The company reported the notice during a conference call last month after announcing a profit for the fourth quarter vs a year-earlier loss as sales of generic injectable drugs, IV solutions, drug pumps and other products increased more than 8 percent.

Hospira said the FDA completed an inspection of its medical device quality systems at its headquarters in Lake Forest, Illinois, last month and issued a list of 10 objectionable conditions. The list is known in the industry as a Form 483.

Some of the quality systems assessed as part of the Lake Forest inspection included supplier quality systems and medical device reporting and complaint systems, a Hospira spokeswoman said.

The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections, the spokeswoman said.

“While there may still be additional device field notifications going forward, we do not believe they will continue at the rate we have seen recently,” she said in an email.

Chief Executive F. Michael Ball said that FDA inspectors acknowledged some progress since the last inspection.

“The observations re-enforced our own assessment there is still a lot of work to be done within our device operations,” Ball said on the conference call.

Ball did not provide any specific details that were outlined in the 483, only said it was “particularly rough” though he said “many” of the observations were a repeat from an inspection that took place in July 2012.

He said management had been doing a complete review of all of its medical devices even before the FDA notice.  He said they are developing a new longer term MMS (Medication Management Systems) strategy that would be “aimed at modernizing and streamlining platforms to best address our customer needs and the nearer-term remediation issues” and include input from the FDA.

Ball said there has been progress at some of its other manufacturing facilities that have had problems, including its Rocky Mount facility in North Carolina. Ball said a reinspection by the FDA would be extensive and lengthy but he expects to increase production this year.

He said Hospira’s other plants emerged from shut downs on schedule, such as the plant in Clayton, North Carolina.  The Clayton facility has resumed manufacturing propofol, an anesthesia that is administered intravenously and has been in short supply, and is building inventory in the fourth quarter of 2012 for an early 2013 relaunch.

He said the drug was being priced at a premium.

Despite the costly remediation efforts and manufacturing issues, Hospira still reported an 8 percent fourth quarter increase in 2012 in comparison to the same quarter for 2011.

The post Hospira Still Facing Manufacturing And Regulatory Issues appeared first on Drug Injury Lawyers.

The OIG said they did the study because The Food and Drug Administration (FDA) requires manufacturers to submit structured plans, known as Risk Evaluation and Mitigation Strategies (REMS), for drugs associated with known or potential risks that may outweigh the drugs’ benefits. If the FDA does not properly monitor REMS’ performance, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks. However, the FDA does not have the authority to require, but may request, drug manufacturers (i.e., sponsors) to submit specific information regarding REMS’ effectiveness.

The FDA uses REMS in situations where regulators have significant concerns that a drug has an unpredictable, severe, and potentially avoidable risk. REMS are a strategy the FDA first adopted in the late 1990s as “voluntary” agreements that drug makers make with the agency. Sponsors would enter in to these arrangements with the FDA as a condition of approval. In most cases, the companies promised to put in place restrictions on how drugs would be used by doctors. These limitations were meant to help mitigate the agency’s safety concerns, and make it easier to get a new product to the market.

These plans might, for example, involve pregnancy testing before woman can use a drug that is known to cause birth defects; or for drugs that could cause an immediate and severe allergic reaction (anaphylaxis), special monitoring of patients when they first received the medicine. Another situation where these risk mitigation plans were used involved scheduled narcotics that could be accidentally ingested by children. The FDA often required risk management plans that would help keep the narcotic drugs secure in the home and out of the hands of small kids.

Over the years, these arrangements evolved. They became dubbed REMS in 2007 when the FDA received explicit authority from Congress to demand these arrangements are part of drug approvals. Gone was the “voluntary” nature of the scheme, where the FDA would effectively pressure companies into agreeing to the restrictions in order to get their products approved. After 2007, the FDA had the explicit legal authority to demand the restrictions. But Congress also tasked the FDA with oversight to make sure that the programs were having their intended public health benefits.

The OIG report reviewed approved REMS implemented since the program’s “legal” inception in 2008, all the way through 2011. The FDA approved 199 REMS over that time; 99 of which were still required in 2012. Nearly half of the assessments for the 49 REMS that the OIG reviewed did not include all information requested in the FDA “assessment plans,” and 10 were not submitted to the FDA within required timeframes. The FDA determined that only 7 of the 49 REMS reviewed met all of their goals.

