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A nationwide outbreak of fungal meningitis, traced to medications from a Massachusetts compounding pharmacy, has prompted lawmakers and others to propose strengthening oversight and regulation of compounding pharmacies around the country. These pharmacies currently have no consistent system of federal oversight, although state governments have a wide range of regulations intended to promote drug quality and patient safety. Indiana’s Board of Pharmacy responded to the meningitis outbreak with reassurances about its oversight.

Two bills introduced towards the end of the last session of the 112th Congress sought to give the U.S. Food and Drug Administration (FDA) additional regulatory authority over certain compounding pharmacies, but neither bill made it out of committee. H.R. 6584, The Verifying Authority and Legality In Drug (VALID) Compounding Act, would have subjected compounding pharmacies that act as drug manufacturers to the same FDA regulations as drug manufacturing companies. It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public “Do Not Compound” list.

H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, would have mandated FDA registration for all compounding pharmacies, labeling of all compounded drugs, and FDA production standards and training programs for state health officials. It also would have required disclosure to patients that they are receiving a compounded drug, and improvements to communication between federal and state health regulators. Both bills were referred to the House Subcommittee on Health, where they died at the end of the 112th Congress.
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The parents of an eight year-old child have filed suit against the child’s school, alleging negligence and violations of their child’s statutory and constitutional rights. Doe v. Ball State University, et al, No. 18C01-1208-PL (Circuit Court No. 1, Delaware County, Ind., Sept. 28, 2012), removed to No. 1:12-cv-01464 (S.D. Ind., Oct. 10, 2012). The suit claims that the school negligently failed to supervise its students, allowing several of the child’s classmates to commit repeated acts of sexual abuse against him. The parents claim the school had knowledge of the abuse, but failed to intervene or notify them. The suit is seeking compensatory and punitive damages.

The plaintiffs, identified in court papers as John and Jane Doe, enrolled their child, identified as Junior Doe, at Burris Laboratory School in Muncie, Indiana. Burris is a K-12 school operated by Ball State University. Junior Doe was eight years old and in the second grade at Burris in the fall semester of 2011. His parents received a telephone call from another student’s parent on December 5, 2011, informing them that Junior had been the victim of sexual abuse and harassment at the school.

The Does learned several days later, according to their complaint, that teachers and administrators at Burris knew of the abuse but did not inform them. At this time, the school told them about the extent of the abuse, which allegedly occurred in the restrooms, library, and one or more classrooms at the school. About four other second-grade boys allegedly touched Junior inappropriately in intimate areas and forced him to engage in other forms of sexual conduct. Students had largely unsupervised and unrestricted access to the restrooms, library, classrooms, and computer equipment. The Does allege that the students were imitating acts they saw in pornographic images and videos viewed on school computers and iPads. They claim that other students approached their teacher to report the abuse, but the teacher allegedly “told the students to sit down and stop ‘tattling'” on others. Complaint at 5.
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Do non-profit and for-profit nursing homes differ significantly in the quality of care they provide to their residents? In an “Economic Scene” article, the New York Times posed that question last week. The author cited several academic papers to suggest that the profit motive may interfere with the goal of providing top-quality care to nursing home residents, as compared to non-profit facilities. This argument, with its implicit indictment of market-driven healthcare, is sure to provoke a wide range of reactions. Our interest, as lawyers and advocates for nursing home residents, is how a nursing home’s for-profit or non-profit status may affect its view of its professional duty of care. Indiana nursing homes and medical professionals must maintain licenses and meet certain ethical standards in order to practice and do business. It makes no difference, legally speaking, whether they are seeking to make a profit or not.

