Drug Recall Lawyer Blog

Here's all the news that's fit to print:

• Tylenol Recall Lawsuit: According to Bloomberg, consumers are striking back against Johnson & Johnson over the recalled Tylenol (and other) drugs. Basically, the federal class action suit seeks to force J&J to pay money for returned products instead of offering coupons for the same products. That is a logical position--who wants to buy Tylenol, now? Would you use it if they gave it to for free? However, J&J's website says they offer refunds or coupons, and it seems like the customer's choice.
• Avandia: The FDA's advisory committee on Avandia is set to meet this week to go over the risk/benefit profile.
• Fosamax Trial: See here for Merck's complaint about plaintiff's trial counsel in the Boles case, and here for the other side of the story (HT: Shearlings Got Plowed).
• Free Speech: Can doctors criticize pharmaceuticals online? (HT: Pharma Marketing Blog)
• Preventing Children Medication Errors by Parents: Just because it's important (scroll down halfway)
• Thimerosal: Another one bites the dust.
• FDA Facebook Page: Good idea or bad idea?
• History of Prescription Drug Recalls: HT Tom Lamb.
• Rapamune: Off-label marketing allegations (HT: Drug Injury Lawyer Blog).

Happy Monday!

Last week was a busy one--our firm had two trials (one continuing on this week with closing arguments tomorrow), and one that concluded very favorably with a plaintiff's verdict. But, now that I'm back, here's this week's edition of the Round-Up:

• The Sixth Circuit and Preemption: As mentioned by Drug & Device Law Blog, the 6th Circuit wants the FDA's viewpoint on preemption by July 29.
• Testosterone Gel: The Drug Injury Lawyer Blog reports on the links between testosterone gel and heart attacks/strokes. We've blogged about Testim, one version of the drug, before.
• Fosamax: I'm really sorry to have missed reporting such a big event. Here's a bunch of stories on the $8 million plaintiff's victory in the Boles Fosamax trial: Drug Injury Watch; Shearlings Got Plowed (victory notice)(post-trial motions)(next trials)
• Vioxx: Can Louisiana sue Merck to recover for money spent on Vioxx?
• BPA: The National Resources Defense Council (NRDC) sued the FDA over the FDA's failure to ban BPA in selected products. We'll see how that goes.... Here's an update on BPA from the FDA.

Hope you had a happy 4th!

Here are the week’s top stories:

• Off-Label Marketing: Jack’s Posterous has a recount of recent off-label marketing fines paid by drug dealers (oops, I mean manufacturers). “As long as off-label promotion is more profitable than the fines for punishing off-label promotion, we will have off-label promotion.”
• Motrin Phantom Recall: Pogust, Braslow & Millrood’s Drug Injury Lawyer Blog has details of Johnson & Johnson’s McNeil Consumer Healthcare and their effort to avoid a Motrin recall.
• Zocor: FDA says it may cause muscle injury (rhabdomyolysis). See our prior Zocor posts.
• Pfizer and Free Samples: Pfizer spends the most doling out free samples--$2.7 billion in a year. Kinda makes you think about those paltry fines, huh?
• Off-Label Marketing, pt. II: Take the poll.
• Drugs and Porn: Can drugs cause porn and gambling addictions? Looks like there are lawsuits in Australia and here in the U.S. I’m highly skeptical of this one.
• Fosamax: Jury selection just ended in the retrial of the Boles case, yesterday.
• Januvia & Janumet: We've been getting a lot of questions about these diabetes drugs lately, so see our website.

Happy Tuesday!

Good morning! Here are the week’s top stories:

• Topamax: Johnson & Johnson is going to pay over $81 million (articles here and here in criminal and civil fines for illegally promoting Topamax. That’s a mere 0.070% of 2009’s $1.15 billion in sales, and 0.039% of 2008’s 2.7 billion in sales (quite the deterrent, eh?). Nevertheless, this compounds J&J’s woes in light of the current Tylenol recall.
• Topamax Whistleblowers: Here’s an article about the courageous Michigan whistleblowers who made it all happen.
• Vaccines & Autism: Dr. Andrew Wakefield, the British physician who wrote the initial Lancet article linking autism to vaccines, has been disbarred from the practice of medicine. He did not offer evidence on his behalf, and he has about a month to appeal.
• BPA—now in cans?: USA Today and Dr. Gupta report on the presence of BPA in cans, and discuss whether pregnant women in particular should be concerned. For more on BPA, see our prior blog posts.
• St. Jude Medical: The FDA recently issued a warning letter to St. Jude Medical about overpromotion of its Epicor Ablation System, used to treat atrial fibrillation. See the Forbes article and the FDA’s warning letter.
• Las Vegas Hepatitis Punitives: See one reactionist and alarmist article, “Health Cost Hikes May Follow $500M Jury Award in Hepatitis C Case.”
• Neurontin: Last week, Pfizer settled a Neurontin wrongful death case for a confidential amount.

