Boston Personal Injury Attorney Blog

The job of a compounding pharmacy is pharmaceutical compounding, which essentially means creating a specific pharmaceutical product in order to meet the medical needs of a specific patient. The industry’s initial role was to combine or to process appropriate ingredients in order to meet a medical need. For example, if a patient required a specific dose or combination of medications, if flavors needed to be added to a drug, or if medication needed to be changed from a solid to a liquid, a compounding pharmacy would do this job.

Compounding pharmacies, when they first began, operated on a relatively small scale. A doctor might prescribe a specific drug to a patient that did not already exist in the specific necessary form or dose. The compounding pharmacy met that need. This was especially common for parenteral medications or intravenous medications.

The industry, however, evolved over time into something much different than a small pharmacy meeting the needs of specific patients. Unfortunately, our Boston defective drug attorneys know that the regulatory system did not evolve with the industry. As a result, compounding pharmacies weren’t properly regulated, pharmacies got negligent or careless, and people started dying.

Compounding Pharmacy Problems

As the number of medications grew and as drug shortages and rising costs started to become problems, compounding pharmacies morphed from small retail or boutique pharmacies to major manufacturing operations. Instead of just mixing drugs for specific patients or to meet a specific need, compounding pharmacies started to manufacture drugs on a massive scale and to sell those drugs across state lines. The compounding pharmacies weren’t pharmacies at all but were drug manufacturers by another name.

Unfortunately, the regulations didn’t change as compounding pharmacies did. The pharmacies were originally regulated by state boards responsible for overseeing pharmacies. The Food and Drug Administration (FDA), which regulates drug manufacturers, didn’t have authority over the compounding pharmacies. State boards, however, also didn’t really have any control over the major compounding manufacturers who were producing drugs on a massive scale. Further, state pharmacy boards weren’t really qualified to handle regulating and overseeing these massive drug manufacturers.

The result of this was that no one was really watching what was going on in these compounding pharmacies. Some Democratic lawmakers tried to change that in 2007 but weren’t successful and compounding pharmacies just continued to produce drugs with little oversight.

Then, however, the problems started. According to the American Society of Health-System Pharmacists:

• Five patients developed an eye infection after being administered bevacizumab that Clinical Specialties Compounding Pharmacy had repackaged.
• More than 50 people died and another 700 or so were injured when New England Compounding Center sent out drugs to more than 20 different states that had been contaminated with a fungus.
• A compounding pharmacy called Med Prep Consulting sent out 50-mL bags of magnesium sulfate in a five percent dextrose injection that contained mold. Fortunately, an employee at the Connecticut hospital that received the drugs noticed the mold floating at the top.

These problems will be just the tip of the iceberg if someone doesn’t step up and start overseeing what compounding pharmacies are doing. The Senate has introduced another bill to vest authority in the FDA, but it is not yet clear if this bill will actually pass or if compounding pharmacies will be free to continue wrecking havoc on unsuspecting patients.
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DePuy is one of several manufacturers who produced and sold metal-on-metal hip implant products to patients who needed a hip joint replaced or resurfaced. Unfortunately, the DePuy metal-on-metal hip implant product did not live up to expectations. The metal-on-metal replacement joints have a high fail rate that necessitates surgical correction for many patients within five years or less from the original surgery, and the implants also are causing complications including metal toxicity and significant pain.

Our Boston medical malpractice attorneys know that DePuy Manufacturing has been under fire in the United States for a long time with thousands of lawsuits filed against the company, many of which are moving forward in multi-district litigation in federal court. However, what people in the U.S. may not know is that they aren’t alone. DePuy hip implant products were sold not just in the United States but throughout the world. As such, DePuy is facing litigation on many fronts.

DePuy Hip Implants Causing Global Problems

DePuy, a unit of Johnson & Johnson, has been waging legal battles in the United States and NJ.com recently reported that more than 10,750 lawsuits have been filed based on the DePuy ASR XL hip replacement product. The lawsuits have been filed in state courts throughout the U.S., and there are both individual lawsuits ongoing and federal lawsuits including consolidated multi-district litigation cases.

