Lawsuit Update Center

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

Facts of Wyeth v. Levine

Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.

The LifePak CR Plus Automated External Defibrillators manufactured by Physio-Control, Inc. (which is owned by Medtronic), is subject to a Class I recall. These recalls are the most serious and are conducted when there is a reasonable probability that use of the device will cause serious injury or death.

The automatic defibrillators are used to treat patients suffering from cardiac arrest in hospitals, by emergency response personnel, and even by those without medical training in public places (defibrillators like these are often seen at airports, swimming pools, and other public places). The recall affects devices with the following serial numbers:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

Judge Nancy Gertner of the United States District Court of Massachusetts ruled for the Plaintiffs, finding that e-mails about birth defects between GlaxoSmithKline (the Paxil manufacturer) and researchers. The plaintiffs believe that these e-mails will show that GlaxoSmithKline attempted to influence the results, and in fact recommended changes that were made to the final paper. Though the researchers have denied being influenced by GlaxoSmithKline, plaintiffs will probe the relationship and, perhaps, place it before a jury to decide.
The plaintiffs contend that William Seale’s mother took the antidepressant Paxil while she was pregnant, and that the drug caused the one-year-old to die of heart defects.

There are approximately 600 Paxil cases pending. The first suit is being tried now in Philadelphia state court, where opening statements have just begun.

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 could not reach an 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, the 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 an 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.

Kugel hernia mesh lawsuits are settling, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated the use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our prior blog post.

Shirley Boles, courtesy of 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:

Bausch & Lomb has entered into settlements with over 600 claimants over its ReNu with Moistureloc contact lens solution. In those cases, the allegations were that the solution could cause fusarium keratitis, a serious fungal eye infection. We discussed this in our previous blog, Bausch & Lomb Eye Fungus Cases.
In that blog, we also discussed that the judges (New York state judge Shirley Cornreich, and South Carolina federal judge David Norton) were tag-teaming the Daubert-Frye hearings to determine if Plaintiffs’ proposed experts could properly link ReNu with non-fusarium keratitis cases. In each case, the Plaintiffs were dealt a blow when the judges ruled separately that the expert is restricted from testifying as to general causation between ReNu and non-fusarium keratitis cases. This means Plaintiffs cannot provide expert testimony that ReNu generally (we are not even talking about in a specific case) can cause these infections. According to the opinions, the Plaintiffs’ expert did not do any specific testing and was not aware of any data that would suggest a link. Defendant’s expert, a physician at the Wilmer Eye Institute at Johns Hopkins (and also a paid consultant of Bausch & Lomb since before the litigation) had a more persuasive argument. He put together a panel of experts early on, studied reports and articles, and noted that there was no acceptance in the scientific community that ReNu causes an increase in non-fusarium keratitis cases.

So, it looks like game over for plaintiffs. They tried to keep the litigation alive, but there isn’t enough evidence for a connection.

Here’s what the Judicial Panel on Multi-district Litigation has been up to with regard to Reglan/metoclopramide:

MDL No. 2049 was denied on June 3, 2009, so for the time being these cases will continue to proceed individually right where they are at. The Panel concluded that there were common factual issues about whether Reglan causes neurological injuries, including tardive dyskinesia; however, the eleven filed actions had no common defendant.

Furthermore, five of the cases were in advanced stages of litigation, and to join them would have a delayed resolution of those cases. All responding defendants (Actavis, Inc.; Actavis-Elizabeth, L.L.C.; Barr Pharmaceuticals, Inc.; Baxter Healthcare Corp.; Duramed Pharmaceuticals, Inc.; Pliva, Inc.; Pliva USA, Inc.; Schwarz Pharma, Inc.; Teva Pharmaceuticals USA, Inc.; and Wyeth) opposed centralization, as did one Plaintiff from Vermont.

It looks like Eli Lilly, the Defendant in a number of lawsuits brought by state attorneys general, is close to agreeing on a settlement. The lawsuits are premised on Lilly’s marketing of Zyprexa for unapproved uses. The settlement comes on the heels of many other settlements:

 Settlements with 31,000 plaintiffs for $1.2 billion

 January 2008: settlement with Alaska for $15 million