Medical Malpractice

January 30, 2013

First Amendment Protects Pharmaceutical Sales Rep’s Off-Label Promotion of Drug, Court Says

by Parr Richey Frandsen Patterson Kruse LLP

A pharmaceutical sales representative’s conviction for conspiracy to introduce a misbranded drug into interstate commerce violated his rights to free speech under the First Amendment, according to the Second Circuit’s ruling in United States v. Caronia, No. 09-5006-cr, slip op. (2nd Cir., Dec. 3, 2012). The court held that the representative’s speech, consisting of the off-label marketing of a drug, was the principal basis for the government’s criminal case, and that the regulations regarding such marketing were overbroad for the goal of maintaining safe drug labeling. The decision adds an interesting and important dimension of constitutional law to the issue of drug safety and medication errors.

The drug at the center of the case is Xyrem, a central nervous system depressant used for narcolepsy. It has a reputation as a “date rape drug” because its active ingredient, gamma hydroxybutrate, can cause abrupt loss of consciousness in sufficiently large doses. It is therefore subject to strict regulations as to its approved uses. The U.S. Food and Drug Administration (FDA) has only approved it for two uses, both related to narcolepsy: excessive daytime sleepiness and cataplexy, a sort of temporary paralysis associated with the condition. Xyrem was developed by Orphan Medical, which is now part of Jazz Pharmaceutical.

Before a pharmaceutical company may introduce a new drug into the marketplace, it must obtain approval from the FDA for specified uses, and the law states that its marketing may only reference these approved uses. The federal Food, Drug, and Cosmetic Act (FDCA) prohibits drug companies and their representatives from introducing “misbranded” drugs into the marketplace, which may include information that is “false or misleading,” or that suggests uses that are “dangerous to health.” Caronia, slip op. at 7, n. 4. The law does not, however, prohibit “off-label” promotion of drugs by physicians when speaking directly to patients. For pharmaceutical companies and their sales representatives, the FDCA imposes criminal penalties for misbranding drugs, but it does not specifically criminalize “off-label” promotion of drugs.
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October 31, 2012

More Than Forty People in Indiana Sickened in Fungal Meningitis Outbreak; State Seeks to Revoke License of Pharmacy Where Outbreak Allegedly Originated

by Parr Richey Frandsen Patterson Kruse LLP

Indiana has been one of the hardest-hit states in a nationwide fungal meningitis outbreak that has caused more than three hundred illnesses and over twenty deaths in eighteen states. Health officials believe an injectable medication from a Massachusetts pharmacy is the source of the infection. The pharmacy has recalled the medicine and ceased its facility’s operations. It is already facing lawsuits from victims alleging injury from a defective product, and Indiana state officials are seeking to suspend its license. Some victims may also be pursuing causes of action for medical negligence against the doctors and healthcare facilities that prescribed or administered the allegedly contaminated drugs.

At least forty-three reported cases, out of a national total, so far, of 328, are in Indiana. Three of the Indiana patients have died. The total death toll, as of October 25, 2012, is twenty-four. Investigations by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the fungal infection came from injections of methylprednisolone acetate, a steroid-based anti-inflammatory medication used to treat back pain. Authorities traced contaminated vials to the New England Compounding Center (NECC) in Framingham, Massachusetts. They suspect that the contamination occurred during the compounding process.

Victims are suffering from fungal meningitis, an infection affecting the spinal cord. Other types of meningitis may result from communicable viral or bacterial infections, but fungal meningitis is not contagious between people. It usually develops when an infectious fungus species gets into the bloodstream, such as through an injection, and spreads to the victim’s spine. The CDC believes it has identified the fungal species Exserohilum rostratum in at least fifty-two patients. The disease can be fatal, particularly in patients with compromised immune systems, and it can cause severe headaches, nausea, light sensitivity, and disorientation.
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September 28, 2012

Verdict for Doctor in Medical Malpractice Lawsuit Affirmed by Indiana Court of Appeals: Ruble v. Thompson

by Parr Richey Frandsen Patterson Kruse LLP

After a jury returned a verdict in favor of the doctor in a medical malpractice case, an estate executor appealed on two questions of abuse of discretion: limitations on the scope of questions during the defendant’s deposition, and refusal of jury instructions tendered by the plaintiff. The Indiana Court of Appeals affirmed the trial court’s verdict in Ruble v. Thompson, finding that the court did not abuse its discretion on any of the points raised on appeal.

Larry Ruble filed suit against Dr. Lori Thompson as an individual and on behalf of the estate of his wife, Natasha Ruble. According to the Court of Appeals’ opinion, Dr. Thompson first saw Natasha during her first day of practice after completing her residency in September 1998. Natasha was fifteen years old at the time and sought treatment for abdominal pain. Dr. Thompson reportedly saw Natasha in about twenty appointments over the following forty-six months. A physician’s assistant working for Dr. Thompson requested a CT scan in July 2002, which revealed that Natasha had advanced liver cancer. The scan showed an eighteen-centimeter cancerous lesion, although CT scans and other diagnostic tools can detect lesions as small as one centimeter. Trial experts testified that Natasha had about a five percent chance of survival by the time she was diagnosed, and that her chances would have been as high as fifty percent had diagnosis occurred a year earlier.

