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?

Sean Wajert of the MassTortDefense Blog has a post on a court’s denial of a plaintiff’s ethics expert in an OBTape MDL pending in Georgia. We routinely disagree with Sean’s blog (we’re on different sides of the aisle, of course), but there isn’t much disagreement with this post.

Disclaimer: I haven’t been following the OBTape litigation too closely, so all my information is secondhand.

Plaintiffs hired a business ethicist, Professor Ann Buchholtz, to testify that the product manufacturer should have provided certain information about the product to physicians and consumers. This is essentially a failure to warn claim. The problem with hiring a business ethicist (who, apparently has no particular expertise in medical devices or medical ethics, which arguably could alter the analysis) is that she is unnecessary. A jury is tasked with determining whether a company failed to warn about specific dangers. Having an expert say what is “ethically” required is merely an attempt to substitute an expert’s opinion for that of the jury. And, the danger is that the opinion comes cloaked in the guise of expert testimony, so a jury might be more willing to accept the expert’s viewpoint.

I don’t know if the plaintiffs hired FDA experts, but that’s really the approach to take. It is important to show that the company had knowledge of specific product problems, defects or dangers that rose the level of requiring the company to report those problems to the FDA, and likely require the company to issue a better warning. That’s the expert opinion testimony needed in a case like this.

Ethics are important, but they are not rules. It’s not something that should be testified to by an expert in most cases. The jury should determine whether or not they apply in any particular case, and what the standard should be.

The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There's an interesting calculation of Baxter's expected loss (though, Baxter is hoping to be able to replace the Colleague pumps with other Baxter pumps).

See our prior post on the Baxter pump recall here.

The pump is a device that delivers various fluids in a hospital, nursing home, or even home setting. According to the FDA, the Colleague-brand pump has had problems going back as far as 1999, including “battery swelling, inadvertent power off, service data errors, and other issues.” Baxter’s attempted solutions have not been successful. Baxter has been ordered to provide replacement or refund to all customers.

All told, the FDA has received 56,000 adverse event reports in the past five years, and has found that the pump may be linked to over 500 deaths.

Baxter has issued a press release, available on its website. However, Baxter’s website addresses problems with other pumps (and older problems with the Colleague), but does not address this situation, yet. Furthermore, we could not find any mention of the Colleague pump in the regular product line (which, is just as well, but it would be another good location to inform customers about the problems). The company gets a C-average for using social media (their website) to keep customers apprised of potentially life-threatening problems.

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.

Heart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed sprint fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subject recall and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

Continue reading "Boston Scientific Defibrillators Recalled " »