• Arena’s  locaserin  is a new chemical entity that affects serotonin levels in the brain.
• Vivus, Inc.’s  Qnexa is a combination of two drugs already approved and sold separately: Phentermine, which was the Phen in Fen-Phen, and Topimarate, an anti-seizure drug.
• Orexigen Therapeutics’ Contrave is yet another combination of two well-established drugs, bupropion and naltrexone, in a sustained release formulation. Bupropion is a prescribed antidepressant and smoking cessation medication; naltrexone is a treatment for alcohol and opioid addiction.

Earlier this year, Vivus’ Qnexa won approval from the FDA panel after previously being rejected due to safety concerns over birth defects and cardiac side effects.   The FDA has not given Qnexa final approval yet— recently pushing back its target date on a final decision from April 17 to July 17.  The agency said it needed more time to consider a new drug safety plan submitted by Vivus.

When the FDA turned down locaserin in 2010, scientists cited concerns about health issues, such as tumors that developed in laboratory test animals.  Since then, the San Diego company has submitted additional data in the hopes of convincing the agency to approve the drug.   And it appears to have worked. After reviewing the new analysis, the FDA now states that there is only a “negligible risk” of tumors in people taking the drug.  However, questions remain about it possibly increasing the risk of high blood pressure in diabetics or damaging heart valves, Fen-Phen’s claim to notoriety.

If the FDA agrees with the panel’s recommendation, lorcaserin could be the first obesity pill of the trio to hit the market.  Arena said the FDA has set a target date of June 27 for deciding whether to approve sales of the drug.  The FDA is not required to follow the advice of the panel, but it usually does.

All of this is big business. On news of the panel’s approval, Arena’s stock rose 74 percent to $6.36, the biggest increase since the company’s shares began trading publicly in July 2000. A similarly impressive gain can be expected the day the drug gets approved, if it does.

I have previously discussed my concerns about these new diet drug cocktails (For more info read: Fen-phen all over again? and Qnexa likely to get FDA approval, but what’s the hurry?), but it is clear from the reports that many people are going to rush to their doctors for Qnexa or locaserin prescriptions as soon as the FDA gives the green light. The more I learn about it, the more concerned I become. I feel compelled to review a little diet drug history with the hope that some of you will use caution before turning to these new drugs for a quick (but temporary) fix to what is likely a lifelong battle of the bulge.

People who forgot – or never knew about – this country’s past diet pill experiences are all too willing to experiment with these new diet drugs. Rather than being cautious, they seem too eager to instead trust an industry which has failed consumers time and time again.  My past and present experience with diet pills for nearly fifteen years now has me convinced: It would be a big mistake to try any new diet drug until it has been on the market for 5 to 7 years and been safely used by millions of people before you.

PAST DIET DRUG EXPERIENCE.  

It is an understatement to say that our country has a bad record when it comes to prescription diet drugs.  The Fen-Phen scandal in the 1990’s is still the granddaddy of them all, involving the most popular, most widely used, and most dangerous diet formulation ever invented.  But earlier news of other problems with diet pills date back to the 1960’s. Side effects (mainly heart and lung problems) associated with Fen-Phen continue to highlight its very serious long term problems.

Diet meds since Fen-Phen have not fared well either with Meridia being removed from the market 13 years after obtaining FDA approval. Currently, the only drug approved for long-term weight loss in the U.S. is orlistat, sold as the prescription drug Xencial and over the counter as Alli.  The drug works by blocking the absorption of fat but has not enjoyed widespread use because of embarrassing and messy, but not necessarily serious, side effects.

PRESENT DIET DRUG EXPERIENCE.

Fen-Phen was removed from the U.S. market in 1997 but only after six million people had consumed the popular drug cocktail. My law firm has represented Fen-Phen victims continuously ever since.  I have seen or read about every side effect associated with Fen-Phen and have litigated every type of Fen-Phen case possible on behalf of injured diet drug users.  But the most amazing thing I have seen in all those years is that new cases continue to develop to this very day. This long-extinct drug cocktail continues to make headlines, and lawyers (some of whom weren’t even licensed to practice law when it started in 1997) still advertise for new Fen-Phen cases. Lawyers and headlines are like smoke and fire…where there is smoke, there is fire.

Fen-Phen users from the 1990’s should be the first to warn today’s overweight would be pill poppers.  But for many, their desperation to lose the weight will cause them to conveniently forget the past.  Instead, they will put their lives and hearts and futures on the line for an industry with a grim history with weight loss.

PLANNING FOR THE FUTURE.

