Drug Recall Lawyer Blog

The California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.

The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.

This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem in this case is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.

This may be an extreme case, but there are countless examples of doctors who receive trips, dinners, sporting event tickets and other “prizes” in exchange for business. Can a doctor really have a patient’s best interests at heart when he receives something of value from one device manufacturer and not another?

The FDA is warning patients and doctors about possible risks posed by 280,000 defibrillators, manufactured by Cardiac Science of Bothell. These are external defibrillators, the kind you find in airports, at hospitals, nursing homes and at swimming pools.

The devices may not provide the correct shocks, may not properly evaluate heart rhythms. There are 14 devices subject to the warning, including Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillators manufactured between 2003 and 2009.

Users should continue to use the defibrillators (which are potentially better than nothing) until they can get replacements or repairs. Obviously, the FDA recommends that high risk locations (hospitals, nursing homes, etc…) immediately arrange for repair/replacement and use alternative devices in the meantime.

See the FDA’s notice here.

The New York Times published an article yesterday, “When Heart Devices Fail, Who Should Be Blamed?” The article puts a nice gloss on how and whether a company and people in charge of a company can properly make amends and taking personal/corporate responsibility.

The backstory is of course that a federal judge is considering whether to accept a $296 million fine, and a guilty plea to two criminal misdemeanors by Guidant (now Boston Scientific). Two cardiologists are urging the judge to reject the deal, and instead want prosecution of the company “and the individuals responsible.” The cardiologists, who cared for 21-year old patient who died because his Guidant device did not properly function, further state:

Manufacturers control the quality of their products. Manufacturers are the first to know when a medical device is dangerous or underperforming. Thus, it is in the best interest of patients, and society in general, for manufacturers to be liable for the safety and effectiveness of their products. To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.

Sadly, it’s hard to know what the cardiologists are really looking for. I suspect they want the executives in charge to be put in jail, or have to pay fines from their own pockets. But, this may be a situation where there is no relief, as thousands of patients and their families know because they are prevented from filing meaningful civil lawsuits. The only thing we can do is work to repair the damage caused by medical device immunity.

For more on the Guidant topic, see our prior blog posts.

The president of the American Association for Justice, Anthony Tarricone, comments about the extreme costs associated with medical device immunity. As one example, he cites to the Sprint Fidelis lead wires which have a high rate of breakage and unnecessary shocks. The manufacturer, Medtronic, is so far immune from claims of injury by people who had the device implanted.

In this day of concern over rising medical costs, the fact that consumers, taxpayers and insurance companies have to foot the bill for problems created by medical device companies should be an outrage. And, that doesn't even take into account the unquantifiable pain and human distress caused by defective devices.

Here is a short video featuring people who have experienced first-hand the pain of repeated electric shocks by the Sprint Fidelis lead, and a description of the legal issues.

Stop Corporate Immunity - Medical Device Safety Act from American Association for Justice on Vimeo.

The first federal Kugel Mesh hernia repair lawsuit began in the U.S. District Court for the District of Rhode Island, yesterday. Plaintiff John Whitfield claims that the mesh, manufactured by Davol, Inc., was defective and broke after it was implanted, causing bowel obstruction, abdominal pain, nausea, permanent bowel injuries, and necessitating additional surgery.

This is the first of four bellwether trials, designed to give lawyers on both sides a sampling of how jurors will deal with the information and trial strategies. This may assist the parties to reach settlement in remaining cases, after they learn the strengths and weaknesses of each side.

There are 1,300 other hernia mesh cases that are consolidated in the Rhode Island federal court MDL. An additional 1,774 cases are in Rhode Island state court, with the first trial expected later in the summer. Many of the hernia patches were recalled since 2004.

Defendants have a great deal of risk with these cases—though damages in the average individual case are not extreme, the volume of the cases and the record of manufacturer indifference to the problems makes punitive damages a possibility.

For more information on Kugel Hernia Mesh Patches, see our website and our prior blog post.

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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