Yourlawyer.com (Biomet Hip Replacements News)

Orthopedic Docs Withheld Info About Industry Pay When Presenting Research

Thu, 08 Oct 2009 00:00:00 -0700

A new study has found that doctors who presented research last year at the annual meeting of the American Academy of Orthopaedic Surgeons weren't always as forthcoming as they should have been about their financial relationships with the manufacturers of artificial joints. The study appears this week in The New England Journal of Medicine.

The financial relationships between the medical industry and doctors have caused controversy in recent years. In 2007, a U.S. attorney in New Jersey filed criminal complaints alleging that some of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons in an attempt to keep their business. As we reported the time, four of the companies, Biomet Inc., DePuy Orthopaedics, Smith & Nephew, and Zimmer Holdings Inc. – paid a total of $310 million, without admitting wrongdoing. A fifth manufacturer, Stryker Corp., cooperated with the probe and was not charged.

According to The Wall Street Journal, the New England Journal of Medicine study measured the accuracy of disclosures by orthopedic surgeons who presented research at the 2008 meeting. The authors of the study compared the doctors' disclosures against a similar list published by the five firms involved in the 2007 settlement. They found that the orthopedists did not disclose more than 20% of the payments they received from the artificial joint manufacturers when they were presenting research involving a the firms' products.

According to the article, of 344 payments disclosed by the companies, only 245 were disclosed by the recipients The study also found that only 165 of 208 payments "directly related" to the doctor's presentation were disclosed.

Critics of industry payments to doctors have long held that such relationships create conflicts-of-interest, and could unduly influence everything from research findings to prescribing practices. According to The Wall Street Journal, several states, including Massachusetts and Vermont, have enacted laws requiring medical companies to disclose the payments they make to doctors. On the federal level, the Physician Payment Sunshine Act would require similar disclosure. The legislation is currently part of the health reform being considered in the U.S. Senate, the Journal said.

Kickback Charges Against Orthopedic Device Makers Dropped

Tue, 31 Mar 2009 00:00:00 -0700

Criminal charges were dismissed yesterday against several orthopedic device makers because they have fulfilled the terms of deferred prosecution agreements they reached with U.S. prosecutors a year and half ago. According to Dow Jones News Wire, Zimmer Holdings Inc., Johnson & Johnson unit DePuy, Smith & Nephew PLC and Biomet Inc. had all been accused of violating federal anti-kick back laws.

According to Bloomberg News, the four companies supply 95 percent of hips and knees used annually in 700,000 replacement surgeries in the U.S. Prosecutors had accused the four firms of handing out excessive consulting agreements, lavish trips and other perks to reward surgeons who used their products. Investigators said physicians performed little or no consulting work, other than to exclusively use the products of whatever company was paying them, and also failed to disclose the relationships with the hospitals where they performed surgery, or to their patients.

In 2007, the government agreed to defer prosecution if the firms paid more than $310 million and made reforms. Under the deferred prosecution agreements, Zimmer paid $169.5 million; Johnson & Johnson, $84.7 million; Smith & Nephew, $28.9 million; and Biomet, $26.9 million, Bloomberg said.

"We are confident that the industry, which had been engaged in illegal kickback practices to secure market share, has made significant changes in their practices to strengthen compliance programs, increase compliance staffs and enhance internal compliance policies and procedures," said acting U.S. Attorney Ralph J. Marra Jr. in a statement Monday. "We expect they will continue these measures beyond the expiration of the agreements and commit to a continued culture of openness, accountability and compliance."

The Department of Justice statement said consulting payments to surgeons by the companies declined to $105 million in 2008 from $272 million in 2007, while the total number of physicians receiving payments from the companies declined to 628 in 2008 from 1,693 in 2007.

According to the New Jersey Star-Ledger, all four companies that entered into civil settlements remain subject to the terms of separate five-year Corporate Integrity Agreements entered into with the Office of Inspector General of the Department of Health and Human Services until September 2012.

A fifth company, Stryker Orthopedics Inc., voluntarily cooperated with the U.S. Attorney's office and executed a non-prosecution agreement, the Star-Ledger said. It also pledged to put reforms in place and had been operating as well under a monitor's supervision that also ended yesterday.