Many people, including past and former clients, will ignore this advice and start experimenting with whatever new diet drug makes it through the FDA regulatory process.  Hopefully, you will be careful before starting this new drug regimen if you decide to give it a try. The advice given here is neither medical advice nor legal, but it makes sense.

Fortune tellers make predictions based on lines in one’s hand or the furrow of their brow, but I make predictions based on experience. In all likelihood, there will be litigation surrounding any new anti-obesity drug less than five years after it is introduced, irrespective of the warnings ultimately included with it.  The litigation will probably involve heart problems and test results from premarket clinical studies, some of which are going on right now in this country or elsewhere.  Those of you who insist on being among the first in this nationwide, live, human experiment should at least talk with your doctors about it beforehand. Get the best cardiac workup your budget will permit before starting any new antiobesity drug.  Then save your test reports, and save your pharmacy receipts and pill bottles and everything related.  Unfortunately, history shows you might need them as evidence in a class action someday.

Petroff & Associates

So what changed?  

Qnexa is the name for a combination of two drugs already on the market: phentermine and topiramate. Vivus, Inc., of Mountain View, California, has sought FDA approval and will manufacture and market the drug combination if approved. As the politicians like to say, the FDA was against Qnexa before it was for it. In October of 2010 the FDA denied approval of the drug in a 10-6 vote.  Vivus was better able to woo the FDA Advisory Committee this time around, but what really changed in that short time period? What caused the Advisory Committee’s about face?

A new study came out during that period that would seem to make the decision makers less likely to vote for approval. It showed that topiramate doubles the risk of cleft lip and palate in newborns of mothers who were taking the drug during pregnancy. But the new FDA panel seemed to ignore the results of this study, accepting Vivus’ reassurances that it will restrict the drug for pregnant women and perform studies after approval to assess heart safety.  Doesn’t that seem a little backwards?  This type of “Phase IV” post-market study is the same thing the makers of Redux (the new and improved Fen-Phen) promised to do if Redux was approved in 1996, but the studies were never completed because the drug was removed from the market a little over a year after it was approved.

As predicted, Vivus argued to the Panel that obesity is causing massive medical problems, increasing the need for effective medical treatments.  Clearly, obesity leads to numerous health problems; it has been shown to increase the risk of heart disease, type 2 diabetes, cancer, high blood pressure, stroke, arthritis, and many other serious health problems.  And yes, this comes with a considerable price tag: the Center for Disease Control (CDC) estimates that obesity costs the United States $147 billion per year in direct medical costs—that is just over 9 percent of all medical spending.  And this number is on the rise.

But a similar argument was made during the push to get FDA approval for Redux in 1996.  The disastrous result was that millions of people’s health was put at risk and virtually no one enjoyed any long term benefits from the medicine alone.

What’s the hurry?

In an earlier post, Fen-phen all over again?, I expressed my concerns over the rush to get Qnexa approved.  There are safety concerns that still need to be addressed and resolved.  So again, I ask, what’s the hurry?

An effective weight loss drug has the potential for enormous financial reward. Given past sales figures for diet drugs, Vivus has the potential to make shareholders very happy.  Vivus’s stock jumped 98 percent in its first day of trading after the FDA panel’s 20 to 2 vote. And one analyst even predicted the drug could be the “next Lipitor,” resulting in hundreds of millions of prescriptions annually[Bloomberg.com article “Vivus Obesity Pill Wins FDA Panel Nod; NeuroSearch Surges,” Feb. 24, 2012].  But financial reward should not cause us to overlook potential health risks.

I have read some comments from doctors that are also concerned about Qnexa’s approval without further studies.  They acknowledge that obesity is a problem that needs a solution, and Qnexa might one day be that drug.  But because its two components (phentermine and topiramate) have not been used in combination before, some experts believe more studies are needed to fully assess any combined side-effects.

In addition to being associated with birth defects, Qnexa’s dangerous cardiac side effects include increased heart rate, heart attacks and arrhythmias.  Critics argue that these risks are too great to make the drug available to millions of people, especially because long term effects of the drug are still largely unknown.

It seems clear that the only safe response is that more studies are needed before approval.  Putting the drug on the market without adequate pre-market testing is what happened with Fen-Phen and Redux.  The American consumers then became the laboratory for one of the country’s largest drug makers, allowing the drug company to begin making profits while we let the consumers serve as guinea
pigs.