The news has been up-and-down for DePuy with the ongoing lawsuits, with the plaintiff winning the first bellwether trial and Johnson & Johnson winning the second. The bellwether trials are essentially test trials, the outcomes of which can determine whether DePuy settles other pending cases and for how much. The bellwether trials are important as they may be determinative of the outcome of U.S. cases pending against Johnson & Johnson as a result of the DePuy hip replacement products.

These trials, however, are not the only thing for DePuy to worry about. The company did not restrict its sales of hip replacement devices to the United States and there are people in multiple locations throughout the world who are experiencing problems as a result of trusting the DePuy products.

Recently, for example, ENCA revealed that there are thousands of South African residents who are coping with problems caused by defective DePuy hip replacement devices. Those in South Africa who have been affected by the defective medical device want their day in court too and now there is a good chance they will get it.

This is made possible because lawyers have been given the go-ahead to sue the British company that made the implants. Now, nearly 200 South Africans are already demanding damages from DePuy due to botched hip replacements that are causing complications including almost constant pain.

DePuy will have to respond to the lawsuits brought by the 200 South Africans who are suing, along with responding to the claims made in the United States and elsewhere in the world. Hopefully, DePuy will accept responsibility for its actions as people throughout the world suffer the consequences, and will step up, do the right thing and fairly compensate victims for their injuries.

Unfortunately, DePuy doesn’t seem eager to right the wrongs caused by its dangerous products and injured victims will need to do everything possible to protect their rights and get their money from DePuy for their losses.
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In 2007 Senator Pat Roberts and Senator Edward Kennedy attempted to pass legislation to expand the power of the Food and Drug Administration (FDA) to regulate compounding pharmacies. Compounding pharmacies where medications are mixed or altered fell into a regulatory gap where it wasn’t really clear whether the FDA or state boards of pharmacies were in charge of oversight and safety compliance. The 2007 legislation would have changed that, but Congress failed to pass it.

Unfortunately, the consequences of the lack of oversight and the consequences of the regulatory gap became far too clear in recent months when contaminated drugs from New England Compounding Center (NECC) caused more than 50 deaths and made more than 700 Americans sick. Our Boston injury attorneys know that the lack of oversight played a direct role in contributing to the deaths and injuries caused by deadly fungal infections in patients taking drugs from NECC. Something needs to be done to prevent this from happening in the future and the Senate is now trying again to take action.

Senate Considers Expanding FDA Regulatory Authority
According to the Boston Globe, the Senate recently introduced a bill intended to prevent future outbreaks like the one caused by the contamination at NECC. The legislation proposing rule changes is bipartisan and was drafted with support from Democrats and Republicans on the Senate Health, Education, labor and Pensions Committee.

The legislation would make clear that large compounding operations — called compounding manufacturers — are subject to direct federal oversight by the Food and Drug Administration. Traditional small compounding pharmacies would continue to be regulated by state pharmacy boards but would still be subject to new federal standards on the ingredients used. Traditional small compounding pharmacies that will remain under state control include pharmacies that mix or produce medication for a specific patient to match a specific prescription.

The bill identifies “compounding manufacturers” who are subject to federal oversight as pharmacies that produce injectable drugs without patient-specific prescriptions from physicians. To be considered a compounding manufacturer, the compounding operation would generally have to ship across state lanes.

This bill will make clear exactly what role the FDA plays in regulating and monitoring compounding manufacturers, which had previously been undefined. The issue is that these manufacturers became much bigger and took on a different role than anyone had originally anticipated. Thus, they need to be more tightly regulated because their new role means that serious and widespread injury can result when a mistake is made.

Now that the bill has been proposed, hopefully it will actually make it through both the Congress and will become law. Unfortunately, several Democrats in the House of Representatives who introduced similar laws have not been successful as Republicans in the House have shown little interest in moving the measures forward.

Hopefully, this Bill will not meet the same demise as the 2007 bill and lawmakers will actually be able to do something to prevent another tragedy occurring like the outbreak caused by the New England Compounding Center’s negligence.
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