Drug Recall Lawyer Blog

Here are this week’s stories:

• 2009 Adverse Event Reports: Avandia (GlaxoSmithKline) and Seroquel (AstraZeneca) topped the charts for most adverse events for the third quarter of 2009, with 1,218 reports and 977 reports, respectively. See The Institute for Safe Medicine Practices (HT: FiercePharma).
• Avandia: “Glaxo Strikes Back at Drug Critics, But It’s a Big Swing and a Miss.” ‘Nuff said.
• $13 Million Zyprexa Settlement: Lilly settled a suit brought by the state of Montana over off-label marketing of Zyprexa, used to treat bi-polar disorder and schizophrenia. Most of the funds will be used to pay for mental health services in the state. See BusinessWeek.
• BPA: Maryland is considering legislation to ban or limit the use of BPA in plastics used by children. See the Baltimore Sun.
• Seroquel Trial: The Seroquel trial (New Jersey), alleging the drug causes diabetes, is in full force. The parties are arguing over whether marketing took precedence over safety research. See Bloomberg.

Happy March!

Here are the stories we're following:

• Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
• Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
• Twombly/Iqbal Statistics: The Federal Judicial Center has collected preliminary data on motions to dismiss before and after Twombly and Iqbal (hat tip: The Civil Procedure and Federal Courts Blog).
• Prempro: Bloomberg discusses Judge Ackerman's reduction of the Connie Barton punitive damages verdict (by 93%, from $75 million to $5.6 million) and added $1.2 million in interest to the jury's compensatory damages verdict of $3.7 million.

Happy Monday!

The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

• Issues related to predicate devices;
• Issues related to new technologies and scientific evidence;
• Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
• Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

• Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
• Live webcast

Related documents:

• The FDA’s Press Release
• Notice of the Public Meeting
• Background information of 510(k) process
• Announcement of Institute of Medicine’s study of 510(k) process

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

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!

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

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?”

Happy Monday!

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 a list of some important stories we’ve been tracking.

• Boston Globe article probing the financial ties between Massachusetts doctors and Eli Lilly, a large drug manufacturer. “When the [drug] company provides the power point [for the doctor’s presentation], the risk of bias is even greater.”
• Seattle Post Intelligencer article examining the fatal overdose of a 15-year-old teen with autism. Michael Blankenship had a dental procedure and was given a Fentanyl Pain Patch. These are typically product liability cases, but it looks like Michael never should have received the patch in the first place, so Michael’s family has filed a medical negligence complaint.
• Drug Recall of specific lots of Infants’ and Children’s Tylenol (Johnson & Johnson) because of bacterial contamination.
• Update on Vioxx settlement: $4.85 billion.

At the Medtronic annual shareholder meeting last week, CEO Bill Hawkins defended the company’s history of physician collaboration, though he noted that the relationships may create conflicts of interest.

However, the probes by the Justice Department and the Congress into the relationships prompted one shareholder to state that he was shocked by how much Medtronic paid physician “consultants.” For example, Medtronic paid Dr. David Polly the tidy sum of $1.2 million between 2003 and 2007. Hawkins says that his company monitors payments to physicians to avoid conflicts of interest.

Call us skeptical and jaded, but this is a story we’ve seen time and time again. It is interesting that Medtronic is professing themselves to be mostly free of blame—we look forward to the outcome of the investigations to see just how well Medtronic monitored the conflicts.

For more on this issue, see our previous post, “Doctors in their Pockets.”

A nice article from the Washington Post, Probing Doctors’ Ties to Industry, evaluates the recent movement for transparency in the relationships between the pharmaceutical and medical device companies and doctors. We’ve all been to the doctor and have seen pens and pads of paper touting the latest miracle drug, but that is only the tip of the iceberg. The pharmaceutical and medical device industry pays for doctors to attend symposiums (sometimes, these are actually just really fancy vacations with an very small lecture component), dinners, and provides them with gifts of all kinds (from pens to much more valuable objects). It is estimated that Big Pharma spends over $20 billion per year pitching their wares to doctors.

What’s the impact? Like the rest of us, doctors are influenced by marketing (if they weren’t, these industries would not be spending the money). So, a doctor is more likely to prescribe Drug A over Drug B if he just got a nice lunch from Drug A’s sales representative. You’d like to think that all doctors will sit in their library and compare the attributes of the drugs, poring over the Physician’s Desk Reference. But, time is at a premium, and it’s often easier to listen to the sales reps (who are very rarely medically-trained). The question is whether patients receive the proper drug, or the properly marketed drug.

Of course, some donations are for the advancement of science. Doctors frequently receive free samples of drugs or devices for research studies they are performing—this helps pharmaceutical companies and medical device companies to determine the safety and efficacy of their products. Those should be reported as well, but they are less likely to influence a doctor’s prescribing habits.

The article includes statements from a number of doctors who admit to being influenced by these marketing strategies. Many states and the federal government are starting to examine whether doctors should be required to report money and gifts. Some even want to make information available on-line. That way, before your appointment you can see who is paying your doctor. And, you can ask you doctor whether other manufacturers’ drugs might not be better. It’s good to know whether the doctor is prescribing a drug, or whether it’s basically coming straight from industry.