The FDA Advisory Panel has apparently endorsed this exact cart-before-the-horse approach. FDA Panel Member Kenneth Burman of the Washington Hospital Center in Washington, DC, summed up this “let-them-profit-before-proving-safety” mentality when he stated, “The potential benefits of this medication seem to trump the side effects . . . But, in truth, only time will tell.” [CBSnews.com article “Qnexa and the FDA: Why safe drugs are hard to come by”, Feb. 24, 2012].  In other words, let’s put the drug on the market before its safety is conclusively proven and allow millions to try it out, and then let’s see what we have.  A parent who followed this approach when giving their child medicine would probably be held criminally negligent and be universally condemned if harm resulted to their child.  Unfortunately, that’s business as usual in our system of medicine delivery in America.

Petroff & Associates

I have previously posted on positions that the Trust and Class Counsel have taken that resulted in the erosion of claimants’ rights to benefits: The Fen-Phen Settlement Trust and its rules are there to protect YOU, right? Maybe not and The Trust’s new interpretation of the Fen-Phen Settlement Agreement does not bode well for Claimants. Fortunately, these previous blogs discussed unusual situations that hopefully will not apply to large numbers of claimants. But the Trust and Class Counsel’s new approach to the “alternative causation factors” question will affect many, if not most, of the surgery claimants who are currently seeking benefits for High Matrix Level Claims. This new approach also will reduce benefits to non-surgical High Matrix Level Claims, but the main impact can be easily understood by looking at the people who have had heart valve repair or replacement surgery after the end of the Screening Period (i.e., after 1/3/03).

The following is the section of the Fen-Phen Class Action Settlement Agreement that is receiving all the attention:

Diet Drug Recipients who ingested Pondimin^® and/or Redux^™ for sixty-one (61) or more days, who were diagnosed by a Qualified Physician as FDA Positive by an Echocardiogram performed between the commencement of Diet Drug use and the end of the Screening Period, with any of the following conditions [preexisting conditions or alternative causation factors]… (Settlement Agreement, Section IV.B.2.d.(2)(c)).

The central issue is: when must alternative causation factors (or “pre-existing” conditions) be diagnosed?  Do they have to be diagnosed before the end of the Screening Period (by Jan. 3, 2003)? Or can alternative causation factors/preexisting conditions be diagnosed at any time, even years after the initial diagnosis of valvular heart disease?

This isn’t just some interesting legal argument; there are dozens, if not hundreds, of severely injured claimants who are going to be disappointed to learn that they might not receive benefits for additional injuries even though most of us (me included) thought that such benefits were guaranteed.  This new interpretation applies to people who had an echocardiogram during the Screening Period that showed no alternative causation factors, but who later develop alternative causation factors at or around the time of a heart valve surgery.  My office has several cases like this and I’m sure there are many more out there.  These are people who settled their claims through the class action settlement and who thought they were guaranteed additional benefits if their condition worsened.

I believe the claimants and their lawyers were all promised that timely registered claimants could make an additional claim if their condition worsened and progressed to a Matrix Level III, IV, or V condition on or before December 31, 2011.  The problem is that these same people who now have developed High Matrix Level conditions also sometimes later develop some of the same “alternative causation factors”, such as mitral annular calcification or aortic stenosis.  We have cases in our office where the alternative causation factor (usually mitral annular calcification) is discovered in medical records seven or eight years after the end of the Screening Period. These new conditions are completely unrelated to the original heart valve leakage and also did not cause the progression to the High Matrix Level condition.

Under the AHP Trust’s and Class Counsel’s current interpretation of the above Settlement provision [Section IV.B.2.d.(2)(c)], many claimants in this situation will receive nothing for their High Matrix Level Claim because they later developed an alternative causation factor or preexisting condition years after the end of the Screening Period and initial diagnosis of heart valve leakage.  This outcome does not make sense and seems unfair to the claimants, but it’s what the AHP Trust is doing.

This new approach seems completely inconsistent with courtroom testimony years ago about the Settlement Agreement and its guaranteed progression benefits. Nearly half-a-million Class Members decided to register for the class action rather than sue American Home Products (later known as Wyeth) in Court. The “guaranteed” right to progression benefits for worsening conditions was undoubtedly a motivating factor for many who made this decision. It certainly was a factor I took into account when advising my clients about their options many years ago.