The New York Times article, written by Eduardo Porter, discusses a study of sedative use in nursing homes by two researchers at the University of Wisconsin-Madison’s School of Pharmacy, Bonnie Svarstad and Chester Bond. They compared the rate at which for-profit, “proprietary” nursing homes prescribed sedatives for their residents to the prescription rate at church-affiliated non-profit facilities. They found that both types of facilities wrote prescriptions at approximately the same rate. They also found that the proprietary facilities prescribed dosages that were four times larger than those at the non-profit homes. They presented their findings in an October 1984 paper entitled “The Use of Hypnotics in Proprietary and Church-Related Nursing Homes,” which is not currently available online.

An economist named Burton Weisbrod cited Svarstad and Porter’s paper in a 1988 book, The Nonprofit Economy. He described the difference between the two types of nursing home as one of fundamental motivation. Because of the profit motive, Weisbrod said, for-profit facilities cut expenses wherever possible, and sedatives cost less than caregivers. The incentive of maximizing profit could therefore lead for-profit nursing homes to favor medicating their residents rather than providing staff for individualized attention and treatment.
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Hundreds of people around the country die every year when they are hit by trains while walking on or along railroad tracks. Despite such a seemingly large number of fatalities, the issue received little attention by lawmakers or the justice system. Railroad companies view the issue as a matter of trespassing and take few, if any, measures to prevent deaths along their rail lines. Laws in many states, including Indiana, make it a crime to walk along the tracks, but put no responsibilities on railroads to avoid such incidents. The families of people killed by trains in this manner have little or no legal recourse.

Research by the St. Louis Post-Dispatch found that trains have killed over 7,200 pedestrians nationwide since 1997 and injured another 6,400. Trains kill more pedestrians each year than motor vehicles, when calculated based on number of miles traveled. On a single day, May 30, 2012, researchers found that trains killed four pedestrians in California, Illinois, Maryland, and Missouri. The death in Missouri, a fourteen year-old middle school student, was the twelfth fatality along that set of tracks since 1996, when another student from the same middle school was killed by a train there. The Missouri victim’s parents asked Union Pacific, the railroad operator, to install fences along the tracks or take other protective measures, but the railroad reportedly refused, even in the face of lawsuit threats.
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A lawsuit filed by an anonymous company sought to remove allegedly false or misleading information about the company’s product from an online product safety database maintained by a federal agency. The plaintiff in Company Doe v. Tenenbaum, No. 8:11-cv-02959, slip op. (D. Md., Oct. 22, 2012), alleged that a report submitted to the website described injuries or damages that were not caused by its product. The court reviewed Congress’ intent in mandating the creation of the website and ruled that reports in the database need to show a direct connection between the product and the injury. It granted the plaintiff’s motion for summary judgment and ordered that the report in question be sealed. The court’s opinion offers important insight for consumers into how federal courts may view the fundamental standards of proof in products liability claims.

Congress mandated the creation of an online database of product safety information in the Consumer Product Safety Information Act of 2008 (CPSIA). 15 U.S.C. § 2055a. The Consumer Product Safety Commission (CPSC) launched SaferProducts.gov in accordance with the law’s requirements. The database contains product safety information obtained from medical professionals, government entities, safety organizations, child care organizations, and reports submitted by consumers. Id. at § 2055a(b)(1). Consumers submitting reports must provide their own names and contact information, along with descriptions of the product and the damage, the identity of the manufacturer or labeler, and a verification stating that the information is true and correct. Id. at § 2055a(b)(2)(B). The law requires the CPSC to provide any manufacturer or labeler identified in consumer-submitted reports with copies of those reports, with an opportunity to comment on or dispute the consumer’s charges. Id. at § 2055a(c).
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A lawsuit brought under the federal False Claims Act (FCA) by an Indiana resident, involving allegations that an Indiana nursing home had defrauded the Medicaid system, failed to establish that the court had subject matter jurisdiction, according to a recent ruling by the Fourth Circuit Court of Appeals. The court held in United States ex rel. Black v. Health & Hospital Corporation of Marion County that the relator, who filed the qui tam lawsuit on behalf of the United States, did not produce evidence to show that he had originally discovered the allegedly fraudulent acts. Allegations of Medicaid or Medicare fraud are of interest to nursing home negligence attorneys because of the impact fraud can have on the quality of care received by residents. This case primarily demonstrates the complexity of the Medicaid system and the multitude of ways that nursing homes can abide by, or defraud, that system.

