West Palm Beach Personal Injury Lawyer - Pain Pumps

Drug and Medical Device Manufacturers: "It is someone else's fault"

John Hopkins — Thu, 03 Sep 2009 10:59:13 GMT

A responsible FDA has brought a drug manufacturer to justice. The FDA has settled with Pfizer over its off label and deceptive marketing of the drug Bextra; $2.3 billion in fines and penalties. Sounds like a lot of money until you consider that in 2004 alone, Pfizer sold over $1.4 billion in Bextra. Sadly, this chapter is simply the tip of an ever increasing iceberg.

Assistant Attorney General Tony West had this to say about the settlement:

"Illegal Conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers and costs the government billions of dollars. This civil settlement and plea agreement by Pfizer represent (sic) yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

Mr. West is correct as long as there is an FDA willing to hold manufacturers to compliance with the law and judges who see corporate obfuscation when it is in front of them. When drug and medical device manufacturers encourage off label, unapproved uses it should be with a foundation of study and evaluation for the safety of the recommended use.

Manufacturers of pain pumps, for example, encouraged an off label, unapproved use of their devices causing severe and crippling injuries in young adults with their whole lives in front of them. Although pain pump manufacturers did no research or evaluation of the safety of their off label use recommendations, they did go to considerable expense to produce manuals and DVD’s to teach doctors how to code billing to maximize profit if the physicians used the pain pumps in the ways recommended by the manufacturer. Breg, Stryker, IFlow and other manufacturers told physicians to use pain pumps in a way that they knew had not been approved by the FDA, in fact in ways that at least some of the manufacturers knew has been absolutely forbidden by the FDA without specific testing and research.

Did the pain pump manufacturers do the testing or research that the FDA had set forth was necessary? Did these manufacturers avoid intensive marketing to physicians for use of the pain pumps in a way not approved by the FDA? The answer is a resounding, no!

But, wait, it gets better. Through their lawyers, the pain pump industry appears to have devised a scheme to create a defense to their conduct by not complying with the FDA. They apparently understood that if they neglected to conduct the appropriate, required scientific studies, no one else would either. If no one conducted any meaningful scientific studies, then pain pump manufacturers would be able to pull the devices once they started hurting people and then argue to judges that all the victims’ lawsuits should be dismissed because no reliable scientific evidence exists to substantiate the injured victims’ claims.

So, manufacturers violated the law by not conducting safety research on their devices.

Devices start causing crippling injuries after being on the market long enough for manufacturers to amass huge profits.

Injured victims sue manufacturers.

Pain pump companies pull their devices before anyone does any meaningful testing (the same testing the FDA told the manufacturers to do before putting pain pumps on the market).

Do pain pump manufacturers defend the lawsuits by arguing that their devices were safe and here is the evidence of the testing they did to ensure the safety of the public? No.

Pain pump manufacturers actually argue that it was the doctors’ fault for using the pain pumps and they (the physicians) should have known better. In the alternative, pain pump manufacturers tell scientifically unsophisticated judges that lawsuits should be dismissed because no reliable evidence exists to prove their pain pumps are defective. Injured victims ask the manufacturers for their studies and pain pump makers respond by boldly stating they did none.

Experts for injured victims testify that the violation of the law by not conducting analysis, which the FDA specifically requires, is negligence. Orthopedic surgeons testify that the patient’s injuries were caused by the improper use of the medical devices. Pain pump manufacturers respond by arguing this testimony is purely opinion and irrelevant because the absence of scientific studies means the injured victims can not prove their cases.

Some judges listen to the medical device manufacturers’ arguments that the lack of scientific study, largely caused by their failure to follow the law, should give them a free ride away from injured victims’ claims.

In the Pfizer case, whistle blower John Kopchinski revealed: “In the Army, I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that." Apparently there are plenty of drug and medical device employees who can make money on the backs of injured people.

