This past weekend, Baxter International Inc. announced that a voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection) was initiated as a precautionary measure because particulate matter—believed to be glass—was observed in some Hylenex vials during routine stability testing. Baxter is working with the product’s NDA-holder, Halozyme Therapeutics, to investigate the root […]
This past weekend, Baxter International Inc. announced that a voluntary recall of all manufactured lots of <"https://www.yourlawyer.com/practice_areas/defective_drugs">Hylenex recombinant (hyaluronidase human injection) was initiated as a precautionary measure because particulate matter—believed to be glass—was observed in some Hylenex vials during routine stability testing. Baxter is working with the product’s NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue. To date, no medical events or customer complaints have been reported.
The companies notified the U.S. Food and Drug Administration (FDA), and Baxter will contact customers to request product return. The company estimates that there are approximately 3,500 vials in the marketplace.
The Wall Street Journal explained that Hylenex is used for pediatric rehydration.
According to the Wall Street Journal, Baxter provides so-called fill-and-finish services for Hylenex production, which is based on Halozyme technology; the two companies announced receipt of FDA approval in October for launch of the product for pediatric rehydration. The product enables fluid to be delivered under the skin as opposed to intravenous delivery, noted the Wall Street Journal.
Baxter, meanwhile, has been plagued with a variety of issues, said the Wall Street Journal, including a massive 200,000-unit recall of drug infusion pumps and a decrease in the market for plasma-based medications.
Also, we recently wrote that Teva Pharmaceutical Industries and Baxter Healthcare Services were hit with a $500 million punitive damage judgment in a lawsuit stemming from a hepatitis C outbreak linked to two Las Vegas, Nevada endoscopy clinics. The judgment was the largest jury award in the state’s history.
The hepatitis C outbreak at the center of the lawsuit was traced to the Endoscopy Center of Southern Nevada and its sister clinic, Desert Shadow Endoscopy Center. The Southern Nevada Health District traced nine cases of hepatitis C directly to unsafe injection practices at the outpatient surgical centers, and said 100 others were possibly linked to them. At least 50,000 people were tested for blood-borne diseases because of the clinics’ practices.
According to a prior Reuters report, plaintiff Henry Chanin claimed he contracted hepatitis C after vials of propofol were reused for his colonoscopy procedure at one of the clinics. Teva made the propofol, and Baxter distributed it, Reuters said. The lawsuit was the first of hundreds of civil lawsuits stemming from a hepatitis C outbreak two years ago.
According to The Las Vegas Review-Journal, Chanin’s lawsuit had alleged the propofol packaging did not include appropriate warnings against reusing vials between patients. The complaint also argued that the 50-milliliter vials of propofol should not have been sold to endoscopy centers because they tempted nurses to reuse the vials instead of throwing away leftover drug.
A Clark County District Court jury ordered Teva to pay $356 million and Baxter $144 million. Earlier, the same jury awarded Chanin $5.1 million in compensatory damages.
