Fosamax

FOR LITIGATION UPDATES, PLEASE SEE BELOW

Fosamax, Boniva, Actonel, Alendronate, Ibandronate, Risedronate

This page was updated as of September 2014

THIS PAGE IS RESERVED FOR OUR CLIENTS. IF YOU ARE NOT A CLIENT, YOU ARE NOT PERMITTED TO REVIEW THIS INFORMATION. THIS INFORMATION IS CONFIDENTIAL CLIENT INFORMATION. THIS INFORMATION MAY NOT BE DISSEMINATED IN ANY WAY.

Clients can contact Jay Arias: jarias@rheingoldlaw.com

Dear Fosamax Client:

Welcome to the confidential page for our Fosamax clients. This page is intended to update you on current information, as well as be a repository for past updates and important documents. This page contains the most updated information. We greatly appreciate that you rely on this information. Inquiries to our office are always welcome about unique questions regarding your claim but asking us to repeat the general information below only slows down our work on the files.

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LATEST LITIGATION UPDATES

September 30, 2014 Update--Latest Newsletter:

SEPTEMBER 30, 2014 NEWSLETTER--FOSAMAX FEMUR LITIGATION UPDATE

Dear Client(s):

This newsletter brings news of important developments, but they are both positive and negative. These crosscurrents make it impossible to make predictions about what to expect. However, the next six months could make or break this litigation.

Fosamax Assigned to Judge Mayer

Judge Jessica R. Mayer has been appointed to replace Judge Higbee in New Jersey state court. She sits in New Brunswick, NJ. She has extensive experience handling drug litigation, including the bisphosphonate-containing cancer drugs Aredia and Zometa. Litigation involved osteonecrosis of the jaw injury, just as with Fosamax. She also handled the hormone replacement therapy which had an older female demographic, just like Fosamax. One of the defendants was Warner Chilcott, the Actonel defendant. On the downside, she is more conservative and less predictable than Judge Higbee. Judge Mayer's jurisdiction is Middlesex County, home to Johnson & Johnson. Her trials may draw jurors employed by Johnson & Johnson and sympathetic to drug companies.

She has not set her first conference date yet, but we assume it will be within sixty days. She will have a lot to consider, as discussed below. We will post updates on our website.

Merck Intends to File Preemption Motions in New Jersey State Court

Merck has filed papers that it intends to make a preemption motions in New Jersey State court, just as it did in the federal MDL court. As we have discussed in prior newsletters, the preemption claim by Merck is that federal statute prevented Merck from changing the label, so therefore they can't be liable for the failure to add warnings. New Jersey practice generally requires permission from the presiding judge for a party to file significant motions. Merck did not make the preemption motion before Judge Higbee, but they do feel emboldened by their win in federal court. Judge Mayer is likely to grant the motion, although she may wish to defer until the mediation process is completed (see below).

Judge Pisano's Surprise Order for the Parties to Mediate Settlement

Judge Pisano issued a surprise Order September 3, 2014, directing Merck and Plaintiffs' Lead Counsel to mutually agree upon a mediator within thirty days. After that, the parties have to provide Judge Pisano a "written status update" within forty-five days from agreeing to the mediator. We do not believe any of the plaintiffs should be excited about this. There are no penalties to Merck if mediation fails, so there is no "bite" to this Order. In fact, Pisano has dismissed the litigation, so the only threat to Merck would be losing the appeal several years from now.

Mediation Orders are an optimistic event when the defendants ask for them, but this is not the case here. However, if Merck is concerned about the New Jersey state litigation, that may make them come to the settlement table. If they choose to resolve this like the osteonecrosis of the jaw litigation, they will only offer greatly reduced settlement offers.

Judge Pisano's Show Cause Order to Remand the Actonel and Boniva Cases

Judge Pisano was only assigned to handle Fosamax cases, although many of the Fosamax suits before him also included claims for Actonel (Warner Chilcott/Actavis) and Boniva (Proctor & Gamble /Genentech). Judge Pisano's Show Cause Order on September 10, 2014, is an administrative way for him to remove the Actonel and Boniva claims from his court. How this ends up is unknown. No court has commenced discovery against these defendants. Judge Pisano's only power is to return them to their original courts, but a federal court administrator may decide to send all the cases to one judge, as was done with Fosamax. Judge Pisano's Order does not in any way affect Actonel and Boniva cases in NJ state court.

Next Steps

Your individual cases are at a standstill until the judges resolve the next wave of administrative and legal issues before them. We will continue to update matters on our client page, as well as send newsletters for significant events.

August 8, 2014:

Still no word on Judge Higbee replacement.

