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HEART VALVE RECALL ALERT:     FDA Issues Class I Recall for Agilis Steerable Introducer Sheath devices made by Sterilmed 

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Heart Valve Recall Alert – Valve Made By Sterilmed, a Johnson & Johnson Company

On January 2, 2018, the FDA issued a Class I recall – the most serious type of recall – for the Agilis Steerable Introducer Sheath devices made by the company Sterilmed.  This device is a hemostatic valve which prevents blood from flowing back through the valve.  According to the FDA, the valve may fail due to an improper seal of the sheath hub.  Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).  This product defect may cause serious health consequences in patients, including death.

  The model and lot numbers are as follows: 

  • Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
  • Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017

The Heart Valve Recall Notice can be found here:  The device is manufactured by Johnson & Johnson.

Patients should check your operative report and surgery records to determine whether they have this valve implanted.  As of now, the FDA is recommending that doctors continue to monitor patients with this valve.  However, this may change as information becomes more readily available.  The FDA recall can be found here:

Injuries caused by heart devices are serious and not to be taken lightly.  This heart valve is under the strictest device recall because it may cause serious injury or death.  I worked on many heart device litigations in the past, including the Guidant heart device litigation where my client testified before the Senate Judiciary Committee and the House of Representatives in support of the Medical Device Safety Act (which Congress chose not to enact).  You should investigate immediately to determine whether you have been affected by this heart valve recall.

If you have the Agilis Steerable Sheath valve implanted, please contact Claudine Homolash, Esq. at or (215) 510-2245 for a free legal consultation.  

Monsanto’s Roundup (glyphosate) weed killer was recently designated by the World Health Organization’s International Agency for Research on Cancer (IARC) as a probable human carcinogen. Those who use or are exposed to Roundup or glyphosate containing products are at risk for developing non-Hodgkin lymphoma (NHL).  Read More

Claudine Homolash, Esq. has been named Top 50 Women by Pennsylvania Super Lawyers for 2016.  Claudine Homolash is grateful to have been named again this year by Pennsylvania Super Lawyers as a top 50 attorney in the state.  Claudine congratulates all of her colleagues with whom she works and is appreciative to have been considered by them and the publication. Top 50: 2016 Women Pennsylvania Super Lawyers

Women Should STOP Using Talcum Powder Immediately.  It Can Be Deadly.

Long-term use of Johnson & Johnson’s baby powder has been lined to ovarian cancer.  Many women use baby powder as part of their daily hygiene routine.  Use of baby powder for this purpose should be stopped immediately.  Read More

Drug Zofran Prescribed for Morning Sickness Deemed Dangerous in Pregnant Women

If you have morning sickness and are taking Zofran (ondansetron), especially during the first trimester of pregnancy, please contact your doctor to discuss the risks associated with this drug to determine whether it is right for you. […]

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XARELTO® Cases Consolidated In Louisiana Before Judge Fallon

On Friday, December 12, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated that Xarelto personal injury lawsuits against Johnson & Johnson’s entity Janssen Pharmaceuticals, Inc. and Bayer Corp. […]

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Claudine Q. Homolash of the CQH Firm Joins Messa & Associates Of Counsel

CQH Firm owner Claudine Q. Homolash, Esquire also joins Messa & Associates Of Counsel to expand Qui Tam / Whistleblower and Pharmaceutical Mass Tort practice.

Claudine Q. Homolash, Esquire of the CQH Firm has joined forces with Messa & Associates to concentrate in her areas of focus, Qui Tam / Whistleblower and Pharmaceutical Mass Tort litigation. Ms. Homolash concentrates her practice representing whistleblowers on behalf of the federal government in the healthcare and pharmaceutical area.  Ms. Homolash is excited to work with an experienced team of trial lawyers and expand her team to combat fraud on the government.

Ms. Homolash has a passion for prosecuting pharmaceutical and healthcare entities for fraud stemming from false and misleading information given to the patients and for illegal payments to doctors and other entities solely to increase profits. “People over profits is not an acceptable means of conducting business, especially when lives are at stake.”

You may contact Claudine Homolash, Esquire at 215- 510-2245 or for a free legal consultation. She may also be reached at

Serious Health Concerns Raised Over XOLAIR

The FDA recently announced that Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems.

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J&J and Bayer Aim to Expand XARELTO Indication Despite Current Health Risks

Johnson & Johnson and Bayer’s Xarelto is already in the lead of the new generation of anticoagulants.  Recently, the drugmakers made known that they are looking to expand that market lead with new clinical trials aimed at widening the drug’s label. […]

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Increased Focus on XARELTO Injuries

XARELTO (rivaroxaban) is one of the newest blood thinners on the market and is manufactured by Bayer and marketed by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, in the United States.  The drug was approved in 2011. […]

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The Game Is On – Menopausal Women a Huge Target for Antidepressant Medications

Menopausal women are a major target for drug companies and their respective antidepressant medications.  In June 2013, the FDA has approved Brisdelle for hot flashes.  The FDA approved the drug against the advisory panel’s recommendation. […]

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Claudine Homolash Chats with ProPublica Senior Healthcare Reporter and Senior Editor

On Friday, May 9, 2014, I had the opportunity to meet Charles Ornstein and Tracy Weber. Mr. Ornstein is a senior healthcare reporter at ProPublica, and Ms. Weber is a senior editor at ProPublica. ProPublica is a nonprofit news organization […]

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FDA Looking into Generic Blood Pressure Drugs

Yesterday, it was reported in the news that the FDA is looking at the effectiveness of generic blood pressure drugs, mostly copies of AstraZeneca’s Toprol XL.  Because many of the generics sold in the United States come out of Indian plants, the question of generic effectiveness has merged with concerns over the quality standards of some drug makers.

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Whistleblower Success for Claudine Q. Homolash

Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations for Off-Label Marketing and Promotion of Drug Mycamine® The Pharmaceutical company Astellas Pharma US, Inc. has agreed to pay the United States a total of $7.3 million to resolve allegations that it violated the False Claims Act […]

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Whistleblowers Serve an Important Purpose

Corruption is rampant.  Despite the fact that the FDA is supposed to conduct independent and unbiased reviews, it often comes to light that this does not always happen.  Many members of the FDA have either worked for the large pharmaceutical companies or work for them when they leave.  It is only natural, unfortunately, that bias occurs. Drug companies are wealthy companies and use this […]

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Claudine Q. Homolash to speak in San Diego on Risperdal

Claudine Q. Homolash, Esquire, and other experienced trial lawyers, will be speaking at the AAJ Education on March 25–26 at the Loews Coronado Bay Resort in San Diego at the Plaintiff-Only Pharmaceuticals and Medical Device Litigation Update Seminar. The full-day seminar opens […]

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Claudine Q. Homolash Comments on Status of Topamax Litigation

Attorney Claudine Q. Homolash opines on the current status of the Topamax litigation against Johnson & Johnson pending in the Philadelphia Court of Common Pleas.  The drug Topamax has been linked to the development of Cleft Lip and/or Cleft Palate in newborns.  The Risperdal gynecomastia cases are also filed in the Philadelphia Court of Common Pleas against the drug manufacturer Johnson & Johnson […]

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