Category: Health Care Law

Seventh Circuit Reverses Course on Reassignment Accommodation, Leaving United Airlines Grounded

An article by R. Holtzman Hedrick of Barnes & Thornburg LLP regarding Reassignment Accommodations, recently appeared in The National Law Review:

 

In arguably its most significant decision under the Americans with Disabilities Act (ADA) in years, the Seventh Circuit, in EEOC v. United Airlines, Inc., reversed its own previous holdings regarding the viability of competitive transfer policies for disabled employees. The case can be found here.

For over a decade, employers in the Seventh Circuit have been able to rely onEEOC v. Humiston-Keeling, 227 F.3d 1024 (7th Cir. 2000), to adopt perfectly valid policies allowing for disabled employees who can no longer perform the essential functions of their current jobs to be considered for reassignment on a competitive basis.  In other words, if a more qualified candidate sought the same position as the disabled candidate, the employer could select the best-qualified candidate without running afoul of the ADA.  No longer, says the Seventh Circuit.

The circuit court held that under the Supreme Court precedent of U.S. Airways, Inc. v. Barnett, 535 U.S. 391 (2002) (requiring an employee to show that an accommodation is reasonable on its face, which then shifts the burden to the employers to demonstrate case-specific undue hardship), reassignment of a disabled but qualified employee to a vacant position is mandatory in the absence of an undue hardship.  Despite reaffirming its best-qualified candidate rule even after Barnett was decided (reasoning that that ADA does not require preferential treatment and that violating facially-neutral employment policies creates an undue hardship), the Seventh Circuit decided last week that it had been wrong all along:  the “ADA does indeed mandate that an employer appoint employees with disabilities to vacant positions for which they are qualified, provided that such accommodations would be ordinarily reasonable and would not present an undue hardship to that employer.”

The importance of this new automatic reassignment interpretation cannot be overstated.  Indeed, questions about an employer’s reassignment obligations are among the most frequently received inquiries by attorneys under the ADA.  United Airlines, whose policy in question provided for preferential treatment of disabled employees, although not for automatic reassignment for those who were qualified – meaning the company actually went beyond what the Seventh Circuit required it to do before last week – must feel blindsided by the court.  Indeed, this Seventh Circuit panel issued an earlier version of an opinion in this case dismissing the lawsuit under Humiston-Keeling before vacating that decision and issuing a new opinion.

Obviously, employers in the Seventh Circuit (and likely beyond, as the D.C. and Tenth Circuits provide for automatic reassignment, and the Eighth Circuit relied onHumiston-Keeling in deciding that competitive transfer policies were legal) will need to adjust their reassignment policies for disabled employees.  In light of this new ruling, it is critical to consult with experienced counsel to navigate what is likely uncharted territory.

© 2012 BARNES & THORNBURG LLP

Retirement and Pensions Law Update

The National Law Review published an article about Retirement and Pensions Laws Changes written by David J. Leiter and Abby Matousek of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.:

 

PBGC Offers Guidance on MAP-21 Rate Changes

On August 29th, the Pension Benefit Guaranty Council (PBGC)released guidance on how the recently enacted MAP-21 legislation, which gives defined benefit plan sponsors flexibility in near-term plan contributions, will affect PBGC premiums. The guidance clarifies that calculation of variable-rate premiums will be unaffected regardless of whether plan sponsors avail themselves of interest rate stabilization provisions. The guidance also says that MAP-21 increases the flat and variable premium rates and caps variable rate premium. This guidance supersedes any “inconsistent guidance” in the PBGC’s 2012 premium instructions—which will be reflected in the 2013 instructions.

PBGC Requests OMB Extend Info Collection on QDRO Booklet Revisions

On August 23rd, the PBGC issued a notice requesting an extension of an information collection request for a booklet on qualified domestic relations orders (QDROs). The booklet contains information on benefit options that the PBGC offers on QDROs, modeled orders and child support. The booklet also clarifies rules on when payments to an alternate payee may begin. PBGC is planning several revisions to the booklet, including changing the description of agency procedures for informal review of a draft domestic relations order.