NEWSLETTER FROM AUGUST 2014

FOSAMAX FEMUR LITIGATION UPDATE

Dear Client(s):

We have gotten many calls about the status of the litigation, and we know it is frustrating that a new judge had not been assigned to replace Judge Higbee in Atlantic County. Unfortunately, the bad luck in Fosamax litigation continued because the new judge in Atlantic County who is replacing Judge Higbee has a conflict in handling the Fosamax litigation! As it turns out, his daughter is a lawyer that works at the law firm defending Merck, the Fosamax maker. The conflict of interest requires the Fosamax cases to be given to another judge.

The deadline for court administration was August 1, but that has passed. When an announcement is made, it will probably appear here: http://www.judiciary.state.nj.us/mass-tort/fosamax/index.htm . We have been told that there are two potential judges to take over the Fosamax litigation. Both are experienced in mass tort litigation. Judge Jessica R. Mayer is in Middlesex County. This poses a problem because that county is home of Johnson & Johnson. Potential jurors are likely to be employees or know employees of Johnson & Johnson and may lean toward the drug companies. However, Johnson & Johnson's reputation has been quite poor lately. Judge Mayer tends to lead toward the defense side. Our most significant experience before her was a successful mediation in the gadolinium litigation, and she was quite forceful at resolving the matter.

Also available is Judge Brian J. Martinotti in Bergen County. He's a "roll up your sleeves and get to work judge." We have many past and current pending litigations with him, including having lead bellwether plaintiffs (all of which were resolved before trial). He has been known to make some significant and surprising pre-trial rulings which can be either plaintiff or defense oriented. While he does not have a big staff, he is aggressive about setting trial dates. He encourages informal meetings with lead counsel to discuss settlement avenues.

NEXT STEPS

We will send another newsletter as soon as there are conferences with the new judge, and he or she has decided how to proceed. Plaintiffs of course want to start as quickly as possible where we left off-getting trial dates for the for plaintiff cases which have been fully worked up under Judge Higbee. We expect Merck to create whatever static possible to slow this down, even to the extent of trying to demand other trial choices.

One thing Merck attorneys have promised is to raise the pre-emption defense, which worked for them to get the federal court cases dismissed. (This is on appeal now.) We are not sure if Merck would be able to make one broad motion or they would wait until there is a specific case to bring it in. In federal court, the motion was made in a specific trial case, but Judge Pisano applied it to all cases.

To raise this defense, Merck would have to make a motion, something the judge must approve. The entire process would be lengthy, perhaps 3 to 6 months. The judge may decide to stay the discovery waves pending this motion.

Cordially,

David B. Rheingold

NEWSLETTER BEING MAILED WEEK OF  MARCH 24, 2014

FOSAMAX FEMUR LITIGATION UPDATE

1. The Unanski Bellwether Trial in NJ State Court is Continued

Due to last minute scheduling problems, on Wednesday, March 19 Judge Higbee continued the Unanski Fosamax femur bellwether trial. This means that the trial will have to be rescheduled. A new date will be chosen once all parties can find a mutually available time. We do not know when the date will be chosen or what date that might be. As you will recall from our January 2014 newsletter, we stated about the trial date: "While we champion Judge Higbee for this rocket docket, her schedule leaves no room for any unexpected curveballs. "

The last straw came this week on Monday when Atlantic City got hit with six inches of late winter snow which prevented jury selection from being completed. On the back end, there was an immovable 4/17/14 stop date for the trial because of the Judge's appellate assignment. That means the trial, jury verdict, and any post-verdict motions would have had to be completed by that date. Judge Higbee had previously decided to only have a one plaintiff trial because a multiple plaintiff trial would have added too much time. You should all know that Merck apparently did everything possible to put the brakes on so the case would not be tried. Plaintiff's counsel bent over backwards to speed up the trial and juggle the dates of expert witnesses.

Please remember that the cancellation of the trial has nothing to do with neither the merits of the case nor the merits of the litigation in general. This is purely a scheduling problem, one which we already predicted - although we would not have guessed it would have been snow on St. Patrick's Day. However, this allows Merck to further stall, and we do not see any reason that Merck will voluntarily decide to settle the litigation. Nor do we see any other reasons on the horizon which would encourage Merck to settle the litigation. We know this is disheartening.

In federal court, it appears that Judge Pisano will not change his preemption decision, meaning that issue will go up on appeal. Meanwhile, Judge Pisano wants to have a trial for a plaintiff who was injured in 2011 after the new warning was added. We believe there would be very little chances of success in late injury cases.