Have a great week!

Here are this week’s stories:

• Dietary Supplements: The FDA Law Blog comments about the FDA’s compliance program for dietary supplements.
• Vaccine-Autism Litigation: Drug and Device Law Blog thinks the most recent Federal Circuit decision basically seals the coffin in this litigation.
• Maryland Whistleblower Protection: Pat Malone writes about a Maryland appellate case approving protection of a nurse’s job when reporting dangerous hospital practices. This could have reverberations for other whistleblower cases, including products cases. See this website for more information on the False Claims Act. And, see this website for more about the whistleblower mindset blowing-the-whistle-on-drugmakers-misdeed-takes-guts-stamina.
• Fosamax: most of the belleweather cases will be tried this summer and fall (HT: Shearlings Got Ploughed).
• CT Radiation: great audio article by NPR.
• Big Brother: Pharmalot reports that GlaxoSmithKline doesn’t like its employees visiting CafePharma, a drug blog devoted to employee criticisms of the pharmaceutical and medical device industry.

Happy Monday!

Here are some stories to follow this week:

• Tylenol Recall: Johnson & Johnson’s statement about the recall is here, and they have a blog post here (with some interaction with consumers via comments).
• Vyvanase and Off-label Marketing: John Mack has an interesting post analyzing an ad that might be promoting off-label use through subtle imagery. Is it off-label, or is just a picture? You be the judge!
• Maalox: The FDA posted a statement (scroll to the bottom) under Patient Safety News regarding the problems with confusing various types of Maalox, which can have disastrous results.
• April 510k Clearances: viewable here.
• Topomax: After the $81 million settlement with the DOJ over its drug Topomax, Johnson & Johnson sales reps are going to be randomly observed during sales pitches (HT: FiercePharma).
• Preemption and Generic Drugs: post by the For the Defense.
• Fosamax: I’ve been trying to get a post on this important decision, but it’s been a busy couple of days. Tom Lamb has a description.

Happy Monday!

Here are the stories we’re following this week:

• Infusion pumps: The FDA is tightening regulation of infusion pumps, which have reportedly caused 710 deaths in the past five years, and have been subject to 79 recalls since 2005 (news links to The New York Times, The Wall Street Journal, Associated Press, Reuters).
• Guidant: Brian Nash’s perspective on the defective Guidant defibrillator settlement proposal.
• Fosamax: Apparently, the trial has been going on all week (HT: Shearlings Got Plowed).
• Sprint Fidelis Leads: Last week, the 8th Circuit Court of Appeals heard arguments in Case no. 9-2290, Anna Bryant v. Medtronic. You can hear the recording here.
• Pfizer: The FDA issues a warning to Pfizer about clinical trials where children received excessive dosages of antipsychotics (HT: FiercePharma).
• Boston Scientific: The Guidant-purchaser is set to resume sale of some defibrillators which were recalled last month after it notified the FDA that some paperwork wasn’t properly submitted. (see The Wall Street Journal (subscription req’d)).

Happy Monday!

The next Fosamax trial, alleging osteonecrosis of the jaw, is likely starting this upcoming Monday, with jury selection today (HT: Shearlings Got Plowed). The case will go before the U.S. District Court for the Southern District of New York (Manhattan).

In the Maley case, Merck tried to obtain a dismissal based on inadequate specific causation, but that attempt failed back in January. Merck contends that the plaintiff does not have osteonecrosis of the jaw but, instead, has a condition known as neuralgia-inducing cavitational osteonecrosis (NICO). Specific diagnosis of plaintiff’s condition is likely to be a big issue at trial.

For more on Fosamax, see prior posts of the Drug Recall Lawyer Blog.

Here are the stories we’re following this week:

• Pfizer: CNN reports on why Pharmaceia, Pfizer’s shell company, “took the fall” for Pfizer’s illegal marketing practices
• Crestor: will the marketing campaign persuade people to take it when they don’t need it? (HT: Patient Safety Blog).
• Seroquel: Two more summary judgment decisions in Delaware (HT: Drug & Device Law Blog).
• Fosamax trials: Scherlings Got Plowed has an update.
• Children and Medical Devices: The FDA is requiring medical device manufacturers to provide additional information on the effects of their devices on children.
• Pfizer Discloses Payments: Pfizer disclosed $35 million in payments to healthcare professionals in the last half of 2009. The payments were for development and marketing. (HT: FiercePharma).

Happy Monday!

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.