Drug Recall Lawyer Blog

It’s a winter wonderland here in Maryland, and our office is running on a skeleton crew. Here are the top drug injury-related stories for the past few days:

• Digitek: Tom Lamb and the Drug Injury Watch post on the status of this litigation (surprisingly, it is not defunct yet, despite long problems in finding the mythical creature, “The Double-Dose Pill.”
• Preemption: An upcoming article by Mary J. Davis in the Hastings Law Journal titled “The ‘New’ Presumption Against Preemption.”
• Gadolinium: A Danish radiologist complains to The Guardian that the United Kingdom’s laws on libel are preventing him from speaking about the dangers of General Electric’s MRI contrast dye, Omniscan. He states that, "I am not giving lectures any more in the UK where it seems you can be sued for telling the truth." He is being sued by GE Healthcare. GE: “We Bring Good Things to Light [or, do our best to quash them through litigation].”
• Fosamax: Exposé by NPR about how Fosamax came to be so popular, and whether it actually works. (Hat tip to Shearlings Got Plowed)

Happy Monday!

Here’s what we’re looking at, this week:

• AstraZeneca sets up a website devoted to its social networking efforts: Twitter, Facebook, YouTube and blogging
• Judge Keenan denies Merck’s motion to dismiss 24 Fosamax lawsuits because a jury may be able to conclude that the drug can cause jaw damage in under 3 years of use
• Increasing use of antipsychotics by pediatric patients
• The Pharma Marketing Blog reports on Big Pharma’s direct to consumer (DTC) advertising trends
• Informative post by Tom Lamb and the Drug Injury Watch on detecting adverse drug reactions and pulmonary embolism

Happy Monday!

Judge Keenan has rescheduled the Boles trial for June 2, 2010, and has scheduled the next Fosamax trial for February 1, 2010. The specific case is not yet known--the judge will randomly select it from the roster.

For more on the Fosamax trials, see our blog.

Some items of interest while you eat turkey sandwiches for lunch, today:

• Class-1 recall of Stryker’s Navigation System II: 23 of these units are potentially faulty. The device is a computer-aided surgery platform that performs hip, spine, knee, neuro and ENT surgeries. The computer may not work properly, which could lead to serious injury or death. Stryker is also a manufacturer of shoulder pain pumps.
• Second bellwether Fosamax case dismissed:
  Judge Keenan (S.D. New York) dismissed the second of three Fosamax bellwether cases last week because of lack of specific causation (proof that Fosamax caused her injury, which is different from general causation—proof that Fosamax can cause these types of injuries). The third case is set for an April 2010 trial.
• Making drug safety information more accessible to patients: discusses the labeling of drugs, and whether those labels are sufficient for detailing drug efficacy and safety issues (hat tip to Tom Lamb at www.DrugInjuryWatch.com).
• AstraZeneca performs its own Seroquel study—surprised at what they found? Dr. Paul Woolf, a paid consultant who has received more than $216,000 from AstraZeneca, intends to testify that he reviewed AstraZeneca’s 2004 study on Seroquel, and that it shows the drug does not significantly affect blood-sugar levels. See our other blog posts on Seroquel and the findings of other studies (including AstraZeneca’s own covered-up research).

Happy Monday!

This week a terrific victory was achieved by plaintiff Peggy Stevens of Missouri in her quest to hold Novartis responsible for covering up the dangers of their osteoporosis drug Zometa. Like Fosamax and other bisphosphonate-drugs, Zometa can cause a condition known as osteonecrosis of the jaw, particularly when the patient undergoes invasive dental procedures (tooth extractions, root canals, etc.). The jury of 12 deliberated for eight hours over 2 days in the Missoula District Court before concluding that Novartis was responsible for $822,000 in lost income and $2,378,000 in non-economic damages (pain, mental anguish, inconvenience, etc.), for a total verdict of $3.2 million.

Ms. Stevens showed the jury that Novartis hid relevant information, and failed to appropriately and reasonably warn patients of the drug’s dangers. The only warning about osteonecrosis of the jaw was given in a 20-fold pamphlet inside the drug’s box, in tiny print. Look at the picture—is this something that should not be front and center? Additionally, internal company e-mails revealed that the company worked to suppress information on the dangers.

There are about 550 other Zometa lawsuits, most of them consolidated in an MDL in Tennessee federal court, and the others grouped in New Jersey state court. The next Zometa trial is scheduled for March 2010 in New Jersey. Many expert witnesses will be the same in these trials.

The Boles’ case, tried and mis-trialed is coming back. From the Shearlings Got Plowed blog, we came across this tidbit from Judge Keenan’s October 7 order stating that “As for the second request, it would be fruitless for Plaintiff to file the motion. The Court intends to retry this case.”

We’re looking into determining what the plaintiff’s request was that spawned the order (perhaps motion for reconsideration of motion for judgment?). At any rate, it’s not surprising. The judge did not have many other options. Of course, Ms. Boles is going to have to wait in line—there are other Fosamax trials set for December and January.