2. Judge Higbee's Tier Discovery

A weapon Judge Higbee has against Merck is to continue pre-trial discovery. This forces Merck to incur costs to defend cases, although their costs are minor in light of their annual profits. Judge Higbee is setting Tiers of 50 cases (25 picked by plaintiffs, 25 picked by Merck). The 5th Tier will be chosen by August 1st. Each case has a deposition of the plaintiff, one of her Fosamax prescribing physicians, and one of her orthopedic doctors. Subsequent to that, the field is narrowed down to a handful of those cases where more discovery is done.

We have recently added some of our clients to the 3rd and 4th Tiers. (We have notified you already if you were chosen.) In our next newsletter, we will discuss their cases in detail. Their depositions were done and both went very well. If you would like to be considered for the 5th Tier, please contact Kelly Larrea at our office and we will get back to you after we review your file. You should be able to meet the following criteria:

· You had an atypical femur fracture involving low or no impact.

· You had the fracture after 5+ years of Fosamax and little, if any, generic alendronate use

· You did not also use Actonel and/or Boniva before the fracture. To this date, there has been no discovery against non-Fosamax defendants, and we do not believe Judge Higbee will consider those cases. She does not even have time to do a Fosamax trial. No other judges in the country are handling Actonel or Boniva cases.

· You must be physically able to travel to New York City or some location in New Jersey for two days during August and September 2014.

· You must pay for your travel expenses here. We will consider paying for a hotel locally if needed.

· There are many factors we will discuss with you individually before making a final decision. Some make your case strong: being non-osteoporotic, bilateral fractures, long term use, and your doctors saying it was a Fosamax break, etc. And some make the case weak: having severe osteoporosis with previous fractures, short term Fosamax use, heavy use of steroids.

3. Judge Higbee's Appellate Division Assignment

Judge Higbee will be temporarily assigned to the Appellate Division from April 14, 2014 to June 20, 2014. She is scheduled to have a case management conference before she begins her temporary assignment, on April 8, 2014. Counsel for both sides will address what will need to be accomplished between now and the end of June.

This temporary assignment is an opportunity for Judge Higbee to try out the Appellate Division. If she returns to the bench we will assume that everything will resume as usual. Otherwise, we don't know how long it will take for a new judge to be assigned to this litigation.

UPDATE : March 11, 2014:

This morning, Melissa Mendoza attended the monthly case management conference. The following issues were discussed:

Tier 2 Discovery Pool- This discovery pool is coming to a close and by the next case management conference (sometime in April) both Plaintiff and Defense counsels will be ready to make their trial selections.

Tier 3 Discovery Pool- This discovery pool is moving along and both sides are meeting the deadlines.

Tier 4 Discovery Pool-The scheduling order was not ready for this discovery pool but both Plaintiff and Defense counsels are working on it with expectation of a release date in the next few weeks.

The next two Plaintiffs (Love v. Merck and Caravello v. Merck) are ready for trial and the Plaintiffs lead counsel made it very clear that they are willing to take the next available date on Judge Higbee's calendar.

Generic Dismissals- The generic defendants are going to convene and create an informal letter establishing their position in this litigation.

Unanski Case- Oral arguments are scheduled to begin Wednesday March 12, 2014 at 9am and opening arguments are scheduled to begin on Monday March 24, 2014.

This trial is expected to go into at least the first week of April.

February 25, 2014:

Judge Higbee in NJ state court has updated with the following: There will be only one plaintiff due to her limited availability-- Carol Unasnski. We have discussed her previously. It should be noted that she had osteoporosis, which makes it a bit easier for Merck to defend.

While Merck opposed a live broadcast of the trial, and will be filing briefs in opposition, we believe the trail may be broadcast. Our firm hopes to watch it. You are free to watch it, but each person has to pay individually, and the service is $1,000.00 PER WEEK! We hope to be watching it and updating the trial on this page.

http://cvn.com/proceedings/carol-anne-unanski-v-merck-sharp-dohme-corp-trial-2014-03-10

In federal court, Judge Pisano is in the process of considering 1)his Show Cause motion to to dismiss pre-label change injuries based on his pre-emption ruling in the Glynn case. The general concensus is that he will issue a dismissal ruling, which the plaintiffs will appeal. There are good reasons why Judge Pisano should be overturned on sustantive and procedural grounds. However, this will be a long process.

2)We expect that Judge Pisano will try to set up the next potential trial to be for a plaintiff who had a fracture after the label change (January 2011). This will allow him to hear a summary judgment motion based on preemption. Merck would be on firm ground as the label change was based on the FDA demand. However, there's an issue as to what damage was done to plaintiffs by Fosamax before the label change occured which would set up an eventual femur fracture.