The relator, Paul R. Black, reportedly first filed suit against Health & Hospital Corporation of Marion County (HHC), pursuant to the FCA, in U.S. District Court for the Southern District of Indiana in October 2003. When the United States government did not intervene in the suit, he dismissed it without prejudice. He filed the present suit in the U.S. District Court for the District of Maryland in February 2008. The United States has also declined to intervene in this lawsuit.

Black alleges that HHC has used three state-level Medicaid funding systems to present falsified or otherwise fraudulent claims to state and federal Medicaid officials. States may directly reimburse Medicaid providers up to an Upper Payment Limit (UPL) set by the Centers for Medicare and Medicaid Services (CMS), equal to the amount the provider could obtain through Medicare. In order to facilitate reimbursement of providers, CMS allows states to transfer money from local government bodies to the state’s Medicaid fund, in a process known as an intergovernmental transfer (IGT). Finally, CMS may approve expenditures by providers, known as Certified Public Expenditures (CPEs), that allow providers to claim direct reimbursement from federal matching funds. CMS has expressed concerns about the potential for fraud in these systems several times in the past decade.
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“Energy drinks,” a general category of drinks with high levels of stimulants like caffeine, taurine, and guarana, have been the subject of much scrutiny in recent years, as their excessive consumption has allegedly led to multiple injuries and deaths. Four Loko, an energy drink that also contains alcohol, has been especially controversial, earning the nickname “Blackout in a Can” among many college students. A series of lawsuits has alleged that the stimulants in the beverage mask the effects of the alcohol, leading to over-consumption, risky behavior, and in some cases, injury or death.

Two insurance companies, including one based in Indiana, have filed a federal lawsuit requesting a declaration that they are not obligated to defend or indemnify Four Loko’s manufacturer, Phusion Projects, in these lawsuits. The companies have reportedly already obtained a similar declaratory judgment, meaning that it may prove difficult for future claimants to recover damages from the beverage maker.

The mixture of caffeine and alcohol, according to doctors quoted by Fort Wayne’s WANE News, can pose serious health risks by concealing the depressive effect of the alcohol content and making the individual more likely to continue drinking. The person might not feel drunk because of the caffeine content, so the person is allegedly also more likely to engage in risky behaviors like driving.
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A welder filed a products liability lawsuit, claiming that defects in the shirt he was wearing caused it to catch fire while he was operating a plasma torch. The suit, Hathaway v. Cintas Corporate Services, Inc., also asserted causes of action for breach of warranty and negligence. The District Court for the Northern District of Indiana granted summary judgment for the defendant on the breach of warranty and products liability claims, but allowed the negligence claim to proceed.

Plaintiff Rex Hathaway worked for Quik Cut, Inc. as a welder and plasma torch operator. His employer used uniforms provided by the defendant, Cintas Corporate Services. The rental agreement between Quik Cut and Cintas provided that Cintas would furnish work clothes and provide laundry and repair services. Hathaway was operating a plasma torch, a machine used to cut various types of metal, on February 12, 2009. Sparks from the plasma torch allegedly caused Hathaway’s shirt, a 100% cotton shirt provided by Cintas, to catch fire, and he suffered severe burns over much of his body.

Hathaway filed suit against Cintas, asserting causes of action for negligence, breach of warranty, and products liability. His wife also brought a cause of action for loss of consortium. Hathaway alleged that the shirt had both a manufacturing defect and a design defect, and he claimed that Cintas was liable for failure to warn of the risk of injury.

