Tag Archives: FDA

Telemedicine pitfalls to avoid at the state and federal levels

Mobile Health Technologies and Devices  and Implications for Doctors.

Mobile Health Technologies and Devices and Implications for Doctors.

Mobile healthcare technology allows doctors and patients to connect in a virtual patient waiting room. Telemedicine, as many call it, has benefits as well as burdens on everyone involved. There are several state and federal regulatory operations, laws and policies overseeing the use of mobile health technologies. Not only users, but also providers of mobile healthcare technologies should be aware of laws and regulations to make sure they deliver healthcare services consistent with laws and policies.

When healthcare services regulations are not satisfied, the agencies charged with enforcement can get involved. Here in Illinois, the Illinois Department of Financial and Professional Regulations (“IDFPR”) and the Illinois Medical Disciplinary Board can be involved in the investigation of complaints, which can lead to the suspension or revocation of a healthcare provider’s license to practice. Other agencies can get involved in a process leading to financial penalties and media coverage of negative occurrences.

Telemedicine practice can be within the oversight of the FDA, HIPAA, FTC, and the IDFPR.

FDA regulations protect patients from harm from mobile medical devices and applications. On February 9, 2015 the FDA published, Guidance for Industry and Food and Drug Administration Staff, defining types of medical devices, mobile apps, mobile medical apps and examples of how the FDA enforces its regulations. The FDA aims to guide and make nonbinding recommendations, not imposing legally enforceable responsibilities, in the above-linked document.

HIPAA rules, enforced through the Department of Health and Human Services (and state level laws), such as the Breach Notification Rule, Security Rule and the Privacy Rule affect mobile health industries. Applying these rules to telemedicine scenarios requires encryption methods, for example, to prevent rule violations, related fines, and negative public attention. Privacy and security concerns are addressed in the Department of Health and Human Services in, Your Mobile Device and Health Information Privacy and Security. A lost mobile device is the first item on the list of risks.

FTC protections keep consumers aware of fraudulent, deceptive and unfair business practices. In telemedicine the FTC rules most often apply to consumer information disclosures contrary to stated policies and regulations. The fines for violating FTC rules may be significant and a breach of duties could upset other users of mobile healthcare apps if their information is inappropriately transmitted to third parties. The FTC document, Complying with the FTC’s Health Breach Notification Rule, explains how the rule requires a notification be sent to groups of users in the event of a security breach.

IDFPR and similar professional licensing agencies are concerned with healthcare professionals practicing medicine and treating patients outside territorial jurisdictions. A doctor in Illinois practicing medicine in giving service to a patient in Indiana involves licensing regulations in both states. A National Practitioner Data Bank, used among the states, identifies licensee discipline and reports of medical malpractice decisions and settlements in one state that could flag other states to make independent license inquiries.

Michael V. Favia & Associates are available to assist with analysis and advice on difficult mobile healthcare practice matters. With offices conveniently located in the Chicago Loop, Northwest side and suburban meeting locations, you can schedule a discrete meeting with an attorney at your convenience and discretion. For more about Michael V. Favia & Associates’ professional licensing work, please visit www.IL-Licensing.com and feel free to “Like” the firm on Facebook and “Follow” the firm on Twitter.

Heads Up: Illinois healthcare practitioners should pay attention to the incidence of the purchase and use of non-FDA-approved medications from foreign countries

State and federal agencies are investigating and prosecuting the acquisition and distribution of non-FDA-approved medications.

State and federal agencies are investigating and prosecuting the acquisition and distribution of non-FDA-approved medications.

Healthcare practitioners should be aware of recent investigations and prosecutions for the purchase and distribution of non-FDA-approved narcotics from outside the U.S. Recent reports of U.S. Federal Drug Administration (“FDA”) activity puts a spotlight on not only the civil and criminal penalties at stake, but also the safety of patients. Concerned physicians and health care administrators and staff should be aware and vigilant against even unintentional acquisition of prohibited narcotics. Negligence is not a defense to liability for breaking these laws. Healthcare practitioners and professionals risk the suspension and loss of their licenses in connection with prescription drugs coming from foreign countries.

State and federal agencies are investigating and prosecuting the acquisition and distribution of non-FDA-approved medications.

A currently circulating news story is catching the attention of healthcare practitioners targeted by foreign supplies of medications not approved by the FDA. The Physician’s Practice website recently published an article focused on importing foreign prescription drugs[i]. The FDA’s focus on doctors who thought they purchased Avastin, a cancer drug, from an online Canadian pharmacy. The imported medication was fake and, “contained cornstarch and acetone, but no active cancer fighting ingredients,” the article reports. “Patients who received the false medication did not receive the cancer-fighting medications they truly required.”

Doctors, hospital administrators and staff should all be concerned about the risks of foreign prescriptions. The civil and criminal penalties are strict and professionals’ licenses are on the line for violations of the laws involved. While a doctor may save up to 50 percent on the cost of a medically equivalent drug from Canada or Ireland, making that purchase can lead to a drug trafficking conviction.

