The background of this motion was ominous for plaintiffs. The court had previously kept their claims alive by a shoestring and struck many of the key “failure to warn” claims that were made in the lawsuits. Plaintiffs received an opportunity to cure the defects in the Complaint which they, thankfully, did.
Judge Selna denied a motion to dismiss that was filed in multiple product liability lawsuits filed on behalf of individuals who experienced problems from the leads. These suits allege the manufacturer improperly designed and sold a defective product. Although St. Jude attorneys maintained that the product was FDA approved, Judge Selna determined the allegations were based on violation of FDA regulations.
Plaintiff’s Claims Are Becoming Clearer
When medical device companies screw up, they always go to their favorite defense which I call hiding behind the FDA’s skirt. This defense has a good history as anyone with a memory of the failed Medtronic lead litigation will tell you.
But plaintiffs’ motions highlighted to the court that the allegations make it tough for St. Jude to hide behind the FDA. Why? The FDA conducted an inspection in June 2009 to try to get to the bottom of adverse reports of problems with St. Jude’s Riata leads. This inspection focused on Design Control and Corrective and Preventative actions involving St. Judge Durata and Riata leads. The company gave the FDA information on the complaints that they got from 2002 until the inspection regarding the leads.
Plaintiffs’ allege – apparently with foundation – that what St. Jude submitted to the FDA did not disclose all the problems that were known to the manufacturer and that some reports were later sent to the FDA long after St. Jude was obligated to reveal the reported problems. So we are not talking about just a garden variety failure to warm claim here. This could be a fraud-on-the-FDA and a failure to disclose alternative designs claim that could have real teeth.
Background of the St. Jude Lead Litigation
St. Jude Riata and Riata ST ICD leads are small wires that are used to connect an implantable cardiac defibrillator to the heart for those with abnormal heart rhythms. In 2010, reports began to circulate that the insulation surrounding the leads were prone to failure and could result in exposed wires in the body, that could send unnecessary shocks or cause the defibrillator to fail. Such failures can require risky revision surgery. The leads were removed from the market shortly thereafter.
In 2011, the manufacturer issued a warning to doctors concerning the possibility of insulation problems, sparking an FDA qualified recall. One year later, the FDA issued a safety communication for those individuals who still have the leads, recommending individuals undergo x-ray monitoring to determine the condition of the already installed leads. It is estimated that over 79,000 leads remain active in patients in the United States.
Hiring a Lawyer for Your Potential Suit
The condition of your heart is something that should always be taken seriously by both doctors and by the companies that make these medical devices. They have an obligation to be honest and to do everything they reasonably can for you. The allegation here is that they did not.
If you or a loved one experienced problems with the St. Jude Riata, you need to learn more about these cases. If you had to undergo the risky revision surgery or experienced shocks from exposed wires, contact us for a free consultation at 1.800.553.8082 or online, here.