Drug Recall Lawyer Blog

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!

Yesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.

This story, the story of Amanda Bennett, Terrence Bennett and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises a number of issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:

Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.

The last four days of Mr. Bennett’s life cost his insurance company $43,711. My mom, a respiratory therapist in Colorado, says that extraordinary measures and costs in the last days of life are the norm. My review of medical records and bills in my own clients' catastrophic cases confirms it.

The story also brings this to mind: though the focus of this blog is on defective drugs and medical devices, it goes without saying that drug companies and medical device manufacturers do great things. They develop products that frequently do help people to live better (if not longer), lives. Of course, our focus is on the negative 5-10% of their behavior and products (I’m just making numbers up, here. You get the idea). The majority of the time, the products are good, and the decisions are responsible. Genetech Inc. and Bayer AG paid for experimental medications for Mr. Bennett. That’s a responsible and noteworthy thing to do.

Clearly, as Dr. Ross notes in his editorial from yesterday’s post, there is a cost-benefit analysis to bringing new drugs to market and approving them. Everyone agrees to that. And, when we decide where the line is that allows some drugs and excludes others, someone is going to be unhappy. But the line has to be drawn somewhere, and we need to do it with the best information possible.

Today’s New York Times featured commentary by Dr. Gilbert Ross (maybe this Gilbert Ross?). “When Senators Play Doctor: Risk-mongering can stifle innovation, cost lives.”

Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that, erecting another level of safety in the regulation of drugs can only be a good thing. But, that’s another blog post.

The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, not the least of which is Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).

Continue reading "Avandia: Much Ado About Nothing?" »

Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).

Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

Continue reading "BigPharma Goes All “Social Media”" »

The FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).

The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. Single exposure to high levels of ionizing radiation causes hair loss, skin burns and cataracts.

The FDA recommends two areas to minimize radiation risk:

1. Appropriate justification of the radiation procedure; and
2. Optimization of the radiation dose used for each procedure

To meet these goals, the FDA will work to issue guidelines for manufacturers of these radiation-emitting devices to create safeguards and appropriate training protocols. Further, health care providers will work with the FDA to implement quality assurance standards.

One of the most important parts of this process is, of course, the patients. Patients should discuss the risks of any procedure involving radiation with their doctors. The FDA is working to develop a patient medical imaging history card, which (if used properly) will better enable physicians to understand the lifetime radiation history of patients, and enable them to better inform patients as to the real risks of subsequent exposure.

The press release focused mostly on the CT images and fluoroscopy, and did not seem to address the procedures for radiopharmaceuticals (nuclear medicine studies), though perhaps that is subsumed in the section on protocols for health care providers who perform imaging services. But, the manufacturers of those pharmaceuticals should also be part of the discussion.

Here are links to some stories we’re following:

• Hormone Therapy: New Philadelphia hormone therapy case proceeds to trial, and the plaintiff’s twin sister, who sits in the courtroom and took a different type of hormone therapy, did not have cancer. Both sides try to use it to their advantage
• Ortho Evra MDL: The judge addresses the issue of plaintiff ex parte communication with treating physicians (HT MassTortDefense Blog)
• Digitek: Bad news for some plaintiffs’ lawyers in the Digitek lawsuits (HT Overlawyered)
• Social Media and Drug Companies: Several drug companies have banded together to comment on the FDA’s proposed policies on promotion of medical products using the internet and social media (HT Pharma Marketing Blog)

Happy February!

Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

• Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
• Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

Bisphenol-A (BPA) is a chemical used in production of polycarbonate plastics and epoxy resins, and until recently it featured largely in baby bottles. In 2008, the public consciousness was flooded with reports that BPA leeches from bottles into liquid (more or less, depending on the temperature of the liquid). Other reports have indicated the potentially dangerous effects of BPA. In April of 2008 the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (part of the National Institutes of Health) drafted a brief concluding that exposure may affect human development (including early puberty, prostate gland changes, behavioral changes) or reproduction.

The concern for babies is that they have potentially the highest BPA intake—on a pound-for-pound basis, they consume more than adults and additionally suck on plastic items that increases the risk of exposure. In rodent tests, there is evidence that young animals cannot metabolize the chemical as efficiently, and therefore have higher concentrations in their blood.

While the FDA was initially lukewarm about BPA concerns, it has raised the temperature of its response by announcing last week that “on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.” Read the full FDA update here.

Other studies, however, have refuted any harmful causes of BPA, including one from the Environmental Protection Agency.

On the litigation front, MDL 1967: In Re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation was transferred to the U.S. District Court for the Western District of Missouri (Judge Ortrie D. Smith) on August 13, 2008. The allegations against bottle manufacturers and baby formula manufacturers (retailers were dismissed) at time of transfer were that BPA is toxic, and may cause cancer. In November of last year, the judge dismissed all of the formula defendants and ordered the parties to submit dates for completion of discovery, filing of motions for class certification, and other motions.

Whether this is overly paranoid or not, most people (especially parents) are taking the safe road, and avoiding baby products containing BPA.