The OIG stated in their report that their “findings raise concerns about the overall effectiveness of the REMS program.”  To address these concerns, they made seven recommendations regarding the FDA’s evaluation and assessment of REMS and its review of sponsors’ REMS assessments. The FDA concurred with six of our recommendations. For the remaining recommendation, to seek legislative authority to make the FDA assessment plans enforceable, the FDA did not state whether it concurred or did not concur. However, the FDA agreed that this recommendation should be considered if another opportunity arises to pursue legislative changes to the statutory provisions that describe the requirements for REMS assessments.

Although, according to the recent report, OIG says that the FDA fell short in how it implemented the provisions, is it really their fault?  Or is the system set up to fail?

According to an article in Forbes, “It was inevitable that these strategies would be hard to execute, and even more difficult to impose and monitor. The risk mitigation plans presupposed that the FDA and the drug makers had legal, if actual control over what doctors did and how they prescribed medicines. The FDA doesn’t have this authority and drug makers can’t exercise that sort of control.”

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“It’s really an exciting paper,” said study co-author Dr. Art Sedrakyan, associate professor of public health at Weill Cornell Medical College in New York City. “What we’ve observed is regardless of size, women had a higher rate of revision occurrence.”

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, who wrote an accompanying editorial to this study in the same journal issue. “Research in this area could save billions of dollars” and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.

For the study, Sedrakyan and his team looked at 35,140 surgeries at 46 hospitals in the Kaiser Permanente health system.

After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems for repeat hip implant surgery included instability, infection, broken bones and loosening.

Sedrakyan said the increased risk was only seen when the cause of rejection was aseptic, meaning not caused by infection, which suggests the problems were not related to issues during surgery. The most common problems that required another surgery were dislocation and wear of the product.

Then what explains the gender differences for repeat hip implant surgery?

Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads — the ball-shaped part of the ball-and-socket joint in an artificial hip – are more likely to dislocate and require a surgical repair.

That explained some, but not all, of the difference between women and men in the study.

Doctors traditionally believed the larger the size of the implant, the more protective it was against failure, according to Sedrakyan.  However, he said his study found regardless of size, women had a higher rate of repeat hip implant surgery, so some other factor besides the actual implants may be leading to this effect.

“I think there’s something beyond the use of the implants that seems to be related to this second surgery recurrence,” he said.

He thinks anatomy may play a role. Women have different pelvic and hip anatomy, he said and it’s also possible that some other unknown activities specific to women make them more vulnerable to a dislocation or higher wear.

Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women.

Sedrakyan said that it’s premature to say women need different, more-specialized hip implants than men, because the overall risk remained low. He references past research on gender-specific knee implants, and how researchers learned they weren’t any more helpful.

“We shouldn’t jump to conclusions,” he said. “We need to understand this better.”

The research was published Feb. 18 in JAMA Internal Medicine, and was funded by the U.S. Food and Drug Administration.

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Research published in the journal Environmental Science and Technology suggests that the dust found in underground railways is different than above-ground, therefore travelling or working on an underground railway for a sustained period of time could have health implications due to concentrations of metal-rich microscopic dust particles that can penetrate the lungs.

A team at the University of Southampton studied the particles found in an underground station in Europe and it turned out to be  unusually high in metals.

Lead author of the study, PHD student Matt Loxham, said, “The high level of mechanical activity in underground railways, along with very high temperatures, is key in the generation of this metal-rich dust.”

Scientists studied the ultrafine particulate matter (PM0.1) found in an underground station beneath an airport in Europe and found there were similar concentrations of airborne metals in the dust particles in heavily-trafficked road tunnels and wood burning stoves.

Working in steel mills and other environments that are rich in airborne metals has previously been shown to have a damaging effect on health. The latest findings suggest that sustained exposure to underground railways – such as by regular commuting or working below-ground – could also have health implications.

However, little research has so far been carried out on the effects of working in an underground railway environment, which may also be rich in airborne metals.

Smaller than PM10 and PM2.5, comparatively little is known about the chemistry of ultrafine PM0.1 particles, but it does not typically pose such a risk to health, the study authors said.

So, why are these metal particles potentially dangerous?  According to the authors, ultrafine particles can reach the deepest areas of the lungs – the alveoli – where oxygen enters the blood and waste gases leave to be exhaled.  And, according to the study, there is evidence that ultrafine dust may be able to evade the protective barrier lining the airways to enter circulation. This means that ultrafine particles may not just impact the airways but also the cardiovascular system, liver, brain and kidneys.

Loxham said, “These tiny dust particles have the potential to penetrate the lungs and the body more easily, posing a risk to someone’s health.”

As a result of the study’s findings, Loxham has called for further research into the health impacts of particulate matter at underground railways.

He said: “Underground rail travel is used by great numbers of people in large cities all over the world.”

