Novartis' blood pressure medication Tekturna®, TekturnaHCT®, Valturna®, Tekamlo® and Amturnide® Linked to Cardiovascular and Renal Side-Effects, Including Stroke

Bad news for Novartis' blood pressure medication Tekturna®, TekturnaHCT®, Valturna®, Tekamlo® and Amturnide®.  Novartis has decided to end a trial evaluating the med in Type 2 diabetes patients with renal impairment who are also at high risk of cardiovascular and renal events after researchers saw an increased number of adverse events--including nonfatal stroke, renal complications, hyperkalemia and hypotension--in the Tekturna plus standard of care arm.


There are many treatments for high blood pressure, but Tekturna works differently versus other meds. The company was trying to establish with this and other studies whether Tekturna, if taken over a longer period of time could protect key organs, such as kidneys and the heart, Dow Jones notes.

The company says it is in ongoing talks with health authorities worldwide about the implications of the trial's findings. As a precautionary measure, Novartis will cease promotion of Tekturna-based products for use in combination with an ACE inhibitor or angiotensin receptor blocker (ARB).

Kepler's Martin Voegtli notes that the higher number of adverse events with the Novartis drug was a "major setback" and could lead to the drug being pulled from the market, according to a Bloomberg report. And it also could serve as bad news to members of Novartis' sales force. Some analysts are speculating that Novartis will now accelerate plans to reduce its sales force in the U.S. to cut costs. In fact, Deutsche Bank estimates that the Swiss drugmaker may reduce as many as 1,000 sales jobs as a direct result of the study results, according to Dow Jones. The drugmaker hasn't commented on this prediction.

"The finding comes very unexpected," says Vontobel's Andrew Weiss, who once saw Tekturna as generating peak sales of about $2.9 billion if it could be shown that the drug had additional benefits for key organs if taken over a long period of time. Now, however, he will reduce his sales estimates.

Novartis predicts in its statement that Tekturna sales "are likely to be negatively impacted by the study results going forward."

Call Claudine Homolash, Esq. at Sheller, P.C. at (215) 790-7379 or (215) 790-7359 for a free case evaluation. 

Fosamax, Actonel and Boniva May Cause Femur Fractures and Esophageal Cancer

Two FDA committees on Sept. 9 recommended that labels for bisphosphonate drugs be changed due to the risk of fractures.

In a 17-6 vote, the committees said the FDA should clarify how long patients should take the drugs, which are prescribed to treat osteoporosis.  The committees were the Reproductive Health and the Drug Safety and Management advisory committees.
The drugs, sold as Fosamax, Actonel and Boniva, have previously been linked to osteonecrosis of the jaw (ONJ), a condition in which new jaw bone fails to grow and the jaw "dies." More recently, studies have linked the drugs to fractures of the femur and to esophageal cancer.

Litigation of claims for ONJ has been ongoing in a multidistrict litigation in the U.S. District Court for the Southern District of New York and in the Atlantic City Superior Court in New Jersey. An MDL for cases alleging femur fractures was recently created in the District of New Jersey.

If you or someone you know took either Fosamax, Actonel and Boniva and either suffered a femur fracture or have been diagnosed with esophageal cancer, please call Claudine Homolash at (215) 790-7379 or email me at chomolash@sheller.com

Artelon CMC Spacer Failures

On April 12, 2011, Pennsylvania Court of Common Pleas Judge Sandra Mazer Moss decided that all cases involving faulty Artelon Spacer implants should be treated as a mass tort. Complaints will be handled as one unified program and managed by Pennsylvania’s Complex Litigation Center.


The Artelon CMC Spacer

The Artelon CMC Spacer was developed by Artimplant AB and marketed by Small Bone Innovations, Inc. In 2007, the Food and Drug Administration approved the device for use in the United States.

The device was intended to treat early and mid-stage osteoarthritis that occurs in the carpometacarpal thumb joint. Osteoarthritis causes the cartilage to breakdown until the thumb joint can no longer provide cushioning for the bones. The Artelon CMC Spacer is supposed to provide a substitute cushion.

The implant only requires outpatient surgery. Doctors place a T-shaped plastic gauze near the base of the thumb at the wrist joint, where the first carpometacarpal joint is located. The spacer is “interpositional,” meaning that it goes between the trapezium bone and the first metacarpal bone.

Artelon CMC Spacer Failures

Artimplant AB and Small Bone Innovations, Inc., claim that the spacer is biocompatible and degradable. They contend that the device offers joint stability, faster recovery, and less pain.

Unfortunately, the manufacturer’s claims have not been born out over the last few years. The FDA has received numerous adverse event reports related to defective Artelon CMC Spacers. Moreover, recent medical studies have shown that the Artelon CMC Spacer is failing at a high rate.