Industry Speaks Out on Brokerage Window Pros and Cons

Amidst concerns over DOL’s brokerage window Field Assistance Bulletins, plan fiduciaries are speaking out on the pros and cons of brokerage windows. In an August 16th interview SIFMA managing director Lisa Bleier said brokerage windows allow plan fiduciaries to give participants maximum flexibility in choosing investment options and are often the only way for employers to attain the fullest possible participation in its 401(k) plan. However, the downside to brokerage windows is that employees sometimes make investment choices fiduciaries would avoid. While a relatively small percentage of defined contribution plans have brokerage windows and the decision to offer them is generally based on participant demand.

Brokerage Window-Only Plans Will Likely be Heavily Influenced by Election Results

In an interview, Bradford Campbell, a benefits attorney and former DOL assistant secretary, said DOL officials will address concerns associated with brokerage windows if President Obama wins a second term; however, the issue will likely go away if Mitt Romney wins in November.

Witnesses Urge ERISA Advisory Council to Not Require Affirmative Beneficiary Designations

At an August 29th ERISA Advisory Council hearing, participants urged DOL to avoid one-size-fits-all regulation that would burden administrators with an affirmative duty to contact participants who undergo significant life events regarding changes to beneficiary designations. Practitioners present at the hearing told DOL that a rule requiring a plan administrator to actively reach out is unnecessary as most plans already encourage employees to update beneficiary choice and burdensome to plan administrators. Witnesses agreed on the importance of up-to-date beneficiary designations and outlined the standards already in place to ensure these designations are updated as necessary.

ERISA Advisory Council Hears from Industry on Lifetime Income and Income Replacement

At the August 30th meeting of the ERISA Advisory Council, flexibility of 401(k) plan distributions was underscored as a valuable tool to meet plan participants’ unique needs. Jason Scott, managing director of Financial Engines Retiree Research Center, told the Council that the common defined benefit model is not necessarily the right way to approach the issue of lifetime income, saying the “real power of the 401(k) plan is its flexibility.” Participants at the meeting agreed that plan sponsors tend to look for lifetime income solutions that are “fully vetted and approved and very easy,” which are not always the best for retirees. Some suggestions to the Council in the area of lifetime income included: encouraging plan sponsors to offer in-plan lifetime income assistance; providing clear guidance that “prudent retirement help includes consideration of the broader picture” (including Social Security); and considering solutions that lower the plan sponsor’s fiduciary risk.

Insurance Experts Should be the Judges of Annuity Providers

Witnesses told the ERISA Advisory Council on August 30th that the DOL should allow plan sponsors to defer to state insurance regulators’ determinations of an annuity provider’s long-term financial viability and ability to satisfy fiduciary duty. Cynthia Mallett, Vice President of Corporate Benefit Funding at MetLife told the Council that the requirement to assess annuity providers’ financial viability leaves the “entire retirement community at a loss” as it should not be expected that plan sponsors have stronger reviews than state insurance regulators. Participants said that the fiduciary responsibility involved in selecting an annuity provider “is one, if not the biggest, issue for plan sponsors” offering lifetime income options.

American Benefits Council Speaks Out Against 401(k) Credit Insurance Legislation

At an August 28th meeting of the ERISA Advisory Council, Diann Howland, Vice President of Legislative Affairs at the American Benefits Council, spoke in opposition to the Retirement Savings Security Act of 2011 (H.R. 3656), introduced by Representative Pete Sessions (R-TX). The legislation would promote an insurance product that repays some 401(k) plan loans in the event a participant defaults due to death or disability and would require plan sponsors to automatically enroll plan participants. The American Benefits Council is concerned that the automatic enrollment aspect in terms of costs of the product and the fact that the legislation waives the ERISA fiduciary responsibility. Howland cited concern that the bill continues to garner cosponsors—current cosponsors include Representatives Bruce Braley (D-IA), Ruben Hinjosa (D-TX), Tom Latham (R-IA), Charles Rangel (D-NY) and Pat Tiberi (R-OH).

