Medical-Legal News

Drugmaker GlaxoSmithKline settled earlier this 2011 a lawsuit concerning the heart attack risks of Avandia, according to Bloomberg.com. The lawsuit was filed on behalf of a North Carolina man who died in 2006 after taking the diabetes drug.  The settlement avoided a jury verdict which may have resulted in punitive damages to the company.

According to Bloomberg, the company already agreed to pay almost half a billion dollars to resolve around 10,000 lawsuits concerning Avandia. 

In the coordinated multi-district federal proceedings (MDL 1871) pending in the United States District Court for the Eastern District of Pennsylvania against GlaxoSmithKline, on August 15, 2011, the parties proposed a schedule for argument on Daubert proceedings to attack the weight and sufficiency of expert testimony on proof of causation.  Daubert proceedings are used in litigation to limit or exclude expert testimony. 

To prove causation in MDL 1871, the plaintiffs must establish sufficient support in the medical and scientific community that Avandia caused health risks in the general population.  This evidence is comprised of data from clinical trials, published case reports, and clinical studies. Once plaintiffs show causation, each individual plaintiff proves, through expert testimony that Avandia caused each person’s specific injury.  

Thousands of cases are going on nationwide against the manufacturer of hormone-replacement therapy drugs.  Women alleged they developed breast cancer and other diseases after taking Premarin or Prempro hormone-replacement therapy drugs.  Some women moved towards recovery after Pfizer Inc. announced it expected to settle for at least $300 million in a last round of lawsuits on the public-health controversy, according to theday.com.

The lawsuits involved women who used Wyeth's Premarin or Prempro.  Effective October 15, 2009, Pfizer Inc. purchased Wyeth in a cash and stock merger. Prempro is a combination of Wyeth's estrogen replacement Premarin and Pfizer's progestin hormone Provera. Prempro is still sold, with $161 million in annual sales in 2009. 

Plaintiffs suing Wyeth, alleged Wyeth failed to test the drugs, and did not warn them or their physicians about breast cancer risks.  During trials, both plaintiffs and defendants have tried to provide expert witness testimony. 

In one case, Leah Royce Hines, Plaintiff, v. Wyeth, d/b/a Wyeth, Inc.; Wyeth Pharmaceuticals, Inc.; and Pharmacia & Upjohn Company, Defendants, filed in United States District Court Southern District of West Virginia at Charleston, defendants attempted to provide pharmacology expert witnesses to testify that combination hormone therapy did not generally cause breast cancer.

On August 11, 2011, the Supreme Court of Tennessee, at Nashville decided in Donna Faye Shipley et al. v. Robin Williams, No. M2007–01217–SC–R11–CV to:  (1) reverse the trial court's judgment disqualifying Shipley's medical experts; (2) reverse the judgment of the court of appeals in part and reinstate summary judgment in Dr. Williams' favor on one of Shipley's negligence claims; and (3) vacate the trial court's order granting summary judgment on Shipley's remaining claims.

At issue in the case was the applicable standard courts should use in evaluating whether a medical expert is qualified to testify as an expert witness in a medical malpractice claim. Shipley filed a medical malpractice lawsuit against two doctors and a hospital, alleging medical negligence. The trial court granted the hospital and one doctor summary judgment. After disqualifying Shipley's medical experts, the trial court granted summary judgment to the remaining defendant, a doctor, and dismissed Shipley's case. The court of appeals upheld the trial court's ruling to disqualify Shipley's medical experts but reversed the grant of summary judgment on Shipley's negligence claims. 

A Kansas doctor's medical records don't show adequate exams of 11 pregnant patients, ages 10-18, she diagnosed with mental health problems and referred for late-term abortions at a Wichita clinic from July to November 2003, a Georgetown University professor testified in early September 2011, during a disciplinary hearing, according to chron.com.

A complaint before the Kansas State Board of Healing Arts alleged the doctor of negligence in conducting exams. At the time of the exams, Kansas law permitted the abortion of a viable fetus starting at the 22nd week of pregnancy only if the woman faced death or "substantial and irreversible" harm to "a major bodily function," which included mental health. Board attorneys presenting the case to a hearing officer called a clinical professor of psychiatry at Georgetown's Medical Center as an expert witness.

The Kansas doctor from Nortonville, a small town about 30 miles north of Lawrence, provided opinions the Wichita clinic needed under the law, diagnosing the patients with anxiety disorder, acute stress disorder and single-episode major depression. At the disciplinary hearing, board attorneys had the expert witness go through the doctor’s records for 9 of the 11 patients.

The expert witness testified the doctor used a computer program, "PsychManager Lite," to create reports with only "generic" statements about patients' conditions, usually minutes after the doctor finished compiling answers to a series of yes or no questions. The expert witness repeatedly stated that based on the documents, the doctor failed to meet accepted standards of care and her records didn't explain how she arrived at her diagnoses.

The expert witness noted in two patients, the doctor’s records said they could be suicidal to be committed for treatment, but there was no indication she sought to intervene in what could be emergencies.  The expert witness said the doctor’s patient records didn't contain information about the patient’s lives to support diagnoses of mental health problems.

The hearing officer will recommend whether the doctor should face sanctions. A 15-member board has the power to revoke the Kansas doctor’s license.

Patient advocacy groups are protesting the government’s shutdown of public access to data on malpractice and disciplinary actions involving thousands of doctors nationwide.

