CLOSE X
RSS Feed LinkedIn Instagram Twitter Facebook
Search:
FMG Law Blog Line

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

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

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.

FDA Continues to Fight the First Amendment But Facteau Deals Another Blow

Posted on: August 18th, 2016

By: Kristian Smith

Last month, a federal jury in Massachusetts acquitted two executives of medical device company Acclarent, Inc. of 14 felony counts of fraud related to off-label promotion of Acclarent’s “Stratus” device. United States v. Facteau, et al. stemmed from the distribution of Acclarent’s Relieva Stratus Microflow Spacer (“Stratus”) for off-label use. Although Stratus was cleared by the FDA as a medical device intended to maintain an opening to a patient’s sinus and provide moisture by using a saline solution, Acclarent’s CEO, William Facteau, and Vice President of Sales, Patrick Fabian, promoted the product off-label, as a steroid delivery device. The FDA claimed that Facteau and Fabian had misbranded the device and had committed fraud on the FDA by intending to use the device in a way other than its cleared use.

Although Facteau and Fabian were convicted on 10 misdemeanor counts relating to the same charges, the jury still accepted that it is not a crime for device manufacturers to make truthful, non-misleading statements about off-label use. The jury instead convicted Facteau and Fabian based on their conduct, mainly because of a violation of the Park Doctrine, which provides that responsible corporate officers can be liable for misdemeanor violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) even if the corporate officer had no intent to commit, or even knowledge of, the offense.

This is only one of many recent victories for medical device companies in the off-label promotion realm.

In February, a Texas jury acquitted medical-device manufacturer Vascular Solutions and its CEO of all counts in a criminal case that alleged the company illegally promoted Vari-Lase, a device to treat varicose veins, off-label. The Vascular Solutions case was particularly memorable for the trial judge’s jury instruction that it is not a crime for a device company to provide doctors with truthful, non-misleading information about off-label product uses. This was a significant blow to the FDA’s long-standing practice of discouraging (and prosecuting) off-label promotion.
In 2015, in Amarin Pharma, Inc. v. FDA, a federal judge in New York found that Amarin, a drug manufacturer, was entitled to engage in truthful and non-misleading speech promoting the off-label use of its medical device, and such speech could not form the basis of a prosecution for misbranding. This decision was based in large part on the Second Circuit’s 2012 watershed decision in U.S. v. Caronia, where the Court held that to avoid infringing on the First Amendment, misbranding provisions of the FDCA could not be construed to prohibit and criminalize truthful off-label promotion of FDA-approved drugs.

Even with more and more federal courts embracing Caronia, the FDA continues to prosecute drug and device manufacturers (and their corporate officers) for off-label promotion. With the decisions in Facteau and Vascular Solutions, though, it looks like the FDA will have a more difficult path to prosecution than ever before.