Planned Parenthood Fraud



In 2011, Susan Thayer filed an action on behalf of the United States and the State of Iowa against Planned Parenthood of the Heartland, Inc. It alleges that Planned Parenthood violated the federal False Claims Act and its Iowa state analog. Thayer's complaint asserted that her former employer submitted false or fraudulent claims for Medicaid reimbursement by seeking payment for services that were either not reimbursable at all or not in the amounts sought. Thayer claimed her knowledge of Planned Parenthood's billing practices was gained during her years of employment as a manager of two of the organization's clinics in Iowa.

Planned Parenthood moved to dismiss the complaint on the grounds that Thayer failed to allege fraud with particularity as required by Federal Rule of Civil Procedure 9(b). The United States District Court for the Southern District of Iowa granted Planned Parenthood's motion, ruling that Thayer did not satisfy Rule 9(b) because she did not plead any "representative examples" of the alleged fraudulent conduct. Thayer appealed.

On August 29, 2014, the United States Court of Appeals for the Eight Circuit largely reversed the district court's decision, holding that an FCA plaintiff who pleads details of the defendant's billing practices and personal knowledge of the defendant's submission of false claims does not need to provide representative examples of the false claims in order to satisfy Rule 9(b).

Reimbursements at higher rates than permitted and the plaintiff alleged that every claim submitted over a sixteen-year period was fraudulent, but did not identify the details of any of the allegedly false claims. The Court dismissed Joshi's complaint for failing to plead fraud with particularity under Rule 9(b), holding that because Joshi was a doctor rather than a member of the hospital's billing department, he could not plead that false claims were actually submitted. Therefore, in order to establish a factual basis for the allegedly systematic practice of presenting false claims, the Court held that he would have to provide representative examples.

Declining merely to employ the test it adopted in Joshi, the Court observed that Thayer's allegations were based on personal knowledge of the billing practices at issue, suggesting greater reliability than the allegations in Joshi's complaint. In these circumstances, the Court held, the complaint could satisfy Rule 9(b) by identifying particular details of the alleged scheme, without the necessity of providing specific examples. Applying this standard to Thayer's allegations, the Court reinstated the majority of her claims, effectively reversing its own earlier decision in Joshi.

Coming soon after the Third Circuit's June 2014 ruling, the Thayer decision tips the balance, suggesting that the federal courts may coalesce around a more flexible standard for FCA complaints, rather than a strict requirement for representative examples. Such a development should be welcomed by whistleblowers who uncover FCA violations, because they are often unable to provide actual billing records.

Antibiotics Being Overused-Deadly Combinations



Hospitals continue to overuse antibiotics despite warnings that pervasive use can lead to drug resistance and cause billions of dollars in excess healthcare costs, according to a retrospective analysis of 505 hospital members of the Premier health alliance.

Inappropriate use of antibiotic combinations was noted in nearly 80% of the facilities analyzed, and overuse of the most common therapies led to an excess spending of nearly $13 million.

Healthcare organizations are encouraged to develop a list of antibiotic “never combinations”—those for which there is no evidence to support continued use—and create an alert system to flag when the drugs are ordered.

Combating overuse of antibiotics remains a major public health concern. Their use is the most important factor leading to antibiotic resistance around the world, according to a Centers for Disease Control and Prevention alert issued last year.

The federal agency estimates at least 2 million people in the U.S. each year become infected with drug-resistant bacteria and at least 23,000 die as a direct result. Over the past few years, the CDC, Food and Drug Administration and several medical specialty organizations through the Choosing Wisely campaign have issued warnings or recommendations to encourage safe use of antibiotics.

Using administrative data from Premier, the company’s researchers and the CDC’s associate director for Healthcare Associated Infection Prevention Programs, Dr. Arjun Srinivasan investigated the incidence and economic impact of potentially overused antibiotics used by hospitals between Jan. 1, 2008, and Dec. 31, 2011. Of the 505 hospitals included, researchers found evidence of “potentially inappropriate, redundant antimicrobial coverage” for 23 antimicrobial combinations in 78%, or 394 of the hospitals. This accounted for 32,507 individual cases of patients who received at least two consecutive days of one or more of the antibiotic combinations.

Meningitis Outbreak and Deaths Linked to Tainted Vaccines!

Pharmacist charged over meningitis outbreak pleads not guilty.

 

The  2012 U.S. meningitis outbreak that killed 64 people and sickened 700 in 20 states is due in court on Thursday to respond to claims that he knowingly shipped a tainted medication.

 

 

 

Glenn Adam Chin, 46, a former pharmacist at the now-defunct New England Compound Company, which produced the tainted steroid that sparked the outbreak, was arrested last week as he boarded a flight to Hong Kong for a family wedding.
He was charged with one count of mail fraud for approving the shipment of 17,000 tainted vials of the medication, used for back pain, despite knowing they had not been properly sterilized or tested, federal prosecutors in Boston said.
His attorney at the time described the arrest as a publicity stunt, saying that Chin, a father of two young children who lives in Canton, Massachusetts, had no plans to flee the country but was simply attending a family function.
Chin was ordered to remain under house arrest until his family returned to the United States.

