Friday, October 31, 2014

MMR Vaccine Not As Effective As Promised By Merck

 

On September 5, 2014 the United States District Court for the Eastern District of Pennsylvania denied Merck’s motion to dismiss Plaintiffs’ antitrust claims.  In doing so, the court held that Plaintiffs had sufficiently alleged claims for violations of the Sherman Act.  First, Plaintiffs demonstrated that Merck, as the sole manufacturer of the MMR vaccine, had monopoly power in the market.  Second, Plaintiffs sufficiently alleged that Merck willfully maintained such monopoly power through falsifying data related to the efficacy of the MMR vaccine.  Accordingly the court held that “taking the facts in the light most favorable to Plaintiffs, Defendant’s fraudulent misrepresentations about Defendant’s own product, coupled with the unique facts of the this case (e.g., the 100% monopoly of the market and arguable statutory and contractual duties to disclose information) create the basis for an antitrust claims that Defendant willfully maintained monopoly power through exclusionary tactics.”

History of the case:

In 2012 an antitrust case was filed in the United States District Court for the Eastern District of Pennsylvania.  The lawsuit, Chatom Primary Care, P.C. v. Merck, was filed as a class action against Merck for unlawfully monopolizing the U.S. market for Mumps Vaccine by misrepresenting the true efficacy of its vaccine.  Specifically, the lawsuit states Merck fraudulently misrepresented and marketed its Mumps Vaccine as having an efficacy rate of 95% or higher.   Plaintiffs allege that in reality, Merck knew and concealed that the Mumps Vaccine was far less than 95% effective.  

Plaintiffs allege:

·         Merck used improper testing techniques and falsified its data to show fraudulent efficacy rates, even after significant mumps outbreaks in 2006 and 2009.
·         As the only company licensed by the U.S. to sell the Mumps Vaccine, Merck has illegally monopolized the market with its inflated 95% or greater efficacy rate, which has deterred and excluded competitors from entering the marketplace.
·         Merck created a high inelasticity of demand in the marketplace.  The government, health care professionals or consumers have no other option to obtain the Mumps immunization.
·         Because Merck was free to charge an artificially inflated price and free competition was limited in the marketplace, antitrust laws were violated.

Dignity Health Not Living Up To The Name!

Dignity Health has agreed to pay the government $37 million to settle allegations that more than a dozen of its hospitals knowingly submitted false claims to Medicare and TRICARE, the U.S. Department of Justice announced Thursday.
The government alleged that Dignity, admitted patients who could have been treated as outpatients, which would have been less expensive, according to the DOJ.

In a statement released Thursday, San Francisco-based Dignity noted that the settlement agreement, “finds no improper conduct or admission of wrongdoing on the part of the health system” and “reflects Dignity Health's desire to resolve the investigation and avoid the expense of continued litigation.”

“The billing disputes reflect widespread confusion in the health care industry on unclear federal standards for approving coverage of patient admissions,” according to the Dignity statement. “As a result, it is often challenging for physicians to ensure their documentation adequately reflects their decision making in order to comply with complex regulations when making their best medical judgments.”The government alleged that 13 Dignity hospitals in Arizona, California and Nevada billed Medicare and TRICARE, from 2006 to 2010, for inpatient care for some patients who had elective cardiovascular procedures such as stents and pacemakers. Those claims should have been billed as outpatient surgeries, the government contends. It also alleged that from 2000 to 2008, four Dignity hospitals billed Medicare for patients undergoing elective, minimally invasive kyphoplasty procedures—used to treat certain spinal compression fractures—that also should have been billed as outpatient procedures.

The government also alleged that 13 Dignity hospitals admitted patients who didn't medically need to be admitted and could have been cared for as outpatients or in an observation setting.

“Hospitals that attempt to boost profits by admitting patients for expensive and unnecessary inpatient hospital stays will be held accountable,” said Special Agent in Charge Ivan Negroni of the HHS' Office of Inspector General San Francisco office, in a statement. “Both patients and taxpayers deserve to have medical decisions made solely on what is best for the patient, based on medical necessity.”

