Suit Charges St. Jude Riata Heart Lead is a Defective Device, Lieff Cabraser Announces

  Suit Charges St. Jude Riata Heart Lead is a Defective Device, Lieff Cabraser
  Announces

Business Wire

SAN FRANCISCO -- March 21, 2014

Fabrice N. Vincent and Wendy R. Fleishman of the national plaintiffs’ law firm
Lieff Cabraser Heimann & Bernstein, LLP, announced today that Robert Loiseau
of Southampton, Pennsylvania, has filed a personal injury lawsuit against St.
Jude Medical for injuries he suffered due to manufacturing defects in St.
Jude’s Riata cardiac defibrillator leads.

Mr. Loiseau was implanted with a St.Jude-manufactured Riata lead in
September2007. In April 2012, Loiseau learned that the lead was defective and
had to be removed. He underwent invasive surgery to remove and replace the
defective lead on April12, 2012. When the device was removed it was
discovered that the lead had fractured and would have malfunctioned had
Loiseau needed an electrical shock from his defibrillator. As a result of the
defect, Loiseau suffered physical pain, mental anguish, and lost income.

“Deficiently manufactured heart leads can literally kill patients and require
risky, painful surgeries to remove them, if they can be removed at all,”
stated Vincent. “The complaint alleges in detail St. Jude’s utter disregard
for good manufacturing and reporting practices with their Riata defibrillator
leads.”

Numerous flaws in St. Jude’s manufacturing process caused the insulation on
the heart lead wires to break down, resulting in the fracturing and premature
failure of the Loiseau’s lead, the complaint alleges. The lawsuit was filed in
federal court in Los Angeles, California, where St. Jude manufactured the
allegedly defective and dangerous heart lead.

Background on the St. Jude Heart Lead and FDA Recall

St. Jude Medical introduced the Riata in 2002 and the Riata ST in 2005,
followed by a purportedly improved Riata lead, named the Durata, in 2008. More
than 250,000 St. Jude Riata and Durata leads have been sold worldwide. The
devices are used in patients to control arrhythmias or irregular heartbeats.

On December 15, 2010, St. Jude Medical published a “Dear Doctor” letter
regarding its Riata leads. In the letter, St. Jude indicated that the silicone
used on these leads was “vulnerable to abrasion” and the abrasion had been
associated with oversensing (leading to inhibition of pacing or inappropriate
high voltage therapy), undersensing, and the inability to deliver the
electrical shock.

Despite the dangers, St. Jude did not initiate a voluntary recall of the leads
at that time. Rather, St. Jude simply noted that it would no longer sell the
Riata lead.

On November 28, 2011, St. Jude Medical published a second Dear Doctor letter
relating to the same set of Riata lead models as the 2010 Dear Doctor letter,
noting that the failure rate of the leads had increased. On December 21, 2011,
the U.S. Food and Drug Administration reclassified St. Jude’s Dear Doctor
advisories as a Class I Recall. This type of recall applies when there is a
reasonable probability that the use of or exposure to the product or device
will cause serious adverse health consequences or death. That is, a Class I
recall means the device is regarded as potentially dangerous and even lethal.

Resources for St. Jude Heart Lead Patients

Lieff Cabraser represents patients nationwide that received the St. Jude
Riata, Riata ST and Durata heart leads. We will review your claim for free,
promptly and without any obligation on your part. Learn more about the
defective St. Jude heart lead lawsuits or call us toll free at 1-800-541-7358
and ask to speak to attorney Fabrice N. Vincent or Wendy R. Fleishman.

About Lieff Cabraser

From our offices in San Francisco, New York, and Nashville, Lieff Cabraser
represents clients nationwide. The National Law Journal has selected Lieff
Cabraser as one of the top plaintiffs' law firms in the nation for eleven
years. Best Lawyers and U.S. News have named Lieff Cabraser as a "Law Firm of
the Year" for 2014 in the category of Mass Torts Litigation/Class Actions –
Plaintiffs. Learn more about our firm at www.lieffcabraser.com.

This press release may be considered an advertisement in certain
jurisdictions. Prior results do not guarantee a similar outcome.

Contact:

Lieff Cabraser Heimann & Bernstein, LLP
Fabrice N. Vincent, 415-956-1000
 
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