Tag Archives: Merck Fosamax Bone Density Osteonecrosis Claims Jaw US Dist Ct NY August 11 2009

Fosamax® Jury Selection Underway This Morning, In Manhattan

After a week’s delay, the retrial of the Boles Fosamax® “bellweather” case is getting underway, before Judge Keenan, in the federal District Courts, in Manhattan, this morning. Mrs. Boles’ lawyers have asked Judge Keenan to rule that at the close of the case, he instruct the jury about alleged non-compliance with FDA rules, as another basis to find liability against Merck.

The argument runs that the jury may presume Fosamax was dangerous and adulterated (in the parlance of the FDA), if Merck failed to comply with FDA rules in securing approval of it, and then later, in the way Merck marketed the drug. With a correction of some typos, I think the plaintiffs’ instructions will work well — see below — and click to enlarge:

The FDA rules compliance issue, in turn, will squarely present the matters implicated by this chart (some background on that):

I will keep you informed as the trial progresses.

The Final Fosamax® Pretrial Order — Setting the Limits. . . .

While my understanding is that the jury has not yet been seated in Manhattan, I do believe jury selection was completed today. If, by any chance, you (now reading this) are among the jurors, or any alternates, you are required by the Court’s orders and intructions to you, today, to stop reading this.

For the rest of the planet, now, here is Judge Keenan’s final Fosamax® pre-trial order, in relevant part. It offers us a glimpse into the limits on argument, and the limits on admissability of some lines of evidence. I may have a couple more on this trial, in the coming days, if developments warrant:

. . . .This order resolves additional pre-trial issues raised by the parties:

Consistent with this Court’s policy, the use of the internet in the courtroom during trial is prohibited. . . .

Merck’s request for a Rule 104 hearing on the admissibility of “other risk” evidence offered to rebut Merck’s risk/benefit defense is granted in part. Before plaintiff seeks to offer any evidence of a purported myocardial infarction risk known prior to the date of plaintiff’s injury, the Court will hold a brief hearing outside of the jury’s presence to determine the foundation for such evidence. Plaintiff’s counsel should not refer to this evidence in opening statement.

Plaintiff may offer evidence of an increased fracture risk known prior to the date of plaintiff’s injury. Such evidence is admissible to rebut Merck’s claims about the fracture reduction benefits of Fosamax. Even if otherwise admissible, “other risk” evidence will be circumscribed under Rule 403 to avoid a mini trial on ancillary issues and the danger of jury confusion. This trial is about the risk of ONJ [Ed. Note: osteonecrosis of the jaw).

Merck’s request to exclude all adverse event reports not involving ONJ or exostosis is denied.

Obviously, reports of tongue ulcers, nasal ulcers, or pancreatitis are not relevant or admissible to show that Merck had notice of a risk of ONJ. However; reports describing jaw problems and symptoms consistent with what would later become known as ONJ may be relevant and admissible for the issue of notice. The Court will rule on the admissibility of such reports when they are offered at trial.

Plaintiff’s proposed jury instruction regarding Wyeth v. Levine will not be given. The Court agrees with Merck that the proposed instruction is one-sided and goes beyond the issues discussed by the Supreme Court in Wyeth. If the parties can stipulate to an instruction that will narrow the issues and evidence, they can submit it to the Court for possible use in this or future trials.

The Court acknowledges plaintiff’s agreement not to offer evidence of Japanese causality assessments. The Court rules that plaintiff may not offer evidence of the 2002 ONJ report with Onclast because plaintiff has not established that any Merck entity received the report prior to the date of plaintiff’ a injury. Therefore, there is no foundation to admit the evidence for the issue of notice.

Copies of the Court’s jury selection procedure will be faxed to counsel this afternoon.

So Ordered:

/s/ Judge John F. Keenan
August 10, 2009

Filed In Associated Cases: 1:06-md-01789-JFK-JCF, 1:06-cv-09455-JFK. . . .

Now — let the games begin, in earnest.

Merck’s Fosmax® On Trial, In New York — Beginning August 11, 2009

[UPDATED 08.11.09 @ Noon EDT — Right here.]

I’ll only mention this in passing (as I don’t intend to start covering all of Merck’s products-liability cases, here), but starting Tuesday morning, Merck will defend the first of what may be nearly a thousand Fosamax® (alendronate sodium) products-liability cases. The plaintiffs allege that Merck failed to adequately warn about jaw-bone side effects, including bone death, experienced by some patients, allegedly as a result of taking Fosamax. Here is a representative snippet, on the topic, from the wire services — this one is from Reuters’ version:

. . . .Some 1,280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax, a one-time blockbuster product that recently began facing generic competition in the United States.

U.S. District Judge John Keenan of the Manhattan District Court will hear arguments from attorneys for Shirley Boles, a 71-year-old plaintiff from Walton Beach, Florida, who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” Merck said in a statement late Monday.

Fosamax, approved in the United States in 1995, belongs to the bisphosphonate family of osteoporosis drugs that include Procter & Gamble’s Actonel and Roche Holding AG’s Boniva. The pills prevent bone fractures — particularly in postmenopausal women — by helping to increase bone mineral density.

In 2003, reports first surfaced linking intravenous bisphosphonate treatments with jaw osteonecrosis, meaning death of jawbone tissue that can include symptoms such as pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth. . . .

As ever, we shall see.