A number of news outlets have reported Ralph Tyler’s switch as Maryland insurance commissioner head of the Maryland Insurance Administration to his new position as top dog in the FDA’s legal department (Law.com, Maryland Lawyer Blog, Maryland Daily Record and FDA Law Blog).

While in his post as the insurance commish for Maryland (since September 2007) he fought over the compensation package for CareFirst BlueCross BlueShield’s former CEO, William Jew. Tyler cut the compensation down from $18 million to about $9 million (that decision was overturned by the Baltimore County Circuit Court in November—the agency has filed a notice of appeal). He also managed to return about $100 million ($13.8 million to the doctor-policyholders, and $84.1 million to the state of Maryland to make up for subsidies that slowed years of malpractice insurance rates) from Medical Mutual Liability Insurance Society of Maryland. To much fanfare in Maryland, he helped to crush a proposed 72% rate increase by Baltimore Gas & Electric.

But, he left all of that behind last week, and is expected to formally start at the FDA on January 19, replacing interim General Counsel Mike Landa. No word yet on what Tyler’s plans for the FDA are—at this point, he states that he is planning to assess the agency’s needs, and go from there. He’s a smart guy, and he has a good track record—I’m sure the FDA and consumers of drugs and medical devices will be well-served.

It’s going to be a great year. If one of your new year’s resolutions is to follow industry news more closely, here’s some required reading:

• Hormone Therapy: Bloomberg reports on the latest Plaintiff’s Prempro victory (actually, the drug at issue here was Provera, later combined with Premarin by Wyeth to make Prempro)—a Pennsylvania appeals court ruled that the trial court wrongly granted judgment for defendants, notwithstanding a jury verdict for Plaintiff. We’ll report more on this later in the week.
• Conflicts of Interest: The New York Times notes that two Harvard Hospitals (Massachusetts General and Brigham and Women’s) have issued new guidelines on outside pay for senior officials. They can now only accept a maximum of $5,000 per day of actual work—and no stock. Importantly, speaker’s fees from drug companies are prohibited for all employees. The momentum is good—let’s hope these attitudes spread.
• Res Ipsa Loquitur in a Medical Device case: We don’t usually agree with the Drug and Device Law blog, but we come as close as humanly possible in this situation—a federal judge in Connecticut dismissed a product defect case for orthopedic bone screws because (get this) plaintiff did not hire an expert. Maybe plaintiff could not find an expert (in which case, the case probably should not have been filed), or maybe the plaintiff could not afford an expert in a tentative case (in which case, you get what you ask for). This world is too complicated to do without experts.
• FDA Fails to Learn: MSNBC reports that the suggestions of congressional investigators following the Vioxx debacle have gone largely unheeded by the FDA. That report suggested that the FDA could better detect problem drugs by giving more decision-making power to scientists who monitor drug side effects following approval.
• More Drugs For “Neglected” Diseases: The FDA Law Blog comments about the rise in drug approvals for historically neglected diseases, including malaria, kinetoplastids, diarrheal diseases, roundworm, bacterial pneumonia and meningitis, and typhoid and paratyphoid fevera. Many of these disproportionately affect third-world countries, so we’re glad to see this advancing research.

Okay—now back to work!

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!

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!

The FDA Law Blog reports on "Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from Office of New Drugs to the Office of Surveillance and Epidemiology." The post cites a GAO report following up on extensive efforts to revamp the postmarket surveillance of drugs by the FDA, something that has become critically necessary, especially in light of repeated abuses by the drug companies in selling and marketing products well after deficiencies come to light.

The GAO report can be found here.

Not drug related, but Happy Anniversary is in order.

Now that you know more about me than you are probably comfortable with (who celebrates that?), let’s get to business with some noteworthy items:

• Reuters discusses the FDAs investigation of using drugs like Seroquel on children.
• Recently expanded indications for Seroquel by children.
• The Chicago Tribune writes about abuses in prescribing psychotropic medications without consent and without a valid medical reason. Note the front-and-center picture of Seroquel.
• The Wall Street Journal discusses a clinical study showing that an experimental once-a-week treatment woks better to treat type-2 diabetes than Januvia.
• Tomorrow (December 8, 2009) the FDA will convene a joint meeting of the Cardiovascular and Renal Drugs Committee and Drug Safety and Risk Management Advisory Committee. They will discuss safety as it pertains to Gadolinium-based contrast agents, which are used before MRI procedures. A copy of the background material (agenda, briefing information and meeting roster) is located here. More information on Gadolinium-based contrast agents can be found at our blog and our website.
• More on Ghostwriting (courtesy Brian Ketterer). I like this excerpt:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Happy Monday!

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!

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

Happy Monday!

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.

Happy Monday!

It is not enough that their pills are dangerous—it now turns out that some of them may not even be effective. The FDA inspected Bayer’s Germany plant in March where drospirenone, the fourth-generation progestin, is created for Bayer’s top-selling YAZ and Yasmin birth control pills. Essentially, Bayer had been sampling their product and averaging the results, then delivering the averaged data to the FDA. Instead, Bayer should have been delivering the results of each sample of the product. Averaging increases the likelihood that the samples will pass efficacy muster.

A copy of the FDA’s letter to Bayer may be found on their website.

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.