The allegations were first brought forward in a whistle-blower lawsuit filed in the U.S. District Court for the Northern District of California under the False Claims Act by Kathleen Hawkins, a former Dignity employee. In successful lawsuits, whistle-blowers are entitled to a percentage of the money recovered by the government. Hawkins will receive about $6.25 million, the DOJ said.

Tuesday, October 28, 2014

United States Sues NY City and Computer Sciences Corp

The United States on Monday joined a lawsuit accusing New York City and Computer Sciences Corp of defrauding Medicaid into making millions of dollars of improper reimbursements by exploiting a computerized billing system that the company designed.

According to the complaint filed in U.S. District Court in Manhattan, the defendants took advantage of the system's automatic defaulting capabilities, enabling the city to boost the amount and speed of reimbursements for services provided to infants and toddlers with developmental delays.

The U.S. attorney for Manhattan, Preet Bharara, said the fraud led to the city and Computer Sciences' submitting tens of thousands of false claims to Medicaid from 2008 to 2012.

Originally filed by a whistleblower, Vincent Forcier, the lawsuit seeks restitution, civil penalties and triple damages for violations of the federal False Claims Act.

That law allows whistleblowers to sue on the government's behalf and share in recoveries. The government is not required to get involved in False Claims Act lawsuits, but sometimes intervenes in cases it considers stronger.

"We are in the process of reviewing the complaint," said Richard Adamonis, a spokesman for Computer Sciences, which is based in Falls Church, Virginia.

New York state plans to bring a related case against Computer Sciences, court records show. A spokeswoman for New York Attorney General Eric Schneiderman declined to comment.

The lawsuit concerns early intervention program services, which are provided to children under 3 years old who have developmental delays, or medical conditions such as autism and low birth weight that are associated with such delays.

According to the government, the city and Computer Sciences engaged in three fraud schemes.

In two, the defendants allegedly circumvented Medicaid's "secondary payor" requirement that they exhaust private insurance coverage before submitting claims.

The third scheme allegedly involved the defendants' changing diagnostic codes that were used by medical providers to a generic code that they knew would result in payment by Medicaid.

Saturday, October 25, 2014

Actos Bladder Cancer Class Action Lawsuit!

Actos Bladder Cancer Overview

Actos class action lawsuits and individual cases are being filed nationwide after it’s been found that taking Actos (pioglitazone) may have caused bladder cancer in up to 40% of patients who took it for more than one year. Takeda Pharmaceuticals released Actos to help improve glucose (blood sugar) control in Type 2 diabetic adults.

Takeda Pharmaceuticals states that Actos (pioglitazone) helps your body better use the insulin you make. Actos is also supposed to help stop your liver from making more glucose or sugar when it doesn’t need to. The Actos class action lawsuit and Actos bladder cancer lawsuits allege that Takeda Pharmaceuticals knew about the risks of developing bladder cancer for diabetics who took Actos for more than one year and didn’t warn patients or doctors of the risk.

 Actos Bladder Cancer Symptoms

The Actos class action lawsuit investigation does not dispute the claims by Takeda Pharmaceuticals that Actos can help treat type-2 diabetes. Actos lawyers and Actos bladder cancer attorneys are investigating claims that long-term treatment with Actos may cause cancerous tumors in the bladder as a side effect of using Actos.

A 10-year study showed that diabetics who took Actos (pioglitazone) for more than a year had not just a slightly elevated risk of cancerous bladder tumors, but, increased their risk of bladder cancer by 40%. Recently a lawsuit was filed by an Actos user who only used the type 2 diabetes treatment for four months before developing bladder tumors and being diagnosed with bladder cancer.

There are multiple symptoms of bladder cancer and those taking Actos should be aware of each of them. These bladder cancer symptoms include:

  • Painful or frequent urination

  • Urinary tract infection(s)

  • Blood in your urine

Hundreds of Actos lawsuits have been filed nationwide. Actos lawyers are investigating all possible injuries connected to Actos side effects.

