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

Here are the week’s stories:

• Adverse Events: Our friends at the US Recall News have a link to governmental agencies in charge of adverse event complaints and concerns.
• Avandia: Lots of concern recently about diabetes drug Avandia and heart problems (HT: Nursing Home Abuse Blog).
• Iqbal: The Lewis & Clark law review released its symposium “Pondering Iqbal.” There’s some good topics here—a must read (HT: PrawfsBlog).
• BPA: More on BPA research (HT: Nash & Associates).
• Fentora: This narcotic painkiller is the subject of possible off-label promotion (HT: Drug Injury Lawyer Blog).
• Pharmaceutical Marketing: The title says it all: “A Snarky Look at Sneaky Marketing Tactics Pharma hasn’t Avoided" (HT: Pharma Marketing Blog).
• Gadolinium/Omniscan: A settlement has been reached in the libel suit brought by General Electric (GE) against Danish researcher Henrik Thomsen.

Happy Monday!

In Foster Care Children and Off-Label Drug Use I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

Assuming these facts are true and that doctors are overmedicating children in Anchorage, some may think that the doctors are to blame. They have the ultimate responsibility, having intimate knowledge (hopefully) of their patients’ conditions, and being able to fully and fairly judge what medication, if any, they should be on. Others may point to the drug companies, who encourage doctors to prescribe drugs to patients, often for off-label uses which have not been safety-tested or FDA-approved. Those same drug companies may use subtle persuasion to enforce these practices—lunches, gifts, and vacations masquerading as medical education seminars.

But one thing is certain—if a drug company sees a physician or group prescribing an inordinate percentage of their drugs, they should spend some time with that physician/group to make sure that the doctor fully understands what the drug is approved for? The drug companies have track these statistics, but something tells me many of them happily look the other way and their profits climb…

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!

Here are some of the stories we’re following this week:

• Janumet: Shearlings Got Plowed reports that the FDA is revising the label for Janumet to warn about pancreatitis. A link to the FDA’s prescribing information is here
• Seroquel: Tom Lamb reports on the difficulties that plaintiffs are facing in these cases, of late. It seems that the odds are against us and the situation is grim—a good time for a reversal
• Prempro: NPR reports on the marketing masquerading as research by drug-makers trying to profit from menopause
• Levaquin: The Mass Tort Defense blog reports on the status of the bellwether trials: consolidation rejected
• Conflicts of Interest: The New York Times reports that Pfizer gives $3 million to Stanford University for creation of continuing medical education courses, where Pfizer has no say on what the money is spent for. Does this prevent conflicts of interest or is it “self-satirizing?”

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.

The FDA has started a “Safe Use” initiative to combat the growing problem of medication errors. An article by The Washington Post reports that greater care in the writing, filling and taking of prescriptions can prevent 50,000 unnecessary hospitalizations per year. Other statistics of interest, according to the article and the Institute of Medicine:

• 1.5 million preventable injuries and deaths are caused by medication errors
• Medication errors cost $4 billion annually
• Between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs.

Much of the onus for preventing these injuries clearly rests on doctors, pharmacists, and patients. However, what responsibility do pharmaceutical companies have?

Continue reading "Reducing Medication Errors: What Can Drug Makers Do?" »

Bayer, the manufacturer of other terrific products (YAZ and Yasmin birth control pills: improperly advertised, cause blood clots, and can necessitate gallbladder removal, among other things; gadolinium-based contrast agents: turn skin orange and hard, make movement difficult, and can harden organs; and Trasylol: blood-clotting drug that causes clots, heart attacks, amputations, and kidney failure), also makes multi-vitamins. Today we’ll talk about the selenium-containing Men’s One A Day (MOAD) multivitamin.

Continue reading "On Multivitamins and Medical Benefits " »