IRS Examining Regulatory Progress on Lifetime Income Guidance

On August 28th, the IRS held a phone forum to discuss a package of guidance and proposed rules on lifetime income options. The guidance, issued in February, is intended to encourage the use of lifetime income options such as fixed and longevity annuities. The package includes:

  • REG-110980-10,  addressing partial annuity distribution options under defined benefit pension plans;
  • REG-115809-11, on qualified longevity annuity contracts (QLACs);
  • Rev. Rul. 2012-3, on how qualified joint and survivor annuity and the qualified pre-retirement survivor annuity rules apply when an annuity is purchased under a profit-sharing plan; and
  • Rev. Rul. 2012-4, on rolling over amounts from a defined contribution plan to a defined benefit plan to obtain an additional annuity.

IRS Cancels hearing on Anti-Cutback Exemption

The IRS has announced that a hearing scheduled for August 24th has been cancelled. The hearing would have considered proposed regulations that would provide a limited exemption to anti-cutback rules for pension plans, allowing single-employer plan sponsors that are in a bankruptcy proceeding to amend its pension plan to eliminate a lump-sum distribution option if it met certain conditions.

American’s Nearing Retirement Face Challenges

Americans approaching retirement age are faced with new challenges as a result of the financial crisis. The almost-retired “suffered disproportionally” according to a recent New York Timesarticle, experiencing falling home process in addition to lower incomes. The article cites a report from Sentier Research which found that household income for Americans age 55 to 64 fell by almost 10 percent in today’s dollars from three years ago.

Workers Show Confidence in Ability to Retire Despite Inadequate Savings

A recent study, Baby Boomers and Generation Xers: Are They on Track to Reach Their Retirement Goals?, conducted by the Insured Retirement Institute found that, although the majority of Baby Boomers and Gen Xers are confident they will have enough money to retire comfortably, many have not calculated what their needs will be and have not saved appropriately. While the report found that “there are large groups of people who just do not have realistic expectations,” the results show that those taking important steps—such as consulting financial advisors, calculating savings or buying annuities—are the most confident in their ability to retire.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

The Republican Platform – What It Means for Healthcare

The National Law Review recently published an article by Andrew Bowman of Drinker Biddle & Reath LLP regarding The Republican Platform and Healthcare:

The Republicans formalized their party platform yesterday as part of the first day of their national convention.  The document does not contain many surprises, but solidifies the direction GOP leadership will take should they win in November.  Here are some highlights for health advocates:

Repeal of the Affordable Care Act: Again, this comes as little surprise, given that Republicans have promised to repeal the measure since the day it was signed, and the Republican-led House has passed numerous bills to do so.  But the party platform confirms the party’s plans, saying “Congressional Republicans are committed to its repeal; and a Republican President, on the first day in office, will use his legitimate waiver authority under that law to halt its progress and then will sign its repeal.”

The document also offers insight into the framework of potential Republican legislation to replace the ACA, promising to “increase healthcare choice and options, contain costs and reduce mandates, simplify the system for patients and providers, restore cuts made to Medicare, and equalize the tax treatment of group and individual health insurance plans.”  The platform also calls for price transparency for health services, a cap on non-economic damages in medical malpractice lawsuits, and promotion of Health Savings Accounts and Health Reimbursement Accounts to be used for insurance premiums.

Medicaid Block Grants: This is another long-standing idea, which was included in the House-passed budget drafted by current Vice-Presidential nominee Paul Ryan.  Calling Medicaid “the next frontier of welfare reform,” the platform recommends block-granting the Medicaid program.  Currently, the federal government sets standards for Medicaid eligibility and pays about 60% of the cost of covering those individuals.  The block grant program would provide each state with a lump sum annual payment in exchange for greater freedom in administering the program.  The platform says this change would allow “flexibility to design programs that meet the needs of their low income citizens.”

