Drug Recall Lawyer Blog

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.

Here are this week’s stories:

• Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
• Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
• Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
• Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
• Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
• Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.

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.

The results of a new study are out, which show the dangers Zocor in high doses or in conjunction with other drugs. Zocor is indicated as one component of multiple risk factor intervention for people at significantly increased risk of atherosclerotic vascular disease due to hypercholesterolemia. Evidence shows that high levels of Zocor, more so than similar cholesterol-reducing drugs (statins), can cause myopathy and rhabdomyolysis, which can cause severe kidney damage, kidney failure, and death.

Myopathy is a muscular disease that causes muscular weakness. Rhabdomyolysis is a very specific type of myopathy, the rapid break down of skeletal muscle due to muscle tissue injury. The broken down material can be released into the bloodstream and may cause acute kidney failure. Signs and symptoms for myopathy include unexplained muscle fatigue, muscle pain, tenderness and an elevation of a muscle enzyme in the blood (creatine kinase). Rhabdomyolysis is often characterized by fatigue and dark or red urine, in addition to the symptoms of myopathy.

In the trial (known as SEARCH), patients taking an 80mg dose were compared to patients taking a lower 20mg dose. 52 patients taking the higher dose developed myopathy, compared to one patient taking the lower dose. Eleven patients taking the higher dose developed rhabdomyolysis, compared to zero patients taking the lower dose.

Merck is hiding the ball somewhat—at first glance, it appears to have no comment—the Zocor website was removed (though, to be fair, I’m not sure when it was taken down). It’s a shame they couldn’t use the website to provide comprehensive information to their customers who no doubt have heard the bad news about Zocor and may want some guidance. But, for intrepid customers who dig a little deeper there is a small statement at Merck’s main website, stating that:

We support the FDA's recommendation that patients continue taking their medication as prescribed by their physicians, and that patients speak to their physician if they have symptoms or questions.

Continue reading "Zocor Warnings Rewritten" »

Drug Recall Lawyer Blog Round-Up (03-22-10)

Here are this week’s stories:

• Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
• Seroquel: Trial number one is won by AstraZeneca (see blogs here and here).
• Zocor: FDA issues a new warning for Merck’s cholesterol drug Zocor (HT: Tom Lamb’s Drug Injury Watch).
• Sanofi-Aventis: More on their lessons from the botched Facebook experiment (HT: Pharma Marketing Blog).

Happy Monday!

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

Time to wake up and face the week! Here are the stories we’re following:

• Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
• Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
• FDA: The FDA is going to step up criminal prosecutions of corporate officials.
• Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
• 510k Approvals in February: See the list here.
• Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
• BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
• Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Some interesting news to follow this week:

• Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
• Benzene: The Accident and Injury Lawyer Blog reports on the dangers of benzene.
• Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?
• Lipitor Whistleblower Lawsuit: FiercePharma reports on an amended complaint by a whistleblower, alleging that Pfizer unethically expanded its marketing base by ignoring cholesterol guidelines.
• Recall of Luer Access Devices: The FDA is posting recalls of Luer Access Devices, including certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems and certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. These devices do not properly lock, causing leakage of intravenous materials or blood, or causing air emboli.
• Pain Pumps: This is a good graphic representation of the pain pump system

As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosomax can cause injuries of this type). The plaintiff did not argue against dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

In other Fosamax lawsuit news, Judge Keenan is set to select a replacement bellwether case shortly.

Judge Keenan is overseeing something like 700 lawsuits. As of last year, Merck had about 953 cases pending against them. Everything I have seen from these cases indicates that the plaintiffs have extremely meritorious claims. This is one litigation that I regret not getting into.