Drug Recall Lawyer Blog

An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.

Continue reading "Stronger Label Urged for Birth Control Products, Yaz and Yasmine" »

The FDA is evaluating post-marketing reports of serious bleeding events in patients that are taking Pradaxa (dabigatran etexilate mesylate). Pradaxa, a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), contains a drug label that warns about significant and sometimes fatal bleeds, bleeding that may lead to serious or even fatal outcomes.

In a large clinical trial involving 18,000 patients, Pradaxa and warfarin were compared, with major bleeding events occurring at similar rates with the two drugs.

The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

At this time, the FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label. Are there right about this? Who knows? Clearly, patients with AF should not stop taking Pradaxa. Should they be talking to their doctor about these new concerns? Of course.

The FDA says it will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

• Pradaxa Problems and Real Costs Compared to Coumadin

Drug companies love to hid behind the FDA's skirt. I don't think the FDA is a bad organization. And it is getting better (I think). But we get almost weekly evidence that the FDA is not the lock down gatekeeper that pharmaceutical companies pretend that it is.

This week's evidence is revealed in the New York Times. In an audit of 17 FDA food recalls, the FDA often failed to follow its own rules in removing dangerous imported foods from the market. Keep in mind the level of screw up here: failure to follow your own rules after you know there is a problem. This audit concluded that government food officials are often sloppy and inattentive in their efforts to ensure that bad food is taken out of our mouths quickly.

The FDA is not a joke or a laughing stock. When it is sticking its chest out, the FDA implicitly but seductively suggests it can protect us. But its reach exceeds its grasp. It can't deliver. Even under the best case scenario with the greatest government regulation in the history of the world, it still can't deliver.

Who can protect us? Product manufacturers and food and drug companies need to be the gatekeeper for safety, not the FDA. When they fail to assume that role for their own product, there should be ramifications. Yes, that means lawsuits, folks.

The FDA has put forth proposed guidelines for implementing the salient portions of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) that requires certain restaurants (20 or more locations) and vending machines to disclose nutrition information.

Critics like Walter Olson, Wes Siegner and Susan J. Matthees are upset by the impact this is putting on small businesses. Although I think a restaurant with 20 locations is a little bigger than a small business, I get their point. No doubt, there are unnecessary burdens that government places on small businesses.

But I think the world is changing and things need to change with it. Obesity is not a problem you can legislate directly. But indirectly maybe by requiring people serving us food to tell us what it is? I'm in favor of it and I think in 20 years we will be amazed it was any other way.

In just an hour, the FDA's Office of Compliance, Division of New Drugs and Labeling Compliance (DNDLC) will present a webinar entitled, "Marketed Unapproved Drugs." The webinar will discuss (1) the history of drug regulation in the United States, (2) the public health risks associated with marketed, unapproved drugs and FDA's Unapproved Drug Initiative, (3) and will identify tools to assist in determining the approval status of prescription drug products.

No word yet on whether Johnson & Johnson will require everyone at J&J who has ever even heard the word "Topamax" to attend.

Okay, that was a weak effort at a joke. I was trying to slide in a "marketing Topamax for everything but the common cold" jab but it does not really fit. You sometimes can't fit in the joke with the story. But checkout the webinar.

In an article about what the FDA does not tell you, Smart Money tells us that 90% of medical devices approved by the FDA go through what is called a "510(k)" which allows device manufacturers to skip testing a device before putting it on the market if there is already a "similar device available."

I'm not saying necessarily that every medical device that has the slightest modification should have to jump through the full FDA approval process. I think few people are really saying that. The question is simply where do we draw the line and it seems fairly clear that we are drawing it in a way that makes it far too easy on medical device manufacturers.

The FDA recently took a shot at making the 510(k) device clearance process "more predictable and smarter" but has not made any real progress. Again, I understand their trepidation. We want to get products with slight improvements on the market quickly. I just think we have to (1) better define what qualifies for 510(k) and (2) intensify the requirement - something in the middle of full blown testing and "bring it on through."

With Meridia tossed to the trash heap of history, there is a void in the market for a new diet drug. That void apparently will not be filled by Arena Pharmaceuticals' new drug lorcaserin. The FDA rejected the drug last week. The problem with lorcaserin was a big one: it caused the formation of cancer in rats, albeit in high doses.