“The high level of mechanical activity in underground railways, along with very high temperatures is key in the generation of this metal-rich dust, and the number of people likely to be exposed means that more studies into the effects of particulate matter in the underground railway environment are needed, as well as examining how the levels of dust and duration of exposure might translate to effects on health.”

These are the findings of a University of Southampton study, ‘Physicochemical Characterisation of Airborne Particulate Matter at a Mainline Underground Railway Station’, published in the Environmental Science and Technology journal on April 16 and funded through the Integrative Toxicology Training Partnership studentship provided by the Medical Research Council UK.

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Signs and Symptoms of High-Grade Prostate Cancer

Normally, a blood test for prostate-specific antigen (PSA) is performed in order to diagnose prostate cancer. This method of testing often allows prostate cancer to be noticed before it can begin causing problems. Although numerous other conditions can mimic the symptoms of prostate cancer, it is important to see a doctor if you notice that:

• It takes a while to begin urinating
• You leak urine even after you’re finished going
• You urinate slowly
• There is blood in your urine or ejaculate
• You suffer from unusual pain in the pelvis or lower back

If you or someone you love has been diagnosed with high-grade prostate cancer while taking Avodart or another 5-ARI drug, an Avodart lawyer may be able to help you receive compensation for lost wages, medical expenses and pain and suffering.

Avodart and Prostate Cancer Risk

The warnings that the FDA mandated for Avodart (dutasteride) and similar drugs were founded upon a pair of studies that found that men who took these drugs had a considerably higher chance of developing prostate cancer than men who took a placebo. One such study, which was named Reduction by Dutasteride of Prostate Cancer Events (REDUCE), intended to see how Avodart stacked up against placebos. In the study, more than 8,000 men between the ages of 50 and 79 were followed for a period of four years. Those taking Avodart had a 23 percent smaller risk of developing biopsy-detectable prostate cancer than those who took placebos because of a reduced chance of low-risk tumors.

Unfortunately, Avodart was associated with a significantly higher occurrence of high-grade prostate cancer compared to placebos. GlaxoSmithKline (GSK), the maker of the drug, tried to use the REDUCE study to get the FDA to allow the drug’s uses to cover prostate cancer prevention, but the plea was rejected. GSK stopped trying when the FDA began requiring warning labels on all 5-ARIs.

Getting Help

If Avodart caused high-grade prostate cancer for you or a family member, you may have the right to legal recourse. It is strongly recommended that you contact an Avodart lawyer near you for help.

The post Avodart Linked to High-Grade Prostate Cancer appeared first on Drug Injury Lawyers.

A new study shows that although many believe health care costs are largely affected by medical malpractice claims, there are other factors causing this increase.

According to Science Daily, “Efforts to lower health care costs in the United States have focused on demands to reform the medical malpractice system, with some researchers asserting that large, headline-grabbing and “frivolous” payouts are among the heaviest drains on health care resources.”

However, a new review of malpractice claims by Johns Hopkins researchers suggests such assertions are wrong.  In all actuality, in their review of malpractice payouts more than $1 million, the researchers say those payments added up to roughly $1.4 billion a year, making up far less than the 1 percent of the medical expenditures each year in the United States.

“The notion that frivolous claims are routinely resulting in $100 million payouts is not true,” says study leader Marty Makary, M.D., M.P.H., an associate professor of surgery and health policy at the Johns Hopkins University School of Medicine.

Called catastrophic claims, payouts more than $1 million are more likely to occur when a patient is killed or injured, is under the age of 1, develops quadriplegia, brain damage, needs life long care as a result of the malpractice, or when the claim results from a problem related to anesthesia the researchers found.

Makary and his colleagues reviewed nationwide medical malpractice claims using the National Practitioner Data Bank, an electronic repository of all malpractice settlements or judgments since 1986. They looked at data from 2004 to 2010, choosing a 2004 start date because that is when data regarding the age and gender of patients and severity of injury became available for the first time. The information includes only payments made on behalf of individual providers, not hospitals or other corporations, meaning the number of payouts may be underestimated by 20 percent, Makary says.

Over that period, 77,621 claims were paid, and catastrophic claims made up 7.9 percent (6,130 payouts). The seven-year nationwide total of catastrophic payouts was $9.8 billion, representing 36.2 percent of the $27 billion worth of total claims paid over that time period.

Makary says the data suggests that the focus of legal reform efforts should be on doctor protections aimed at reducing defensive medicine rather than the creation of malpractice caps.

The Real Issue Behind Rising Health Care Costs

“The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don’t order them. That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system — it’s the fear of them.”