The jury was finally let go today after deliberating since September 3. The reports from the court have been that the jury was convinced almost from day one that they would not be able to reach agreement--the judge tried his best, and gave them every opportunity to talk it out. However, today, Judge Keenan declared a mistrial.

The defense believes they had 7 of the 8 jurors on their side. The one thing I have learned from watching juries is that you rarely know who's with you and who's against you. However, the jury notes may give some credibility to that argument (and, Plaintiff's counsel did request the mistrial the other day, perhaps sensing a losing battle). It looks like Ms. Boles will have to wait until spring, so by then two other Fosamax trials may get to go, first. We'll see what happens in round 2...

Jurors sent notes to Judge Keenan during their deliberations in the Fosamax bellwether trial, yesterday. The notes referred to a lack of unanimity of the eight jurors, and a feeling that they would never reach agreement. The judge instructed them to keep working.

They've been deliberating for about 9 hours (which, when you consider the number of weeks the case has gone on, really isn't much). This is the most exciting part of trials--just knowing that the jury is hashing it out, working on some kind of agreement amidst certain disagreement, and knowing that the case can still come out either way.

Shirley Boles, courtesy Michael Appleton, New York Times

The Shirley Boles case went to a jury of three men and five women, yesterday afternoon. Attorneys for Ms. Boles, a retired deputy from the Okaloosa County Sheriff’s Office, told jurors that she had to sleep at night with a towel to wipe away puss that oozes from her jaw, and that she avoids playing with her grandson for fear that he may accidentally break her fragile jaw. Without a doubt, she is a very compelling plaintiff with an unimaginable injury.

The jury is asked to decide:

• Was Merck/Schering-Plough negligent in formulating Fosamax?
• Did the company fail to warn Ms. Boles and her physicians of the risks of osteonecrosis of the jaw?
• Is Fosamax defective?
• Did Fosamax cause Ms. Boles’ jaw injury?

Merck, in the process of finalizing a $41 billion merger with Fosamax manufacturer Schering-Plough, is defending the cases (to the tune of $7 million in the second quarter of this year), and has budgeted $42 million to defend the other 900 to 1,200 federal and state Fosamax cases.

The bottom line of the companies has suffered, especially after the FDA required warnings about osteonecrosis. Fosamax had 15 million prescriptions in 2007—that number dropped to 2.6 million in 2008. As for worldwide sales, the drug sold $1.55 billion in 2008, a decrease of about 50% from the year before.

For more information on Fosamax and the on-going litigation, see other posts of the DrugRecallLawyerBlog.

Four weeks later (see earlier Fosamax blog posts), evidence has closed in the Shirley Boles Fosamax trial (New York). Only closing arguments and jury deliberations remain. Remember, this is the very first of three bellwether Fosamax trials, alleging that Ms. Boles suffered from osteonecrosis of the jaw after taking a drug for prevention of osteoporosis. The jury could begin deliberations as early today or tomorrow.

Following an earlier pre-trial order of the judge, the jury will not hear about the profits that Merck has made on Fosamax, nor will they be able to entertain punitive damages.

The Plaintiff has presented all of her evidence in the Fosamax trial in New York. Merck has filed for judgment as a matter of law--asking the judge to rule that, even if everything the Plaintiff said was true, she did not meet her burden to prove her case. These motions are routinely made, and routinely denied. The Plaintiff's case lasted about 10 days, and it is unlikely that the judge will find any significant errors in that presentation of evidence sufficient to take the case from the hands of the jury.

If the judge denies the motion, the defense will present their evidence.

See our original blog post on the trial here.

The first of three bellwether (“lead”) Fosamax trials is starting today in New York federal court. Fosamax is part of MDL-1789, in the Southern District of New York (Manhattan). The case is consolidated with about 700 other Fosamax cases; there are an additional 140 cases in a New Jersey state court.

As with all bellwether trials, this will give all litigants and their lawyers a good idea of what a jury does with the evidence and testimony. From there, settlement discussions typically ensue.

Fosamax was sold by Schering-Plough Corporation, which is being bought by Merck & Co. It is among the class of drugs known as bisphosphonates, and is used to treat osteoporosis. Plaintiffs claim that the manufacturer did not adequately warn that the drug could cause osteonecrosis of the jaw, which is the death of jawbone tissue.

In the trial, punitive damages will not be allowed. Plaintiffs claim that Merck was the only bisphosphonate-making company that did not adequately change their label, as requested by the FDA. Merck will defend their warnings, and will argue that the evidence does not show Fosamax causes osteonecrosis of the jaw. However, osteonecrosis of the jaw has only been found in users of the drug and some cancer patients receiving chemotherapy. Merck has an uphill battle on this one. It is impossible to predict the outcome, especially because all cases are fact-dependent, but these are awful injuries, causation seems clear, and we are predicting a plaintiff’s victory.