December 26, 2013:  (THE FOLLOWING IS A NEWSLETTER WE WILL SOON BE MAILING)

OSTEONECROSIS OF THE JAW PROPOSED SETTLEMENT

To Our Fosamax Osteonecrosis of the Jaw Clients:

After almost eight years of litigation, the federal supervising judge finally took a judicial action which has brought Merck to the settlement table. We expect more details to be announced in early January. We believe the plan will be have some very strong merits. David Rheingold will be attending a settlement conference in Atlanta on Tuesday January 7, 2014. Immediately following that, we would like to talk to each individually to discuss the settlement plan. We will first recap how we got to the point of the settlement plan.

1. A Recap: Osteonecrosis of the Jaw ("ONJ")

Fosamax was first sold in 1995. About 10 years later, dentists started noticing cases of osteonecrosis of the jaw which they soon connected to Fosamax. Long term use was associated with very small amounts of the jaw bone dying, especially when the jaw bone was exposed after a tooth extraction. Most cases were only mildly painful and resolved with use of a rinse or antibiotics. Some cases were more painful and doctors removed dead gum or bone, known as debridement. This was done in an oral surgeon's office and rarely required hospitalization.

Merck moved quickly in 2006 to add ONJ warnings to the prescribing information given to doctors. Dentists and oral surgeons became more vigilant in treating patients. Normally a defendant will not settle claims which occurred after a warning change, but this plan will not use that as a criterion.

2. A Litigation Recap: How We Got to this Point

The litigation was consolidated before Judge Keenan in federal court and Judge Higbee in New Jersey State court. Merck made an early decision to fiercely defend all trials. This is not unusual as many drug and medical device companies will gladly pay litigation costs in order to drag out litigation and increase costs for plaintiffs. Merck's strategy did quite well as they won five of seven trials. Merck defends the product by stating:

a) The incidence of osteonecrosis of the jaw is relatively rare.

b) When following proper protocol, dentists and oral surgeons prevent ONJ.

c) Most plaintiffs claiming ONJ really had infections unrelated to Fosamax caused by smoking, poor dental hygiene or other non-Fosamax problems commonly found in an older population.

d) The benefits of Fosamax in preventing osteoporotic fractures far outweighed the risks.

Merck used these effectively to win most of the trials, or at least mitigate a jury award to plaintiffs. The recent verdict for plaintiff Rhoda Scheinberg was only $285,000, a figure which is probably equal to the cost to the plaintiff for the trial expenses. Merck has done everything possible to appeal the verdict. Further, this was a case where the ONJ use was before the warning label change.

This fall, Judge Keenan finally issued a "Remand Order" targeted to commence on December 2, 2103. A remand order releases all the consolidated pending suits for trial tracks before available judges. Until this, Merck refused to talk settlement (or even mention the word "settlement" while in court) and was content to keep defending trials. Under a remand order, Merck would be faced with massively increased defense costs. This forced Merck to the negotiating table and on December 10, 2013, they agreed to fund a settlement for $27.7 million. However, the specific details will not be agreed to until early January.

3. Information Released About the Proposed Settlement

The general framework of the settlement appears very favorable for the 1,200 outstanding claims throughout the country.

a) The claim categories are clearly defined and only require a modest amount of medical documentation for those who have a clear ONJ diagnosis.

b) The administration will be designed for quick processing with claim evaluation aimed to be completed by.

c) The administration will be done by Merck and the Plaintiffs' Steering Committee, thus requiring minimal administrative costs and saving more money for settlements.

d) Only three months of documented Fosamax use at any time before the ONJ is needed to substantiate a claim. (There is very little proof that ONJ can occur unless you take Fosamax for thirty-six months or more.)

4. Claim Categories and Compensation (Proposed)

INJURY

PROPOSED

SETTLEMENT AMOUT

No evidence of ONJ

$500.00

ONJ (or 8 weeks of exposed bone)diagnosed in medical records by dentist or oral surgeon

$7,500.00

ONJ (or 8 weeks of exposed bone)diagnosed in medical records by dentist or oral surgeon PLUS surgical removal of dead tissue or bone (known as debridement) in a doctor's office OR one of various complications

$25,000.00

ONJ (or 8 weeks of exposed bone)diagnosed in medical records by dentist or oral surgeon PLUS surgical removal of dead tissue or bone (known as debridement) in a hospital

To be determined

on individual evaluations

based on various factors

5. Important Settlement Plan Dates (Proposed)

The submission for medical records to the settlement plan is March 31, 2014. Merck has a "walk away" right which means that if not enough people participate in the plan, Merck can refuse to enter into the settlement plan. (A defendant does not gain anything by only a few people settling and many people still litigating.) The walk away right has to be exercised by May 15, 2014. Should the plan survive, one would hope that final claim determinations would be made in fall or winter 2014, with payments following afterward depending on resolved medical liens (see below).

