Civil Liability Arising From Product Labeling

 
I. INTRODUCTION.

One area of significant concern to medical products manufacturers, particularly in a relatively new and rapidly expanding field like biologics, is the scope of potential civil liability from injured users of the products. The most common claim in medical products lawsuits is a "failure to warn," in which the plaintiff ( the user of the product) alleges that he or she was not told of the risks and dangers associated with the product and, had they been so informed, he or she would not have used the product at all. Failure to warn claims bring a product's labeling under close scrutiny by lawyers, judges, and juries, making the careful preparation of product labeling a critical element of risk management.

Unfortunately, whether or not a product's labeling can create civil liability is, for the most part, unrelated to whether the labeling complies with FDA requirements.1 Indeed, the only time that FDA compliance will insulate a manufacturer from civil liability is when the manufacturer suggested to the FDA that a specific risk be warned of, and was instructed by the FDA not to include the risk in the labeling.2

Moreover, as a practical matter, it is impossible for any manufacturer to completely immunize itself from potential liability. However, there are steps that can be taken to minimize liability exposure, through an understanding of the civil liability standards and how they work in practice, and by designing labeling ( and reviewing existing labeling) with those standards in mind.

This presentation is designed to do three things: (1) explain the legal standards for evaluation of the adequacy of product labeling; (2) describe how those standards are implemented in the real world of litigation; and (3) provide concrete suggestions to assist in the review and preparation of labeling to minimize civil liability

 
II. THE CIVIL LIABILITY STANDARD.

As mentioned earlier, probably the most important thing to remember about civil liability from product labeling is that compliance with FDA regulations and requirements is not enough to prevent civil liability. Similarly, the fact that the FDA reviewed and approved a product's labeling before it was marketed does not, by itself, establish that the labeling and warnings were adequate.

One significant problem to bear in mind is the role of hindsight in civil litigation. When labels are proposed to the FDA, in many instances the manufacturer is discussing risks which occurred, either in bench top testing or clinical trials, and which are known to be associated with the product. however, the manufacturer may also be dealing with more uncertain risks - such as risks which were anticipated but did not occur in trials, or unexpected risks which occurred but which could not definitively be causally associated with the product. In deciding what risks to warn of, the manufacturer brings education and experience together to make assessments about risk.

A lawsuit will be decided by persons in a much different position. By the time a lawsuit is filed, the risk is no longer potential or theoretical, but real - it happened to the plaintiff. Whether, viewed from hindsight, the risk should have been warned of is a question that will be decided by judges and jurors with no education or experience whatsoever. Although each state has its own specific laws, the general rule is this: a manufacturer of biologic products has a legal duty to warn the medical profession of risks inherent in the use of the product, which are known or reasonably scientifically knowable at the time the product is marketed. There are several components to that rule which warrant further explanation.

First the manufacturer's duty is to warn the medical profession, not the individual patient.3 The courts recognize that the ultimate user of the product, the patient, lacks the scientific and medical knowledge to understand the product, and is therefore not in a position to understand the nature of the risks, the significance of the risks, or the probability that a given risk might occur. Moreover, the patient lacks the knowledge to make an informed decision about whether a particular product is safe and effective under their specific circumstances. Instead, patients rely on their doctors to use their education and judgment in determining the best (and safest ) course of treatment. The doctor is therefore considered by courts to be a "learned intermediary" between the product manufacturer and the patient.

Next, the obligation is to warn of those risks which are known or reasonably scientifically knowable.4 A manufacturer will not be held liable for the risks which, whether due to the state of medical science or other reasons, no one could have foreseen. Whether a risk is "reasonably" knowable depends on what a reasonable manufacturer would have known about, both from its own research and from reviews of pertinent medical literature.

Finally, the risks must be known or knowable at the time the product is marketed. However, an important caveat to this rule is that, in some instances, a manufacturer can be held liable for failing to provide updated warnings to physicians when additional risks are discovered after the product is marketed.

 
III. APPLICATION IN THE REAL WORLD OF LITIGATION.

So, how does this standard work in real life? In the event of litigation involving the adequacy of warnings, a judge and jury will examine the labeling and the plaintiff's claimed injury and, with the aid of hindsight, assess whether the warning was sufficient, or whether an additional or different warning should have been given. Again, there are a number of facets which should be examined.

