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FDA Meeting Held to Address Complaints About the Medical Device Approval Process

Carrie Strasser — Mon, 27 Apr 2009 14:44:55 GMT

The New York Times reported last week that a rare internal meeting was held by the FDA on Wednesday to address the complaints surrounding the medical device approval process.

Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, sent an e-mail message on April 10 announcing an “all-hands meeting” to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

This meeting was spurred by letters to President Obama signed by nine scientists alleging that agency officials had acted improperly and put patients at risk by approving medical devices for use in spite of numerous objections from scientists reviewing the devices.

These letters have led to the opening of a Congressional investigation and a critical report of the device center released by the Government Accountability Office in January. Additionally, Congress is to propose legislation this week asking the Institute of Medicine to investigate the device division.

Specific devices that the scientists complained about were imaging equipment used to detect breast cancer and an orthopedic knee device. The scientists also charged that the agency has allowed hospitals to clean and reuse certain devices intended for only one use.

This meeting will hopefully be the first step toward greater concern for patient safety when it comes to medical devices. As of now, many patients harmed by certain medical devices have no recourse through the judicial system. However, if the approval process becomes more rigid, this could prevent avoidable injuries due to faulty medical devices. For more information on medical devices, click here.

Originally posted at InjuryBoard by Carrie Strasser

Lasik and the Patients Right to Know

Bruce Bierhans — Sat, 26 Apr 2008 11:30:11 GMT

In the summer of 2001, I tried a landmark case in Worcester, Massachusetts. I represented the family of a young man with hemophilia that died from receiving clotting concentrate infected with the HIV in the early 1980s. The tragedy of the 10,000 hemophiliacs that died unnecessarily has , to this day, still not been adequately reported.

In any event, we tried the case on a theory that sounds simple, but was aggressively opposed by the defendants and the medical community. We argued that, even though research regarding AIDS was not completed, that the medical community still had a responsibility to inform the families of children receiving clotting concentrate of the potential risk of AIDS. Although we could not prove what lot of concentrate killed our client, the jury found one defendant physician negligent for failing to adequately disclose known risks. I would certainly feel honored if this case, on which I worked for 6 years, turned out to be my legacy.

However, today we now read that the FDA is beginning to look into the "risks" associated with Lasik surgery. This, after a decade of patients/victims suffering from life altering side effects, including worse vision, dry eye, pain, glare and others. One law school student, Colin Dorrian, committed suicide last year after suffering from a deep depression associated with his eye pain.

Does anyone think, or believe, that these conditions and risks were not known ten years ago. Of course they were. Interestingly, a well known oncologist that I recently worked with on a cancer diagnosis case told me he wouldn't have Lasik surgery if they did it for free. He also would not allow anyone in his family to have the surgery. Unfortunately, the FDA investigation comes years too late for many patients that have suffered permanent damage.

Someday, the medical community and the FDA will learn that patients have the right to know. It is the patients right to have the information required to make an "informed decision" about whether or not to take a medication or have a procedure. In the 1980s it was AIDS. Today you can pick a medication. Did the patient know about all the risks before a medication was prescribed or a procedure was recommended? Did the FDA have all the information that should have been provided by the manufacturer? Simple but essential questions.

In 2001, my jury in Worcester said the patient had a right to know. Hopefully, juries will continue to make this important statement.

Originally posted at InjuryBoard by Bruce Bierhans

Lawyers Can Say "No"

Bruce Bierhans — Sat, 19 Jul 2008 11:07:31 GMT

In my home town of Wellfleet, there is an ongoing controversy regarding the construction of what is now knows as the "Blasch" house. The home, referred to as a "McMansion", will be situated in one of the most visible areas of the National Seashore in our town. Suffice it to say, that the issues surrounding this home have engendered more emotional discussion than any in the 8 years I've lived in town. Long time residents have told me that it is the most divisive and controversial issue that they recall in our community. In fact, I can't go to the general store or a local function without someone coming up to me and asking for my opinion on the issue.

The Blasch applicants are represented by a local attorney. The attorney is a gentleman, and, by all accounts, a very fine lawyer. He's a local whose family has been in town for generations. Many have asked me why he would take a case that could, perhaps, have negative implications for his own community. Obviously, only he can answer that question.

My only comment. While every client is entitled to the best representation or defense available to them, there is one great thing about being an attorney in private practice. We have the ability to say "no" to a potential client. If we do not believe in the cause or the issue, we can simply decline the opportunity to represent the client. Throughout the years, I have, on occassion, represented clients in unpopular causes. I have also turned down many cases where I did not believe in the legal issue at hand, or felt that the interests of the whole were more important than the interests of the individual. The primary motivation in each decision is whether or not I believe in the legal principle or cause involved. I find that, if you don't believe in the case, it's hard to muster the motivation to zealously represent the client.