So, do not blindly allow physicians to use medical devices and drugs to treat you. Ask questions. Make inquiries. Do research. Require complete answers. The physicians may possibly be as much in the dark as the patient in some cases.

Originally posted at InjuryBoard by John Hopkins

Post-Operative Pain Pump Use in Knees Discouraged

Brenda Fulmer — Wed, 17 Jun 2009 11:49:56 GMT

A new study published in The Journal of Bone & Joint Surgery discourages surgeons from using post-operative pain pumps undergoing knee surgery, concluding that there are equally effective ways to manage post-operative pain that would not subject patients to such significant potential harm. The authors of the study from Wansbeck General Hospital in Ashington, England concluded that surgeons could avoid the “possible chondrotoxic insult” to knee cartilage by utilizing local anesthetics around the portals rather than “intra-articular infiltration.”

Use of post-operative pain pumps, such as those marketed by Breg, Stryker, I-Flow, and Don-Joy, have come under great scrutiny lately as a number of patients have developed chondrolysis or destruction of their cartilage after the pain pump catheters were placed into the joint spaces of patients and then bathed in local anesthetics such as bupivacaine and marcaine. Lawsuits against the manufacturers of the pain pumps and the anesthetic drugs are pending in state and federal courts across the nation. The stories of these plaintiffs are quite compelling, as many are very young, health patients who underwent surgery to correct minor sports-related injuries and are now facing a lifelong series of joint replacement surgeries and disability.

The authors of this study noted:
Intra-articular bupivacaine is widely used as a local anesthestic in arthroscopic surgery, either as a single agent or to supplement regional or general anesthesia. A growing number of laboratory studies have demonstrated the potential toxicity of bupivacaine to articular cartilage. Most recently, Chu et al demonstrated that exposure of human chondrocytes in vitro to 0.5% bupivacaine for just 15 minutes resulted in cell viability of only 41%. Gomoll et al examined a rabbit shoulder in vivo and showed significant histopathological and metabolic changes in articular cartilage following continuous intra-articular infusion of bupivacaine. Recent reports have also implicated the use of bupivacaine in post-operative chondrolysis in the human glenohumeral and ankle joints.

This latest study adds further evidence to the mounting pile of studies, case reports, animal data, and adverse event reports documenting widespread development of chondrolysis in young, otherwise healthy patients who utilized a post-operative pain pump with delivery of anesthetic drugs directly into their joint space after surgery. The Food & Drug Administration is currently investigating these reports as well, and at least some of the manufacturers are now, for the first time, warning surgeons that intra-articular placement of the pain pump catheter may present a risk to patients.

Originally posted at InjuryBoard by Brenda Fulmer

2008 Stanford Study Proves Injectable Pain Medicine from Pain Pumps Kill Tissue

Cal Warriner — Tue, 02 Sep 2008 18:10:53 GMT

A very recent laboratory study conducted at Stanford University heavily suggests that common anesthetics used in pain pumps cause significant tissue destruction. The study, prompted by poor outcomes associated with the use of Intra-articular Pain Pumps, revealed that epinephrine and bupivacaine both caused alarming amounts of tissue death in a controlled laboratory setting.

Intra-articular pain pumps are commonly used to reduce the pain associated with surgery. These pumps inject pain reducing medication directly into the joint space. Recently, doctors have noticed that their surgical patients who are using these pumps are developing disabling conditions that often require numerous surgeries and potentially joint replacement.

The results were so impressive, the authors suggested that epinephrine not be used at all and that bupivacaine not be used in certain concentrations for over 48 hours. What is alarming about the ever growing evidence that these pumps are hurting patients is the fact that these pumps continue to be implanted in surgical patients every day and the pump manufacturers continued to sell them without special warning about the potential devastating consequences.

These pumps most frequently are used following routine outpatient shoulder surgery. Joint destruction significant enough to require complete joint replacement has been reported.

Originally posted at InjuryBoard by Cal Warriner