1. The Judge.
   Who is the judge? The judge presiding over the lawsuit will be a former lawyer who, in the vast majority of cases, has no medical or scientific training. You may be lucky enough to get a judge who formally practiced in the field of medical malpractice or medical products liability and thus has some understanding of medicine, but frankly this is unlikely.

   In fact, the judge may not have even been a civil litigator in practice, so you may have a judge whose only experience is in criminal law. And whether the judge's background is in civil or criminal law, he or she probably has no experience with the product at issue, or with medical products in general.

   Even worse, the judge probably has a hundred or more cases on his or her docket. This means that the judge will have little time to become familiar with the case. Indeed, much of the day-to-day work of civil trial judges falls to their law clerks, who are either law students or recent law school graduates.

   The judge's role in the case will be to decide legal issues, but not decide factual issues. He or she will be guided only by the evidence and law provided by the parties, and may rely heavily on "expert" witness testimony. Moreover, bear in mind that the judge is viewing the matter in hindsight, with the understanding that the risk at issue has already come to pass in at least one patient - the plaintiff.

2. The Jury.
   An assessment of the jury will likely be even more disheartening, and almost certainly will not be the "jury of your peers" that you may have expected. The jury, composed of between twelve and as few as six people, will more likely than not have no medical education whatsoever. In fact, many people in the jury pool will have minimal formal education - many not beyond high school. In reality, the jurors may be pretty similar to the plaintiff - and very much unlike the physician and manufacturer.

   Moreover, as judges take a more active role in jury selection, the parties have less and less influence over who ultimately sits in the box - and less opportunity to learn about potential jurors through voir dire. Many judges now permit only limited jury questioning by attorneys, and many are reluctant to even have potential jurors complete written questionnaires drafted by the parties.

   This is even more discouraging when one considers the jury's role in litigation. The jurors will evaluate all of the evidence and decide all factual issues - including the ultimate issues of whether the warnings were adequate under the circumstances and, if they decide the warnings were not adequate, whether the failure to warn was the cause of the injury.5 This determination will include the jury's assessment of: whether the warnings adequately described the scope of the risk, whether the style and format of the warnings were such as to adequately alert the physician to the risk, whether they adequately described the risks from misuse, and whether they reasonably communicated the extent or seriousness of harm from misuse.6

3. What is Considered "Labeling"?
   A product's "labeling" is more than just package inserts and other materials that accompany the product. Labeling also includes advertisements in medical journals and in other publications, "Dear Doctor" letters, articles in medical journals, statements made by sales representatives, and testimony by both the prescribing physician and by expert witnesses.7

4. How Juries Determine Whether Labels Are Adequate.
   As mentioned earlier, the jury will evaluate the plaintiff's claimed injuries and the labeling to determine whether the warnings described in the labeling were adequate under the circumstances. It is important to remember that a 'failure to warn" is more than just failing to describe a risk in the labeling entirely. A product label can also be defective if the method or means of providing the warning is insufficient to adequately describe the nature and extent of the risk, or if the label fails to adequately describe methods for determining whether particular patients should not use the product, or if it fails to adequately describe the methods necessary to detect and treat a patient who encounters a known risk.
   1. Method of warning.
      Part of a manufacturer's duty to warn is a duty to provide the warnings in such a way that it will draw the attention of a reasonable medical provider.8 Even if a manufacturer knows of a risk, and describes the risk on the labeling in a manner which is approved by the FDA, it can nonetheless be held liable if a jury finds that the method or manner in which the warning was provided was not adequate under the circumstances. In making this determination, the jury will examine and balance a number of factors, including:
      • The dangerous nature of the product;
      • The form in which the product is used;
      • The form and intensity of the warnings;
      • The burdens associated with providing the warnings;
      • The likelihood that the specific warnings will be adequately conveyed;
        and
      • Alternative forms of providing warnings9

   2. Adequacy of Warnings to Detect Dangers of Use.
      A warning can also be inadequate if, even though it describes a particular risk associated with the product, it gives physicians insufficient information to determine whether the particular patient is experiencing the side effect or other risk.10 This is particularly true if the side effect is one which begins with specific subtle changes which might otherwise be overlooked.

      For example, in one case a manufacturer included in its labeling a warning that blindness could result from the use of a certain drug, and recommended that physicians prescribing the drug provide frequent eye examinations. However, the warnings did not inform physicians that a specific type of eye exam, using specialized equipment and the services of an ophthalmologist, would be necessary to properly detect the early signs of blindness. The manufacturer was found liable for failing to provide physicians with the additional information needed to properly diagnose patients with the early signs of an adverse reaction.