The bottom line. Lawyers can, should and do have the ability to say "no." It certainly makes it easier to sleep at night.

Originally posted at InjuryBoard by Bruce Bierhans

Some Helpful Hints to Avoid Long ER Waits

Carrie Strasser — Fri, 26 Jun 2009 11:03:21 GMT

CNN reported that, since 2002, the average waiting time for Emergency Room visits had increased 27 minutes. In 2008, the average waiting time in the ER was four hours and three minutes.

The increase in time spent waiting at the ER can be attributed to the increase in people who have lost their jobs and, in turn, lost their health insurance. These newly uninsured usually have delayed seeking medical care and are unwittingly putting strain on an already burdened system.

Here are some hints offered by four Emergency Room doctors to get attention in the ER if you feel that you or your loved ones will be harmed by delaying care:

1) Describe your loved one's worsening condition to the triage nurse:

This would work most of the time. If I got a hostile answer, I would ask to speak with the charge nurse or charge physician. If I felt like I was not getting anywhere, I would ask to speak with the administrator on call. The last resort is to call the hospital operator (dial 0 from the emergency department waiting room phone) and ask to page the patient advocate and hospital administrator. ... I would not use inappropriate or threatening language.

2) Don't be confrontational:

A basic principle of medical care is that 'the squeaky wheel gets the grease.' I would recommend advocating on behalf of your spouse. It's uncomfortable that it has to be this way, but it works the same in any service business. The more you complain, the faster the service. But it's a fine line. Complaining can piss off the staff, so it's important not to go over the top. Family members who are too vocal are sometimes escorted out by security.

3) Empathize with the fact that the ER staff is busy, but be persistent in advocating for your loved one:

I would ask to speak with the Emergency Department director. If they weren't there, I would ask to speak with the charge nurse or shift supervisor. ... I would advise them that you think the patient has an 'emergency medical condition that should be evaluated right away.' Most of us in emergency medicine define the urgency in those terms and should be responsive.

If you don't get a response, advise the individual in charge dispassionately and without confrontation, 'I understand you are busy, but I feel the patient will have a bad outcome if not seen right away.' If the person in charge was a nurse, ask to speak with the physician and repeat the same thing. If there's no response, further advise the individual in charge, 'I feel strongly about this and must call the administrator on call.' If no response, I would call the hospital administrator on call and advise him or her of those same concerns.

4) Name drop if necessary, but only with caution:

As far as invoking the threat of a letter to the CEO, that can trigger the 'VIP Care' response, which may save time, but also may expose the patient to increased risk by changing practice patterns. VIP treatment subverts the normal way we practice medicine and in my experience usually leads to medical errors. I have made my worst mistakes while treating friends, colleagues, and other VIPs. ... Belligerence, histrionics or requests for VIP treatment usually end up working against the doctor-patient relationship.

Basically, if you remain calm, but forceful in seeking medical attention for your loved ones, you may be able to decrease that wait time. The important thing to remember is to try to maintain a balance between respecting the ER staff while advocating for a patient.

Originally posted at InjuryBoard by Carrie Strasser

Managed Competition and Your Liability Coverage

Bruce Bierhans — Fri, 29 May 2009 11:08:00 GMT

With Managed Competition now here in Mass; and liability carrier commercials flooding the airwaves, I thought a little motor vehicle insurance primer was in order.

In this economy, I find that many injured clients have inadequate liability coverage to compensate them for their injuries. In Mass. your motor vehicle coverage is intended to protect your hard earned assets if you or a family member injures another person, and to compensate you if you are injured by a driver who has inadequate or minimal coverage.

Coverage designed to protect you and your family as a result of injuries caused to another is called "bodily injury (BI) to others", or "optional bodily injury to others". State law requires you to carry minimum coverage of $20,000/$40,000, but you should purchase additional coverage through the optional component of the policy of at least $100,000/$300,000 ($50,000/$100,000 and $250,000/$500,000 are also available). Also, you should obtain coverage for "bodily injury caused by an underinsured/uninsured auto (UM)" or optional coverage of the same name. A vehicle is underinsured if the value of your claim exceeds the amount of bodily injury coverage carried by the at-fault driver. For example, if there is $20,000 available per injured person, and your claim is worth $100,000, the at fault vehicle is underinsured by $80,000. This is where carrying adequate uninsured/underinsured coverage becomes crucial.