An Actos Class Action Lawsuit may be filed when many people have experienced the same, or a very similar injury. This could be financial damages, medical expenses, time away from work due to being in the hospital, or even time away from work while caring for an injured or sick loved one who took Actos. Sometimes a class action lawsuit may not be the best strategy for someone injured by Actos. In that case, an attorney representing you or your loved one personally may be the best course of action.

If you are represented individually because you or a loved one has shown signs of bladder cancer due to Actos you may have a much better chance of being compensated for your injuries, medical treatment and pain and suffering due to Actos (pioglitazone). Individual Actos lawsuits may also be able to compensate the spouse or significant other who took care of their loved one while being treated for bladder cancer or other serious side effects of Actos like congestive heart failure, severe cardiovascular problems, lactic acidosis or bone fractures. In addition Actos attorneys are filing wrongful death lawsuits against Takeda Pharmaceuticals if your loved one died from an alleged Actos side effect

Friday, October 24, 2014

Kia And Hyundai Fraud on Gas Mileage Claims

Detroit, MI: A preliminary $395 settlement has been reached in a consumer fraud class action pending against Hyundai Motor Corp. and Kia Motors alleging gas mileage rating were overstated by the automotive manufacturers. The settlement will affect some 600,000 of Hyundai’s 2011-13 models and about 300,000 of Kia‘s 2011-13 models in the US.

In November 2012, Hyundai and Kia Motors agreed to restate expected gas mileage for 1.1 million vehicles in North America, following an investigation by the Environmental Protection Agency. The automakers admitted they after overstated mileage claims on vehicle window stickers for 900,000 vehicles in the United States. The settlement impacts about 600,000 of Hyundai’s 2011-13 models and about 300,000 of Kia‘s 2011-13 models in the U.S. Hyundai’s settlement is valued at up to $210 million, while Kia’s is valued at $185 million.

The 2012 restatement reduced Hyundai-Kia’s fleetwide average fuel economy from 27 to 26 mpg for the 2012 model year. Individual ratings, depending on the car, will fall from 1 mpg to 6 mpg. Most vehicles saw combined city-highway efficiency drop by 1 mpg, the Detroit News reports. Exact figures will depend on how many customers elect to participate in the settlement’s one-time lump sum payment option or remain in the lifetime reimbursement program, the automakers said.

The settlement will resolve more than 50 lawsuits filed across the country to address the issue. Hyundai agreed to add the option of taking a lump sum payment. The proposed cash amount, which varies by vehicle model and ownership type, will result in an average payment of $353 to Hyundai owners and lessees. For example, an owner of a 2012 Elantra would receive a lump sum payment of $320 minus any previous reimbursement payments. For Kia owners, the proposed average cash lump-sum amount will be about $667.

Hyundai and Kia owners can also elect other options such as a dealership credit of 150 percent of the lump sum amount, or a credit of 200 percent of the cash amount toward the purchase of a new Kia or Hyundai.

A federal judge is expected to review the proposed settlement for preliminary approval in early 2014. If approved, settlement notices will be sent to individual class members. Initial details of the settlement are available at hyundaimpginfo.com or www.kiampginfo.com.

Tuesday, October 21, 2014

Trinity Industries Saves $2.00 Results in Many Injuries--And Now Costs Them $175 MILLION

 

Trinity Industries, the highway guardrail maker accused of selling systems that can malfunction during crashes and slice through cars, was found by a jury to have defrauded the federal government.

The case was brought under the False Claims Act by Joshua Harman, a competitor who discovered that the company made changes in 2005 to its rail head — the flat piece of steel at the front of the system — without telling the Federal Highway Administration, as is required. The company sold the guardrails to state governments that, in turn, received federal reimbursement.

