Maryland Attorney General Announces $48 Million Settlement over Unapproved Bed Sore Ointment
The Maryland Attorney General announced last month Maryland has reached an agreement with
with Healthpoint and DFB Pharmaceuticals, its partner. The settlement, to which fifteen additional states and the federal government are also plaintiffs, is a result of allegations that Healthpoint was responsible for causing false claims to be submitted to the Maryland Medicaid programs for one of its products called Xenaderm. Xenaderm is a skin ointment that was prescribed to many nursing home, and potentially other, patients for the treatment of bed sores. However, the drug has not received the required approval from the Food and Drug Administration (FDA).
The various complaints related to the settlement alleged that Healthpoint unlawfully marketed Xenaderm without FDA approval. The allegations further claimed that this marketing was modeled upon a drug created some time before 1962, which itself had received review from the FDA. The FDA ruled in the1970s that the principal ingredient in Xenaderm was "less than effective" for treating bed sores, its intended use. The defendant(s) allegedly misrepresented the drug's regulatory status repeatedly in reports that it submitted to both federal and state agencies.
Subject to terms of the $48 million settlement, which is to be awarded to 47 states and the federal government, defendants Healthpoint and DFB Pharmaceuticals will have to pay roughly $33 million to settle Medicaid-based claims nationally. Maryland itself will receive nearly $350,000 in refunds to the state’s Medicaid program, which accounts for the improper payments on behalf of both the state and federal governments.
This settlement was reached primarily on the grounds of fraud, as it was brought under the false claims act. Individuals may have a case under either theories of fraud or products liability. Manufacturers are potentially liable for the injuries their products cause. For example, if your loved one used Xenaderm and suffered an aggravation of their bed sores, causing additional injuries or damage, you may have a claim against the manufacturer. Bed sores are one of the most common sorts of complications that residents can suffer in nursing homes, so a widespread effect from using this product would not be surprising.
If you or a loved one was harmed as a result of using this or a different defective product or substance, you should consult with a Maryland products liability attorney right away regarding your potential claims. You have rights under the law, and you may be entitled to file a product liability claim.
Relatedly, if you have a loved one in the Maryland area who has experienced injury as a result of nursing home abuse or neglect, the attorneys at Lebowitz & Mzhen, LLC can assist you with properly handling a legal claim against those responsible for the poor treatment of your loved one. Contact our experienced nursing home abuse and negligence attorneys today to schedule your initial complimentary and confidential consultation. You can reach us through the contact form on our website, or by calling us at 1-800-654-1949
Additional Blog Posts:
Planning Ahead: Medicare Does Not Cover Nursing Home Long Term Care, Maryland Nursing Home Lawyer Blog, published February 26, 2013
Federal Law Protects Nursing Home Residents from Bed Sores, Maryland Nursing Home Lawyer Blog, published February 19, 2013