He says his findings argue for more research to determine what interventions might prevent the type of errors that result in catastrophic payouts, with the overall goal of improving patient safety and reducing costs at the same time.

But real cost reductions, he says, will come from reducing the overuse of diagnostic tests and procedures.

This study was published online in the Journal for Healthcare Quality.

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They have issued a drug safety communication concerning Tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia.

The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death.”

The liver injury risk was discovered in clinical trials testing tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). The drug label has been updated and now states that use of the drug should be limited to 30 days and that it is no longer indicated in patients with cirrhosis. The FDA recommended that Tolvaptan should be discontinued in patients with liver disease who are currently taking the drug.

This announcement follows a previous FDA alert released in January, warning of an increased risk for liver injury.

Tolvaptan received a boxed warning when it was approved that requires drug initiation and re-initiation to entail close monitoring of serum sodium in a hospital setting.

The agency based its warning on a double-blind, 3-year, placebo-controlled trial involving some 1400 patients with autosomal dominant polycystic kidney disease along with an open-label extension trial.

Three patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.

Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. Following discontinuation of treatment, all 3 patients improved. An external panel of liver experts assessed these 3 cases as being either probably or highly likely to be caused by Tolvaptan. These findings indicate that Samsca (Tolvaptan) has the potential to cause irreversible and potentially fatal liver injury. These data is not adequate to exclude the possibility that patients receiving Samsca for its indicated use of clinically significant hypervolemic

In addition, the FDA reminds healthcare professionals that patients suspected of having liver injury should stop receiving Tolvaptan immediately. Clinicians should perform liver tests as soon as possible in patients who report fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice, or any other symptom that may suggest liver injury, the FDA said in its previous alert.

From the drug’s approval in May 2009 through February 2013, approximately 16,000 prescriptions were dispensed to 4500 patients from US outpatient retail pharmacies.

“Sales to outpatient retail pharmacies accounted for approximately 40% of Tolvaptan sales; 41% was distributed to non-retail pharmacies, and 18% to mail-order/specialty pharmacies during this time,” the FDA said.

To report problems with Tolvaptan, contact MedWatch, the FDA’s safety information and adverse event reporting program.

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The widow of Mark Alan Whitely sued Pfizer after his death in November 2007, alleging the company failed to sufficiently warn that Chantix, a smoking cessation drug, could increase the risk of suicide. The Whitely lawsuit was the first of more than 2,500 Chantix cases pending in federal court in Alabama set for trial, according to court records.

“We can confirm that we have settled this case,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement. “Terms are confidential.”

The settlement comes after Pfizer appealed U.S. District Judge Inge Johnson’s order that its Chief Executive Officer Ian Read and two other executives testify in person at the Whitely trial. Read and the other executives dropped the appeal yesterday because a settlement had been reached, according to court records.

“Mr. Whitely’s family is happy with the settlement,” Ernest Cory, a Birmingham, Alabama-based lawyer representing the plaintiffs, said in a telephone interview.

The Whitely case and other lawsuits have been combined in a multidistrict litigation before Johnson in Alabama for pretrial evidence-gathering and the first trials.

Safety concerns have plagued Chantix almost since the pill was approved in 2006 and, consequently, have frustrated Pfizer, which had high hopes the drug would generate impressive – and much-needed – sales.

The lawsuits claim that Chantix causes depression and other psychiatric disorders, some so severe that patients attempt or commit suicide. The plaintiffs allege that Pfizer knew of a link between Chantix and suicide and failed to sufficiently warn patients.

Pfizer has denied that Chantix was the cause of Whitely’s suicide or that the company withheld information about the drug.

Pfizer has provided warnings on the package insert of reports of suicidal thoughts since 2006, Johnson said in court papers in July. The notice was updated in 2007 and 2008, culminating in a ‘black box warning’ being placed on the package insert in July 2009.

The plaintiffs’ lawyers contend that Pfizer should have provided such warnings earlier.

Cory said he didn’t believe the Whitely settlement was a signal that Pfizer was pushing to settle the cases that have been consolidated before Johnson in federal court in Florence, Alabama.

The next trial is not scheduled until January 22 and involves a man who claims Chantix caused him to have suicidal thoughts. Whether CEO Read will be asked again to testify remains to be seen, but it is likely the same arguments over an appearance will occur, even though his deposition was videotaped.

Last year, the FDA declared that Chantix benefits outweigh their risks after reviewing the results of two epidemiological studies that compared the controversial Chantix smoking-cessation pill with NicoDerm patches. The decision came three years after the drugmaker added warnings its anti-smoking drug is connected to suicidal thoughts and behavior.

