Pa. firm to pay $23M for illegal bone cement tests

Oct 05, 2010 By MARYCLAIRE DALE , Associated Press Writer

(AP) -- A medical devices company will admit criminality and pay the maximum $23 million fine for illegally testing bone cement on about 200 spinal patients, three of whom died in surgery, U.S. prosecutors said Monday.

Norian Corp. trained surgeons to conduct unapproved clinical tests of its bone cement from 2002 to 2004, subverting U.S. safeguards, prosecutors said. The trials were stopped after the third patient death, they said.

The cement, which is used to fill in bone defects, is approved for use in the arm but not the load-bearing spine, authorities said. The surgeries often involved older patients with compression fractures, they said.

"The aging of the baby boomer generation makes the market for treatment of VCFs (vertebral compression fractures) a large and lucrative one," prosecutors wrote in a March memo in the case.

Norian and its parent company, Synthes Inc., both based in West Chester, a 35-mile drive west of Philadelphia, not only tested the bone product for unapproved uses but also failed to report the deaths to the FDA and lied to agency investigators, prosecutors said Monday. The deaths occurred in California and Texas.

Norian will plead guilty to conspiracy to impede FDA functions, a felony, and 110 misdemeanor counts of interstate shipping of misbranded Norian XR. Synthes will plead guilty to the same misdemeanor shipping count.

As part of the agreement, Norian will be sold to an outside buyer, the parent company said.

"Synthes remains committed to operating in accordance with the highest legal and ethical standards, and bringing closure to this matter will permit the company to focus on its mission to improve patient care," the company said in a statement.

Four Synthes executives are awaiting sentencing after each pleaded guilty to the misdemeanor shipping charge. call their crimes intentional and say a Synthes medical consultant warned that the tests amounted to "human experimentation," according to the March government memo.

Defense lawyers argue that their clients pleaded guilty only as responsible corporate officers and deny any intent. No sentencing dates have been set.

The four executives are: Synthes North America President Michael D. Huggins, 51, of West Chester; senior vice president Thomas B. Higgins, 52, of Berwyn; vice president Richard E. Bohner, 55, of Malvern; and director of regulatory and clinical affairs John J. Walsh, 46, of Coatesville.

According to the June 2009 indictment, the company's pilot studies showed the bone cement product could cause blood clots in humans, while pig research suggested such clots could move to the lungs.

The patients who died suffered severe hypotension, or low blood pressure, following injections of Norian, authorities said. None of the surgeons could rule out the as a factor in the deaths, an FDA investigator has said.

U.S. Attorney Zane David Memeger said Monday that device manufacturers have legal obligations not to test their products on humans without FDA oversight.

"This case is especially troubling because in search of greater profits Norian bypassed this process," Memeger said.

Explore further: Health care M&A leads global deal surge

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Novartis fined $422.5M in marketing, kickback case

Sep 30, 2010

(AP) -- Novartis Pharmaceuticals Corp. will pay $422.5 million in penalties for marketing an epilepsy medicine for unapproved uses and for paying kickbacks to doctors to prescribe it and five other drugs, ...

BetOnSports fined $28 million, gets probation

Dec 02, 2009

(AP) -- Defunct online gambling site BetOnSports.com has been sentenced to probation and a $28.2 million fine that lawyers on both sides say probably will never be paid.

Fla. man accepts plea in record data theft case

Aug 28, 2009

(AP) -- An accused computer hacker charged in what prosecutors call the largest identity fraud case in U.S. history has agreed to plead guilty to conspiracy, wire fraud and aggravated identity theft charges.

Ex-CEO of BetOnSports pleads guilty

Apr 01, 2009

(AP) -- The former chief executive of BetOnSports pleaded guilty Wednesday to federal racketeering conspiracy, admitting that the Internet company falsely portrayed Web-based gambling as legal and caused customers to lose ...

Accused spam scammer pleads guilty in Detroit

Jun 23, 2009

(AP) -- A Michigan man described as one of the world's most prolific senders of spam e-mail has pleaded guilty to charges accusing him of defrauding people by manipulating Chinese stock prices.

Recommended for you

Health care M&A leads global deal surge

Nov 23, 2014

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.