unless they continue or are bothersome: nausea, temporary hair loss, and menstrual disorders in females.

Side effects that should be reported to your physician as soon as possible: fever or chills, lower back or side pain; painful or difficult urination; swelling of feet and lower legs; black, tarry stools, cough or shortness of breath; sores in mouth and on lips, stomach pain.


EDIT: Here is the actual prescribing information for Novantrone from Serono (should anyone just be curious). http://www.novantrone.com/pdf/novantron ... g_info.pdf
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Postby OddDuck » Tue Mar 08, 2005 10:04 am

And remember, the fertility, reproduction, and birth defects issue that I mentioned and was asking about back in November has NEVER yet been addressed or answered fully and completely regarding Tysabri.

That one is still on the "back burner", shall we say.

Deb
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Postby OddDuck » Tue Mar 08, 2005 10:14 am

Sorry, I keep talking here..........

Hey, Flora. Ya know, if Novantrone by any chance HAS caused PML in any patients, we (the public) may not have been informed of it, nor would the drug (Novantrone) have needed to be taken off the market, simply because the extreme possibility of infection, and the warnings to patients, and the restrictions that come along with Novantrone are DISCLOSED.

That's the main difference. The disclosure (or lack thereof), and the appropriate warnings and recommended safeguards, etc., that Novantrone DOES have with it, that Tysabri did not. (Even though I wrote to the FDA asking them if they were SURE that Tysabri didn't need it.)

8O :?

And that is what all this surrounds. Whether or not Biogen should have known and whether they should have disclosed the same. Which the courts will need to decide.

Deb

EDIT: Awww....jeez....and if that's all they are basing their argument on (which in and of itself, they must feel is enough), if and/or when they find the published findings by Biogen itself that I found in November, their case will probably only get stronger against Biogen.
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Postby OddDuck » Tue Mar 08, 2005 12:19 pm

Better yet, (and I can't believe I missed this until just now), I wonder if they are going to subpoena Dr. Stephen Miller from Northwestern University!

The two published findings that I found back in November (before Tysabri approval) that I keep referring to all over (regarding VLA-4 antagonists) were done by Biogen in connection with Dr. Stephen Miller from Northwestern University.

In a news article: http://www.latimes.com/business/la-fi-b ... ?coll=la-h Dr. Miller is quoted as saying:

"....Stephen Miller, a microbiologist at Northwestern University who has collaborated with Biogen on studies in the past, said the body's immune cells were a poor target for an MS drug. Tysabri "blocks the ability of [immune cells] to get from the blood vessels to the tissue to fight infection," he said. "In my opinion, that is not the way to go."


What that article above doesn't mention is which particular studies did Dr. Miller participate in? The studies that caused me to question how much Biogen knew beforehand (and refer to above as me finding back in November), were the ones done on VLA-4 antagonists specifically (which Dr. Miller was a part of).

Oh, boy. It appears that Biogen may have more to worry about from Dr. Miller's testimony than anything someone like me could ever come up with. Especially if it is true that Dr. Miller didn't believe this avenue was the way to go, and more importantly WHY he didn't think so.

Wow! You can't get a better expert witness than that! Not in my opinion, anyway.

Deb

EDIT: In case anyone is wondering who Dr. Miller is: http://www.northwestern.edu/nuin/faculty/Miller_S_D/
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Postby Houdini » Tue Mar 08, 2005 12:32 pm

And I don't suspect that you're an attorney or have any legal background, because in my 30 years of experience, no attorney would speak and make such black and white statements with such CERTAINTY the way you just have.


I happen to be an attorney at one of the world's most prestigious law firms and teach law as an adjunct professor. In posting here, I am not giving advice to a client but expressing my own personal view on the matter, and I have no problem stating my personal view with CERTAINTY. I stand by my assessment.
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Postby OddDuck » Tue Mar 08, 2005 12:44 pm

Well, then as we both know, Houdini, everything hinges on ALL of the facts or substantive evidence in any one particular case. We both know you probably shouldn't rely on any assumptions in order to try to predict any legal outcome. Not as a certainty. Even if it is a personal opinion. Nor can a person really state anything in law as a "general rule" (not in my humble opinion). We've probably both "seen it all" as far as the courts and lawsuits are concerned, am I not close??

Take for example, "assuming" that ALL clinical trial consent forms say what you thought they do.

In any event, this isn't a court of law.

I will say, though, that in the past, I have worked for and with attorneys who have made very strong cases based on emotional issues or pain and suffering. Especially if something can be alleged wasn't disclosed up front. And with something like MS, in which it can be fairly reliably presented that ongoing "stress" not only activates the HPA axis, etc. etc., it is highly suggested and suspected that underlying stress or "worry", etc., can lead to regression of MS.

Oh, yeah.............there are lots of legal angles to create fairly meritorious cases, I'd suspect.

Deb

EDIT: Oh, yeah.........not to mention how all of the Tysabri recipients are being advised, so it has been published, to be closely monitored for at least the next year. That's another little tidbit that could possibly be thrown in to support prayers for relief.
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Insider Trading Story

Postby better2gether » Wed Mar 09, 2005 3:31 pm

.
Insider Trading Story

07:37 BIIB Biogen Idec executives sold stock shortly before Tysabri news - WSJ (38.35 )

According to the WSJ, before bad news hit in Feb, executives at Biogen Idec sold stock in their respective co. The way they did it highlights the usefulness, and the potential pitfalls, of "automatic" stock-trading plans. Biogen Idec Chairman William Rastetter sold about $8 mln of co stock shortly before the co's multiple-sclerosis treatment, Tysabri, was taken off the mkt.

Mr. Rastetter received $67.73 a share on Feb. 15. While Mr. Rastetter has largely avoided scrutiny for his stock sales, the co has been fielding queries regarding sales by General Counsel Thomas Bucknum. According to a filing with the SEC, Mr. Bucknum sold 89,700 shares from exercised options the day the co received news of a problem with Tysabri, and received roughly $2 mln in proceeds from the sale.

The bulk of his stock options would have been worthless at the co's current stock price. The co has said Mr. Bucknum didn't know about the problems with Tysabri when he sold the shares.
.
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Re: Insider Trading Story

Postby HarryZ » Wed Mar 09, 2005 6:33 pm

Better.

The bulk of his stock options would have been worthless at the co's current stock price. The co has said Mr. Bucknum didn't know about the problems with Tysabri when he sold the shares.
.


Just heard from a reliable source this afternoon that Mr. Bucknum has resigned from Biogen. Perhaps not too many people believed Thomas!!!

Harry
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Biogen Idec Announces Management Change

Postby better2gether » Thu Mar 10, 2005 1:45 am

Harry,

Your information is correct:


March 09, 2005 04:32 PM US Eastern Timezone

Biogen Idec Announces Management Change

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 9, 2005--Biogen Idec Inc. (NASDAQ: BIIB) announced today that Thomas Bucknum, Executive Vice President and General Counsel, has resigned from the company. The resignation is effective immediately.

http://home.businesswire.com/portal/sit ... ewsLang=en
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