Drug Recall Lawyer Blog

We're just hearing about a May 7, 2010 FDA warning letter to Medtronic over Medtronic's failure to establish protocols to review customer complaints and to validate device designs. The letter relates to image-guided surgical systems for spinal, cranial, and ENT applications.

This probably isn't a huge deal, and doesn't imply any particular defects. On the other hand, it's hard to know about defects if Medtronic isn't actively looking for them...

Here are this week’s stories:

• Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
• Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
• PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
• AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
• Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
• Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
• More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Here are the stories we’re following this week:

• Infusion pumps: The FDA is tightening regulation of infusion pumps, which have reportedly caused 710 deaths in the past five years, and have been subject to 79 recalls since 2005 (news links to The New York Times, The Wall Street Journal, Associated Press, Reuters).
• Guidant: Brian Nash’s perspective on the defective Guidant defibrillator settlement proposal.
• Fosamax: Apparently, the trial has been going on all week (HT: Shearlings Got Plowed).
• Sprint Fidelis Leads: Last week, the 8th Circuit Court of Appeals heard arguments in Case no. 9-2290, Anna Bryant v. Medtronic. You can hear the recording here.
• Pfizer: The FDA issues a warning to Pfizer about clinical trials where children received excessive dosages of antipsychotics (HT: FiercePharma).
• Boston Scientific: The Guidant-purchaser is set to resume sale of some defibrillators which were recalled last month after it notified the FDA that some paperwork wasn’t properly submitted. (see The Wall Street Journal (subscription req’d)).

Happy Monday!

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.

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