   3. Adequacy of Warnings to Treat Dangers.
      Because of the extensive testing done on products before they are marketed, the manufacturer has often encountered side effects or other product dangers during testing, and usually has the best information on proper treatment of adverse reactions should they occur. A manufacturer can be held liable if its labeling fails to adequately inform the medical profession of proper treatment to reverse adverse reactions and other dangers. This is particularly true if the reaction is one which arises swiftly and puts the patient at great risk, such as certain allergic reactions.

5. Later - Discovered Risks.
   In some instances, after labeling is approved and the product marketed, a manufacturer may learn of additional risks associated with the product, or of increased probability that a previously - known risk will occur, or of risks occurring in a different population of patients. What is a manufacturer's liability for risks discovered after the product is marketed, and what can be done to minimize such liability?

   First, the manufacturer is deemed to be an expert in the specific field encompassing the product, and is therefore obligated to stay abreast of new developments, including new risks, and to inform the medical profession.11 This duty encompasses not only what the manufacturer learns through its own research and from feedback from physicians, but also what it should have learned through a review of pertinent medical and scientific literature. The manufacturer must then take reasonable steps to adequately warn physicians. This latter duty will be measured using the same standards that juries use to judge risks known prior to marketing.

   1. Discovered After Approval but Before Sale.
      Although the manufacturer's responsibility is to warn of those risks which are known or reasonably knowable at the time of sale, in reality a manufacturer will not do well in front of a jury if it learns of a new risk in time to warn physicians but does nothing. In such circumstances, the manufacturer should consider revising its advertisements, sending "Dear Doctor" letters, and instructing its sales representatives to discuss the newly-discovered risks with physicians during sales calls, while at the same time drafting proposed revised labeling. A jury will examine the methods used to communicate the new information, and determine whether the manufacturer used an adequate and effective method for communicating with the medical profession.

   2. Discovered After Sale.
      If the risks are discovered after sale of the product, the analysis is made somewhat more complex. If the product is one which is designed to be used immediately upon sale, the manufacturer will probably not be held liable for failing to timely provide updated warnings.

      However, if the product is one which has a significant shelf life, the manufacturer can be held liable for failing to advise physicians of the new information.12 In one case, a manufacturer of reagents for blood testing learned of a new risk which could result in false test results. Although the manufacturer sent letters to the medical profession, the hospital claimed to have never received the new warnings, and a jury found in favor of the plaintiff against the manufacturer. Imagine if the manufacturer had sent its sales representatives to communicate the new warnings; it probably would have been far more difficult for the hospital to claim to have not received them, as the manufacturer would have had a witness ( the sales representative) to testify to the communication.

6. Causation.
   If the jury determines that the manufacturer should have warned of a particular risk, or should have described the risk differently or warned in a different manner, it will then proceed to determine whether there is a casual connection between the failure to warn and the injury; that is, (1) whether the injury was in fact caused by the product, and (2) whether the manufacturer's failure to provide adequate warnings played a role in the injury.

   The first question will be an issue of science, governed largely by expert testimony. In the second, the prescribing physician's knowledge becomes key: if the physician will testify that he or she did not rely on the printed warnings, or was aware of the risk despite the absence of warnings in the labeling, or would have prescribed the product even if warnings had been provided, the manufacturer may be relieved of liability because the failure to warn is unrelated to the injury -proper warnings would not have changed the outcome.13

 
IV. MINIMIZING YOUR LIABILITY FOR LABELING.

Having seen some of the pitfalls in labeling, what can your company do to minimize the risk of liability? The most important thing to do is have liability risks in mind at the time labels are prepared. Ideally, product labeling should be a marriage of sound science, effective marketing, and risk management. Be careful not to let the marketing department drive the contents of labeling, and be sure that sales representatives are properly trained so that they do not dilute the effectiveness of the labeling.

Include your legal department or outside legal counsel in the preparation of labeling. While lawyers certainly cannot make scientific decisions about what risks should be included in the warnings, lawyers can identify the liability risks of proposed labeling and provide guidance as to the phrasing of labels. And when in doubt, include a warning of a particular risk in your labeling submission to the FDA. The FDA may well respond by asking that some warnings be removed from the labeling - which is a great protection against liability.