Changes to Medicare: The platform also adopts the portion of the Ryan plan which would convert Medicare from a defined-benefit system into a defined contribution system for Americans under the age of 55.  This is what has come to be known as the voucher system, wherein Medicare beneficiaries would be given the option of traditional Medicare or income-adjusted premium support to purchase their own health insurance.  The platform also suggests an increase in the age of eligibility “without disadvantaging retirees or those nearing retirement,” but does not lay out particulars on when such changes would be implemented or to what age eligibility might be raised.

Investments in Healthcare: While much of the platform’s focus is on reigning in federal spending, Republicans do endorse “investment in healthcare delivery systems and solutions creating innovative means to provide greater, more cost-effective access to high quality healthcare,” specifically “basic and applied biomedical research, especially the neuroscience research that may hold great potential for dealing with diseases and disorders such as Autism, Alzheimer’s, and Parkinson’s.”

©2012 Drinker Biddle & Reath LLP

How Many Calories is in that Burger? PPACA Makes Sure you know.

The National Law Review recently published an article by Molly Nicole Lewis of McBrayer, McGinnis, Leslie and Kirkland, PLLC regarding The Food Industry and The Patient Protection and Affordable Healthcare Act:

 

We all occasionally grab a quick bite on the go. With fall in full swing, and our schedules filling up, it is much more tempting to drive through and pick up dinner rather than slaving over the stove after a non-stop day. Consider this:  What if the menu was labeled with calorie information and you could see that the Hardee’s Thickburger you wanted to order contained 910 calories.  A healthy caloric intake for an average person is 2000 calories per day – that’s also stated on the menu.  The burger just became ½ of your daily allotment of calories. That information would definitely prompt anyone to reconsider their choices.

Menu labeling, as outlined in the Patient Protection and Affordable Health Care Act (PPACA), might actually change the way we eat, when we eat out!  That is exactly what the National Restaurant Association and the National Association of Convenience Stores is grappling with.  In the wake of the Supreme Court upholding the PPACA, it is not just the medical and insurance communities buzzing. The food industry is wadding through their own set of new rules regarding how they present their product and interact with consumers.

As outlined in Section 4205, nutritional menu labeling is required for chain restaurants across the country. The provisions include labeling requirements for restaurants and food vendors, with 20 or more outlets. Calories have to be posted on menus and menu boards, including drive-thru menus. Display tags with additional information, including fat, saturated fat, carbohydrates, sodium protein, and fiber must be available in writing, upon request. Vending machine companies that operate at least 20 machines are also subject to these requirements. For buffet-style or self-serve restaurants, a sign must be placed adjacent to each food and beverage item listing calories per item or serving.  There are some exceptions that will not require calorie disclosure. Items not listed on the menu such as condiments, daily specials or temporary offerings. If an item appears on the menu less than 60 days per calendar year, or a test market items appears on a menu for less than 90 days, they are both exempt.

The Food and Drug Administration (FDA) considered Section 4205 effective immediately. However, without detailed guidance from the FDA, these provisions cannot be required.  The final FDA regulations are expected by the end of 2012.  Industry implementation would become effective six months after publication, in early 2013.  If a restaurant that is not required to comply with Section 4205, voluntarily registers with the FDA and follows the federal disclosure guidelines, they are not subject to any state or local nutrition disclosure requirements.

There is more at stake here then complying with disclosure regulations. For owners and operators in the food industry there are real costs to be considered. The new menu requirements alone will demand printing new menus and menu boards. Nutritional analysis may have to be performed to accurately report the information to the consumer. All of these added expenses could mean thousands in unbudgeted expenditures, and will result in consumer behavioral changes where the full financial impact cannot be determined – until after the fact.

It is interesting to contemplate how each of us will react to menu labeling. Will it help change the health of our country? The jury’s still out, but we are eagerly anticipating the verdict.

