FDA Warning Letter May Be Issued Over St. Jude Lead Problems

St. Jude Medical has told investors that it may receive a warning letter from U.S. regulators over manufacturing issues or other problems at a California manufacturing plant, where many St. Jude defibrillator lead products are made, some of which have suffered from alleged manufacturing defects that could cause the wires to poke through the insulation after they are implanted in patients.

During a conference call with analysts last week, the company’s Chief Executive Officer indicated that an FDA warning letter may be issued by the U.S. Food and Drug Administration (FDA) following a recent inspection of a St. Jude manufacturing plant in Sylmar, California.

Although details of the investigation or any problems discovered have not been provided, FDA warning letters are typically sent over quality control issues, failure to report or follow up on adverse events or other violations of good manufacturing practices.

The plant is one of five where St. Jude manfactures cardiac rhythm management products, including lead wires that are used to connect implantable cardioverter defibrillators (ICD) to the heart.

In recent years, St. Jude has faced increased regulatory scrutiny after a number of problems surfaced with different models of their defibrillator leads. The wires in some models of St. Jude defibrillator leads have been found to poke through the insulation, resulting in an exposed wire inside the body. This could cause patients to suffer unnecessary shocks or cause an ICD to fail to deliver a life-saving jolt when needed.

The company has recalled the St. Jude Riata lead wires, amid reports of premature insulation failure. A growing number of consumers are now pursuing a St. Jude defibrillator lead lawsuit, alleging that manufacturing problems and design defects caused their leads to fail shortly after they were implanted.

St. Jude Lead Manufacturing Problems Alleged in Lawsuits

As of the beginning of this month, at least four product liability lawsuits had been filed in the federal court system over problems with the St. Jude Riata and Riata ST leads, alleging a number of manufacturing issues could have caused problems with the leads.

The complaints allege that manufacturing problems caused the St. Jude Riata leads to become vulnerable to abrasion and insulation failure, which may allow the small wire to poke through the insulation.

Some plaintiffs have indicated that St. Jude failed to manufacture the leads consistent with the FDA approved process, creating a defective product.

Lawsuits allege that the St. Jude Riata leads featured inconsistent insulation diameters and inconsistent lubricous interface between the inner and outer insulation, which can lead to problems with abrasion or wear at thinner sites. In addition, claims indicate that St. Jude may have failed to properly cure and sterilize during the manufacture of the leads, which may have resulted in reduced strength of the silicone insulation.

FDA Response to St. Jude Defibrillator Lead Problems

After St. Jude stopped selling the Riata defibrillator leads in 2010 and issued a letter to doctors in November 2011, warning about reports of insulation problems, the FDA classified the actions as a Class I Recall, suggesting that use of the product may pose a substantial risk of serious injury or death.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude defibrillator leads implanted. Due to risks associated with trying to replace the leads, individuals have not been told to remove the leads unless problems have been confirmed.

The FDA indicated that individuals who received a St. Jude Riata or Riata ST leads should undergo x-ray or other imaging exams to monitor the condition of the leads. The agency also indicated that doctors should consider remote monitoring for patients with the Riata leads in order to quickly catch electrical problems.

At that time, it was also disclosed that the FDA ordered St. Jude to conduct additional studies on the potential risk of early insulation failures and probelms with the defibrillator leads. In addition to the Riata leads, the FDA also ordered three-year surveillance studies on newer versions of the St. Jude leads, sold under the names Riata ST Optim and Durata.

St. Jude introduced the Riata ST Optim lead in 2006, and subsequently renamed it the St. Jude Durata in 2008. Although these newer leads were introduced with redesigned insulating material, reports have suggested that problems with the insulation may also exist with the Riata ST Optim and Durata leads.

Concerns have been raised about St. Jude’s handling of the lead problems. According to a report published earlier this month, several doctors have indicated that St. Jude was aware of the Riata lead problems for years before it was removed from the market. The Wall Street Journal indicated that St. Jude Medical was contacted by at least three doctors in 2006, when they noticed that Riata leads were failing in patients and the company told the doctors that they were aware of the problem and that the incidents were isolated.