6. Medical Expense Reimbursement Liens

Medical expenses related to your treatment for ONJ may be subject to a medical lien which has to be repaid as part of the settlement. Whenever an insurance plan pays for your injury-related medical treatment, that entity may have a lien on the personal injury proceeds. If so, they are entitled to get back what they advanced for you (or some portion of it). All governmental payments--Medicare, Medicaid, TriCare, etc.-must be repaid by statutory guidelines. Private insurance plans, especially if your employer provided them through a self-funded insurance plan, may have a contractual right to be reimbursed.

The repayment comes from the litigant's proceeds, but this settlement plan will have a lien resolution program which will determine if there are any valid statutory or contractual liens. If so, the exact amount will be determined and then a negotiation process will take place, hopefully reducing any lien.

7. What Are the Realities of the Litigation Option?

Those plaintiffs not entering the settlement plan will have the option to litigate their case. In reality, this option has little or no prospect for success. Merck has shown it will gladly pay any amount of money to defend trials (in Fosamax ONJ, Fosamax femur and any other drugs they are defending) and juries have returned verdicts for Merck. To prosecute a case will cost a plaintiff more money than one would expect from a verdict, especially where there was no treatment in a hospital or permanent injury. If this is an option you are considering, we can discuss it in detail when we talk.

8. Attorney Fee & Expenses

When we talk to you next, we will discuss with you the applicable attorney fee and expenses which will come from the gross settlement amount. As you will recall, the attorney fee is one-third of the gross settlement. If you were referred to us by another lawyer, the referral lawyer will be given a portion for the attorney fee. This does not in any way reduce your recovery. Also, there is a "common benefit" fee of 3%. This is a fee to the plaintiff steering committee ("PSC"). The 3% is calculated from the gross settlement, but is deducted solely from the attorney fee and does not reduce the client's proceeds.

When we talk with you, we will inform you about the expenses. As discussed in the retainer, these are deducted from the gross settlement before the fee is determined. Our firm will have expenses, and if you had a referring counsel, that counsel may have expenses. The PSC gets a 3% expense reimbursement which is calculated from the gross settlement. This repays all the litigation expenses advanced by the PSC.

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December 22, 2013 FEMUR NEWSLETTER TO BE MAILED IN EARLY 2014

1. Osteonecrosis of the Jaw ('ONJ') Settlement

After vigorously defending trials for the last 8 years, and winning most of them, Merck has come to the settlement table with a $27.7 million settlement program for the 1,200 pending suits. For those of you with osteonecrosis of the jaw cases, we have contacted you individually about the settlement program. For our femur clients, we have enclosed a copy of that newsletter for you as it may be of some interest. There is no indication that Merck is considering settlement on femur cases.

2. The Next NJ State Femur Trial Date is Rescheduled for March 10, 2014

Judge Higbee in NJ state court, where most of the Fosamax femur suits are pending, has changed the November trial date until March 10, 2014. The delay was made necessary by the need to do a new round of discovery pertaining to the FDA approval of Fosamax of the femur warning.

As you will recall from the last newsletter, Judge Pisano dismissed the Glynn trial based on the preemption defense. He ruled that Merck was technically incapable of adding femur fracture warnings to the warning liable as the FDA had decided it would dictate how the femur fracture warnings would written.

Judge Pisano's decision, however, seems to have completely disregarded all the evidence of femur fractures which was known years before 2009. Since the Pisano decision this summer, the plaintiffs steering committee has been conducting more discovery about Merck's knowledge of femur fractures and interaction with the FDA. In legal jargon, this is known as "data mining" and "pharmacovigilance."

This new discovery work done this fall must now be digested by each side's respective experts to be followed by depositions and briefing. Both sides are working overtime during the holidays to meet Judge Higbee's expedited deadlines. Expert reports were exchanged in December, and depositions must take place by January 31, 2014. Motion briefing will take place on an expedited schedule in February. This includes all the motions, oppositions and reply briefs. The briefing deadline is February 26. Judge Higbee has cleared her docket to hear the motions during the week of March 3. She intends to rule on the motions before trial starts on March 10.

While we champion Judge Higbee for this rocket docket, her schedule leaves no room for any unexpected curveballs. If there are delays, we hope Judge Higbee will have an open calendar for other trial dates. We will update you on our password-protected client page as to the developments.

As far as the federal MDL litigation, this new FDA discovery will have to be reviewed in order to determine if Judge Pisano will alter his preemption ruling for future trials.