© 2012 by McBrayer, McGinnis, Leslie & Kirkland, PLLC

Another Loss for the Robinson-Patman Act

The National Law Review recently published an article by Harvey Saferstein, Bruce D. Sokler, Nada I. Shamonki, and Robert G. Kidwell of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., regarding the Robinson-Patman Act:

In Drug Mart Pharmacy Corp. v. American Home Products Corp., 2012 U.S. Dist. LEXIS 11582 (E.D.N.Y. Aug. 16, 2012), Magistrate Judge Steven M. Gold gave the Robinson-Patman Act another drubbing. He granted summary judgment for the defendants in this complex, long pending antitrust litigation between retail pharmacies and various pharmaceutical companies.

Numerous independently owned retail pharmacies claimed that five manufacturers of brand name prescription drugs offered discounts and rebates to their competitors in violation of the Robinson-Patman Act prohibition on price discrimination. In order to establish their losses, the pharmacies set out to compare their customers with the customers of favored pharmacies for the brand name prescription drugs in question. The “matching” process showed a very low number of lost customers. On average, each plaintiff pharmacy lost less than 200 customers and 537 transactions over the entire period examined—a 12-year time frame from 1998 to 2010.

Magistrate Judge Gold characterized these results as “de minimis.” “Many pharmacies lost no more than ten customers per defendant over the relevant twelve-year time period, or less than one customer per year.”

Accordingly, Judge Gold held summary judgment was appropriate—especially in light of the Supreme Court’s admonition in Volvo Trucks N. Am, Inc. v. Reeder-Simco GMC, Inc., to construct the Robinson-Patman Act narrowly. With that view in mind, the court concluded that plaintiffs could not show competitive injury required by Section 2(a) of the Robinson-Patman Act. Moreover, the same de minimis impact made it impossible for plaintiffs to demonstrate antitrust injury.

Despite the existence of a price disparity in drug prices, the plaintiffs were not able to show any real consequences in their business or as a matter of antitrust competitive injury. This doomed their Robinson-Patman claims.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

First-Ever Electronic Medical Records and Advanced Imaging Technology Being Brought to 2012 London Olympics

For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs.  GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance.  The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping.  We first saw the popularity of this drug grow among Tour de France cyclists.

Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics.  GlaxoSmithKline will be the official lab services provider for the 2012 Olympic and Paralympics Games.  Test results will be analyzed at King’s College London, within an independently operated World Anti-Doping Agency (WADA) accredited laboratory.  The average number of samples analyzed throughout the year at King’s College is approximately 7,000, but during the Olympic Games, it is expected that 5,000 samples will be analyzed in only 17 days.

The history of drug testing in the Olympics dates back to the 1968 Olympic Games in Mexico City.  Many notable athletes have had world records and Olympic medals rescinded due to testing positively for performance-enhancing drugs in post-race drug testing, others have had to resign from their Olympic team just weeks before competing on the world stage due to failed drug tests, and still others have received lifetime bans from the games.  With the rapid advancement of technology within medical imaging and testing, we are likely to see a closer eye on the issue of doping in the Olympics.  While we can begin to feel reassurance from advanced testing such as that provided by GE’s ImageQuant, some of us may be watching this year’s Olympic Games with a skeptical eye about what has gone on before…

©2012 Drinker Biddle & Reath LLP

The FDA Safety and Innovation Act: Much More Than Just User Fees

The National Law Review recently published an article by Hae Park-Suk and Lynn C. Tyler, M.S. of Barnes & Thornburg LLP regarding The FDA Safety and Innovation Act:

 

 

 

 

With almost no fanfare, President Obama signed the FDA Safety and Innovation Act (SIA) into law earlier this month. The popular and legal media coverage of the bill leading up to its enactment seemed to focus on the reauthorization of user fees for prescription drugs and medical devices and the creation of new user fees for generic drugs and biosimilars. As usual, the user fees are accompanied by performance goals for the FDA’s review of the related applications. But the SIA also contains a host of other provisions relating primarily to drugs and medical devices.

With respect to medical devices, § 601 of the SIA precludes the FDA from refusing to approve an Investigational Device Exemption simply because it determines that the proposed study alone will not support an approval to market the device. Section 602 refines the “least burdensome” provisions to specify that FDA can only request the “minimum required information” to support clearance or approval to market a device. Section 603 requires the FDA to document the rationale for “significant decisions” in connection with IDEs, 510(k)s, and PMAs.

