Horrific Truth behind the movie “Puncture” – Inadequate Needle Safety in the US

It is not a very well-kept secret that medicine is big business and that money and corporate influence play a significant role in to what medications, treatments and equipment reach patients and healthcare workers. This reality was highlighted in the 2011 movie Puncture. Puncture details how control over the market for needles contributed to the death of a nurse.

The Movie
The screenplay for Puncture was written by attorney Paul Danziger, who along with attorney Michael Weiss, brought a lawsuit against needle manufacturers. The problem of needle manufacturer monopolistic activities was brought to light after a nurse named Vicky was stuck by a contaminated needle while caring for a patient. As a result of the needle prick, Vicky contracted HIV. She eventually died from AIDs. Saddened by her predicament, Jeffrey Dancort, a friend of Vicky’s and an inventor, designed a needle with built in safety features that would substantially cut down on the number of accidental needle pricks. While healthcare workers were eager to use safer needles, Dancort encountered significant roadblocks in attempting to bring the needle to market. This led Dancort to tell his story to Danziger and Weiss.

Puncture details the story of how Vicky’s needle prick and Dancort’s desire to prevent this from happening again led to the discovery by Danziger and Weiss of a conspiracy involving a needle manufacturer and its distributor to monopolize the medical needle market. Danziger and Weiss agreed to take Dancort’s case and sued the needle manufacturer that blocked him from entering the marketplace. Along the way they discovered that only manufacturers who were willing and able to buy their way into the distribution channels could get their products into the hands of hospitals and healthcare workers.

Hospitals purchase equipment and goods through group purchasing organizations (GPOs). In theory this allows several hospitals to pool their buying power and take advantage of savings that the bulk purchasing would provide. Ironically, another goal of GPOs is to promote quality healthcare. However, GPOs and manufacturers often enter into long-term exclusive agreements that have financial repercussions if the GPO purchases products from another manufacturer. Thus, even if a hospital wanted to purchase the safer needle at the same price, the GPO refused to sell it because of the agreement it had with the current needle supplier.

After several dramatic twists and turns and with the help of a third attorney, Mark Lanier, the lawsuit was eventually settled for over $100 million.

The Reality
The problem of healthcare workers getting injured by needle sticks is a significant one. Each year there are 800,000 accidental needle stick injuries in hospitals. Over 1,000 healthcare workers who are stuck contract HIV, hepatitis B, hepatitis C, and other blood-borne diseases. Worldwide the statistics are even more shocking. Because hospitals purchase medical devices through GPOs, legislative intervention has been necessary to help get safer needles into the hands of healthcare workers. In 2000, President Clinton signed the Needle-Stick Safety and Prevention Act which requires the use of safer needles. As a result, the Occupational Safety and Health Administration (OSHA) issued rules requiring hospitals and other employers to “identify, evaluate, and implement the use of safer medical devices.” On a local level several states including California have enacted laws with similar requirements. Such legislative intervention is sure to have an impact on the number of needle sticks as well as healthcare worker illnesses and deaths from needle sticks. But how much of an impact?

Despite the federal and local government attempts to get safer needles into the hands of healthcare workers, hospitals may be able to continue to use needles that are arguably not very safe. OSHA’s rules do not specify which needles are safer as it has a policy of not endorsing specific products. Furthermore, an employer can circumvent the requirement of using safer needles if such needles are not readily available in the market. Could an employer skirt OSHA’s requirements by either arguing that the needles that is uses are safe, or by arguing that because a particular needle is the only one its GPO offers, it is the only one available in the marketplace?

Coakley Advertisment Misspells Massachusetts

BOSTON (Legal Newsline) – An advertisement for Massachusetts Attorney General Martha Coakley’s senatorial campaign misspelled the name of the state Monday night.

After a three-person debate Monday night, an attack ad on Republican state Sen. Scott Brown paid for by the state’s Democratic Party spelled it “Massachusettes.”

The ad was “authorized by Martha Coakley for Senate and approved by Martha Coakley.”

“The punchlines write themselves: Before you represent a state in the Senate, shouldn’t you learn how to spell its name?” Jim Geraghty wrote for National Review Online.

“This isn’t the sort of thing that sways votes, but it does suggest a certain haphazard hastiness surrounding the Coakley campaign; they probably never thought they would have to run attack ads against a little-known state legislator in this state.”

Recent polls have shown Brown with anything from a 1-percent lead to a 15-percent deficit.

The Boston Herald live-blogged the debate and included a poll on who was winning. By the end of the debate, Brown was receiving 86 percent of the votes, Coakley 9 and Independent candidate Joseph Kennedy 5.

The three are vying to succeed the late Ted Kennedy. A special election is being held Jan. 19.

