Drug Recall Lawyer Blog

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.

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!

The Washington Post featured an informative article this weekend about efforts by people and groups connected to medical device manufacturers to resist inclusion in health care reform. One issue is whether medical device manufacturers are partly responsible for driving up the costs of healthcare. Here are some interesting talking points from the article:

• Profit margins of many medical devices are over 20%. The industry makes $130 billion per year. Many are concerned that medical devices are “overutilized” in the United States.
• Medical technology represents 6.2 percent of total national health expenditures in 2006.
• A $40 billion tax (over the next 10 years) on device makers was approved by the Senate Finance Committee earlier this year.
• Prominent manufacturers of medical devices in Minnesota, Indiana, New Jersey and others find support against the proposed tax from their states’ political representatives, many of whom are concerned about jobs in these states.
• Concerns still abound about inappropriate marketing, lobbying and payouts by device manufacturers to the FDA and doctors.
• The medical device industry spent $15.7 million on lobbying in the first 6 months of this year. Money sometimes goes to political candidates and representatives.

Ask any pharmaceutical or medical device lawyer—one of the biggest problems in tackling these cases is product identification (sometimes referred to as PID). As an example, in the gadolinium MRI cases, it can take months (or longer) to go through and determine (1) whether the patient had gadolinium used for any particular MRI or MRA scan, and if so then (2) what brand of gadolinium was used. The brand is important because the lawsuit must identify a proper defendant.

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