A look inside a tissue processing plant

Mon, 12 Jun 2006 00:00:00 -0700

Corneas, tendons and bones from the dead, packed in bed pillow-size packages, arrive regularly by overnight delivery at Tissue Banks International.

This nonprofit tissue processor, located in a nondescript office park near San Francisco, makes about 300 products surgeons use to fix torn knee ligaments, bad backs, burned skin and a host of other ailments.

"This is the best technology going for a lot of surgeons," said James Forsell, who runs TBI's processing center in San Rafael, a suburb about 15 miles north of the Golden Gate Bridge.

An increasing number of doctors are using tissue bank products, and TBI now processes some 600 cadavers a year, translating into about $20 million in annual revenue. But the entire industry has fallen under a cloud after a New Jersey company was accused of taking body parts without families' consent.

"This is the worst thing that could have happened," a teary-eyed Forsell said. He has been working in the donated body parts industry for 20 years and is president of the American Association of Tissue Banks.

He points out that the scandalized company, Biomedical Tissue Services, was not accredited by the organization, as most tissue banks are. The association has stringent consent requirements that include dozens of questions asked of family members who make donation decisions, Forsell said.

On a recent day, TBI workers wearing hospital gowns, goggles and masks in sterile rooms began ridding the tissue of its living matter.

Marrow is blown from the bone with high-pressure water spray and fat cut from muscle with scalpels, scissors and other instruments typically used in operating rooms. The goal is to turn the tissue into inorganic material that can be stored on hospital shelves until needed.

Once that first step is completed, some tissue such as spinal bone is carved and shaped by an industrial-sized table saw programmed by a computer to cut the material to specific shapes commonly used in back operations.

The tissue and bone is then freeze-dried, bottled and shipped to another company to be irradiated, which kills any lingering viruses. The radiation turns the clear bottles brown.

While all of this is happening, TBI administrators are reviewing the donor's medical history. Even before the team begins operating on a cadaver, family members are asked about the donor's medical and social history. A donor is disqualified, for instance, if he or she was recently released from prison or led a high-risk lifestyle.

And before any body parts arrive at TBI, the company's operating team gives the cadaver a physical examination usually in a morgue or hospital. These technicians are looking for piercings, previous injuries and any other signs that the body isn't right for processing.

The donor's blood is also immediately shipped out to be tested for HIV, hepatitis and other infectious diseases. The medical charts are checked to ensure a clean history and often the attending physician is consulted.

"The real safety is in the monotonous details of going through the charts and the paperwork," Forsell said.

Some Quit Joint Replacement Settlement

Thu, 16 May 2002 00:00:00 -0700

About 120 patients who experienced faulty hip and knee replacements plan to opt out of a $1 billion settlement in a class action lawsuit.

Nearly 3,500 patients nationwide who received faulty artificial joints made by Austin, Texas-based Sulzer Orthopedics are covered by the settlement.

Parent company Sulzer Medica, located in Switzerland, said Thursday that it will negotiate to reduce the number of patients opting out of the settlement.

Sulzer's lead counsel, Richard Scruggs, has said that patients who choose to pursue litigation independently could bankrupt the company.

Those who got the implants replaced without complications will each receive about $200,000 under the settlement. The payment will be higher for patients with complications. About $40,000 of each patient's share will go toward attorney fees.

Cleveland U.S. District Judge Kate O'Malley approved the settlement last week following a two-day hearing.

In December 2000, the company was forced to recall thousands of artificial joints due to a manufacturing problem that had contaminated some with an oily residue. The substance prevented the new joint from bonding with patients' bones.

The agreement specifies that Sulzer Medica should pay $725 million toward the settlement.

Swiss Co. Seeks to Settle U.S. Suits

Thu, 14 Mar 2002 00:00:00 -0800

Swiss medical technology company Sulzer Medica AG said Thursday that it has submitted a final $1 billion proposal to settle thousands of U.S. lawsuits filed by people who received faulty hip and knee replacements.

A statement released by Sulzer Medica said that all parties involved have signed the final wording, but that any of them still reserve the right to "opt out" between April 12 and May 14.

