Unapproved Knee Replacement Device: OtisKnee Used Before FDA Approval

Currently, the most common elective surgery in the country is for knee replacements, approximately 700,000 per year. With an aging population driving demand, more companies are creating opportunities to get into the market. OtisMed Corporation marketed OtisKnee before FDA clearance, resulting in numerous knee surgeries that ultimately failed.

According to a recent NY Times article, the OtisMed Corporation did not obtain FDA approval for their device before selling and shipping them. When OtisMed did apply, the FDA rejected it, indicating that the company did not show that their product was safe and effective. According to the Justice Department, before the rejection, between 2006 and 2009, OtisMed sold and distributed 18,000 OtisKnee devices. As a result, in December, 2014, the former CEO of OtisMed pleaded guilty to criminal charges as part of an $80 million settlement. Sentencing is scheduled for March 18, 2015. “Americans must be able to trust that they are treated with medical devices that have been shown to be safe and effective,” said Deputy Assistant Attorney General Jonathan Olin for the Justice Department’s Civil Division. “The Department of Justice will not tolerate companies and individuals that cut corners when it comes to the public’s health.”

A principal reason why the OtisKnee was an appealing option for the surgeons who installed it was how fast the device could be installed, allowing them to perform as many as twelve knee replacements in one day. OtisMed marketed the OtisKnee directly to providers as an option to simplify surgery and bring in extra income. However, problems with the alignment of the device in turn caused the procedures to frequently not go as planned. Eventually, it was determined that the cutting guide materials had been changed and may have warped during the sterilizing procedure.

It is not known how many patients were harmed by the unapproved OtisKnee. Are knee replacement patients being used as guinea pigs for unapproved devices? Are medical device companies pre-marketing or mis-classifying devices so that they can bypass F.D.A. regulations? Until more mistakes are discovered, the answers to these questions remain unknown. But what is known is that consumer safety should always be placed ahead of corporate profit.

Disturbing Study Shows Psychiatric Illness More Likely After Brain Injury

A 1999 study, Rate of psychiatric illness 1 year after traumatic brain injury, published in the American Journal of Psychiatry, sought to determine whether patients who experience traumatic brain injury might be at increased risk of developing psychiatric illness. No prior study that had considered this possibility used accepted research standards or chose a sufficiently large sample size.

The researchers who designed this study relied on a traditional two-state diagnostic method. Over the period of a year, Wales’ Cardiff Royal Infirmary admitted 3,667 adults (over age 17) with a head injury. Each patient, admitted between July 1994 and June 1995, suffered from traumatic brain injuries. All participation was voluntary, and the study included 196 patients, 65% of whom were male. Patient ages ranged from 18-94 years. Each participant completed a questionnaire, and doctors conducted a standardized interview on 164 patients who exhibited high indicator levels for psychiatric illness.

One year following their TBI trauma, of 62 patients identified by the questionnaire, 30 had been diagnosed with a psychiatric problem, per the ICD-10’s criteria, and 20 patients had been diagnosed with multiple psychiatric issues.

The most common illnesses in the test group included depression and panic disorder. The study noted a higher rate of psychiatric illness in those who had suffered a prior traumatic brain injury. No statistically significant relationship existed between those who tested positive for mental illness and those who sought compensation in a legal claim.

As we’ve discussed in previous posts about scientific studies of TBI, correlation does not imply causation. In other words, just because researchers can find associations between two variables does not mean one has caused the other. In this study, for instance, many factors could have contributed to higher rates of psychological illness, including:

History of mental illness;

  • Age;
  • Diet;
  • Level of formal education;
  • Degree of brain trauma;
  • Nature of the TBI-induced disability;
  • Etc.

To strategize effectively to obtain fair compensation and excellent medical care after a brain injury, you need qualified, smart and skilled people on your side. Consider connecting with the Washington D.C. brain injury lawyers at Regan, Zambri & Long today for a consultation. Our D.C. medical malpractice attorneys can help you and your family understand your potential options to seek compensation.

Broken Heart Syndrome Leads to Increased Risk of Cardiovascular/Other Illnesses

The physical pain you feel after the loss of a loved one is real. Studies conducted in the UK indicate the first 30 days of grief bring immediate increased risk for heart attack and stroke. The body’s response to loss starts psychologically and impacts physical responses. Over a period of time, this can lead to adverse health outcomes.

Evidence of “broken heart syndrome” provides insight into how to cope after loss. Research shows that maintaining health during that first critical month after a loss significantly decreases the risk of death. Consider these shocking statistics from a UK study of 30,000 broken hearted individuals ranging in age from 60-89, when compared to those who had not experienced the recent loss of a partner:

  • The risk of heart attack or stroke doubles in the first month after a partner’s death.
  • The risk of blood clots found in the lungs is 2.5% greater.
  • Older adults face a 25% increase in the risk of death stemming from grief within the first year of loss.
  • After a year, the evidence suggests that increased risk of death starts to decline.

Protect yourself and your loved ones with these tips:

Encourage Stress Relief

Take advantage of loss support groups, yoga, meditation, and other stress relief exercises. These focused activities directly decrease the effect of stress on the body, thereby reducing the chance of cardiovascular events.

Take Cardiovascular Support Medicines and Improve Your Diet

Aspirin or cholesterol reducing prescriptions may be able to support the body’s blood flow. Reducing consumption of sugar, refined carbohydrates and rancid vegetable oils may also provide some modicum of protection against inflammation and CVD risk. Ask friends and family to help you remember to take your medicines regularly.

Seek Advice From a Health Care Provider

Everyone handles grief differently. Don’t be afraid to ask your physician about additional support methods. You or a loved one may need further medical care or emotional support to cope.

9 Winter Safety Tips From the Red Cross

This winter is set to be one of the coldest on record, with massive cold air fronts predicted for most of the United States. Fortunately, the American Red Cross offers steps anyone can take to ensure their safety during this inclement season.

While we settle into the winter season, get acquainted with appropriate seasonal safety habits. A little bit of preparation can go a long way toward ensuring everyone has a great time in the snow. Follow these 9 safety tips from the Red Cross to avoid possible dangerous situations this winter:

  • Know the symptoms of frostbite, which can include: numbness, flushed gray, white, or blue skin, or numb or waxy skin.
  • Always shut down space heaters and ensure fireplace embers are fully extinguished prior to leaving a room or going to bed.
  • The signs of hypothermia include shivering, dizziness, confusion, and exhaustion. If you notice these symptoms, seek immediate medical attention.
  • Layers of lightweight clothing trap heat and regulate body temperature. Also, don’t overlook necessities like gloves and a hat.
  • Continuously run water, even at a trickle, to prevent frozen pipes. Maintain a consistent thermostat night and day.
  • Set space heaters on a firm, level surface, and keep flammable objects a minimum of three feet away.
  • Stoves and ovens are not designed to heat homes; they are a fire hazard if left on.
  • When using a fireplace, make sure you have a metal or glass fire screen large enough to prevent rolling logs or sparks from escaping.
  • Protect your pets. If they must reside outdoors, ensure they have adequate shelter for warmth and a secure source of drinkable water.

The coldest, darkest poses quite a few safety challenges. Adhere to the tips above and stay safe, no matter what Old Man Winter throws your way.

Copyright 2020 Lawyers Blog | All Rights Reserved.