No doubt many people elected to go with the class action settlement because they believed that they would be “guaranteed” progression benefits if their condition worsened.  And who wouldn’t with statements from Class Counsel and its experts like this:

This is all about protecting people.  And the only way we are going to protect significant numbers of people is by … allowing people to grow through the settlement. (Fairness Hearing Transcript, Day 3: May 4, 2000 at p. 73:13-17)

What was really important for people was not so much the money that they would get today, but the prospect that they would be compensated if as and when they progressed to surgery within some reasonable period of time.  (7th Amendment Fairness Hearing Transcrip, Jan. 18, 2005 at p. 79:17-21)

The way that works, your Honor, is that the surgery benefit
is guaranteed at the level that exists on the current Matrix. (7th Amendment Fairness Hearing Transcript, Jan 18, 2005 at p.85:17-19)

But today, years after the hearings, the AHP Trust and Class Counsel have taken a very different position—one that threatens to erase the “guaranteed” progression benefits promised to all Class Members years ago.  More denials of claims will undoubtedly continue unless the Court or the 3^rd Circuit Court of Appeals stops this.

So, you might wonder what you can do about this if you have filed or are considering filing a High Matrix Level Claim.  You can be sure the Trust will try hard to find evidence of any alternative causation factors, and their lawyers and claims administrators will use those factors to reduce your claim by at least eighty percent, even though the later-developed “alternative causation factor” obviously could not have caused the original heart valve leakage. You may as well ask your doctor if he or she thinks you have developed any of these alternative causation factors.  You don’t want to build an expectation of payment (even though it was called “guaranteed”), because I am certain the Trust and their doctors will find them if they can and then reduce or eliminate your claim because of them.

Petroff & Associates

The obesity drug Qnexa is in the news this week as its maker, Vivus, Inc., tries to convince a concerned FDA Advisory Panel that the drug is safe and effective.  FDA officials still have safety concerns about this experimental diet pill.  The drug’s maker, Vivus, Inc., failed in its first attempt to get this drug approved in 2010, but it is preparing to make a second attempt to convince regulatory experts of the drug’s safety tomorrow.

According to the Vivus webpage, Qnexa would be available in extended release capsules and it is an investigational, once per day, weight-loss therapy that combines two medicines approved by the FDA, phentermine and topiramate. An FDA panel denied approval in October 2010 in a 10-6 vote.  Panelists sited a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.  Vivus has resubmitted the drug application with additional follow-up information, hoping for a more favorable ruling.

Further studies, Vivus continues to seek approval

On Wednesday, an advisory panel will review the drug and its side-effects, specifically the risks of cleft lip defects.  The experts will also probably discuss increased blood pressure and higher heart rates reported for patients taking the drug. The group’s recommendation is not binding, and the FDA is expected to make its final decision in April.

Vivus will apparently offer to conduct a follow-up study to monitor patients for any heart problems, if Qnexa is approved. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug because of a birth defect concern about topiramate.  

Vivus is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. With U.S. obesity rates allegedly near 35 percent among adults, drugmakers know that even a modestly effective weight loss drug could have blockbuster potential.

Wall Street analysts estimate that sales of Qnexa could reach at least several hundred million dollars a year.  Although competitors could not copy the patented formulation, doctors could continue to prescribe the two drugs in combination, which are both available in inexpensive generic forms.

Time for Caution – what’s the hurry in drug approval?

This whole process is beginning to look a lot like the regulatory maneuverings that surrounded the approval of Redux, the new and improved “Fen-Phen” that occurred in 1996.  Redux also was voted down by the Advisory Committee first time around and its manufacturer came back with new information and a promise to conduct post-market safety studies (on neurotoxicity) if the drug was approved. Redux was on the market less than two years before being withdrawn (along with Fenfluramine, half of the “fen-phen” cocktail) amid serious health concerns. The phentermine used in Qnexa is the exact same speed-like drug that was in Fen-Phen.

Even though the F.D.A. declined to approve Qnexa two years ago, citing the risks of birth defects and cardiovascular problems, doctors are allowed to prescribe the two components together as they see fit. Doctors have been prescribing these two drugs together for months in some parts of the country, and the drug’s sponsor should have no problem developing further studies to more rigorously analyze the safety and effectiveness of these drugs before releasing them on the general public. There are still unanswered questions about these drugs in combination, and past experience shows that the best time to get answers from the drug’s maker is usually before the drug is approved. Let’s hope the regulators are patient and hold the drug maker to strict standards of safety and effectiveness before approving this new diet drug combination.

Petroff & Associates

Remember that the difference between an A-Level and B-Level claim can be several hundred thousand dollars. Proper classification can make the difference between getting paid for your new, severe medical condition or possibly receiving nothing—despite having a new condition that should place you on the A-Matrix. (To learn more about misclassification of claims read our post: Misclassification of Fen-Phen High Matrix Level Claims – the compensation that you may be missing out on).