Section 604 requires FDA to withdraw a draft guidance on when a modification to a device requires a new 510(k) and to submit a report to Congress on a new approach. FDA may not issue a new guidance until at least 12 months after it submits the report. Other sections require FDA to improve the device recall program, authorize clinical holds on IDEs, allow a sponsor to seek a de novo classification directly rather than only after pursuing a 510(k) and receiving a “not substantially equivalent” determination, allow FDA to reclassify a device category by administrative order, reauthorize third-party reviews and inspections, revise the Humanitarian Device Exemption to allow a manufacturer to make a profit in more circumstances, require FDA to issue a proposed rule for a unique device identification system (which it recently has), expand the drug “Sentinel” system to medical devices, add timing requirements to post-market surveillance orders, and revise the definition of a “custom” device, among other changes.

The SIA makes many changes to the regulation of drugs also. Similar to the unique device identification system, FDA must create a unique facility identification system for drug facilities and maintain an electronic database of their registration and listing information. A drug is now adulterated if it is made, packaged or stored in a facility that delays, denies, or limits an inspection. The biennial inspection schedule for drug facilities will be replaced with a “risk-based” system. FDA may require manufacturers to furnish records in advance of an inspection. FDA now has ex-US jurisdiction over any violation of the Food, Drug & Cosmetic Act (FDCA) related to an article to be imported into the US. FDA may require an importer to submit records in advance of importation showing compliance with the FDCA. FDA now has authority to detain drugs an inspection reveals may be adulterated or misbranded.

The SIA makes permanent the Best Pharmaceuticals for Children Act and its six months of marketing exclusivity in exchange for conducting pediatric studies. It also makes permanent the Pediatric Research Equity Act which requires pediatric studies for most drugs and biologics. The SIA also includes several provisions to encourage the development of antibacterial and antifungal products, including an additional five years of marketing exclusivity for a product designated by FDA as a “Qualified Infectious Disease Product.”

Other drug-related provisions include § 901 which expands the products that qualify for fast track review and the endpoints that may be used to gain fast track approval. Section 902 allows FDA to accelerate approval of “breakthrough therapies” defined as those which may show “substantial improvement over existing therapies on one or more clinically significant endpoints.” The SIA requires FDA to “implement a structured risk-benefit assessment framework in the new drug approval process.” It creates a “priority review voucher” as an incentive to develop treatments for rare pediatric diseases.

The SIA includes provisions designed to mitigate the recent drug shortages. Manufacturers are required to notify FDA at least six months, or as soon as is “practicable,” before they discontinue or interrupt manufacture of a particular drug to an extent that may cause a disruption in supply. FDA must consider the impact of any warning letter or other enforcement action on the supply of a drug. FDA must create a task force to develop and implement a strategic plan to prevent and mitigate shortages. The Comptroller General must study drug shortages and their causes.

The SIA contains several miscellaneous provisions as well. Within two years, FDA must issue a guidance on the use of the internet (including social media) to promote regulated products. FDA is to work with regulators from other nations to develop uniform, scientifically driven clinical trial standards. FDA is to research the use of nanomaterials in regulated products. FDA cannot further delay the effective date of its final rule on over-the-counter sunscreens. The SIA clarifies and modifies the time frame within which an ANDA must receive tentative approval to avoid forfeiting the 180 day marketing exclusivity. The time for FDA to respond to certain citizen petitions related to generic drugs and biosimilars is shortened from 180 to 150 days. There are changes to the conflict of interest rules for FDA advisory committees.

The SIA contains other provisions, as we have mentioned only those we thought most likely to be of interest. Anyone subject to FDA regulation may wish to investigate the act, which can be found here, more thoroughly for items of potential relevance to their business.

© 2012 BARNES & THORNBURG LLP

Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects

A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid.  Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s.  The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.