 

 

        Providing details of the case, the AP  notes that “prosecutors say Chin oversaw the sterile clean rooms” compounding center in Framingham, “which custom-mixed medications in bulk and where tainted steroids blamed for the 2012 outbreak were made.” Chin is “accused of participating in a scheme to fraudulently cause one lot to be labeled as injectable, meaning it was sterile and fit for human use.” That medication “was shipped to Michigan Pain Specialists” in Brighton, MI, and injected into patients. Subsequently, 217 patients were infected with fungal meningitis, with 15 of them losing their lives.

 

 

 

 

 

 

 

 

 

 

 

FDA Warns of NuVision Contamination!

Connecticut health care providers are being urged by the FDA to cease using sterile products from NuVision Pharmacy. The FDA discovered poor sterilization practices being used by NuVision Pharmacy during an inspection that took place in April. Due to the findings of the inspection, the FDA has called upon the pharmaceutical manufacturer to issue a recall for all their sterile products that have not yet passed their expiration dates.


The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.


Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.



Boston Scientific Mesh Case hit with $73.5 million jury verdict

 

 

 

How the mesh case verdict was decided!

A jury hit Boston Scientific with $73.5 million in damages this week in one of thousands of suits the device maker faces over an implant intended to treat incontinence.

The verdict in a Dallas court is part of a recent overload of product-defect and failure-to-warn litigation the device industry faces over similar products. Boston Scientific, which had won two similar suits in Massachusetts, has 23,000 more pending against it.

 

The plaintiff in the Texas case, 42-year-old Martha Salazar, is the first to win an award against the company over alleged defects with its Obtryx sling. Salazar said she suffered nerve damage and persistent pain and infections from the vaginal implant.

 

“I think it’s a really big case,” said David Matthews, the Houston personal-injury lawyer who represented her in the two-week trial. “A woman’s life was turned upside down because of a device she was using for a minor issue of urinary incontinence.”

 

Boston Scientific, which has a large workforce in the Twin Cities, said in an e-mailed statement that it was disappointed in Monday’s ruling and vowed to appeal.

The company argued at trial that doctors’ continued widespread use of the devices shows that they understand the benefits and risks.

 

“Devices like the Obtryx serve an important public medical need,” company attorneys wrote in legal filings.

“The prevalence of their usage in the medical community demonstrates that mesh slings are beneficial to patients.”

 

Seven companies are sued

 

A total of seven companies are facing lawsuits over alleged defects in vaginal mesh devices, including C.R. Bard and Johnson & Johnson’s Ethicon subsidiary, Reuters reported. Last April, a subsidiary of Dublin-based Endo International agreed to pay $830 million to settle about 20,000 defect lawsuits without admitting wrongdoing.

 

The devices are designed to treat incontinence and the shifting of organs from pelvic-floor prolapse, which can occur with age and after childbirth. Mesh slings are supposed to support weakened or damaged internal tissues, and may be removable or permanent.

 

Salazar accused Boston Scientific of negligence for designing and marketing the flawed Obtryx device even though it had a safer alternative design before January 2011, when her doctor implanted her device. The jury agreed, and awarded Salazar and her husband, Felix, $23.5 million in compensatory damages and an additional $50 million in punitive damages.

 

The jury verdict form said the Dallas jurors decided that the company’s actions amounted to gross negligence because executives knew of the risk from the product and sold it “with conscious indifference to the rights, safety or welfare of others.”

 

Company lawyers strongly dispute the strength of Salazar’s evidence at trial. They said she failed to show the device was “unreasonably dangerous” and never proved that the company failed to warn doctors of the risks inherent in the device.

 

“As explained by Ms. Salazar’s treating surgeon, Dr. Lopez, the Obtryx is recognized by the medical community as the standard of care,” company lawyers wrote in court filings before the verdict, referring to stress urinary incontinence.

 

 

Whistleblower Special Meeting for Your Rights!

 

BREAKING NEWS

 

Whistleblower Special Meeting

Tomorrow, Tuesday September 9^th at 2:00 pm ET, the House Oversight Government Reform Committee’s Federal Workforce, US Postal Service and Census Subcommittee will  hold the following hearing, “Examining the Administration’s Treatment of Whistleblowers”. It will explore whistleblower retaliation since passage of the Whistleblower Protection Enhancement Act.

 

 

Witnesses have not yet been publicly announced, but GAP legal director Tom Devine, Federal Air Marshal whistleblower Robert MacLean, and VA whistleblower Dr. Van Boven will be testifying, among others.

 

The hearing is open to the public and will be held at 2154 Rayburn House Office Building.

 



 

Elderly Overmedicated--When Will This Abuse Stop



Elderly pay the price once again for someone's greed!

NPR (9/5, Jaffe, 519K) reported in its "Shots" blog that a Federal lawsuit against two California nursing homes accused of overmedicating patients may offer a new approach to dealing with the persistent problem of such facilities overmedicating their residents."

 The US Attorney for Northern California "claims that the two nursing homes provided 'grossly inadequate, materially substandard and/or worthless services,'" while they "received about $20 million from Medicare and Medicaid for those services."

 Kelly Bagby, a senior attorney with the AARP Foundation, said, "Under the False Claims Act, the government can ask for triple damages."