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Archive for the ‘Medical & Health Care’ Category

Federal Court Rejects Jane Doe’s Wrongful Conception Claims Too

Posted on: March 21st, 2017

By: Shaun Daugherty

It made headlines when several families around the county sued Atlanta based sperm bank Xytec Corp. for claims that they were lied to regarding the specific characteristics of a donor that had been responsible for the birth of 36 children through the bank. The bank had promoted donor 9623 as having a PhD and being physically and mentally healthy. As it turned out, Mr. James Aggeles was a convicted felon who had not finished college and had multiple mental health diagnoses.

At the state court level, a suit filed by Angela Collins and Margarent Hanson, Canadian residents, was dismissed in 2015. The judge ruled that the allegations of fraud, negligence and product liability were essentially claims alleging wrongful birth which is not a recognized cause of action in Georgia. Wrongful birth claims are ones contending that the parents would have not had a child if they have been fully aware of a child’s condition. Typically these claims arise in the scenario of undiagnosed disabilities or conditions materially affecting the fetus and later child development. Plaintiff’s sue for the damages related to the increased cost of raising a disabled child.

In 2016, an Ohio woman, identified as Jane Doe, filed suit against Xytec Corp. in federal court related to her interactions with the company and receipt of donor 9623’s sperm. Eleven different counts were alleged, including fraud, negligence, and breach of warranty. Defendants immediately moved to dismiss the complaint for failure to state a claim as they argued that all of Ms. Doe’s claims were based in a theory of wrongful birth and not actionable in Georgia. Plaintiff argued that it was not a case of wrongful birth, but one of wrongful conception, which is recognized under the law. Wrongful conception claims arise when a sterilization or abortion procedure goes wrong and a live birth results.

On Friday, March 17, 2017, US District Judge Thomas Thrash, Jr. issued his ruling granting the defendants’ motion and dismissed the case. The Judge explained the difference between accepting one theory over the other was a matter of the measure of damages.  A successful wrongful conception claim could recover the expenses for an unsuccessful sterilization procedure, pain and suffering, medical complications, cost of delivery, lost wages and loss of consortium. By contrast, “wrongful birth claims are disfavored because they require the court to decide between the value of the life with disabilities and the value of no life at all.” The Judge found that Ms. Doe’s claims were rooted in the theory that she would not have used the sperm from donor 9623 if she had known of his true nature and, therefore, her child would not have been born, i.e. a wrongful birth claim.

As pointed out by the state court judge in Ms. Collins and Ms. Hanson’s case, this appears to be another instance where science has overtaken the law and leaves no remedy to the parents.

For any questions, please contact Shaun Daugherty at [email protected].

How Fine is the Line Between Medical Malpractice and Life in Prison?

Posted on: February 22nd, 2017

By: Shaun Daugherty

It was all over the major news networks and the print media. On Monday, February 21, 2017, a Dallas, Texas jury sentenced Dr. Christopher Duntsch, neurosurgeon, to life in prison for a “botched surgery.” While he was initially arrested on five counts of aggravated assault, the 13-day trial apparently focused on one 74-year old patient and the infliction of an injury that constituted a first-degree felony under the circumstances. The jury apparently had to find that Dr. Duntsch acted “intentionally, knowingly, recklessly, or with criminal negligence” in injuring an elderly person.

In reading several articles on this story, I had to go back and make sure that I was not reading a case alleging medical negligence and punitive damages. The fact pattern was strikingly similar. The elderly patient at issue reportedly lost a significant amount of blood during the procedure and lost the full use of her legs. These are complications that are not uncommonly alleged in surgical medical negligence cases. The subsequent treating surgeon testified that he found implants placed in muscle instead of bone, a screw directly placed into her spinal cavity and severed nerves. Testimony that one would expect from an expert opinion on the standard of care and elements of causation. He was quoted as saying that the prior surgery was “as egregious as you can image.” A motion in limine would hopefully keep this particular opinion out of a civil trial.

During Dr. Duntsch’s trial, the jury was also provided testimony from multiple other patients that experienced “complications” following their own encounters with the surgeon dubbed “Dr. Death.” This is the type of evidence that one might expect to be presented in the punitive damages phase of a medical negligence trial. This is the type of evidence that would be presented to show the “reckless disregard for the consequences.”

Obviously there are major differences between criminal and civil law and the evidence to prove each. However, when you read of medical providers being convicted and imprisoned for fact patterns that resemble those that we deal with in the medical negligence claims, you start to wonder. Remember Conrad Murray, Michael Jackson’s physician, who was convicted of involuntary manslaughter for exercising his medical judgment? I recall the media reports in that case sounded more like medical negligence rather than a criminal case.

These are examples of exceptional cases with extenuating circumstances. A civil lawsuit leading to monetary recovery is the typical scenario and then the case ends. However, in the right circumstances, a jury could find that the same evidence presented to prove negligence, gross negligence and/or punitive liability in the civil setting could also lead to jail time in a criminal trial.

For any questions, please contact Shaun Daugherty at [email protected].

FDA’s Draft Guidance on When to Submit A 501(k) Bolsters Potential for Medical Device Manufacturers to Argue that State Tort Claims are Impliedly Preempted

Posted on: September 8th, 2016

Doctor workplace with digital tablet and stethoscope

By: Michael Bruyere and Amanda Hall

On August 8, 2016, the FDA issued draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Current regulations provide that a manufacturer of a medical device must submit a premarket notification submission to the FDA at least 90 days before beginning to sell a device that has been changed or modified in any manner “that could significantly affect the safety or effectiveness of the device.” 21 C.F.R. § 807.81(a)(3). The draft guidance clarifies this language, providing more specific examples of when a 510(k) submission must be made.