The importation of non-FDA-approved drugs is a violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”) which is enforced by the FDA. The FDA can prosecute a first offense of importing a non-FDA-approved drug resulting in either or both a year in prison and up to a $1,000 fine; a second offense can earn a three year sentence and up to $10,000 fine.[ii]

The Illinois Department of Financial and Professional Regulation (“IDFPR”) can suspend or revoke a professional license to practice for violations of the FDCA.

The Illinois Medical Practice Act of 1987 (“MPA”)[iii] sets for the law concerning the activity of licensed healthcare practitioners. The mission of the IDFPR is, “To serve, safeguard, and promote the public welfare by ensuring that licensure qualifications and standards for professional practice are properly evaluated, accurately applied and vigorously enforced.[iv]” The IDFPR can suspend or revoke a professional’s license for violations of the MPA. On their website, the division published a news release with helpful information, How the Division Responds to a Request for an Investigation of a Physician.

Being proactive and vigilant with everyone involved is a best practice to protect against foreign drugs.

Doctors and their administration and staff should be made aware of the risks of overseas prescription medication sales and the consequences for violations of state and federal laws. It may be helpful to identify the online and offline sellers attempting to lure in American purchasers with the promise of big savings and more. Being proactive and educating healthcare professionals about the risks and penalties of purchasing non-FDA-approved drugs from overseas is a recommended practice.

For more information about professional licensing and what to do upon receiving notice of a complaint, you may review 10 Short Tips for Responding to an IDFPR Investigation. You may also contact an attorney at Michael V. Favia & Associates for more information.

Michael V. Favia & Associates are available to help and meet for client consultations with offices conveniently located in the Chicago Loop, Northwest side and suburbs so you can schedule a discrete meeting with an attorney at your convenience and discretion. For more about Michael V. Favia & Associates’ professional licensing work, please visit www.IL-Licensing.com and feel free to “Like” the firm on Facebook and “Follow” the firm on Twitter.

[i] PhysiciansPractice.com, blog, Big Consequences for Doctors Importing Prescription Drugs, Feb. 6, 2013, by Ericka L. Adler.

[ii] See article HNi above.

[iii] Illinois General Assembly, Medical Practice Act of 1987, 225 ILCS 60/1 et seq.

[iv] IDFPR News Release, How the Division Responds to a Request for an Investigation of a Physician. Aug 2005.

About transvaginal mesh, lawsuits and product defects

FDA: "Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement."

FDA: “Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.”

Any mother, sister, daughter or female friend, who has experienced medical conditions requiring physician care, and even surgery, knows how upsetting these life events can be. To make matters worse, some of the surgical products used to cure problems, such as transvaginal mesh, can fail and cause tremendous suffering and re-occurrence of the original symptoms causing surgical treatment. As far as the law is concerned, product defect liability extends far beyond traditional consumer products, and includes transvaginal mesh implant and bladder sling defects.

“Jury awards $3.35 million in vaginal mesh case against Johnson & Johnson”

In South Dakota, a woman sued Johnson & Johnson and won $3.35 million for their failure to adequately warn her physician about potential risks and dangers of the vaginal mesh implant made by its subsidiary company, Ethicon, who allegedly misrepresented the product in marketing brochures[i].

Why these surgeries performed and what are can go wrong.

What causes the need for surgical care and transvaginal mesh implants? A condition such as pelvic organ prolapse (“POP”), similar to stress urinary incontinence, is often linked to strain during childbirth can cause a medical issue. “Normally your pelvic organs are kept in place by the muscles and tissues in your lower belly. During childbirth, these muscles can get weak or stretched. If they don’t recover they can’t support your pelvic organs.[ii]” Additional organs that could be involved in POP include: bladder (most common); urethra; uterus; vagina; small bowel; and rectum. Factors that can worsen POP are: obesity; a long-lasting cough’ frequent constipation; and pelvic organ tumors.

Transvaginal mesh treatment involves surgery to permanently install the mesh that works as a sling, to keep the organs in place and reduce or prevent stress on the bladder to treat urinary incontinence. Women, who suffered pain, urinary incontinence and other complications after transvaginal mesh surgery, are a concern of the FDA who released a warning video about rare but serious complications with the surgical mesh used in POP and stress urinary incontinence treatment.

The Law Offices of Michael V. Favia represent plaintiffs in cases with substantially similar claims as the recent reported Bard suit: “Bard Loses $2 Million Verdict in Vaginal-Mesh Trial”

A recent lawsuit, where flaws with some of the implants were known but not disclosed, recently reported in Bloomberg News, ordered a manufacturer of device defects that caused damages in plaintiffs including organ damage and painful sexual intercourse when the devices erode. “This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.[iii]

Women experiencing pain, discomfort and complication symptoms following transvaginal mesh implant surgery should know that their physician may not be the one at fault and the manufacturers are often to blame. If you or a friend is in pain and needs surgery to remove a mesh implant, you can call the Law Offices of Michael V. Favia for help. For more information about the firm’s practice areas, you can visit the website, Facebook and Twitter sites.