The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study  may hinder efforts to conduct trials of Alzheimer’s drugs.  In 2010, an Institute of Medicine summary  of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in which they agreed to participate, and 90% of all clinical trials worldwide fail to enroll the target number of subjects on time and must extend their enrollment periods.  Though the federal Office for Human Research Protections and the Secretary’s Advisory Committee on Human Research Protections have considered the issue of participation of decisionally-impaired subjects in research in recent years, no guidance has been released.  Further, few states’ laws explicitly address who has authority to consent to research participation on behalf a decisionally-impaired individual.

In the absence of clear guidance, to be in the best position to participate in Alzheimer’s research and other research involving subjects who are or may become decisionally-impaired, institutions and their IRBs should develop their own policies on enrollment of and consent for decisionally-impaired subjects and subjects whose capacity may diminish over the course of a study.  Having policies in place before opportunities to participate in such studies arise will help ensure consistent and efficient review by institutions and IRBs.  Individuals who have a strong interest in participating in Alzheimer’s research studies should complete health care power of attorney documents, record their wishes in writing, and discuss them with their designated health care agents.

©2012 Drinker Biddle & Reath LLP

FDA Issues Proposed Rule on Medical Device Labeling

The National Law Review recently published an article regarding Medical Device Labeling written by William O. Jackson of von Briesen & Roper, S.C.:

On July 10, the Food and Drug Administration (FDA) released a proposed ruleon medical device labeling. The FDA promulgated the rule to “substantially reduce existing obstacles” to medical device identification. Among other benefits the FDA recognized, the rule is intended to reduce medical errors due to misidentification or incorrect medical device use and improve reporting of adverse events caused by devices.

Under the proposed rule, medical devices are required to have a unique device identifier (UDI) with a standard date format (e.g., JAN 1, 2012). The UDI will also identify the specific version or model of the device, the labeler of the device, and a production identifier, such as a lot or batch number, a serial number, an expiration date, or a manufacture date. The UDI must be in two forms: easily-readable plain-text and automatic identification and data capture (AIDC) technology format.

Subject to limited exceptions, every medical device will require a UDI. Excepted medical devices include (but are not limited to) non-prescription devices sold at retail establishments; a device used solely for research, teaching, or chemical analysis, and not intended for any clinical use; and exported medical devices. The proposed rule also has a procedure to request an exception from or alternative to the UDI requirements.

The FDA plans to phase in the UDI requirement. Class III medical devices and devices licensed under the Public Health Service Act must be labeled within one year after publication of the UDI final rule. Class II medical devices must be labeled within three years. Class I medical devices must be labeled within five years.  Finally, the proposed rule contains reporting requirements, including requiring “labelers” to submit data to the Global Unique Device Identification Database.

The FDA’s press release on the proposed rule is available here. For an example of a UDI, click here.

©2012 von Briesen & Roper, s.c

DOL Publishes New Employees’ Guide to the FMLA

The National Law Review recently published an article by Joel M. Nolan of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., regarding FMLA:

Recently, the U.S. Department of Labor released a user-friendly Employees’ Guide to the Family and Medical Leave Act.  The guide is targeted at employees, but may also serve as a helpful tool for employers looking for an efficient summary of the law.

The guide does not provide new information or legal interpretations of the law; rather, it provides a plain-language overview of the FMLA’s major provisions and contours, such as FMLA eligibility, FMLA rights and protections, the process for requesting leave (and associated notice provisions), FMLA certifications, and job reinstatement.  In addition, the guide highlights certain unique circumstances and incorporates some of the DOL’s  interpretive guidance on particular issues.  For example, the guide discusses eligibility guidelines for airline flight attendants and flight crew employees, describes when employees may be eligible to take FMLA leave to care for certain children with whom the employee has no legal relationship (or to care for another as such a child), and emphasizes the importance of employer FMLA policies.  Further, the guide provides clear flowcharts regarding FMLA eligibility and certification and the process for taking FMLA leave, as well as information for employees on filing an FMLA complaint with the DOL’s wage-and-hour division.

The DOL has also archived a webinar about the guide, which is available here:  http://www.dol.gov/whd/fmla/employeeguide-webinar.htm

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.