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Use of the antiepileptic drug may cause blue skin discoloration on or around the lips, in nail beds on fingers and toes, and potentially on the face and legs. Discoloration on the white of the eye and inside the eyelids has also been reported, the agency has announced.

The seizure treatment may also induce pigment changes in the retina, which may result in serious eye disease with loss of vision, the communication cautioned.

Ezogabine, formerly known as retigabine, received FDA approval as Potiga for adjunctive treatment of partial-onset seizures in adults on June 10, 2011.

To date, approximately 2900 patients have received a prescription for ezogabine in the United States and 6000 globally. Blue-gray pigmentation, observed on the sclera and conjunctiva, lips, nail beds of fingers and toes, and more widespread on the body, has occurred in 38 (6.3%) of 605 patients followed in clinical trials. Nearly all of the patients who had skin discoloration, 36 of 38 (95%), had taken the drug for at least 2 years.

Does Antiepileptic Drug Cause Permanent Damage?

It is not known if these changes are permanent or if the retinal pigment changes caused by use of the drug can lead to vision problems. The skin discoloration generally occurred after 4 years of treatment with the drug, according to the FDA, but has appeared earlier in some patients. In some instances, retinal abnormalities have been noted without accompanying skin discoloration.

Of 36 patients still in ongoing studies who had eye examinations, 11 (31%) had retinal pigment abnormalities. Four of the 11 (36%) did not have skin discoloration. Although 5 patients had worse than 20/20 visual acuity, baseline values for visual acuity were not available for comparison. Consequently, it is not known whether the retinal pigment changes resulted in visual loss. One patient, who received a full panel of retinal tests, had findings consistent with “retinal dystrophy.” All cases of retinal abnormalities were exposed to ezogabine for at least 3 years.

Antiepileptic Drug Precautions

The FDA recommended that patients taking ezogabine, or who are about to start treatment with the drug, receive an eye examination and periodic examinations afterward. Patients who experience decreased visual acuity or skin discoloration should cease using the drug unless there are no alternative medications.

However, patients should not cease use of the drug without consulting a healthcare professional, as halting use of anti-seizure drugs can precipitate withdrawal seizures, which can be fatal, the FDA warned.

According to the announcement the FDA does not currently know if these changes are reversible. FDA is working with the drug manufacturer Valeant Pharmaceuticals of Quebec to gather and evaluate all available information to better understand these events.  And they will update the public when more information is available.

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According to the FDA, we should probably be concerned, as damaged or worn covers on medical bed mattresses pose a risk for contamination and infection.

According to their Safety Communication, from January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and other body fluids from leaking into the mattress.

“Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures,” the FDA warns.

Some reports indicate that if blood and other body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed, placing patients at risk for infection if they come into contact with blood and other body fluids from other patients, the FDA says.

According to the medical literature, damaged and soiled medical mattresses can be a source of contamination during infection outbreaks, the agency notes.

The agency is concerned that fluid ingress from worn or damaged medical bed mattress covers may be “widespread and largely under-recognized” by healthcare providers, healthcare facility staff, and caregivers.

According to the report, the types of mattresses may include alternating pressure (ac-powered) air flotation mattresses, non-powered flotation mattresses, and other mattresses that are part of hospital beds.  Medical bed mattress covers may be coated with or contain a substance that kills germs (viruses or bacteria) or prevents bacterial growth. There are multiple terms used to describe medical bed mattress covers: water-resistant (keeps liquid away from the material), water-proof (prevents liquid from entering inside the material), or water-repellent (keeps liquid away from the material and prevents liquid from entering inside the material).

Medical bed mattress covers, whether water-resistant, water-proof, or water-repellent, may lose their effectiveness over time, the FDA says. The duration of time that a medical bed mattress cover is expected to last (expected life) varies from manufacturer to manufacturer. In addition, the expected life of a medical bed cover may differ from that of the mattress itself. For example, a medical bed mattress may have a longer expected life than the mattress cover.

The FDA is recommending specific recommendations for inspection and maintenance of medical bed mattresses and mattress covers, which includes, regularly checking each medical bed mattress cover for any visible signs of damage or wear, such as cuts, tears, cracks, pinholes, snags, or stains, routinely removing the medical bed mattress cover and check its inside surface, etc.  They also recommend removing and replacing any damaged, worn, or visibly stained medical bed mattress according to the healthcare facility’s procedures and manufacturer’s instructions.

The FDA says it will continue to monitor this issue and keep concerned parties informed if new information becomes available.

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