Several people have contacted us privately asking for examples of how this is occurring. Instead of talking in generalities, we will show you a specific example of how the Trust is attempting to deny benefits to a claimant, who we believe meets all the criteria for an A-Matrix claim. In our example the Trust reduces an A-Level claim based on their finding of “aortic stenosis”—or a narrowing of the heart’s aortic valve.

Without getting too technical, the Settlement Agreement reduces a Claim from an A-level to a B-level if the claimant has “Aortic stenosis with an aortic valve area < 1.0 square centimeter” based on the Continuity Equation. (The “continuity equation” is the equation that the Settlement Agreement states must be used when determining the area of an aortic valve based on an echocardiogram).

Put more simply:

Area ≥ than 1.0 sq cm = A-level
Area < 1.0 sq cm = B-level.

This seems fairly easy to understand and apply. The Settlement Agreement specifies the conditions that will reduce a claim and it even provides the precise mathematical equation that must be used when measuring the valve area.

But despite this clear language and the Trust’s own findings, the Trust and their doctors have still reduced at least one claim to B-level based on what they call the “totality” of the medical records and documents submitted. The Trust and their doctors used the continuity equation as specified in the Settlement Agreement and found the area of the aortic valve to be > than 1.0sq cm. That means the claim, according to the Settlement Agreement, should have been classified as an A-level claim and the claimant should have received several hundred thousand dollars in addition to the previous payment.

Correct? That is our reading of the Settlement Agreement. But the Trust has a different interpretation. The Trust reduced the claim to a B-level based on this new “totality of the medical records” standard. This new standard for evaluating claims is no where to be found in the plain language of the Settlement Agreement. This new standard ignores the Settlement Agreement provision that states the Continuity Equation is the sole method for determining the area of the claimant’s aortic valve based on an echocardiogram.

If we follow this new interpretation, the actual measurement of the valve using the “continuity equation” becomes meaningless; the Trust can still apparently reduce the claim based on any other medical records and documents submitted. The Trust’s “independent expert” only needs to state that the “totality” of the medical records allows him or her to do so.

This new interpretation of the Settlement Agreement is particularly frustrating for claimants because in an earlier PTO the Court held that the Continuity Equation was the only permitted method for disproving the existence of aortic stenosis, as specifically required by the Settlement Agreement.

So it appears that Claimants are required to follow the Settlement Agreement and use the Continuity Equation when proving their claim, but the Trust is not. We know of at least one case where the Continuity Equation established an A-level claim, but the Trust’s “independent expert” ignored that and concluded that the totality of the evidence supported paying the claimant reduced benefits of $154,984.00, even though the “required” continuity equation would have resulted in a payment of approximately $780,920.00. That is a difference of over $625,000.00 in just one case involving this question. We are contesting that decision. Anyone who submits an A-level claim must be prepared for the Trust to evaluate their claim based on the “totality” of the evidence—even if all experts, using the exact formula dictated by the Settlement Agreement, find a valve area that supports an A-level claim.

As you can see from the above, this process can become quite complex and requires an in-depth knowledge of the Settlement Agreement, its Amendments, Pretrial Orders and Court Approved Procedures. You should be prepared to timely contest any efforts by the Trust to unjustly and drastically reduce the value of your claim. In some cases, the opinions of a Board-Certified Pathologist may be needed to prove that your claim should not be reduced from an A-level claim to a B-level claim.

The Trust has become very aggressive about trying to reduce legitimate claims for what appear to be questionable reasons, and you should be familiar with these tactics in advance or it might be too late once it happens to you. The above is just one example of a tactic we are seeing the Trust use in their Final Determination Letters. We will continue to post about ways the Trust is attempting to reinterpret the Settlement Agreement in order to reduce or eliminate claims, and we encourage readers to share examples of this as well.

Petroff & Associates

The Trust was established to administer the claims and payment of benefits to class members; however, the Trust has become increasingly aggressive when processing claims, often resulting in reducing or eliminating payments of legitimate benefits to claimants. Many claimants do not realize that the Trust, its employees, independent contractors, and advisors are frequently not on their side, until it is too late.

It is true that you are not required to have an attorney to file a claim with the Trust, but the claims administration process has become very complex and contentious. It is a complex process that requires an in-depth understanding of the Settlement Agreement and its amendments. One must also understand over a dozen Court Approved Procedures, dozens of Audit Rules, and some of the > 8,000 Pretrial Orders. You can be sure the Trust and its employees and lawyers are very familiar with all these Procedures, Orders, and Rules. The Trust and its lawyers were involved in creating many of these guidelines and they know how to use them in the day-to-day handling of these claims. In order to be successful you or your attorney must be equally familiar with all the applicable rules and procedures.