The proposal is based on an agreement reached in last month U.S. District Court in Cleveland. It replaces an earlier $783 million settlement proposed by Sulzer Orthopedics Inc., the Austin, Texas-based subsidiary of Sulzer Medica.

"The final proposal is a milestone, but only on May 14 will we be able to say whether or not it will come through," Sulzer Medica spokeswoman Beatrice Tschanz said.

A federal court in Ohio is scheduled to have a final hearing on the fairness of the proposal on May 6.

Tschanz said the company is confident that more than 90 percent of the patients will choose to take the settlement, but added there is still a risk of further lawsuits.

She said she expects an U.S. court to extend an injunction barring individual lawsuits against Sulzer Medica, which runs out March 15.

The company has said Sulzer Orthopedics might have had to file for bankruptcy if the settlement fails.

The company was forced to recall thousands of artificial joints in December 2000 after it was disclosed that a manufacturing change had contaminated some with an oily residue that prevented the new joint from bonding with patients' bones.

Around 3,400 patients fitted with artificial hips and knee baseplates had to be operated on again. The number may rise to as many as 4,000.

Sulzer, Sulzer Medica Reach Deal on Liabilities Related to U.S. Claims

Mon, 25 Feb 2002 00:00:00 -0800

Sulzer AG and its former unit Sulzer Medica (NYSE: SM - news) AG have reached an agreement on the future financial obligations stemming from U.S. lawsuits related to hip- and knee-joint replacements.

Sulzer Medica (SM) agreed to pay all future liability that goes beyond a settlement proposal between the company and U.S plaintiffs that brought thousands of lawsuits after receiving faulty hip and knee replacements.

The deal means Sulzer will no longer bear any remaining financial risks, including risks relating to patients who opt out of the settlement, the group said. Sulzer said it signed the agreement with Sulzer Medica last weekend.

Sulzer Chief Executive Fred Kindle said: "I am confident that the settlement will overcome the last hurdles and that we can finally close this chapter for Sulzer."

However, Sulzer spokesman Markus Niederhaeuser said that should the settlement -- worth $1 billion -- not be accepted by a large number of U.S. patients, the accord between Sulzer and Sulzer Medica may have to be revised.

Under the plan, Sulzer Medica and Sulzer will pay $725 million and $75 million, respectively, in cash and financial instruments. A further $200 million is covered by insurer Winterthur International Insurance.

Patients who don't wish to accept Sulzer Medica 's settlement proposal will be able to file individual lawsuits after March 8 . A final fairness hearing is scheduled May 14 .

In December 2000 , Sulzer was forced to recall thousands of artificial joints after it was disclosed that a manufacturing change had contaminated some with an oily residue that prevented the new joint from bonding with patients' bones.

Earlier this month, Urs Kamber, Sulzer Medica 's chief financial officer, said the details of how much money each person would receive must still be worked out. "We don't know for certain yet, but it is in the range of $200,000 per patient," he said. Tommy Jacks, a plaintiffs' attorney who helped negotiate the deal, said at the time, "I think this is a settlement that will really provide for patients who had to endure a lot of suffering." At the same time, he added, "it's a settlement that will not force Sulzer into bankruptcy, because that's when the patients would really lose out."

Some Quit Joint Replacement Settlement

Tue, 01 Jan 2002 00:00:00 -0800

Artificial hips under recall over joint ball

Sat, 15 Sep 2001 00:00:00 -0700

Hundreds of artificial hips are being recalled because one piece - the joint ball - is made of a ceramic that may suddenly crack.

It is the second major recall of artificial hips in the last year.

The Food and Drug Administration announced the recall yesterday, warning surgeons not to use the affected implants - and patients to call their doctors if they experience symptoms suggesting the joint has cracked.

The FDA has at least 14 reports of Americans in whom the recalled hips have broken.

Not all the recalled hips will break, and there is no need for more surgery unless one does. But there is no way to predict which hips will fracture.

Patients should "be aware this increased risk exists," FDA medical officer Dan Schultz said. "If they have any symptoms whatsoever, they need to get in to see their physician as quickly as possible. Don't assume . . . it's something that is just going to go away."

