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

Archive for the ‘Life Sciences’ Category

Higher Screening Standards Needed to Prevent Fentanyl Misappropriation in Hospitals

Posted on: November 4th, 2016

remigho-syringeBy: Robyn Flegal

A disturbing trend is on the rise. Hospital employees are misappropriating drugs intended for patients. The drug of choice is fentanyl, which has been used as a prescription painkiller since the 1960s, but is up to fifty times more powerful than heroin and up to 100 times more potent than morphine.[1] In some areas of the United States, deaths resulting from fentanyl overdoses are more prevalent than deaths resulting from heroin overdoses.[2]

Several newsworthy cases illustrate this trend toward fentanyl misappropriation by hospital staff. A nurse in Colorado is suspected of misappropriating fentanyl intended for patients after she was found with fentanyl doses exceeding the amounts nurses typically need for their patients.[3] A month before, in another Colorado hospital, a surgical technician was arrested for allegedly tampering with “a syringe containing fentanyl citrate by removing the syringe containing [fentanyl] and replacing it with a similar syringe containing ‘other substances.’”[4] Other hospital employees, including surgical technicians,[5] emergency medical technicians,[6] and pharmacy technicians[7] have been investigated for similar circumstances of fentanyl misappropriation.

Hospitals should be aware of this dangerous trend and should limit employee access to fentanyl. Hospitals should implement thorough screening procedures and background investigation before hiring employees who will have access to fentanyl. The surgical technician mentioned above had previously been fired after testing positive for a controlled substance, but he answered “no” on his job application as to whether he had ever been fired from employment as a surgical technician.[8] It is important to be aware, however, that even the most thorough background screening may not prevent fentanyl misappropriation in every instance. One of the pharmacy technicians under investigation for replacing fentanyl with saline solution passed a criminal background check and his reference check did not raise any red flags.[9]

[1] Katharine Q. Seelye, Heroin Epidemic is Yielding to a Deadlier Cousin: Fentanyl, N.Y. Times, March 25, 2016, http://www.nytimes.com/2016/03/26/us/heroin-fentanyl.html?_r=0.

[2] Id.

[3] Noelle Phillips, Nurse Accused of Stealing Fentanyl from Summit County Hospital, Denver Post, March 19, 2016, http://www.denverpost.com/2016/03/19/nurse-accused-of-stealing-fentanyl-from-summit-county-hospital/.

[4] Elizabeth Hernandez, Feds Arrest Swedish Medical Surgical Tech Accused of Stealing Drugs, Denver Post, February 16, 2016, http://www.denverpost.com/2016/02/16/feds-arrest-swedish-medical-surgical-tech-accused-of-stealing-drugs/.

[5] Lane Lyon, Former Rose Hospital Employee Admits to Needle Swapping, July 3, 2009,  http://www.thedenverchannel.com/news/former-rose-hospital-employee-admits-to-needle-swapping.

[6] U.S. Attorney’s Office, Raymond Man Sentenced for Diverting Fentanyl at Exeter Hospital, August 29, 2014,  https://www.fbi.gov/contact-us/field-offices/boston/news/press-releases/raymond-man-sentenced-for-diverting-fentanyl-at-exeter-hospital.

[7] KSN-TV, Pharmacy Tech Swapped Fentanyl for Saline Solution, Hospital Says, October 27, 2016,  http://ksn.com/2016/10/27/pharmacy-tech-swapped-fentanyl-for-saline-solution-hospital-says/

[8] Elizabeth Hernandez, Feds Arrest Swedish Medical Surgical Tech Accused of Stealing Drugs, Denver Post, February 16, 2016, http://www.denverpost.com/2016/02/16/feds-arrest-swedish-medical-surgical-tech-accused-of-stealing-drugs/.

[9] KSN-TV, Pharmacy Tech Swapped Fentanyl for Saline Solution, Hospital Says, October 27, 2016,  http://ksn.com/2016/10/27/pharmacy-tech-swapped-fentanyl-for-saline-solution-hospital-says/

 

 

 

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.

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.

MDL Procedures At-Risk For Closer Scrutiny Going Forward

Posted on: January 21st, 2016

option 1By: Ryan Babcock

For years, the resolution of large-impact product defect and personal injury litigation has been shifting away from class actions in favor of Multidistrict Litigation cases that are consolidated in front of one judge in the federal and state systems.  

