Pharmaceutical Litigation

FDA Announces Expansion of Nationwide Recall by Sagent Pharmaceuticals

By Cullan & Cullan on June 26, 2013 - Comments off

According to a U.S. Food and Drug Administration (FDA) press release dated June 13, 2013, Sagent Pharmaceuticals is expanding its nationwide recall to all lots of Vecuronium Bromide for injection. The Vecuronium Bromide was manufactured by Mustafa Nevzat (MN) Pharmaceuticals. The recall now includes all lots made from July, 2011 through May, 2012.

Problem

An elevated impurity has been discovered in the Vecuronium Bromide, which could potentially harm critically ill patients who have renal failure. The initial recall began on June 7, 2003, and included only three lots for injection to the user level. That recall has been expanded, according to the FDA, based on results obtained in more analyses completed since the original recall. Read the rest »



Steroid Injections Recalled in 11 States

By Cullan & Cullan on June 4, 2013 - Comments off

Nebraska Defective Steroid InjectionsSeven patients have developed abscesses attributed to anti-inflammatory steroid injections they received. As reported by CNN, the patients affected were in Illinois and in North Carolina.

A Tennessee compounding pharmacy has recalled the steroid injections including all of its sterile products. The Newbern, Tennessee company, Main Street Pharmacy, LLC, is already on probation.

Officials from both the federal and state agencies began inspections of the company’s facility on May 22, 2013. Read the rest »



Recall of Certain Compounded Prescription Therapies for Renal Patients

By Cullan & Cullan on May 28, 2013 - Comments off

Nebraska Pharmaceutical RecallAccording to the U.S. Food and Drug Administration and published by Reuters.com, Pentec Health has announced a limited voluntary recall of in-date nutritional prescriptions for renal patients.  The recall is due to the lack of the assurance of sterility of one of its laminar flow hoods that was used in compounding.  Renal therapies that used this hood on or prior to May 2, 2013 are covered in this recall.  These therapies were given directly to renal patients and to renal dialysis centers.

The scope of this recall involves prescriptions for 163 patients.  Sterility tests have been conducted with one of the company’s laminar flow compounding hoods that influenced the recall, as have tests on the finished products produced in this hood.  Those tests have indicated sterility, and as of May 16, Pentec Health had not received any reports of illnesses or injuries associated with possible contamination. Read the rest »



U.S. Supreme Court to Consider Generic Drug Manufacturer’s Liability

By Cullan & Cullan on March 14, 2013 - Comments off

As reported in The New York Times, a New Hampshire woman developed a severe reaction to the drug sulindac. Her doctor prescribed the drug to treat shoulder pain. She spent two months in a burn unit due to the loss of nearly two-thirds of her skin. Her lungs were permanently damaged as was her esophagus. The reaction also left her legally blind. Sulindac is a drug similar to ibuprofen. Both are in the class of drugs called nonsteroidal anti-inflammatory drugs (Nsaids).

The manufacturer of the generic drug, Mutual Pharmaceutical Company, was sued and the victim was awarded $21 million in compensation in a 2010 trial in Federal District Court in Concord, NH. The verdict was later upheld by an appeals court decision.

Later this month, the Supreme Court will hear arguments in regard to the case and whether or not Mutual should be held accountable for the victim’s injuries. Read the rest »



Meningitis Litigation Centralized in State Where Alleged Contamination Occurred

By Cullan & Cullan on February 28, 2013 - Comments off

Plaintiffs in the more than 120 suits filed against the New England Compounding Center where a steroid was produced that allegedly led to an outbreak of fungal meningitis requested that their cases be centralized in Minnesota. However, the U.S. Judicial Panel on Multidistrict Litigation has assigned the suits to a judge in Boston, Massachusetts instead. The suits were filed against a pharmacy that has been linked to an outbreak of fungal meningitis in 20 states.

As reported by The Associated Press and published on boston.com, Massachusetts is the state where the alleged contamination occurred. State and federal investigation into the company’s practices are focused in that state. The defendant, the New England Compounding Center, was headquartered in Massachusetts, and that is the state where their bankruptcy case is pending. Primary evidence, primary witnesses, and documentary evidence will all be located in Massachusetts. Read the rest »



Jury Awards $63 Million to Family of Girl Who Suffered a Serious Skin Disease after Taking Motrin

By Cullan & Cullan on February 26, 2013 - Comments off

Courtesy of CBS News, a jury in Massachusetts has awarded $63 million to a teen and her mother and father. When the girl was seven, she took ibuprofen under the brand name Motrin. Afterwards the girl lost 90 percent of her skin from a rare side effect called toxic epidermal necrolysis. Toxic Epidermal Necrolysis, also known as TENS, is a painful and potentially deadly skin disease caused by drug reaction. Infections contracted as the result of this skin disease can cause death. The young Massachusetts girl was blinded.