A Texas jury on Monday awarded $175 million that will, under federal law, be tripled to $525 million. The money will be split between the United States Treasury and Mr. Harman, who, although a competitor to Trinity, is considered a whistle-blower. After discovering the design change during litigation in 2011, he filed the case on behalf of the government.

Beyond the jury verdict itself, the judge hearing the case will determine exactly how many “false claims” apply in the case to Trinity. Statutory penalties for each instance of a false claim range from about $5,000 to $12,000, and Trinity would be responsible for such payments.

At the heart of the dispute was a design change Trinity made in 2005 to its ET-Plus rail head, which could cause a guardrail system to fail, according to some state regulators and the federal lawsuit. Those changes were not disclosed to the Federal Highway Administration for seven years, despite requirements that any such changes be reported immediately. Trinity has said that the failure was inadvertent.

While states are ultimately responsible for their highway equipment, the federal agency plays a crucial role, providing guidance on which products are eligible for federal reimbursement dollars. The agency has continued to approve the ET-Plus even as state officials have raised concerns.

The guardrail system works by collapsing when hit head-on, absorbing the impact of a vehicle and guiding the railing out of its path. The rail head or end terminal, which is often marked with yellow and black stripes, is supposed to slide along the guardrail itself, pushing it to the side.

But the redesigned Trinity product narrowed the channel behind the head, which can cause it to jam instead of sliding along the rail, some state officials said. When that happens, the rail can pierce an oncoming vehicle like a harpoon, endangering occupants.

At least 14 other lawsuits blame the guardrails for five deaths and more injuries. Trinity is a major guardrail supplier nationwide. According to internal company documents, the change was expected to save about $2 on every rail head.

 

A small saving for a lot of people who were devastated by the faulty rails!

Saturday, October 18, 2014

Soldiers Put at Risk of Faulty Equipment

 

A man who alerted the U.S. Department of Defense (DoD) to a Humvee manufacturing change that could potentially put soldiers at risk won nearly $1 million after settling his whistleblower . David McIntosh lost his job at M.K. Battery in 2007. This came after he called defense officials to warn them the manufacturing process on Humvees gun turrets had changed. Mr. McIntosh said the change cut the life span on the battery that turned the turret by about half, which could result in fatal consequences for soldiers involved in a gun fight in Iraq.

 Mr. McIntosh tried to persuade his employer to tell the Army about the change. He finally realized the company was not going to report the matter. After 14 months had elapsed, he called the Defense Department himself. Subsequently, he was fired for insubordination. M.K. Battery has denied that the batteries fail to meet the required specifications, but interesting and perhaps telling, the company saw fit to settle with Mr. McIntosh.

Friday, October 17, 2014

U.S. Department of Justice Claims Overbilling by Sikorsky Aircraft Corp.

 

The U.S. Department of Justice said it has filed a complaint against Sikorsky Aircraft Corp. and its Milwaukee subsidiary, Derco Aerospace Inc., over millions of dollars in alleged overbilling for aircraft parts.

The Justice Department filed its "complaint in intervention" in a whistle-blower lawsuit brought by Mary J. Patzer, a former Derco employee.

That lawsuit, disclosed in August, alleged that Derco and its parent and sister companies, Sikorsky Aircraft and Sikorsky Support Services Inc., submitted false bills to the Department of Defense with an impermissible 20% markup on parts the companies had purchased from other vendors.

It amounted to nearly $50 million in false billings, according to Patzer's attorney, Nola Hitchcock Cross.

"We continue to believe that the allegations regarding this matter have no merit, and we intend to defend this lawsuit vigorously," Sikorsky spokesman Paul Jackson said.

The government's complaint contends that Sikorsky approved an illegal "cost-plus-a-percentage" subcontract between Sikorsky Support Services and Derco. The complaint further alleges the defendants used this to overcharge the U.S. Navy for parts and materials used to maintain Navy aircraft.