Steps can be taken from the scientific end as well. Use your company's tracking system to monitor adverse events described in clinical trials and other product testing, in the medical and scientific literature, and in post-approval marketing experience. If other competitors manufacture a substantially similar product, monitor FDA submissions to determine whether the competitor's product is suffering adverse events and whether such events may be applicable to your product as well. Make sure that your marketing department has a procedure for sales representatives to inform the company of adverse events or other problems described by doctors. Review the tracking data periodically and assess whether to propose revised package inserts to the FDA, or whether to send "Dear Doctor" letters or change the product advertising.

 
V. CONCLUSION.

Civil liability associated with alleged inadequacies in product labeling is a growing problem among manufacturers of biologics and other medical products, and a problem which cannot be eliminated simply by following the FDA's regulations. However, by understanding the civil liability standards regarding product labeling, and by carefully considering those standards in designing new labels and reviewing existing labeling, you can minimize the extent of your liability.

1 Carlin v. Superior Court, 13 Cal.4th 1104, 1115 (Cal. 1996); Feldman v.Lederle Laboratories, 132 N.J. 339, 347; 625 A.2d 1066 (N.J. 1992); Chambers v. G.D. Searle & Co. , 441 F. Supp.377, 383 (D.Md. 1975).

2 Carlin, 13 Cal.4th at 1114-15.

3 Carlin, 13 Cal.4th at 1116; Wagner v. Roche 77 Ohio St. 3d 116, 120, 671 N.E. 2d 252 (1996); Garside v. Osco Drug 976 F.2d 77. 80 (1st Cir. 1992); Mowrey v. Crittenton Hospital, 155 Mich. App. 711, 717, 400 N.W.2d 633 (1986); Stevens v. Parke, Davis & Co, 9 Cal.3d 51, 65, 107 Cal.Rptr. 45, 507 P.2d 653 (Cal. 1973); Krug v. Sterling Drug, Inc. 416 S.W.2d 143, 146 (1967).

4 Anderson v. Owens-Corning Fiberglas Corp. , 53 Cal.3d 987, 1000, 281 Cal Rptr. 528, 810 P.2d 549 (Cal. 1991); Butler v. PPG, 201 N.J. 558, 563, 493 A.2d 619 (1985); Advance Chemical Co. v. Harter, 478 So. 2d 444, 447 (Fla.App. Div.1) (1985); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548, 180 Ind.App. 33 (1979).

5 Smith v. E.R.Squibb & Sons, 405 Mich. 79, 273 N.W.2d 476 (1979).

6 Richards v. Upjohn Co. , 95 N.M. 675, 625 P.2d 1192 (N.M.Ct. App. 1980.)

7 Kordel v. United States, 335 U.S. 345, 349, 93 L.Ed. 53 (1948); U.S. Vital Health Products, Ltd. , 786 F. Supp. 761, 775 (E.D.Wis. 1992); 21 U.S.C. §321(m).

8 Bristol-Myers v. Gonzales, 548 S.W.2d 416 (Tex. Civ. App. 1977), rev'd on other grounds 561 S.W.2d 801 (Tex. 1978).

9 Dougherty v. Hooker Chemical Corp. , 540 F.2d 174 (3d Cir. 1976); Stanley Industries, Inc. v. W.M. Barr & Co., Inc. , 784 F. Supp. 1570, 1575 (S.D.Fla. 1992).

10 Singer v. Sterling Drug, Inc. , 461 F.2d 288 (7th Cir. 1972).

11 Wooderson v. Ortho, 235 Kan. 387, 400, 681 P.2d. 1038 (1984); McEwen v. Ortho Pharmaceutical Corp. , 270 Ore. 375, 386, 528 P.2d 522 (Ore. 1974); O'Hare v. Merck & Company 381 F.2d 286, 291 (8th Cir. 1967).

12 Kincl v. Hycel, Inc. , 56 Ill. App.3d 772, 372 N.E.2d 385 (Ill. App. 1977).

13 Plummer v. Lederle Laboratories, 819 F.2d 349, 358 (2nd Cir. 1987); Formella v. Geigy 100 Mich. App. 649, 653-57, 300 N.W.2d 356 (1980); Mulder v. Parke, Davis & Co. , 288 Minn 332, 181 N.W.2d 882 (Minn. 1970); Douglas v. Bussabarger, 73 Wash. 2d 476, 477-78, 438 P.2d 829 (Wash. 1968).