BRISTOL, Mass., April 13 LAWFUEL – The Law Newswire -…

BRISTOL, Mass., April 13 LAWFUEL – The Law Newswire — Johnson & Johnson subsidiary
DePuy Spine Inc., lost an important ruling Wednesday, when a Massachusetts superior court judge denied the company’s effort to dismiss four lawsuits filed by patients claiming its product, the Charite Artificial Disc, is defective.

Judge Susan Garsh ruled against DePuy’s claim that the company should
be protected from the legal action since the FDA approved the device, a
legal defense known as preemption.

The Charite Artificial Disc is used in back surgery to replace diseased or damaged invertebrate discs as an alternative to spinal fusion.

“In short, DePuy was claiming that since the FDA gave its approval for the disc’s use, it was inoculated against claims of defect or negligence in its design,” said Thomas Sobol, a partner with Hagens Berman Sobol Shapiro, one of the firms representing the plaintiffs. “We demonstrated to the court that the preemption defense in this case went well beyond the pale.”

According to the judge’s extensive 34-page ruling, DePuy made specific
performance claims in the application process to receive FDA approval which the plaintiffs argued the device failed to achieve. In her ruling, Judge Garsh notes that “there is evidence to support the device does not perform in the manner which DePuy represented to the FDA that it must perform.”

The original complaints also noted that DePuy gave patients material
that read “The Charite Artificial Disc has a clinical history spanning 17
years. Its safety, efficiency and remarkable durability have been proven
through thousands of implants worldwide,” and went on to make the claim
“Natural Motion is Back.”

“We argued that just because a medical device manufacturer has FDA
approval, that manufacturer still must live up to its obligation to deliver on the promises it makes,” said Pete Flowers, a partner with Foote, Meyers, Mielke, & Flowers, LLC, the other firm representing plaintiffs. “Certainly that does not mean that every patient must receive complete satisfaction
from procedures, but if a company makes performance promises to get FDA
approval, they need to live up to those performance promises.”

The judge also reviewed evidence that the device manufacturer failed to notify the FDA that it had modified the Charite disc it was using in Europe because of safety and effectiveness concerns, instead telling the FDA the
changes were made for physician convenience, court records note.

The cases were originally filed in 2006 after four individuals
underwent procedures inserting the Charite disc in the patients’ spines. In each instance, the plaintiffs claim the device failed, causing serious and lasting damage.

In March 2006, DePuy filed the motion to dismiss the charges, citing
claims of FDA preemption. The judge’s ruling allows Sobol and his team to
begin the discovery process.

“Device manufacturers have been hiding behind the preemption argument
with alarming frequency,” Sobol noted. “We are very pleased that Judge
Garsh saw that this sort of blanket immunity was not just, and that a jury should hear the facts of this case.”

HBSS and FMMF began investigating DePuy after the named plaintiffs came forward with evidence of severe health risks, claiming were a direct result of the Charite Artificial Disc. They are seeking to recover damages for
injuries its clients have suffered.

HBSS filed its first case against DePuy Spine Inc. on January 19, 2006 in the Superior Court in Bristol, Mass. and has since filed cases on behalf of more than 100 plaintiffs alleging the Charite Artificial Disc is

Copies of the ruling and other court documents are available at

About Hagens Berman Sobol Shapiro
The law firm of Hagens Berman Sobol Shapiro is based in Seattle with
offices in Chicago, Cambridge, Los Angeles, Phoenix and San Francisco.
Since the firm’s founding in 1993, it has developed a nationally recognized
practice in class-action and complex litigation. Among recent successes,
HBSS has negotiated a pending $300 million settlement as lead counsel in
the DRAM memory antitrust litigation; a $340 million recovery on behalf of Enron employees which is awaiting distribution; a $150 million settlement
involving charges of illegally inflated charges for the drug Lupron, and
served as co-counsel on the Visa/Mastercard litigation which resulted in a $3 billion settlement, the largest anti-trust settlement to date. HBSS also served as counsel in a $850 million settlement in the Washington Public Power Supply litigation and represented Washington and 12 other states in lawsuits against the tobacco industry that resulted in the largest settlement in the history of litigation. For a complete listing of HBSS cases, visit

About Foote, Meyers, Mielke, & Flowers, LLC
Foote, Meyers, Mielke & Flowers, LLC is a nationally recognized
litigation law firm with offices in Chicago and Geneva, Illinois. The
firm’s litigation practice is concentrated in recovery for catastrophic
injuries resulting from medical malpractice, transportation accidents and
products liability. In addition to representing individual plaintiffs, the firm represents thousands of injured parties in class-action litigation,
acting as co-lead counsel in cases involving consumer fraud, defective
medical products, over billing by drug companies, and improprieties
affecting the quality of health care. The firm has been instrumental in the HMO litigation which has netted over $2 billion in settlements. The firm acts as lead and co-counsel in numerous medical malpractice, product
liability and personal injury cases throughout the country.

SOURCE Hagens Berman Sobol Shapiro

Scroll to Top