"Those who contract with the federal government and accept taxpayer dollars must follow the rules,"

"Under the authority of the False Claims Act, we pursue fraud of this sort to ensure that taxpayer dollars are spent lawfully, and that overcharges and other types of contracting misconduct are addressed," U.S. Attorney James Santelle, for the Eastern District of Wisconsin, said in the statement.

As the "relator" in the whistle-blower lawsuit, Patzer may be entitled to between 15% and 25% of any money recovered.

Patzer alleged that special software hid the Sikorsky markup as the price billed to the government appeared to be the actual purchase price of the spare parts, but was instead the price plus the markup.

She was hired by Derco in 2002 as a financial analyst. In 2003, she became assistant controller for financial reporting and Sarbanes-Oxley compliance. By 2009, she was the point of contact for the company's defense contract audits, according to her complaint.

"In the course (of) her employment, Patzer gained firsthand knowledge of fraudulent and improper billing practices by Derco and its parent and affiliated companies," her complaint said. "Such practices included presenting inflated bills for costs to the United States government based on an unauthorized and undisclosed markup of parts and repair services obtained from suppliers, billed to Sikorsky Support Services Inc., and ultimately billed to the United States government."

Soon after Patzer exposed the billing issues to a Sikorsky manager in 2010, she was fired due to a "reduction in force," according to her lawsuit.

"I had to stand up and do the right thing. But after I questioned the markups with the company, I was walked out," Patzer said through Cross in an earlier statement.

Cross said the government intervenes in only a little more than 20% of False Claim Act cases.

"They pick the strongest ones, that have the most impact, that have the potential for the most recovery," Cross said Thursday. "When that happens, the government puts all of its resources into the (case). It strengthens the case hugely."

 

Thursday, October 16, 2014

Cymbalta-Eli Lilly & Company Once Again Covering Up Dangerous Facts!

 

Plaintiffs in 28 Cymbalta lawsuits alleging that Eli Lilly & Co. failed to adequately warn about the likelihood of debilitating withdrawal side effects after discontinuing the anti-depressant are asking a federal judge to transfer all of the cases to one Central California judicial district.

The plaintiffs argue that transferring all of the Cymbalta withdrawal lawsuits to a single district makes sense to avoid duplicative discovery and hearings and will also make it easier to handle future Cymbalta lawsuits. The Central District of California is the most appropriate venue since 10 of 28 Cymbalta withdrawal lawsuits filed are in the Golden State, according to a court filing.

Lawyers for the plaintiffs hope that by establishing a Cymbalta mass tort, plaintiffs will receive faster vindication since they will be able to share in pretrial proceedings.

Eli Lilly Downplayed Cymbalta Withdrawal Symptoms, Plaintiffs Say

Cymbalta maker Eli Lilly & Co. is accused of failing to properly warn consumers about the severity of Cymbalta withdrawal. The withdrawal symptoms include extreme mood swings, anger, irritability, electric-shock sensations in the body and brain known as “brain zaps,” physical and neurological problems, dizziness, nausea, vomiting, vertigo, excessive sweating, insomnia, nightmares, diarrhea, suicidal thoughts, involuntary laughing or crying, hypomania, tinnitus and seizures.

In addition to being an anti-depressant, Cymbalta, a serotonin-norepinephrine reuptake inhibitor (SNRI), received FDA approval to treat fibromyalgia — chronic body pain and tenderness in the joints, muscles, tendons, and other soft tissues — in 2008.

Complaints about severe Cymbalta withdrawal led the FDA in 2009 to post on its website information about something known as Cymbalta Discontinuation Syndrome, noting that there are thousands of internet entries addressing Cymbalta withdrawal trauma.

The FDA published claims that “Cymbalta discontinuation syndrome is more severe and much more widespread than acknowledged by Eli-Lilly, Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of discontinuation syndrome, Lilly Direct to Consumer (DTC) advertising is misleading related to the probability, severity and complexity of Cymbalta discontinuation, and Lilly has not developed and fielded a clinically proven protocol for safely discontinuing Cymbalta.”