It is not possible to mention here all the rules and procedures that apply to any particular case. Careful research of these materials is possible through the following websites:

• AHP Settlement Trust: http://www.settlementdietdrugs.com/
• Seventh Amendment: http://www.7thamendmentdietdrugs.com/
• U.S. District Court for the Eastern District of Pennsylvania: http://www.paed.uscourts.gov

It is a big mistake to think you can simply wait until the Trust has reached a decision on your case and then start studying these rules.

You are in litigation. It is important to realize that the Trust treats the claims process like it was actual litigation, especially at the Contest and Show Cause stages that many of you are still in. This is an adversarial process that will ultimately be resolved by the Court. It is true that the Trust is required to have “Independent” Auditing Cardiologists review your claim to determine if you qualify for additional benefits, but you should be aware that the “independent” Auditing Cardiologist is acting as an expert witness for the Trust. The Trust has taken the position that communications between the Trust’s attorneys and their “independent” auditing cardiologists are “privileged” and can be kept secret. This basically means the Trust’s attorneys can have secret conversations and communications with the “independent” doctors who are reviewing your claim. The Trust claims that these communications are exempt from the Audit rules, and you are not entitled to learn about them whether you have a lawyer or not. That is what the Trust means when they say an “independent” cardiologist will review your claim and make a decision. Imagine watching an athletic event where the referees huddle with the other side before making a decision on the field. That’s how I feel when awaiting a decision from the “independent” cardiologists judging my clients’ cases.

Know when to seek legal help. Because of the complex and often adversarial nature of the claims process we encourage you to seek legal help. You should make sure to hire an attorney who is experienced in handling these types of claims if you hire one at all. Once the Trust rules against you, you may not have the ability to go back and correct any mistakes and it may be too late to find an attorney willing to take your case at that point.

Petroff & Associates

Click here to see the the Matrix.

Under the Seventh Amendment Wyeth guaranteed payment to Class Members participating in the Seventh Amendment who:

1. were diagnosed with FDA Positive or mild mitral regurgitation between the commencement of diet drug use and January 3, 2003, (or by a later date for those Class Members who were unable to receive an echocardiogram from the Trust’s Screening Program by January 3, 2003, and who obtained a Court-approved extension) (“the Screening Period”); and
2. who have a medical condition that qualifies them for payment on Matrix Levels III, IV or V, as modified by the Seventh Amendment, and such condition(s) occurred and were diagnosed by the earlier of December 31, 2011, or 15 years from the date of their last diet drug use.

What does this mean in terms of possible recovery?
Class members with Matrix Levels III, IV and V progression claims who previously received benefits on the A-Matrix (or its corollary under the 7th Amendment) may be eligible to receive additional compensation if they experience certain medical conditions or events by the earlier of December 31, 2011, or 15 years from the date of their last diet drug use (See Section IV.B.2.c.(3) through (5) for the medical conditions that may qualify claimants for additional payments under a High Matrix Level Claim).

For example, if at the time of diagnosis you were 45 years of age and were found to have a “Level III Severity” under the A-1 Matrix you were eligible to recover $727,741.00. If now, at the age of 59, you have suffered from a “qualifying medical” condition or event and qualify for “Level IV Severity” under the A-1 Matrix you are eligible to recover $933,327.00 less $727,741.00 (your original payment) or $205,586.00.

 
However, if your claim is misclassified as “Level IV Severity” under the Matrix B-1 claim (or reduced by the Trust, more on this in later posts), you are eligible to recover $186,665.00. But because this is less than the original payment under Matrix A-1 of $727,741.00, you will receive nothing. As you can see this is a difference of over $200,000.00.

 
We regularly hear from folks with valve surgery claims who have filed their claims improperly or without the correct classification. And, unfortunately, sometimes it is too late to correct their claims. It is extremely important that you analyze every possible way your claim can be filed as an A-claim rather than a B-claim. As you can see this is critical because the monetary difference between an A-claim and a B-claim is hundreds of thousands of dollars in many cases. At our firm, we never file a B-claim without having someone independently confirm there’s no reasonable medical basis for filing an A-claim.

 
It is best if you can classify the claim properly at the time you file it, but we believe you can and should try to upgrade your classification even after you filed your claim, if you decide the claim was filed under the wrong classification.