Symptoms include hip pain, a sensation of grinding or limitation of motion, Schultz said. The fracture sometimes is preceded by an audible pop.

The at-risk hips tend to break between 19 and 28 months after they're implanted, FDA compliance officer Carol Fedorchak said.

The French company St. Gobain Desmarquest recalled nine batches of its ceramic femoral heads - the ball portion of the hip implant - that were manufactured since early 1998.

The worst batch has an 8 percent breakage rate, well above the one-hundredth of one percent breakage rate expected for such parts, Fedorchak said. The other eight batches had a far lower breakage rate, but were being recalled as a precaution.

Apparently, a change in the manufacturing's heating process left the ceramic more fragile.

Eight U.S. makers of artificial hips use the French maker's ceramic part, and they are pulling affected implants out of surgeons' offices. The eight are: Apex Surgical of Lakeville, Mass.; Encore Orthopedics Inc. of Austin, Texas; Osteoimplant Technology Inc. of Hunt Valley, Md.; Smith & Newphew of Memphis; Stryker Howmedica Osteonics of Allendale, N.J.; and Biomet Inc., DePuy Orthopaedics Inc. and Zimmer Inc., all of Warsaw, Ind.

Patients likely will not know if they have a hip made with a ceramic femoral head; the joint part also can be made of metal. FDA officials said they did not require doctors to keep a registry of which artificial joints they had implanted in patients, but that patients could ask their surgeons if they kept such a record.

It's also unclear just how many artificial hips are affected. The French company recalled about 7,200 femoral heads, but not all were sold to U.S. hip makers.

Texas Medical-Device Co. Faces Suit

Thu, 14 Jun 2001 00:00:00 -0700

Medical-device maker Sulzer Orthopedics, facing 700 lawsuits over a hip-replacement part it recalled last year, has been sued by a man who says his knee implant had the same defect.

Leroy Harp of Tulsa, Okla., sued Sulzer in March. His lawsuit is believed to be the only one involving a Sulzer knee, but attorneys representing hip-implant recipients said patients in other states are contacting lawyers and more lawsuits are expected, the Austin American-Statesman reported in Thursday's editions.

Until last month, Sulzer said its other products were manufactured differently than the hip part and were safe. Then, the company announced the knee implant might have the same defect as the hip part.

Sulzer spokesman Bill Miller said the company first received reports of potential problems with the knee in mid-January and learned soon after that one patient had an implant replaced.

By then, Sulzer had already changed the way it makes the implant, called a stemmed tibia baseplate.

The part had gone through some of the same manufacturing steps as the flawed hip part.

The company is investigating how patients are doing after knee surgery and has no plans to recall that part.

Sulzer wrote to surgeons on May 17 and publicly announced the potential problem on May 21. On May 30, Sulzer sent a ``special alert'' letter to physicians asking them to return for study any implants they had removed.

Sulzer also asked doctors to monitor patients and promised to reimburse patients who needed remedial surgery.

Nearly 17,500 patients received Sulzer hip implants, and about 1,800 have had them replaced, according to the company. By contrast, only 1,485 patients, 37 of them in Texas, received the knee implants.

Like the hip implant, the knee part has a porous coating that allows bonding with the patient's bone. Until December, both parts went through machining steps that left traces of oil, which prevented bonding in some patients.

Hip Replacement Patients May Face More Surgery

Wed, 17 Jan 2001 00:00:00 -0800

Rhonda Silva used to take long walks with her husband. Now she's confined to her Oakland, California, apartment, immobile for ten months with defective hip replacements that cause her "excruciating pain."

"I feel like I have an alien living in my body," she said.

The active and athletic 48-year-old public relations executive had her left hip replaced in April, 2000, after being diagnosed with osteoarthritis. But after six weeks of recovery and physical therapy, the hip failed to heal.

"By June, I was told that I wasn't progressing and the physical therapist said, 'We don't know what to do for you.'"

Silva sought her doctor's opinion -- then, at his urging, a second opinion. Both were the same: Replace the replacement.