The draft guidance, although it is not final nor binding, is significant not only because it should assist medical device manufacturers in determining when a 510(k) submission should be made. The increased clarity also bolsters the likelihood of a medical device manufacturer being able to successfully employ an implied preemption argument akin to those that have been successfully used with respect to generic drugs (see PLIVA v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013)) to defeat state law tort claims. In the generic drug context, a generic drug manufacturer cannot unilaterally change its label because it has the duty of sameness with respect to the brand drug. Accordingly, courts have concluded that state law claims against such manufacturers – typically alleging that the generic drug manufacturer was somehow negligent by failing to immediately provide a specific warning on its label – are impliedly preempted because the generic drug manufacturer could not immediately alter its label on its own without violating the law. As the Court said in Mensing, “[i]f the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law…Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”

To date, attempts by medical device manufacturers to make an analogous argument, i.e. that they could not immediately change their device to make it safer (thus complying with a duty pursuant to state tort law) because such a change would require submitting a new 510(k) to the FDA and waiting 90 days (thus complying with an obligation under federal law), have been unsuccessful. By clarifying instances in which a 510(k) must be submitted, the draft guidance increases the possibility of medical device manufacturers successfully defending against state tort claims on this basis.

OCR Casts a Wider Net on HIPAA Breaches

Posted on: August 29th, 2016

HIPAA health care document in duo tone blue

By: Agne Krutules

Under the Health Insurance Portability and Accountability Act (HIPAA), covered entities and their business associates have duties under the Privacy Rule and the Security Rule to protect patient health information. The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) regional offices are required to investigate all reported breaches involving the protected health information (PHI) of 500 or more individuals. With regard to smaller breaches, however, OCR has discretion whether to conduct an investigation.

From 2003 through May 31, 2016, OCR received more than 134,246 HIPAA-related complaints and investigated and resolved more than 24,241 cases. The vast majority of these investigations involved larger breaches of unsecured PHI affecting 500 or more individuals. That is typically what most people have grown to expect—more attention to large-scale breaches, with smaller breaches under 500 individuals typically not receiving as much scrutiny. However, these traditional expectations are about to change due to a recent announcement from OCR about its plans to increase efforts to investigate smaller breaches more frequently.

Through an August 18, 2016 email, OCR announced that it is launching an initiative “to more widely investigate the root causes” of HIPAA breaches affecting fewer than 500 individuals. According to the announcement, OCR’s regional offices have ramped up their efforts to identify and obtain corrective action to address “entity and systemic noncompliance” related to these smaller scale breaches. While not every HIPAA breach will be the subject of investigation due to limitations on resources, OCR says that the following factors will be considered in determining whether to pursue such investigations:

  1. The size of the breach;
  2. Theft of or improper disposal of unencrypted PHI;
  3. Breaches that involve unwanted intrusions to IT systems (for example, by hacking);
  4. The amount, nature, and sensitivity of the PHI involved; and
  5. Instances where numerous breach reports from a particular covered entity or business associate raise similar issues.

OCR’s announcement also states that “Regions may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.” This is the first time OCR has ever specifically announced that it would consider the factor of underreporting when determining whether to investigate a data breach. Thus, covered entities and business associates should use this message to focus on their breach investigation techniques and breach reporting processes.

Although the investigations of the smaller scale breaches will remain discretionary, more investigations affecting less than 500 individuals are certain. Accordingly, covered entities and business associates should not become complacent when dealing with smaller or “routine” incidents, and they should take proactive steps to review their HIPAA compliance obligations and update safeguards to protect against breaches. Becoming an object of an OCR investigation can be time-consuming and expensive, even without considering the potential costs of civil monetary penalties if HIPAA non-compliance is uncovered.

From 3D Printing to 4D Printing – New Advances in Science Implicate Changes in Existing Products Liability Law

Posted on: February 25th, 2016

option 3By: Amanda K. Hall

On January 25, 2016, researchers at Harvard University and The University of Illinois Urbana-Champaign detailed their creation of “4D-Printed” structures –made by mimicking the way orchids and other plants move and twist – that could ultimately lead to advances in the way medical devices are created both in the United States and abroad. For instance, scientists are working to create 4D-printed robotic tools that move and bend in order to assist in surgeries.  3D Printing, also known as additive manufacturing, is already being used to revolutionize the healthcare industry through the creation of things such as prosthetic devices.

As technology continues to advance, the effect that this emerging technology will have on traditional theories of products liability remains unseen. For example, in the products liability realm, the persons or entities responsible for injuries or damage caused by a defective medical device are typically those who manufactured or sold the defective product.  Because of the nature of 3D printing, however, there is a challenge in determining who should be held liable.  The manufacturer of the 3D printer itself, the software designer or CAD developer who assist in developing the code that is fed into the 3D printer in order to create the product, and the doctors and hospitals who own and use the 3D printer, are all potential candidates.  Under existing law, however, there are potential pitfalls to an injured plaintiff seeking to hold any of these individuals or entities liable.  A more thorough analysis of these issues can be found in “3-D Printing of Medical Devices,” DRI Magazine, September 2015, available here.  Additionally, our lawyers are available to assist you in taking steps to minimize the potential risks and liability associated with the use of this technology.