Chartwell Pharmaceuticals LLC of Rockland County has sued Woodfield Pharmaceutical LLC for $1 million, blaming it for delays in manufacturing one of its drugs because of a federal Food and Drug Administration inspection.
“It is incomprehensible,” the lawsuit states, that Woodfield “would have so little regard for Chartwell, as its customer, and ”¦ efforts at bringing the product to market.”
Chartwell initially sued Woodfield last year in Rockland County Supreme Court. The case was moved Jan. 6 to federal court in White Plains.
“We think their claim is baseless and doesn”™t have merit,” Robert Gerstein, a Woodfield Pharmaceutical vice president said in a telephone interview. “The fact that they didn”™t get to market didn”™t have anything to do with us.”
Woodfield Pharmaceutical in Houston was established in 2010 and is headed by Adam Runsdorf of Boca Raton, Florida.
Chartwell, of Congers, was established in 2010 and is managed by Jack Goldenberg. It produces millions of capsules and tablets a day in its facility.
In 2017, it began looking for an outside company to manufacture an oral solution of prednisolone sodium phosphate, a steroid used for treating inflammatory conditions and allergies.
In May 2018, the companies struck a deal for Woodfield to manufacture, package, label, test, store, and distribute the drug.
Woodfield agreed to quickly inform Chartwell about communications with regulatory agencies, according to the complaint, and to provide a copy of any inspection report.
The FDA inspected the Woodfield factory in June and July 2019 and identified major deficiencies in the manufacturing practices that potentially could affect the quality of the product, according to the complaint. Woodfield answered the FDA with a 29-page response.
Chartwell claims it did not know about the inspection or Woodfield”™s response until Aug. 13, 2019, when the FDA rejected its new drug application because of major deficiencies at the Texas facility.
The sole issue, Chartwell alleges, was the facility not the product.
Gerstein disagreed. “Basically, the FDA didn”™t approve the product.”
He described FDA inspections and “observations” as routine. “It”™s just a question of whether they are addressed and cleared by the FDA. ”¦ All of the observations were addressed and cleared.”
On Oct. 1, Woodfield notified Chartwell that the FDA issues were resolved, according to the complaint.
Chartwell then submitted an amended drug application to the FDA, resetting the regulatory review clock. Now the company expects approval as early as March 31 or as late as July 31.
Chartwell claims that a customer was ready to buy the prednisolone supplies last August, and that the delay in getting the product to market has caused “staggering losses.”
Had Chartwell been informed more quickly about the inspection, it claims, it could have immediately switched manufacturing to another location.
“They feel they lost sales because they did not get to market in a timely fashion because of Woodfield,” Gerstein said. “We don”™t agree with their assertion. The fact is, any observations by the FDA were addressed.”
Chartwell accuses Woodfield of breach of contract and breach of fiduciary duty. It is represented by Brooklyn attorney H. Jonathan Rubinstein.