Petroff & Associates

The Nationwide Class Action Settlement Agreement with American Home Products Corporation (“Settlement Agreement”) provides money benefits called “Matrix” benefits for people who used (or ingested) a qualifying diet drug and have been diagnosed with certain levels of heart valve regurgitation or other specific conditions or events. Click here to see the “Matrix”.  Class Members who qualify for Matrix benefits do so on one of five levels. Levels I and II generally are for Class Members who have not had heart-valve surgery. Levels III, IV, and V are for Class Members who have had heart-valve surgery, or who have experienced other specific conditions or events, such as a stroke due to atrial fibrillation, or a post-surgical condition, such as an ejection fraction below 40% six months after valve surgery. These benefits are administered by the AHP Settlement Trust (the “Trust”). The Trust administers benefits to Class Members and determines whether a Class Member is eligible for benefits.

The “Seventh Amendment” to the Settlement Agreement was formed for several reasons, including the presence of an overwhelming number of Matrix claims filed by Class Members, especially on Matrix Level II. Additionally, there were also significant delays and uncertainties in the payment of Matrix claims, along with concerns over the validity of some Matrix Claims.

The Seventh Amendment was intended to reduce or avoid many of these problems. Under this new arrangement, Wyeth agreed to pay an additional $1.275 billion to create a new fund with a new process for reviewing and paying claims.

Under the Seventh Amendment, Class Members may be eligible to receive additional compensation if:

1. they were diagnosed with FDA Positive or mild mitral regurgitation between the commencement of diet drug use and January 3, 2003, (or by a later date for those Class Members who were unable to receive an echocardiogram from the Trust’s Screening Program by January 3, 2003, and who obtained a Court-approved extension) (“the Screening Period”); and
2. they have a medical condition that qualifies them for payment on Matrix Levels III, IV or V, as modified by the Seventh Amendment, and such condition(s) occurred and were diagnosed by the earlier of December 31, 2011, or 15 years from the date of their last use of a qualifying diet drug.

The Seventh Amendment does not change the amount payable to claimants at Matrix Levels III, IV or V. The Seventh Amendment has changed some of the medical criteria for Matrix Levels III, IV, and V for Seventh Amendment participants. For example, surgery-related claims will qualify for benefits on Matrix Level III only if surgery is actually performed.

This is a very simplified explanation of the Settlement Agreement, Seventh Amendment and Matrix Benefits and how they relate to one another. Again, the claims process can be very complicated and it is important to know when to seek legal help. If you choose to hire an attorney, we recommend that you select an attorney who has experience in handling these types of claims. Remember, once the Trust rules against you, you may not have the ability to go back and correct any mistakes.

Petroff & Associates

We frequently hear from people who are dissatisfied with the results they achieve from the Trust—the unfavorable results are almost always due to incorrect claims classification, incomplete claims submission, or inadequate claims preparation and analysis.

Many times a better result may have been possible if these potential pitfalls had been identified and corrected in advance. Instead, too often they ruin or drastically diminish the value of your claim. This post will elaborate further on a few of the pitfalls you can anticipate and try to avoid or overcome when handling a High Matrix Level Claim.

1.  Know The Rules. These are potentially very large claims that frequently involve hundreds of thousands of dollars, and the Trust has become very aggressive in finding ways to minimize or eliminate the benefits that are payable for a HMLC. Successful handling of one of these claims requires a thorough understanding of all the applicable “Audit Rules,” “Court Approved Procedures,” and the Pretrial Orders (“PTOs”) interpreting and applying them. The Trust’s employees and the medical experts handling these claims are very familiar with all these rules and are very experienced at using them against the claimants. You cannot expect the Trust or Class Counsel to apply these rules for your benefit. You and/or your lawyer need to “level the playing field” by understanding all these procedures or you will probably be disappointed with the results. The best way to utilize these procedures to your benefit is to know them and use them before the Trust denies or minimizes your claim, and you cannot do that unless you or your lawyer know these rules and procedures inside and out.

2. Know How the Rules Are Applied in the Claims Process. Simply knowing the rules and procedures as written is not usually enough to achieve the desired results. That’s because the application of the rules and procedures to a particular case sometimes results in outcomes that seem inconsistent with the actual wording of the rules. You or your lawyer needs to know how these rules are applied in the claims process. Keep in mind that there are numerous ways these items can be used to your benefit if you or your lawyer takes the time to thoroughly understand them in advance. Failing to utilize a rule or procedure to your benefit is as bad as failing to understand how to avoid the traps and pitfalls that are out there. You or your lawyer will be completely overwhelmed and outnumbered unless you know how these rules are applied in the claims process.

