The Securities and Exchange Commission today charged Johnson and Johnson (J&J) with violating the Foreign Corrupt Practices Act (FCPA) by bribing public doctors in several European countries and paying kickbacks to Iraq to illegally obtain business.

The SEC alleges that since at least 1998, subsidiaries of the New Brunswick, N.J.-based pharmaceutical, consumer product, and medical device company paid bribes to public doctors in Greece who selected J&J surgical implants, public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J pharmaceutical products. J&J subsidiaries also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program.

J&J agreed to settle the SEC’s charges by paying more than $48.6 million in disgorgement and prejudgment interest. J&J also agreed to pay a $21.4 million fine to settle parallel criminal charges announced by the U.S. Department of Justice (DOJ) today. A resolution of a related investigation by the United Kingdom Serious Fraud Office is anticipated.

“The message in this and the SEC’s other FCPA cases is plain – any competitive advantage gained through corruption is a mirage,” said Robert Khuzami, Director of the SEC’s Division of Enforcement. “J&J chose profit margins over compliance with the law by acquiring a private company for the purpose of paying bribes, and using sham contracts, off-shore companies, and slush funds to cover its tracks.”

Cheryl J. Scarboro, Chief of the SEC Enforcement Division’s Foreign Corrupt Practices Act Unit, added, “Bribes to public doctors can have a detrimental effect on the public health care systems that potentially pay more for products procured through greed and corruption.”

According to the SEC’s complaint filed in federal court in the District of Columbia, public doctors and administrators in Greece, Poland, and Romania who ordered or prescribed J&J products were rewarded in a variety of ways, including with cash and inappropriate travel. J&J subsidiaries, employees and agents used slush funds, sham civil contracts with doctors, and off-shore companies in the Isle of Man to carry out the bribery.

Without admitting or denying the SEC’s allegations, J&J has consented to the entry of a court order permanently enjoining it from future violations of Sections 30A, 13(b)(2)(A), and 13(b)(2)(B) of the Securities Exchange Act of 1934; ordering it to pay $38,227,826 in disgorgement and $10,438,490 in prejudgment interest; and ordering it to comply with certain undertakings regarding its FCPA compliance program. J&J voluntarily disclosed some of the violations by its employees and conducted a thorough internal investigation to determine the scope of the bribery and other violations, including proactive investigations in more than a dozen countries by both its internal auditors and outside counsel. J&J’s internal investigation and its ongoing compliance programs were essential in gathering facts regarding the full extent of J&J’s FCPA violations.

Kelly G. Kilroy and Tracy L. Price of the Enforcement Division’s FCPA Unit and Brent S. Mitchell and Reid A. Muoio conducted the SEC’s investigation. The SEC acknowledges the assistance of the U.S. Department of Justice, Fraud Section; Federal Bureau of Investigation; Serious Fraud Office in the United Kingdom; and 5th Investigation Department of the Regional Prosecutor’s Office in Radom, Poland. The SEC’s investigation is continuing.

Source: http://www.sec.gov/news/press/2011/2011-87.htm

The United States Food and Drug Administration (FDA) issued a warning this month regarding the drug Topamax. A 2008 scientific study showed that pregnant women taking Topamax had an 11 times higher rate of birth defects. Due to the dangerous side effects, the FDA increased the pregnancy warning for Topamax to Category D – meaning there is positive evidence of human fetal risk based on human data.

Topamax is an anti-convulsant drug, originally used for the treatment of epileptic seizures. However, in 2004 the FDA also approved Topamax to aid in the prevention of migraine headaches. Topamax has also been investigated for use in treating obesity, cocaine dependence, bipolar disorder, alcoholism, and post traumatic stress disorder.

The most common side effects of Topamax are numbness and tingling, fatigue, taste change, weight loss, memory loss and difficulty concentrating. However, the drug can have dangerous side effects if taken while pregnant. Taking Topamax prenatally can cause serious facial birth defects, such as cleft lip or cleft palate. These abnormalities occur when the areas of the palate and lip fail to fuse together, and can cause serious speech and ingestion issues.

If you took Topamax during pregnancy and your child has a cleft lip, cleft palate, or other serious birth defect, contact The Law Office of David H. Williams today for a free consultation. These abnormalities may be due to Topamax, and we will work to hold these drug manufacturers accountable.

Last year there wasn’t a single fatal airline accident in the developed world.

So why is the U.S. health care system still accidently killing hundreds of thousands?

The answer is a lack of transparency.

By Marshall Allen (Marshall Allen is a health care reporter for the Las Vegas Sun.)

Georgeanne Mumm’s surgeon emerged from the operating room with welcome news for her worried family. He had removed her cancerous kidney, he said, and her outlook looked good.

The surgeon failed to mention, however, that he also had accidentally removed part of her pancreas, having mistaken it for a tumor. Nor did he mention that he had in-advertently cut the blood flow to her spleen, damaging it irrevocably. Only an emergency operation by another doctor the next day kept Georgeanne from dying right then and there. Read more »

A settlement has been reached eight years after a pilot instructor and his student took off at the Ormond Beach Municipal Airport and came crashing down minutes later.

Preventable Crash

When flight instructor, Nicholas Grace, and his pilot in training , Mark Godfrey, took off from the airport they never expected to be landing in a tree soon after.

The carburetor in the plane reportedly suddenly failed due to a mechanical defect causing the engine to die.

“The engine quit cold, forcing them to make an emergency landing,” explained Arthur Alan Wolk, attorney for the two men. “Horrible injuries were suffered…brain injuries resulting in depression, anxiety, inability to remember, inability to concentrate.”

Settlement Reached

Last week a jury concluded that the plane’s manufacturers, Teledyne, and carburetor, Precision Airmotive, are to pay the men a combined total of $54 million.