To be adequately protected in all events, everyone should carry BI coverage to others, as well as UM coverage for themselves of at least $100,000/$300,000. If you or a household member seriously injure another person and only possess minimum coverage, your personal assets could be attached to satisfy a judgment that exceeds policy limits. Conversely, if you are injured and possess minimum UM coverage, your recovery will be limited to the actual amount of coverage held, even if the value of the claim exceeds that coverage. In the above $100,ooo example, you would have been able to recover that $80,000 above the $20,000 from your own UM coverage. Without it, you would be limited to a recovery of $20,000 only.

The additional cost involved in purchasing this extra coverage is less than many people believe. Also, I routinely find that many people have never had a discussion with their insurance agents about these coverage issues. "My agent never told me" is a common refrain. Talk to your agent or attorney about these issues before you place your coverage. After the accident, it's too late!

Protect yourself and drive safely.

Bruce Bierhans

Originally posted at InjuryBoard by Bruce Bierhans

Documents Show that Psychiatrist Promised Favorable Results for Drug Company

Carrie Strasser — Mon, 23 Mar 2009 18:02:39 GMT

Dr. Joseph Biederman, a prominent child psychiatrist at Harvard University, promised the drug company Johnson & Johnson that certain studies of its medicines in children would yield positive results for the company, reported the New York Times on Friday. Documents outlining these interactions between Dr. Biederman and Johnson & Johnson came to light as a result of the multistate litigation regarding the improper marketing of antipsychotic drugs. The New Jersey Superior Court Judge overseeing the multistate litigation ordered that Dr. Biederman be deposed and as a part of that process, Biederman released certain documents to his lawyers about his interactions with Johnson & Johnson.

Dr. Biederman is a staunch advocate of diagnosing bipolar disorder in young children and using antipsychotic drugs to treat this disease. However, much of his work has been funded by drug companies for whom he does private consulting.

An inquiry by Senator Charles E. Grassley, Republican of Iowa, revealed last year that Dr. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but $200,000 of this income to university officials.

Dr. Biederman is currently being investigated by both Harvard and the National Institutes of Health to determine whether the psychiatrist violated federal and university research rules.

In a number of the documents provided by Dr. Biederman, he promised a positive outcome in his research studies for Johnson & Johnson drugs such as Risperdal and Concerta.

Originally posted at InjuryBoard by Carrie Strasser

Dear President Obama/Part II/ What Mortgage Program?

Bruce Bierhans — Sat, 14 Mar 2009 10:48:18 GMT

Dear President Obama: I know you didn't read my last letter. But...someone in your office must have. You seem to have covered all my salient points. Reasonable debt/equity ratios, market interest rates, practical principal amounts, etc. Look; you're the big cheese with all the power. So, I'm glad I was able to help but you should take all the credit.

But...isn't there always a but; you forgot one thing. Implementation of the program and efficiency of the process.

Since the program was announced, these are samples of actual inquiries we have received from clients or potential clients.

a) I was negotiating with the bank and then some foreclosure lawyer sent me a foreclosure notice;

b) I can't get a human being on the phone;

c) I got a human being on the phone; but since then, I've dealt with 8 other human beings and none of them know what the last human being told me;

d) We had a deal, and then someone else at the bank changed their minds. Not a nice human being;

e) The bank won't lower the interest rate (which is presentl 9.5%) but will only stretch my loan to 40 years.

Mr. President. This is only a sampling of calls, but I think you get the point. How about a requirement that all banks that have received federal funds are required to negotiate in "good faith" with consumers. If they do not, penalties can be imposed, in addition to preserving on behalf of the borrower all remedies available under state consumer laws. How about talking tough and hitting the banks with a big stick. They helped create this mess. A little tough love would go a long way.

I'm around if you have any questions or need any more suggestions. Thanks,

Bruce Bierhans

Originally posted at InjuryBoard by Bruce Bierhans

Nursing Home Ratings

Bruce Bierhans — Sun, 04 Jan 2009 12:40:59 GMT

Believe me...when I wrote my last post on Nursing Homes in my Cape Cod Barrister blog on CapeCod Today, I had no idea that nursing home grading would be the headline story in the Cape Cod Times just a few days later. Perhaps my timing is so good, I ought to buy a lottery ticket!

In any event, what do we learn from the study conducted by the HHS Centers for Medicare and Medicaid Services?? As for Barnstable County, we learn that 45% of homes were ranked "above average" and 33% were rated "below average". On Cape Cod, 17% of the homes received the lowest coveted (tongue planted firmly in cheek) one star rating, compared with 14% statewide. Although Norfolk County received the lowest percentage of one star ratings, that happens to be the county where many of my cases to date have originated. In this county, how do you feel if your Mom or Dad is in one of the one star facilities or one of the 33% that were rated below average. Probably not warm and fuzzy.

What do these statistics tell us. Not much really, other than the fact that, as I have stated previously, due diligence and monitoring your family members care is paramount. Tragedies can occur in the best and worst of homes. For example, let me give you a brief rundown of the types of cases we have handled on behalf of client families. These will give you a beginning primer on what to look out for. Some of these cases have occurred in homes that were high end and sparkling.

a) Development of bed sores and other ulcerative conditions and the failure to treat the conditions when they occur;

b) Falls, frequently multiple falls, resulting in serious injury or death. This is the most common type of case we have handled. Patients "at risk for falls" are supposed to be assessed upon admission and closely monitored thereafter, with assistive devices, i.e lap buddies with wheelchairs, to prevent falls.

c) Failure to administer medication or actual overdosing of the patient. Again, a situation that results in serious injury or death;

d) Assault and Battery and theft. Yes, patients can be physically and emotionally abused behind closed doors. In addition, we have seen multiple cases where there is a theft of personal property.

Nursing homes are subject to a myriad of state and federal regulation because of their receipt of federal and state funds. The maze of regulations and payment options can be confusing to the best and the brightest. However, your first course of action is to be informed and to be an aggressive advocate for your family member. I will talk in later posts about some of these issues with more specificity.

Originally posted at InjuryBoard by Bruce Bierhans

AntiDepressants and Suicide

Bruce Bierhans — Sun, 27 Jul 2008 11:08:54 GMT

In todays Cape Cod Times, we learn more about the tragic death of David Hill. On October 17, 2006, David was killed after being shot multiple times by a local police officer. That evening, David was carrying and discharging a firearm and wearing a bullet proof vest. The tragedy is being referred to as a "suicide by cop" incident.

All but lost in the story is the fact that David had been prescribed "Ritalin, Zoloft and antidepressants, each with the broken promise of some return to normalcy."

I have represented and continue to represent families that have been broken as the result of suicides occuring while family memebers were being treated with antidepressants. Each has a common theme. The acts of suicide were violent events beyond the comprehension of family members. Hangings, selfinflicted gunshot wounds, or as in the Hill case, intentional self destructive behavior. Many will argue that depression related suicide is unavoidable. However, one must also wonder whether or not the use of antidepressants that are not appropriately monitored by a well trained physician create an "enabling" type of behavior that allows individuals not only to commit suicide, but do with an almost inexplicable act of violence.

A Harvard trained expert that I have worked with on my cases takes the position that antidepressants, WHEN USED PROPERLY, can be helpful in certain cases. However, what of the patients that are now prescribed them like candy, in an unsupervised or poorly monitored treatment plan? Much has been written about the "drugging" of America. The Hill case leaves many questions unanswered that may help us better understand this tragedy. What medications was he on at the time of death; what was the dosage; had the dosage recently been increased; was he in withdrawal from a recent change in medication; was he receiving talk therapy in addition to antidepressants; what was the experience of the physician that prescribed the medications in the admistration of these drugs?

If we carefully examine the Hill case, as well as others that have, or may have connections to the use of antidepressants, i.e the Virginia Tech massacre, we may learn more about the context in which the medications ought to be prescribed and how their use should be monitored. It's not just about money; it's about lives!

Originally posted at InjuryBoard by Bruce Bierhans

Predatory Lending/The Worst "Personal" Injury

Bruce Bierhans — Sun, 06 Apr 2008 15:19:56 GMT

What's worse than losing your home? Not much. Unfortunately, we are seeing many people in our office confronting this nightmare scenario.

You've all seen the statistics. Foreclosures at record levels; mortgage companies going under; trillions sucked out of the international economy. Doesn't make the homeowner confronting foreclosure feel any better, does it?

Our office has been involved in litigation which has successfully kept people in their homes where they were the victims ot unscrupulous brokers or lenders. It's not always easy and we must be able to show that there has been fraud in the transaction or a violation of state or federal law. So far, we have been able to obtain injunctive relief where fraud has been found, and have also counseled many people in working with their lenders to do "short sales" or "short refinances". In these scenarios, lenders will accept less that the full amount of principal to allow a sale or refinance to occur.

What has occured in the subprime catastrophe as the result of greed and deceptive behavior should not be altogether surprising. There is always someone waiting around the next corner trying to scam the public. This scam was on a massive scale with international consequences. However, we stand prepared to help people that are having their American Dream taken away from them.

Originally posted at InjuryBoard by Bruce Bierhans