Silva underwent that surgery in October, but more bad news arrived just before Christmas. Her doctor was notified that replacement, too, was defective.

"He said 'Come to my office and I need to talk to you and you might want to call your husband,'" she recalled.

Silva, who is scheduled for her third surgery on the same hip next month, is anxious, angry and apprehensive.

"I lie in bed at night and so panicked, and I've had a couple of anxiety attacks just knowing I have this device."

Will the third time be a charm, or merely more pain and disappointment?

"I know what's in store for me when I have the operation and dealing with that aftermath again."

Estelle Knowland, of nearby Alameda, California, also has the same defective hip replacement, but has not been told if she will need another hip replacement.

"It's a major surgery with hospitalization and rehabilitation, learning to walk again. And a lot of pain."

Pain is what Silva feels the most.

"The beginning and the end of the day are the toughest parts because they're the most painful. So to get out of bed is the most excruciating." Doctors agree that those with damaged hips have the most difficulty getting in and out of bed because of the bending and pressure the movement places on the hip joints.

Silva's orthopedic surgeon, Dr. Mac Reynolds, has notified 250 of his patients of the defective hip replacement.

"Devastating. Devastating. We see the gamut of emotions from people bursting out and crying to people being angry, to people storming out."

Not all come back.

"A hip replacement is a life-changing, life-altering operation to make people better and it's difficult to get them back for the second operation sometimes," Reynolds said.

The problem
The socket portion of the implant was determined to have an oily residue that prevented it from adhering to the patient's hipbone. Some sockets are so-called "force fit" -- that is, they snap into place and the bone is allowed to grow and graft to it. An alternate technique to cement the socket to the bone is more often used in elderly patients.

The implant's manufacturer, Sulzer Orthopedic of Austin, Texas, said it began receiving notices from doctors of problems with the implants in September, 2000, and immediately checked patient records, surgical techniques, therapy regimens and, ultimately, the product itself. The company ordered the recall after an 8-week investigation, according to Sulzer general manager Steven Whitlock.

"It's not a fault of the surgeon, it's not a fault of the patient. It was ultimately a fault of one of our products, and we're taking full responsibility for that," he explained.

The recall involves 17,500 hip replacement units, nearly a full year's production. One month into the recall, some 129 patients have undergone "revisions" -- replacements of the replacement.

Whitlock added that he has heard of cases like Silva's where a third surgery is needed.

"We accept full responsibility for that. We're sorry that occurred. We would like to and have communicated to the patient we would like for them to not incur any out of pocket expenses associated with this recall."

Sulzer has changed its manufacturing process to ensure that the oil residue found on the recalled implants is not present on newer units, according to Whitlock.

"We have instituted changes in the manufacturing process. We have validated those changes and what we're producing now are clean parts."

Patients who have had the socket cemented in place are not affected by the recall -- their implants should function normally.

Sulzer has set up a web address for doctors and patients who have questions about their hip implants. Products made by other companies are not involved in the Sulzer recall.

The American Academy of Orthopedic Surgeons reported that around 310,000 people in the United States undergo partial or full hip replacement each year. It is considered major surgery, though now a very common one. Sulzer is a major manufacturer of hip implant devices. Its replacement femoral stem -- the long part that attaches to the leg bone -- is used in about one-fifth of U.S. hip replacements. Overall, Sulzer's full hip replacement business makes up about 11 percent of the market, the company said.

At least one lawsuit has been filed against Sulzer in connection with the recall and others are expected.

San Francisco attorney Don Arbitblit disputed the company's timeline.

"They were receiving reports of loosening of this hip implant device since at least October 1999," he said. However, the company said it did not begin hearing about the defect until much later.

A National Institutes of Health panel reported last year that more study should be done on what happens to medical devices after they are implanted in patients. The panel said the research was essential for making improvements to artificial joints, pacemakers and other implants.

Estelle Knowland does not yet know if she'll replace the replacement, while Rhonda Silva wondered if it could be any more painful than the defect she carries now.

"I'd like to walk down the street holding my husband's hand instead of a crutch or a walker. I just want my life back."