On many occasions, patients have had to undergo painful revision surgeries to have the defective Artelon implant removed. Patients complain of inflammation and swelling. Other symptoms include:
- Shooting or burning pain
- Inflammation
- Swelling
- Limited range of motion with hand
- Thumb has become misshapen

Some patients have even reported that the Artelon Spacer breaks apart while in the hand, requiring immediate secondary surgery. In many cases, these additional procedures require the surgeon to remove tendons from other areas of the body in order to repair the thumb joint. Still other patients have experienced permanently misshapen thumbs as a result of the faulty Artelon Spacer.

If you or a loved one has been injured by a faulty Artelon Spacer, please call attorney Claudine Q. Homolash at (215) 790-7379 for a free consultation.

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CVS pays $17.5 Million to Settle Medicaid Fraud Lawsuit

Stephani LeFlore, as Relator for the United States v. CVS Pharmacy, Inc. -
CVS, the giant retail pharmacy chain, has agreed to pay $17.5 Million to settle a whistleblower lawsuit accusing it of Medicaid fraud.  According to her False Claims Acts lawsuit, CVS pharmacist Stephani LeFlore of Minnesota brought evidence to the government that CVS used a billing system for years that was designed to overbill Medicaid on prescription charges.  The billing was done in relation to dual-eligible customers - those legitimately on Medicaid who also maintained their private health insurance coverage. The insurance coverages required CVS to charge the insurance company a smaller amount for prescriptions, and limited co-pay from the customer. When a person is allowed Medicaid coverage, the government always obtains an assignment of the person's rights under their private health insurance coverage. The government essentially takes over the citizen's rights under the coverage. This includes the common right to pay a smaller co-pay amount on prescriptions.

Ms. LeFlore claimed in her federal and state lawsuits that CVS should only have billed the Medicaid program the same limited co-pay on prescriptions that it would have normally billed the customer under the insurance plan.  She alleged that CVS designed a billing software program for its pharmacies that consistently overcharged Medicaid on these co-pays.  She claimed that these overcharges occurred on hundreds of thousands of prescription sales for well over five years.

The $17.5 Million settlement covers over-billings by CVS in the states of Minnesota,California, Massachusetts, Michigan, Florida, Indiana, Alabama, Nevada, New Hampshire and Rhode Island.

Ms. LeFlore first complained internally, but she was told by a supervisor that “corporate took care of the billing” and that she need not be concerned.
The lawsuit stayed under seal (non-public), according to the False Claims Acts and court orders, until the announcement of this settlement. The civil reward totaled $2,595,460.00.

This case is just another example of the way in which Medicaid fraud occurs.  In my professional experience, usually whistleblowers try to report the fraud internally and hope that the company will "do the right thing" before they actually bring information to the government.  In this case, Ms. LeFlore reported it to CVS and she was told that corporate took care of the billing.  This is another lesson for companies to better their internal reporting structures. 

Claudine Q. Homolash, Esq. is an attorney who represents whistleblowers in a variety of lawsuits, including pharmaceutical fraud and billing.  She can be reached at (215) 790-7379 or chomolash@sheller.com

Claudine Homolash Presents LexisNexis Webinar on False Claims Act

On April 5, 2011, Claudine Q. Homolash presented, with a panel of legal experts, a Webinar on the False Claims Act ("FCA").  The Webinar entitled, "Whistleblowers: Friend or Foe to Industry, Litigation and Society?" was a huge success, with over 160 attendees.  Ms. Homolash's presentation focused on liability under the FCA, newly adopted provisions, and how plaintiffs build a case.

Ms. Homolash represents whistleblowers in a variety of cases, including cases involving off-label marketing, illegal kickbacks and "best price" against pharmaceutical companies.  Ms. Homolash's experience litigating against pharmaceutical companies in the mass tort arena provides her with a legal edge in whistleblower cases against big pharma. 

Contact Ms. Homolash at chomolash@sheller.com or (215) 790-7379 for a free consultation. 

Johnson & Johnson . . .ANOTHER RECALL!

Johnson & Johnson is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the U.S. last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only about 6,000 are still circulating. Topamax has recently been in the news because on March 4, 2011, the FDA informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax during pregnancy have an increased risk for developing cleft palate or cleft lip.

Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.

Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.

J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.

Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines.  The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!

Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com

J&J DIDN'T PROOFREAD!

Johnson & Johnson just can’t seem to do anything right. On top of all the quality-control problems that have led to tens of millions of product recalls for over-the-counter meds, syringes, contact lenses and hip replacement devices, now J&J is recalling more than 660,000 Sudafed packages because the labeling has an extra ‘not’ in the instructions. FOR REAL!!

A notice on the J&J web site says the McNeil Consumer Healthcare initiated the recall at the wholesale level “due to a typographical error in the directions section on the label, which incorrectly repeated the word ‘not’ as follows: ‘do not not divide, crush, chew, or dissolve the tablet.’ To date there have been no reports of adverse events caused by this labeling error.”

Proofreading is a big pet peeve of mine but I do sympathize with whoever made the typo. I’ve made my fair share. And in the grand scheme of things, it’s not as bad as the faulty hips that leech cobalt and chromium particles causing tissue death, musty smelling tablets, cracked syringes or contact lenses that cause stinging eye pain!