People from across the country have filed Cymbalta lawsuits against Eli Lilly saying the drug company misled them. While the drug’s labeling stated only one percent or two percent of users experienced withdrawal symptoms when discontinuing Cymbalta, studies indicate that figure to more accurately be between 50 percent and 78 percent.

In 2012, Eli Lilly was slapped with a Cymbalta class action lawsuit accusing the company of concealing the withdrawal risks, estimating that Lilly sold some $18 billion in Cymbalta between 2004 and 2011.

“Instead of honestly disclosing the risks associated with Cymbalta withdrawal and letting consumers and prescribing healthcare professionals decide if Cymbalta was worth the risk, Lilly engaged in unfair and unlawful marketing practices,” the Cymbalta class action lawsuit states.

In general, Cymbalta withdrawal lawsuits are filed individually by each plaintiff and are not class actions.

Wednesday, October 15, 2014

Higher One Fraudulant Charges Are You Included in This Settlement?

HigherOneLogo

A proposed $15 million settlement has been reached in a class action lawsuit against Higher One Holdings Inc., Higher One Inc., The Bancorp Bank, Wright Express Financial Services Corporation (now known as WEX Bank), and Taylor Capital Group Inc. regarding the marketing and fees associated with the Higher One OneAccount. If you opened a OneAccount bank account between July 1, 2006 and Aug. 2, 2012, you could be eligible for benefits from the class action settlement.

The Higher One OneAccount class action lawsuit alleges that the defendants failed to disclose the refund disbursement methods available to students for their tuition and financial aid refunds. The plaintiffs also allege the defendants inadequately disclosed fees such as PIN-based transaction fees and ATM fees associated with Higher One accounts.

The defendants deny any wrongdoing but agreed to settle the OneAccount class action lawsuit to avoid the expense and uncertainty of trial.

You must file a claim to receive a cash payment by visiting OneAccountSettlement.com and providing the necessary details like your current address and contact info, and your notice number, which was provided either with the e-mail or postcard notice you received, and some other type of distinguishing info like the last 4 digits of your Social Security number, your birth date or OneAccount number. Class Members who submit valid claims will be eligible to get cash payment, which is based on the number and type of fees incurred and the number of claims filed for the Higher One class action settlement.

Higher One OneAccount Settlement information:

Case Name: In re: Higher One OneAccount Marketing and Sales Practices Litigation, Case No. 3:12-md-02407, in the U.S. District Court for the District of Connecticut
Settlement website: http://oneaccountsettlement.com/
Submit claim form: https://oneaccountsettlement.com/mainpage/SubmitYourOnlineClaim.aspx
Claim form deadline: January 23, 2015
Final hearing: November 24, 2014
Claims Administrator:
Higher One OneAccount Settlement
P.O. Box 1631
Faribault, MN 55021-1631
1-877-310-4642
Class Counsel:
Tycko & Zavareei LLP
Shepherd Finkelman Miller Shah LLP
Gentle Turner Sexton Debrosse & Harbison
Jones Ward PLC

Saturday, October 11, 2014

Shire Pharmaceuticals Taking Matters Into Their Own Hands

 
Shire Pharmaceuticals  will pay $56.5 million to settle allegations that it violated the False Claims Act by engaging in unlawful drug marketing and promotion practices of several drugs.  Shire manufacturers and sells pharmaceuticals including Adderall XR, Vyvanse and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD) and Pentasa and Lialda, which are approved for the treatment of mild to moderate active ulcerative colitis. 

The settlement resolves allegations that Shire violated the False Claims Act by making false and unsupported claims related to Adderall XR, Vyvanse and Daytrana and that Shire promoted Pentasa and Lialda for off-label uses not approved by the FDA and not covered by federal healthcare programs. As part of the settlement, Shire entered into a Corporate Integrity Agreement that requires comprehensive compliance safeguards, oversight of Shire promotional activities, and compliance certifications from Shire’s board of directors and  management.