Cintas moved for summary judgment on the negligence, breach of warranty, and products liability claims. The court first ruled that the plaintiff’s breach of warranty claim was subsumed by his products liability claims. The court held that because the plaintiff did not claim economic damage for the loss of the shirt, the breach of warranty claims were based in tort, and were therefore part of the products liability claim under the Indiana Products Liability Act (IPLA).
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We recently addressed a wrongful death lawsuit brought in federal court that invokes Nebraska’s fetal death statute, and how that law differs from corresponding statutes in Indiana. The lawsuit, Baumann v. Slezak, et al, also asserts a cause of action for alleged violations of federal commercial truck driving regulations, including restrictions on the number of hours a driver may be behind the wheel without a break. Indiana law has allowed for evidence of regulatory violations in order to prove a claim of negligence, although such evidence may not be sufficient to establish liability by itself.

The Nebraska lawsuit arises from a September 9, 2012 accident on westbound Interstate 80 in western Nebraska. A family traveling through the state in two separate cars was stopped at the rear of a line of traffic, which had backed up nearly a mile because of an accident involving two semi-trailers. Another semi-trailer collided with the back of one of the family’s vehicles. This propelled the car into the family’s other car, which collided with another vehicle. All occupants of the two vehicles died in the accident. The truck driver, Josef Slezak, was allegedly driving at seventy-five miles per hour, and did not slow or stop prior to the collision.

The family’s legal representatives filed suit against Slezak and his employer, alleging negligence per se and violation of Federal Motor Carrier Safety Administration (FMCSA) regulations. The two regulations cited in the complaint prohibit operating a commercial motor vehicle while impaired, such as by fatigue, and regulate the length of time a vehicle operator may drive without rest. The hours-of-service (HOS) regulations prescribe maximum lengths of time a driver can be on-duty or behind the wheel before a required period of time off duty. According to the complaint, Slezak had arrived at a trucking terminal in Milwaukee, Wisconsin at 10:49 a.m. on September 8, and left after less than three hours off duty at 1:49 p.m. The accident occurred more than eighteen hours later, at around 5:19 a.m., and about 920 miles away.
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A Nebraska law allowing wrongful death claims for unborn children is getting its first test in a federal lawsuit. The suit, Baumann v. Slezak, et al, arises from a multi-vehicle accident that killed a family of four and their unborn child. It asserts causes of action for negligence and violations of federal trucking regulations. Several states, including Indiana, have passed statutes allowing wrongful death claims for unborn children at various stages of gestation, and courts in other states have recognized causes of action related to fetal death.

The accident giving rise to the lawsuit occurred on westbound Interstate 80 during the early morning of September 9, 2012. Traffic had become backed up for about a mile after two semi-trailers collided at about 4:30 a.m. One semi-trailer had become disabled and pulled onto the right shoulder. The driver, Vladimir Zhukov, however, allegedly left the trailer in a lane of traffic. Another semi-trailer driven by Keith Johnson reportedly collided with Zhukov’s trailer. The impact killed Johnson and caused his tractor to catch fire. The accident blocked all westbound lanes of the highway, creating a significant risk of further accidents for vehicles forced to stop on the highway.

Christopher and Diana Schmidt were traveling to California from Maryland with their two children, and Diana Schmidt was seven-and-a-half months pregnant with a child they had named Ethan. Diana Schmidt was driving a 2007 Toyota Corolla with the two children, and Christopher Schmidt was following her in a 2010 Ford Mustang. They were at the rear of the line of cars stopped because of the semi-trailer accident, with the Corolla stopped behind another semi-trailer, and the Mustang behind the Corolla. A semi-trailer driven by Josef Slezak approached the stopped traffic reportedly travelling at about seventy-five miles per hour. Allegedly without slowing or stopping, Slezak’s vehicle collided with the back of the Mustang at about 5:19 a.m., propelling it into the Corolla. This pushed the Corolla under the trailer in front of it. All four members of the Schmidt family and their unborn child died in the impact.
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Phone: 317.269.2509
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