According to reports, the carburetor knew there were problems with the screws and needle valves in the plane.

However, the company never warned the Federal Aviation Administration or pilots that carburetor failures were causing crashes.

Wolk believes the verdict reached is a fair one.

“It’s an airplane. If you don’t fix an airplane, somebody is going to get killed,” he states referring to the company’s negligence.

(Source: News Journal Online)

In the past week one of the widow’s of four men that were killed in a 2006 plane crash, filed a $10 million suit against the Richmond company who performed maintenance on the plane before take-off.

Wives Take Action

The widow of Albert Jacoby Jr., Elizabeth Jacoby, filed the wrongful-death suit against the Richmond Jet Center.

The wives of the three others killed in the crash, Graham Green III, Michael Gus Pappas and Rick Potter, are also taking action on behalf of their late husbands.

Green and Pappas have also individually filed $10 million against Potter’s wife, claiming he was in control of the aircraft and is responsible for its crash.

Who’s to Blame?

While Pappas and Green believe that Potter is to blame for recklessly flying the plane that fateful night as the men returned from a basketball game, there is no evidence of who was in control of the plane at the time of the crash.

Jacoby is accusing the Richmond Jet Center that they were aware of flaws in the plane but still permitted the men to fly.

The manufacturer of the jet and the flight display are also named in the ongoing suit.

Attorneys involved in the suit say that because of the complexity of figuring out exactly how the crash occurred and what caused the accident, this case could continue into next year.

(Source: The Free Lance Star)

A tractor trailer hit and killed an elderly South Bay man who was walking on U.S. Highway 27 early Monday, authorities said.

Jerome Williams, 78, was walking in a southbound lane around 1:45 a.m. near South Bay when he was hit, according to a Florida Highway Patrol traffic report.

Jorge Gattorno, 63, of Miami, was driving the tractor trailer and swerved to the left when he saw Williams in his path, the report said.

Williams died at the scene. It is not yet clear why he was walking in the roadway, but authorities are checking to see if he was intoxicated. Gattorno was not, according to the report. Read more »

Over 500 children are killed and many more injured each year due to a lack of effective restraint. A significant number of the deaths and injuries suffered by our most precious cargo – our children – could be avoided by design and warning changes, which should be made by automobile and child restraint manufacturers. This article will first focus on potential dangers to our babies and toddlers; make recommendations for parents to protect their youngest children; and suggest design changes that manufacturers should implement. The second portion of this article addresses the “forgotten children.” Children between 4 years and 8 years are often taken out of child restraints, yet cannot safely be restrained in adult automotive seat belts. Automotive manufacturers need to make changes to protect the gap in safety that exists with our forgotten children. Read more »

John F. Libby, a partner in Manatt’s Los Angeles office and co-chair of the firm’s Government Investigations and White Collar Defense practice group, spoke to Law360 for a report on the federal government’s plan to nearly triple the number of its Medicare fraud strike force units around the United States. Healthcare companies, the article says, are bracing for more aggressive prosecutions aimed not only at unscrupulous doctors and fraudsters but at legitimate businesses. An increasing number of healthcare providers, medical device manufacturers and pharmaceutical companies will likely face government scrutiny in the coming year, according to Law360.

With government taking a more proactive enforcement posture that goes beyond blatantly fraudulent enterprises and includes looking for potential healthcare fraud and abuse in otherwise legitimate companies, having a comprehensive compliance program in place is critical, according to Libby. Read more »

The FDA cleared the DePuy ASR Acetabular Cup System for use in traditional hip replacement in 2005. The device was cleared through a process that did not require it to undergo clinical trials. Since the beginning of 2008, the FDA has received about 300 complaints regarding the DePuy ASR cup involving patients in the US. Most of the DePuy lawsuit plaintiffs had to undergo an operation to have the device replaced soon after getting it.

The DePuy ASR is a large diameter, metal-on-metal hip replacement system. Metal-on-metal hip implants, which were introduced about a decade ago, have ball-and-socket joints that are made from metals like cobalt and chromium. They became popular because it was thought that metal-on-metal would be more durable than earlier types of implants.

According to a report in The New York Times, such hip implants have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. However, many of the nation’s leading orthopedic surgeons have reduced or stopped use of these devices because of concerns that they can cause severe tissue and bone damage.

No one knows why the DePuy ASR hip implant is prone to early failure. According to The New York Times, studies in recent years indicate that metal-on-metal devices can quickly begin to wear. This creates a large amount of metallic debris that is absorbed into a patient’s body. The metallic debris can cause inflammatory reactions that lead to pain in the groin, death of tissue in the hip joint and loss of surrounding bone.

The same New York Times article said some orthopedic surgeons have also asserted that the DePuy ASR hip implant, – which is shallower than some similar devices – has a design flaw that made it difficult to implant, an allegation DePuy had denied.

DePuy withdrew the ASR hip from the Australian market in December 2009 and indicated a plan to phase the device out worldwide in 2010. However, the company did not issue a recall of the DePuy ASR hip implant, instead insisting it was being removed from the market due to slow sales.

Then, in a letter dated March 6, 2010, DePuy warned doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient. According to the letter, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk.
Symptoms of a DePuy ASR hip implant failure could include:

- Unexplained Hip Pain
- Thigh Pain or Groin Pain
- Pain with Walking
- Pain Rising from a Seated Position
- Pain with Weight Bearing

If you experienced such symptoms within a few years of hip replacement surgery, you should make an appointment to see an orthopedist immediately. There is a high chance you were the recipient of a DePuy ASR Acetabular Cup System that has failed prematurely. If it did happened to you, don’t keep silent and assert your legal rights by way of instituting a DePuy ASR lawsuit. Our professional law firm will fight for you.