On Wednesday, February 13, 2013, a Plymouth Superior Court jury ordered Johnson & Johnson and its McNeil-PPC Inc. subsidiary to pay the girl and her parents $109 million which includes interest. Read the rest »



Dozens of Lawsuits Filed Against Pharmacy Responsible for Meningitis Outbreak

By Cullan & Cullan on December 19, 2012 - Comments off

As reported by Nola.com, at least 50 federal lawsuits have been filed against the New England Compounding Center (NECC), which is the Framingham-based pharmacy responsible for contaminated steroid injections that led to a deadly meningitis outbreak this year. The lawsuits allege that the NECC negligently produced the defective product, and families are seeking millions in damages for lost wages, mental and emotional suffering, painful physical recoveries, and the death of a spouse.
As of December 13, more than 500 people have gotten sick after receiving the contaminated injection and 37 have died due to the outbreak.

To streamline the legal process, attorneys on both sides have asked to have a single judge preside over the pretrial and discovery phases for all of the federal lawsuits, which is known as multidistrict litigation (MDL). This approach would prevent inconsistent pretrial rulings and conserve the resources of the parties, but the lawsuits would eventually be returned to the judges in the original district for trial. Read the rest »



Meningitis Outbreak Highlights Need for New Authority over Compounding Pharmacies

By Cullan & Cullan on November 6, 2012 - Comments off

The recent fungal meningitis outbreak, which was linked to contaminated steroid injections manufactured by the Massachusetts-based New England Compounding Center (NECC), has brought to light the need for stricter regulations over these specialty pharmacies. According to a report by The New York Times, the NECC has a troubled history that includes failure to follow standard procedures to keep its facility clean and products sterile, as well as violating state law by selling compounds in bulk without prescriptions for individual patients. The MA-based pharmacy apparently escaped sanctions over the years despite repeated complaints.

State regulators, who are responsible for policing compounding pharmacies, reportedly did very little monitoring before this fatal outbreak, which has currently claimed the lives of 30 people and sickened 419 as of November 5. The regulatory system that oversees pharmaceutical compounding essentially failed and needs to be strengthened in order to prevent another serious outbreak and protect innocent patients from harm. Read the rest »



Meningitis Outbreak Causes 12 Fatalities, 119 Infections in Multiple States

By Cullan & Cullan on October 10, 2012 - Comments off

Contaminated Steroid InjectionAs of October 10, a fungal meningitis outbreak linked to a contaminated steroid injection has caused 119 infections and 12 fatalities, spreading to 10 different states. After receiving an injection in their spine of the preservative-free steroid methylprednisolone acetate, which is used for the treatment of pain and inflammation, patients in multiple states contracted a potentially fatal fungal meningitis. The New England Compounding Center (NECC), a Framingham-based specialty pharmacy, has announced a recall for the three lots of the injected steroid, as well as the rest of the products they manufacture as a precaution, though currently there are no signs that other products have been contaminated.

Federal health inspectors investigating an NECC plant found fungus in unopened vials of the steroid on October 1, and the specialty pharmacy has since surrendered its license to operate until the U.S. Food and Drug Administration (FDA) has completed its investigation into the cause of the contamination. Health officials estimate that 13,000 people may have been exposed to the contaminated steroid, and reportedly 76 medical facilities in 23 states received the tainted steroid injection. The FDA is urging consumers, clinics, and doctors to stop use of any product that came from the NECC. Read the rest »



Lawsuits Being Filed Alleging Zoloft Caused Birth Defects in Children

By Cullan & Cullan on August 14, 2012 - Comments off

As reported by The Legal Examiner, defective drug liability cases are being filed against pharmaceutical giant Pfizer after mothers alleged their children suffered birth defects due to Zoloft. Zoloft, which is a Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant manufactured by Pfizer, has been associated with a number of health risks, the most serious involving women who are pregnant and taking the drug.

Various studies have linked Zoloft and SSRI use during pregnancy to severe birth defects. Here are the noteworthy results of several of these studies:

  1. A study conducted by the British Medical Journal in 2009 showed that exposure to Zoloft before birth can triple a baby’s risk of septal heart defects.
  2. The New England Journal of Medicine reported two studies that link the use of SSRI antidepressants during pregnancy to increased risk of birth defects of the brain, heart, spine, organs, and more. Read the rest »