3. Check Your Proof of Use. We have recently seen the Trust reverse its previous decision concerning the sufficiency of evidence submitted to prove the claimant actually used Pondimin or Redux, a necessary prerequisite to receive any compensation under the Settlement. The Trust accepted the documentary proof around 2002 but now, after more than 9 years, the Trust is attempting to reject the very evidence that it found sufficient. This is a good example of how aggressive the Trust has become in its attempts to minimize or eliminate payments to claimants. It is a good idea to make sure all available evidence of Pondimin or Redux use has been submitted even if that means locating and submitting more evidence now.

4. Check Your Echo Results. Previous posts have suggested that the Trust and its medical experts are getting “two bites at the apple” by reevaluating claims long after they were originally submitted. The Trust has done this in several ways, including reversing its decision about the adequacy of proof of use of a qualifying diet pill. A similar approach has been taken with echocardiogram studies—we have seen the Trust re-review echo tests recently to see if their own experts missed a way to reduce the claim the first time around. This sometimes results in a person with a legitimate HMLC receiving no money at all because the Trust reversed its original decision, resulting in a situation where the Trust claims it overpaid the claimant the first time around. There are many reasons to believe that the Trust and its experts will continue to expand on this practice of reevaluating claims so future payments can be reduced or eliminated.

The Trust is engaging in all these practices openly and publicly, and it is a good idea to be familiar with these practices before the Trust uses these practices against you. Know the rules or make sure your lawyer knows them so you can avoid these pitfalls.

Petroff & Associates

But a High Matrix Level Claim injury also includes, but is not limited to, the following events/conditions: (1) ineligibility for surgery due to medical reasons, (2) a stroke due to bacterial endocarditis or as a consequence of chronic atrial fibrillation, (3) peripheral embolus due to bacterial endocarditis or as a consequence of atrial fibrillation, (4) heart transplant, (5) ventricular fibrillation, (6) sustained ventricular tachycardia which results in hemodynamic compromise, (7) death resulting from a condition caused by valvular heart disease or valvular repair/replacement surgery.

This post will focus on the non-surgery High Matrix Level Claims.

The information below provides only an overview of this complicated process. It is important to have a good understanding of the claims process and the applicable terms of the Diet Drug Settlement Agreement, the Seventh Amendment to the Settlement Agreement, Audit Rules, Court Approved Procedures, and Pre-Trial Orders (PTOs).

As with any High Matrix Level Claim, the following basic rules apply:

• File claims with correct classification
• Make sure the Trust has all the necessary information
• Get a copy of all relevant medical records
• Know when to seek good legal help

(for more info on the items above, please read 5 things to consider when filing a surgery claim).

In addition, you must be prepared to timely contest any efforts by the Trust to unjustly and drastically reduce the value of your claim. The Trust has become extremely aggressive about trying to reduce legitimate claims for what appear to be questionable reasons, and you should be familiar with these tactics in advance or it might be too late once it happens to you. There are many examples of these tactics in the Final Determination Letters that have been decided by the Trust in similar cases.

One example of this practice consists of a new procedure whereby the Trust experts find ‘alternative causation factors’ as the cause of one’s valvular heart disease even if such ‘alternative causation factors’ did not arise until AFTER the valvular heart disease was first diagnosed. This amounts to the Trust taking two bites of the apple, but the Trust is freely doing exactly that when it can get away with it. These ‘alternative causation factors’ include, but are not limited to:

• aortic sclerosis,
• aortic root dilation > 5.0 cm,
• aortic stenosis,
• mitral valve prolapse,
• mitral annular calcification, and
• evidence of rheumatic mitral valves.

These alterative causation factors will lower the value of your claim by a factor of five (5). However, you should not allow the Trust to reduce the value of your claim if ‘alternative causation factors’ are not present until AFTER you were first diagnosed with valvular heart disease.

Pursuant to the explicit terms of the Diet Drug Settlement Agreement, these alternative causation factors can only reduce the value of a claim if they are found at the time of initial diagnosis of valvular heart disease. Hence, they are presumed ‘alternative causation factors’ of the valvular heart disease pursuant to the Diet Drug Settlement Agreement —- they are not ‘alternative causation factors’ of the High Matrix Level condition or injury. Nonetheless, in some cases, the opinions of a Board-Certified Pathologist may be needed to prove your claim should not be reduced from an A-claim to a B-claim.

You will know this has happened to you if you were originally approved as a Level A claim and now, after suffering a new and serious medical condition, the Trust reclassifies you as a B-claim. In some cases this means people are recovering no additional money even though they clearly have a High Matrix Level Claim. This is happening to people more and more frequently as of late. It is a good idea to anticipate the Trust trying to reduce your claim value in this and other ways, and you should have a plan for how to respond when this happens to you.

Petroff & Associates