3. The March 10, 2014 Trial

The plaintiff for the trial is Carol Ann Unanski. She was originally paired for the first trial with Christina Su but was severed at the last minute. Judge Higbee has also named two other plaintiffs who might be added as joint plaintiffs to the trial. Having more than one plaintiff can complicate and extend the length of a trial, but it does allow plaintiffs to have more trials.

4. Alendronate (Generic Fosamax) Dismissals

Thanks to the current Supreme Court which has set all-time records for decisions favoring business interests over consumers, generic drug sellers were determined to not be liable for issues related to inadequate warning labels. This is known as preemption, and we have discussed it extensively in other newsletters.

Fosamax went generic in February 2008. For the vast majority of Fosamax uses after February 2008, their health insurance plans switched them to generic Fosamax automatically. (Actonel and Boniva did not go generic. If you were on one of those, you probably remained on that.)

After the June 2011 Pliva v. Mensing Supreme Court decision, Judge Pisano immediately dismissed all claims against generic alendronate defendants. The vast majority of federal and state court judges also quickly dismissed claims against any generic drugs.

Late this year, over two years after the Pliva decision, the U.S. Food and Drug Administration finally published a draft proposal that would remedy the Pliva decision. The proposal goes through a public comment period, which was recently extended sixty days until March 13, 2014. After that, a final decision will be made. If the FDA proposal is accepted, it will only apply to new litigation which is commenced after the rule changes apply.

Some judges have found loopholes for alendronate liability, but these are very narrow and will probably have no ultimate benefit. In New Jersey, Judge Higbee is allowing discovery to be done against generic alendronate defendants who did not update their labels promptly after the FDA issued the new warnings in March, 2011. The largest alendronate seller was Teva, and they updated the label in about six weeks. Most others were also quick to change their labels. Even if once could show that the warnings were not changed promptly, there are legal hurdles in showing that a prescribing physician would have read the new warnings and stopped prescribing it. This is highly unlikely in that doctors still continue to prescribe alendronate and Actonel/Boniva (which carry the same warnings).

5. The Effect of Alendronate Dismissals on Litigation

How the generic dismissals will affect Fosamax claims where the femur fracture occurred after the generic use started has yet to be seen. Femur fractures may have occurred after limited alendronate use and other fractures occurred years after alendronate use. The argument against Fosamax will be that the detrimental effects were set in motion by the previous Fosamax use and without which the fracture would not have occurred with the alendronate alone.

6. The Third Wave of Plaintiffs

Judge Higbee has asked for a Third Wave of discovery. The upcoming trial will be part of the First Wave of plaintiffs. Last year a Second Wave of bellwether plaintiffs were chosen. Interesting, Judge Higbee does not deem the Third Wave to be bellwether plaintiffs meeting strict trial criteria. This wave is meant to be a wider selection that keeps pressure on Merck with time and expenses in defending cases, as well as preparing cases for trial in the event Merck does not settle cases. We have several clients in this wave and will discuss those in our next newsletter.

7. In Conclusion

Fosamax litigation has dragged out longer than most litigations for various reasons which were not foreseeable at the start of the litigation. Attorneys for plaintiffs continue to fight the good battle and look forward to changing the tide in 2014!

August, 2013:

Judge Pisano dismisses the Glynn on preemption grounds. His decision is attached HERE. There is an explanation of this decision in our August 2013 newsletter below.

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Women using Fosamax have been diagnosed with osteonecrosis (ONJ) of the jaw and femur fractures. ONJ cases are proceeding in two consolidated actions: In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan), Judge Keenan

May 2, 2013: Judge Higbee will start the second Fosamax femur trial in November 2013. Here are a list of the proposed plaintiffs. You will note that Unanski was part of the first scheduled trials that got severed right before trial. These plaintiffs used Fosamax for over 5 years. They were osteopenic or osteoporotic. The age range is 62 to 70 years old, with a single or bilateral fractures. Judge Higbee is deferring a decision as to whether there will be just one plaintiff, or a multiple plaintiff trial.

May 1, 2013: We are now hearing that the jury did not find it to be an "atypical fracture" and hence determined that it was not related to Fosamax. We have also seen a comment that plaintiff plans to appeal several irregularities.

April 29, 2013: The jury returned a defense verdict in the Glynn case. As we are posting this the day after, we have been unable to get a detailed analysis. The jury was only out about an hour, so this means the jury had already made up their mind on the verdict before deliberating. We do not know what was so persuading. We have hear that Judge Pisano made some evidentiary rulings which were very favorable to Merck. The next NJ state trial is slated for October, 2013. (The plaintiff in the first NJ state trial, Su, suffered a heart attack at the start of the trial and has since died from complications.) We do not have a date for the next federal trial.