A recent scholarly article authored by University of Georgia law professor Elizabeth Chamblee Burch, Judging Multidistrict Litigation, 90 N.Y.U. L. Rev. 71 (2015), offers some empirical evidence that supports many anecdotal stories and apparent trends regarding the management and resolution of these types of cases, and points to the likely need for additional future regulation of these kinds of cases, especially in the federal system.

The MDL process was set up and is used for the pretrial management of similar cases, and typically, a steering committee of experienced plaintiffs lawyers are appointed by the MDL judge to help manage discovery, and usually, to guide the case toward settlement.  As Professor Burch’s research indicates, those panels are overwhelming stocked with repeat players from the plaintiff’s bar, both individually and from a select group of firms. 

There are some practical reasons why we see so many repeat players from the plaintiffs’ bar, and why there likely will not be a sea change in that practice going forward.  When determining leadership positions, and presence on these committees, the MDL judge has many considerations in mind, but one is that the judge will usually need counsel from a plaintiff’s firm that has the financial resources to manage the case and see it through discovery, and potentially settlement or one or more bellwether trials, which can be an expensive proposition when dealing with the vagaries of discovery and cutting-edge tort suits that may not have a ready “play book,” as is often the case in this type of litigation.  That factor tends to guarantee that a relatively small number of firms and lawyers will tend to receive more appointments in these sorts of cases.

Nonetheless, that same MDL system creates financial disincentives and ethical pitfalls that often leave individual plaintiffs with different interests than their counsel, and the lead plaintiffs’ counsel, may have.  Corporate defendants are then placed in the often awkward position of trying to resolve those cases, even when confronted with these professional hurdles and conflicting interests, which can impact the ultimate value of the case at settlement.  Meanwhile, MDL judges are struggling with reigning in felt excesses, all without a solid basis for doing so under the Federal Rules of Civil Procedure, or federal statutory law, as contrasted with their considerable authority in the class action setting, as set forth in Rule 23 of the Federal Rules of Civil Procedure.  And all of this is done without meaningful appellate review, as these cases are usually settled before these cases make it that far in the process.  In total, these circumstances point to the potential for new rulemaking in this area to help address some of these systemic issues going forward.

Several MDL actions are winding their way through the federal courts, including in Georgia, and many of those cases impact product liability claims in the health care industry.  Given the complexities and shifting landscape in this kind of litigation, it is important for medical companies, and others facing the potential consolidation of personal injury suits, to stay abreast of these developments, and to consult with counsel as needed.

 

Insurance Application Omissions Not Enough to Rescind Policy

Posted on: January 19th, 2016

option 4By: Kristian Smith

Insurers may need to pay closer attention to insurance applications. A Pennsylvania jury recently ruled that an insurer knew (or should have known) about omissions on an insurance application, preventing the insurer from rescinding the policy.

In May 2015, H. J. Heinz Co. filed suit against Starr Surplus Lines Insurance Co. for breach of contract, declaratory judgment and bad faith, arising from Heinz’s claim for coverage under a Starr product contamination policy for losses Heinz incurred when its baby cereal product was recalled for lead-contamination. Heinz made claims for $25 million involving baby cereal that Heinz sold in China. Starr denied coverage for the claim, and Heinz filed suit.

Starr responded with a counterclaim seeking rescission of the policy. Starr claimed that Heinz’s applications for the product contamination policy, submitted in May and June 2014, failed to disclose four accidental contamination losses Heinz suffered in early 2014, misstated the value of a loss for a 2008 contamination incident and failed to disclose a 2013 fine by the Chinese food safety agency. One of the 2014 incidents that Starr contends Heinz failed to disclose was a $12 million loss related to production and sale of baby cereal in China that was contaminated with high levels of nitrite. Starr claimed that if Heinz had accurately disclosed these losses and recalls in its policy application, Starr would not have issued the policy or would have issued it with substantially different terms.  In response, Heinz claimed that Starr should have done more due diligence regarding Heinz’s application. Heinz also claimed that these omissions were not “material” to constitute rescission.

In regards to Starr’s counterclaim, a jury ruled on December 16, 2015 that although Heinz made misrepresentations in its application, Starr knew about the misrepresentations and sold the policy anyway.

There was also a noteworthy discovery ruling in this case – the judge ruled that Starr must produce to Heinz information from its underwriting files for similar product contamination policies that Starr issued to other insureds, in order for Heinz to test Starr’s claim of materiality.