Americans Ignorant of Their Implants

Wed, 12 Jan 2000 00:00:00 -0800

Up to 25 million Americans are living with implanted medical devices, from pacemakers to artificial joints, but too many patients have unrealistic expectations of how long implants will last and don't even know what model is in their bodies, a scientific panel said Wednesday.

Also, scientists are hampered in efforts to create better medical implants because too few of the devices are removed from patients' bodies - when they die or need a replacement - to study which lasted longest, worked best and was safest, said experts convened by the National Institutes of Health.

One big reason: Fear of lawsuits if scientists point out a flaw to correct.

But that lack of research means doctors today have few ways to compare different implants and choose the best model - and in turn are providing their patients with too little information, leading to unrealistic expectations, the panel said.

Even the panel's co-chair ran into the problem when she had hip replacement surgery last August.

The surgeon held up her X-rays, ``and said, 'Two new hips.' That's all I was going to learn about it if I had not come with all sorts of questions,'' said Northwestern University engineer Julia Weertman.

So the panel called on the government Wednesday to fund better education of patients and doctors, including establishing an Internet site with the latest information comparing different implants' risks and benefits. The idea is if a patient needed, say, a new hip, he or she would have a source of reliable information on what is state-of-the-art and how long to expect the joint to last given the patient's age and other factors.

Also, doctors should more thoroughly inform patients before surgery of the short- and long-term risks of their implant, the panel stressed.

Perhaps of most immediate importance, the panel also recommended each implant recipient be given a card to keep that lists the make, model and serial number of their implant - important in case of a recall or questions about a device's safety, but information most patients today never get.

Such steps also could persuade patients of the need to let scientists retrieve and study their implants upon their death or, in the worst-case scenario, a device failure.

Actually, most medical implants work well, the panel stressed - many last years, even decades.

But patients ``never seem to think a mechanical (medical) device is ever going to wear out, even though ... they have enough experience with their automobiles,'' Weertman said. ``We are trying to educate the consumer so he will realize things don't last forever, and there is a need to improve these devices.''

Still, the NIH panel acknowledged it faced complex hurdles. The panel declined to recommend a national database to track implant patients, as some other countries do, because of confidentiality concerns and cost. Nor could the panel estimate how much consumer education and the hoped-for Web site would cost, or even who would ensure patients received those implant information cards.

Also, some manufacturers do manage to retrieve and study certain implants, but typically consider their findings a trade secret, so doctors don't learn of product concerns.

``I would like to draw attention to what I believe is a code of silence I believe is imposed ... by the threat of litigation,'' complained panel member Arthur Kantrowitz, a Dartmouth College engineer.

The panel, however, urged NIH to hold another meeting of legal experts hunt a solution.

But some manufacturers do publish their studies of retrieved implants, and would provide information if the government starts an implant Web site, said Jim Benson of the Health Industry Manufacturers Association.

Biomet Hip Replacement Implant Recall Lawsuit

Wed, 12 Jan 2000 00:00:00 -0800

Biomet Hip Replacements

In September 2001, the FDA announced that Biomet and seven other U.S. medical devices firms would recall hip implants because of problems with a component that can fracture and require surgical replacement. The faulty component is the zirconia ceramic femoral heads, which is the ball portion of artificial hips that is used in hip replacement surgery.

The Zirconia Ceramic Femoral Head was manufactured by St. Gobain Desmarquest of France. This femoral head was used in hip replacement products for Biomet and seven other medical manufacturers, including: Apex Surgical LLC, DePuy Orthopedics Inc., Encore Orthopedics Inc., Osteoimplant Technology Inc., Smith & Nephew Inc., Stryker Howmedica Osteonics and Zimmer Inc.

Symptoms of a fractured zirconia ceramic femoral head include hip pain, a sensation of grinding or limitation of motion. The fracture is sometimes preceded by an audible pop. The at-risk hips tend to break between 19 and 28 months after they have been implanted.

It is estimated that 6 percent of the 150,000 to 200,000 persons that undergo hip replacement surgery each year receive an artificial hip containing the zirconia ceramic femoral head. The recall applies to zirconia ceramic femoral heads manufactured since January 1998.

If you or a loved one had a Biomet hip replacement and you suffered injuries, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.