April 25, 2013 update of the Glynn trial: Merck Denied Summary Judgment in N.J. Federal Fosamax Case; Trial Commences

April 11, 2013 update of the Glynn trial: Opening Statements

April 4, 2013 update: The Glynn trial (as discussed in our February 2013 newsletter) will begin next week in federal court. As the Su trial ended in a very early mistrial, the Glynn case will be the first trial. Attached is a brief Bloomberg News report on the Fosamax femur litigation. We are all keeping our fingers crossed! Merck's tactics have always been to dig in for a long fight and defend many trials.

First Femur Trial-

PLAINTIFF CHRISTINA SUFFERED A VERY SERIOUS HEART ATTACK AT THE BEGINNING OF HER TRIAL, UNRELATED TO HER FEMUR INJURY. JUDGE HIGBEE DECLARED A MISTRIAL. WE UNDERSTAND MS. SU'S CONDITON IS QUITE GRAVE. BY MID-APRIL, WE EXPECT JUDGE HIGBEE TO NAME THE NEXT TRIAL, AND THE DATE.

We are very excited the first Fosamax femur trial has started. The plaintiff, Christina Su, who lives outside New Brunswick, New Jersey, is a retired computer-systems analyst who took Fosamax for more than five years starting in June 2003. She suffered a broken right femur in 2009 and doctors later that year inserted a metal rod in her left femur to deal with stress fractures. The trial is expected to last four weeks, extending into April. As described in our newsletter, the next trial will be in federal court this April before Judge Pisano.

May 7, 2013: We now have more information on the Glynn trial-which recently was a defense verdict. In short, Judge Pisano made most of his trial rulings in favor of Merck and against the plaintiff. These rulings appear to have had a significantly impact on the verdict, and appeals will be taken. As we understand it, Judge Pisano excluded evidence such as many of the adverse event reports Merck received about femur fractures.

In an unusual move, Judge Pisano gave the jury a written instruction regarding the definition of an atypical femur fracture by using the criteria found in the American Society of Bone and Mineral Research's 2010 Special Task Force report. Normally, there isn't a jury instruction regarding the specific criteria of what in injury is. The jury found it wasn't an atypical femur fracture based on what the judge insisted it was, even though the science is still evolving and experts disagree on the exact nature.

On a more concerning note, the judge is addressing the issue of "preemption" in post-trial motions. I discussed this on page 2, section C, of this newsletter. Again, this is a highly unusual development and could result in an appeal if it goes against the plaintiff. (We should note that in the Su trial before Judge Higbee, Merck never made any of the preemption motions, being concerned that Higbee's ruling would be favorable to the plaintiffs.)

The next trial appears to be in late August in an Alabama state court case. There is a question as to whether it is an atypical femur fracture. The next MDL case may be a defense bellwether pick. Judge Higbee will be trying plaintiff bellwether picks in November.

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Women using Fosamax have been diagnosed with osteonecrosis (ONJ) of the jaw and femur fractures. ONJ cases are proceeding in two consolidated actions:

In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan), Judge Keenan

The Court in the Multidistrict litigation has decided that there needs to be one additional bellwether cases tried and has set forth specific criteria for what the cases should be like. One case must involve Fosamax use beginning before the July 2005 label change with a claimed onset of injury after the July 2005 label change. The other case must involve commencement of Fosamax use and a claimed injury date that both post-date the July 2005 label change.

Unfortunately in the most Osteonecrosis case in the MDL the jury has come back with a defense verdict on October 3, 2011. Judge Keenan had previously thrown out the majority of the causes of action, including failure to warn, in this case so it comes as no suprise however it is still not the best news for ONJ cases. There will continue to be more bellwether cases in SDNY, and we will continue fighting for our ONJ clients to get the just compensation they deserve. Read more about the cases here.

In Re Fosamax Litigation, Case No. 282, Atlantic County, NJ. Judge Higbee.

In the MDL litigation, several trials for ONJ plaintiffs have been tried with mixed results. The MDL does not process femur cases. This court does accept femur cases, and discovery is continuning in preparation for a summer 2012 trial. Our firm feels very positive about the femur fracture cases. We are deeply involved in the femur fracture litigation and are proud to say we have one of the cases in the bellwether trial pool. One of the bellwether trial cases will be tried in the fall  of 2012. Currently the Plaintiffs firms are reviewing over 17 million documents that have been produced by Merck.

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March 2013 FDA Update

This link will bring you to a new FDA article about the length of use appropriate for bisphosphonates. The conclusion is 3 to 5 years if your bones appear strong. The FDA calls for more investigation to learn more. Unfortunately, the FDA has no outrage against the drug companies who have been selling these for decades and promoting long-term, lifetime use, without having ANY studies showing use beyond 3 to 5 years is beneficial.