Mistaken Medication a Hard Pill to Swallow

My recent article about defective consumer products and the vagaries of customer service elicited a flurry of responses. Friends and strangers alike shared with me their own stories of defective products, laziness, surliness and even outright hostility from the folks entrusted with “customer service.”Hinky computers, poor phone service and dour flight attendants are frustrating, but other consumer problems can more directly and imminently threaten life and limb. I experienced one of these several years ago.
At one pharmacy in Menlo Park, California, part of a national chain where I usually had my prescriptions filled, I picked up a refill of the statin drug that I had taken for many years. When I began using that particular container of pills – for my morning dose – I noticed that there were two species of pills in the container, one football-shaped, marked “93/670,” and the other rectangular and marked “M357.” (The pills would sometimes vary in appearance from refill to refill, depending on the particular manufacturer of the generic drug, so I assumed there were two different brands of generics in the vial.)

Because I was feeling odd – tired and a little “out of it” – after some of my morning doses of medication, after a couple of weeks I phoned the pharmacy and spoke to a pharmacist, to whom I described the appearance of the pills and my puzzlement. He was able to identify the football-shaped pills as a generic version of my statin, gembribozil, from a company called Teva, but he could not explain the presence of or identify the second kind of pill. He said that unfortunately, that particular pharmacy didn’t have the reference book that would enable him to identify the second species, but he suspected that it was, perhaps, another manufacturer’s generic for gemfibrozil. I asked him to call another store that did have the book, and he agreed to do so and to phone me back. He phoned a few minutes later to tell me that the second species of pill appeared to be alpha-methyl dopa, an antihypertensive that is seldom prescribed any longer.

I was shocked and angry at this turn of events and asked him to have the pharmacy manager phone me when she returned from a conference.

About a half-hour later, the pharmacist phoned me again, to tell me that the second species was probably not alpha-methyl-dopa after all, but the analgesic Vicodin, a controlled drug, a combination of the opiate hydrocodone, and acetaminophen (the active ingredient in Tylenol).

Not having heard from the manager, I phoned her. She explained to me that neither gemfibrozil nor Vicodin is actually dispensed by human pharmacists but by a robot, and she speculated that the robot must have filled my prescription (with gemfibrozil) and then gone on to the next prescription (Vicodin), somehow putting the pills into the same vial. She phoned me back about half an hour later, saying that she had spoken to her boss, who was certain that the robot could not have been at fault, and that neither of them had an alternate explanation.

At the manager’s request, I brought the container of pills that contained the mixture of gemfibrozil and Vicodin to the store so that she could examine it. She verified the identity of the pills, and gave me a fresh container of gemfibrozil, which was, ironically, labeled with a date two months earlier.

This comedy of errors is no joke. Although I did not suffer a catastrophe such as might have occurred had I unwittingly combined Vicodin and alcohol or other sedatives, I did suffer significant inconvenience and decreased professional productivity which, in retrospect, I recognized as being the result of my periodically ingesting Vicodin instead of statin. Specifically, I noticed that on some mornings I was groggy and had difficulty concentrating at work, and once I fell asleep in my car while waiting to meet someone. (All of these events were most unusual for me.) My productivity — as measured by my production of articles for major newspapers and journals — was demonstrably lower during that time, and people told me that I looked tired. (And, of course, on the days I was taking a morning dose of Vicodin, I wasn’t getting the cholesterol-lowering benefit of my statin.)

As a physician and a former senior official at the FDA, I know the problems that drugs can cause even when prescribed, dispensed and taken correctly. I dislike taking medications except when they are absolutely necessary. Being exposed unnecessarily and involuntarily to a drugs — an opiate and controlled substance, no less — was therefore, for me, a particular affront. I felt as though I’d been assaulted. When I think about what the outcome of the pharmacy’s error could have been, I am outraged all over again.

I had a lawyer friend write a non-hostile letter to the pharmacy describing my experience. The company went into classic hunker-down mode. Their response was like the classic lawyer’s refrain: My client was nowhere near the site of the crime, but even if you can show that he was, he didn’t do it; and even if you can prove that he did commit the crime, he promises to not to do it again. The essence of the company’s response was that I couldn’t prove that I received a mixture of drugs; but that even if I could, I couldn’t prove it was the pharmacy’s fault; and that as a physician, from the beginning, I should have noticed that something was amiss.

Aside from choosing carefully which pharmacies to avoid, my story offers some important lessons for consumers of prescription drugs.

First, I regret that I didn’t complain at the time to the state pharmacy board and to the local police. After all, someone contaminated my drug purchase with a potent narcotic; and whether it was done by a terrorist or an incompetent pharmacist, I could have been severely injured. Moreover, according to former police chief and drug control expert Joseph McNamara, for possessing a controlled substance without a prescription I was also in legal jeopardy (especially had I been driving while impaired).

How can consumers detect such errors? Be vigilant for anything amiss in any prescription drug – a mixture of pills of different appearance; unusual color, texture, markings or packaging; and any change in effectiveness or side effects. As an aid to customers, my current pharmacy includes a physical description of the pill right on the label of the container; a vial that I picked up this week offers this description, “Oval White,10/PD 155,” which corresponds to the appearance and markings on the tablets. This cheap, effective and systematic expedient enables patients to verify that they’re getting the correct drug in each prescription.

Medication errors in hospitals have received a lot of attention, but mistakes occur in neighborhood pharmacies, too. Be attentive, be careful, be well.