There is obviously big demand for a diet drug that works and has limited side effects. Eventually, modern science is going to produce such a drug and extreme obesity will be a thing of the past. Arena Pharmaceuticals probably would tell you that while not a panacea, we are getting closer with lorcaserin and they will be able to prove it is both safe and effective. History gives us doubts.

The Huffington Post has an interesting blog post about how little the government is doing in spite of the fact that MRSA - the drug resistant staff infection that kills thousands every year - is being found in random samples of raw pork, beef and chicken. The biggest culprit seems to be pork.

The CDC acknowledged the presence of MRSA in some meat but does not seem overly concerned because the levels of MRSA are low. That may well be true. I doubt anyone at the CDC would want their kids eating meat that they knew had any level of MRSA in it. I'm not sure I would want to use the "would I let me kid eat it?" standard for a recall. But the CDC tells us that there were 76 million new cases of food related illnesses that were reported - reported - in 2009 causing more than 5,000 deaths. So we need to make sure we are minding the store on food safety because we cannot rely on the food producers to balance the costs and benefits of what is safe to put on our plate.

An editorial in the Carroll County Times (Maryland) provides some information about contaminated food that will surprise some: 300,000 are hospitalized and 5,000 die every year because of contaminated food.

Congress is now looking to give FDA the authority that most people thought they already had: to order food recalls.

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.

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!

Here are the stories we’re following this week:

• Yasmin: Bayer is updating its European warning label after recent Swiss studies (HT: Tom Lamb)
• Direct-To-Consumer Drug Advertising: FDA proposes new regulations (HT: Mass Tort Defense Blog)
• Zicam: Update on the Zicam (nasal spray that may cause loss of sense of smell) MDL, pending in Phoenix (HT: Searcy Blog)
• Pain Pumps: California state judge cuts up pain pump claims (HT: Drug & Device Law Blog)
• Drug Companies: Three drug companies (Pfizer, Solvay, and Procter & Gamble) found to have breached the British Pharmaceutical Industry’s code of practice (HT: PharmaGossip)

Happy Monday!

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!

News reports in the past couple of days have hit on part two of the CT radiation overexposure. Before, the issue was whether certain CT devices, whether because of manufacturing, design, or technician error, provided too much radiation to patients. A secondary question was whether patients were receiving too much radiation through scans over the course of their lives (the FDA reports that the average person’s radiation exposure has doubled in the last thirty years).

Now, the question is focused on whether CT scans are a good idea for screening purposes where a patient has no indication that they have any disease—the three that have been most mentioned are whole-body CTs (to see if there is anything wrong); CT colonoscopy (to detect colon cancer), and CT scans of the heart (to detect heart disease). Most of the debate has been centered around the colonoscopy procedure.

On one side are those who believe that traditional methods—a colonoscopy, are best to detect colon cancer. Proponents (including the American College of Gastroenterology, who come out on the side of their financial interests in the question) state that CT colonoscopies are not as certain as the traditional visual colonoscopy; that removal of polyps would require a second procedure with a CT colonoscopy (versus being done at the same time in the traditional procedure), and that incidental findings on a CT scan may lead to unnecessary procedures. Additionally, repeating these scans increases patient exposure to radiation.

Detractors, those who support the “virtual colonoscopy” (including the American College of Radiology, who likewise come out on the side of their financial interests in the question) state that virtual colonoscopies are less invasive and more people will probably use them; that there is less chance of perforated bowel or anesthesia risks.

Even the FDA is undecided—there is a fight there about whether the procedure, which General Electric wants to have approved (it manufactures scanning equipment), should be approved (meaning GE would be able to market the virtual colonoscopy to patients and doctors). Some doctors and scientists believe the extra radiation exposure would cause actual harm, when even now between 1.5 and 2 percent of cancers are caused by CT scan radiation exposure.

As uncomfortable as the traditional method may be, it seems like the safest way to go. The problem with radiation exposure is that you don’t know how much you will have during your lifetime—a few major diseases, and your CT (and other) radiation exposure could magnify tenfold, meaning you might regret a virtual colonoscopy every few years. Additionally, the virtual colonoscopy, though perhaps effective to a degree, is not as certain as a traditional colonoscopy. And, peace of mind is a good thing.

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!