Wednesday, October 8, 2014

Glaxo Smith Kline In Trouble In China! More Medical Fraud!




GlaxoSmithKline has been fined a record 3 billion yuan ($488.5 million) for bribing doctors. A verdict was handed down by a Chinese court, which also sentenced several of the drugmaker’s executives to up to four years in prison. A court in Changsha, China, found the Chinese branch of the British pharmaceutical company guilty of paying bribes to doctors to boost sales of its products and ordered it to pay the biggest fine ever imposed by a Chinese court.
 
Separately, the London-based multinational pharmaceutical and biotechnology company is facing a number of allegations of unethical behavior by its doctors. Investigations are ongoing in Syria, Jordan, Lebanon and Iraq. GSK also disclosed in late May that it is under investigation by the U.K.’s Serious Fraud Office. executives confessed in July 2013 to commercial bribery and tax-related crimes, including paying physicians and hospitals in order to bolster drug sales. Chinese officials said the scheme involved some 3 billion Chinese yuan in payments since 2007. From 2004 to 2010, physicians were allegedly bribed to use drugs for conditions that, in some cases, they weren’t even designed to treat.

Tuesday, October 7, 2014

Millenial Media Stock Fraud!

 



An investor of Millennial Media, Inc. (MM) has filed a federal securities fraud class action complaint in the U.S. District Court for the Southern District of New York. The complaint alleges that the company and certain of its officers and directors violated the Securities Exchange Act of 1934 between March 28, 2012 and May 7, 2014. Millennial Media is a digital advertising company that provides mobile advertising solutions to advertisers and developers in the United States and internationally.
 
Millennial Media Is Accused of Misrepresenting its Performance

According to the complaint, shares of Millennial Media fell multiple times, representing a total decline of 86.56% from the stock's class period high. Shares of Millennial Media initially declined $5.38 per share or over 37% to close at $8.95 per share on February 20, 2013, following a February 19, 2013 press release announcing lower than expected revenues for the fourth quarter 2012 and bleak revenue guidance for 2013. Following subsequent declines, shares of Millennial Media fell most recently on May 7, 2014, after the company announced: (i) revenue for the first quarter of 2014 was again below analysts' projections; (ii) dour revenue guidance; and (iii) the resignation of the company's Chief Financial Officer, Michael B. Avon. As a result, Millennial Media's stock declined $1.99 per share, or over 37% percent, to close at $3.36 per share on May 8, 2014.

The complaint further alleges that Millennial Media failed to disclose that: (i) its technological products were not fully functional when announced, leading to rushed products with poor performance; (ii) it had little ability to track and report end-user clicks, leading to over-billing and customer abandonment; and (iii) corporate acquisitions the company undertook did not offer the business synergies claimed but were utilized to fill holes in Millennial Media's capabilities and further presented integration challenges for the company.



Friday, October 3, 2014

Health Canada VS FDA Did They Really Think They'd Win?





Whatever the FDA told Health Canada has had an effect. Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.

Health Canada initially responded to the FDA putting Apotex's finished dose plant in Bangalore, India under import alert by asking the company to quarantine products manufactured at the facility. The quarantine bought Health Canada time to learn why the FDA issued the import alert and formulate its own response. Six days after calling for the quarantine, Health Canada has banned the import of 30 finished products--and a similar number of APIs--that Apotex manufactures at its Bangalore plants.

The regulator has also banned almost 20 APIs--and 50 products in which they are used--from IPCA Laboratories. A common thread links the regulatory actions: Data integrity. "This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products," Canadian health minister Rona Ambrose said in a statement.

Reports of data integrity failings at IPCA emerged after FDA visited a plant in July and issued a Form 483. Staff at the IPCA site allegedly falsified temperature records, tweaked integration parameters and overwrote raw data. FDA inspectors visited Apotex around the same time, leading to a warning letter detailing the discarding of undesirable assay results and other data integrity problems.