May 2012 New England Medical Journal Perspective

Attached is a May 2012 New England Medical Journal "Perspective" about whether bisphosphonate use is appropriate after 3 to 5 years. We have highlighted the summary, but we know it's confusing. The most important fact is that NO drug seller can provide any proof of benefit in women who don't have osteoporosis-as defined by a T score of -2.5 or greater. Also, the benefit is only in those already experiencing a vertebral fracture. NOTE: Merck always tried to fraudulently define osteoporosis as only -2.0. The rest of the world defines -2.0 as osteopenia.

Femur Cases

Our firm recently conducted one of the first prescriber and treater depositions for the femur fracture cases. The deposition went as expected, and there weren't any surprises. We are currently working with the Court and the defendants to schedule the depositions of Merck's sales reps for this one case.  The first trial is still scheduled for the fall of 2012, however it is always possible this date will get pushed back, but as of right now Judge Higbee is still shooting for an October 2012 trial. We do not know which case will go to trial then, but it will be one of the remaining 9 selected. If you were one of those 9 you would have already been contacted by our office. Just because you are not one of the 9 does not mean your case is without merit, only that it didn't fit the very narrow criteria the Plaintiff's and Defendant's were looking for when selecting these cases. In the future, we will be looking for different types of cases  and will be re-evaluating all of our cases at that time. If you have any questions feel free to contact us.

There will most likely be susbsequent rounds of bellwether cases that will have different criteria the judge is looking for.

For general information about Fosamax and related injuries, you can view our general page:

http://www.rheingoldlaw.com/Drugs-Overview/Fosamax-and-Osteonecrosis-of-the-Jaw-Injuries.shtml

http://www.rheingoldlaw.com/Drugs-Overview/Fosamax-and-Fractured-Femur-Injuries.shtml

Definition for Bisphosphonate Femur Fractures

The American Society for Bone and Mineral Research has defined bisphosphonate femur fractures by calling them "Atypical Femur Fractures." This was arrived at by forming a task force which reviewed massive amounts of medical documentation, as well as interviewing FDA representatives.

The task force defined major and minor features of complete and incomplete atypical femoral fractures. Major features include -location in the subtrochanteric region and femoral shaft

- transverse or short oblique orientation -minimal or no associated trauma -medial spike when the fracture is complete -absence of comminution

A new study published in February 2011 in the Journal of the American Medical Association questions the efficacy of bisphosphonate therapy after five years of use due to the association with Atypical Femur Fractures now widely associated with bisphosphonates. You can read the complete article following the link below.

http://jama.ama-assn.org/content/305/8/783.short

See the bottom of the page for more medical journal articles related to Fosamax and associated Femur fractures.

Minor features include association with

-cortical thickening

-a periosteal reaction of the lateral cortex -prodromal pain, bilaterality -delayed healing -comorbid conditions, and concomitant drug exposures, including BPs, other antiresorptive agents, glucocorticoids, and proton pump inhibitors

Links to latest news in our blog:

http://www.rheingoldlaw.com/blog/2011/08/fosamax-could-increase-throat-cancer-risk.shtml
http://www.rheingoldlaw.com/blog/2010/11/iv-bisphosphonates-therapy-linked-to-stroke-and-heart-problems.shtml

http://www.rheingoldlaw.com/blog/2010/09/expert-panel-links-biphosphonates-to-femur-fracture-wants-new-labels.shtml

http://www.rheingoldlaw.com/blog/2010/06/merck-loses-fosamax-case-8-million-in-compensatory-damages.shtml

Other Items:

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

An FDA Panel Suggests More Label Changes for Bisphosphonates

http://www.judiciary.state.nj.us/mass-tort/fosamax/index.htm

-NJ Superior Court Mass Tort Forms, Authorizations, and Articles

-Southern District of New York Fosamax ONJ MDL (Forms):

SDNY Plaintiff Profile Form ONJ Southern District Plaintiff Profile Form.doc

SDNY Plaintiff Profile Form with Authorizations.pdf

-FDA Announcements and Other Information/ArticlesRegarding Femur Fractures:

American Bone and Mineral Research Soceity Article Prompting Label Change 10/2010

New England Journal of Medicine Bisphosphonate Aytpical Fracture Article 5/2011

New York Times Article Discussing Link Between Rare Fractures and Fosamax 7/2008

Case Report Linking Atypical Fractures to Alendronate 5/2008

New England Journal of Medicine 2008 Letter to the Editor 3/2008

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm