Medical Malpractice · 2019. 8. 20. · By Kim M. Ruder B y definition, spoliation refers to the “destruction or failure to preserve evidence that is necessary to contemplated or

By Kim M. Ruder

By definition, spoliation refers to the “destruction or failure to preserve evidence that is necessary to contemplated or pending litigation.” Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005). Spoliation in the con-

text of a medical malpractice case can raise many issues for lawyers representing doctors and hospitals. These issues can often be overlooked until it is too late to repair the damage done.

While most attorneys have heard of the concept of spoliation and have a gen-eral or basic understanding of what it means, few appear to have had the op-portunity or necessity of litigating the issue before a trial court or on appeal. Due to its less-than-pervasive appearance in litigation — and more particularly in medical malpractice actions — the subject needs some light thrown upon it. This article shows how medical malpractice attorneys need to “think outside the box” in their defense of their medical practitioner clients.

A CAse to PonderConsider the following hypothetical: Dr. Smith is a pathologist in a community-

based hospital. As has become routine in hospital settings, Dr. Smith’s professional group maintains a contract with the hospital. The physicians are considered to be independent contractors at the hospital as opposed to being hospital employees.

Dr. Smith interprets a pathology sample on a patient as completely benign and signs out his report. A few years later, Dr. Smith is sued for wrongful death/medi-cal malpractice and the plaintiff contends that Dr. Smith misread the pathology on his deceased spouse. As a result, he says, the spouse’s cancer went undiag-nosed and untreated.

Just months before Dr. Smith was served with the lawsuit, the paraffin wax “block” containing the remaining portions of un-reviewed tissue was discarded by

In This IssueSpoliation in a Med Mal Case . . . . . . 1The Compassionate Use Doctrine . . . . . . . 1Psychiatrist Liability Cases . . . . . . . . . . . . 3Med Mal News . . . . . 7Drug & Device News . 9Verdicts . . . . . . . . . 11Movers & Shakers . . 12

Volume 26, Number 5 • February 2009

By Janice G. Inman

People with chronic illnesses and incurable diseases are often willing to do almost anything to improve their health. That in-cludes seeking alternative treat-ments and trying unapproved drugs. While gaining access to drugs not yet approved by the Food and Drug Administration (FDA) can be a difficult task, many people will go to nearly any lengths to get them, to in-clude suing a drug manufac-turer to force it to provide them the drug. That’s what happened in the case of Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 4003377 (D.N.J.,2008), a case recently overturned on appeal. In this month’s issue, we look at the reasoning of the district court. In next month’s issue, we’ll see why the appel-late court disagreed, and discuss the implications of the compas-sionate use doctrine for drug re-search and for individual patient outcomes.

A Boy And His FAmily FigHt For mediCAtion

Jacob Gunvalson is a boy in his teens with the terminal disease Duchenne Muscular Dystrophy (DMD). DMD is a genetic disease that causes muscles, including the heart, to

Medical MalpracticeLaw & Strategy ®

Spoliation in a Medical Malpractice Case Thoughts to Ponder and Some Words to the Wise

continued on page 2

Experimental Drugs and the Compassionate Use DoctrinePart One of a Two-Part Article

continued on page 6

2 Medical Malpractice Law & Strategy ❖ www.ljnonline.com/alm?medmal February 2009

employees of the hospital in accor-dance with a written retention poli-cy. When suit was filed, the plaintiff requested the block from both the pathologist and the hospital (also a named defendant). Clearly neither could produce it.

is tHere sPoliAtion And WHo is resPonsiBle?

How does a court analyze wheth-er spoliation occurred in the first place? As stated above, spoliation oc-curs when there is a destruction or failure to preserve evidence that is necessary to contemplated or pend-ing litigation. Clearly, the concept of “pending” litigation is self-explanato-ry. However, the concept of contem-plated litigation necessarily involves a case-by-case analysis of facts. For example, in the case of Wal-Mart Stores, Inc. v. Lee, 290 Ga. App. 541 (2008), Wal-Mart was alleged to have spoliated videotape evidence that depicted surveillance of a Wal-Mart parking lot at the time when the plaintiff was shot. Once a suit was filed, the plaintiff learned that the footage had been destroyed. The plaintiff therefore moved for spolia-tion sanctions. Wal-Mart argued that it merely re-used the tape in its or-dinary course of business and that it did not destroy the tape during liti-gation. In determining whether the tape had been destroyed in antici-pation of litigation, the court seized upon the notion that the plaintiff’s former attorney had sent Wal-Mart’s CEO a pre-suit demand letter and found this fact sufficient to place Wal-Mart on notice of contemplated litigation. See also Gilmore v. SCI Tex-as Funeral Services, Inc., 234 S.W.3d 251 (Tex. App. 2007) (duty to avoid spoliation “arises only when a party knows or reasonably should know that there is a substantial chance

that a claim will be filed and that evidence in its possession or control will be material and relevant to that claim.”); Fuller Family Holdings, LLC v. Northern Trust Co., 371 Ill.App.3d 605 (Ill. App. 2007) (“a defendant owes a duty of due care to preserve evidence if a reasonable person in the defendant’s position should have foreseen that the evidence was ma-terial to a potential civil action.”); Robertson v. Dept. of Public Safety, 2005 WL 2364817(Ohio Ct. Cl. 2005) (“pending or probable litigation”). Simply stated, it is incumbent upon a plaintiff to place a defendant on notice that litigation is being con-templated.

Returning to our hypothetical, is there spoliation of the tissue block that was discarded in accordance with the hospital’s policies? Absent addi-tional information that would place the doctor and hospital on notice of a potential claim, the answer would seem to be a resounding “no.”

Let’s change the hypothetical around to assume that the tissue block was spoliated. Who is respon-sible for the spoliation? Is it the doc-tor, the hospital, or both? This much more complicated question poses what could be the single largest puzzle for medical malpractice at-torneys in the context of represent-ing a hospital, a physician or a prac-tice operating in a hospital setting. Without truly understanding the in-tricate division of labor between the hospital and the physician’s group, what may seem to be an easy an-swer does not turn out the way ex-pected. It is virtually impossible to determine where the responsibility lies for the spoliation without delv-ing into the mundane terms and conditions in the agreement gov-erning the relationship between the physician’s group and the hospital. Unlike in other med-mal cases, in-tense scrutiny of the agreement is required in these situations, not just a focus on the medicine.

tHe Question oF resPonsiBility

In answering the question of re-sponsibility for the spoliated tissue

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Spoliationcontinued from page 1

Kim M. Ruder is Of Counsel with the Atlanta office of Carlock, Cope-land & Stair, LLP. Her practice focus-es on the defense of physicians in medical malpractice actions as well as other matters of general liability. continued on page 8

February 2009 Medical Malpractice Law & Strategy ❖ www.ljnonline.com/alm?medmal 3

By Joshua D. Koskoff

When handling a case against mental-health professionals such as psychiatrists, psychologists or social workers, there are special consider-ations that should be kept in mind. The average juror may not be aware of the extent of mental-health pro-fessionals’ duty to protect innocent third parties from their dangerous patients, and they may be reluctant to hold these professionals responsible. Following are some strategies that will help to get the plaintiff’s point of view across to the fact finder.

Voir DireYou need to make sure that the

jury accepts the concept that a pro-fessional can be liable where the harm occurs as a result of a delib-erate, intentional act of a patient. The jury needs to know during voir dire that the case is only about the civil liability of the professional — the question is whether he or she did his or her job, and not whether the psychiatric patient is criminally liable. Make it clear that the crimi-nal part of the case is over. Ask the jurors to state affirmatively that they could hold a therapist liable for not doing his job even where a murder is carried out by one of his patients. If they cannot, they obviously are not good jurors for the plaintiff.

If the perpetrator is in jail, it will make some sense to the jury that he won’t be testifying. Make sure to point out this circumstance to the jury in advance so they don’t see the per-petrator’s absence from the witness chair as a weakness in your case.

The type of juror you are looking for in a Tarasoff case is different than you might look for in any oth-

er plaintiff’s cases. (As explained in Part One of this article, in Tarasoff v. Regents of University of Califor-nia, 17 Cal.3d 425 (1976). a gradu-ate student named Prosenjit Poddar, who was attending the University of California at Berkley, confessed to his counselor a desire to kill an-other student he was obsessed with: Tatiana Tarasoff. Although his coun-selor recognized that Poddar was dangerous and even briefly had him committed, neither Tatiana nor her family were warned of the threat. Two months later, Poddar murdered Tatiana Tarasoff.)

Conservatives, gun owners, and tough-on-crime types are not go-ing to be sympathetic to a criminal’s right to confidentiality over the “right to know” of a law-abiding citizen. Such jurors are fine for the plain-tiff’s side, as long as they are not tort-reformers. The “right to protect oneself” is so fundamental to gun owners that obligating a therapist to warn a potential victim in order that she might exercise that right will make absolute sense to them. Pro-tective fathers, in general, are also good jurors for these cases.

If there is any suggestion in the case that the victim should not have been “mixed up” with the patient/criminal in the first place, stay away from jurors who are too much like the victim demographically. They are likely to have defense mecha-nisms in place in order to convince themselves that what happened to the victim in this case “would nev-er happen to me because I never would have been involved with him in the first place.” This is the so-called “identification bias.”

When you present a case like this for the victim of a psychiatric pa-tient, you are alleging that a men-tal health professional should have taken some kind of decisive action — to commit, to warn, to contain. Therefore you should probably avoid the mealy-mouthed, passive, or overly intellectual juror. You also don’t want jurors who have had therapy themselves. Of course, this question has to be delicately raised outside of other jurors’ hearing,

perhaps in a form with a question like, “Have you had any experiences with mental health professionals?” There is too much risk in accept-ing a juror who has had periods of therapy. Such a juror is less likely to respond to the idea that a therapist has an obligation, in some cases, to someone other than the patient. Their own fears that their personal, private thoughts could be subject to disclosure to third parties may color their ability to see the value in com-pelling mental health professionals to speak. tHe oPening

The focus of the trial is, of course, critical. In making an opening state-ment, the focus needs to be square-ly on the professionals; how they are trained to identify risk factors and how they are required to act to prevent harm to their patients and others.

Beyond this, you will need a rea-son or guiding principle. In our opening, in the case in which a young woman (Elaine) was killed by an ex-boyfriend whose therapist did not warn her of the possible danger (see Part One), I talked first about the “right to know” as stated above. I explained the risk factors known to increase the likelihood of violence. I then told the story, focus-ing on the therapist’s initial evalua-tion of the boyfriend (Jim) and all that he knew prospectively as set forth in the medical records. Hav-ing already listed the risk factors for violence, I was able to line up the medical records and check the risks as we went along “Homicidal ideation?” Check. “Inability to con-trol anger?” Check. “History of vio-lence?” Check.

We described the “deal” between the therapist and Jim, where it was reported that Jim said he would not act on his thoughts but would “call if this changes.” I suggested to the jury, rhetorically: “You might ask yourself whether it made any sense for the therapist to rely on a patient he just met, with serious anger control prob-lems, to pick up the phone and call him if he decided to harm Elaine?”

Trial Tactics in Psychiatrist Liability Cases

continued on page 4

Joshua D. Koskoff is an attorney with the Connecticut firm of Ko-skoff, Koskoff and Bieder PC. He concentrates his practice in medical malpractice and air accidents.

Part Two of a Two-Part Article


We have all watched movies where we know what is about to happen to an unknowing victim and wish there was some way to prevent it. Jurors are conditioned through movies and television to know when a person is in danger before the person does. In telling the story of the crime, re-create the scene dispassionately but specifical-ly and slowly. Be sure that the jury knows exactly what is about to hap-pen and how the victim has no clue. You will be tapping into this com-mon thread. Instinctively, the jury will wish that they were in the posi-tion to do something — and that is the essence of your case. The thera-pist could have done something!

Obviously, you need to avoid any-thing that could be perceived as ap-pealing to sympathy. I personally don’t believe in saying much about damages during opening statement, especially in death cases.

tHe order oF WitnessesIf the records aren’t bad for your

side of the case, and if you have help-ful group protocols, call the office manager first. You can go through the records and introduce the poli-cies. This puts the defendant(s) squarely under the gun and the focus is exactly where you want it to be. You want to go methodically through the treatment, and it is best to do this first with an adversarial but disinterested witness (so that you can lead).

When it comes to the practice’s policies, first make sure they were in effect at the time the patient was be-ing treated. Then, the jury needs to know where the policies came from, and why they were put in place. You are looking to highlight for the jury references to risk assessment, homi-cidality, suicidality, Tarasoff and exceptions to confidentiality. Your goal is to show that these issues are fundamental to a therapist’s doing his job. The policies will help you show that a therapist is expected to take action in certain circumstances to protect others.

If you don’t have strength in the records or policies, you may have to lead with a “teaching expert,” fol-lowed by the defendant. In any case the defendant should go early in the case.

In a homicide case, put the family on at the end of the case. You need to be brief with the family, and don’t call every family member. If you have the jury, they will have built up enough concern for the family with their imagination. It is not difficult to identify with the pain a family suffers when their loved one is mur-dered. Obviously you need to show some pictures of the victim, but you need to be extremely careful about going overboard. You are going to get a big verdict if you win, and you want to avoid the appearance of “looking for money.” You will need to ask some simple questions about what the family would have done to protect themselves if they had been warned about the dangerous patient. You want to establish that being deprived of that opportunity made a difference in the outcome.

exPert testimonyThe problem with expert testimo-

ny in a psychiatric malpractice case is this: You will have to deal with psychiatrists, who tend to be overly analytical, long-winded, and fun-gible — terrible qualities for court cases.

When preparing your psychiatry expert for trial and depositions, you need to discuss the case extensively so that you can help the psychiatrist wade through the psycho-babble to arrive at his or her concrete opin-ions. I advise having the psychia-trist write all conclusions down on a piece of paper. The list should start with a declarative statement like “Dr. Smith should have … ” or “Dr. Smith did not”: 1) Commit the patient; 2) Warn the police; 3) Do a risk assessment; 4) Bring in the patient’s family; etc.

If you have one expert, you will have to put the defendant on be-fore the expert. In my experience, the defendants in these cases make lousy witnesses and your goal will be to alienate them from the jury. If

you have two experts, you should call one to teach (before the defen-dant) and one to offer the criticisms (after the defendant).

You want the jury to understand that evaluating patients at risk for suicide and homicide is central to what a psychiatrist is trained to do. When reviewing the background of the expert, make sure to elicit the fact that they are educated on how they are supposed to approach pa-tients at risk for homicide and sui-cide in the first year of their training! They are also taught that, some-times, they are required to protect the public from their patients. This it is one of the most important parts of their job.

The records in these cases are usually deficient and incomplete. To the extent that you can, you want your expert to rely on the records as much as possible because your goal is to build a case around the records. While this is true in any malpractice case, it is especially true in a wrongful death psychiatry case where the additional information is going to come primarily from the mouth of the defendant.

At trial, first ask a hypothetical question based solely on the medi-cal records. Preface this so the jury knows what you are doing: “Dr Ex-pert, I am going to ask you a ques-tion that is based solely on the official records in this case — the records made when John Doe was still alive — and not on what has been said after the death of John Doe.”

Then go methodically through the records, asking along the way whether the standard of care was met at various instances. Once you have elicited all the opinions, its time to ask your second hypotheti-cal question: “Now, I would like you to assume that Dr Defendant has testified after the fact … ” Fill in the testimony of the defendant and point out contrasts with the records where possible. I like to ask ques-tions like, “If you assume what the defendant says is true, isn’t that an excuse for not committing the pa-tient?” (knowing full well it isn’t).

Psychiatrist Liabilitycontinued from page 3

continued on page 5


Or, “If we assume what the defen-dant says today is true, does that change your opinion?” Often, the excuses make the original conduct look worse.

Remember not to let the expert roam too much. Also, be honest when you don’t understand some-thing the expert has said, or you sense that the jury has become con-fused. I always interject with some-thing like, “You lost me on that one doctor,” or, “Maybe I’m the only one, but I don’t understand what you mean by (long medical term).” Chances are, if you aren’t following the discussion, neither is the jury.

Also, please meet the expert the day or night before his testimony. Go to dinner. Put him or her up at a nice hotel. You also do not want your expert driving to court the day of his testimony. The expert needs to be brought into the zone of the case without the stresses caused by fighting traffic and finding the courthouse and a parking space.

Cross-exAminAtion oF tHe deFendAnt

As we’ve already noted, mental-health professionals make bad wit-nesses. This applies not only to your expert, but also to the psychiatrist your client is suing. Obviously we are trained to control cross-exam, and that is important. However in these types of cases, my experience has been that you need only pro-vide the rope to the defendant, and he will tend to hang himself under a mass of psycho-babble. Remember your case is about the therapist not taking some kind of action — not warning the family, not committing the patient, not getting the patients records, etc. If the defendant ram-bles on, it will likely support the im-pression that this is a conflicted per-son, and not a person of action. The defendant is bound to deliver some gems through an answer that you can use surgically on him or her.

Prior to crossing the defendant, I put together a list linking any ad-missions from the deposition or

from other sources together with the specific question I will ask. This is my “go to” list from which I can pull the defendant’s words for my questions. I’ll say, “You would agree that … (fill in statement from de-position).” If the defendant agrees, that’s great. If not, that’s even better, because you can nail the witness on the issue of credibility and intro-duce the prior statement.

Always try to pit the medical re-cord against the courtroom testimo-ny. “What you are telling us today, doctor, is that John Doe appeared to be better on the day before he killed his victim — but that’s different from what you recorded in your official medical record prospectively, before John Doe killed her, correct?”

If there were policies that the de-fendant didn’t follow, let the defen-dant make excuses as to why those policies were not followed, and write them down. Later, with your expert on the stand, you will need to reiterate all the excuses given by the defendant for the decisions that were made concerning the patient’s dangerous propensities. Next, ask your expert about each excuse with questions like: “Dr. Smith told us that the reason he didn’t call the patient’s family was because he didn’t want to break confidentiality, doesn’t that excuse what he did?” Remember when it comes to confi-dentiality, it is owned by the patient, and not the therapist. Therefore you will want to establish that the de-fendant never asked the patient if it was acceptable to disclose the infor-mation to family members.

FinAl ArgumentIf you get to final argument in

a Tarasoff case (I have yet to), re-mind the jury that “People have a right to know when they are in dan-ger. People have a right to protect themselves.” This is what will mo-tivate your jury on an instinctive “reptilian” level. Your jury wants to be protected from lurking preda-tors, and probably doesn’t care all that much if getting that protec-tion means confidentiality between a psychiatrist and his patient must be breached. You want to remind

the jury that a patient who confides dangerous propensities or ideation to his therapist wants to be stopped, whether they are speaking of sui-cide or homicide. If they just wanted to kill themselves or someone else, they wouldn’t try and get help, they would do it.

By their nature, these cases are dramatic and compelling. During closing, I would retell the whole story to the jury, with an emphasis on the opportunity the defendant had to step in. I would also speak from the point of view of the victim who is going about her daily life not knowing of the lurking danger.

I would also point out that thera-pists are not fortunetellers who can see into the future. Therefore, they have to act based on the well rec-ognized risk factors discussed in Tarasoff and its progeny before it is too late. This turns a classic defense argument on its head.

At the conclusion of the first por-tion of the final argument, after damages, I would do what I almost always do in summation: I would ask the defense to answer some questions “on behalf of the estate of John Doe.” Questions like, “Why didn’t the psychiatrist obtain the old records on his patient? Why didn’t he even try? Why did he choose not to do a thorough risk assessment? Why didn’t he bring in one of his colleagues to discuss the patient’s care with? Why is he still denying that he has any responsibility?” You get the idea. The beauty of ending with questions in your first part is it prevents the defense from standing up and saying “see this is all about money.” Also the defense — in my experience — will not answer the questions, which you can point out on rebuttal. If you craft your ques-tions carefully, you’ll know there are no satisfactory answers to them.

Psychiatrist Liabilitycontinued from page 4

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degenerate and become paralyzed. Most DMD victims die by the age of 25. Although no drug is currently available to treat DMD in any long-term meaningful way, there are med-ications that can help relieve symp-toms or slow their progression.

Jacob was already taking Gen-tamicin to treat his DMD when his mother, Cherie Gunvalson, inquired about his taking part in a new drug study being performed by PTC Ther-apeutics Inc. The company was set to conduct a Phase 2 clinical trial of a drug to treat DMD, called PTC 124. The trial would last 28 days, during which time participants would not be permitted to take Gentamicin.

In their suit, the Gunvalsons al-leged that PTC’s Vice President, Claudia Hirawat, advised Mrs. Gun-valson that her son should remain on Gentamicin because it offered him some relief from his symptoms. The plaintiffs said that Hirawat ad-vised them that Jacob should there-fore wait to participate in a later PTC 124 trial. Because of this and other conversations with PTC representa-tives, the Gunvalsons claimed they were induced to forego treatment at the time of that first inquiry. Later, when the first trial was successful, PTC began an expanded trial of the drug, which was to last for two years. When Jacob sought to enter into the group of trial participants for the expanded testing, he and his parents learned that the group was limited to those who had taken part in the first, 28-day trial. Thus, Jacob was now ineligible to participate in a clinical trial of PTC 124. By the time he was rejected for this second clinical trial, Jacob’s condition had deteriorated considerably.

Because he was barred from the clinical trial, Jacob tried a second method for gaining access to PTC 124; he sought permission to use the drug through the FDA-regulat-ed “compassionate use” exception to the normal prohibition against drug-manufacturer distribution of unapproved medications.

‘Compassionate Use’Drug companies are permitted to

give terminally ill people experimen-tal drugs outside of the clinical trial setting in two ways: 1) on a group basis (expanded access program); or 2) on a single-patient basis. When the company is not offering an ex-panded access program, the single-patient basis for expanded access is the only route open. To use this op-tion, the potential user of the phar-maceutical product must get his or her doctor to ask the drug company to let the patient use the investiga-tional drug. If the company agrees, the doctor and the manufacturer can ask the FDA to approve the use of the drug for that single patient. The process can be completed in as little as a day, although it generally takes several weeks. In Jacob’s case, PTC declined to apply to the FDA on his behalf for an exception.

When this last hope fell through, Jacob and his parents brought suit against PTC to compel the company to provide PTC 124 to Jacob. They claimed that PTC induced Jacob to pass up the chance to participate in the first trial group by promising him that he could take part in a sec-ond phase of testing, when in fact he could not take part in that sec-ond phase if he did not participate in the first. They sued on theories of promissory estoppel, fraudulent misrepresentation and negligent misrepresentation. Significantly to the holding of December 2008, the Gunvalsons also sought a prelimi-nary injunction from the U.S. Dis-trict Court for the District of New Jersey to immediately compel PTC to give Jacob the drug.

The district court had to consider four factors before granting the re-quested preliminary injunction. They were: 1) The Gunvalsons’ likelihood of ultimate success on the merits; 2) The irreparable harm to Jacob if the injunc-tion were denied; 3) The hardship the injunction would cause to PTC; and 4) the public interest in the issue. Success on the Merits

Concerning the first hurdle, the district court broke the question of whether the Gunvalsons would ul-

timately prevail on the merits into two parts: 1) Could the plaintiffs show that PTC 124 comports with the requirements of the FDA's “com-passionate use” exception?; and 2) Could they show that PTC had made them an enforceable promise that they would provide Jacob the drug?

To show that PTC 124 comports with the requirements of the FDA's “compassionate use” exception, such that the FDA would allow a drug company to distribute the unap-proved drug, four conditions had to be met: 1) The drug must be intended for use in treating a serious or life-threatening disease; 2) There must be no good alternative; 3) The drug must currently be under investigation in a clinical trial; and 4) The sponsor must be actively pursuing market-ing approval. 21 C.F.R. § 312.34. The court noted also that, even if PTC 124 met these criteria, the FDA could still deny permission for Jacob to use the drug through the compassionate use exception if there was insufficient ev-idence of the drug’s safety. Looking at all these criteria, however, the district court found no impediment to Jacob’s being permitted to use PTC 124 un-der the compassionate use exception. Thus, the first prong of the test to see if the Gunvalsons might win on the merits was met.The Second Prong

Moving on to the second prong, the court had to determine if a promise had been made to Jacob and his family that the company would provide Jacob with PTC 124. And because Jacob had offered noth-ing in return for the promise that he could take part in a later clinical trial (lack of consideration), he was rely-ing on the doctrine of promissory estoppel to compel PTC to give him their medication. In order to win on a promissory estoppel theory, Jacob and his parents had to show: 1) That a clear and definite promise was made; 2) That the promise was made with the expectation that the plain-tiffs would rely on it; 3) That the plaintiffs reasonably relied upon the promise; and 4) That the failure to make good on that promise resulted

Compassionate Usecontinued from page 1

continued on page 10


surrogAte motHer’s suit AgAinst Attorney And doCtor ProCeeds

A New Jersey court has held that a suit against a lawyer and a doctor who arranged a surrogate pregnan-cy deal can go forward. The profes-sionals are being sued for civil con-spiracy, as well as legal and medical malpractice, for allegedly mislead-ing the surrogate mother about her rights. The ruling came in A.G.R. v. Brisman , Mon-L-1012-08, a case in which a woman who agreed to be a surrogate mother later decided she wanted to keep the twin babies she bore. In a separate suit, she is seek-ing custody of the children.

The landmark 1988 state Supreme Court case, In the Matter of Baby M, 109 N.J. 396 (1988), held surrogacy contracts unenforceable in New Jer-sey. Therefore, in New Jersey, cus-tody of children born to surrogate mothers who want to retain custody is decided by the courts, in accor-dance with the best interests of the children involved. Baby M did not deal, however, with the liability of professionals who set up surrogacy arrangements. The A.G.R. v. Brisman case is a first in that it is seeking money damages for harms related to a surrogacy agreement.

doCtor Found not guilty in rusHed trAnsPlAnt CAse

The California surgeon charged with harming an organ donor in an effort to speed the harvest his kidney and liver was acquitted of the charge of abuse of a dependent adult on Dec. 18, 2008. Dr. Hootan Roozrokh is a transplant surgeon who was called to the bedside of the donor, a 25-year-old brain damage victim, in February 2006. He was there to remove the donor’s organs as soon as death occurred, following the do-nor’s removal from a ventilator. The doctor planned to use a technique called “donation after cardiac death,” which involves quick harvesting of organs immediately following the

donor’s cardiac death. The donor, however, did not die until eight hours after the ventilator was removed. In the interim, Dr. Roozrokh adminis-tered medications such as morphine to the donor, which the prosecution alleged were excessive and meant to hasten the donor’s death. By the time the donor died, his organs were no longer viable and could not be used for transplant.

neArly simultAneous deAtHs At nursing Home PromPt CriminAl investigAtion

Three men died on Dec. 18, 2008, in a Long Island, NY, nursing home, prompting a police investigation as to the causes of death. All three deaths occurred on the third floor of the New Carlton Rehab and Nurs-ing Center, beginning with a man who was discovered in his bed not breathing in the early hours of the morning. An hour later, two more men were found unconscious, and they later died. All three patients were gravely ill before their deaths, and there were no immediate signs of foul play. The possibility that the three simply died coincidentally at around the same time was consid-ered highly probable, but autopsies were ordered to determine for cer-tain the causes of death.

stAte sAys mAssACHusetts toWn’s AmBulAnCe serviCe Cut Corners

In December 2008, the Massachu-setts Department of Public Health (DPH) suspended the town of Ham-ilton’s ambulance license after an in-vestigation unearthed evidence that training and certification require-ments for the town’s emergency medical technicians (EMTs) were not being met. In Massachusetts, para-medics are required to receive 28 hours of initial training, and must at-tend annual refresher courses. In ad-dition to the town, 24 individual EMTs were cited by the DPH for falsifying training records. The DPH suspended

13 of these individuals’ licenses and has proposed that their licenses be revoked for periods up to one year, depending on the severity of each accused’s infractions. The other 11 EMTs cited have received reprimands for falsifying their own continuing education training records.

In a release, DPH’s Director of the Bureau of Health Care Safety and Quality, Paul Dreyer, said, “This investigation has revealed serious problems in the way that the emer-gency medical services were deliv-ered in the town of Hamilton. Train-ing requirements are in place for a reason: to insure the highest quality of care for the residents of the Com-monwealth.”

neW HAmPsHire Jury triAls Put on Hold

The economic downturn has af-fected many sectors of society, in-cluding the court systems of the sev-eral states, which are being asked to cut their budgets. The State of New Hampshire’s court system decided to save money by suspending jury tri-als for a month this year, putting on hold not only medical malpractice trials but also employment, matri-monial and other types of civil tri-als. The situation will stick attorneys and their clients not only with the prospect of delayed justice but also with the costs and inconvenience of rescheduling trial dates.

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block, it is important to look at the following: Does the agreement state who is the custodian of the tissue block? Do the physicians “own” any-thing in the laboratory? Who is re-sponsible for the running or oversight of the pathology laboratory? Who is responsible for authoring and enforc-ing the rule regarding the discarding of tissue blocks? Do the physicians have the right to direct the activity of hospital employees? Each agreement is different, so this list is not meant to be exhaustive in terms of the ques-tions the attorney must ask. But, ulti-mately, this factual inquiry will be re-solved by a trial judge who will also be interpreting the facts surrounding the division of labor between the hospital and the physician's practice group. The attorneys for both sides must be prepared.

After the contractual interpretation of the agreement has been done, there is yet one more thought to consider. There is a line of case law authority that would impose responsibility for spoliation under an “agency” theory. Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005); see also Bo-swell v. Overhead Door Corp., 292 Ga. App. 234 (2008) (finding no spolia-tion sanctions against Overhead Door when City of Atlanta discarded door on its own and not at the request of Overhead Door). In Bouve & Mohr, a defendant was held liable for spolia-tion sanctions despite the fact that the defendant had no personal involve-ment in actually destroying evidence. More specifically, in a premises liabil-ity case, a plaintiff filed suit against an apartment complex following her al-leged rape at the apartment complex. A police officer who acted as security for the apartment was assigned to the criminal rape case. Through a se-ries of factual circumstances, the po-lice officer disposed of the rape kit. The court found there to be circum-stantial evidence of agency between the police officer and the apartment complex.

In applying the theory of agency to our hypothetical, it is important

to be careful to investigate not only the contractual relationship be-tween the hospital and the physi-cian’s practice, but also the actual day-to-day operation of the labora-tory. If the physician directs or is consulted by laboratory personnel in reference to the storage or dis-carding of tissue blocks, the physi-cian's group as well as the hospital could find themselves on the hook for spoliation. However, if the hos-pital employees are alone respon-sible for carrying out the discarding of the tissue blocks, the hospital is most likely solely responsible for the alleged spoliation.

tHe ConseQuenCes oF sPoliAtion

In determining the appropriate remedy for spoliation, Georgia’s courts, for example, review the fol-lowing factors: “1) whether the [par-ty seeking sanctions] was prejudiced as a result of the destruction of the evidence; 2) whether the prejudice could be cured; 3) the practical im-portance of the evidence; 4) wheth-er the [party who destroyed the evi-dence] acted in good or bad faith; and 5) the potential for abuse.” R.A. Siegel Co. v. Bowen, 246 Ga. App. 177, 180 (2000). Other states gener-ally look at the same general fac-tors. See Joyner v. B&P Pest Control, Inc., 852 So. 991 (Ala. Civ. App. 2002); Whirlpool Corp. v. Camacho, 251 S.W.3d 88 (Tex. App. 2008). See also Barnett v. Simmons, 2008 WL 4853360 (Okla. 2008); Wilson v. Frye, 2008 WL 4561505 (Wash. App. Div. 2008) State v. Hay, 756 N.W.2d 480 (Iowa App. 2008); Hap-py Bunch, LLC v. Grandview North, LLC, 142 Wash. App. 81 (2007).

WHAt is tHe remedy?Assuming spoliation has occurred,

what is the remedy? First and fore-most, most attorneys are aware of the dreaded “adverse inference” charge. The jury can be charged that there is a rebuttable presumption that the lost or destroyed evidence contained information adverse to the spoliator. In the hypothetical identified above, the trial court could instruct the jury that the missing tissue block contained something harmful to the

doctor’s and the hospital’s defense. This could result in the jury forming the impression or presumption that the tissue block contained evidence of malignancy. Simply the giving of an adverse inference charge in the hypothetical could have dire conse-quences and turn a seemingly de-fensible case into one that poses se-rious risks in being tried to verdict.

Even more so than the giving of the adverse inference charge, trial courts are vested with discretion to fashion even more damaging rem-edies for alleged spoliation. For ex-ample, a trial court could dismiss the case or could exclude testimony concerning the destroyed or lost evi-dence. See, e.g., R.A. Siegel Co. v. Bo-wen, 246 Ga. App. 177, 180 (2000); Covucci v. Keane Consulting Group, Inc., 21 Mass. L. Rptr. 228 (Mass. Su-per. 2006); Harborview Office Cen-ter, LLC v. Camosy Inc., 290 Wis.2d 511 (2006); Farr v. Evenflo Co., Inc., 287 Wis.2d 827 (Wis .App., 2005). Additionally, a trial court could even enter findings of fact pertaining to the lost or destroyed evidence, thus removing certain issues from consideration from the jury’s pur-view. See, e.g., Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005) (where spoliated evidence was a rape kit performed on the plaintiff after the alleged rape, court entered a finding of fact that the plaintiff was raped in the apartment com-plex run by the defendant).

As you can see, depending on how a trial court perceives an al-leged spoliation, the merits of the case could be vastly affected. Impor-tantly, assuming a litigant wishes to appeal the entry of spoliation sanc-tion, that decision is generally re-viewed under the deferential abuse of discretion standard.

ConClusionWhat is the lesson to be learned

by the prudent medical malprac-tice attorney? First and foremost, it is not just about the medicine and the patient’s medical record. When you are representing physicians or their practices in the setting of a community hospital, you must




ClAss ACtion oFF-lABel drug lAWsuit dismissed

A U.S. District Court judge sit-ting in Los Angeles dismissed an off-label drug promotion multi-district litigation on Dec. 17, 2008. The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not ap-proved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL08-1934 (ARG) (C.D. Calif.), that the seven plain-tiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has ex-clusive jurisdiction over enforce-ment of the rules against promot-ing off-label drug uses. “Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that de-fendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder,” wrote the court. Justice Gutierrez did, how-ever, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done.

Following the dismissal, Amgen attorney Mark Cheffo, of Skadden Arps Slate Meagher & Flom in New York, said, “The judge is not letting insurers second-guess medical pro-viders across the country. I think he also respected the FDA’s role and was not going to allow judges and juries to make decisions around the United States that are inconsistent with the FDA.”

FtC sues PHArmACeutiCAls ComPAny For Antitrust violAtions

The Federal Trade Commission filed a lawsuit in December 2008 against Ovation Pharmaceuticals Inc., alleging that the company has obtained an illegal monopoly over the only two drugs available to treat premature babies with certain heart defects. The FTC claims in its suit, filed in Federal District Court in Min-nesota, that the company in August 2005 purchased the rights to one of the two medications, Indocin. Five months later, it acquired the rights to the second medication, NeoProfen. Soon after this acquisition, the price of a vial of Indocin jumped from $36 per vial to $500 per vial. In a statement issued by the FTC, acting FTC Bureau of Competition Direc-tor David P. Wales said, “By acquir-ing its only competitor in the treat-ment of a serious heart condition affecting premature babies, Ovation has been able to charge dramatical-ly higher prices for its drugs. While Ovation is profiting from its illegal acquisition, hospitals and ultimately consumers and American taxpayers are forced to pay millions of dol-lars a year more for these life-saving medications. The action taken today is intended to restore the lost com-petition and require Ovation to give up its unlawful profits.” The FTC claims the only alternative to the two medications for babies with the heart defect patent ductus arterio-sus is surgery, which is expensive and dangerous. With surgery the only other option, medical caregiv-ers and parents of affected babies are forced to pay the allegedly ar-tificially inflated prices Ovation is charging for its medications. All the participating FTC commissioners voted to approve the complaint.

Commissioner Jon Leibowitz is-sued a separate concurring state-ment, in which he said, “Ovation’s profiteering on the backs of critical-ly ill premature babies is not only

immoral, it is illegal. Ovation’s be-havior is a stark reminder of why America desperately needs health care reform and why vigorous anti-trust enforcement is as relevant to-day as it was when the agency was created almost one hundred years ago in 1914.”

CA nArroWs deFinition oF ‘PrimAry CAregiver’ For

mediCinAl mAriJuAnA useThe California Supreme Court has

ruled unanimously that the term “primary caregiver,” as used in the state’s medical-marijuana-dispens-ing law, the Compassionate Use Act of 1996, refers only to a very limited class of people. “The words the stat-ute uses — housing, health, safety — imply a caretaking relationship directed at the core survival needs of a seriously ill patient, not just one single pharmaceutical need.” The statute thus does not shield from state prosecution growers of small amounts of marijuana who want to supply it to their ailing friends.

The question arose in a 2005 case against Roger Mentch, who claimed he was growing the 190 plants found in his home because he was providing marijuana to five people with various physical and psychological infirmities. He assert-ed that he counseled his clients as to proper usage of the drug, taught them how to grow it and occasion-ally drove them to medical appoint-ments. Mentch lost his battle to prove his innocence by way of the primary caregiver defense after the trial court refused to allow Mentch to present evidence on the issue. The intermediate appellate court found that Mentch should have been allowed to assert the affirma-tive defense.

The State Supreme Court reversed, holding in People v. Mentch, 08 C.D.O.S. 14435, that medical mari-juana primary caregivers are only those who consistently provided

d r u g & d e v i C e n e W s



determine all the parties’ involve-ments in the everyday operation of the physician’s practice, and estab-lish who is responsible for what. Once you have resolved this one very important fact, you will be in the best possible position to prop-erly represent your client’s interest

and prevent the blunders that lead to a claim of spoliation. Even absent a claim of spoliation, this inquiry should occur as early as possible in litigation in order to determine which party will be responsible for preserving relevant evidence dur-ing suit. Absent such an early inves-tigation, you could find your client on the receiving end of a motion for spoliation sanctions.

Finally, if you have a co-defendant, keep the lines of communication open in order to ensure that all relevant documentary evidence is being main-tained and preserved, even if it's not your client's documents. This will help in avoiding the issues of who had the responsibility to preserve each item of relevant evidence during discovery.


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in a definite and substantial detri-ment to the plaintiffs. See, e.g., Lo-biondo v. O’Callaghan, 357 N.J.Sup. 488 (N.J.Super.Ct.App.Div. 2003).

For evidence of the requisite clear and definite promise, the court not-ed these and other statements in Cherie Gunvalson’s affidavit:

That she “asked PTC Vice •President Claudia Hirawat if Jacob should be enrolled in the initial Phase 2a trials, and Hirawat responded that ‘it was not worth taking Jacob off of Gentamicin for only a 28-day dosage of PTC124.’ (Aff. of Cherie Gunvalson 17.)” That she “asked Hirawat if there •were any adverse effects on Ja-cob for not participating in the trial, and she told me there were none.” (Cherie Aff. 17.) That Hirawat told Cherie Gun-•valson “that Jacob had no bet-ter or worse chance to be treat-ed in the future based on his non-enrollment in the Phase IIa trial.” (Cherie Aff. 25.) That Hirawat “assured [Cherie] •that Jacob would get access to PTC124.” (Cheri Aff. 26.)

The court also found that many statements in Hirawat’s affidavit confirmed Cheri Gunvalson’s con-tentions, even though other state-ments in Hirawat’s affidavit contra-dicted them. The court explained its tendency to lean toward Cheri Gunvalson’s version of the facts sur-rounding her interactions with PTC personnel, stating: “As an initial mat-ter, all communications between

PTC and Plaintiffs must be viewed in light of the unique relationship between Jacob's mother, Cherie, and PTC. Cherie worked at length to lob-by funds from Congress for DMD re-search. In this capacity, she had re-lationships with PTC employees and officers that transcended the typical relationship that PTC had with par-ents of children with DMD. Of most relevance to this Court, Cherie ap-pears to have had extensive commu-nications on both a professional and social level with PTC Vice President Claudia Hirawat. Indeed, it is undis-puted that Cherie and Jacob have even stayed overnight at Hirawat's home on at least one occasion. Be-cause of these extended connections alone, it seems to the Court that PTC would be more likely to communi-cate to Plaintiffs more compassion-ately and less formally than with other parents of DMD children.”

Because of the corroborating state-ments of the opposing party and the witnesses’ relationship with one an-other, the district court’s determined that the promise had been made to the Gunvalsons.

The court next concluded that the last three elements required to make a case under the theory of promissory estoppel were present, stating it was “reasonably likely that Plaintiffs relied on these and other similar statements made by PTC in declining to enroll Jacob in the Phase 2a clinical trials. This failure to enroll Jacob worked to Plaintiffs' detriment, as Jacob is now not eligible for the extended Phase 2a trials. In summary, the Court finds it reasonably likely that Plaintiffs rea-sonably relied to their detriment on PTC's promises to provide PTC 124 to

Jacob, so the Court prevents PTC from denying Plaintiffs that promise.”

In the district court’s view, this settled the second prong of the question — “Are the plaintiffs likely to succeed on the merits?”

tHree more elementsThe court next moved on to the

other requirements the plaintiffs were required to show before a pre-liminary injunction could be issued. They were: 2) The irreparable harm to Jacob if the injunction were de-nied; 3) The hardship the injunction would cause to PTC; and 4) the pub-lic interest in the issue.

Concerning irreparable harm, there was little question here. Jacob is dying of a disease with no cur-rently available cure, and PTC 124 offers some minimal hope.

The hardship to PTC of having to provide the drug to Jacob was also easily dismissed as an impediment to injunction by the district court, as all the company could cite to was the difficulty of filing paperwork with and working with the FDA to obtain a compassionate use exception for the boy. According to PTC, this process could take weeks, but that seemed a small price to pay for, perhaps, sav-ing or prolonging a life.

Finally, the district court found no harm to the public in issuing a pre-liminary injunction compelling PTC to provide Jacob with PTC 124, as the public has an interest in provid-ing life-saving experimental drugs to terminally ill persons. This public in-terest was evidenced, the court said, by the FDA’s very enactment of the compassionate use exception.




Juror's disHonesty did not PreJudiCe tHe PlAintiFF

When seeking a new trial based on a juror's dishonest answer during voir dire, a party must show that the misconduct prejudiced the outcome of the case, the Ohio Supreme Court ruled on Dec. 11, 2008. Grundy v. Dhillon, 2008 WL 5234354, 2008 - Ohio - 6324 (Ohio, 12/11/08).

A jury delivered a defense ver-dict on claims that hospital and emergency medical staff negligently caused the death of Susanne Sum-ner. Her estate sought a new trial, asserting that, during jury selection, a juror had failed to disclose that he had a low opinion of the medi-cal facility based on a family mem-ber’s treatment there. The plaintiff alleged that this failure constituted misconduct warranting a new trial. The trial judge denied the motion. A state intermediate appellate court reversed and the defendants ap-pealed.

The Ohio Supreme Court re-versed, reinstating the defense ver-dict. There was no evidence that the juror deliberately lied. Furthermore, if any party had reason to excuse the juror, it would have been the defen-dants. To obtain a new trial in such cases, the moving party first must demonstrate that a juror answered a material question dishonestly and that prejudice resulted, the court said. To do that, the moving party must show that the juror’s accurate response would have provided a valid challenge. In weighing this is-sue, an appellate court may not sub-stitute its opinion for the trial court's judgment “unless it appears that the trial court’s attitude was unreason-able, arbitrary, or unconscionable,” the court said. The trial court here did not abuse its discretion.

AmBulAnCe Worker not liABle under georgiA lAW

Georgia’s statute immunizing am-bulance workers from civil liability, as long as their organization is per-

forming the emergency medical ser-vices for no remuneration, applied to the emergency medical techni-cian in this case even though the ambulance company intended to charge plaintiff’s decedent a fee to assist with defraying the administra-tive costs of operating the service. Presley v. City of Blackshear, Slip Copy, 2008 WL 5431177 (S.D.Ga., 12/31/08).

Plaintiff Administratrix of the Es-tate of the decedent, Antonio Pres-ley, brought suit after the decedent died while in police custody for suspected cocaine possession. Pres-ley had, in fact, consumed a large amount of cocaine at the time of the arrest in an attempt to hide the evi-dence. The decedent died from an overdose after having been treated and transported to a hospital by emergency medical technician Da-vid Farrior. The Administratrix made claims for medical malpractice and negligence against Farrior, a para-medic with Pierce County EMS. Farrier filed a motion for summary judgment, which the court here granted.

Farrior claimed in his motion for summary judgment that he was statutorily immune from liability for negligence and medical malpractice under Georgia law. The relevant Code Section provides:

(a) Any person, including agents and employees, who is licensed to furnish ambulance service and who in good faith renders emergency care to a person who is a victim of an ac-cident or emergency shall not be liable for any civil damages to such victim as a result of any act or omission by such person in rendering such emergency care to such victim....(c) The immunity provided in this Code section shall apply only to those persons who per-form the aforesaid emergency services for no remuneration. O.C.G.A. § 31-11-8.

Plaintiff did not dispute the con-tention that Farrior was an employ-ee of Pierce County EMS, which was licensed to provide ambulance services by the Georgia Department of Human Resources. In addition, plaintiff presented no evidence sug-gesting that Farrior did not act in “good faith.” So, viewing the evi-dence in light most favorable to plaintiff, the evidence showed, at best, that Farrior’s judgment was faulty, which would not support a finding of bad faith. See, e.g. Thom-as v. DeKalb County, 489 S.E.2d 58 (Ga.Ct.App. 1997) (“Even if the paramedics exercised bad judgment and acted negligently, such does not amount to a lack of good faith.”).

The plaintiff claimed, however, that the statute did not apply be-cause the decedent was supposed to have been charged for the am-bulance services in accordance with Pierce County, GA, policy. The coun-ty bills those using a Pierce County EMS ambulance for two things: 1) a standard transportation fee; and 2) a mileage fee based upon the length of the transport. The monies collect-ed from transport fees and mileage fees do not cover the budget for the operation of Pierce County EMS, but are used solely to assist with defraying the administrative costs of operating Pierce County EMS. With this in mind, the court looked to Ramsey v. Forest Park, 418 S.E.2d 432 (Ga.Ct.App. 1992), in which the Georgia Court of Appeals held that “a fee charged by a governmental organization to assist in defraying the administrative costs of ‘trans-porting a person to a hospital’ is not the equivalent of receiving remu-neration for providing stated ‘emer-gency care,’ within the meaning of O.C.G.A. § 31-11-8(c).” Relying on Ramsey, the court determined that Farrior was protected by the immu-nity statute, even though the dece-dent was to have been charged for the ambulance services received.

v e r d i C t s

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Looper Reed & McGraw (Hous-ton): Joel C. Thompson joins the firm’s general civil litigation, com-mercial litigation and class action practice groups as partner in the Houston office. Thompson will fo-cus on products liability, wrongful death, insurance litigation, negligent security litigation, premises liability and construction litigation. Previ-ously, Thompson was an attorney in his own private practice.

Akerman Senterfitt (Miami): J. Ev-erett Wilson and Michael Gennett join the firm’s health care practice as partner and of counsel, respectively, in the Miami office. Wilson will focus on licensing and reimbursement dis-putes and negotiated managed care. Gennett will focus on representing health-care practitioners and institu-tional providers. Previously, Wilson

and Gennett were members of the health law practice group at Shutts & Bowen, which was chaired by Wilson.

Drinker Biddle & Reath (Phila-delphia): George H. Kendall and Audrey A. Hale join the firm’s health law practice group as partners in the Florham Park, NJ, office. Kendall and Hale will focus on mergers, acquisi-tions and joint ventures. Previously, Kendall and Hale were partners at McCarter & English of Newark, NJ.

Sedgwick, Detert, Moran & Ar-nold (San Francisco): Linda A. Wil-lett has been promoted to head of the firm’s drug and medical device practice group. Willett joined the firm in July and previously was vice president and deputy general coun-sel at Bristol-Myers Squibb Co.

Eckert Seamans Cherin and Mel-lott (Charleston, WV): The Pittsburgh-based firm of Eckert Seamans Cherin and Mellott has merged with the 12-attorney firm of Hendrickson & Long of Charleston, WV. Among the 12 attorneys to join the firm are Hen-drickson & Long’s named partners, David Hendrickson and R. Scott Long. Hendrickson has more than 25 years of trial experience and focuses his practice on products liability, toxic torts, medical malpractice, insurance defense and general business litiga-tion. Long concentrates his practice on products liability, personal injury, medical malpractice, toxic tort and asbestos defense. The new office of Eckert Seamans will remain at the same location where Hendrickson & Long was based.

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care to patients prior to deciding that medical marijuana use might be beneficial for them. “What is not permitted,” wrote the court, “is for an individual to establish an after-the-fact caregiving relationship in an effort to thereby immunize from prosecution previous cultivation or possession for sale.” The court went on to note that its decision should not put true primary caregivers in fear of prosecution: “The spouse or domestic partner caring for his or her ailing companion, the child car-ing for his or her ailing parent, the

hospice nurse caring for his or her ailing patient each can point to the many ways in which they, medical marijuana aside, attend to and as-sume responsibility for the core sur-vival needs of their dependents.”

mAnuFACturer uPgrAdes WArning on CrAniAl imPlAnt kits

In October 2008, Stryker’s Crani-omaxillofacial (CMF) business unit voluntarily recalled four lots of its Custom Cranial Implant Kits because there was some danger that they were not sterile. It took the FDA a two months after that recall to de-termine that the products in ques-

tion posed an imminent hazard to health, meaning that this is a Class I recall. The company announced the FDA’s finding on Dec. 23, 2008, and urged hospitals and physicians with the affected products — those with catalogue numbers 54-00101, 54-00102, 54-00103 and 54-00104 — to return them to the manufacturer. If the kits are used and are not, in fact, sterile, serious problems could ensue, including patient infection and long-term neurological deterio-ration. The company’s notice can be found at: http://www.fda.gov/oc/po/firmrecalls/ stryker12_08.html.

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Drug & Device Newscontinued from page 9

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Having found that the plaintiffs met all the criteria for obtaining a preliminary injunction, the district court ordered PTC to attempt to get

an FDA compassionate use exemp-tion for Jacob so that the company could provide him with the drugs he needed.

ConClusion

In next month’s issue, we’ll see what happened when the district

court ruling went up on appeal, and we’ll look at the policy consider-ations at stake in rendering help to individual disease sufferers through the compassionate use exception.

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Medical Malpractice · 2019. 8. 20. · By Kim M. Ruder B y definition, spoliation refers to the “destruction or failure to preserve evidence that is necessary to contemplated or

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