Drug Recall Lawyer Blog

The Lancet has retracted [free subscription required] the 12-year old article connecting autism to MMR (measles, mumps and rubella) vaccinations. The Lancet stated:

Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were "consecutively referred" and that investigations were "approved" by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

Click here for the original article, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children” (emblazoned with a bold, red typeface “RETRACTED”).

Here’s a summary of the posts on the internet and blogosphere:

Continue reading "In The News: Vaccines & Autism" »

Here’s some stories we’ve been following:

• Trasylol: Plaintiffs’ request to remand Trasylol cases denied pursuant to Class Action Fairness Act (courtesy Mass Tort Defense blog)
• Sprint Fidelis: Over half of the 260,000 Sprint Fidelis lead wires are still active in the United States (courtesy Tom Lamb and the Drug Injury Watch)
• Medical Device Interoperability: The FDA is holding a workshop on Medical Device Interoperability, open to the public, to discuss (among other things) pre- and post-market studies, safety, and risks.
• New criticism of FDA’s Medical Device Approval Process (courtesy Shearlings Got Plowed)

Happy New Year!

The Searcy Blog has an informative article about the abuses of the hormone therapy manufacturers. Specifically, Premarin is an estrogen that is manufactured from horse urine—specifically, pregnant horses (hence the name, PREgnant MARe urINe. Whatever your feelings on the drug itself, the method of manufacture, as seen in the embedded video (narrated by Mary Tyler Moore), is clearly cruel.

In the first hormone therapy trial since the Connie Barton case where the jury awarded $3.7 million in compensatory damages and an undisclosed amount in punitive damages (the specific amount has been posted in unconfirmed reports on the web), a second Philadelphia jury has determined that Pfizer (which purchased Wyeth, the original manufacturer of the drug) owes plaintiff Donna Kendall $6.3 million in compensatory damages. The jury will reconvene on Monday to determine the amount of punitive damages that should also be awarded, to punish Pfizer for its conduct.

The Plaintiff, Ms. Kendall, took hormone therapy for 11 years, developed breast cancer, and had to have a double mastectomy (surgical removal of her breasts). Of course, no amount of money can repay her for her injuries. And likely, no amount of money awarded can adequately punish Wyeth for their negligence. But, it's a good start.

Busy week ahead—lawsuits to file, meetings to attend, articles to write and continuing legal education seminars to plan. So, we’ll keep this short:

• More on Aranesp, the anemia drug by Amgen: It is associated with increased risk of stroke in patients with diabetes and chronic kidney disease (courtesy @TomLamb and www.drug-injury.com).
• The FDA will discuss Merck’s cholesterol drugs Vytorin and Zetia as they relate to pediatric-focused safety reviews on November 18 in Maryland. See our prior blog post on the dangers of Vytorin and Zetia).
• A quick criminal history of Pfizer (courtesy @PharmaGossip). Are they more focused on saving lives than making money?
• A little on the merger between Merck and Schering-Plough and their new web issues (courtesy www.shearlingsplowed.blogspot.com).
• More on Accutane, which has been recalled in light of links to inflammatory bowel disease
• New Jersey considers giving mass tort status to the YAZ, Yasmin and Ocella birth control injury litigation

Happy Monday!

The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.

In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

Continue reading "Next Step: Punitive Damages" »

In case you are still coming down from your post-Halloween sugar buzz, here’s a collection of recent blogs and articles about subjects relevant to the Drug Recall Lawyer Blog.

• Iqbal and Twombly hearings are continuing. This is a complex issue, and much e-ink has been spilt on it. American Lawyer, Mass Tort Litigation Blog, Drug and Device Law, Point of Law.
• Drug-juggernaut Amgen faces accusations that it used illegal kickbacks to promote Aranesp, its anemia drug: New York Times, Los Angeles Times, Wall Street Journal, Associated Press. The New England Journal of Medicine reports that it nearly doubles the risk of stroke in people with diabetes and kidney problems.
• FDA increases Byetta warnings about pancreatitis: Associated Press. For more on Byetta, see our blog and website.
• Editorial on FDA’s inability to police dietary supplements: Boston Globe. We blogged about this earlier.
• More dismissals in the sad cases of Medtronic’s Sprint Fidelis leads: Minneapolis Star Tribune.

As happens with all Prempro trials, the news is reporting updates at a frenzied pace. Back in September, a jury held that Pfizer must award Connie Barton $3.7 million in compensatory damages for their role in causing her breast cancer. The judge put the punitive damages phase of the trial on hold, but yesterday the jury convened for 25 minutes and agreed that Pfizer must pay punitive damages to Connie Barton. Punitive damages are imposed on a Defendant who acts in circumstances of “violence, oppression, malice, fraud, or wanton and wicked conduct” according to Black’s Law Dictionary. And, the reports of the trial indicate that the jury had ample proof of that type of conduct.

Unfortunately, we won’t know what the punitive damage award is, at least until the conclusion of another hormone therapy trial that is continuing in the same courthouse (Court of Common Pleas, Philadelphia, Pennsylvania). But, it must be a good one—Pfizer’s lawyer said that “We are disappointed with the jury’s verdict.”

Congratulations, Ms. Barton. You deserve every penny, and more.

The manufacturers of Super Poligrip, the zinc-containing denture adhesive that can cause numbness, decrease in strength, tingling, balance problems and other issues, has updated its product with a new warning.

Now, consumers are warned that the denture adhesive contains zinc, and that they should talk with their doctor if they are taking zinc supplements because of the potential for zinc-toxicity. It also warns that excessive amounts of Poligrip can cause serious health effects. Finally, diagrams are included detailing proper use, and the labeling informs consumers about how long a tube should last. This is a good step forward. The problem with the adhesive up to now has been that many consumers with ill-fitting dentures use prodigious amounts of adhesive, causing extensive neurological injuries. These warnings may go a long way to prevent further problems.

Continue reading "Super Poligrip Warning Update" »

Lawsuits involving Zicam have been consolidated for discovery under U.S. District Judge Frederick J. Martone of the U.S. District Court for the District of Arizona. These Zicam lawsuits involve claims that Zicam caused patients to lose their sense of smell or taste.

The FDA just issued a warning letter to Johnson & Johnson over their athlete’s foot drug Ertaczo. The letter, located here, alleges that Johnson & Johnson’s advertisement features a broadening of the indication (misleadingly suggests that Ertaczo is approved for all patients, regardless of age or immune status, with any form of tinea pedis caused by any organism); unsubstantiated efficacy claims (ad says that the drug will “Crush. Kill. Destroy” when studies show it to be 13.1% to 27.2% effective); that the ad does not include significant drug risks, and that Johnson & Johnson failed to submit the ad for review prior to publication.

Let’s take a step back—this is for an anti-fungal cream. For athlete’s foot. If Johnson & Johnson is willing to go to such extreme measures for something like this, what are they willing to do for a blockbuster drug? And, after the drug company responds, is it too late—the ads have already hit the streets. No corrective action can be corrective enough to undue whatever damage was done. And, I bet the drug companies know that.

Of course, it may be that the efficacy issues (“Crush. Kill. Destroy”) qualifies as puffery. Most of us are jaded with regard to advertisements, and we know they overstate their products a fair bit.

Here’s a link to the advertisement. Puffery or false claims? You be the judge.

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.