Natasha died on April 30, 2004, having married Larry Ruble on March 15, 2003. Larry filed a proposed malpractice complaint against Dr. Thompson with the Indiana Department of Insurance and a state court lawsuit in July 2004. He alleged that Dr. Thompson negligently failed to follow accepted standards of care in her treatment of Natasha, resulting in her death.
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September 6, 2012

Indiana Father Plans to Sue Department of Child Services for Wrongful Death

by Parr Richey Frandsen Patterson Kruse LLP

A Shelbyville man has submitted a tort claim to the Indiana Attorney General, indicating his intention to file a wrongful death lawsuit against the state’s Department of Child Services (DCS) over the death of his one year-old son. He alleges that DCS ignored warnings that the child’s mother and her boyfriend were abusing the child, and that the agency’s failure to intervene and protect the child contributed to his death. The man also notified the hospital that treated his son of his intent to file a medical negligence lawsuit.

According to Jerraco Noel, he reported the abuse of his son, Jayden, to DCS in July 2011. Jayden was treated in the emergency room of Major Hospital in Shelbyville on July 15, 2011 for injuries resulting from abuse by his mother and her boyfriend. DCS reportedly found Noel’s claims at the time “unsubstantiated.” Jayden died on January 18, 2012 from “multiple blunt-force traumatic injuries to the head.” Prosecutors have charged the mother and her boyfriend with neglect of a dependent causing death. Both have pleaded not guilty.

Noel claims that DCS “failed to conduct a reasonable investigation” after he reported his suspicions of abuse. He also alleges that the agency failed to consult with any of the medical professionals who treated Jayden, and that those medical professionals failed to report the injuries to DCS. He is demanding $700,000, the maximum amount of damages allowed by statute from DCS, for “loss of love and affection.”
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August 13, 2012

Indiana Department of Health Says 2010 Had Highest Number of Reported Medical Errors in Five Years of Collecting Data

by Parr Richey Frandsen Patterson Kruse LLP

The Indiana State Department of Health (ISDH) has collected medical error reports from hospitals, outpatient clinics, and other medical facilities since 2006. In that time, it has compiled data on medical errors and injuries and tracked trends. Reports from 2006 to 2010, the most recent year for which comprehensive data is available, indicate an increasing number of medical errors in the state. 2010 had more medical errors than any of the other years for which data is available.

Executive Order 05-10, issued by Governor Mitch Daniels on January 11, 2005, directed ISDH to implement a system for reporting medical errors. Among the stated purposes for the system was an increase in public awareness of “the problem of medical errors,” collection and analysis of data to identify areas needing correction, the availability of information and data to help both health care providers and patients understand how to reduce the number of errors, promotion of open discussion about the issue, and reduction of the cost of health care. ISDH created the Medical Error Reporting System (MERS), which requires medical error reporting by hospitals outpatient surgical clinics, birthing centers, and abortion clinics. The system began collecting data on January 1, 2006. MERS now covers 295 health care facilities around the state.
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November 7, 2009

ATTORNEY PAUL KRUSE RESPONDS TO EDITORIAL ON TORT REFORM FOR MEDICAL MALPRACTICE LAWSUITS

by Parr Richey Frandsen Patterson Kruse LLP

Below Parr Richey Frandsen Patterson Kruse Attorney Paul Kruse responds to an editorial published earlier this fall in the Lebanon Reporter. Mr. Kruse counters several myths relating to tort reform for medical malpractice lawsuits, citing studies supporting his argument that medical malpractice costs represent a small percentage of overall healthcare costs. Furthermore, Mr. Kruse explains why no further tort reform for medical malpractice claims is necessary.
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Your recent editorial on September 17, 2009, authored by Chip Minemyer, titled “Without Tort Reform, There Should Be No Health Overhaul,” was misleading and inaccurate. It was simply an attempt to influence public opinion in favor of big corporations and insurance companies and harpoon injury victims’ claims.

Minemyer starts his column with the statement that litigation reform is an issue “central to improving the cost of healthcare and access to treatment.” In fact, the cost of medical malpractice is actually a tiny percentage of healthcare costs, in part because medical malpractice claims are far less frequent than insurance companies would lead people to believe. According to the Congressional Budget Office (CBO), malpractice costs amount to less than two percent of overall healthcare spending.

President Obama proposed to implement measures to limit the legal rights of severely injured persons as part of the healthcare discussion, apparently as a bargaining chip to reduce Republican opposition to his healthcare reform plan. His medical malpractice reform proposal will hurt patients and dump more cost on taxpayers. It would not eliminate death and injuries but merely shift costs of caring for malpractice victims from perpetrators of malpractice to hard pressed state Medicaid systems, for which state and federal taxpayers share the cost. In fact, according to the insurance industry’s own data, medical malpractice insurance claims and premiums have been trending downward for years.
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September 21, 2009

Infections after surgery, are they medical malpractice?

by Parr Richey Frandsen Patterson Kruse LLP

As an Indiana medical malpractice lawyer, I am regularly contacted by people who have developed infections following medical procedures. These infections can be from many types of bugs such as staph or strep. No matter what the particular infection is, these post surgical infections can have serious consequences and can be life threatening.

When thinking about these cases, it is important to remember that infections can develop from most any surgical procedure. Even when medical care providers do everything correctly, post surgical infections can still result. Therefore, just because a patient develops an infection does not mean that any of the doctors or nurses did anything wrong.
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