The National Practitioner Data Bank maintains confidential records that state medical boards, hospitals and insurance plans use in granting licenses or staff privileges to doctors.

Although records naming physicians aren’t available to the public, the data bank for many years provided access to its reports with the names of doctors and hospitals and other identifying information redacted.

The California Department of Public Health (CDPH) announced fining a dozen California hospitals, including well known University of California San Francisco (UCSF) Medical Center.

The following hospitals failed to comply with requirements that would likely cause serious injury or death to patients:  Alameda Hospital, Brotman Medical Center, California Men's Colony, Dominican Hospital, Emanuel Medical Center, Kaiser Foundation Hospital & Rehabilitation Center, LAC+USC Medical Center, Riverside Community Hospital, Stanislaus Surgical Hospital, Sutter Delta Medical Center, Torrance Memorial Medical Center, and UCSF Medical Center.

According to a California Department of Public Health spokesman most of the errors by the hospitals were preventable medical errors, but led to either someone being harmed or killed or likely to be harmed.  For example, according to the Los Angeles Times, at LAC-USC Medical Center, state officials determined a 48-year-old man undergoing surgery to treat severe burns suffered neurological damage after being administered anesthesia by an unsupervised nurse anesthetist.

Depending on the number of violations, the penalties for a cited hospital ranged from $50,000 to $100,000. Since 2007, the California Department of Public Health has cited 124 hospitals with 198 penalties, resulting in $4.6 million in collected fines.

The Norfolk, Virginia sister of a man who died at a jail filed a $5 million wrongful death lawsuit in federal court alleging "deliberate indifference", against the Virginia Beach, Virginia sheriff and the jail medical staff, according to The Virginian-Pilot.

The lawsuit alleged poor medical care, in violation of the 8th and 14th US Constitution Amendments.  The man, age 54, entered jail on October 29, 2010, to serve a 10-day sentence for driving with a suspended driver's license. Five days later he died.

Pursuant to the lawsuit, upon arriving to jail, he told a nurse he suffered diabetes and hypertension and needed certain medicines.  He didn't receive such medications for four days.  When the jail provided him with insulin, he still did not receive anything to control hypertension.

On November 3, 2010, the man reported to jail staff he had eye pain. He was unsteady on his feet and sweating. He fell and struck his head on a table.  The medical staff at the infirmary implied "he was malingering," according to the lawsuit. When he returned to his cell, a deputy, a doctor and nurses told other inmates he was "faking blindness".

The lawsuit alleged the man then reported he felt nauseated and he again fainted.  When he tried to get up, he struck his head on a toilet and lost consciousness.  The inmates in his cell block banged on the window and only then did jail staff call 911, and the man was taken to an emergency room in handcuffs.  He was transferred to Virginia Beach General Hospital. He was pronounced brain dead and died November 7, 2010.

Allegedly there was a history of inadequate medical care at the Virginia Beach jail.  The jail housed about 1,100 inmates daily. One physician named in the wrongful death lawsuit was the same physician who treated an inmate who died in 2001.

As the 10th anniversary of 9/11 passes, and the country gets hit with natural disasters such as the CBS News recently reported hurricanes that drenched the mid-Atlantic states, including North Carolina and Virginia, forcing at least one hospital to run on generator power, the issue on medical provider readiness for unexpected events arises. 

A report by the Trust for America's Health and the Robert Wood Johnson Foundation hints that budget cuts have left holes in staffing at medical facilities.  Though social media and administrative support has improved emergency preparedness than 10 years ago, there is a healthcare work force shortage, with 50,000 fewer public health workers than two decades ago, and one in three eligible to retire within five years, according to the Trust for America's Health and the Robert Wood Johnson Foundation report. 

The US may not be prepared for disease outbreaks such as the letters laced with anthrax in September and October 2001, bioterrorism, and other emergency events, which have left people dead.

Many instances of adverse drug reactions (ADRs) experienced by patients at hospitals and emergency care facilities are preventable, according to a study by International Pharmaceutical Federation. 

A pharmacist, along with research colleagues, from the Nordic School of Public Health, Gothenburg, Sweden undertook a meta-analysis of preventable adverse drug reactions (PADRs) in out-patients and in-patients. A meta-analysis is a combination of evidence from a number of studies to provide a result with statistical strength. The pharmacist’s study brought together the results of 22 studies to measure the frequency of ADRs and their preventability in a hospital and emergency environment. 

PADRs take many forms including: 

• internal bleeding associated with anticoagulant (blood-thinning) therapy to prevent clotting;
• contraindication for a specific treatment ignored or overlooked;
• proper treatment where the dose is too high. 

At a time when more medications are available, it is important to distinguish between ADRs and PADRs when evaluating whether to discontinue medications or therapy.

Traditionally courts have strictly enforced the statute of limitation for medical malpractice cases.  In a case of misdiagnosis a decision in Maine by the Maine Supreme Court could allow patients to bring claims beyond the three years statute of limitations.   That case involved a misdiagnosis continuing over the period of six years.  The court allowed the patient to bring the action under the “Continuing Negligence Treatment Doctrine” which is part of the Maine Health Security Act.

Neither side of the aisle thought this ruling was going to flood the courts with a large number of misdiagnosis cases, but counsel for the doctor did express a concern that it could increase liability exposure for doctors and increase the costs of liability insurance.  This ruling may give individuals the ability to bring an action for misdiagnosis if some related act occurred outside the three-year statute of limitations.