Thursday, October 2, 2014

Hospira Guilty of Having Foreign Particles in Injectable Medications According to The FDA

 

FDA cites Hospira for drug manufacturing violations


Drugmaker Hospira said Wednesday that it received a warning letter from the (FDA) Food and Drug Administration regarding poor manufacturing quality at one of its facilities in Australia.

The FDA inspected Hospira's drug manufacturing building in Mulgrave, a suburb of Melbourne. Hospira manufactures specialty injectable drugs including mitoxantrone at the facility.

The FDA wrote that there were “significant violations of current good manufacturing practice regulations for finished pharmaceuticals,” according to a company disclosure. For example, the agency said that it found impurities in the injectable drugs and that it appeared Hospira was unaware of the situation.

Lake Forest, Ill.-based Hospira said the warning letter would not halt production or shipment of drugs from the facility, and it “is evaluating what corrective actions may be required.”

“The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA's warning letter,” Hospira said in its filing. Hospira officials were not available for further comment.

Hospira does not anticipate the issue will dampen its 2014 financials, but if the FDA demands large-scale changes, it could “be significant to our ongoing business and operations,” Hospira said.

Warning letters from the FDA are not entirely uncommon among pharmaceutical companies. To date in 2014, the FDA has issued a dozen warning letters to drugmakers based on manufacturing or product quality concerns.

Hospira's specialty injectable drugs were a big driver in the company's improved earnings in the second quarter of this year.

Valeant Shortcomings Caught By FDA

 

Pharma Manufacturing  reports that the FDA has

posted a warning letter stating that management at

Valeant Pharmaceuticals failed to properly oversee a

contract manufacturer that supplied it with Sculptra

Aesthetic (injectable poly-L-lactic acid). In particular, the

FDA found no evidence that anyone at Valeant had

reviewed and approved the vendor’s deviation report

after the manufacturer stopped production to fix

problems affecting drug quality. The article says that the

FDA “wants to see evidence Valeant has taken steps to

improve its monitoring of CAPAs and review of supplier

deviation reports.” However, Valeant is confident it can

resolve the issues raised and has already divested

Sculptra Aesthetic as part of a deal with Nestle’s

Galderma unit.

Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.

 

Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.

We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing."  A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]

 

 

Wednesday, October 1, 2014

Over Charging Overdraft Fees -- Thanks Comerica Bank

 

New York- Final approval has been granted in the $14.5 million settlement of consumer fraud class action involving overdraft fees charged by Comerica Bank NA. The class action involved people who had been charged overdraft fees on their Comerica Bank accounts between 2004 and 2010. The Comerica overdraft class action lawsuit alleged the bank posted debit card transactions in dollar amounts ordered from highest to lowest so as to maximize the number of overdraft fees it could levy against its customers.
According to the lawsuit, rather than declining transactions that would put a customer into overdraft, Comerica authorized the transactions, subsequently processing them in an order that would increase the banks’ overdraft revenue.

Eligible class members include anyone who held a Comerica bank account in Arizona, California, Florida, Michigan or Texas and incurred one or more overdraft fees as a result of Comerica’s non-consecutive posting of transactions between 2004 and 2010. Specific class periods vary by state.

The Class Periods by state are:

• For Settlement Class Members who opened accounts in Arizona, the period from February 18, 2004 through August 15, 2010.

• For Settlement Class Members who opened accounts in California, the period from February 18, 2006 through August 15, 2010.

• For Settlement Class Members who opened accounts in Florida, the period from February 18, 2005 through August 15, 2010.

• For Settlement Class Members who opened accounts in Michigan, the period from February 18, 2004 through August 15, 2010.

• For Settlement Class Members who opened accounts in Texas, the period from February 18, 2006 through August 15, 2010.

Eligible class members must have had two or more Overdraft Fees caused by debits posted to their accounts on a single day during the time period listed above. For further information on the Comerica class action lawsuit settlement, and to download forms, visit: http://comericabankoverdraftsettlement.com